BioSpectrum Asia November 2022

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4 BIO EDIT

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Dr Milind Kokje TAINTED AND TOXIC

Chief Editor Cough syrups have suddenly become a point of concern following the death of some
children and sickness possibly linked to the syrups. Indonesia has suspended sale
[email protected] of all syrups and liquid medicines following the deaths of 133 young children in its
22 provinces in two months due to acute kidney injuries (AKI). Over 240 cases of AKI,
mostly in children under five years, have been reported. Indonesian health authorities
have found some syrup medicines containing ingredients linked to AKI.

Indonesia seems to have been alerted following similar deaths of children in Gambia.
After 66 children died in Gambia last month, the World Health Organisation (WHO)
issued a global alert over possible links between the deaths and four cough syrups
produced and exported by an Indian pharma company. In July, when AKI in children
under five soared, the Gambian authorities suspended use of all paracetamol syrups.

Though the Indian cough syrups are possibly responsible for the deaths in Gambia,
in case of Indonesia the syrups are locally produced. Following the Gambia incident,
the Indonesian authorities examined the locally produced syrups in their markets and
found AKI causing ingredients. Australia has sent vials of a rare antidote to Indonesia to
treat chemical poisoning.

Until this article was written, there was no confirmed link between the Gambian
and Indonesian deaths as the investigation is on. Still, the issue of substandard cough
syrups is serious. In the case of Gambia, if Indian syrups are really responsible for
children’s death it may create a dent into the $42 billion worth Indian pharma sector’s
reputation as a supplier of quality medicines. It is more so when the country has earned
the ‘Pharmacy of the World’ moniker.

The four ‘tainted’ Indian cough and cold syrups - Promethazine Oral Solution,
Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup –
are produced by Sonepat, Haryana-based Maiden Pharmaceuticals. Indonesian syrups
are however locally produced.

Following analysis, two toxic ingredients, Diethylene Glycol (DEG) and Ethylene
Glycol (EG), present in the four syrups are purportedly responsible for the children’s
death. They lead to kidney and neurological toxicity. Their toxic effects include abdominal
pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and
acute kidney injury. Unacceptable amounts of both the chemicals were found in all the
four syrups. In Indonesia too, some of the syrups contained EG and DEG. Tests of 26
locally produced medicines showed that five of them contained excessive levels of EG.

In the case of Gambia, Maiden pharmaceuticals failed to provide guarantee about the
safety of the medicines, WHO has claimed. WHO is conducting its investigation as out
of 23 samples tested by it EG was found in four samples. Following WHO’s alert about
potential harmful effects of the medicines, the Drug Controller General of India (DCGI)
has swung into action and launched an investigation along with the Haryana regulatory
authority. It has appointed an expert committee to investigate the matter.

Inspection of the manufacturing facility by the drug regulator has led to detection of
12 violations. The company has also been given a notice for not performing the quality
test of raw materials used in the syrups. However, the drug authorities had also pointed
out that WHO was unable to provide an exact “one to one causal relation between the
deaths and medicines.” Details of labels and products have also not been shared by the
WHO to India’s Central Drug Standards Control Organisation (CDSCO). The experts’
committee has found at its first meeting that clinical features and treatment received by
the children in Gambia as shared by WHO so far was inadequate to determine etiology.

At the time of writing this piece, reports of the tests by the Indian drug regulator
were still awaited. But an inspection of the manufacturing facility has led to detection
of 12 violations and the production of the syrups has been stopped. If India’s reputation
as an exporter of excellent quality drugs has to be maintained, such deadly oversight by
manufacturers and regulators must not be repeated.

BIO MAIL 5

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Acknowledgements/ Feedback Thank you BioSpectrum Asia for the
feature ‘Why Life Sciences sector in
Great job on the cover feature on soaring in China’ in the October edition.
sleep story in the October edition.
ProSomnus was more than happy to - Katrina Chui, Hong Kong
participate. Thank you.
The interview with Frontier
- Sean Leous, US Biotechnologies went well and we are
glad to be able to have this opportunity
The interview format with MGI looks to present the work that Frontier does to
really good. Thank you BioSpectrum your readers. Thank you BioSpectrum
Asia for your interest in MGI’s Asia for your help and we really look
involvement in Indonesia’s National forward to working with you again!
Genome Project in Indonesia. We are
happy to have the opportunity. - Timothy Cheok, China

- Wenhui Liu, China

Vol 17; Issue 11; November 2022 MM Activ Singapore Pte. Ltd. Taiwan
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6 BIO CONTENT

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

COVER STORY 18

There are over 235 million diabetic patients in Asia.
China and India account for almost half of the

world’s diabetic population. By 2030, without
intervention, both China and India combined
will have nearly half a billion diabetics. These
are grim figures but for pharma firms, they
represent a huge opportunity, and big
pharma firms are spending billions
in search of the next blockbuster

drug for diabetes, according to
the estimates from Singapore-
based Asian Diabetes Prevention
Initiative (ADPI). The diabetes care
drugs market is highly fragmented
in Asia Pacific (APAC) region with
a few major manufacturers gaining
presence in major countries of the
APAC market, while the remaining
market comprises other local or
region-specific manufacturers. Mergers and acquisitions
that happened between players in the recent past helped
companies strengthen their market presence, as well
as drive innovations, helping the diabetes drugs market
to increase in the APAC region. Let’s look at who owns
the more significant piece of the pie and the competitive

landscape of diabetes treatment in the region.

Invincible Diabetes
Turns APAC Into
Pharma Goldmine

20 22 25

“The most intriguing aspect of Investing in diabetes Diabetic Nephropathy
diabetes care is the relentless education today to Treatment Modalities
pursuit of orally active insulin” protect tomorrow
and Market

Dr Mahesh Bhalgat, Prof. Andrew Boulton, Poornachandra Tejasvi K,
Chief Operating Officer, President, Senior Director,
Syngene International
International Diabetes Federation (IDF) Emerging Markets - India, Citeline

BIO CONTENT 7

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Who Needs Next Gen Vax Tech? Digizine

IMPLANTS SMART MANUFACTURING

32 42

Intelligent Implants Take Centre-stage Building Resilience in
Pharmaceutical and
SPEAKING WITH Biologic Manufacturing

34 Marcelo Tarkieltaub,
Regional Director,
“We are seeing a shift towards Southeast Asia, Rockwell Automation
localisation of supply chains –
from innovation to REGULARS
manufacturing and production”
BioEdit.........................................................................04
Francis Van Parys, BioMail........................................................................05
Vice President (Commercial) APAC, Cytiva Policy and Regulatory News...................................08
Company News........................................................10
36 Finance News............................................................12
Start-Up News...........................................................13
“We are eyeing the region’s World News...............................................................15
lucrative markets of China and WHO News.................................................................17
India by early next year” People News..............................................................44
R&D News..................................................................46
Chris Lee, Supplier News...........................................................48
Founder & CEO, VentureBlick Lets Talk Health........................................................50

38

“Accelerated ageing is
associated with reduced
diversification of the gut
microbiome that further
increases the risk of
developing disease”

Associate Professor Sunny Wong,
Programme Director, the Centre for Microbiome Medicine,
Lee Kong Chian School of Medicine

BIOSPECTRUM AWARDS

47

BioSpectrum Asia sets the tone for Excellence
Awards 2022 on December 2 in Singapore

8 REGULATORY NEWS

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

India unveils Tele Mental Health
Assistance and Networking Across States

Establishing a new milestone programme includes a network of Technology-Bangalore (IIIT-B)
in the field of mental health on 23 tele-mental health centres of providing technology support.
the occasion of World Mental excellence, with National Institute Tele-MANAS will be organised in
Health Day on October 10, of Mental Health and Neuro two tier systems; Tier 1 comprises
Tele Mental Health Assistance Sciences (NIMHANS) being the state Tele-MANAS cells which
and Networking Across States nodal centre and International include trained counsellors
(Tele-MANAS), an initiative of Institute of Information and mental health specialists.
the Union Ministry of Health & Tier 2 will comprise specialists
Family Welfare, Government of at District Mental Health
India, has been launched in the Programme (DMHP)/Medical
country. Tele-MANAS aims to College resources for physical
provide free tele-mental health consultation and/or e-Sanjeevani
services all over the country for audio visual consultation.
round the clock, particularly Presently there are 5 regional
catering to people in remote coordination centres along with
or under-served areas. The 51 State/UT Tele MANAS cells.

Australia pledges Singapore to
$25M for dementia, ageing
and aged care research incorporate

The Australian government has announced $25 million Health Information
for dementia, ageing and aged care research. A total of 18
grants, provided through the Medical Research Future Bill next year
Fund, will go to Australia’s best and brightest researchers.
The projects will view a range of ways to improve The Health Information Act will be
support for older Australians. These include developing introduced next year, Dr Janil Puthucheary,
Senior Minister of State for the Ministry
an app for older people to of Communications and Information and
recognise early signs of Health, said at a conference organised by
dementia; and increasing the Duke-NUS Medical School Centre of
dementia diagnosis and Regulatory Excellence. He revealed that
early treatments through the Ministry of Health (MoH) has started
primary care and awareness discussions with stakeholders on key policies
programmes. Researchers in the Bill. The government is introducing the
will look at reducing Health Information Bill in 2023 to support
the risk of dementia, care continuity by facilitating proactive data
cardiovascular disease sharing between healthcare providers. MoH is
and falls through healthy already in the midst of engaging stakeholders
lifestyle and diet changes, on key policies under the Bill. The government
including a specific exercise and falls prevention intends to seek further feedback from the
programme for older culturally and linguistically public later this year. The views shared during
diverse Australians. Researchers will also trial the use these consultations will help to refine key
of metformin medication to treat blocked leg arteries; policies and regulatory processes under the
and use informatics to improve medication management Bill. The MoH has presented a White Paper
in nursing homes. These research projects have the on Healthier SG strategy in Parliament. In
potential to provide real, on-the-ground, benefits to older the paper, increased focus on preventive
Australians, and usher in a new era of aged care. health has been outlined, with an emphasis
on empowering individuals to choose health
for themselves.

REGULATORY NEWS 9

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

New Zealand’s Health Taiwan and Japan hold
deliberations on medical
Ministry unveils products regulation

annual report 2021-22 Taiwan Food and Drug Administration (TFDA) with
Japan’s Ministry of Health, Labour, and Welfare (MHLW)
The Ministry of Health in New Zealand has and Pharmaceuticals and Medical Devices Agency (PMDA)
outlined major results of the organisation’s hosted the 10th Joint Conference of Taiwan and Japan on
latest annual report. Highlights in the Medical Products Regulation on October 20, 2022. The
Ministry’s 2021/22 Annual report include “Framework of the Cooperation on the Medical Products
more than 1.4 million influenza vaccines Regulation” was signed by Taiwan-Japan Relations
were distributed and the equity gap for Association and Japan-Taiwan Exchange Association in
Māori aged over 65 was reduced to 4.4 per November 2013, with both sides hosting the Annual Joint
cent from 8.4 per cent in the previous year. Conference in alternative turns for ten years. This year, the
The National Bowel Screening programme representatives from TFDA, MHLW and PMDA shared
completed its nationwide rollout and the latest information on medical products regulations,
provided free screening to 835,000 New as well as other important topics such as digital tools for
Zealanders aged between 60 and 74. Since clinical trials, measures in response to COVID-19, updates
its inception in July 2017 to the end of of medical devices regulation.
June 2022 the programme has distributed
1 million test kits, identified 1,422 cancers
and removed thousands of pre-cancerous
polyps. Funding 166 cochlear implants,
nearly double the 86 funded the previous
year, significantly improving the quality of
life for individuals with a severe hearing
loss or profound deafness. These highlights,
and much more of the work delivered by
health and disability services, were carried
out at the same time as the country was also
responding to the COVID-19 pandemic.

Japan approves Medtronic’s
robotic-assisted surgery system

The Ministry of Health, Labour, robotic surgery. It encompasses of minimally invasive surgery,
and Welfare (MHLW) has given several different surgical robotic-assisted procedures offer
its approval for Medtronic’s specialties including hernia patients fewer complications,
urologic surgical and gynaecologic repair, the fourth most common shorter hospital stays, and faster
laparoscopic indications in surgery performed globally. Japan return to normal activities. The
Japan. Together, general surgery, is the third-largest RAS market Hugo RAS system, combined with
urology, and gynaecology account in the world today. As a form Touch Surgery Enterprise, offers
for more than
80 per cent of all a smart, digitally
robotic-assisted enabled surgical
surgery (RAS) experience, and is
procedures already being used
performed in general surgery
globally. General procedures at
surgery is the hospitals in the
fastest growing Asia Pacific and
segment within Latin America
regions.

10 COMPANY NEWS

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Telix Pharma adds new PET imaging
radiotracers to GE Healthcare’s portfolio

Australia-based to provide key information about sales of Telix’s imaging
Telix Pharmaceutical the metabolic environment of agents to pharmaceutical
has announced tumours, which could help to companies, with the close
a collaborative inform and improve therapy support of Telix, whilst
development and reseller selection. Under the agreement, Telix will be responsible
agreement with GE GE Healthcare will be responsible for manufacturing and
Healthcare to supply for the direct marketing and ongoing development
its investigational of each product. Telix
positron emission and GE Healthcare
tomography (PET) will explore validation
imaging radiotracers, TLX250- of [18F]-FLac for use in GE
CDx (89Zr-DFO-girentuximab), Healthcare’s FASTlab, an
and [18F]-FLac (18F-3-fluoro- automated PET radiochemistry
2-hydroxypropionate) for use in synthesiser, widely used for onsite
third party clinical research and production of FDG6 and other
development activities. These PET tracers. The agreement has
novel tracers offer the potential an initial term of five years.

Biocon out-licences Baxter opens global
2 biosimilar assets for
commercialisation in Japan pharmaceuticals

Indian firm Biocon Biologics has entered into a strategic R&D centre in India
out-licensing agreement with Japanese pharmaceuticals
company Yoshindo Inc. for commercialising two of Baxter Pharmaceuticals India has announced
its pipeline biosimilar assets, bUstekinumab and the inauguration of a global Pharmaceuticals
bDenosumab, in the Japanese market. Under the terms R&D Centre in Ahmedabad. The centre will
of this deal, Yoshindo gets exclusive commercialisation help further the company’s mission of saving
rights in Japan for bUstekinumab and bDenosumab and sustaining lives by accelerating innovation
in the generic and differentiated injectable
developed and manufactured pharmaceuticals space. The 20,500-square-
by Biocon Biologics, for an foot, state-of-the-art R&D centre features an
addressable market opportunity array of sophisticated equipment and research
of ~$700 million. Biocon labs that will focus on pharmaceutical product
Biologics will receive an development and capabilities in therapeutic
upfront licence fee as well areas such as critical care, analgesic, renal,
as additional payments on cardiovascular anaesthesia, anti-infective
the achievement of certain and antipyretic. It will support Baxter’s
development milestones over global manufacturing facilities, including
the next few years. The financial those in Ahmedabad, Germany, Ireland,
terms of the agreement are Italy, and the United States, among others.
confidential. Ustekinumab, This Pharmaceuticals R&D Centre is part
a biosimilar referencing Stelara, is a monoclonal of Baxter’s network of more than 25 global
antibody used to treat several autoimmune conditions, R&D centres, including 4 in the Asia Pacific
including psoriasis, Crohn’s disease, ulcerative colitis, (APAC) region. The existing team of scientists,
plaque psoriasis and psoriatic arthritis. Denosumab, a pharmacists, microbiologists, and analysts at
biosimilar referencing Prolia, is a monoclonal antibody the Pharmaceuticals R&D Centre have already
for the treatment of osteoporosis. contributed to the launch of several Baxter
products globally.

COMPANY NEWS 11

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Galderma to expand Fujitsu Asia and A*STAR to
advance AI-based healthcare
manufacturing & medical technologies

and innovation Singapore based Fujitsu Asia Private Limited (FAPL)
and the Agency for Science, Technology and Research
footprint in APAC (A*STAR) have signed a master research collaboration
agreement for joint projects to accelerate the R&D of
Reaffirming its bold ambition to become the artificial intelligence (AI) and converging technology
leading dermatology company in the world, solutions around healthcare and medical applications.
Swiss pharmaceutical company Galderma Fujitsu and A*STAR will leverage their respective
has announced its intention to expand its strengths to translate innovative ideas by developing
manufacturing and innovation footprint in commercial solutions for the Asia Pacific (APAC)
the Asia-Pacific region, with support from region, by resolving challenges in manufacturing and
the Singapore Economic Development Board. commercialisation. Further, Fujitsu is in a long term
Galderma intends to explore opportunities partnership with A*STAR to explore technologies in
to build a fifth manufacturing plant with a relation to sustainable manufacturing and supply chain
high degree of digitisation and automation resilience. Under the new master research collaboration
in Singapore in response to growing agreement, Fujitsu will be able to enter research and
consumer demand and to support long- development collaborations with A*STAR research
term sustainable growth over the coming entities for a period of three years. The new research
years. The announcement comes as part of projects agreement will facilitate to nurture Singapore’s
Galderma’s strategic manufacturing roadmap, talent pool in advanced medical technology through
aligned with the company’s unique Integrated Master Research Collaboration Projects.
Dermatology Strategy. Following a record 2021
performance, Galderma has demonstrated
strong commercial and financial performance
in the first half of 2022, with continued
strong growth across product categories. In
particular, dermo-cosmetics has grown by 31
per cent year‑on‑year on a constant currency
basis, fueled by the strong performance of
Cetaphil driven by e‑commerce and launches
in China and the rest of Asia.

Samsung Biologics unlocks additional
capacity for production at newest Plant 4

Samsung Biologics, South Korea- it becomes fully completed development and manufacturing
based contract development in the first half of next year. capability in response to growing
and manufacturing organisation Plant 4 is expected to help biopharmaceutical demand. Upon
(CDMO), has announced that its Samsung Biologics maximise the full completion of Plant 4,
Plant 4, the world’s largest single operational efficiency in addition Samsung Biologics will boast a
bio manufacturing plant, has to further enhancing its scale up total capacity of 604,000 litres at
commenced GMP operations in Bio Campus I, the world’s largest
October 2022. Plant 4’s partial bio manufacturing site, and
operations comes just 23 months account for nearly 30 per cent of
after construction began in the global CDMO manufacturing
November 2020, adding fresh capacity. Samsung Biologics has
production capacity of 60,000 already sealed a number of large-
litres. Plant 4 will have a total scale manufacturing contracts
capacity of 240,000 litres when with presales activities for Plant 4.

12 FINANCE NEWS BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Simcere, Rx Propellant plans Rs 3k
Almirall ink Cr investment to build life
$492 M deal sciences lab spaces in India
for treating
autoimmune Rx Propellant, an Actis portfolio company and India’s leading life sciences
diseases infrastructure and cluster developers, has announced the launch of 9
lakh sq ft of lab spaces in Genome Valley, Hyderabad, India. With a major
Simcere Pharmaceutical footprint in Genome Valley, Rx Propellant has already developed 5 lakh
Group, an innovation and sq ft of lab space, most of which are operational with marquee names in
R&D-driven pharmaceutical life sciences. In total, the current planned development of Rx Propellent
company, and Almirall S.A, at Genome Valley constitutes 7 independent projects namely, Innopolis,
a global biopharmaceutical Genopolis, Touchstone, ARX, Nextopolis, GV1 and B-hub, spread across
company focused on skin 17 lakh sq ft. One of the key projects, B-hub, is a biopharma accelerator
health; have entered into an being built in collaboration with the Government of Telangana to boost
exclusive licensing agreement the research ecosystem in Genome Valley. Spread across 2 acres, the
for Simcere’s IL-2 mutant 1.6 lakh sq ft, B-hub features a fully functional biopharma scale-up
fusion protein (IL-2 mu-Fc) manufacturing facility along with a GLP grade turnkey incubator of
autoimmune drug candidate, 40,000 sq ft. The company has invested Rs 900 crore in development
SIM0278. SIM0278 is an of current life sciences infrastructure and is committed to invest an
interleukin 2 mutant fusion additional Rs 2000 crore to build a cumulative portfolio over 100 lakh
protein (IL-2 mu-Fc) that sq ft of lab space over the next 5 years across Hyderabad and other major
selectively activates regulatory life sciences hubs of India.
T cells. As an IND ready
subcutaneous injection, it can MSD injects $500M over
be developed to potentially 5 years into new manufacturing
treat various autoimmune facilities in Singapore
diseases. Under the agreement,
Almirall will be granted an MSD has announced the opening of a new secondary packaging facility
exclusive right to develop and to support the production of vaccines and biologics, including the
commercialise SIM0278 for company’s cancer immunotherapy products. MSD also broke ground
all indications outside of the for a new inhaler production facility for the manufacture of new
Greater China region (Mainland generation inhaler medicines in Singapore. The new manufacturing
China, Hong Kong, Macau facilities are key components of the company’s up to $500 million
and Taiwan). Simcere will investment over five years that started in 2020. This is in addition to the
retain all rights to develop and $2 billion invested since the start of MSD’s manufacturing operations
commercialise SIM0278 within in Singapore in 1997. The investment is estimated to create over
Greater China. 100 new jobs over the next few years to support the new facility and
multi-year investment plan, with many positions requiring advanced
manufacturing and digital skills. This would bring the company’s total
employees in Singapore to more than 1,800 over the next few years.

START-UP NEWS 13

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Gene delivery startup Deep Bio explores
AI support for prostate
VectorBuilder cancer diagnosis

secures CNY410 M South Korea-based startup Deep Bio Inc. has announced
that it will sign trial purchase agreements with five Korean
in Series C round hospitals for its artificial intelligence (AI)-based prostate
cancer diagnosis support software, DeepDx-Prostate Pro,
VectorBuilder Biotechnology (Guangzhou) through the Public Procurement Marketplace programme
Co., a top gene delivery startup based in run by the Korean Public Procurement Service (PPS). The
China, has announced the completion of software was designated as an ‘Innovative Product’. To
its Series C round with CNY410 million, successfully complete the integration of DeepDx-Prostate
co-led by Legend Capital. The proceeds will Pro into the pathology workflows by this November, the
facilitate VectorBuilder in continuously hospitals participating in the trial purchase - the SMG-SNU
promoting the upgrading and capacity Boramae Medical Center, Chungnam National University
expansion of the gene delivery R&D and Sejong Hospital, Korea Institute of Radiological & Medical
production technology platform, further Sciences, Jeju National University Hospital, and Gyeongsang
accelerate the global business presence, and National University Changwon Hospital – and Deep Bio
boost the R&D of life sciences and genetic are progressing through required procedures and making
medicines. VectorBuilder has provided arrangements. The AI will be used for various purposes,
more than 1.2 million gene delivery including support for pathologists in tumour severity
solutions to more than 4,000 scientific determination, confirmation of diagnoses, and research.
research institutes and pharmaceutical DeepDx-Prostate Pro is a deep learning-based medical
companies worldwide, and its gene-drug software that assists the histopathological diagnosis of
CRO and CDMO projects are spread all prostate cancer by analysing the Whole Slide Image (WSI)
over North America, Europe, Japan and of the prostate needle biopsies. It automatically classifies the
South Korea. The startup jointly launched severity of prostate cancer, which empowers pathologists to
the construction of a 45,000-square- make diagnostic decisions with increased accuracy & speed.
meter gene delivery R&D and production
base with Guangzhou Development
District Investment Group in April 2022.
The company provides services such as
scientific research and clinical carrier CRO,
gene-drug CDMO and gene delivery IP out-
licensing, covering the entire field of life
science and gene medicine.

Pfizer acquires Australian startup ResApp Health for $179 M

US-based Pfizer has acquired records a patient’s cough on a of chronic and acute diseases.
University of Queensland (UQ) smartphone and analyses sounds They include asthma, pneumonia,
startup ResApp Health Limited and simple symptoms, such as bronchiolitis, croup and chronic
for $179 million. ResApp, an a runny nose, to diagnose and obstructive pulmonary disease.
ASX-listed company based in measure the severity of a range ResApp recently announced
Brisbane, has developed simple positive results for its COVID-19
and inexpensive smartphone screening test. Clinical trials are
technology that can accurately continuing and the company said
identify respiratory diseases if successful the technology could
based on cough analysis. UQ’s potentially reduce the number
commercialisation company of PCR and rapid antigen tests
UniQuest licensed the UQ used worldwide. ResAppDx is CE
technology to ResApp in Marked in the European Union
September 2014. The technology and TGA approved in Australia.

14 START-UP NEWS BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Taiwan’s Yapan Bio adds new process
Micronbrane development facility in India
Medical raises
$4.5M Piramal Pharma has announced that Yapan Bio has expanded its
capabilities with a new process development facility at Genome Valley,
Micronbrane Medical Hyderabad in India. Piramal Pharma holds a strategic minority
has raised $4.5 million of stake in Yapan and markets its services through Piramal Pharma
investment in A round led by
CDIB Capital International Solutions (PPS), an industry-
which operates on multiple leading, patient-centric Contract
markets in Asia and North Development and Manufacturing
America and has $1.2 Organisation (CDMO) serving the
billion in total asset under global pharmaceutical and biotech
management. Micronbrane market. With this expansion, Yapan
Medical, established in has enhanced its ability to support
February 2020, is the first end-to-end development and
company in Taiwan focusing manufacturing of RNA, DNA and
on clinical pathogen diagnostic gene therapy products starting from
test using next generation plasmids. The expansion includes
sequencing (NGS) and its own three upstream suites (including
host depletion technologies Bio-Safety Level-2 containment),
with global patent. The startup a downstream process development lab, an analytical development
has already launched two lab, and supporting infrastructure. The new labs will allow Yapan to
commercial products which optimise the utilisation of the GMP facility to support manufacturing of
include Devin filter for fast clinical trial material for the clients.
and efficient depletion of host
DNA interference from whole NousQ receives $175K
blood of patients and Kit for grand prize for paediatric
microbial DNA extraction. ear tube insertion device
With these products, the
company expects to reduce MedTech Innovator, the largest accelerator of medical devices in the
the cost of sequencing up to world, in partnership with Asia Pacific Medical Technology Association
75 per cent which will make (APACMed), the first and only regional association to provide a
sequencing test in diagnostics unified voice for the medical technology industry, has announced
of infectious diseases much NousQ as the winner of the 2022 Asia Pacific Accelerator programme.
more affordable for patients. NousQ is a Singapore-based startup that
Micronbrane Medical is now has developed CLiKX, a novel handheld
working with two medical robotic ventilation tube applicator that
centres in Taiwan on clinical offers paediatric patients with otitis
testing of PaRTI-Seq (Pathogen media a simple and quick alternative
Real-Time Identification by to invasive ventilation tube surgery.
Sequencing) which includes a Selected from a pool of more than
full range of consumables and 250 applicants, NousQ was awarded
reagents required for end-user the $175,000 non-dilutive grand
clinical diagnostic tests. Within prize to advance its business goals
the next two years the company and mission to improve future health
plans to use funding to hold outcomes of patients in the Asia Pacific
the same clinical studies with region. The company was also awarded a one-year membership to
several partners in the US and APACMed and was the recipient of the Cambridge Consultants Product
enter markets of the US and Development Award, where they will receive exclusive technical and
Europe with its products. consultation services from Cambridge Consultants.

WORLD NEWS 15

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

US provides funds to potentially
transformative biomedical research projects

The High-Risk, High-Reward using the female songbird as a Americans across the United
Research programme, supported model; tissue regeneration using States; and a new model organism
by the Common Fund at the the uterus as a model; a mixed to lead in the development of
National Institutes of Health methods examination of skin an HIV vaccine. The 103 awards
(NIH) in the US has awarded 103 tone and health among African total approximately $285 million
new research grants to support in support from the institutes,
highly innovative scientists centres, and offices across NIH
who propose visionary and over five years beginning in 2022,
broadly impactful meritorious pending the availability of funds.
behavioural and biomedical The High-Risk, High-Reward
research projects. Awards Research programme supports
include the impact exposure to investigators at each career stage
fracking might have on pregnancy who propose innovative research
and conception; how brain that, due to their inherent risk,
mechanisms influence memory may struggle in the traditional
performance; the neural basis NIH peer-review process despite
of social bias and association their transformative potential.

Gavi inks agreement with IVI announces
Moderna for COVID-19
vaccine supply to LICs vaccine partnership

Gavi, the Vaccine Alliance, has signed an agreement with with LSHTM
Moderna related to the supply of COVID-19 vaccines to
lower-income countries (LICs) supported by the Gavi COVAX South Korea-based International
Advance Market Commitment (AMC). Under the agreement, Vaccine Institute (IVI) and the
Gavi and Moderna agree to cancel remaining volumes under London School of Hygiene & Tropical
their previous agreement in 2022, and establish a framework Medicine (LSHTM) have signed a
for LICs to access doses of variant-containing vaccine (VCV) Memorandum of Understanding
beginning in 2023. Gavi will have the (MoU) to establish a collaborative
right to access up to 100 million VCV partnership. Joint activities will
doses, at Moderna’s lowest tiered include developing materials to train
price, on behalf of AMC participants. early-career vaccinologists as well
In the two years since the first as collaborating across the entire
COVID-19 vaccine received WHO spectrum of vaccine development.
emergency approval in December LSHTM alumni represent a
2020, COVAX has delivered 1.8 number of IVI epidemiologists,
billion doses to 146 countries around clinicians, and biostatisticians.
the world – the largest and fastest Both parties would strengthen this
public health rollout in history. This collaboration across every stage of
includes nearly 186 million doses vaccine evaluation. This includes
of the Moderna vaccine, through basic science, preclinical studies
both the advance purchase agreement with Moderna and and clinical trials, effectiveness
dose donations. This effort has enabled 92 LICs to protect, on and implementation studies,
average, more than 50 per cent of their populations with two epidemiology, modelling, and
doses of COVID-19 vaccine – and protect the majority of those economic evaluation to generate
at highest risk such as health care workers and the elderly. evidence for policy and facilitate
introduction, uptake, and sustainable
impact on vaccine equity.

16 WORLD NEWS

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Strengthening Lassa fever alert
sounded in Africa
mortality
Climate change and other environmental factors could
surveillance in Africa cause Lassa fever to spread to additional regions within
Africa, new research predicts. Norway-based Coalition for
The Republic of Zambia in collaboration Epidemic Preparedness Innovations (CEPI) is the leading
with the Africa Centres for Disease Control funder of research into vaccines against the potentially
and Prevention (Africa CDC) and the Africa deadly virus. Up to 600 million people could be at risk
Union (AU) Commission recently hosted of developing the potentially deadly Lassa fever in the
a High-level Expert Panel to launch the future as a result of climate change and other factors,
Continental Framework for Strengthening a new study conducted by scientific experts at Scripp
Mortality Surveillance (CFSMS) in Africa. Research and the University of Brussels has found. After
This Framework document was developed analysing environmental data looking at factors like
through a series of consultations since temperature, rainfall, and presence of pasturelands, the
2019, through which several feedbacks and study has warned that the virus could extend its reach
inputs were received from all stakeholders, from West Africa (where it causes regular outbreaks) to
including Member States and partners, also become a public health problem in other regions in
leading to its launch on September 29, 2022, Africa. Calculations on the number of people at risk also
in Lusaka, Zambia. The CFSMS draws on the accounted for expected population growth in Africa over
lessons learnt from the COVID-19 pandemic the next 50 years. First identified in two nurses in the
and other previous public health emergencies town of Lassa, in remote Nigeria, in 1969, Lassa fever is a
to provide guidance for AU member states haemorrhagic disease, caused by a virus of the same name.
on how to leverage existing information It is typically carried and spread by a species of infected
systems to build their national repositories rodent known as the Natal Multimammate rat.
for mortality data in order to strengthen vital
statistics, including births and deaths and
use the resulting information to better secure
the population’s health. The pandemic has
led to significant loss of lives and livelihoods
in Africa, and despite the over 12 million
cases and over 250,000 deaths documented,
the true burden of the pandemic on health
systems still remains unknown.

Sierra Leone adds HPV jabs to routine immunisation schedule

In a move to protect adolescent from Gavi, the Vaccine Alliance schools, targeting 153,991 10-year-
girls from cervical cancer, the (Gavi), the United Nations old girls, who will each receive two
government of Sierra Leone, Children’s Fund (UNICEF) and doses over a six-month period.
in West Africa, has introduced World Health Organisation Despite the HPV vaccine providing
the Human Papilloma Virus (WHO), will administer HPV a proven and safe tool to protect
(HPV) vaccine to the routine vaccines nationwide through women and girls against HPV and
immunisation schedule and the risk of cervical cancer, global
launched the start of a campaign coverage rates among 15-year-old
to reach 153,991 girls with the girls remain low at 15 per cent
vaccine. The introduction of with two doses on average. Latest
HPV vaccine is one of the key global immunisation coverage
strategies that the government data shows that just 12 per cent
is implementing toward cervical of girls globally are receiving the
cancer elimination in the country. crucial vaccine with immunisation
The Ministry of Health and campaigns particularly disrupted
Sanitation (MoHS), with support by lockdowns and school closures.

WHO NEWS 17

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com WHO issues

IANPHI, WHO to enhance new framework
public health functions and
health emergency preparedness to strengthen

The World Health Organisation (WHO) and the International collaborative
Association of National Public Health Institutes (IANPHI) have signed
a Memorandum of Understanding (MoU) outlining their joint efforts to action on
achieve their common objectives to strengthen public health functions
and health emergency preparedness. WHO and IANPHI share the same TB and
vision that essential public health functions are a comprehensive and
cost-effective approach to advance universal health coverage, health comorbidities
security and healthier populations. The pandemic underlined the key role
of national public health institutes. These institutes are at the forefront of The World Health Organisation
preparedness, detection and response efforts in their respective countries. (WHO) is launching a new
Through this new agreement, WHO and IANPHI will work together framework for collaborative
to establish or strengthen the role of national institutes, particularly in action on tuberculosis (TB) and
emergency preparedness and response. The IANPHI is a network of comorbidities to address the
111 members in 94 countries and regions. It links and strengthens the limited uptake of collaborative
government agencies responsible for public health. activities to reduce the burden
of TB and comorbidities
KSrelief funds measles, and to support countries in
polio epidemics prevention enabling access to people-
initiatives of WHO, UNICEF centred care. The framework
is designed to stimulate action,
The World Health Organisation (WHO) and UNICEF have welcomed recognising that addressing
funding agreements from the King Salman Humanitarian Aid and health-related risk factors
Relief Centre (KSrelief) valued at $10 million to further bolster polio and comorbidities among
and measles programmes in eight countries. The new funding will people with TB is essential
provide UNICEF and WHO with $5 million each in response to a to end the TB epidemic.
call for emergency action by WHO and UNICEF to avert major polio The framework outlines the
and measles epidemics. WHO and UNICEF have urged countries to key steps to establish and
prioritise vaccination for children as they rebuild their immunisation strengthen collaboration
systems following major global immunisation disruptions caused by across health programmes and
COVID-19. The pandemic has left millions of vulnerable children at across sectors for delivering
heightened risk of preventable childhood diseases. With this generous people-centred services
contribution from KSrelief, WHO will support the polio and measles for TB and comorbidities,
programmes in Somalia, Iraq, and Sudan through the procurement of provides guidance on planning,
laboratory equipment; enhancing surveillance; digitalisation of EPI; implementation and evaluation
strengthening the cold chain; and training of campaign vaccinators. of these services and is designed
to facilitate scale-up of new
WHO recommendations on
TB, comorbidities and health-
related risk factors.

18 COVER STORY

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Invincible Diabetes
Turns APAC Into
Pharma Goldmine

There are over 235 million diabetic patients in Asia. China and India account
for almost half of the world’s diabetic population. By 2030, without
intervention, both China and India combined will have nearly half
a billion diabetics. These are grim figures but for pharma firms,
they represent a huge opportunity, and big pharma firms are
spending billions in search of the next blockbuster drug for diabetes,
according to the estimates from Singapore-based Asian Diabetes
Prevention Initiative (ADPI). The diabetes care drugs market is
highly fragmented in Asia Pacific (APAC) region with a few major
manufacturers gaining presence in major countries of the APAC
market, while the remaining market comprises other local or region-
specific manufacturers. Mergers and acquisitions that happened
between players in the recent past helped companies strengthen
their market presence, as well as drive innovations, helping the
diabetes drugs market to increase in the APAC region. Let’s look at
who owns the more significant piece of the pie and the competitive
landscape of diabetes treatment in the region.

On October 10, 2022, Chinese firm Hua Moreover, the production basis of certain
Medicines snagged the first-in-class nod antidiabetic drug companies in the region
in China for a diabetes drug Dorzagliatin, also boosted the market growth. However, the
a glucokinase activator (GKA). This ends a 10 increasingly high cost of drugs is considered one
year drought in type 2 diabetes in terms of lack of of the major restraining factors for the market.
‘medicines with new mechanisms of action’ entering According to the Organisation for Economic Co-
the market. This is welcome news for the region operation and Development (OECD) iLibrary in
which has 60 per cent of diabetics in the world. It is APAC, about 227 million people live with type 2
no wonder then that the largest number of ongoing diabetes and about half of them are undiagnosed
clinical trials for type 2 diabetes are conducted in the and unaware of developing long-term complications.
region, with 665 ongoing clinical trials. Also, according to the International Diabetes
Federation (IDF) data, 90 million adults in the
Over the past few decades, Asian countries have age group of 20-79 are living with diabetes in the
witnessed a rapid increase in diabetes patients, SouthEast Asia (SEA) Region in 2021 which is
especially those with type 2 diabetes. The APAC is projected to increase to 113 million by 2030 and 152
anticipated to experience considerable growth due million by 2045.
to a more geriatric population and rising prevalence
of diabetes mainly due to the enhanced stress Asia represents a golden pot for diabetes
level, sedentary lifestyles, smoking, and excessive drugmakers. The South Asian diabetes drugs market
consumption of alcohol that elevates the body’s alone is worth $2.73 billion in 2022 and is projected
sugar levels have led to the growth of the market, to reach $3.57 billion by 2027, according to a report
according to a Mordor Intelligence report. from Statista, a German company specialising in

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BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

market and China
consumer data.
In 2021, it was estimated that China had about
The current global 141 million diabetics aged from 20 to 79 years, the
diabetes market is mainly dominated by four giants highest number in any country. The figure would
namely- Novo Nordisk (Denmark), Sanofi (France), very likely climb to 174 million by 2045, according
Eli Lilly (USA), and Merck (USA). Combined, they to Statista. It’s no wonder that the country ranks
account for about 80 per cent of the market. In second in the world in diabetes-related medical
Asia also these behemoths reign supreme in the spending, at $165.3 billion. That year, there were
diabetes landscape. Lets see how these big players about 1.4 million deaths due to diabetes in China,
are making their presence felt in the countries such about one-third of which occurred in people aged
as China, India, Japan, Korea and Australia amidst below 60 years. In 2021, China spent about $165
competition from the local players who are investing billion on diabetes - approximately $1,173.5 per
in this huge market opportunity and launching new person.
products catering to the local population.
Diabetes is a major growth driver for China’s
pharmaceutical industry. With the gradual increase
of diabetes prevalence, the oral diabetic drug market
sales from public hospitals in China were up to
more than 20 billion yuan in 2021, according to a
report from Daxue Consulting, a market research
and management consulting firm focusing on the
Chinese market.

Global multinationals dominate the Chinese
diabetes market. In 2021, the top performers were
AstraZeneca (UK), Bristol Meyers Squibb (US)
and Merck (US). Domestic players like Nanjing
Hailing Pharmaceutical Hangzhou Zhonghuadong
Pharmaceutical and Sichuan Luye Pharmaceutical
also performed well.

Unlike in the global market, insulin and oral
hypoglycemic agents comprise most of the Chinese
diabetes market. Glucagon-like peptide-1 (GLP-
1) agonists accounted for 18.8 per cent of global

diabetic drugs in 2020, with a
market share of more than
$13.1 billion. In comparison,
the GLP-1 receptor agonist
market in China is 1.6 billion
yuan, accounting for 2.6 per

cent of the total diabetes market
in China, says a report from Daxue Consulting.
The promotion of GLP-1 products’ inclusion in
the ‘Guidelines for the Diagnosis and Treatment
of Type 2 Diabetes in China’ has given the GLP-1
medicine market in China a sizable development
window and room for expansion.
Although global firms roost the town when it
comes to diabetes, Chinese firms are catching up.
Recently, the Chinese regulator approved Hua
Medicine’s innovative first-in-class Glucokinase
Activator (GKA) HuaTangNing. HuaTangNing is
the first approved GKA worldwide. Going forward,
Hua Medicine will partner with Bayer (Germany) to
commercialise HuaTangNing in China, benefiting
diabetic patients and their families. Various other

20 COVER STORY

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“The most intriguing aspect of
diabetes care is the relentless
pursuit of orally active insulin”

Dr Mahesh Bhalgat, formulations - insulin as part and insulin lispro with
Chief Operating Officer, enhanced rapid action and less prandial glucose
Syngene International excursions with lower hypoglycemia risk have been
introduced.
Syngene is the contract development and
manufacturing organisation (CDMO), an arm For type 2 diabetes, other medications include
of Biocon, India, one of the leading insulin glucagon-like peptide 1 receptor (GLP-1) agonists,
makers in the world. In an email interaction with sodium-glucose cotransporter 2 (SGLT2) inhibitors
BioSpectrum Asia, Dr Mahesh Bhalgat, Chief with or without metformin, based on glycemic needs
Operating Officer, Syngene International, shares with may be prescribed for individuals who are at high
us the latest developments in diabetes care. Edited risk for atherosclerotic cardiovascular disease, heart
excerpts; failure, and/or chronic kidney diseases.

What are the latest developments in While all these approaches exist, regular
diabetes treatment drugs and therapeutics testing, lifestyle and diet play a very important role
in Asia and globally as well? in managing diabetes and need to be part of the
regimen as advised by medical professionals.
It is important to look at the diabetes
management approaches since India is home to the What steps can be taken to bridge the
world`s second-largest adult diabetes population, disparity in diabetes care, while improving
and every sixth person with diabetes in the world is access to insulin and other drugs?
an Indian.  
Affordable access is important when it comes
The Indian Council of Medical Research (ICMR) to managing chronic conditions where the drugs
has issued new guidelines for type 1 diabetes used for management are often indicated for lifelong
earlier this year, in June. According to the American treatment. Hence, along with cost, a reliable supply
Diabetes Association (ADA) and the ICMR, the of the drug is very important for good disease
management of type 1 diabetes involves the use of management. Syngene does not manufacture
insulin, among other recommendations. However, diabetes drugs. However, the company has several
hypoglycemia (sudden drop in blood sugar causing assays for testing insulins to allow clients to ensure
falls and unconsciousness) represents one of the lower-cost biosimilar versions of insulin can be
common side effects of insulin; therefore, insulin developed. Other contributions that have come from
analogues which have a quicker onset and shorter scientific improvements are the use of efficient
duration of action compared to regular insulin were expression systems, which provide higher yields
discovered. More recently, two new injectable insulin and faster timescales for producing insulin through
recombinant technology.

Share your long-term goals for improving
the lives of people with diabetes. What are
Syngene’s other efforts to make life better
for people with diabetes?

According to ICMR, the past three decades
witnessed a 150 per cent increase in the number
of people with diabetes in the country. An area of
concern is the progressively lower age at which
type 2 diabetes is being diagnosed, with the disease
prevalence becoming apparent in the age group

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BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com Leading Diabetes Drugmakers

of 25-34 years in both urban and rural areas. ● Novo Nordisk, ● Gan & Lee
Additionally, according to The Lancet Diabetes
& Endocrinology journal’s modelling study, Denmark Pharmaceuticals,
among the estimated 8.4 million people living ● Eli Lilly, USA
with type 1 diabetes across the globe in 2021, ● Sanofi, France China
India ranked in the top ten countries with the ● AstraZeneca, UK ● Sumitomo
highest prevalence of the disease, with the ● Biocon, India
major population being children below 18 ● Sun Pharma, India Dainippon Pharma,
years old. Bearing in mind the varied nature ● Hua Medicine, China
of the population, it is important to provide ● Mitsubishi Tanabe Japan
multiple and parallel treatment options for such ● Daewoong
patients. Syngene’s expertise in the areas of Pharma, Japan
drug discovery, development and manufacturing Pharmaceutical,
can all contribute towards diabetes research.
For example, working on insulin analogues, Korea
newer formulations, and identifying new ● LG Chem, Korea
targets can potentially help in controlling blood
sugar through different modalities. Currently, firms developing different treatments for the disease
our efforts are focussed on the testing of are in phase III trials. The most prominent is
insulin analogues in different bioassays as Retagliptin developed by Jiangsu HengRui Medicine
recommended by regulatory authorities, which for type 2 diabetes. The firm started a phase III trial
include adipogenesis, inhibition of lipolysis and in October 2021.
glucose uptake assays. Consequently, we are
most directly associated with this research by The Chinese government is also ramping up its
bringing in high-quality assays for testing insulin fight against diabetes. In November 2021, China’s
potency. centralised drug procurement agency selected 42
insulin products, resulting in an average price cut
We also perform other assays, which of 48 per cent. The products, from 11 domestic and
include insulin receptor binding assays and foreign-invested companies, cover 16 varieties of
insulin-neutralising antibody assays. A variety second and third-generation insulin commonly
of different platforms are used to ensure that used in clinical treatment. In 2019, the government
the analogues have the right potency, perform launched The Healthy China Initiative (2019–2030),
efficiently and are safe for patients. Also, a roadmap to a healthy China and an innovative
characterisation and comparative assays and public policy system project. The Diabetes
pharmacokinetics studies are done at Syngene Prevention and Control Action is one of the four
for clinical and non-clinical purposes. chronic and noncommunicable diseases prevention
and control actions in the Healthy China Initiative.
Which advancement are you most
excited about? India

I think the most intriguing aspect of India is home to 74 million diabetics, the second
diabetes care is the relentless pursuit of orally highest in the world, and is expected to increase to
active insulin. Neither the world at large nor 125 million by 2045, according to the International
the research community has given up on the Diabetes Federation (IDF). The competition is
hope of having to not inject insulin. In the fierce in the diabetes market in the country. While
meantime, ensuring that a variety of analogues it’s largely dominated by Danish diabetes major
are available to patients is a significant Novo Nordisk, French firm Sanofi and domestic
advancement in managing diabetes, and, on player Biocon. 2022 saw the launch of the generic
the research side, the availability of high-quality and cheaper versions of the popular diabetes drugs
assays like ours to test insulin and its analogues in the country. On October 6, 2022, Alkem Labs,
for potency and activity makes a significant the country’s 5th largest drugmaker launched for
difference. In the laboratory, continuing research the first time in India, a triple-drug fixed-dose
on advancements such as oral insulin, IGF-1 combination (FDC) of dapagliflozin, sitagliptin and
(Insulin-like growth factor I) and stem cells may metformin under the brand name of dapanorm
offer important options for patients in the years trio at an affordable price for adults with type 2
to come. diabetes. On the same day, Glenmark, the country’s
top generic drugmaker launched thiazolidinedione
Lobeglitazone (Lobeglitazone) for the treatment of
type 2 diabetes in adults.

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Investing in diabetes education
today to protect tomorrow

Prof. Andrew Boulton, understanding and education is vital. This starts at
President, the point of diagnosis, with people having access
to comprehensive information and education from
International Diabetes Federation (IDF) day one, and then throughout their lifetime. This
will enable people living with diabetes to effectively
Diabetes affects more than half a billion people manage the condition and avoid or delay potentially
across the globe today, around 537 million, and life-threatening complications including blindness,
rising. By 2030, that figure is expected to reach kidney failure or stroke.
640 million, equating to one in nine people globally
living with diabetes, according to estimates from the However, research shows that for people living
10th edition of the International Diabetes Federation with diabetes, consultation time is limited, with the
Diabetes Atlas. average person spending less than three hours per
year with a healthcare professional. This makes it
In a unified effort to help stem the tide, Member all the more important for healthcare professionals
States of the World Health Organisation (WHO) to make the most of the time they have available
have set ambitious global targets for diabetes to be during appointments and have access to ongoing
achieved by 2030. These include ensuring that 80 training in order to provide the best possible diabetes
per cent of people living with diabetes worldwide are treatment, care and advice when it’s needed most.
diagnosed and have good control of blood glucose
and blood pressure. More work to be done

With the overall aim of the targets to reduce With current estimates suggesting that nearly
the impact of diabetes and move towards a world half of adults living with diabetes are undiagnosed,
where all people who are diagnosed have access the need for access to education has never been
to ‘equitable, comprehensive, affordable and quality more important. According to Dr Tedros Adhanom
treatment and care’, diabetes education must be Ghebreyesus, Director-General of WHO, diabetes is
made a global priority. now the only major non-communicable disease for
which the risk of dying early is continuing to rise.
Education from the outset
This World Diabetes Day, IDF is campaigning for
To ensure that people living with diabetes can improved education and training for people living
successfully manage their condition, the right with diabetes and healthcare professionals to ensure
support is there for all to help detect, diagnose and
provide the best possible care.

IDF is calling on the global diabetes community
and members of the public to lobby their national
health minister to request the right resources – both
human and financial – be allocated to diabetes
education. The only way we can protect the health
of global citizens tomorrow is to invest in the right
education and access to information today.

Glenmark and Cadila both launched the the launch of generic versions of sitagliptin in India
generic version of Merck’s blockbuster drug under the brand names Jankey and Sitenali to
sitagliptin in the country. On August 2, 2022, address type 2 diabetes.
Cadila Pharmaceuticals, a pioneer in vitamin D3
supplements and a legacy of 50 years in offering A month earlier on July 7, 2022, Glenmark,
an affordable range of cardiovascular medicines, launched the sitagliptin for adults with type 2
made a foray into the diabetes care segment with diabetes. In April, the company also launched a
novel fixed-dose combination (FDC) of a widely used

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BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

DPP4 inhibitor (Dipeptidyl Peptidase 4 Inhibitor), BEST SELLING DIABETES
teneligliptin, with pioglitazone. This is the only DRUGS/THERAPIES IN INDIA
available DPP4 and glitazone combination brand in
India for adults with uncontrolled type 2 diabetes. S. No Product Company
1 Lantus Sanofi, France
Earlier this year, in January 2022, Novo Nordisk 2 Mixtard Novo Nordisk, Denmark
launched an oral formulation for an anti-diabetes 3 Novomix Novo Nordisk, Denmark
drug that was available only as injections and 4 Gluconorm-G Lupin, India
claimed the new drug can help better control
blood sugar levels in diabetic patients. The Indian 5 Istamet Sun Pharma, India
government is also taking steps to make diabetes
therapies accessible for all. In September 2022, the 6 Gemer Sun Pharma, India
Union Health Ministry launched the new National 7 Huminsulin Eli Lilly, USA
List of Essential Medicines (NLEM), expanding the 8 Amaryl M Sanofi, France
list to include newer therapies for diabetes, such as 9 Ryzodeg Novo Nordisk, Denmark
the medicine teneligliptin and insulin glargine. 10 Actrapid Novo Nordisk, Denmark

According to IQVIA sales data for the 12 months Source: Anand Rathi research report
ending August 2022, the market for oral anti-
diabetic drugs in India is estimated to be Rs 11,725 TOP 10 ORAL DIABETIC DRUGS IN PUBLIC
crore. with an annual growth of 7 per cent against MEDICAL INSTITUTIONS IN CHINA (2020-2021)
the corresponding period last year (MAT August
2021). The number is set to further increase. S. Product Name Company Name Sales
The diabetes care market in India is expected to No (Tablet) in %
reach about $60 billion in the next 10 years, from growth
approximately $17 billion, according to Redcore,
the research arm of Bengaluru-based research firm 1 Dapagliflozin AstraZeneca, UK 156
Redseer consulting.
2 Metformin Bristol-Myers -30
Japan hydrochloride Squibb, USA

There has been a flurry of activities in the 3 Sitaaliptin phosphate Merck, USA 3
diabetes sector in Japan. On July 7, 2022, Eli
Lilly Japan K.K. and Mitsubishi Tanabe Pharma 4 Acarbose Bayer, Germant -46
Corporation (MTPC) signed a sales collaboration
agreement in Japan for tirzepatide, which is 5 Epalrestat Nanjing Hailing 24
under development by Eli Lilly Japan. Tirzepatide Pharmaceutical
(injection) belongs to the GLP-1 class of drugs of Yangtze River,
which has seen remarkable growth in the country. China
In 2021, French firm POXEL SA along with its
partner, Sumitomo Dainippon Pharma, launched 6 Repaalinide Novo Nordisk, -42
TWYMEEG (Imeglimin hydrochloride), another Denmark
GLP-1 drug for the treatment of type 2 diabetes in
Japan. 7 Pioolitazone Hangzhou 65
metformin (15mg I Zhonahuadong
Sodium-glucose Cotransporter-2 (SGLT2) is 500mg) Pharmaceutical,
another class of drugs that is gaining traction. China
In 2021, AstraZeneca’s Farxiga was approved in
Japan. The drug is an instant blockbuster in the 8 Acarbolose capsules Sichuan Luye -3
country and became the top-selling diabetes drug in
Japan, displacing Merck’s DPP-4 inhibitor Januvia Pharmaceutical,
(sitagliptin) for the first time in 11 years, according
to a report from IQVIA. DPP-4 inhibitors, while China
gaining traction in other parts of Asia, are on the
decline in Japan. According to IQVIA, the Japanese 9 Ligli tine Boehringer 111
diabetes market was valued at 635.5 billion yen lngelheim,
in 2021, making it the second-largest therapeutic Germany
category after cancer drugs.
10 Gliclazide sustained- SERVIER, France 47
release

Source: Daxue Consulting

South Korea

The South Korean diabetes treatment market is
forecasted to be worth approximately $16 million
by 2023, according to Statista. The market is mostly

24 COVER STORY

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Expanding Access to Insulin in Germany. IDG16177 is a new drug candidate of
the GPR40 (G-protein-coupled receptor 40) GPR40
Insulin serves as a poster child of medicine agonist class.
inequality, and big pharma firms are often held
accountable for growing insulin inequality. Top Australia
diabetes players - Eli Lilly, Novo Nordisk and Sanofi
have taken significant steps in bridging this gap. In 2021, the Australian government released a
new 10-year plan to better support Australians living
In 2022, Eli Lilly announced a commitment to with all forms of diabetes. The Australian National
support the United Nations International Children’s Diabetes Strategy 2021–2030 will drive real
Emergency Fund (UNICEF’s) work with funding of improvements in the prevention, early detection,
$14.4 million until 2025. The contribution will be management, and care of people with diabetes.
directed towards improving the prevention, care and With approximately one in 20 Australians affected
treatment of non-communicable diseases (NCDs), by diabetes, the new strategy will bring together
including diabetes, at different levels of care. the latest research and evidence to ensure health
response continues to adapt to the changing health
In 2021, Novo Nordisk launched the iCARE environment.
initiative to increase access to insulin in sub-
Saharan Africa (excluding South Africa) by 2025. Can diabetes be cured?
iCARE has been launched in seven pilot countries
so far: Ethiopia, Ghana, Côte d’Ivoire, Kenya, 2022 marks 100 years since the discovery
Nigeria, Sudan and Tanzania. of insulin and this remains one of the standard
treatments for the disease. Diabetes cannot be
In 2021, Sanofi launched its Global Health Unit, cured, and the medication available helps with
which will continue and expand the company’s keeping the blood sugar under control. But that
work with local governments and stakeholders, hasn’t deterred pharma firms from chasing the holy
intergovernmental agencies and non-governmental grail- the cure for the diseases. Pharma firms are
organisations to increase access to its medicines. deploying various strategies in this search:
Sanofi plans for this unit’s remit to cover 40 Low and
Low Middle-Income Countries (LMICs). A new report Promising developments
by the Access to Medicine Foundation said that the
industry efforts currently fall short in addressing the Peptides: On July 20, 2022, in a new study
extent of the insulin inequity problem. coordinated by Inserm researcher Vincent Marion
in collaboration with Monash University (Australia),
dominated by global multinationals like Sanofi, the University of Birmingham (UK), and Alexander
Merck and AstraZeneca. On May 3, 2022, Korea Fleming, a former senior endocrinologist at the
approved Novo Nordisk’s Rybelsus, the world’s first US Food and Drug Administration (USFDA), the
oral GLP-1 analog treatment for type 2 diabetes. scientists have developed PATAS, a peptide that is
DPP-4 inhibitors account for more than half of part of a new class of anti-diabetic drugs. PATAS can
the Korean diabetes drug market, but GLP-1 and correct the metabolic abnormalities leading to type
SGLT-2 are gaining traction as well. In January 2 diabetes and its associated comorbidities, which
2022, Daewoong Pharmaceutical released positive include insulin resistance.
phase III results for enavogliflozin monotherapy and
combination therapy with metformin. Enavogliflozin Microbiome therapeutics: Gut microbiomes
is the first SGLT-2 inhibitor being developed in as therapeutics are gaining traction. The French
Korea. The firm aims to launch the drug in 2023. biotech company Valbiotis, is currently conducting
phase II/III trials for a drug aimed at increasing the
Demand for new diabetes drugs is growing microbiome diversity for early-stage type 2 diabetes.
worldwide, and Korean firms are scrambling to On August 5, 2022, scientists at the University of
develop novel treatments for the disease. LG Chem, California, San Diego found that engineered native
one of the largest pharma companies in the country gut bacteria show promise to treat diabetes.
LG Chem is developing a new diabetes drug that
improves desensitised insulin reactions. In January Stem cell transplantation: Injections of
2022, the firm began phase I clinical trials in the US. insulin may become obsolete if research from
GSK has also been researching insulin resistance. In the University of Alberta, Canada is successful.
July 2021, Ildong Pharmaceutical, a Korean major In January 2022, diabetes researchers from the
pharma firm started the phase I trial of IDG16177 University of Alberta reported early success in
a first-in-human clinical trial to test whether
pancreatic cells grown from stem cells can be safely

COVER STORY 25

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Diabetic Nephropathy
Treatment Modalities and Market

Poornachandra Tejasvi K, with preserved ejection fraction (HFpEF). As part
Senior Director, of their general recommendation for use of SGLT-2
inhibitors in diabetes patients with chronic kidney
Emerging Markets - India, Citeline disease (CKD), the KDIGO (Kidney Disease: Improving
Global Outcomes, a global organisation developing
Datamonitor Healthcare from Citeline (formerly and implementing evidence-based clinical practice
Pharma Intelligence) estimates that in 2021, guidelines in kidney disease) guidelines on diabetes in
there were approximately 128.1 million CKD note the benefit of these agents on HF, including
prevalent cases of diabetic nephropathy (DN) in HF as an outcome that is critically important to
adults aged 20 years and older with type 2 diabetes patients, in addition to CV and kidney outcomes.
worldwide, and forecasts that number to increase
to 138.2 million prevalent cases by 2027, driven by For cardiometabolic benefits, they also note
population demographics. Approximately 30 per that while glucagon-like peptide 1 receptor (GLP-1)
cent of diagnosed diabetics are also diagnosed with agonists and SGLT-2 inhibitors reduce MACE (Major
DN. However, screening practices differ between adverse cardiovascular events) to a similar degree,
countries and local health systems, which can GLP-1 receptor agonists may be preferred for ASCVD,
impact patients identified for treatment. whereas there is currently stronger evidence for SGLT-
2 inhibitors for reduction in HF and CKD progression.
According to a recent report, DN may occur Still, they emphasise that SGLT-2 inhibitors should be
in 19–30 per cent of diabetics, depending on preferred as initial therapy in diabetics with CKD.
the region of the world. It is a leading cause of
end-stage renal disease (ESRD) in the developed For renin–angiotensin–aldosterone system (RAAS)
world, although patients can have a quite variable inhibitors, the other KDIGO guidelines not specific to
course, and only a minority progress to ESRD with diabetes note that angiotensin-converting-enzyme
contemporary treatment. DN also imparts a higher (ACE) inhibitors and angiotensin receptor blockers
risk for cardiovascular disease (CVD) beyond that for (ARBs), which are standard HF treatments, have also
diabetes alone. shown a benefit in HF patients with CKD. Similarly,
as noted above, the American College of Cardiology
Connection with heart failure (ACC) consensus decision pathway includes HF in
the comorbidities for which it recommends SGLT-
Heart failure (HF) is a significant co-morbidity in 2 inhibitors in diabetics. Updated American Heart
DN, especially in more advanced patients. American Association (AHA)/ACC/ Heart Failure Society
Diabetes Association (ADA) guidelines recommend of America (HFSA), heart failure guidelines also
sodium-glucose cotransporter 2 (SGLT2) inhibitors recommend SGLT-2 inhibitors for type 2 diabetics
with a demonstrated benefit to reduce the risk of with established CV disease or high risk to prevent
Hypertensive Heart Failure (HHF) in those with HHF, and for those with HFrEF to reduce HHF and
Atherosclerotic cardiovascular disease (ASCVD), CV death. They say the agents may be beneficial
multiple risk factors, or DN, and also to reduce the risk in those with HFpEF or HF with mid-range ejection
of worsening heart failure, HHF, and cardiovascular fraction (HFmrEF) to reduce HHF and CV death. They
(CV) death in diabetics with heart failure with also recommend ACE inhibitors and, if those are not
reduced ejection fraction (HFrEF) or heart failure tolerated, ARBs for HFrEF patients, but only when use
of the combination angiotensin receptor/neprilysin
inhibitor Entresto is not feasible. ACE inhibitors and
ARBs may also be considered in HFmrEF and ARBs in
HFpEF.

Treatment modalities

The SGLT-2 inhibitors are renewing the
genericised market due to their renal and CV benefits
in DN patients. Along with mineralocorticoid receptor

26 CLIMATE CHANGE

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antagonist (MRA) Kerendia, they are expected to its renal benefit and impact on HHF do not appear
continue to grow the market in the intermediate as strong as for Farxiga in its renal trial, though
term, with sales growth slowing in 2026 and then this could be due to trial differences. Kerendia also
eventually declining as the SGLT-2 inhibitors lose has a trial in non-diabetic CKD, as well as HFpEF,
patent protection. so it will be interesting to see how it fares in those.
The company hopes to differentiate Kerendia by its
Even before approvals in DN, SGLT-2 inhibitors mechanism of action, with effects on inflammation/
were used to treat diabetes in DN patients, albeit fibrosis, as well as specialists not having to adjust
hampered by some side effects and waning diabetes medications, as for SGLT-2 inhibitors. It also
antiglycemic efficacy with more advanced CKD. is planning to build awareness of the importance of
Members of the class have also been found to earlier testing for DN.
have benefits in important CV comorbidities –
especially HF, but also in some situations CV Clinical trials landscape
death or MACE – leading to label expansions,
which along with specific approvals for DN and/ Phase I–IV clinical trials for primary
or broader CKD have spurred sales growth in the investigational drugs with at least one industry
class as a whole, though in the US this has been sponsor in the diabetic nephropathy space in the
somewhat offset by net price declines. Invokana curated Trialtrove database from Citeline. Drugs
was the first SGLT-2 inhibitor with a type 2 DN do not need to be tested in as many combinations
indication, but has been unable to capitalise much with other classes as in diabetes pivotal trials, and
on it due to concerns about a possible increased success in Phase II is somewhat lower, so there are
risk of amputations. Farxiga was approved for CKD relatively fewer Phase III trials in DN. Since drugs
in the US in April 2021 based on stellar results may be investigated first in other indications, there
from a CKD trial that included both diabetics and are also relatively fewer Phase I studies. Phase I/
non-diabetics, and Jardiance’s pivotal trial was II and Phase II/III trials are counted as Phase II and
halted in 2022 due to a positive interim analysis, Phase III, respectively.
with details pending.
Apt choice of drugs
MRA Kerendia was approved, starting in 2021,
for reducing the risk of renal and CV events in The DN market is complex because in addition
DN. It showed renal and CV benefits in its pivotal to specific mechanisms that directly impact the
Finerenone in Reducing Kidney Failure and Disease disease, blood pressure and glycemic control are
Progression in Diabetic Kidney Disease (FIDELIO- additional general targets that affect the condition.
DKD) Phase III study in type 2 DN, and CV benefits Moreover, there is high CV risk in DN patients, and
with a numerical renal composite improvement in many physicians may be more concerned about that
its Finerenone in Reducing Cardiovascular Mortality than the risk of end-stage renal disease, especially
and Morbidity in Diabetic Kidney Disease (FIGARO- in patients who aren’t in the advanced stage. Hence,
DKD) study of a broader group of DN patients. drugs that directly impact DN and also benefit
However, in the latter, unlike FIDELIO-DKD, the CV these other targets or have a CV benefit, can have a
benefit was only seen in HHF. Moreover, in general, competitive advantage.

implanted and begin to produce insulin. throughout the day for maintaining normal blood
Dietary supplements: Valbiotis has developed glucose levels, such as oral anti-diabetic medication
or ingestion of additional carbohydrates by
a dietary supplement comprising a combination monitoring their blood glucose levels.
of extracts from five plants. In July 2019, they
announced positive results from a phase IIA study of Leading manufacturers are focusing on
their compound which sought to evaluate its efficacy technological innovations and the development
in pre-diabetic populations compared to a placebo. of advanced products to gain a substantial share
of the market. The future of diabetes treatment is
Evolving potential evolving, from lowering glucose levels to finding the
cure at the grass-root level. The global diabetes drug
The APAC region has witnessed an alarming market is projected to reach $68 billion by 2026,
increase in the prevalence of diabetes in recent with everyone aiming to get the bigger piece of the
years. In developing countries, such as China and pie.
India, the rate of diabetes is at an all-time high.
Patients with diabetes require many corrections Ayesha Siddiqui

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WHO NEEDS NEXT
GEN VAX TECH?

The COVID-19 vaccines were developed in record time. As the ‘novel’ coronavirus mutates, the
vaccine makers, too, are adapting by innovating vaccine technologies. Researchers continue to
work, aiming for more potent immunity, reduced transmissibility, cheaper manufacturing, easier
transport, and mutation-targeted vaccines. The novel vaccine models may facilitate rapid and
effective responses to new infectious diseases, allergies, autoimmune conditions, and cancers.
Vaccination programmes can be more cost-effective and efficient by achieving global outreach,
maintaining vaccine potency, and optimising logistics, thus increasing global preparedness for
future pandemics and disease outbreaks. Let’s explore some of the latest advancements in vaccine
technology which emerged in the era of COVID-19.

Globally, mass vaccination practices and stability of mRNA by preventing its degradation.
procedures were not pleasant experiences Similarly, nanotechnology can also enhance
for everyone. Different age groups and
vulnerable populations had to undergo mandatory immunogenicity and stability of ‘soluble protein
national vaccination procedures to access the antigens’ combined with adjuvants. Targeted
essentials in public spaces. Additionally, minimising delivery reduces antigen in a dose, which is helpful
injection discomfort and biohazards from syringe when striving for mass vaccination.
disposal are also serious concerns. The aim of
innovative vaccines is to achieve multi-target The co-delivery of nanoparticle-based vaccines
vaccines to eliminate the need for multiple-bolus with adjuvants can greatly enhance vaccine potency.
regimens. Being compliant to both manufacturer The versatility of nanoparticle systems makes
and consumer could be a potential solution for high- them suitable for delivering vaccines against other
impact mass vaccination. emerging pathogens. Vaccine adjuvants reduce
vaccine cost, improve antigen immunogenicity, and
While expenses on vaccine manufacture/ increase antigen stability.
delivery/storage/supply chain have become a
burden on a nation’s economy, the World Health Novel all-in-one vaccine
Organisation (WHO) is acknowledging the idea of a
single-injection vaccine, as a preferred immunisation for multi variant virus
method. Novel injection-free and single-dose In July 2022, Coalition for Epidemic
medication and vaccine delivery strategies are a
pressing need of the moment. There are different Preparedness Innovations (CEPI) announced up
ways of delivery of drugs and vaccines and some
of the latest trends include Nanosystems for to $30 million in funding to the University of
Transdermal Delivery, Nasal sprays, Dissolvable
microneedles etc. Oxford to develop nanoparticle vaccines

Nanosystems for Transdermal delivery offering protection against a range of

Nanosystems comprising nanoparticles and coronaviruses. In contrast
liposomes can effectively transport antigens
within parenteral (intravenous) administration. to many existing vaccine
Majority of COVID-19 mRNA vaccines under
clinical development are designed to deliver by lipid designs that use mRNA
nanoparticles (LNP). Immunity triggering viral
antigens can be incorporated into the nanoparticles or a viral vector to
via encapsulation or by conjugation to prolong the
present sections of the

spike protein of a single

type of virus to the

immune system, this

new vaccine will use

protein nanoparticles

containing a protein

‘glue’ to attach related

antigenic sections MOSAIC-8 VACCINE
of the spike proteins

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“Bharat Biotech’s ChAd36- similar to a SARS-CoV-2 infection and thus the
SARS-CoV-S COVID-19 nasal route is seen as a promising vaccine strategy.
Intranasal flu vaccines, such as FluMist, were
recombinant nasal vaccine introduced to the US market in 2003.
has been approved by @
CDSCO_INDIA_INF for “If the infectious disease attacks the respiratory
primary immunisation tract then you need respiratory mucosal immunity.
In such case aerosolised vaccine could be
against Covid-19 in 18+ age beneficial,” explains Aurelio Bonavia from the
group for restricted use in vaccine development group at Bill & Melinda Gates
Medical Research Institute.
emergency situation”
- Dr Mansukh Mandaviya, In early September 2022, India’s first intra-
nasal COVID-19 vaccine iNCOVACC (BBV154)
Health Minister of India by Bharat Biotech received Emergency Use
Authorisation (EUA). With the approval in India,
from eight different viruses. By incorporating a it thus became the second needle-free intranasal
‘mosaic-8 vaccine’ design created at Caltech these vaccine to clear regulatory approval after China’s
nanoparticles would favour immune responses to CanSino Biologics’ vaccine. Approximately, 100
the shared parts of each of the different types of similar nasal vaccines are under development for
coronaviruses within a single vaccine. Influenza and Covid-19 across the world concerning
low- and middle-income countries.
“The “glue” for sticking proteins together was
developed by Dr Mark Howarth of Biochemistry, “Bharat Biotech’s ChAd36-SARS-CoV-S
Oxford. Together we used this technology to make COVID-19 recombinant nasal vaccine approved by
a prototype nanoparticle SARS-CoV-2 vaccine @CDSCO_INDIA_INF for primary immunisation
that induced highly potent responses in preclinical against Covid-19 in 18+ age group for restricted use
studies. We made a fully functional version of the in emergency situation,” tweeted Health Minister of
vaccine produced in microbes, thus reducing the India, Dr Mansukh Mandaviya.
cost of production” said Alain Townsend, Oxford
Lead of the consortium, Professor of Molecular Dr Krishna Ella, Chairman & Managing
Immunology at the MRC Weatherall Institute of Director, Bharat Biotech, said, “Despite the lack
Molecular Medicine, University of Oxford. of demand for COVID-19 vaccines, we continued
product development in intra nasal vaccines to
Dr Jack Tan, Project Manager (Oxford) of the ensure that we are well prepared with platform
consortium, Senior Postdoctoral Scientist at the technologies for future infectious diseases.”
MRC Weatherall Institute of Molecular Medicine,
said, “CEPI to further this nanoparticle technology Likewise, AstraZeneca and the University of
with the goal of producing efficacious, low-cost, Oxford are also testing an intranasal version of the
infrastructure-independent vaccine that will be vaccine.
accessible to low- and middle-income countries.”
Aerosol vaccine: In June 2022, scientists
Nasal sprays and Aerosol vaccines at McMaster University, Canada announced a
unique inhaled aerosol form of COVID vaccine,
Nasal vaccines: Vaccines are usually better protection and stronger immunity than nasal
administered intramuscularly, subcutaneously, sprays. Researchers report that, as opposed to nasal
or intradermally using hypodermic needles. sprays, inhaled aerosols bypass the nasal passage
Nasal vaccines, jet injectors, microneedles, and and deliver vaccine droplets deep inside the airway,
nanopatches are arriving as a potential painless where they can trigger a broad immune response.
and cost-effective approach to vaccination while
avoiding expensive cold-chain transport and “The immune response generated when vaccine
storage. is delivered deep into the lung is much stronger
than depositing the vaccine material in the nose
The prospects of nasal vaccines are seemingly and throat because of the anatomy and nature of
optimistic for COVID-19 which can further lay the tissue and the immune cells that are available
the foundation for noninvasive vaccine delivery to respond are very different,” explains Matthew
modes. Intranasal needle-free vaccines are easier Miller, a co-author of the study who holds the
to distribute among low income countries lacking Canada Research Chair in Viral Pandemics at
healthcare aid. They can elicit both mucosal McMaster University.
and systemic immune responses releasing
immunoglobulins, mucosal IgA, and serum IgG, “This study for the first time provides strong
preclinical evidence to support the development

VACCINES 29

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of inhaled aerosol delivery over nasal spray for ‘CEPI to further this
human vaccination against respiratory infections nanoparticle technology
including TB, COVID-19 and influenza,” says Zhou with the goal of producing
Xing, co-investigator of the study and a professor
at the McMaster Immunology Research Centre and efficacious, low-cost,
Department of Medicine. infrastructure-independent

Furthermore, CanSino Biologics’s inhaled vaccines that will be
vaccine, “Convidecia Air’’ is approved by China accessible to low- and middle-
National Medical Products Administration (NMPA)
as COVID-19 booster dose. Utilising the same income countries”
adenovirus vector technological platform as the - Dr Jack Tan,
intramuscular version Convidecia, “Convidecia Air’’
provides a non-invasive option that uses a nebulizer Project Manager (Oxford)
to change liquid into an aerosol for inhalation of the consortium, Senior
through the mouth. Convidecia Air is needle-free Postdoctoral Scientist at the
and can effectively induce comprehensive immune MRC Weatherall Institute of
protection in response to SARS-CoV-2 after just
one breath. In addition, Convidecia Air can be Molecular Medicine
stably transported and stored between 2°C and
8°C, compatible for mass vaccination. vaccine retention in the skin, activate immune

CanSino and Bharat have cleared regulatory cells, and stimulate humoral and cellular immune
hurdles, and they will be available soon. As per
WHO data, globally there are 172 vaccines in responses in comparison to conventional mode.
clinical development, including two inhaled
formulations and 12 nasal-spray formulations, The microneedle array is similar to band-aid
including two that have been approved.
patches and provides cold-chain storage avoidance
Dissolvable microneedles Patch vaccines
and self-administration flexibility. However,
Microneedles (MNs) are arrays of micrometer-
sized solid fabricated needle projections that can microneedles only offer either rapid or sustained
painlessly deliver therapeutics into the epidermis/
dermis. Microneedle patches designed to precisely release, which limits their application in vaccine
deliver vaccines into the intradermal space, rich
in immune cells, provide a noninvasive and self- administration. A transdermal microneedle device
applicable vaccination approach, eliminating the
need for hypodermic needles and trained medical with programmable pulsatile or delayed burst
personnel for vaccine administration.
release with various desired lag times is needed to
Dissolving microneedles (DMNs) are miniature
needles made of polymers such as polylactic- replicate traditional immunisation.
co-glycolic acid (PLGA), polylactic acid (PLA),
and polyglycolic acid (PGA) that dissolve in the The UK based Emergex Covid-19 microneedle
skin to deliver encapsulated medicines, leaving
no sharp waste. Transdermal vaccination using patch by Oxfordshire company has developed skin
biodegradable microneedles ensures controlled
release of drugs via a dissolvable microneedle that patch to administer a T-cell vaccine. Emergex, is
improves dosing accuracy and ensures precise
vaccine delivery. owned by Singaporean venture capital firm Vickers

Several companies are developing a microneedle Venture Partners.
patch to administer vaccines. The microneedles are
impregnated with a vaccine that targets immune In May 2022, Emergex Vaccines announced
cells in the dermis. Patches are being investigated
as a potential alternative to intramuscular vaccines that its COVID-19 vaccine candidate, “synthetic
for influenza and COVID-19.
CD8+ T cell Adaptive Vaccines’’ can be successfully
In addition, 3D-printed microneedles improve
coated onto Zosano Pharma’s Micro-Needle Patch

system. Zosano’s patch consists of an array of

approximately two thousand drug-coated titanium

microneedles mounted on an adhesive patch that is

administered to the skin using

a reusable applicator.

Emergex’s COVID-19

vaccine is stable on the

patches over a wide

temperature range

for up to six

months at 40°C/

75 per cent relative

humidity,

reducing cold

chain logistics.

“Our T cell AN EMERGEX COVID-19
MICRONEEDLE PATCH
Adaptive

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BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

“If infectious disease attacks Medical Branch, in July 2022 reported the
the respiratory tract, you first non-infectious, bacteriophage T4-based,
need respiratory mucosal multicomponent, needle and adjuvant-free mucosal
immunity. In such a case, vaccine. The needle-free “mucosal bacteriophage
(phage) T4-based COVID-19 vaccine” is effective
aerosolised vaccine could be against SARS-CoV-2 infection.
beneficial”
According to a study report published in
- Aurelio Bonavia, July this year in ScienceDaily, This intranasally
Vaccine development group, administered vaccine generates superior mucosal
Bill & Melinda Gates Medical immunity in mice in addition to inducing robust
humoral and cell-mediated immune responses,
Research Institute and provides complete protection and sterilising
immunity against SARS-CoV-2 variants. The
“Despite the lack of demand vaccine is stable, adjuvant-free and cost-
for COVID-19 vaccines, effectively manufactured and distributed, making
we continued product it a strategically important next-generation
COVID-19 vaccine for ending this pandemic.
development in intra nasal This modular, needle-free, phage T4 mucosal
vaccines to ensure that we are vaccine delivery platform is an excellent candidate
to design efficacious mucosal vaccines against
well prepared with platform other respiratory infections and for emergency
technologies for future preparedness against emerging epidemic and
infectious diseases” pandemic pathogens.
- Dr Krishna Ella,
Chairman & Bivalent and Trivalent recombinant vaccines
Managing Director,
Bharat Biotech, India Vaccines companies are adopting a recombinant
bivalent and trivalent vaccines approach against
Vaccine technology has the potential to provide SARS-CoV-2 and influenza viruses due to
broad immune protection – covering viral strains limitations at monovalent vaccines. Majority
and escape mutations as well as cellular immune emerging vaccine researchers anticipate bivalent/
memory that may last for decades. Innovative, trivalent vaccine platforms to create vaccines
easy-to-use patch delivery could radically against resurgent SARS-CoV-2 variants and IAV
transform the vaccine landscape” says Robin infections.
Cohen, Chief Commercial Officer at Emergex.
In early September 2022, China’s Sinovac
University of Queensland, Australia, developing trivalent COVID-19 vaccine progressed as the
a next-gen vaccine delivery system using a world’s first study researching multivalent
technology called the high-density microarray inactivated COVID-19 vaccine. The clinical trial
patch (HD-MAP), of 7x7 mm with 5,000 needle- will evaluate the immunogenicity and safety of one
like protrusions that are able to pierce the skin booster dose of the two candidate vaccines in adults
and deposit the vaccine into the immune-rich who had received two booster doses of CoronaVac,
epidermal and dermal tissue layers without pain mRNA, or adenovirus vector COVID-19 vaccine.
or skin bleeding. The patch can be stored stably at
room temperature for up to 1 month. Similarly, Australian biopharma EnGeneIC is
developing the world’s first COVID-19 vaccine able
Further, in November 2021, India’s Zydus to offer immunity against all variants. The 2nd Gen
Cadila (now renamed as Zydus Lifesciences) vaccine produces “high affinity” antibodies that
received the EUA for ZyCoV-D in India, the neutralise all COVID-19 variants.
world’s first needle-free Plasmid DNA Vaccine for
COVID-19. The vaccine, ZyCoV-D, is exclusively EnGeneIC is currently conducting anti-
administered using the PharmaJet Tropis Needle- COVID-19 vaccine trials with its patented platform
free Injection System. And in April 2021, a new technology based around a biological nanocell
continuous needleless injection system called (EDV; EnGeneIC Dream Vector) in Sydney and
Comfort-M was launched in Korea by MIKA Melbourne. Initially developed as a breakthrough
MEDICAL. in cancer treatment, these EDVs are loaded with
anti-viral molecules to deliver a world-first “Nano-
The new study, by The Catholic University cellular COVID-19 vaccine”. The COVID-19 EDV
of America, and The University of Texas

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MRNA VACCINE DELIVERY SYSTEMS APPLICABLE FOR COVID-19 VACCINE DEVELOPMENT

vaccine from EnGeneIC is also believed to be NUMBER OF VACCINE CANDIDATES
effective in immunocompromised people. USING DIFFERENT ROUTES OF
ADMINISTRATION IN CLINICAL PHASE
It may be noted that in mid May 2022, India’s
Bharat Biotech International Ltd (BBIL), has Route of Number of Percentage (%)
collaborated with University of Sydney, Australia administration candidate of candidate
and ExcellGene SA, Switzerland for developing vaccine vaccine
a ‘variant-proof’ COVID-19 vaccine fighting both Oral
current and future variants of viruses. Injectable 5 3
Subcutaneous (SC)
World’s first plant-based vaccine 156 91

In February 2022, Medicago, a Canada- 5 3
headquartered biopharma company, and
GlaxoSmithKline (GSK) announced that Health Intradermal (ID) 9 5
Canada has granted approval for COVIFENZ,
COVID-19 vaccine, (plant-based virus-like particles Intramuscular (IM) 142 83
[VLP], recombinant, adjuvanted). With “positive Intra nasal (IN) 13 8
efficacy and safety results’’ world’s first plant- Aerosol (AE) 11
based vaccine. This vaccine is indicated for active Inhaled (IH) 21
immunisation to prevent coronavirus disease 2019 TBD / No Data (ND) 11 6
(COVID‑19) caused by severe acute respiratory
syndrome coronavirus 2 (SARS‑CoV‑2) in Source: WHO, as of September 15, 2022
individuals 18 to 64 years of age.
firm, Mitsubishi Tanabe Pharma Corporation
Health Canada based its decision on scientific (MTPC) Group, is the parent company of Medicago.
data shared by Medicago as part of their rolling
submission that began in April 2021 under an What does the future hold?
Interim Order, and concluded with the filing of a
New Drug Submission-CV. SARS-CoV-2 continues to emerge over time,
while new virus variants arise and threaten to
COVIFENZ uses Coronavirus-Like Particle reduce the impact of existing vaccine efforts.
(CoVLP) technology with the vaccine composed Clearly, strategies are needed to deal with emerging
of recombinant spike (S) glycoprotein expressed variants and to safeguard populations against
as virus-like particles (VLPs) co-administered potential health threats in the future. Structure-
with GSK’s pandemic adjuvant. The vaccination based vaccine development, new vaccine platforms,
regimen calls for two doses given intramuscularly and automation are key to overcoming current
21 days apart (3.75 micrograms of CoVLP antigen vaccine development challenges. Technology
in combination with GSK pandemic adjuvant in the advances have enabled the development of vaccines
same injection). The vaccine is stored at 2 °C to 8 with increased efficiency within shorter time
°C. COVIFENZ antigen will be manufactured in frames, as demonstrated by COVID-19. These
Canada and in North Carolina (US). novel approaches and development strategies are
expected to pave the way to developing vaccines
From a plant similar to tobacco plant, a against diseases where traditional approaches have
mimicking particle is extracted and is combined failed.
with an adjuvant made by GSK, for immune
reaction following administration. The Japanese Hithaishi C Bhaskar
[email protected]

32 IMPL ANTS

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Intelligent Implants
Take Centre-stage

There has been a steady rise in the development of smart implants- devices that act as therapeutics
with diagnostic capabilities. Smart implants contain embedded sensors that give surgeons real-time
information for implant location during surgery and post-operative assessment for enhanced patient
care throughout the treatment pathway. With smart implants, remote monitoring post-surgery
becomes easier. Could talking organs become a reality? Let’s find out.

On August 30, 2021, Zimmer Biomet, a global enter this space with recent acquisitions. In January
medical technology leader from the USA with 2021, Stryker acquired OrthoSensor, a leader in the
revenue worth $7.836 billion, and Canary digital evolution of musculoskeletal care and sensor
Medical, a medical data company from Canada technology for total joint replacement.
started rolling out the world’s first United States
Food and Drug Administration (USFDA) approved Intelligent Implants is a Swedish startup
smart knee, Persona IQ. developing the SmartFuse System to improve
outcomes in lumbar spinal fusion procedures. In May
Once surgically implanted in the knee, Persona 2021, the firm received FDA breakthrough device
IQ records and wirelessly transmits a wide range of designation for SmartFuse.
gait data to a patient’s personal base station at home.
The data are then securely delivered to a cloud-based Researchers at the USA-based University
platform. Surgeons can assess post-surgery recovery of Pittsburgh Swanson School of Engineering
progress by comparing pre-operative mobility metrics are creating patient-specific 3D-printed smart
captured by the my mobility app, with post-operative metamaterial implants that double as sensors to
gait metrics collected by Persona IQ. monitor spinal healing.

Canary’s foundational insight is that implanted Researchers from around the world are also
devices sit at the site of a patient’s illness, and so focused on developing smart implants. Researchers
can provide unique and invaluable data on device from Australia’s national science agency, The
function and patient health. Yet, for most devices, Commonwealth Scientific and Industrial Research
when the last suture is closed, they go dark. Canary’s Organisation (CSIRO) have developed new
technology platform has already broken new ground implantable devices equipped with machine learning
in orthopaedics, creating the world’s first commercial to help prevent seizures and monitor patients after
talking knee, with hip and shoulder prostheses under brain surgery. The researchers will now use a $1
development, with more applications soon to come in million Australian Government grant awarded to
spine, trauma, aesthetics and vascular Australian company Anatomics to develop a ‘smart
helmet’ to monitor brain swelling in stroke and
Talking about the company’s traumatic brain injury patients.
plans Dr Bill Hunter, CEO,
Canary Medical, Canada Medical device companies are increasingly trying
said “What Canary is doing in to put sensors in the device so that it functions as
orthopaedics it aims to do in theranostics - providing therapeutics and diagnosis
each of its targeted therapeutic for a disease before it can actually occur. The most
areas: providing real-time widely implanted smart devices are the pacemaker/
collection, and near the real-time defibrillator and the cochlear implant. Smart medical
remote analysis of data that Canary implants are increasingly being used for both long-
Medical believes will be key to the next frontier of term and short-term post-operative monitoring.
monitoring, diagnostics, and treatment.” By ensuring rapid implementation of the necessary
treatments, the implanted device enables early
Stryker, another leading player in the space from detection of adverse events, minimising post-
the USA and Zimmet’s competitor, is also trying to operative complications.

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Market opportunities Medical device companies are
increasingly trying to put sensors
The global smart implants market is estimated in the device so that it functions as
at $3.9 billion in 2022 and is forecast to surpass a theranostics - providing therapeutics
market value of $22.2 billion by 2032, according and diagnosis for a disease before it
to Fact.MR report. The market is enormously can actually occur. The most widely
compelling, with opportunities to create better implanted smart devices are the
outcomes for patients, better practice operations for pacemaker/ defibrillator and the
clinicians, and cost savings for insurers. cochlear implant. Smart medical
implants are increasingly being used
Sharing his views on the market for both long-term and short-term post-
potential, Edward Yager, operative monitoring.
Head of Regional Strategic
Marketing, Zimmer Security issues
Biomet Asia Pacific said
“In Asia, there is also a larger Cybersecurity is a pressing issue for smart devices,
opportunity for those patients especially healthcare devices. There’s an ongoing
that live a considerable distance debate on the safety and how best to regulate these
from their physician. If a patient devices.
lives one hour away, for example, that patient has a
total travel time of two hours to see their physician “Canary’s operating philosophy is that patients
for a follow-up. Plus, the patient may need a family own their data; Canary is only a steward of that data,
member – daughter, son, partner – to travel with and always in the patient’s interests. Our operating
her/him which could include that family member model is designed around those principles. For
taking time away from school or work. Now with example, the raw data from canturio te, our tibial
smart implants, a patient and physician can be extension sensor technology, is encrypted and
connected so that the physician has access to data transmitted, via a base station located in the patient’s
about the patient’s activity level and recovery no home, to Canary’s The Health Insurance Portability
matter the distance. There is also an advantage for and Accountability Act (HIPAA) compliant, closed,
when the patient and physician do meet, as there is cloud platform, where it is processed and then
a considerable increase in objective data to inform securely distributed to clinical and patient interfaces,
the physician or physician’s team on the progress which are regulated by the FDA. These data are only
being made by the patient. There are many win-win ever used in ways that patients have consented to,
scenarios.” and patients can withdraw that consent whenever
they wish,” said Dr Hunter.
But does the rising popularity and developments
of smart implants mean they will be as ubiquitous as Smart implant companies are using various
wearables? security methods. These use encryption and unique
code identifiers to communicate with one another.
“It seems likely that the trend will continue to This can be similar to BlueTooth technology where
grow and expand rapidly in the future as our society two devices share a connection that is encrypted and
continues to become more aware and interested unique to the two devices communicating.
in increasing activities of daily living after surgery
and returning to a more active lifestyle. Smart “Data is anonymised so that there is no
implants offer opportunities to not only improve/ identifiable patient health information made
repair physical pain associated with osteoarthritis, available to third parties without patient consent.
for example, but also the opportunity for patients, And companies work closely with countries’ health
their physicians, and the physicians’ care teams regulatory bodies to comply with local codes, laws,
to understand more about the mental anxieties and regulations,” said Yager.
or concerns a patient may have regarding their
recovery post-operatively and can act or answer We are on the cusp of transformative
questions more quickly because of the access to breakthroughs in smart implants. When integrated
objective data on the patient’s recovery,” added with the traditional healthcare system, smart
Yager. implants have the potential for massive cost savings
and improved patient care.
Dr Hunter, however, feels that the comparison
is rather unfair because most wearables are Ayesha Siddiqui
fundamentally consumer products, not healthcare
devices.

34 SPEAKING WITH

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

“We are seeing a shift towards
localisation of supply chains – from
innovation to manufacturing and production”

« precision medicine trials, the development of highly
unique medicines however is still fraught with high
Francis Van Parys, manufacturing costs, complex logistics and supply
Vice President chains, and high risks of failure.
(Commercial)
APAC, Cytiva Scalable integrated solutions to support the
transition from clinical trials to commercialisation
For developers of cell and gene therapies have been limited. Many of the multiple cell
(CGT), translating a drug from a biological therapy manufacturing process steps remain largely
concept to a scalable and manufacturable unintegrated and manual, with open transfers
treatment can be the largest challenge in achieving between steps increasing contamination risk.
commercial success. This is especially difficult in
the CGT field, because there is a limited number of Cytiva was involved in the first successful
qualified personnel with both biological and process paediatric trial of CAR-T therapy in 2012. During
engineering know-how. Other challenges are evolving that time, we foresaw the challenges and the need
regulatory constraints and aggressive timelines from for simplification and automation, we developed new
investors. Even for experienced teams, it can be tricky technologies to help move toward an automatable
to balance the efforts of reaching the first clinical trial closed end-to-end system/workflow/process.
using a manual, open method with building a more
commercially suitable process. In an interaction with Since the first CAR-T therapy trial, there have
BioSpectrum Asia Francis Van Parys, Vice President been more than 900 regenerative medicine trials
(Commercial) APAC, Cytiva shared his views on underway globally, including trials in cell and gene
how can biopharma companies optimise their therapy.
manufacturing process to capitalise on the rapidly
growing CGT market and company’s growth plans Risk reduction and time to market are critical
for the APAC hub in FY 22-23. Edited excerpts; parameters for success. Manufacturing technologies
have also matured to allow for the reproducible
How can biopharma companies in Asia manufacturing of cell therapies. Cytiva provides a
optimise their current manufacturing process range of innovative, flexible solutions that blend
for precision medicine, particularly in Cell platforms and facilities with services and expertise.
and Gene Therapy (CGT), to capitalise on the
rapidly growing market? How would you describe Cytiva’s novel

Advancement of technology has certainly efforts in enabling the development and
influenced the way medicines are being developed.
The power of genomics, big data, and new scientific commercialisation of precision medicine in
discoveries are driving progress in personalised
medicine. This leads to manufacturing wider Asia?
varieties of monoclonal antibodies, for instance,
in smaller quantities; in the case of cell and gene Cytiva is tackling these challenges with a wide
therapy, individualised treatment tailored for the range of tools and services. We have developed a
individual patient. Despite the increased number of suite of offerings ranging from integrated scalable
systems that can be adapted for Current Good
Manufacturing Practice (cGMP) compliance in
commercial production, to providing intuitive
preventive maintenance services, to facilitating life
cycle asset management – we are single-mindedly
focused on equipping our research counterparts
with the best available support. Most recently, we
developed closed and semi-automated processing
of CAR-T cell manufacturing workflow that saw an
enhanced transduction efficiency greater than 80 per
cent. We intend to continue fine-tuning each step
while maintaining a robust and scalable process.

Last but not least, training of researchers,

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BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

manufacturers, and on-site technicians, through our Earlier in 2019, we integrated automation, IT, and
Fast Trak centre is crucial to the development and single-use solution expertise to build a bioprocessing
commercialisation of novel therapeutic candidates. operation that is flexible and scalable for the future.
Recently we expanded the collaboration to APAC,
As biopharma global supply chains become where Cytiva and Rockwell Automation will build
more fragmented, how can Asia adapt and an automation and digital transformation centre
build its competencies? in Shanghai. We believe in enabling stronger
integration, data collection, and analysis, and create
We are seeing a shift towards localisation of a standardised manufacturing platform capable of
supply chains – from innovation to manufacturing core data management. To complete our biopharma
and production. This pursuit of self-reliance for 4.0 offering, we implemented an Augmented Reality
countries that do not have an already developed solution. By tapping onto our platforms such as
capability is a massive undertaking; it requires OptiRun View and My Equipment, downtime can be
skilling of the workforce, capital investment, policy, decreased and repairs can be sped up.
and regulatory development as well as infrastructure.
What are the plans for the APAC hub’s growth
This is where public-private partnerships can
play a role. Cytiva’s Fast Trak centres are learning in FY 22-23? Has there been any recent M&A
labs that facilitate training and development of the
workforce, for instance. In Korea, Cytiva APAC Fast activity or any in the pipeline?
Trak centre is running our BioChallenge programme
with the country’s largest business media, MaeKyung, We recognise that there is a wealth of discovery,
to accelerate access to the market for biotech technologies, and innovation taking place within the
startups. In the BioChallenge, entrants pitch their academic, scientific, and biotech community. Cytiva
business and technical plans to a panel of experts for accesses and scales leading technological solutions
the chance to receive support from Cytiva in the form by fostering partnerships and collaborations with
of access to resources at our Fast Trak centre as well both the public and private sector, and spearheading
as training and mentorship. The programme has been industry-wide initiatives, that enhance and/or enable
such a success that the Korean Ministry of Health and the discovery and development of new diagnostics,
Welfare and the Ministry of Food and Drug Safety vaccines, biologics, and novel cell and gene therapies.
have both joined BioChallenge as co-sponsors. One such initiative is the Cytiva BioChallenge series,
which was created with the aim to fuel biotech
Cytiva also contributes to the local ecosystem development by providing funding and services to
through a partnership with the government to support research, bioprocessing development, and
support infrastructure development. One of the large- commercialisation. The BioChallenge was launched
scale collaborations I’ve been really excited about in China, Korea, Australia/New Zealand, and will be
here in Asia Pacific is China-Singapore Guangzhou launched in ASEAN in Q3 2022.
Knowledge City (CSGKC). CSGKC is truly a joint
effort, bringing together the governments of China In addition to accessing these solutions, talents
and Singapore alongside thousands of commercial are the precursors of our industry’s innovation, which
organisations. Cytiva is involved in CSGKC’s led us to invest in our training centers, known as
development in association with BeiGene, Lonza and FastTrak, in Shanghai. The expanded centre will be
Akesobio, who have assisted in rapidly establishing fully operational by Q2 2023.
manufacturing capabilities in the park with our
KUBio prefabricated biopharma facilities. To manage the rapidly growing demand for
medicines and health solutions, we have made
I believe that countries looking to develop their investments in strategic collaborations with Wego,
ecosystem can benefit from opening the space for Rockwell Automation, and Pall Corporation over the
greater collaboration with the private sector – past year tol support our growth plans in the region.
creating a ‘win-win’ for all.
Additionally, we are investing in South Korea to
Have there been recent investments to bring build a single-use manufacturing facility to support
transformational biopharma manufacturing vaccine production and to establish a stable and
and diagnostics technologies to the APAC resilient supply chain for vaccine raw materials in the
region? region.

Our mission is to continuously seek out and make We are confident that with the combination of
available new, transformational biopharmaceutical these strategic approaches, our growth plans for
manufacturing and diagnostics technologies globally. APAC remain robust and optimistic.

Hithaishi C Bhaskar
[email protected]

36 SPEAKING WITH

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

“We are eyeing the region’s lucrative markets
of China and India by early next year”

« fundraising platform at present that equips
healthcare startups with funding, market insights,
Chris Lee, and customer validation by matching them with
medical investors. Using deep healthcare expertise,
Founder & CEO, VentureBlick connects startups to the right people
and the right resources, so they do things right in
VentureBlick the shortest time possible. This will shorten the
development cycle of healthcare innovations.
Healthcare is unique and complex. It
requires all stakeholders, small and Medical professionals have the financial means
big players, to work more cohesively and unique insights to support new inventions. The
together. There’s a huge unmet need to unlock group exclusively includes physicians, clinicians,
additional capital and support systems to help hospital administrators, or industry professionals
healthcare startups navigate challenges and move with deep expertise in healthcare (e.g., health
forward quickly with maximum flexibility. To economists, payer executives, healthcare company
overcome these gaps, Chris Lee, one of the most executives, etc.).
experienced healthcare executives having held
senior positions including president of Medtronic Hence we created a platform and a community
Asia Pacific and head of Bayer Healthcare Asia where healthcare startups can get early feedback,
Pacific, started VentureBlick, a platform aiming early buy-in, and early funding support from
to transform healthcare fundraising by matching people who could be their eventual customers.
healthcare startups with medical investors in VentureBlick connects the dots for everyone within
September 2022, in Singapore. In an interaction the healthcare ecosystem with the simple goal of
with BioSpectrum Asia, Chris Lee, Founder and helping new innovations thrive. With the launch
CEO of VentureBlick shares his views on how scheduled for early 2023, the novel platform
VentureBlick will assist early-stage healthcare connects healthcare stakeholders and is currently
startups and on prospects of the burgeoning APAC encouraging healthcare startups and investors to
healthcare startup ecosystem. Edited excerpts; express their interest.

How does VentureBlick assist early-stage How do you strategically identify promising
healthcare startups in securing funds,
product validation, and market insights? healthcare startups and their market

After 30 years in the healthcare industry, I opportunities? How comprehensive is
found this gap between inventors and the market.
There are a lot of good ideas out there that could VentureBlick in attracting both medical and
improve healthcare for all, but many of these
young startups die a natural death because there non-medical investors?
is not enough funding to sustain their product
development journey, or because they couldn’t find We will launch our open call for entries to the
the right market fit for their products. Healthcare is startup community later this year. In the meantime,
very complex. It requires participation and support we are looking to partner with healthcare
from different stakeholders for any new innovations incubators, accelerators, industry associations,
to succeed. and government agencies in various countries to
identify the most promising healthcare startups out
In other words, VentureBlick is the only there.

As long as the startup has a product or solution
for the healthcare industry and is looking for
funding of up to $5 million, they can apply for our
fundraising platform. This is open to all healthcare
sectors from pharmaceuticals and biotech to
medical devices, diagnostics, digital health,
consumer health, animal health, and healthcare
services.

Healthcare startups that apply will be
systematically evaluated by our VentureBlick team

SPEAKING WITH 37

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

and a team of external advisors with expertise specialised support to startups and nurture them
covering different segments of the healthcare together with stakeholders with different expertise.
ecosystem before they are shortlisted and placed on
the fundraising platform for medical investors to How can a startup founder secure funding
review, rate, and invest. with effective product validation and by
optimising its resource management
Once the startups have achieved a certain level without diluting startup control?
of investment from medical investors, participation
will be open to general investors – accredited Our fundraising concept is different from
investors, who are keen on investing in healthcare that of VCs and PEs and typical angel funding,
but do not have medical backgrounds. The unique where founders usually need to give up a sizable
mechanism provides additional access, enhances percentage of equity to one or two lead investors.
both quality and volume of investment, and also With VentureBlick, multiple investors are involved
lowers transaction costs. for every round of fundraising.

Medical investors - physicians, clinicians, and VentureBlick plays as an intermediary to pool
industry professionals benefit from VentureBlick’s the funds together into a special purpose vehicle
platform by investing in the latest healthcare and manage it on behalf of the investors. Each
innovations pre-screened by healthcare experts. It investor will hold only a small fraction of equity,
gives them an opportunity to share their insights which on its own will not be sufficient to influence
and shape innovation within an industry they know control over the startups and cannot be exercised
best. Similarly, general investors benefit from a within a certain period of time.
shortlist of healthcare startups whose ideas have
been screened and validated by medical experts. This arrangement will be subject to the laws and
regulations within each country we operate, but the
How is VentureBlick’s proprietary model idea is to raise funds while giving founders peace
of mind to focus on their product in line with the
aid institutional investors in screening and vision they had.

de-risking startups before they collaborate How do you foresee prospects in the
burgeoning APAC Healthcare startup
with VCs or PEs? ecosystem? What are the expansion and
collaboration milestones ahead, esp for FY
We are specifically focused on supporting 22-23?
healthcare startups at the early stage of their
development. There are two things startups VentureBlick already has a presence in
generally struggle with: how to get funding without Australia, Korea, Singapore, and the USA, and is
losing focus on their product; and finding a way focused on building our teams there towards our
to test if the product they invented is really what launch early next year. We are also working on
their customers want. Startups in healthcare establishing a presence in China and India by early
face even more challenges such as a higher next year. We believe those are the key markets
barrier to market due to regulatory, quality, and that we should tap into and capitalise on the
clinical matters, longer development lead time huge opportunities with the booming healthcare
requiring more rounds of funding, and the lack of ecosystems there. In fact, having an international
commercialisation experience by founders. network will be one of the key differentiators of
our business model. It will be beneficial for both
Through our stringent screening process and investors and startups to broaden their reach,
the insights startups receive from the advisory access, and impact.
board and medical investors, they will be in a
better position to shape and adjust their products We also plan to set up our own venture
to cater to what the market needs. By doing so at capital fund, the VB Healthcare Fund, to invest in
this early stage, we set startups on the right path promising healthcare startups that will help create
from the start, which should contribute to a higher synergies with our fundraising platform and the
rate of success and prepare them for later-stage professional community. In the meantime, we
development with VCs and PEs. are trying to find a creative solution by leveraging
the latest technology to fundamentally solve the
All the startup projects will have to reach a liquidity issue faced by all investors.
certain level of investment from medical investors
before the fundraising is valid and open to non- Hithaishi C Bhaskar
medical investors. This itself is a main differentiator [email protected]
from other fundraising methods. And our
healthcare community will provide on-going and

38 SPEAKING WITH

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

“Accelerated ageing is associated
with reduced diversification of the
gut microbiome that further increases
the risk of developing disease”

« human health and find new ways to treat diseases by
leveraging the microbiome.
Associate Professor
Sunny Wong, Furthermore, accelerated ageing is generally
Programme Director, a manifestation of hidden chronic disease, often
the Centre for caused by a dysfunction in more than one organ of
Microbiome Medicine, the body. Accelerated ageing is also associated with
Lee Kong Chian School reduced diversification of the gut microbiome that
of Medicine further increases the risk of developing disease.
The mechanisms underlying age-related changes in
Singapore’s Nanyang Technological University microbiome composition are not known nor do we
(NTU Singapore), has launched the Centre know the mechanisms by which microbiome richness
for Microbiome Medicine, a research and diversification can be sustained.
facility that aims to improve human health and
find new ways to treat diseases by leveraging the As we age, interventions aimed at preventing
microbiome, the community of microorganisms or reversing organ decline should address
that can usually be found living together in multiple organs, including gut microbes. A holistic
any given habitat. The research centre at NTU approach requires detailed knowledge of organ-
Singapore’s Lee Kong Chian School of Medicine to-organ communication, including gut microbe
(LKCMedicine) has partnered with Singapore’s communication. The gut microbiome theme is
‘National Healthcare Group, Imperial College dedicated to identifying the molecular dynamics
London, and AMILI, a precision gut microbiome of interorgan crosstalk and interaction with gut
company. As microbiome research advances, microbes and to translate this information to develop
researchers hope to uncover the relationship diagnostic and prognostic tools to help identify
between microbiome mechanisms and their the baseline and the transition from a healthy to a
correlation with diseases, to translate discoveries disease state.
into improved diagnostics and new treatments. In
support of microbiome research, the new centre Our mission is to create a healthier world
has received a S$2.5 million supporting fund. In through better understanding of and modulating
an interaction with BioSpectrum Asia, Associate the microbiome which can improve the lives of
Professor Sunny Wong, a clinician-scientist and patients. We also hope to develop new ways to
Programme Director of the centre shares the mission protect and promote human health. Our vision is to
and vision of the centre and plans on addressing be a leading research centre to make discoveries and
comprehensive health challenges. Edited excerpts; transform healthcare. The centre will bring together
advanced research infrastructure and microbiome
How would you describe your primary technology, relevant clinical expertise as well as
mission and vision of the Centre for strong partnerships to develop novel diagnostic and
Microbiome Medicine? therapeutic strategies for patients. Through our work
in microbiome medicine, we hope to make a positive
Microbiome is the little world of microbes living impact and transform healthcare in Singapore and
in each of us. The Centre for Microbiome Medicine beyond.
advances research into the microbiome to improve
What are the potentials and objectives of the

newly launched Centre?

The centre was founded to transform healthcare
through research on microbes and their impact on
human health. As a key research facility within NTU

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Singapore’s LKC Medicine, the centre is uniquely Using human sample collections, advanced DNA
positioned to harness the potential of microbiome sequencing, and laboratory experiments, we will
research in Asia. It brings together leading look at how microbiomes cause a range of diseases
researchers from a variety of disciplines. Through like obesity, diabetes, fatty liver, and chronic lung
its research, it seeks to improve our understanding diseases like bronchiectasis. The centre is currently
of the role of microbes in human health and disease. working on understanding the role of the microbes
The facility also aims to develop new diagnostics, in obesity-related cancers such as colon and other
therapeutics, and preventive strategies against digestive cancers.
microbiome-related conditions. With its innovative
research programme, the centre is poised to make a What are the possibilities for translating
major impact on healthcare in Asia and beyond. microbiome studies into breakthroughs in
diagnostics?
The gut microbiome thematic platform includes
studies using animal models, ex vivo organoids and We are driving the translation of microbiome
population health data. Research activities include, studies into new diagnostics that are more accurate
but are not limited to, identification of signalling and reliable. The increased accuracy is made possible
pathways and molecules that regulate microbe host by the identification of new biomarkers that can be
interactions during health and disease, including used to diagnose a range of conditions. Some of these
brain function, skin biology, liver function and biomarkers are closely related to microbiomes, such
metabonomic biochemical research that identify as microbial genes or proteins that can be detected in
microbial metabolites guiding metabolic homeostasis blood that are sensitive and specific. These tools will
in our body. We are particularly interested in research allow clinicians to make better decisions about which
programmes that aim to uncover the interaction treatments are most likely to be effective. The work
between gut microbes and the immune system and of the centre is therefore exciting and promising, and
how this contributes to maintaining cognition as we it is making a significant contribution to improving
age. The gut microbiome thematic research engine is the accuracy of diagnosis and the quality of care for
dedicated to delivering integrated pathways to sustain patients.
human health life span and slowing down ageing
symptoms by food intervention regimes. Could you summarise the NTU 2025 strategic
plan which aims to address Singapore’s
How do you plan on addressing national priorities?

comprehensive health challenges? The NTU 2025 strategic plan details the
University’s education, research and innovation
We are on the cutting edge of research into ambitions and goals for the next five years. The plan
the microbiome, and its application in a variety highlights three major goals for NTU – achieving
of health challenges. The centre is working to uniformity of excellence in all activities; growing
transform healthcare by harnessing the power of the NTU’s national, regional, and global impact; and
microbiome to develop innovative new diagnoses and deepening disciplinary strengths while nurturing
treatments, for conditions like metabolic diseases, greater interdisciplinary collaborations that span
cancers, lung diseases and skin diseases. The research the entire spectrum of our core activities. We will
being done at the centre has the potential to improve focus on these clusters with potential for significant
the lives of people around the world, and we are intellectual and societal impact, aligned with
excited to see what future innovations will come from Singapore’s national plan.
this cutting-edge research.
We are aligned with NTU’s strategic plan in ‘Health
To develop new treatments for diseases, it is and Society’. The centre is dedicated to advancing this
essential to understand how diseases arise in the research to improve the health of Singaporeans and
first place. We are working hard to gain a better make a positive impact on national health priorities.
understanding of the microbiome, and how it The research conducted at the centre has the potential
interacts with the human and environment. With to make a real difference to our lives. Furthermore,
deep research, we can identify novel biomarkers the microbiome is part of the natural ecosystem, an
or molecular targets for therapeutic development. interface between humans and the environment. The
Additionally, new engineering technologies can be centre will study the impact of microbiome in humans
tested in laboratory and clinical trials to determine and the environment on our health.
their effectiveness in treating disease. These
represent innovative solutions to some of our most Hithaishi C Bhaskar
pressing challenges. [email protected]

40 PARTNER CONTENT

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

First satellite bioanalytical lab
offers fastest option for PBMC
processing in Australian clinical trials

By Madison Esely-Kohlman

On 09 September 2022, Australia will cytokine storm.
welcome its first ever bioanalytical As soon as a blood sample is drawn
laboratory inside a Phase 1 clinical
unit. from a person’s body, that sample begins
Agilex Biolabs, the leading bioanalytical to deteriorate as blood cells are no longer
laboratory supporting Australian clinical trials, resupplied with oxygen. When a clinical
has established its first satellite processing unit trial hinges on reliable count of PBMCs or
staffed with highly specialised technicians on cytokines, whole blood from the patient must
the fifth floor of the CMAX Clinical Research be processed as quickly as possible to stop
facility in Adelaide, SA. The Agilex satellite deterioration and ensure that quantitative
laboratory will perform time-sensitive sample analysis of the sample is an accurate reflection
processing techniques in the same building of the cells in the human they came from. The
as clinical trial participants, opening the door sooner a whole blood sample is treated, the less
for new drug sponsors to reduce risk in their deterioration of cells has occurred and therefor
studies by truncating the decline of sample sample integrity is higher.
integrity.
While clinical sites are well-equipped to draw
Peripheral blood mononuclear cells (PBMCs)
include several hallmark cell types involved
in immune response, such as T cells, B cells,
and NK (natural killer) cells. The count of a
certain blood cell type is often a critical piece in
assessing the impact of a drug on the immune
system. Similarly, cytokines released by immune
cells can indicate level of immune response or
unwarranted inflammatory response, such as

CMAX Clinical Research has been a leader
in delivering early phase clinical trials for over
28 years, making it one of the most respected
clinical trial businesses in Australia. Since 1993
CMAX has delivered more than 700 early phase
clinical trials, including more than 150 first
in human studies. CMAX’s modern facility is
equipped with 78 inpatient beds, inclusive of a
new low-stimuli suite and negative air-pressure
isolation rooms, and has ready access to state-
of-the-art facilities, equipment, and world-class
medical and pharmacology specialists.

PARTNER CONTENT 41

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

samples from clinical trial participants, they Agilex Biolabs is Australia’s largest
are not normally outfitted with a specialised and most technologically advanced
laboratory where sample preparation can take regulated bioanalytical and toxicology
place. Instead, after a sample is taken from laboratory. For 25 years, Agilex has
the vein of a patient it must immediately be equipped biopharma companies
transported by truck to another location for around the globe with reliable and
processing. Through the Healius network defendable, clinical bioanalysis,
and Linear Clinical Research, offsite PBMC biomarker data and toxicology studies
processing is accessible to Phase 1 units as they champion new therapeutics and
throughout Australia. modalities that improve human health.
Our global clientele includes drug
“Even when the processing lab is only sponsors shepherding small molecules,
a few kilometres from the clinical site, risk biologics, cell and gene therapies,
accumulates with every passing minute,” said and vaccines through preclinical and
the CEO of CMAX, Jane Kelly. “An extra stoplight clinical development. Agilex is a proud
here, a road closer there—the integrity of member of the Healius network.
a sample is declining, so every trip is a race
against time. In partnership with Agilex, we are One of Australia’s leading healthcare
eliminating that risk from CMAX clinical trials.” companies, Healius is synonymous
with quality, affordable and accessible
At CMAX, a blood sample will soon go from healthcare for all Australians. It has
patient to processing at a specialised laboratory an expansive network of pathology
unit in 15 minutes—the Agilex satellite laboratories, diagnostic imaging centres
laboratory is only metres away. and day hospitals. Healius provides
quality healthcare services that are
Technicians at the Agilex laboratory on easily accessible and cost efficient,
the 5th floor can immediately stop the clock while supporting the coordination and
and begin processing samples. In addition continuity of quality patient care.
to isolating PBMCs from whole blood, Agilex
laboratory specialists are also trained in other blood stimulation or PBMC processing had to
time-sensitive sample preparation techniques, occur at off-site processing units in Adelaide. A
such as stimulation of whole blood for cytokine clinical research facility with onsite processing
release assays or stimulation of isolated PBMCs capabilities presents an opportunity to achieve
for studies measuring NLRP3 inflammasomes. faster turnaround of sample processing and
more reliable results.”
Following onsite processing, samples are
shipped quickly to the nearby Agilex Biolabs This collaboration between Agilex and
headquarters also located in Adelaide. With CMAX improves reliability of bioanalytical data
their rapid-turnaround sample analysis team, by conserving sample integrity with faster
Agilex provides reliable quantitative data within processing. Equipped with the services of Agilex
just a few days of sample collection at CMAX. and CMAX, drug sponsors can have confidence
in their data and save time getting through
PBMC quantitation by flow cytometry is clinical trials to deliver new, safe, and efficacious
just one of many bioanalytical services Agilex therapies to the patients with an unmet need.
performs for biopharma clients worldwide—the
sprawling campus includes multiple facilities
for large and small molecule bioanalysis,
supporting new and repurposed drug
programs in many therapeutic areas including
immunology, immuno-oncology, infectious
diseases, vaccines, and many others.

In a steadfast commitment to quality and
speed, the satellite laboratory is just one of
several leaps in innovation Agilex is making
to improve pipeline advancement for their
customers.

“This is a huge win for clinical trials in
Australia,” said Agilex Chief Scientific Officer,
Kurt Sales. “Until now, time-critical whole

42 SMART MANUFACTURING

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Building Resilience in Pharmaceutical
and Biologic Manufacturing

« comes with multiple challenges. This is especially
true in a pharmaceutical manufacturing setting.
Marcelo Tarkieltaub,
The pharmaceutical industry has stringent
Regional Director, regulatory compliance needs, highly complex
processes, and sensitive ingredients needing sterile
Southeast Asia, production environments. Biologic manufacturing
has even stricter regulations to ensure drug safety
Rockwell Automation and efficacy.

The pandemic exposed the depth of challenges Flexible and highly efficient factories are
that manufacturers are facing, including needed to improve productivity and efficiency
supply chain disruption, skilled worker in pharmaceutical and biologic manufacturing.
shortages, and risk mitigation. Environmental, social, According to a Plex analysis report, Digital
and corporate governance (ESG) has emerged as a manufacturers benefited from a 26 per cent increase
critical component of the business. Meanwhile, the in revenue performance index (RPI) and a 27 per
combination of data-driven insights, speed, and cent increase in their profit performance index (PPI),
automation is more accessible than ever. As a result, whereas non-digital manufacturers experienced
smart manufacturing is rapidly gaining traction. decreases of 9 per cent in RPI and 2 per cent in PPI.

For manufacturers, the pandemic put a spotlight Let’s uncover the current state of smart
on the urgency for digital transformation and manufacturing, the challenges manufacturers are
processes automation to prepare for the inevitable. facing, and the expectations for the future of the
The State of Smart Manufacturing Report by Plex industry.
Systems, a Rockwell Automation company, revealed
that smart manufacturing adoption accelerated by 50 Key challenges in pharma/biotech
per cent globally in 2021, and these new technologies
are now solving the industry’s critical challenges. manufacturing
Asia Pacific organisations (93 per cent ) view smart
manufacturing as a crucial aspect to their long-term Pharma and biotech manufacturers are operating
success, compared to North America (84 per cent ) in an increasingly competitive and fast-moving
and Europe, Middle East, and Africa (EMEA) (75 per environment, and face multiple challenges including:
cent ).
● Inventory mismanagement: Many
The skilled worker shortage, supply chain companies still use manual processes for routine
disruptions, and risk mitigation show up as key operations, including inventory management.
industry-level growth obstacles every year, but This leads to incorrect charging of materials and
the reasons for each are ever-evolving. To solve consumables on the shop floor and sometimes a
these problems and other dynamics yet unknown, shortage of materials within the warehouse and
technology – specifically smart manufacturing – manufacturing facilities.
is the key. Drivers like the increase in plant-level
data, greater machine and human connectivity, the ● Human error: Many companies still use
growth of Industrial IoT, and the practical use and paper batch records for documentation of their
affordability of once-hyped technologies are changing processes. This can lead to data entry issues, missing
manufacturing and expanding human possibility. signatures, incomplete information, etc. Minor errors
such as increased turnaround times, unnecessary
Technology and automation are driving the spending, and errors can quickly lead to confusion
next generation of manufacturing, and smart and potentially even jeopardise patient health.
manufacturing adoption will continue to accelerate. Human error can cost pharma and biotech businesses
However, digital transformation is no easy feat and from $25,000 to $55,000, topping $1,000,000 or
more per error if product loss is involved.

● Long R&D processes: The pharmaceutical
industry is characterised by capital-intensive and
lengthy R&D processes. Improving, standardising,
and automating processes can result in higher overall
R&D efficiency.

SMART MANUFACTURING 43

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

● Regulatory inspections and compliance: delayed implementation of corrective actions.
Pharmaceutical companies face the challenging task ● Simplified production: MES centralises
of complying with regulations across all aspects
of their business in every market they operate in. production data in context, and quickly and easily
The pressure to stay compliant with regulations recognises deviations from performance targets to
drives pharma and biotech manufacturers to understand the root cause of operational issues.
increase transparency and adopt innovative digital
technologies. ● Operational excellence: Implementing
an MES not only increases the efficiency of the
A Manufacturing Execution System (MES) production line by maximising asset utilisation and
connects, monitors, and controls complex reducing scrap and waste; it also helps increase
manufacturing environments and data flow on the production quality and customer satisfaction.
factory floor. They help pharma manufacturers
overcome these challenges and enable them to ● Review by exception: MES enforces controls
move away from paper-based operations. Further, throughout the manufacturing process to ensure
modularisation of software, which can allow that each batch is produced within a controlled set
incremental technology adoption, is gaining traction of parameters space. This is especially important for
as manufacturers look to become more agile in the critical processes and quality attributes. Utilising an
face of adversity. MES means reviews can focus on exceptions rather
than the entire batch record.
This can help businesses improve plant
productivity, track and synchronise plant resources, ● Regulatory compliance: MES solution
and empower business systems and people with provides better visibility and transparency of
real-time information about what is happening across manufacturing processes and promotes regulatory
production. This reduces risks, time to market, and compliance. This enables businesses to take
production costs and increases process efficiency and control of their vendor compliance, product safety,
product quality. genealogy, and traceability with better reporting and
documentation.
Many companies are wanting to address the gaps
and overlaps between their Information Technology ● Improved cybersecurity: MES applications
(IT) and Operational Technology (OT) domains are embedded with multi-layered protection systems
which can be an obstacle in the production process committed to reducing risk, safeguarding data, and
and cost overruns for solution deployments. Using an monitoring threats. This ensures security at the data
MES, companies can develop an IT/OT partnership, source and protects data integrity throughout the
helping drive the company’s global serialisation value chain.
programme.
Finding right MES
This will enable the company to steward a global
solution to provide regulatory-mandated traceability As manufacturers embark on their digital
for all final product units. The solution converges transformation journeys, finding the right MES
IT and OT domains by integrating vision systems, partner will make all the difference. A well-versed
high-speed control, event management systems, and MES provider can help design and implement
Enterprise Resource Planning (ERP) systems. customised solutions to meet the manufacturer’s or
manufacturing facility’s specific needs. Pharma and
Benefits of an MES biotech manufacturers will also be able to leverage
the MES vendors’ understanding, experience, and
An MES plays a fundamental role in the digital in-depth knowledge of industry-specific products and
transformation process of pharmaceutical and shop-floor processes.
biotech organisations. Here are some of the benefits:
The right MES software can be a game changer for
● Automating real-time data recording: pharma and biotech manufacturers, providing greater
Using an MES, pharma and biotech manufacturers visibility and transparency into manufacturing
can automatically capture real-time data on every processes, promoting compliance, lowering operating
process step, enabling standardisation of processes costs, and improving productivity and quality.
and speeding up decision-making.
Technologies that were once viewed as over-
● Digitisation of production processes: hyped and unlikely to contribute in a meaningful way
MES eliminates the need for paper-based Standard are now deemed vital to success. Cloud, industrial
Operating Procedures (SOPs) or records and hardened devices, and process automation are
equipment and material labels, significantly reducing helping companies overcome challenges and the
inaccurate, unreliable information, human error, and trend is expected to flourish with the evolving
industrial revolution.

44 PEOPLE NEWS BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

CUHK Prof. GSK India names Bhushan
Dennis Lo Akshikar as Managing Director
receives
America’s top The Board of Directors of the GlaxoSmithKline (GSK) Pharmaceuticals
biomedical has appointed Bhushan Akshikar as a Managing Director of the
science prize company for a period of four years effective December 1, 2022. He
succeeds Sridhar Venkatesh who is moving to a new senior role within
Professor Dennis Lo Yuk Ming GSK Group effective November 30, 2022.
from The Chinese University of Akshikar is a seasoned business leader
Hong Kong’s (CUHK) Faculty of with a successful track record of over 26
Medicine (CU Medicine) has been years across local and area roles within
announced as a winner of the the pharmaceutical industry. He joined
Lasker~DeBakey Clinical Medical GSK India in September 2011 to lead
Research Award. The Lasker the specialty and commercial excellence
Awards, created more than 75 business units. In 2014, he was appointed
years ago, are widely regarded as Head of the Mass Markets business. He
America’s top biomedical research was subsequently elevated as the Managing
prize. Prof. Lo was honoured for Director of the publicly listed entity of GSK
his revolutionary contribution to in Nigeria, Africa in end- 2016. Apart from
medical science by discovering a strong business turn-around, he also built a high performing, resilient
cell-free foetal DNA in maternal team. He then moved to Turkey in 2019 to lead GSK’s Vaccines business
blood and developed non-invasive to drive strategic initiatives and launches in both private and tender
prenatal testing for Down segments in the Middle East, Russia CIS & Africa region. In December
syndrome, laying an important 2020, he returned to India as the Commercial Head of the General
cornerstone for the development Medicines business and has led a cultural transformation journey for
of molecular diagnostics. Based the large Rs 2500+ crore General Medicines business.
on the similarity he found in
cell-free foetal DNA molecules Joyce Lee joins Moderna
and tumour DNA molecules, Prof. as General Manager of
Lo has developed genome-wide Taiwan and Cluster Lead
genetic and epigenetic approaches
for cancer detection. This work US-based pharmaceutical firm Moderna has announced the
has laid the foundation for early appointment of Joyce Lee as the General Manager of Taiwan and
detection of multiple types of Cluster Lead. As the company expands its footprint and scale
cancer. Prof. Lo and his team operations within the Asia Pacific region, the company has on-
have successfully developed boarded Joyce to lead operations in Taiwan, driving
technologies that allow the progress to propel the promise of mRNA technology
detection of dozens of cancer across infectious diseases, immuno-oncology, rare
types and have been working with diseases, cardiovascular diseases, and autoimmune
a biotechnology company in the diseases. Joyce was previously working at Amgen
US for clinical applications. as the General Manager- Taiwan. She served in
that position for 4 years. Before that, Joyce was
working at Bristol-Myers Squibb in different
roles across geographies such as Taiwan,
Singapore and the US. Joyce has also worked
at Novartis, P&G, Pfizer and Merck during the
early days of her career. She is an innovative
biopharmaceutical leader with a strong
track record of managing specialty care
and general medicines.

PEOPLE NEWS 45

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com Nobel Prize in

Scientists working on click Medicine 2022
chemistry get Nobel Prize 2022
honour for
The Royal Swedish Academy of Sciences has decided to award the Nobel
Prize in Chemistry 2022 to a trio- Carolyn R. Bertozzi, Stanford University, Svante Pääbo
CA, USA; Morten Meldal, University of Copenhagen, Denmark; and K.
Barry Sharpless, Scripps Research, La Jolla, CA, USA; for the development The Nobel Prize in
of click chemistry and bioorthogonal chemistry. Barry Sharpless, who is Physiology or Medicine
now being awarded his second Nobel Prize in Chemistry, started the ball 2022 has been awarded to
rolling. Around the year 2000, he coined the concept of click chemistry, Svante Pääbo, a Swedish
which is a form of simple and reliable chemistry, where reactions occur geneticist specialising in
quickly and unwanted by-products are avoided. Shortly afterwards, Morten the field of evolutionary
Meldal and Barry Sharpless, independently of each other, presented what genetics, for his discoveries
is now the crown jewel of click chemistry: the copper catalysed azide- concerning the genomes
alkyne cycloaddition. This is an elegant and efficient chemical reaction of extinct hominids and
that is now in widespread use. Among many other uses, it is utilised in the human evolution. Through
development of pharmaceuticals, for mapping DNA and creating materials his pioneering research,
that are more fit for purpose. Carolyn Bertozzi took click chemistry to a new Svante Pääbo accomplished
level. To map important but elusive biomolecules on the surface of cells – something seemingly
glycans – she developed click reactions that work inside living organisms. impossible: sequencing the
Her bioorthogonal reactions take place without disrupting the normal genome of the Neanderthal,
chemistry of the cell. These reactions are now used globally to explore cells an extinct relative of
and track biological processes. Using bioorthogonal reactions, researchers present-day humans. He
have improved the targeting of cancer pharmaceuticals, which are now also made the sensational
being tested in clinical trials. discovery of a previously
unknown hominin,
Left to Right: Carolyn R. Bertozzi, Morten Meldal, K. Barry Sharpless Denisova. Importantly,
Pääbo also found that gene
Bora Pharma strengthens transfer had occurred from
global manufacturing capabilities these now extinct hominins
with new appointment to Homo sapiens following
the migration out of Africa
Taiwan-based Bora Pharmaceuticals, a full-service contract development around 70,000 years ago.
and manufacturing organisation (CDMO), has appointed Don Liscombe as This ancient flow of genes
their Vice President and General Manager to lead its flagship manufacturing to present-day humans has
facility in North America, located in Mississauga, Ontario, Canada. physiological relevance
Liscombe will be responsible for leading the ambitious growth plans for the today, for example affecting
Mississauga facility and its current 400 strong workforce. Bringing a wealth how our immune system
of experience in pharmaceutical operations and the contract manufacturing reacts to infections. Pääbo’s
industry, he is recognised for driving profitable growth through customer seminal research gave rise
service, employee engagement and a commitment to operational excellence. to an entirely new scientific
discipline; paleogenomics.

46 R&D NEWS

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

IIT Jodhpur designs robotic
trainers for lower limb rehabilitation

Researchers at the Indian Institute Most existing robotic systems treat sagittal movement is not sufficient
of Technology (IIT) Jodhpur have the patients by performing motions and movements in transverse
designed robotic trainers that only in the sagittal plane – the (upper and lower body) and
can be used in physiotherapy to imaginary plane that divides the coronal (front and back) planes
treat lower limb disabilities. Limb body into the left and right parts. are also essential. The IIT Jodhpur
disability is a serious malady For complete limb movement, research team has proposed a
among Indians, and is caused by robot manipulator arrangement
age-related ailments, physical that is capable of providing motion
deformations, accidents, strokes, to the ankle in all three planes i.e.,
polio, etc. Recently, there has been sagittal, transverse and coronal
interest in designing robotic devices plane. The trainer proposed by the
for lower limb rehabilitation. In IIT Jodhpur team is conceptually
robotic rehabilitation, the therapist simple and has a modular
only needs to provide supervision mechanical configuration that is
and the setting up of the device. easy to fix and use.

NTU manipulates stress CUHK develops
novel RNA nanoparticle
response in cells to help for atherosclerosis
treatment
slow down ageing
A team of researchers at The Chinese University of
Nanyang Technological University (NTU) Hong Kong (CUHK) has developed a novel RNA
Singapore scientists have found that a stress nanoparticle to offer a potentially safe, effective
response in cells, when ‘switched on’ at a post- treatment for atherosclerosis. The blockage
reproductive age, could be the key to slow down of blood vessels caused by atherosclerosis is a
ageing and promote longevity. In lab experiments major cause of stroke and ischemic heart disease.
on a type of roundworm that shares similarities Research has shown that this RNA nanoparticle
can naturally target receptors of plaque cells for
with humans, the delivering genes to atherosclerotic plaques, while
NTU Singapore team alleviating atherosclerosis by modulating genes
found that switching related to atherogenesis, consequently reducing
on this stress response and stabilising plaque without inducing severe
in aged worms by toxicity. It paves the way for the use of nucleic acid
feeding them a high- nanotechnology to treat cardiovascular diseases.
glucose diet extended Gene regulation is an emerging therapeutic
their lifespan as approach to atherosclerosis, but current technology
compared to worms for gene delivery to plaque remains inefficient.
fed a normal diet. This Existing atherosclerosis nanomedicines mostly
is the first time a link employ cationic carriers to complex gene cargoes
between this stress through electrostatic interactions for gene delivery
response and ageing has been uncovered, said the into plaque cells. Yet, these nanomedicines are
NTU team of their findings published in Nature often bulky, larger than 100 nm, meaning they can
Communications. While further studies are be rapidly filtered by the liver and spleen following
needed to gain a deeper understanding of this link, an intravenous injection before they reach the
the scientists said determining cellular pathways plaque; and they are cationic which may induce
that underpin the ageing process open the door to cytotoxicity in the body.
the development of therapies that could delay the
onset or even tackle age-related disorders such as
cancer, dementia, and stroke.

BIOSPECTRUM AWARDS 47

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

BioSpectrum Asia sets the tone

for Excellence Awards 2022

on December 2 in Singapore
To appreciate the Asian companies and
individuals for their commendable The Jury Special awards have well-defined criteria
performance and achievements during for which BioSpectrum’s editorial team has brought
Calendar Year (CY) 2021, and noting that Asia is together a six-member international jury to evaluate
the new hub for potential growth and innovation, the shortlisted nominees.
BioSpectrum Asia is setting the tone for an exciting
opportunity in the form of BioSpectrum Asia BioSpectrum Asia Excellence Awards 2022 jury
Excellence Awards 2022. comprised of Prof. Patrick Tan Executive Director,
Genome Institute of Singapore; Prof. Gagandeep
These awards are an extension to observe and Kang, Laboratory Director, The Wellcome Trust
highlight the winners in Research Laboratory, India; Clare Blain, Chief
the long battle to tackle
the world’s emerging Executive Officer, Life
health problems and Sciences Queensland
find solutions. Since the Limited, Australia;
years 2020 and 2021 Dario Heymann,
were majorly affected PhD, Chief Research
by the COVID-19 Officer, Galen Growth,
pandemic, we saw Singapore; Dr Satya
the industry players Dash, Founding &
relentlessly working towards developing novel Former Head Strategy;
solutions in the form of diagnostic tests, vaccine, Biotechnology Industry
monoclonal antibodies, drugs etc. to fight the Research Assistance Council (BIRAC), Department
emergency. of Biotechnology (DBT), Government of India; and
Xinyi Tow, Director, Hello Tomorrow Asia Pacific,
Through these awards, BioSpectrum Asia is Singapore.
playing the role of picking tomorrow’s winners, Editor’s Choice awards have been selected by the
nudging today’s entrepreneurs to achieve greater magazine’s editorial team to turn the spotlight onto
glory and honouring yesterday’s key players who laid companies we believe will lead the way in the near
the foundation for success. future.
Back in 2006, the Asia edition of BioSpectrum
The BioSpectrum Asia Excellence Awards 2022 was launched to chronicle the growth of the Life
will be divided into two segments- Jury Special Sciences sector in the Asia region. Since its launch
and Editor’s choice. The former segment has six in March 2006 in Singapore, the magazine has been
categories associated with it- Emerging company or successful in bringing an Asian flavor to the world of
startup of the year; Technology/ product of the year; life sciences, dominated for over a century by global
Woman Entrepreneur of the year; Entrepreneur of companies.
the year; Business person of the year; and Lifetime BioSpectrum Asia’s inaugural Life Sciences
achievement award. Industry Award was conceptualised way back in 2008
and the event took place in 2009. After organising
The latter segment will focus on the following several successful annual events to celebrate
categories- Top Company in Bioprocessing; Top and recognise leadership, entrepreneurship and
Company in Manufacturing Technology and innovation in Asia’s life sciences industry since 2009,
Equipment; Top Company in API development; Top and with a small gap in between, we are now back to
company for Analysis, Testing, and Quality Control; continue this legacy forward in 2022.
Top Company in Packaging & Drug Delivery Services; We hereby invite you to attend the star-studded
Top Company in Supply Chain, Logistics, and evening with your team at Lavender Ball Room, Hotel
Distribution; Top Company in clinical research-based Fort Canning in Singapore on December 2, 2022.
development; and Best Vaccine efforts of the year.

48 SUPPLIER NEWS

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

CMP Scientific & Waters automates solid
phase extraction of
Agilent to advance biological samples with
Andrew+ Pipetting
CE-MS solutions
Waters Corporation has introduced Extraction+
CMP Scientific Corp. has signed a global Connected Device, a new software-controlled product
co-marketing agreement with Agilent for the Waters Andrew+ Pipetting Robot that automates
Technologies to provide an integrated capillary the preparation of biological, food, forensics and
electrophoresis–mass spectrometry (CE-MS) environmental samples by solid phase extraction (SPE).
solution to the life science & pharmaceutical The Extraction+ Connected Device eliminates the need
industry. CMP & Agilent will work together to to manually pipette and extract samples with a hands-
implement new applications for the CE-MS free, automated approach to SPE. It can save scientists
system, which is a sensitive, alternative method up to four hours of bench time for each sample set and
to liquid chromatography-mass spectrometry reduce the risk of user-to-user variability. It is one of
(LC-MS) in mapping biological components. several “connected devices” for the Andrew+ Pipetting
One of CMP’s major products, EMASS-II Robot, which are controlled using Waters’ OneLab
CE-MS ion source integrates seamlessly Software. With a simple and intuitive user interface,
with Agilent’s MS instruments to identify OneLab Software makes it easy for designing and
therapeutic monoclonal antibody (mAb) charge executing automated sample preparation protocols such
variants, & to analyse other diverse biological as pipetting, shaking, cooling and heating, and purifying
molecules. CMP first introduced the EMASS- genomic, plasmid and mitochondrial DNA samples.
II CE-MS, which utilises an electrokinetically
pumped nanospray sheath liquid interface
to provide reliable & robust performance, in
2015. Leading biopharmaceutical companies
now routinely use the EMASS-II CE-MS ion
source in high sensitivity applications ranging
from mAb intact mass analysis, charge variant
analysis, CE-SDS impurity analysis, subunit
analysis, peptide mapping analysis, biosimilar
comparisons to preclinical biotransformation
studies.

Thermo Fisher launches new solutions
to help evolve cell therapy manufacturing

Thermo Fisher Scientific Inc. instrument provides a scalable, of high performing therapies
has unveiled the Gibco CTS flexible, automated and closed as well as the development of
DynaCellect Magnetic Separation system to help optimise the cell the next class of cell therapy
System (DynaCellect) to help cell therapy manufacturing process. breakthroughs. Designed to
therapy developers easily be used with Dynabeads, the
move from process and As a result, DynaCellect DynaCellect system delivers
clinical development to helps ensure the right exceptional performance, high-
commercial manufacturing. cells are isolated and throughput capacity and process
This next-generation failures in manufacturing flexibility while enabling an end-
cell isolation, cell are minimised. With to-end closed process. Cell therapy
activation, cell the cell therapy market manufacturers utilising the
depletion and poised for rapid growth, DynaCellect system can leverage
Dynabeads a highly efficient workflow that
magnetic this evolution in cell reliably delivers high-performing
beads removal therapy manufacturing target cells.
can support the
commercialisation

SUPPLIER NEWS 49

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

PerkinElmer unveils industry-first cell analysis solution

PerkinElmer, Inc. has launched and trackable data reporting all antibodies from PerkinElmer’s
the Cellaca PLX Image Cytometry in one system without requiring BioLegend business are also part
System, a first-of-its-kind complex calibration procedures or of the proprietary solution. The
benchtop platform that enables intense training requirements. To new offering provides researchers
researchers to assess multiple further streamline the customer with expanded cell sample CQA
Critical Quality Attributes analysis options beyond flow
(CQAs) of cell samples experience, optimised cytometry and staining methods,
in a single automated reagent which historically have required
workflow, including cell kits with a variety of different instruments
identity, quality and validated and analytical methods. By
quantity. The cutting- combining these capabilities,
edge Cellaca PLX researchers can now detect
system, designed by the multiple markers simultaneously
company’s Nexcelom (multiplexing) and perform
unit, combines best-in-
class image cytometer immunophenotyping and
hardware, software, viability assays in seconds
validated consumables with an easy-to-use,
modern user interface.

Fujifilm to establish Peli BioThermal
subsidiary in South
Korea to accelerate opens new service
cell culture media biz
centre in Japan
Japanese firm Fujifilm Corporation has announced the
establishment of a local subsidiary in South Korea to Peli BioThermal, the life science industry’s
accelerate business growth of cell culture media. The partner from discovery to distribution, has
new subsidiary commenced its business operations on announced the opening of its new service
October 4. It will offer high-quality cell culture media for centre in Japan. The new facility, which
bioproduction and advanced cell and gene therapies. It is the latest location to be added to the
will be able to, through direct sales and marketing, provide company’s growing network in Asia, is
custom media which fulfil local customers’ needs. The ideally situated near Tokyo’s international
market for cell culture media is currently expanding at the Narita Airport. The latest location will also
rate of more than 10 per cent along with the increasing serve as an additional network station for
demand for antibody drugs and vaccines as well as the the company’s rapidly expanding Crēdo on
development of advanced cell and gene therapies. In Demand rental programme, which offers a
particular, the market in South Korea is growing at the high-performance, flexible rental option for
rate of approximately 15 per cent and is expected to temperature controlled pallet shippers, with
continue its growth in the future. worldwide reach. Strategically located within
Tokyo, Peli BioThermal’s latest facility is in
close proximity to Narita Airport and will
be able to support Japan’s thriving biotech
sector. Tokyo is also home to a number of
leading healthcare companies including
Takeda, Astellas Pharma, Pfizer Japan,
GlaxoSmithKline, Novartis Japan and Eisai.
This latest location joins the expanding
network of Peli BioThermal facilities
servicing key hubs for pharmaceutical
manufacturing and transfer activities and is
available to customers on a global scale.

50

BIOSPECTRUM | NOVEMBER 2022 | www.biospectrumasia.com

Paying the Price of Physical Inactivity
Regular physical activity promotes both
mental and physical health in people of all and physical activity among China’s rapidly growing
ages. Yet, today, more than 80 per cent of elderly population.
adolescents and 27 per cent of adults do not meet
World Health Organisation’s (WHO) recommended The lack of progress in other regions might be
levels of physical activity. This affects not only explained by the fact that, although more than 70 per
individuals over their life course, but also places a cent of countries have an operational physical activity
financial burden on health services and society as a policy, the scale and reach of its implementation is
whole. yet to have a national impact.

According to WHO’s first-ever Global Status In another report on ‘Global trends in insufficient
Report on physical activity released on October physical activity among adolescents’ published on
19, 2022, almost 500 million people will develop November 21, 2019, The Lancet noted that the region
heart disease, obesity, diabetes or other non- with the highest prevalence of insufficient activity in
communicable diseases (NCDs) attributable to 2016 was high-income Asia Pacific for both boys (89
physical inactivity, between 2020 and 2030, costing per cent) and girls (95·6 per cent). The regions with
$27 billion annually, if governments don’t take the lowest prevalence were high-income Western
urgent action to encourage more physical activity countries for boys (72·1 per cent), and south Asia for
among their populations. girls (77·5 per cent).

The report noted that the economic burden To overcome issues related to insufficient physical
of physical inactivity is significant and the cost of activity among the population, governments across
treating new cases of preventable NCDs will reach the world have started introducing related policies.
nearly $300 billion by 2030. Nearly half of these The WHO report pointed out that less than 50 per
new cases of NCDs (47 per cent) will result from cent of countries have a national physical activity
hypertension, and 43 per cent from depression. policy, of which less than 40 per cent are operational.
Three quarters of all cases will occur in lower- It also observed that only 30 per cent of countries
and upper-middle-income countries. The largest have national physical activity guidelines for all age
economic cost is set to occur among high-income groups. In policy areas that could encourage active
countries, which will account for 70 per cent of and sustainable transport, only just over 40 per cent
healthcare expenditure on treating illness resulting of countries have road design standards that make
from physical inactivity. walking and cycling safer.

According to a report published in The Lancet Whilst national policies to tackle NCDs and
on September 4, 2018, the prevalence of insufficient physical inactivity have increased in recent years,
physical activity varied greatly across regions and currently 28 per cent of policies are reported to
income groups in 2016. It found the highest levels be not funded or implemented. To help countries
in Latin America and the Caribbean, high-income increase physical activity, The WHO’s Global Action
Western countries, and high-income Asia Pacific, and Plan on Physical Activity 2018-2030 (GAPPA)
prevalence was more than double in high-income sets out 20 policy recommendations – including
countries than in low-income countries in 2016. policies to create safer roads to encourage more
Across all regions, with the exception of east and active transport, provide more programmes and
southeast Asia, women were less active than men in opportunities for physical activity in key settings,
2016. such as childcare, schools, primary health care and
the workplace.
The Lancet report further pointed out that the
largest increases in insufficient physical activity The global action plan calls for countries, cities
have occurred in high-income countries, whereas and communities to adopt a ‘whole-of-system’
the largest decreases have occurred in east and response involving all sectors and stakeholders
southeast Asia. These decreases are largely explained taking action at global, regional and local levels to
by increased participation in physical activity in provide safe and supportive environments and more
China, the most populous country in the region. opportunities to help people increase their levels of
Leisure-time physical activity in China has increased, physical activity.
which might be explained by increased park use
Narayan Kulkarni
Editor

[email protected]