BioSpectrum Asia May 2018

ternational
stant
cisive
formative

[email protected]/ [email protected] ASIA EDITION

www.biopectrumasia.com

4 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

BIO EDIT

Milind Kokje UPCOMING BIOSIMILARS
OPPORTUNITIES
Chief Editor
Issue of drug pricing seems no more restricted to only poor or developing
[email protected] countries. Even in supposedly rich and developed counties like US, it appears to
be assuming a lot of importance. Ensuring the accessibility of medicines can be a
cost-effective way of treating sickness, as medicine is the most essential component
of health care. But one of the important components of accessibility is affordability
or price, which needs to be taken care of by the policy makers since affordability and
accessibility are directly proportional.

It is disturbing to learn that according to ‘The Commonwealth Fund’ study in
2014, 35 million Americans could not afford prescription medicines. American Heart
Association estimates that failure to take a prescribed medicines or reducing its dosage
costs $ 300 billion extra in medical expenses and contributes 125,000 deaths a year.
The reason being that medicines sold in Canada are 55% less costly than US, points out
Web. Reuter’s analysis says prices of top 20 selling medicines are on an average triple
than in Britain. As a result, 5 million Americans bought their medicines from other
countries in 2013 to save money. Kaiser Family Foundation poll of November 2016
found out that 19 million Americans import medicines from Canada or other countries.

That shows Americans are feeling the pinch. India, Europe and many other
countries are either pursuing or trying to pursue the policies to control drug prices. US
feels like following them if one reads the recent speech of Scott Gottlieb, USFDA Head.

He announced in Healthy Returns conference that USFDA is working on over a
dozen policies to promote use of cheaper versions of costly biotech medicines. The
new policies will be in direction to create more avenues for biosimilar competition.
USFDA has given priority to approving generic drugs by passing over 1,000 generic
drugs in a year. It has approved nine biosimilar therapies. But only three of them have
reached the market and six others have been caught into legal issues as they have been
challenged by drugmakers to protect their own medicines.

Besides, The Alliance for Health Policy in its briefing session in July 2017 on
drug affordability and innovation had considered improving access to generics and
biosimilars as one of the initiatives for the purpose. One hindrance in the process is
permission given to drugmakers to pay generic manufacturer to delay introducing
generic called ‘pay for delay’.

In spite of such obstacles, will the biopharma sector in Asia be able to take advantage
of the USFDA announcement of creating more avenues for biosimilar competition is
the key issue. It had happened in case of generics. The global generics market had
grown to account for 38% of global pharma spending when US adopted regulation
favouring generics in 1984, a LEK consulting report said. It added that Asia has led in
generics adoption with approximately 40% of global generics spending coming from
this region. Being a generics driven area, the APAC region is expected to provide good
opportunity for biosimilars. As claimed by the APAC bioimilars market forecast report,
many Asians companies have biosimilars molecules under development. Over 300
biosimilars are under development in the Asia region. Within Asia, India appears to
be in a good position to take advantage of the situation since it has over 50 biosimilar
products as against 16 in Europe and only two in US. Indian companies are reportedly
making significant investments in biosimilars development.

Asian companies will have to adopt various steps to enter into US biosimilar market
at a large scale. Understanding the regulatory processes and maintaining quality are
two key steps. With all such issues and actions, will Asian pharma companies be able
to follow the generics pattern is to be seen. Experts are of the opinion that they will. If
they do, then it will open up huge opportunities for Asian companies in biosimilars.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 5

BIO MAIL

Transforming Healthcare Innovative Australia

The growing competence and investment The healthcare sector in Australia is
in new healthcare based technologies working big time in order to provide
in China is surely going to promote benefits to patients through regional
the transformation of the healthcare funds. It is heartening to know that a lot
industry. Do carry more articles focusing is being done in the field of innovative
on the healthcare business development research as well. Good article.
in all Asian countries.
- Rashmi Jha, New Delhi
- Emma Manuel, Singapore
Cyber Intrusions
Patent Battle
I have read a lot of articles highlighting
A rather interesting article covering the that as healthcare space continues
issues related to patents in the pharma digitizing all of its information, it
industry. It is in a way providing an continues to attract more attention from
upper edge to the generics sector. Do cyber criminals. Keep addressing such
write more updates on this. concerns as a regular in your magazine.

- Olivia John, Malaysia - Dr Ravi Malik, Mumbai

Vol 13; Issue 05; May 2018 MM Activ Singapore Pte. Ltd. India
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6 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

BIO CONTENT

COVERStory 21

BIOSIMILARS GAINING ACCEPTABILITY

The expiration of patents and other intellectual property rights of biological innovators over the next decade
opens the opportunity for biosimilars to enter the market and increase competition among producers of
biologics. A number of new companies are expected to enter the biosimilars market worldwide, including big
pharma, small biotech, and generic participants. Asia-pacific region has the maximum number of biosimilar
products in development currently as compared to anywhere else in the world, leading to wealth of
opportunities for investigators and patients interested in taking part in biosimilar clinical trials. India, Japan,
South Korea, and China are particularly active in biosimilar research efforts.

27

“Regulations have
influenced evolution
of biosimilars market”

Dr Charu Manaktala
MD, Head of Asia Pacific Biosimilars Center of Excellence at IQVIA

18 ANALYSIS 29 COUNTRY FOCUS

China on expanding Japan offers growth
mode of hierarchical opportunities in
medical system generics & biosimilars

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 7

33 COUNTRY FOCUS BIO CONTENT

“Addressing cancer and dementia CONNECT
are key focus areas for Japan” ENGAGE
SHARE
Soichiro Sasago
Director for Policy Planning, Ministry of Health, Labour and Welfare, Government of Japan Connect with us

35 BIO SPECIAL twitter.com/
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70 Million Indians
suffering from rare diseases facebook.com/
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https://goo.gl/QY4nUp
“Changes are sweeping through the /BS-LinkedIn
healthcare landscape in all countries”
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Pavan Mocherla
Managing Director, BD India and South Asia operations

REGULARS

BioEdit........................................................04
BioMail.......................................................05
Regulatory News.....................................08
Company News.......................................10
Finance News..........................................12
Start-Up News..........................................13
World News..............................................15
WHO News...............................................17
Science News..........................................40
Academics News....................................42
Supplier News..........................................43
People News............................................45
Bio Event....................................................47

8 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

REGULATORY NEWS

Japan grants fast-track approval to Merck molecule

Merck, a leading science and technology company, medical devices, and regenerative medicines, and can
recently announced that the Japanese Ministry of Health, reduce a drug’s review period down from 12 months to a
Labour and Welfare (MHLW) has granted SAKIGAKE target of 6 months. This is the first regulatory designation
‘fast-track’ designation for its investigational molecule granted to tepotinib. The SAKIGAKE Designation
tepotinib for patients with advanced non-small cell System is a core component of the MHLW’s “Strategy
lung cancer (NSCLC) harboring MET exon 14 skipping of SAKIGAKE”. The system’s objective is to designate
mutations. drugs that have the potential of prominent effectiveness
against serious and life-threatening diseases in order to
SAKIGAKE designation promotes research and make them available to patients in Japan ahead of the
development in Japan, aiming at early practical rest of the world.
application for innovative pharmaceutical products,

Israel plans Big USFDA approves Taiwan’s HIV drug
Data health project
A biologically-based alternative HIV treatment developed
Israel is planning to invest nearly 1 in Taiwan and manufactured in China has won approval
billion shekels ($287 million) in a project from the U.S. Food and Drug Administration (FDA),
to make data about the state of health of becoming the first such made-in-China drug to receive
its population available to researchers such approval.
and private companies.
TaiMed Biologics of Taiwan received US marketing
Almost all of Israel’s nine million approval for a novel HIV-1 treatment aimed at multi-drug-
citizens belong to four health resistant patients. China’s WuXi Biologics manufactures
maintenance organizations (HMOs) who Trogarz (ibalizumab) for TaiMed, and Montreal’s
keep members’ records digitally, thus Theratechnologies owns US rights to the drug.
comprising a huge medical database.
Trogarzo, with its unique mechanism, is the first new
Nadav Davidovitch, head of the Public HIV treatment in ten years. The drug will be given as a
Health School at Ben Gurion University second-line treatment to patients who are failing normal
in southern Israel, has stated that the antiretroviral treatments. Trogarzo is administered by
country’s push to harness big data for injection on a bi-weekly schedule. The wholesale price is
healthcare had huge potential, but also said to be $118,000, presumably for a year.
held risks in terms of privacy and medical
confidentiality.

Big data analytics - comparing
information provided by large numbers
of patients - give some of the world’s
biggest drug makers indications of how
medicines perform in the real world.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 9

REGULATORY NEWS

GHIT grants funds for Iran, Mauritania
malaria vaccine research
sign MoU for
The Global Health Innovative vaccine, or TBV. The new grant
Technology (GHIT) Fund has healthcare
awarded the University of Florida from the Global Health Innovative
and partners in the United States Iran and Mauritania have
and Japan $3.2 million to advance Technology Fund will further signed a memorandum
a promising vaccine to prevent of understanding (MoU)
transmission of malaria. development of processes to move on a wide range of health
cooperation issues. The
Rhoel Dinglasan, an associate the vaccine from the experimental MoU deals in particular
professor of infectious diseases with the prevention of
in UF’s College of Veterinary stage to human trials and, diseases, medical coverage,
Medicine and the university’s exchange of expertise,
Emerging Pathogens Institute, ultimately, a clinical treatment. sending of specialized
has spent years developing a missions and equipment
malaria transmission blocking The GHIT Fund is an of health facilities in
Mauritania, Africa. The
international public-private MoU was signed in Tehran
by Mauritanian Health
partnership spearheaded by the Minister Kane Boubacar
and his Iranian counterpart
Government of Japan, the Bill Hassan Qazizadeh Hasehmi.
The memorandum provides
and Melinda Gates Foundation, for the exchange of data and
information on contagious
Wellcome Trust and a group of diseases, creation of health
networks and sharing of
pharmaceutical companies. experiences in the field
of monitoring the quality
Suven Life Sciences of medicines and medical
secures 3 product patents equipment. The parties
also agreed to cooperate on
Suven Life Sciences, a life sciences company based in Hyderabad in training through scholarship
India has been granted a patent each by Norway, South Korea and programmes for medical
Singapore corresponding to new chemical entities (NCEs) for the and paramedic students,
treatment of disorders associated with neurodegenerative diseases. in addition to additional
The patents are valid till 2027, 2034 and 2036, respectively. internships for the current
year and the next two years.
The granted claims of the patents are being developed as therapeutic They also decided to expand
agents and are useful in the treatment of cognitive impairment their cooperation to include
associated with neurodegenerative disorders like Alzheimers disease, research on malaria, HIV-
attention deficient hyperactivity disorder (ADHD), Huntington’s AIDS and maternal and
disease, Parkinson’s and Schizophrenia. child health.

Suven has 4 clinical stage compounds, a Phase 2 undergoing
SUVN502, Phase 2 ready SUVN-G3031, Phase 1 completed
SUVN-D4010 and Phase 1 commenced SUVN-911.

10 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

COMPANY NEWS

Eisai, Nichi- Carna Bio, Sumitomo team up
Iko enter into for neurological drug discovery
strategic
partnership Carna Biosciences, Inc. and Sumitomo Dainippon Pharma Co., Ltd. have
signed an agreement on joint research with the aim of discovering novel
Eisai Co., Ltd. and Nichi-Iko kinase inhibitors for psychiatric and neurological disorders, as well as on
Pharmaceutical have entered the subsequent development and commercialization of such therapeutic
into a strategic alliance agents. Under the agreement, the two companies will commence joint
agreement as well as a share research with a view toward discovering novel kinase inhibitors indicated
transfer agreement for a capital for psychiatric and neurological disorders by combining accumulated
and business alliance, aiming Carna Biosciences’s know-how on kinase inhibitor discovery with
to expand and grow the generic Sumitomo Dainippon Pharma’s know-how on drug discovery research
pharmaceutical business and in the area of neuroscience. Sumitomo Dainippon Pharma will retain
bring about increased profit for exclusive worldwide rights to the clinical development and marketing of
both companies by leveraging any kinase inhibitors that may be discovered through the joint research
the assets and strengths of both and that Sumitomo Dainippon Pharma decides to commercialize for all
companies to their full potential therapeutic areas except oncology.
and maximizing synergies.
Under the agreement, Eisai The two companies expect that this joint research project will
will transfer all shares of Eisai’s allow them to deliver innovative drugs in the area of psychiatry
wholly-owned subsidiary Elmed and neurology, where unmet medical needs are high. Pursuant to
Eisai Co., Ltd. to Nichi-Iko the Agreement, Sumitomo Dainippon Pharma will provide up to
incrementally in accordance 80 million yen to Carna Biosciences with an upfront payment and
with progress of the strategic milestone payments in each research phase.
alliance agreement, and both
companies will promote Dongkoo Bio signs deal
cooperation in building Eisai’s to sell OTC prostate drug
Total Inclusive Ecosystem
as well as collaboration on South Korea based Dongkoo Bio & Pharma has signed a licensing-in
the active pharmaceutical deal with Swedish drugmaker AB Cernelle to sell Cernitol Novum, an
ingredient (API) business over-the-counter (OTC) treatment for chronic prostatitis.
promoted primarily at Eisai’s Under the agreement, the Korean drugmaker will exclusively supply
Vizag Plant in India. Eisai has and distribute Cernitol Novum not only in the local market but
been expanding its API supply China, Taiwan, 10 ASEAN (Association of Southeast Asian Nations)
business which focuses on countries, and six GCC (Gulf Cooperation Council) members such as
high quality price competitive Saudi Arabia and the United Arab Emirates.
API by maximizing its use of Cernitol Novum is an OTC medication that doubled the efficacy of the
the various functions of the active ingredient of Cernilton, which Dongkoo Bio & Pharma began
Vizag Plant in India, including importing in 1978 from AB Cernelle. Cernilton treats benign prostatic
research and development, hyperplasia (BPH) and chronic prostatitis.
manufacturing, quality Dongkoo Bio & Pharma hope that the latest OTC remedy will perform
management and audit. The well in the domestic and overseas prostate treatment market.
Vizag Plant has high quality
manufacturing capacity that
is already compliant not only
with Japan’s quality standards
but also with the high quality
standards of WHO, and has
proven its ability to demonstrate
competitiveness on price.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 11

COMPANY NEWS

Nabriva, Roivant collaborate for
China rights to novel antibiotic

Nabriva Therapeutics, a clinical stage biopharmaceutical company
engaged in the research and development of novel anti-infective
agents to treat serious infections, with a focus on the pleuromutilin
class of antibiotics, and Roivant Sciences, have announced the
initiation of a collaboration to develop and commercialize lefamulin
in greater China.

As part of the license agreement, Nabriva has granted a Roivant
subsidiary an exclusive license to develop and commercialize
lefamulin in the greater China region, specifically the People’s
Republic of China, Hong Kong, Macau, and Taiwan.

The companies will establish a joint development committee to
review and oversee all development and commercialization plans.
Nabriva will receive a $5 million upfront payment and will be eligible
for up to approximately $90 million in additional payments tied
to the successful completion of certain regulatory and commercial
milestones related to lefamulin for community-acquired bacterial
pneumonia (CABP).

Vaccine JV to Mylan, Biocon receive
target FMD in China EC approval for Semglee

Boehringer Ingelheim (BI) has teamed up with two Mylan N.V., one of the world’s leading pharmaceutical
companies, and Biocon Ltd., Asia’s premier
China animal health companies, Beijing KangMu biopharmaceutical company, have announced that
their co-developed biosimilar insulin glargine Semglee
Omni-Honesty Animal Health Products Co., Ltd. has received marketing authorization approval from
the European Commission following the positive
(KMOH), and China Agricultural Vet. Bio. Science and recommendation by the Committee for Medicinal
Products for Human Use (CHMP) of European
Technology Co., Ltd. (ZNWT), to form a $134 million Medicines Agency.

Joint Venture (JV) to address foot-and-mouth disease Semglee 100 units/mL 3 mL prefilled disposable
pen for people with diabetes, is the first biosimilar
(FMD) in pigs, cattle and sheep. BI will contribute its from Biocon and Mylan’s joint portfolio to be approved
in Europe.
vaccine technology to the JV, which will be located
Additionally, the Therapeutic Goods Administration
in Xi’an and called Shaanxi Meili Omni-Honesty (TGA), Australia has also approved biosimilar insulin
glargine Semglee 100 IU/mL 3 mL prefilled pen for
Animal Health. The total investment amounts to 840 the people with diabetes in Australia. The EC approval
of Semglee applies to all 28 European Union (EU)
million yuan. The venture will focus on research, member states and the European Economic Area (EEA)
member states of Norway, Iceland and Liechtenstein.
development and manufacture of vaccines against
In addition to these approvals marketing
foot-and-mouth disease on a site that will answer applications for Semglee have also been submitted in
Canada and the U.S. Several submissions are planned
the latest BSL3+ biosafety standards. Production for key Emerging Markets. Mylan plans to launch
Semglee in Australia later this year and expects to
is expected to start in 2021. ZNWT is approved by begin launching the product across various markets in
Europe in the second half of 2018.
the Ministry of Agriculture to produce the full set of

vaccines against foot-and-mouth disease. KMOH has

extensive market channels across the country,

as well as rich marketing experience.

12 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

FINANCE NEWS

Fujifilm to acquire 2 biotech units for $800M

Fujifilm intends to expand its ability to develop and mainly in its namesake country as well as across Asia.
manufacture biopharmaceuticals and regenerative The dual acquisitions are Fujifilm’s latest efforts to
medicine treatments by acquiring a pair of cell culture
media businesses owned by Japan-based JXTG expand its cell culture and broader biopharma CDMO
Holdings for a combined $800 million. business or BioCDMO business.

Fujifilm plans to acquire all outstanding shares
of Irvine Scientific (ISUS) and IS Japan (ISJ) and
incorporate the businesses into its existing contract
development manufacturing organization (CDMO)
unit Fujifilm Diosynth Biotechnologies.

Both companies to be acquired serve biopharmas
and academic institutions by offering culture media for
biopharmaceutical production, in vitro fertilization,
and cell therapy. Irvine Scientific distributes mainly
in the U.S. and Europe, while IS Japan distributes

ASLAN Pharma files for US listing SemaThera

Singapore-based biopharma firm ASLAN Pharmaceuticals has filed announces
for a proposed initial public offering (IPO) in the US to raise capital
for clinical development of its products and trials. licensing deal

The Taipei Exchange-listed company recently filed a registration for China, Japan
statement with the Securities and Exchange Commission (SEC) for
the proposed issue of its American Depository Shares (ADSs) on Montreal based biotech company,
Nasdaq. The pharma company may be looking to raise up to $86 SemaThera Inc. recently
million through the US IPO. announced the closing of a $2
million co-investment from
ASLAN focuses on therapies for cancers, such as gastric cancer Senju Pharmaceutical Co., Ltd.
and biliary tract cancer, that are considered orphan diseases in the and AmorChem L.P. for the
US and Europe. It plans to use the IPO proceeds to speed up clinical development of its lead candidate,
development of its products. Last year, ASLAN had listed on the ST-102, in preparation for a
Taipei Exchange to raise $33 million. However, earlier reports had clinical trial application in diabetic
suggested that the company had been targeting to raise $40 million macular edema (DME). As part
through the listing. of this financing, SemaThera
also signed an exclusive option
of license with Senju. Under the
terms of the agreement, Senju
acquired the option rights to
exclusively develop and market
SemaThera’s ST-102 in China and
Japan as an intravitreal injection
for DME. Senju would assume all
clinical development costs and
regulatory fees related to China
and Japan. In exchange for these
rights, Senju would pay SemaThera
milestone payments with a total in
eight-digit, and a two-digit percent
royalty on sales. Senju would also
have exclusive rights to other
indications in China and Japan.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 13

Hua Medicine START-UP NEWS
secures $117.4M funding
Singlera
Hua Medicine, a clinical-stage drug development company in China
developing novel therapies for the treatment of Type 2 diabetes, Genomics
recently announced the closing of a combined Series D & Series E
financing of $ 117.4 million. raises funds

The financing included new investors Blue Pool Capital Ltd, GIC worth $60M
Pvt Ltd, AVICT Global, 6 Dimensions Capital, Adrian Cheng (via
K11 Investments), Ping An Ventures, Mirae Asset Financial Group Singlera Genomics, a non-
and certain healthcare funds managed by a leading US investment invasive genetic diagnostics
management firm, as well as existing investors ARCH Venture company in China that
Partners, Eight Roads, F-Prime Capital Partners, Venrock, WuXi focuses on early-stage cancer
AppTec Corporate Ventures, Ally Bridge Group, Harvest Investments, detection, has successfully
co-founders and management. secured a $60 million Series
A+ financing round led by
The financing is expected to fully fund the Company through Green Pine Capital Partners
completion of its two Phase 3 trials and commercial launch in China and Prosperico Ventures
for Dorzagliatin (HMS5552), a new first-in-class, 4th-generation with participation from new
glucokinase activator (GKA) that treats the impaired blood glucose and existing investors, UCF
sensor function, and thereby seeks to address the underlying cause Medical Investment, Jointown
of Type 2 diabetes. Pharmaceutical Group, and Lilly
Asia Ventures among others.
Asian investors lead $140M Based in La Jolla and Shanghai,
funding for Oxford Nanopores Singlera has developed
proprietary technologies
Oxford Nanopore Technologies Ltd, the company behind the only related to the analysis of cell-
portable real-time DNA/RNA sequencer, MinION, has raised free DNA. Singlera’s main
£100M ($140 million) in new investment. Funds were raised from products and services include
global investors including GIC (Singapore), China Construction cancer screening, diagnosis
Bank International (CCBI, China), Hostplus (Australia), and and personalized treatment.
existing investors. Singlera is striving to improve
clinical outcomes for cancer
The funds will be used to support the Company’s next phase patients through early-stage
of commercial expansion. This includes a new high-volume; high- detection and accurate and
tech manufacturing facility in Oxford to meet accelerating demand informative cancer diagnoses.
for Oxford Nanopore’s sequencing technology, and growth of the Singlera has made remarkable
commercial team that already serves more than 70 countries. progress on applying high-
throughput sequencing of
The funds raised will also support R&D as Oxford Nanopore methylated circulating tumor
expands its suite of nanopore analysis devices. The currently DNA (ctDNA) to detecting and
available pocket MinION and desktop GridION are being joined by diagnosing early-stage cancer.
high-throughput modular sequencing with PromethION and small, The funds will help Singlera
single-test sequencing with Flongle. expand the development
and commercialization of its
non-invasive genetic tests for
early-stage cancer detection and
clinical validation studies.

14 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

START-UP NEWS

Oxford Vacmedix raises $12.5M DocDoc
from Chinese & Korean investors plans
product
Oxford Vacmedix UK Ltd (OVM), OVM secured Series A investment scaling with
a UK-based biopharma company from Cancer ROP, a leading South new funding
and a spin out of Oxford University Korean healthcare institution, listed
Innovation, is commercializing the in KOSDAQ, and from existing DocDoc, Asia’s leading
research developed as a partnership shareholders in China. The financing patient empowerment
between Oxford University’s round represents the first time that company has raised
a UK cancer vaccines company has $5.45 million in their
Department of Oncology and been financed by both South Korean latest round of funding.
the Medical Research Council’s and Chinese investors. The financing is led by
Weatherall Institute of Molecular ADAM (Adamas Finance
Medicine. OVM will use the funds to Asia Limited); a London
complete preclinical development listed Investment
With a consortium of South and to enter Phase 1 clinical trials Company who invested
Korean and Chinese investors, with its two lead vaccines, OVM-100 $2 million via a
OVM has completed its Series A and OVM-200, focusing on unmet convertible bond offering
financing round of $12.5m (£9m). clinical need. alongside regional family
offices and high net worth
OVM-100 is an HPV vaccine individuals. DocDoc
targeted at cervical cancer, and leverages the latest in
OVM-200 represents a new type of clinical informatics,
vaccine utilizing survivin to target artificial intelligence
solid tumours. Both vaccines will be and healthcare quality
developed as single agents and in assessment across
combination with immune-oncology Asia’s largest healthcare
agents. The company will also provider network to
continue to develop its diagnostic deliver simple yet
kits for cellular immunity. powerful solutions.
In Asia’s healthcare
Temasek backs $90M market, the majority
funding for JW Therapeutics of the healthcare
decisions are based
A consortium of leading global investors including Temasek and Sequoia on recommendations
from personal network
Capital China has joined the $90-million Series A financing round of or arbitrary sources
which are not backed
Shanghai-based biotech startup JW Therapeutics. Others investors who by concrete data. By
empowering patients
joined the round include YuanMing Capital, Oriza Seed Capital, Yipu with the relevant data
in their time of need,
Capital, AVICT Global Holdings. Existing investors WuXi AppTec Group DocDoc aims to connect
every patient to the
and Juno Therapeutics also participated in the round. The latest financing most suitable doctor
and thereby resulting
will help the team further advance the JWCAR029 clinical programme, in efficiently priced
treatments, better
develop a therapeutic pipeline and build a new outcomes and improved
experiences for patients
commercial manufacturing facility. across Asia.

The startup mainly focuses on

leading cell-based therapy

technologies. JW Therapeutics’

recent developments include

JWCAR029, a CAR-T therapy

(emerging form of cancer

treatment, primarily for blood

cancers like leukaemia) for treatment

of B-cell (a type of white blood cell)

malignancies.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 15

WORLD NEWS

GSK to buyout Novartis’ stake for $13B

GlaxoSmithKline (GSK) has Last year, GSK’s Consumer 2 March 2035 to require GSK to
reached an agreement with Healthcare business reported sales purchase its stake (or specified
Novartis for the buyout of of £7.8 billion and since 2015 sales tranches of it) in the Joint Venture.
Novartis’ 36.5 per cent stake have grown 4 per cent on a 3 year This put option, in both size and
in their Consumer Healthcare CAGR basis (2015-2017 at 2014 possible timing, creates inherent
Joint Venture for $13 billion. CER) with an overall improvement uncertainty for the Group’s capital
The Consumer Healthcare Joint in operating margins from 11.3 per planning. The new agreement to
Venture was formed as part of the cent in 2015 to 17.7 per cent in 2017. buyout Novartis’ stake removes
three-part transaction between Under the terms of the original this uncertainty and improves the
GSK and Novartis which was transaction, Novartis has the right, Group’s ability to plan allocation of
approved by shareholders in 2014. exercisable from 2 March 2018 to capital to its other priorities.

Europe gets a life- Novartis, Harvard team up
extending cancer drug
for cancer immunotherapies
A life-extending cancer drug developed by scientists
at Newcastle University is now available for patients The Wyss Institute for Biologically Inspired Engineering
in Europe. Women with recurrent ovarian cancer at Harvard University and the Harvard John A. Paulson
have been given access to the pioneering treatment, School of Engineering and Applied Sciences (SEAS)
Rubraca, following approval of the drug by the have granted British pharmaceutical company Novartis
European Medicines Agency (EMA). This allows the access to commercially develop their therapeutic,
drug to be available on the European market. biomaterial-based, cancer vaccine technology.

Rubraca, also known as rucaparib, is a class of Under the licensing agreement, spearheaded
drug called a PARP inhibitor which exploits a defect by Harvard’s Office of Technology Development
in the cancer cell’s ability to repair normal wear and (OTD), Novartis will have worldwide rights, in target-
tear to its DNA to kill the tumour cells without unduly limited applications, to bring the biomaterial-based
harming healthy cells. Studies have shown that the cancer immunotherapies into clinical development
oral medication has a high success rate as 54 per cent and translate this approach to treat patients. The
of women on clinical trials had complete or partial technology will aim to promote anti-cancer immunity.
shrinkage of their tumour for an average of 9.2 months.
The EMA has approved the use of the drug for women The trial followed extensive preclinical studies
with ovarian cancer who have been treated with two performed by a collaborative team headed by Mooney
or more chemotherapies and whose tumours have a and Glenn Dranoff. The team demonstrated that the
BRCA mutation. This follows last year’s approval in cancer vaccine could potentially shrink or eradicate
the USA by the Food and Drug Administration. multiple types of tumours, in addition to providing
prophylactic protection, in various animal models.

Dranoff is now global head of exploratory
immuno-oncology at the Novartis Institutes for
Biomedical Research. Novartis has also established
a collaboration agreement with the Wyss Institute to
further develop biomaterial systems for its portfolio of
second-generation immuno-oncology therapies.

16 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

WORLD NEWS

Imperial Logistics Aide Chemists wins accolades

expands supply Aide Chemists Ltd, a chain of retail pharmacies that deliver
quality and affordable branded generic products, was declared
chain in South Africa a winner of the ‘Emerging Brand of the Year’ award at the
maiden Ghana Pharma Awards held in Accra recently.
Healthcare supply chain leader, Imperial
Logistics, has recently commenced Run by a determined young woman, Abigail Amma Abora
operations at its state-of the-art Adoo, seeking to succeed in a male dominated profession, Aide
pharmaceutical compliant storage space, Chemists, a leading retail pharmacy chain in the country has
at Centurion, in South Africa. With state- a firm focus of becoming the first pharmaceutical retail choice
of the-art pharmaceutical compliant in Ghana and the West African sub-region, offering affordable
storage space, and a new faster picking but quality products to clients.
methodology, Imperial Logistics is
expected to optimise its logistics service In 2015, Aide Chemists expanded into other regions in
for various customers. It will also help the country with 20 outlets, selling prescriptions and over
Imperial Logistics to transport life-saving the counter drug to customers. Aide Chemists plans to have
medicine to the people of Africa, faster and presence in all the ten regional capitals and key district capitals
more cost-effectively. Imperial Logistics’ by 2019, and to increase its retail outlets to 60 by 2021. On the
expansion included the construction of Corporate Social Responsibility front, Aide Chemists offers
two cold storage warehouses, one newly free health and medical screening every other month to better
built and the other a refurbishment of the the lives of the vulnerable in deprived communities, testing for
existing cold storage facility. Currently, malaria, blood sugar, and typhoid and providing medication
phase one of the Centurion build is to the beneficiaries where necessary and within its remit.
complete, and Imperial has moved its
sister company, Pharmed onsite, thereby
creating a 2-tiered offering of distributor
& wholesaler. Pharmed is a complete
healthcare provider, focused on bringing
reliable, effective solutions to independent
healthcare professionals across South
Africa, to the benefit of the end patients.

Nigeria introduces healthcare fund committee

In compliance with the National Provision Fund is part of the provide essential drugs, vaccines
Health Act and towards National Health Act, a law that and consumables for eligible
increasing funding for the health came into effect in 2016 to primary health care facilities.
sector, the Nigerian government improve the access of Nigerians to
has recently inaugurated a health care delivery. The Act further provides that
National Steering Committee 15 per cent of the fund be used for
on Basic Health Care Provision According to the Act, 50 per the provision and maintenance
Fund. According to the Federal cent of the fund shall be used for of facilities, equipment and
Ministry of Health, the committee the provision of basic minimum transport for eligible primary
will seek more resources and package of health services to health care facilities; 10 per cent
ensure smooth operation of the citizens in eligible primary and of the fund shall be used for the
Basic Health Healthcare Provision secondary healthcare facilities
Fund. through the National Health development of human re­sources
Insurance Scheme (NHIS), while for primary health care and 5 per
The Basic Health Healthcare 20 per cent shall be used to cent of the fund shall be used for
emergency medical treatment.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 17

WHO WHO NEWS
recommends
use of first Donors pledge
typhoid
conjugate over $15M
vaccine
to WHO for
The World Health Organization (WHO) is recommending the
introduction of typhoid conjugate vaccine (TCV) for infants and emergencies
children over six months of age in typhoid-endemic countries.
This new policy will help ensure access to typhoid vaccination in Donors have pledged an
communities most impacted by the disease, which is responsible for additional $15.3 million to
nearly 12 million infections and between 128,000 and 161,000 deaths support quick action by the
a year. WHO issued these recommendations following a review of World Health Organization
evidence on TCVs by WHO’s Strategic Advisory Group of Experts (WHO) to tackle disease
(SAGE) on Immunization in October 2017. The group considered outbreaks and humanitarian
data on vaccine safety, efficacy, feasibility, and affordability, as well as health crises through its
growing rates of drug-resistant typhoid. Based on these discussions, emergency response fund
SAGE recommended TCVs for children over the age of six months. in 2018, the Contingency
These recommendations were recently accepted and reported in the Fund for Emergencies (CFE).
WHO updated position paper on typhoid vaccines in the Weekly Canada, Denmark, Estonia,
Epidemiological Report. Germany, the Republic of Korea,
Kuwait, Luxembourg, Malta,
WHO updates DR-TB Netherlands, Norway, and
lab guidance report the United Kingdom of Great
Britain and Northern Ireland
The Foundation for Innovative New Diagnostics (FIND) has supported announced contributions
the World Health Organization (WHO) through the generation of ranging from $20,000 to $5.6
critical evidence that has informed the updated technical report on million at a conference hosted
critical concentrations for drug susceptibility testing of medicines at WHO headquarters in
used in the treatment of drug- Geneva, Switzerland recently
resistant tuberculosis, now – increasing CFE funding
released online. levels to $23 million. This will
enable the rapid financing of
The technical report health response operations in
includes updated laboratory the coming months filling that
parameters for drug critical gap between the moment
susceptibility testing (DST) of the need for an emergency
medicines used to treat drug- response is identified and the
resistant tuberculosis (TB). point at which funds from other
Testing of drug resistance sources can be released. WHO
against these medicines will seek to secure further donor
require growing Mycobacterium tuberculosis (the bacterium causing commitments to achieve its
human TB) in the laboratory and exposing the growth (cultures) to $100 million funding target for
different concentrations of a specific medicine to determine the best the 2018/2019 biennium.
cut-off (‘critical concentration’) at which the M. tuberculosis strain is
defined as resistant or susceptible to the specific drug.

18 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

ANALY SI S The Beijing Municipal Commission of
Health and Family Planning said on
China on January 28 that Beijing saved about
expanding 6.7 billion yuan ($1.06 billion) on medical
expenses since the separation of clinic from
mode of pharmacy in April 2017. As hierarchical
hierarchical medical care advances, the outpatient visits
in large hospitals have decreased by over
medical 10 per cent, and 20 per cent less patients
system are seeking appointments with experts. In
the meantime, the outpatient visits have
The hierarchical medical system has become an increased by 16 per cent in community
essential system in many developed countries. hospitals.
It plays an important role of forming the basis
for guaranteeing health care. The basic working The recent report on the work of the
of a hierarchical medical system involves initial municipal government highlighted the
establishment of hierarchical medical
diagnoses at primary medical institutions and two- system as this year’s primary task. Each
way referrals among hospitals. In China, which has district in Chia will build a compact medical
treatment unit that strengthens primary
a population of over 1.37 billion, there are many medical care. Meanwhile, the reservation
problems in the medical system, such as biased service will be improved to facilitate
resource allocation and extremely high patient flows patients and crack down on scalpers. The
to large hospitals. Since 2009, China has vigorously Beijing Municipal government has also
promoted the implementation of the hierarchical announced that, by 2020, it will provide
at least three general medical practitioners
medical system to realize rational allocation of and five rehabilitation nursing beds for
medical resources, promote the equalization of every 10,000 residents, and help to
primary medical services, and reduce the cost of raise the average life expectancy
medical services. The hierarchical medical system to 82.4 years old. By the end
launched in April last year with separation of clinic of 2017, a total of 251
from pharmacy started showing some positive community medical
results as Beijing announced in January 2018 that it centers, or 75 per
saved $1.06 billion on medical costs in 2017. This cent of the
system is likely to provide a new perspective and
strategic choice of health care service, not only for

China, but also for other countries.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 19

ANALYSI S

total, had changed the payment method to paying after over 3,000. The hospital hierarchy is also helped by
diagnosis and treatment, instead of paying upfront. the new reimbursement system, which provides higher
coverage for primary hospitals and below (55 per cent)
Since April 2017, more than 3,700 hospitals and lower coverage for secondary hospitals and above
have eliminated the margins in sales on medication, (50 per cent). In addition, the new system standardized
according to the commission. The separation of clinic the insured categories of medication, medical service
from pharmacy has propelled the establishment of and medical facility for all the urban and rural residents,
hierarchical medical care, rendering 12 per cent and and expanded the types of medicine under coverage
3 per cent less outpatient/emergency visits to tertiary from 2,510 to more than 3,000.
and secondary hospitals respectively, as well as 16 per
cent and 25 per cent more visits to primary hospitals Intensifying medical reform
and community healthcare institutions respectively.
The number of outpatient and emergency visits to It may be recalled that in January last year, the
medical experts has also decreased, making it easier for Chinese State Council released a circular in an effort
patients with real needs to make such appointments. to enhance medical reform during the 13th Five-Year
Plan period (2016-2020). According to the circular,
From January 1, this year the city merged urban China has made substantial improvement in medical
and rural medical insurance policies to undertakings since the 12th Five-Year Plan, with 95
become an integrated insurance per cent basic medical coverage and steady integration
policy for both urban and rural of urban and rural insurance. The circular notes that in
residents in Beijing. This the next five years, the nation looks to build a complete
expanded the number of public hygiene and medical service system, guarantee
medical institutions medicine supply and decrease personal expenses on
under insurance medical care. Meanwhile, efforts should be made to
coverage to optimize distribution of medical resources, clarify roles
of medical institutions at different levels and promote
the sharing of resources and diagnosis results. Health
centers in towns and communities should improve
capacity in diagnosing common diseases. Public
hospitals should be guided in the hierarchical system to
play a role in treating complicated and serious diseases.

SINCE APRIL 2017, MORE THAN 3,700
HOSPITALS HAVE ELIMINATED THE MARGINS
IN SALES ON MEDICATION. THE SEPARATION
OF CLINIC FROM PHARMACY HAS PROPELLED
THE ESTABLISHMENT OF HIERARCHICAL
MEDICAL CARE, RENDERING 12% AND 3%
LESS OUTPATIENT/EMERGENCY VISITS TO
TERTIARY AND SECONDARY HOSPITALS
RESPECTIVELY, AS WELL AS 16% AND 25%
MORE VISITS TO PRIMARY HOSPITALS AND
COMMUNITY HEALTHCARE INSTITUTIONS
RESPECTIVELY. THE NUMBER OF OUTPATIENT
AND EMERGENCY VISITS TO MEDICAL
EXPERTS HAS ALSO DECREASED, MAKING IT
EASIER FOR PATIENTS WITH REAL NEEDS TO
MAKE SUCH APPOINTMENTS.

20 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

ANALY SI S

IN CHINA, HOSPITALS AT DIFFERENT LEVELS level regions. The commission further states that
more policies will be issued regarding the hierarchical
FORMED A REGIONAL MEDICAL CONSORTIUM medical system, hospital management, medical
insurance, medicine supplies and comprehensive
(RMC). THE GOVERNMENT IS URGING supervision. China has earmarked over 1.4 trillion
yuan ($203 billion) in its budget for health and
HOSPITALS AT DIFFERENT LEVELS IN AN RMC medical expenditure in 2017.

TO STRENGTHEN THEIR COOPERATION AND Issues need attention

RECOGNIZE EACH OTHER’S PATIENT MEDICAL China has not established an effective model of the
hierarchical medical system. In China, hospitals at
RESULTS, WHILE ENCOURAGING TWO-WAY different levels formed a regional medical consortium
(RMC). The government is urging hospitals at different
REFERRALS AMONG THEM. HOWEVER, AN levels in an RMC to strengthen their cooperation
and recognize each others’ patient medical results,
RMC CANNOT ACHIEVE THE RESULTS THAT while encouraging two-way referrals among them.
However, an RMC cannot achieve the results that can
CAN BE EXPECTED FROM A HIERARCHICAL be expected from a hierarchical medical system.

MEDICAL SYSTEM. According to a report - ‘Hierarchical medical
system based on big data and mobile internet: A new
The circular notes that as part of the hierarchical strategic choice in health care’ published in JMIR
system, family doctors should be expanded to Medical Informatics in August 2017, from 2005 to
cover the entire population by 2020. The circular 2014, the number of hospitals in China increased
also pushed for establishing an efficient system for by an average of 716 per year, whereas the primary
modern hospital management separating government medical institutions increased by an average of 6785
administration and business operation, while also per year. By contrast, the average annual growth
laying out policies to ensure public hospitals’ role as rate of outpatients in hospitals and primary medical
an independent legal entity. institutions were 11.43 per cent and 6.82 per cent,
respectively. The growth rate of outpatients in primary
At the same time, the government should increase medical institutions has not matched the growth rate
input and adjust medical service prices to reduce of outpatients in institutions. Additionally, the number
operational costs of public hospitals while curbing the of beds and the rate of bed utilization increased more in
unreasonable rise of medical expenditures. It urges the hospitals than in primary medical institutions. Large
establishment of human resource management and hospitals are still overcrowded, while primary medical
a payment system that operates well in the medical institutions are sparsely populated. High-quality
industry, providing performance-related salaries to medical resources are concentrated in large hospitals,
hospital employees. According to the circular, an but primary medical institutions are seriously lacking
efficient national medical insurance system should in medical resources.
also be established, with sustainable fundraising
channels, and an adjusted reimbursement ratio. In addition, the health-information-sharing
platforms and associated mechanisms have not been
In May last year, the National Health and Family established. Patients’ information cannot be shared
Planning Commission (NHFPC) announces that the among hospitals at different levels so patients cannot
hierarchical medical system pilot programme will be enjoy the continuity of medical services between
expanded to reach at least 85 per cent of prefecture- different hospitals. These problems increase the
difficulty and cost of medical services in China, the
report added.

There is need for more research and dialogue
on these issues and the impact associated with this
innovative model of hierarchical medical system.
This model is likely to provide a new perspective and
strategic choice of health care service, not only for
China, but also for other countries.

Narayan Kulkarni
[email protected]

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 21

COVER STORY

BIOSIMILARS

gaining acceptability

The expiration of patents and other intellectual property rights of biological innovators
over the next decade opens the opportunity for biosimilars to enter the market and
increase competition among producers of biologics. A number of new companies are
expected to enter the biosimilars market worldwide, including big pharma, small biotech,
and generic participants. Asia-pacific region has the maximum number of biosimilar
products in development currently as compared to anywhere else in the world, leading to
wealth of opportunities for investigators and patients interested in taking part in biosimilar
clinical trials. India, Japan, South Korea, and China are particularly active in biosimilar
research efforts.

22 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

COVER STORY

The global biosimilars drug market is expected to small molecule generics across important attributes
grow from $2.6 billion in 2014 to $26.5 billion like scientific difficulty, a cost of over $200 million
by 2020 (according to Allied Market Research), to bring to market, manufacturing complexity and
thereby being one of the fastest growing segments in a variety of decision-makers, which are going to
global pharma. Geographically, the global biosimilars require promotion detail and education. Regulatory
market is dominated by Europe, followed by Asia- pathways which set appropriately high standards will
Pacific, Rest of the World (RoW), and North America. be important for ensuring quality, reliably-supplied
However, the Asia-Pacific region is likely to witness biosimilar medicines are available, and in establishing
the highest growth rate during the forecast period. It is both physician and patient confidence.”
considered that Asia-pacific region has the maximum
number of biosimilar products in development A game changer for biopharma
currently as compared to anywhere else in the world,
leading to wealth of opportunities for investigators With the expected loss of patent exclusivity for some
and patients interested in taking part in biosimilar of the leading biological products globally over the
clinical trials. India, Japan, South Korea, and China next five to ten years (patents for more than 10 top-
are particularly active in biosimilar research efforts. selling biologics will expire in the United States and
Europe), there is a significant market opportunity for
Alternatively referred to as bio-pharmaceuticals or the commercialization of equally effective, lower cost
follow-on biologics, biosimilars differ from generics in biosimilars.
the entire manufacturing process, right from the raw
materials used in their manufacturing. The main drivers behind the emergence of this
market are patent expiries on key biologic products,
Scott Foraker, GM and VP, Biosimilars, Amgen better defined regulatory pathways, especially in the
says, “Biosimilar development is a highly skilled, multi- Europe, and escalating healthcare costs which have
step process requiring significant biologics expertise, prompted governments and insurers to find cost
infrastructure and capital investment to successfully containment solutions while maintaining, or even
bring these medicines to market. The fundamental improving quality of care.
concept underpinning the development pathway is
that biosimilars will not be, and are not required to Europe is the largest contributor of biosimilar
be, structurally identical to the reference medicine, revenues worldwide. The market is expected to have
and it follows that each biosimilar will also differ from
another biosimilar. Because of this, we believe that
biosimilars will look more like branded biologics than

“Most generic companies have the
technical know-how. They can leverage
their generic experience for biosimilars.
Companies that have succeeded in Europe
have strengthened their R&D investment

and first-to-market strategies
through collaborations.
Reluctance from physicians
and patients to prescribe
and use biosimilars
because of potential
efficacy and safety issues
might have a negative
impact in the market.”
- Sanjeev Kumar,
Industry Manager-
Asia Pacific, Frost &
Sullivan

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 23

COVER STORY

MARKET DRIVERS biosimilars and patent expiries on major biological
products are expected to make US one of the fastest
● More patent expiries lead to increase in growing major markets for biosimilars in the next five
market opportunity to ten years. In the meantime, the EU and other major
markets in rest of the world are also expected to see
● Reductions in medical expenditure drive the multiple biosimilars launches and significant growth
demand for biosimilar drugs in the market size.

● The emergence of new market participants Although the products have been available
would drive market expansion elsewhere—including Europe—for several years,
physicians and other key stakeholders in the United
an increase in demand for biosimilar drugs with the States have only recently begun to anticipate their
increase in pressure from insurers and payers for a arrival. Commenting on the present situation of the
reduction in medical expenditure. Sanjeev Kumar, market, Sanjeev Kumar said, “While current regulations
Industry Manager- Asia Pacific, Frost & Sullivan allow for the approval of generic copies of conventional
noted, “Most generic companies have the technical pharmaceuticals at greatly reduced costs, until recently
know-how; therefore, they can leverage their generic there has not been the technology nor the regulatory
experience for biosimilars. Companies that have pathway with which to introduce lower-cost versions
succeeded in Europe have strengthened their R&D of biologics. The U.S. Congress recently enacted
investment and first-to-market strategies through legislation to enable and encourage the introduction of
collaborations. Reluctance from physicians and biosimilars/follow-on biologics, paving the way into an
patients to prescribe and use biosimilars because untapped market. However, many obstacles to a clear
of potential efficacy and safety issues might have a abbreviated regulatory pathway and market uptake
negative impact in the market.” in the US remain, such as guidance regarding clinical
research requirements, naming convention, and end-
While the US is the largest biologics market user acceptance to name a few.”
globally, it currently accounts for only a small part
of the global biosimilars market. The emergence In addition to the above factors, across all markets,
of a supportive regulatory approval pathway for the introduction of more affordable and equally
effective biosimilars is expected to increase usage of
biological products among patients who currently
cannot afford such a treatment option.

Driving the market

The expiration of patents and other intellectual
property rights of biological innovators over the
next decade opens the opportunity for biosimilars to
enter the market and increase competition among
producers of biologics. The reason for this opportunity
is to ensure that patients get access to the benefits of
successful blockbuster drugs at a reduced price. Over
a period of time, the number of patent expiries will
influence the market.

The high cost of biologics will spur payers to look
to biosimilars for cost savings. The price of biosimilars
is 20 per cent to 30 per cent lower than the innovator
biologic products. Specialty biologics are among the
most expensive medicines, ranging in price from
$5,000 to $300,000 per year. Over the next 4 to 5
years, the market will see an uptake of more biosimilar
drugs.

A number of new companies are expected to
enter the biosimilars market worldwide, including
big pharma, small biotech, and generic participants.
In particular, some Indian participants such as Dr
Reddy’s, Shantha Biotech, and Reliance Life Sciences

24 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

COVER STORY

are aiming to enter the European market. Sanjeev
Kumar is very hopeful of a bright biosimilars future.
“Because of limited experience, initially these
companies may take some time to capitalize on the
European biosimilars market. However, in the next 5
to 7 years, the contributions of the above companies
in terms of new products and revenue will boost
the market. The increasing number of biosimilar
approvals in Japan, India, LATAM, and other regions
and the financial strength of the big pharma and
generic companies are some of the reasons for the
emergence of new market participants”, he says.

Ramping up capabilities in Asia

Singapore is a highly efficient and a business-friendly
place and promotes companies with highly qualified
labour and support from public institutions. This makes

“Biosimilar development is a highly skilled, it an easy access to transportation routes serving Asia
multi-step process requiring significant and the world. Swiss healthcare giant Novartis, opened
biologics expertise, infrastructure a $500 million manufacturing plant in Singapore in
and capital investment to successfully 2017 that can produce both biologics and biosimilars.
bring these medicines to market. The It also sited the Asia Pacific headquarters of its Sandoz
fundamental concept underpinning the division, which concentrates on biosimilars and
development pathway is that biosimilars generic pharmaceuticals, in Singapore.
will not be, and are not required to be,
structurally identical to the reference In 2014, Amgen, based in America and one of the
medicine, and it follows that each world’s leading biotechnology companies, also opened
biosimilar will also differ from another a S$200 million biologics manufacturing plant in
biosimilar. Because of this, we believe that Singapore, its first in Asia. The firm currently has many
biosimilars will look more like branded biosimilars in its pipeline, in addition to a biosimilar
biologics than small molecule generics for inflammatory diseases (AMJEVITA) that has
across important attributes like scientific been approved by the United States Food and Drug
difficulty, a cost of over $200 million to Administration (US FDA). While the Singapore plant
bring to market, manufacturing complexity currently does not produce biosimilars, Amgen is well-
and a variety of decision-makers, which positioned to support the company’s global growth.

are going to require promotion Talking about Amgen’s approach to biosimilars
detail and education. market, Scott Foraker noted, “As a leading biologics
Regulatory pathways which innovator and biosimilar developer, Amgen has
set appropriately high designed our biosimilars approach and product
standards will be important development programs to directly address the need
for ensuring quality, for confidence in biologic quality, and to continue to
reliably-supplied biosimilar commit a reliable supply. With nearly four decades
medicines are available, and of biologics experience, our biosimilars are subject
in establishing both physician to the same rigor, standard operating procedures
and patient confidence.” and quality controls as our innovator medicines. To
- Scott Foraker, ensure reliable supply, we also manufacture our
GM and VP, biosimilars alongside Amgen’s innovative biologics
Biosimilars, in our cutting-edge facilities. Amgen is specialized in
Amgen unlocking the potential of biology to create new ways
to combat the most difficult diseases. With the growth

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 25

COVER STORY

REGULATORY SCENARIO FOR BIOSIMILARS

JAPAN distributors, the successful manufacturing
» Limited maturity of the biosimilar market and marketing of biosimilars will also require
» Dedicated regulatory pathway
partnerships with domestic companies
» About seven pipeline biosimilar molecules in » Lack of physician trust and enthusiasm for
non-branded drugs exacerbated by unsafe and
development
counterfeit drugs

» Growth potential considered limited today
SOUTH KOREA
based on the reluctance from both prescribers » Most mature biosimilar “development” market

and patients as well as
the general mistrust » Enabled by unprecedented support from the
toward “generic makers”


South
INDIA » Korean government: 35% of the national
» Biosimilar guidelines established in 2012

» Indian companies have extensive experience medical R&D budget was invested into
biosimilars development
in 2012
with generics and have made in-roads in other » Government-set goal for domestic
countries as well through exports
biopharmaceutical companies to win 22% of
» Indian companies grapple with the image of the global biosimilars market by 2020
manufacturing as unsafe with poor quality » Twelve biosimilars have been approved and
drugs another 36 biosimilars are in the pipeline
» Partnerships between global pharmaceutical » Leading the race in the high-risk and complex
companies and domestic companies are development of monoclonal antibody (mAb)
helping to improve the quality of biosimilars biosimilars with 17 mAbs in the pipeline
marketed in India
» Approximately 19 biosimilars in the RUSSIA
development pipeline; large proliferation of » Aims to boost its domestic pharmaceutical
non-original biologics
» Large middle class with growing disposable market and increase the market share of
income who prefer brand name products, domestic players from 20% in 2012 to 50% by
so there is a good opportunity for branded 2020

biosimilars » The strong preference for local manufacturers
will require international companies to engage
CHINA in cooperative partnerships with Russian
» Issued draft biosimilars guidelines in 2014; companies
» Indicative of the burgeoning domestic
once a
clear regulatory pathway for biosimilar industry, a rituximab biosimilar, developed
approval is established, the market will be by Russian company Biocad, was the rst mAb
very attractive – not only due to the volume biosimilar approved in Russia in April 2014


potential but also the growing ability to pay
» About eight biosimilar molecules in the
» Similar to the tight controls requiring development pipeline
international companies to create
partnerships or use domestic pharmaceutical Source: Deloitte- Winning with biosimilars

of Amgen’s portfolio of 10 biosimilars, we are excited Leading Asian companies themselves are
for the future and our strengthened ability to reach ramping up their efforts in biosimilars research and
additional patients around the world. development. In 2012, the South Korean electronics
and healthcare giant Samsung Group joined forces
To bolster their position in Asia’s biosimilars with American biotechnology company Biogen to form
market, Amgen and other Western companies are also a joint venture focused on biopharmaceuticals, called
inking collaborations with Asian firms. In September Samsung Bioepis. To accelerate its development of a
2017, for instance, Amgen announced an agreement biosimilar version of Enbrel, a prominent rheumatoid
with Chinese pharmaceutical company Simcere to arthritis drug created by Amgen, Bioepis set aside 100
co-develop, manufacture and manage the approval bioreactors and assigned 300 researchers to oversee
application process for four of its biosimilars for the 1,500 experiments. In 2016, and after just four
Chinese market.

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COVER STORY

CHALLENGES noted, “This resistance may affect the market heavily
and bring down the probability of success for early
● Regulatory uncertainty use of biosimilars. Over a period of time, this scenario
● Uncertainty and reluctance of physicians will likely change as more experience and education in
biosimilars may produce greater acceptability.
to adopt biosimilars may have a negative
impact on sales The disadvantage of biosimilar manufacturers
● Lack of access to process information may is that they do not have access to the long-term
affect product quality safety and efficacy data or the production process
● Time-consuming approval process may lead information of the originator products. The biosimilar
to slow market growth manufacturing process is complex and deals with a
● Uncertainty of profitability structure cell-based process, and each drug is product specific.
and higher profit margins for biosimilar This may lead to manufacturing difficulties in terms of
manufacturers consistency and quality issues.”

- Sanjeev Kumar, Industry The timeline for approval of biosimilars from
Manager- Asia Pacific, the clinical stage to the commercial product is
Frost & Sullivan approximately 6 to 10 years, which is longer when
compared to generics (3 to 4 years). In context to
years of development, it was the first to introduce its this, Sanjeev Kumar adds, “The complexity of the
etanercept biosimilar in Europe where Wyeth markets manufacturing process, numerous clinical tests
Enbrel. Most biosimilars take eight to 10 years. Very involved, and safety and efficacy concerns have led to a
recently in January 2018, Biogen announces to up prolonged approval time. The longer waiting time may
its share in Samsung Bioepis owing to the record hinder market growth, thereby creating a demand and
biosimilar revenues. This has been made possible due supply gap after patent expiry of blockbuster biologics.”
to the recent approvals and launches of biosimilar
products by Bioepis. Even after approval, profitability of biosimilars
could be hurt by innovators reducing prices to make
Issues need attention biosimilars cost prohibitive.

Although it is generally expected that biosimilars Future ahead
will emerge as a rapidly growing segment of the
biopharmaceutical industry, their uptake faces several As a result of major patent expirations for blockbuster
challenges. biologics, the global biosimilars market is expected
to grow, especially with the new legislation for
The regulatory policies governing biosimilars are biosimilars in the United States, Japan, and other
still in flux, with major markets like China lacking APAC countries. Physicians may be more or less
consistent and clear pathways. The United States willing to prescribe biosimilars, depending on the
issued draft biosimilars guidance in 2013, and indication (cancer or immunological disorders).
although the FDA recently approved the filgrastim Biosimilars for chronic diseases will experience
biosimilar, the agency finalized a formal approval continuous demand with lower costs. Also, products
pathway only till late 2016. with different administration routes may gain favour
over less desirable methods.
Uncertainties and risks for biosimilar
manufacturers will continue to be relatively high Launch of innovative production platforms will
initially. The lack of clear guidelines on substitutability reduce the cost of biosimilar production and thereby
and interchangeability with reference biologics will provide substantial price differentiation. Though the
likely cause physicians to exercise more caution in traditional expression systems are expensive and
prescribing biosimilars until they gain comfort with require a lengthy timeline for process optimization and
the quality and efficacy of biosimilars. Sanjeev Kumar achieving the desired yield, they are still being used for
production of biologics at gram to kilogram quantities.
Hence, biosimilar firms are looking at novel platforms,
which would help them to shorten the time by rapidly
assessing drug candidates and producing products
for preclinical and clinical studies in a shortened
timeframe. The new systems will likely meet the needs
of biosimilar developers in the coming years.

Priyanka Bajpai
[email protected]

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 27

COVER STORY

“Regulations have influenced
evolution of biosimilars market”

« What is the future of biosimilars?

Dr Charu Manaktala The future of biosimilars is bright – regulatory
MD, Head of Asia pathways are becoming clearer and physician
Pacific Biosimilars acceptance is growing.
Center of Excellence
at IQVIA For example, the regulatory pathway for
biosimilars is well established in the International
The biosimilars space continues to evolve Conference on Harmonization (ICH) regions
rapidly and presents a number of unique and regulatory requirements are becoming more
challenges and fierce competition. There are straightforward. To date the European Medicines
many biosimilars in development for some of Agency (EMA) has approved 40 biosimilars for 12
the top-selling biologicals creating an intense unique biological targets; the US FDA has approved
competition amongst the sponsors, especially eight biosimilars (post 2010) for six unique biological
those wishing to enter the western markets. targets. Further, more than 500 biosimilars for 50+
To avoid any delays, biotech companies need unique biological targets are reported to be in various
solid clinical development plans built on stages of development.
the latest regulatory guidance with intimate
knowledge of the clinical trial landscape. Various publicly available market research reports
Recently, Priyanka Bajpai from BioSpectrum indicate that the biosimilars market will be over $13
Asia spoke to Dr Charu Manaktala MD, Head of billion by year 2024. It is projected that biologics
Asia Pacific Biosimilars Center of Excellence market will exceed $390 billion and account for up to
at IQVIA on how companies can design their 28 per cent of the global pharmaceuticals market by
clinical development plans to meet the western 2020. The biosimilars market will continue to grow as
regulators expectations. Dr Manaktala has over biologic patents continue to expire in the future.
20 years of work experience in the healthcare
and pharmaceutical industry and has worked The biosimilars pipelines and approvals so far
in all stages of clinical drug development from were predominantly focused on biological targets with
Phase-I through commercialization. patent expiries around 2020. Some refer to these
targets as “Wave I” biosimilars. There are signs that
companies are now shifting their focus to the next of
biological targets with patent expiries in 2020-2025
and beyond (termed “Wave II” targets).

There are multiple biosimilars in development for
any given biological target, with numbers in double
digits for some of the top selling products such as
Humira, Herceptin, Rituxan /MabThera, Neulasta,
Avastin. However, the market may support only a
limited number of entrants. Consolidation of the
multinational markets is also expected.

Patient and prescriber acceptance of biosimilars is
also improving with the emergence of more data.

This indicates a strong future for biosimilars though
the exact dynamics on pricing and reimbursement are
yet to emerge, especially in the US market.

What role do you see of process innovation and

contract manufacturing in its growth?
Biosimilars development is a challenging area as the
proposed biosimilars need to demonstrate a high
degree of similarity with the innovator biologic in
terms of their physicochemical structure, biological

28 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

COVER STORY

activity, immunogenicity, pharmacokinetics, pathway for biosimilars development and registration
pharmacodynamics, safety and efficacy. The and the current biosimilars regulations create a
biosimilars must be developed within that defined favourable environment for biosimilar manufacturers.
design space to match up to the characteristics of the
reference biologics. First and foremost, regulatory requirements for
biosimilars are in place in most of the largest markets
Technological advances and innovations have and the regulatory expectations are becoming more
certainly helped biosimilars development in many aligned. The regulations rightly recommend the
ways such as increase in yield of protein production developers to focus on establishing robust analytical
by employing an innovative feed media; reduction of biosimilarity as the basis for abbreviated clinical and
overall cost of manufacturing process by improving non-clinical development.
purification techniques and reducing purification
steps. These a just a few examples of process The fact that the guidelines around the world are
innovation that took place since first biological drugs aligned is a very positive influence as this enables
became available on the markets in late 80s. biosimilar developers to have global development
programmes that could support marketing
One important area that is required for biosimilar authorization in multiple markets at the same time.
drug development is mapping out the innovator For example, when the initial guidelines were released
biologic in terms of its structure, physicochemical it was expected that each regulatory agency would
properties and biological activity through the like to see biosimilarity studies against the reference
demonstration of analytical similarity. The use of biologic sourced from their own jurisdiction.
advanced analytical techniques for evaluation potency
and purity of biosimilars can contribute to streamlining However, with the passage of time, and possibly
the non-clinical and clinical development. Biologics based on requests and feedback from biosimilar
with better impurity profiles will likely have better manufacturers, the agencies are now accepting that
safety (& immunogenicity) profiles. some of the pivotal clinical data could be generated
in comparison with reference biologic sourced from
All these innovations could potentially support another jurisdiction. However, clear and stringent
biosimilars to be more competitive on the price terms requirements exist for provision of scientific bridging
and this would be very relevant as some geographies data in support of such an approach.
have experienced crowding in this area with multiple
biosimilars for a given innovator biologic. Similarly, if the agencies in major markets do not
agree to have the same endpoint for a pivotal clinical
Do you think that regulation can have an impact study, it is still possible to have a common study
protocol with local amendments/adaptations.
on how the market evolves? If so, how?
Yes, regulations have definitely influenced the Further many governments and government
evolution of biosimilars market. For example, the agencies around the world have been consistently
EU regulators paved the way for biosimilars around encouraging/recommending/supporting the use of
the globe. In the US, regulations have more slowly biosimilars over innovator biologics. Some of the
evolved and this led to reluctance on the part of some notable examples include the French healthy ministry
biosimilar sponsors with global aspirations to enter that is encouraging prescription of biosimilars with
this market. the target of starting at least 70 per cent of the new
biological prescriptions with the biosimilars; England’s
Current regulations seem to provide a fairly clear National Health Service (NHS) recommendation
that at least 90 per cent of new patients should be
prescribed the best value biological medicine within 3
months of launch of a biosimilar medicine and at least
80 per cent of existing patients within 12 months; US
FDA’s educational initiatives for healthcare providers;
and the Norwegian Ministry of Health and Care
Services that funded the landmark NorSwitch study to
support use/substitution of biosimilar infliximab.

More and more physician expert bodies such as
the EULAR, ESMO, ASCO are endorsing biosimilars
as viable treatment options. Overall, these are creating
a very conducive environment for the biosimilars.

Priyanka Bajpai
[email protected]

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 29

XXXXCXOXUXNXTXRXXYXFXOXCXUXSX

Japan offers
growth

opportunities
in generics
& biosimilars

Demographic pressures on healthcare Japan is the third largest pharma market
costs in Japan are driving a political globally. According to a GlobalData survey,
agenda that will benefit players with the pharmaceutical sector is forecast to reach
lower costs solutions. Generics are an $72 billion by 2021, representing 17 per cent growth
obvious route, but Japan’s status as a between 2011 and 2020. Yet, in the past, the market
highly-developed economy with a pharma has not been an easy access for many international
industry that leads in innovation opens companies. This is accounted by a historically insular
other possibilities, particularly in the longer domestic market as well as impervious entry barriers,
term for the biosimilars segment. In fact, leading to lesser opportunities.
an overwhelming 59 per cent of domestic
respondents believe biosimilars will be the However, times are changing now and Japan’s
fastest growing sector, according to CPhI Pharma economy is in a state of transition towards
Japan 2018 report. The Japanese pharma greater openness. 2018 could be a transformative year
economy is in a state of transition towards for the Japanese pharma market, according to a new
greater openness, potential rewards for report from CPhI 2018, with strong growth evolving
early international movers were cited from elevated use of generics, biosimilars and increased
as another key factor in the rapid shifts internationalization. Japan’s domestic market is
predicted in 2018. CPhI forecasts 2018 looking increasingly at exports, and international
will be a transformative year for Japanese companies are seeking opportunities to invest in and
pharma as the market evolves towards access the large, well-funded healthcare system.
growth in generics, biosimilars and
increased internationalization. For the past ten years, Japan has been able
to sustain the growth curve in pharma industry.
Japan’s demographic profile, with a rapidly ageing
population, provides considerable growth potential
for innovative drugmakers given the growing
demand for chronic disease medicines, along with
broad access to healthcare. The regulatory regime
is amongst the most robust globally, with a well-

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COUNTRY FOCUS

developed drug approval process and one of the LEADING COMPANIES
strongest intellectual property protection systems. IN JAPAN (SALES)
In addition, Japan’s market expenditure - both on a
per capita and absolute basis - is among the highest ● Takeda ● Novo Nordisk
globally, indicating a strong preference for and an ● Daiichi Sankyo ● Merck & Co
ability to pay for high quality medicines. Further ● Astellas ● Sanofi
compounding drugmaker opportunities in Japan is ● Roche ● Bayer
the high level of urbanisation, meaning a high level ● Pfizer ● Johnson &
of access to advanced healthcare facilities. With the ● AstraZeneca
keen interest of international world to enter into the ● Eli Lilly Johnson
domestic market, Japan is spearheaded to develop ● GlaxoSmithKline ● Merck KGaA
into an acquisitioned environment. ● Shire

Challenges damage sectors beyond pharma by increasing labour
Patent expiry, annual price cuts, generics taking hold- costs and reducing competiveness. With already high
Japan is facing a series of challenges. To add on to co-payment rates at around 30 per cent, there is little
the list of problems is the growing funding gap. It is scope for further expansion. Few recent examples of
estimated that if the situation is not put in control, this the impact of these changes on the strategies of pharma
gap will rise to around $160 billion by 2020 and $370 companies are: Recent cuts to Opdivo from Ono
billion by 2035 (according to Deallus Consulting). Pharmaceutical and Gilead’s Sovaldi and voluntary
reduction in Merck’s cancer therapy, Keytruda.
Japan’s government spends $93 billion on
pharmaceutical annually. The pharmaceutical market Japan has long been a great spot for patented
is highly fragmented, with over 1,000 companies, drug consumption, with a strong innovative pharma
hundreds of which are very small enterprises selling industry, but as an impending patent cliff has loomed,
traditional Chinese medicines. many companies are now forced to reconsider their
long- and medium- term strategies.
Simply increasing the country’s insurance
premiums will hardly make an impact as it will Opportunities
Because of numerous challenges, Japan’s pharma
“There are several significant factors we market holds a dearth of opportunities. Through
need to take into account considering diverging strategies, innovative big pharma can
the business landscape in Japan- from step into the market and invest in its pipeline and
investment or regulatory perspective. grow exports. Opportunities for both Japanese and
Japanese government is now proactively international generic companies are clear, especially
starting to enhance and support the with the gradual shift of public attitude from cultural
pharma companies by providing sufficient scepticism of generic medicines. Many Active
grants and providing a consulting system. Pharmaceutical Ingredient (API) and generic finished
However, there is a lot of scope for dosage suppliers have recognised this potential and
improvement. There are very few venture have acknowledged the unique needs and challenges of
the Japanese market. Japan government is committed
capitols to support start-up to transform its pharmaceutical landscape from an
companies. This is a big internally-facing market to a global one.
challenge that needs
special attention.” Generics Market and government initiatives
- Dr Minoru
Ono, Professor promote investments
and Chairman, Once considered one of the most immature generics
Department of markets, Japan has launched a series of reforms since
Cardiac Surgery, 2007 to cope up with the challenges. This resulted in
Graduate School generics reaching 60.1 per cent in the second quarter
of Medicine, The in 2016 in Japan, up from 18.7 per cent in 2007
University of Tokyo (Research and Markets).

In order to reduce the healthcare expenditure
burden, including a burgeoning national budget
deficit the Japanese government is promoting the use

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 31

COUNTRY FOCUS

PMDA APPROVED BIOSIMILARS

Product Name (JAN) Active Substance Therapeutic Area Manufacturer/Company Name
Epoetin alfa BS JCR Pharmaceuticals
[epoetin alfa biosimilar 1] epoetin alfa Anaemia
Filgrastim BS Renal anaemia
[filgrastim biosimilar 1]
filgrastim Cancer Haematopoietic stem cell Fuji Pharma/ Mochida Pharmaceutical
transplantation Neutropenia

Filgrastim BS filgrastim Cancer Haematopoietic stem cell Sandoz
[filgrastim biosimilar 3] transplantation Neutropenia Teva Pharma Japan/Nippon Kayaku
Cancer Haematopoietic stem cell Celltrion/Nippon Kayaku
Filgrastim BS filgrastim transplantation Neutropenia Nichi-Iko Pharmaceutical [2]
[filgrastim biosimilar 2] Crohn’s disease Rheumatoid
arthritis Ulcerative colitis
Infliximab BS (Remsima) infliximab Crohn’s disease Rheumatoid
[infliximab biosimilar 1] arthritis Ulcerative colitis

Infliximab BS (Remsima) infliximab
[infliximab biosimilar 2]

Insulin glargine BS insulin glargine Diabetes Eli Lilly/Boehringer Ingelheim [3]
[insulin glargine biosimilar 1]

Insulin glargine BS insulin glargine Diabetes Biocon/Fujifilm Pharma [4]
[insulin glargine biosimilar 2]
Anemia Cancer Chronic kidney
Nesp darbepoetin alfa failure Kyowa Hakko Kirin
Growth hormone deficiency
Somatropin BS somatropin Turner syndrome Sandoz

Source: EMA website

of generics as a cost-containment tool. To that end, the government has intently abolished many unfavourable
government in May 2017, stated that it would boost rules that it once followed. The ‘two-week restriction’
the use of generic drugs from 56 per cent to more than policy permitting doctors only to write a prescription of
80 per cent by September 2020. two weeks as a safety precaution, as Japan was not a part
of global clinical trials, has now been rendered invalid.
●   From December 2016, the Ministry of Health, This was a major deterrent to the Japanese market.
Labour and Welfare has started reviewing drug prices
annually instead of once every two years, based on the “We are constantly working with other
difference between the actual market price and the Asian countries, on a multitude of research
official price. topics. Intention is to facilitate knowledge
exchange between doctors and professors
●   Although increasing generic substitution and from these countries, while collaborating
yearly pricing reviews are likely to restrict growth in and contributing to areas of mutual
the Japanese pharmaceutical market in the future, the interest. Data security and privacy is also
government is also working to reduce long regulatory a key consideration – especially
processes faced by pharmaceutical industry in order to when it involves sharing
expedite the approval of products and improve access of electronic or patient
to novel therapeutics. This will not only attract foreign documents deployed
companies but also positively influence the healthcare in the system, if they
market. have to be shared across
borders.”
●   PMD Act: The revolutionary 2014 revision of - Soichiro Sasago,
Japan’s keystone pharmaceuticals law (renamed PMD Director for Policy
Act) for pharmaceutical and medical devices was the Planning, Ministry
biggest government initiative. Japan now boasts to of Health, Labour and
have a faster and smoother drug approval process as Welfare, Japan
compared to both Europe and the US. This has brought
a positive change in the approach of international
companies towards the Japanese market, and have
triggered a number of partnerships, licensing deals,
and research collaborations in Japan with existing
business there.

●   Two-week restriction policy: Japan

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COUNTRY FOCUS

Favourable market for biosimilars and expertise to become a “partner-of-choice” for
Japan is considered an emerging market for innovators lacking such infrastructure, as evidenced
biosimilars as the uptake for some products is now by its Japanese commercialization partnership with
at par with generics. It is well known that biologics Faron Pharmaceutical for Faron’s acute respiratory
have gained significant traction in the pharmaceutical distress syndrome asset, Traumakine.
industry for the past couple of years. It is estimated
that by 2020, biosimilars will comprise 27 per cent Global drug development partnerships
of the pharmaceutical market, generating a predicted A more recent trend that has come up as a result of
revenue of $290 billion. Globally, there are more than government initiatives is that the big pharma in Japan has
700 biosimilars approved or in the pipeline. This started to increasingly look to partner with international
is driving their uptake across the world and Japan firms for co-development of novel therapies.
is proving to be a particularly lucrative market for
biosimilar makers. International Domestic Kind of
companies organisations/ collaboration/
Japan’s ageing population, coupled with less companies partnership
stringent regulatory environment than other countries Research
could be the reason behind such a strong motivation Borhringer Kyoto University collaboration to
for the early uptake of biosimilars. The first biosimilar Ingelheim develop drugs to fight
in Japan was approved in 2009, and to date, the hearing loss
Pharmaceuticals and Medical Devices Agency Eli Lilly National Cancer Research
(PMDA), has given the go ahead for 10 biosimilars. Center Japan collaboration on
stomach cancer
The volume shares of biosimilars suggest that Amgen Astellas Pharma Joint venture lead to
in the next five years Japan could become a key approval of Amgen’s
market, closely following the EU’s lead. The overall Samsung Takeda Repatha drug
outlook for biosimilars looks good for Japan. As Bioepis Strategic partnership
a developed country, they have large access to to fund and co-
affordable products, an established regulatory Cardurion Takeda develop multiple novel
environment, good engagement with payers Pharmaceuticals biologic therapies in
in favour of biosimilars and a high presence of unmet disease areas
biosimilars in the pharmaceutical market. PRA Health Takeda Cardiovascular
Sciences development
Japanese globalisation partnership
Companies are now following a different approach to Bayer Strategic partnership
enhance strong distribution and sales capabilities. for clinical
development and
Takeda, the country’s largest pharma company, post-approval work
has been in acquisitive mood recently, and is one on Takeda’s drug
of the main leaders in spearheading a more global pipeline and marketed
outlook from Japan’s pharma sector. Takeda has products.
bought its stem cell therapy partner TiGenix for $626
million, with the suggestion that further acquisitions Opened an innovation
could follow. center in Osaka, Japan

Takeda’s recent joint partnership with the Strategic alliances: New name of the game
manufacturing scale of Teva Pharmaceuticals, one of
the world’s largest generics companies is an excellent The Japan pharmaceutical industry has great
example that showcases how companies are entering potential. As Japanese pharma market is in a state of
into new ventures to improve their sales prowess and transition and is more open to new strategies to boost
distribution relationships. global influx, potential rewards for early international
movers cannot be ignored. However, this cannot be
Similarly, Daiichi Sankyo has partnered with achieved without an appropriate strategy in place.
Amgen to combine its commercial scale with Amgen’s Partnership with domestic firms – taking advantage of
emerging biosimilars portfolio in the Japanese local knowledge as well as technical expertise – appears
market. Maruishi, a smaller Japanese company, a binding strategic move. The potential for direct entry
focuses its energies on a finite set of hospital call points and even acquisitions cannot be discounted in the
along the surgical continuum, where it has a market- medium term which will make this land of rising sun,
leading position in anesthesia and post-surgical pain. a hub of growth for pharma companies.
Maruishi leverages this targeted commercial scale
Priyanka Bajpai
[email protected]

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COUNTRY FOCUS

“Addressing cancer and dementia
are key focus areas for Japan”

« can further the growth of industry and betterment of
patient services.
Soichiro Sasago
Focus is therefore to be able to use this data in an
Director for Policy effective way – we have a record of about 1.3 billion
patients, including names and all other relevant
Planning, Ministry of information, including genome data. Given that
Japan has a high focus on technology advancement,
Health, Labour and including biotechnology and artificial intelligence, it is
our key consideration to leverage all our resources and
Welfare , Government strengths for an outcome that benefits the public as
well as the industry.
of Japan
Also keeping in step with changing times, ministry
Japan is a world leader in technology, innovation is developing its keen sense of business innovation,
and R&D spending, trailing only the United so as to ensure that it can effectively facilitate all
States in the number of new patents filed. Medical interventions that have the potential to benefit Japan’s
device and pharmaceutical consumption are two healthcare and medical industry.
sectors that roughly account to one-third of Japan’s
annual $300 billion in spending on healthcare. For Given Japan’s well-established technology
many years, Japan has also been a global leader in the
discovery and development of new medicines. Japan excellence, what role does it see for itself – in
ranks third for new chemical entities—the core to drug
advancement—only in line after the United States and driving innovation and growth in the healthcare
United Kingdom. In addition, Japan offers universal
health coverage, making its healthcare system one of technology space?
the best in the world. Addressing deadly diseases of cancer and dementia
are key focus areas for Japan. As a result, this is a key
In this interview with Priyanka Bajpai from determinant for deciding where our resources are
BioSpectrum Asia Magazine, Soichiro Sasago, Director directed towards. Additionally, Japan is also keenly
for Policy Planning, Ministry of Health, Labour and interested in collaboration and sharing of expertise in
Welfare, Government of Japan discusses Japan’s these areas.
healthcare vision and assesses the government’s new
efforts to leverage the sector as a key driver of economic Further, another very important focus area is
growth. He also talks about the importance of data in demographic related. The average age of the Japanese
the healthcare industry and how the Japanese policy is getting higher every year, and with it, the associated
makers are putting a step forward to leverage the old age problems and diseases. We also believe that it
recent IT trends. is also a very acute and important challenge not only
for Japan but for the elderly people everywhere, and
Can you please talk about the vision that the specifically in the Asia region. As a result, another
Japanese government has for its healthcare? area where Japanese government is making sure
Japan has a number of healthcare priorities that that we develop appropriate technology and service
are important considerations for the government. offering towards catering to the healthcare needs of
Developing its long-term vision is therefore a tough the elderly. Additionally, this is something that we can
balancing act, amidst these constantly evolving and also offer as a package [technology + service] to other
competing priorities. Asian countries.

Resources and capabilities at our disposal will also Please share some information on the
drive our impetus. Just as a comparison for instance,
Singapore has a very advanced medical industry and collaboration and partnership initiatives that
is achieving amazing successes. Japan, on the other
hand, has a humungous amount of patient data, Japan government has entered into with industry
which can be used for a multitude of outcomes that
or other countries?
We are constantly working with other Asian countries,
on a multitude of research topics. Intention is to
facilitate knowledge exchange between doctors and
professors from these countries, while collaborating

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COUNTRY FOCUS

JAPAN BELIEVES THAT TECHNOLOGIES from all the other noise.

SUCH AS ROBOTS AND SENSORS, AND Is there any specific Japanese healthcare policy

INTERNET OF THINGS (IOT) SYSTEMS IN intervention for the business (pharma, medical

GENERAL, HAVE AN IMPORTANT ROLE device, etc.), for which you will like to share

TO PLAY EVEN IN THE NEAR FUTURE some information or your views on?
While we talked about the need to collect and mine
EVEN WHILE THEY CONTINUE TO BE FAST data for insights, next steps from a government’s point
of view is to analyse trends and impediments that need
EVOLVING. to be addressed at a policy level, so as to facilitate an
accelerated realization of our stated vision.
and contributing to areas of mutual interest. Data
security and privacy is also a key consideration – A specific example to share, which further enables
especially when it involves sharing of electronic or this, is related to new regulation that has just been
patient documents deployed in the system, if they established. We realized that there was a strict law that
have to be shared across borders. prevented sharing of patient information. However, it
is now possible for doctors and hospitals to do this,
How important is data for the healthcare of course subject to explicit patient consent. Intention
industry? is to provide this raw and aggregated data, without
As mentioned earlier, data is critical for healthcare, compromising patient privacy rights, to pharma and
quite similar to a number of other industries. Quality related companies – who can then use it to drive useful
of data being collected is very important, and so is its insights on patient and disease demographics, as also
traceability to source and changes, completeness of identify correlations that will help find meaningful
the profile. It helps to derive necessary analysis, and and timely interventions for improving prognosis and
timeliness for data especially if required for critical service levels.
purposes. Further, I think it is also important to
standardize and centralize data collection and storage On the technology front, is there any Japanese
solutions that are deployed. A number of new and
innovative technologies, in big data analytics, cloud policy view on how recent IT trends should be
computing and data science, are therefore pertinent
for healthcare too. An additional aspect to consider managed or leveraged (referring to areas such
is regarding the need for data rationalization –
especially when it is being collated and aggregated as robotics, machine learning, security, etc.)?
from across multiple sources having varying degrees Japan believes that technologies such as robots and
of authenticity and relevance. Key data analytics and sensors, and Internet of Things (IoT) systems in
insights are required to stifle out useful information general, have an important role to play even in the near
future even while they continue to be fast evolving.
Japanese government is overall very supportive of the
idea and will also ensure that companies who need
this for improving their product or service offerings
are able to do so without any concerns of safety or
policy hurdles.

As a specific example that comes to mind, doctors
and nurses here in Japan are very busy and some of
these innovative technologies can help ensure that
their workplace environment is such that productivity
can be improved and resources deployed in areas where
they add maximum value. Also, for women doctors for
instance – when they have to go on pregnancy leaves,
their professional lives should be least disrupted when
they subsequently join back the workforce, and they
should also be able to seamlessly work from home
while managing work and personal priorities.

This is the kind of enabling ecosystem that the
Japanese government is trying to establish here, by
using these technologies as enablers.

Priyanka Bajpai
[email protected]

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 35

BIO SPECIAL

70 million Indians suffering

FROM RARE DISEASES
According to a recent study
Rare diseases, often referred to as orphan diseases, published in the journal
occur rarely and do not affect a large number of Intractable and Rare Diseases
people. However, there are around 350 million Research, 80 per cent of rare diseases
patients worldwide suffering from rare diseases, are genetic and 35 per cent of deaths
and the majority of them are children. India has in patients with rare diseases occur
in infants with less than one year.
no standard definition for rare diseases as there is New diseases are discovered each
no comprehensive epidemiological data available, year and added to the databases such
as Orphanet database maintained
but the estimates put the number at 70 million. by the European Union. There is no
In terms of treatment options available, there has universal definition of rare disease but
the importance of having a consistent
been limited research in the field of rare disease definition across each country is well
drug development because they are not a public acknowledged.
health priority. Moreover, due to lack of awareness
and knowledge about rare diseases even among “Awareness, accessibility and
healthcare professionals, there is a lack of proper affordability are key needs of patients
suffering from rare disease and early
referral of patients to qualified doctors.

36 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

BIO SPECIAL

diagnosis is a critical challenge in the management of RARE DISEASES
rare diseases. The cost of treatment for rare disorders SCENARIO IN INDIA
is very high and a lifelong expense running into tens
of lakhs of rupees each year. Most patients and their Rare Genetic Incidence Births
families find this an enormous economic burden. Disorders in India per year
There exists an urgent need for clinical research
to ensure better and more affordable medicines Metabolic disorders 1:201 22,477
for rare diseases so we can provide sustainable
care to patients. From a policy perspective, we Congenital 1:50 678,000
Malformations
need legislation that specifically
targets budgetary support, access, Down Syndrome 1:801 34,000
innovation, and investment
for rare disease treatment Congenital 1:2477 10,900
in India”, shares Prasanna Hypothyroidism
Shirol, Founder Member,
Organisation for Rare Disease Duchenne Muscular 1:5000 2,700
India (ORDI). Dystrophy
Very recently, Dystrophy Annihilation Research
Trust (DART), a parent run Ministry of Science and Spinal muscular 1:10000 2,700
Technology, Government of India (Department of atrophy
Scientific & industrial Research) certified research
lab, had organized a 2-day conference in Bengaluru (Source- National Center for Biotechnology Information)
to create awareness on treatments and drug trials,
and to facilitate research into alleviating the scourge the management of Duchenne Muscular Dystrophy
of Muscular Dystrophy. DART is the first Research (DMD). But because it is termed as a rare disease,
lab in India focusing on Duchenne Muscular there is not much awareness of the same. India with
Dystrophy (DMD). At the conference, the 180 its rapidly increasing population
delegates comprised of more than 50 patients and is touted to have more than one
their families, researchers, clinicians and students. lakh boys suffering from DMD.
The affected ones were given a platform to share DART has taken up on itself to be
their views and also given an opportunity to question the nodal center for all information
researchers, industry experts and even policy makers concerning DMD”, points out
regarding their work in the field of rare diseases. Ravdeep Singh Anand,
“Over the past decade huge strides and President, DART.
innovations made in technology has opened up a vast
avenue of potential therapies and interventions for Until sometime, policy makers and public health
authorities had no or minimum awareness about
these conditions. However, today, we can see a
shift in public opinion, which has resulted in the
execution of certain noteworthy actions. Ministry of
Health & Family Welfare (MoH&FW) has finalized
the National Policy for Treatment of Rare Diseases,
with an allocation of Rs 100 crore. A realistic policy
intervention is important to control the growing
threat of rare diseases, but it is required for the states
to be equally involved in implementing the action
plan.

“Last year, the Indian Council
of Medical Research (ICMR) has
launched ‘The Indian Rare Disease
Registry’ which is aimed towards
addressing the unmet needs of
patients with rare diseases and
also helping the country develop
data and information to support
research & development and enhance innovation.
The Registry is an organized system that uses
observational study methods to collect uniform
data to evaluate specified outcomes for a population
defined by a particular disease, condition, or

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 37

BIO SPECIAL

exposure, and that serves a predetermined scientific, treatment costs and do not
clinical, or policy purposes”, mentions Dr Soumya receive the guidance and support
Swaminathan, Deputy Director General for they need. Sanofi Genzyme, the
Programmes, World Health Organisation specialty care global business unit
(WHO). of Sanofi, is committed to working
with the community of patients,
Dr Vijay Chandru, physicians and researchers to
Chairman, Strand Life enable effective diagnosis, focused
Sciences, is currently education and sustainable access to treatment.
spearheading a consortium of Through our charitable access programme, known
doctors, researchers and biotech as INCAP (INdia Charitable Access Program),
companies that has drafted a Rare Sanofi Genzyme is currently providing free Enzyme
Disease and Orphan Drug Policy Replacement Therapy to patients with Lysosomal
for the state of Karnataka. Storage Disorders (LSDs) in India. INCAP has grown
“Karnataka has always been a progressive state in significantly since its inception in 1999 and is widely
the use of science and technology for development. appreciated for its altruistic efforts to support the
The state stands out in bringing together
stakeholders in academia, industry and government OCCURRENCE OF RARE
to address challenges and devise solutions for various DISEASES IN INDIA AND
societal issues. Karnataka is uniquely positioned to OTHER COUNTRIES
address the difficult challenges faced by citizens who
suffered from various rare diseases – it is estimated Country Definition Patients
that nearly 7.2 crore citizens of India fall in this of rare
category and Karnataka has its fair share of perhaps disease
30 to 40 lakh patients. A drafting committee was
appointed to formulate a policy for the state on rare US <0.75% 25-30
diseases and orphan drugs. The recommendations million
made in the draft policy is towards developing rare
disease centres of excellence with high-quality expert Australia <0.11% 1.2 million
care using the existing infrastructure of hospitals
and research institutes like Indira Gandhi Institute EU <0.5% 27-36
of Child Health, NIMHANS, Centre for Human million
Genetics and Kasturba Medical College, Mangalore.
The policy is undergoing some India Not Defined >70 million
final edits before being taken up
for discussion in the concerned Duchenne Muscular 1:5000 2,700
secretariats”, shares Dr Ramesh Dystrophy
Hariharan, Chief
Executive Officer, Spinal muscular 1:10000 2,700
Strand Life atrophy
Sciences.
Of the 7,000-odd rare diseases, (Source: Organization for Rare Diseases India)
only 500 have US FDA-approved
drugs. The remaining have to be
managed by physiotherapy, surgical
intervention, or occupational therapy.
Several multinational companies offer
treatment protocols in India but the cost
is prohibitive.
N. Rajaram, Managing
Director, Sanofi India, explains,
“Given the low burden of rare diseases
in the country, these patients are often
invisible to the public health system.
They incur very high diagnostic and

38 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

BIO SPECIAL

What can be done as lysosomal storage diseases.
We have made an application to
» Mandatory prenatal testing in early launch the drugs. The application
pregnancy is under review and as of yet, we
do not know whether a clinical
» Setting up of special centres for diagnosis, trial will be needed in India”,
treatment and genetic counseling shares Vineet Singhal, Country
Head, Shire.
» Provision of health insurance for families
with rare diseases Recently, Oraxion Therapeutics, Inc., a spin-
off from Bengaluru based Aten Porus Lifesciences
» Investment in basic research on rare diseases entered into an Option Agreement with a US-based
» Policy to guide data sharing and best Biopharmaceutical company, for licensing its lead
asset ORX-301 for the treatment of Niemann-
practices development for clinical trials of Pick Type C disorder (NPC) and Focal Segmental
rare diseases Glomerulosclerosis (FSGS). “We have confirmed
» Formulation of an orphan drug policy the therapeutic efficacy of our lead compound,
» Special incentives to companies to develop ORX-301, in the relevant preclinical models of these
drugs for rare diseases diseases and now plan to transfer the asset to our
partner for clinical development. We would also like
Recommendations of the to acknowledge the support from the Biotechnology
Rare Disease and Orphan
Drug Policy, Karnataka Industry Research Association
Council (BIRAC), an initiative of
» Training of health care professionals and the Department of Biotechnology,
genetic counsellors to work with patients and Government of India, for initial
their families. grant support for our work”, shares
Dr Aditya Kulkarni, Founder
» Development of state of the art diagnostic & Chief Scientific Officer,
centres for statewide adoption of early Oraxion Therapeutics, Inc.
detection (including new born screening, Dr Vijay Chandru, adds, “I feel that a quick and
carrier screening and prenatal testing) for cost-effective option for treatment of rare diseases
appropriate interventions is for Indian companies to develop biosimilars of
existing drugs. Enzyme Replacement Therapies
» Incentives in the form of tax subsidies and can be easily manufactured here. Innovator
fast tracking in regulatory pathways for the pharmaceutical companies should work out licensing
indigenous development of orphan drugs, and agreements with Indian manufacturers”.
therapeutic strategies such as gene editing Due to the rare incidence of these diseases,
and regenerative therapies for rare disease drug-makers find innovation and development
patients. of drugs for them unprofitable. This holds true
worldwide, but more so in India where the lion’s
» Insurance and CSR endowment schemes for share of the healthcare and medical research budget
public health funding for these patients and goes towards more common diseases such as HIV,
their families to financially withstand the tuberculosis and cancer.
challenge of caring for rare diseases.
Dr Manbeena Chawla
LSD community by providing therapy to patients [email protected]
who lack sufficient financial resources to avail of
these therapies. Today, over a hundred patients are
benefitting from the enzyme replacement therapies
being provided under INCAP, for rare diseases like
Gaucher disease, Pompe disease, Fabry disease, and
MPS I (Mucopolysaccharidoses) disease.”

“In India, drugs to treat rare diseases are largely
procured by the government and dispensed at public
hospitals. Currently, Shire sells 12 products in the
form of injectables in India, including those treat
blood disorder haemophilia. We have now applied
to the Drug Controller General of India to introduce
drugs to treat a category of genetic disorders known

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 39

B I O TA L K

“Changes are sweeping through the
healthcare landscape in all countries”

« Asia operations, I will also be driving our investments in
Infrastructure like Warehouse rationalization leveraging
Pavan Mocherla GST roll-out in India; technology adoption for better
in-market sales visibility, Salesforce effectiveness. I will
Managing Director, also be responsible towards increasing our presence
in South Asian Association for Regional Cooperation
BD India and South (SAARC) countries of Bangladesh, Nepal, Sri Lanka
and Maldives to name a few.
Asia operations
What are the major plans for the South Asian
BD (Becton, Dickinson and Company) has recently
announced the appointment of Pavan Mocherla operations in the coming years?
as the new managing director for India and South The medical devices sector plays a critical role at
Asia operations. Pavan will be relocating to India from the each stage of the healthcare continuum and BD has a
US to be at the helm of affairs in the country. With more business footprint in Bangladesh, Sri Lanka, Nepal and
than 25 years of experience across various industries, Maldives. Every year we have been driving increase
Pavan has held multiple positions and managed several in our business in these important countries. We stay
projects in both emerging and developed markets. A committed to continue with our plans. As we launch
strong believer in living the BD values of continuously new products in India, we are making efforts to register
improving and innovating and doing it right, he has them for these markets and launch, thereby providing
been with BD for more than 14 years in business and an opportunity for innovation to be taken to the patients
strategic roles. In his last assignment in BD for Strategic and healthcare providers in these countries.
Innovation, he was instrumental in setting up an
Innovation System to accelerate growth opportunities for Some of our products that have been recently
the markets of China and South East Asia. In his current launched in India are BD Surepath Direct to Slide
role, Pavan will be driving patient safety initiatives like Technology for cervical cancer screening, BD Venflon
Antimicrobial Resistance (AMR), Healthcare Associated I (IV cannula with BD Instaflash Needle Technology).
Infections (HAI) reduction etc. and spearhead projects to Additionally, Multi color flow cytometry (MCF) is
improve access to technology in the global health space a growing application segment where BD Horizon
(HIV, TB etc.) through engagement with stakeholders Brilliant portfolio from our BD Life Sciences-
across Government and multilateral agencies. In an Biosciences reagents business brings differentiated
exclusive interview with BioSpectrum, after taking offerings and unique advantages to its customers.
over as MD for India and South Asia operations, Pavan
Mocherla shared his plans for the company and the What changes do you foresee in the current
current trends in the market.
Excerpts of the interview healthcare trends in the South Asian countries?
Changes are sweeping through the healthcare landscape
Congratulations on your new appointment. What in all countries, more importantly in India. Ayushman
are the key projects you’ll be heading in your Bharat rolled out by the Indian Government, if
current role? implemented well could expand coverage to millions
Thank you. The key expectations from Management is of people for the first time. It can drive our healthcare
to help position BD to serve the patient better in India. market in size, reach newer levels. New Medical Devices
With a rapidly evolving Indian healthcare landscape, rules will enable businesses execute/introduce new
it is important to stay anchored with patient at the products that will bring greater value into the healthcare
centre and not be distracted by headwinds like National ecosystem. Healthcare costs being discussed amongst all
Pharmaceutical Pricing Authority (NPPA) price caps, stakeholders, be it Government, Healthcare Providers or
preference for local players, et al. In addition to giving a Patients. The medical device sector is highly innovative
strategic direction to the organisation’s India and South and I believe, it can address some of the growing
healthcare needs of India without compromising on
patient access to quality healthcare.

Dr Manbeena Chawla
[email protected]

40 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

SCIENCE NEWS

Researchers in Israel invent nanodrops for improving sight

A revolutionary, Business Officer of the new onto the superficial
cutting-edge technology. layer of the corneal
technology, developed epithelium with a laser
by researchers at Nano-Drops achieve their source. The shape of
Bar-Ilan University’s optical effect and correction by the optical pattern
Institute of locally modifying the corneal can be adjusted for
Nanotechnology and refractive index. The magnitude correction of myopia
Advanced Materials and nature of the optical (near sightedness),
(BINA), has the correction is adjusted by an hyperopia
potential to provide optical pattern that is stamped (farsightedness) or
a new alternative to presbyopia (loss
eyeglasses, contact of accommodation
lenses, and laser correction for ability). The laser stamping
refractive errors. onto the cornea takes a few
milliseconds and enables the
A related patent on this nanoparticles to enhance and
new invention was recently ‘activate’ this optical pattern by
filed by Birad - Research & locally changing the refractive
Development Company Ltd., index and ultimately modifying
the commercializing company the trajectory of light passing
of Bar-Ilan University. Steve through the cornea.
Elbaz is a Co-Founder and Chief

Chinese scientists Indian engineers
develop artificial heart
use silk scaffolds
A group of Chinese scientists has developed an
artificial heart using rocket technology and it for bone regeneration
is currently undergoing testing after thorough
experiments on animals. The heart was developed A group of researchers at the Indian
jointly by the China Academy of Launch Vehicle Institute of Technology (IIT) Guwahati has
Technology (CALT) and the Teda International developed a scaffold made of silk composite
Cardiovascular Hospital in North China’s Tianjin. functionalised with copper-doped bioactive
glass to facilitate faster bone regeneration.
The artificial heart uses magnetic The scaffold seeded with stem cells was found
and fluid levitation from a rocket to differentiate into bone cells, facilitate
system, and the “aerospace heart” is growth of blood vessels and successfully
integrate the newly formed bone cells with
expected to move to clinical trials the native bone. The researchers were able
during the 13th Five-Year Plan to replicate the results in rabbits using
(2016-20). functionalised non-mulberry silk composite.
The magnetic and fluid Rabbits with scaffolds implanted at the site
levitation technology can of bone injury showed successful growth of
reduce the friction in the bone cells and integration with the native
device to increase the working bone at the end of three months. The research
efficiency and extend the life team developed the silk composite by adding
span of the power generator. chopped silk fibre to liquid silk. Unlike pure
This technology can reduce silk, the silk composite has greater strength.
damage to the blood and The addition of bioglass further enhanced the
enable the blood pump to strength of the composite. The team plans to
work longer. undertake trials on larger animals now, and
is hopeful to get regulatory clearance soon.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 41

Korean researchers develop SCIENCE NEWS
nano-containers for drug delivery
Australian
A group of researchers at the Institute for Basic Science (IBS) in South
Korea has developed nano-containers to deliver anticancer drugs at precise team to
timings, to specific locations in the body. The study combines uniquely
designed molecules and light-dependent drug release, which may provide develop blood
a new platform to enhance the effect of anticancer therapeutics.
test for lung
The researchers employed a near infrared two-photon laser, which
has the ability to penetrate deeper into tissues with increased accuracy. cancer
The team applied this technology to deliver the chemotherapeutic drug
Doxorubicin to cervical cancer cells (HeLa cells) in the laboratory. They A team of scientists from
observed that the drug was able to exit the vesicles, reach the nucleus of the Walter and Eliza
the cancer cells, and eventually kill them. Hall Institute of Medical
Research in Australia
The two-photon laser (wavelength 720 nanometers) is a better tool to have discovered a unique
use than a single-photon laser (365 nanometers) as it can reach deeper molecular signature of
inside flesh with less scattering. As the irradiated area is smaller, the an aggressive lung cancer
drug delivery is confined to the targeted area, resulting in less damage to called adenocarcinoma.
healthy tissue surrounding the tumor. The biomarker is expected
to aid in predicting
NUS researchers develop patients who would
chip for faster diagnosis potentially respond to
anti-PD-1 and anti-CTLA-4
A team of researchers at the National University of Singapore (NUS) immunotherapies that
has developed a tiny microfluidic chip that could effectively detect are currently used in
minute amounts of biomolecules without the need for complex lab clinics for the treatment
equipment. The tiny biochip can sensitively detect proteins and of other types of cancer.
nano-sized polymer vesicles with a concentration as low as 10ng/ As the molecular
mL (150 pM) and 3.75μg/mL respectively. It also has a very small characteristic is present
footprint, weighing only 500 mg and is 6mm³ in size. Detection in the blood, researchers
can be performed using standard laboratory microscopes, making believe it could possibly
this approach highly attractive for use in point-of-care diagnostics. allow development of a
To complement this chip technology, the team is also developing simple test for detection
a portable smartphone-based accessory and microfluidic pump to of the lung cancer. The
make the whole detection platform portable for outside laboratory researchers intend to
disease diagnostics. The researchers hope to further develop this extend their current
technology for commercialization. research from preclinical
models to human sample
analysis to ensure that
the observations would
be similar in lung
adenocarcinoma patients.

42 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

ACADEMICS NEWS

NTU launches nationwide Insilico establishes
research for lung health
Asia’s First AI R&D
Nanyang Technological University (NTU), Singapore is
planning to launch a nationwide research initiative on lung Base in Taiwan
health, in order to understand the unique characteristics of
lung diseases in Singapore and improve their prevention, Insilico Medicine recently announced that
treatment and care services. The Academic Respiratory its subsidiaries “Insilico Medicine” and
Initiative for Pulmonary Health (TARIPH), which will be “Asia’s First AI R&D Base” are to officially
be established in Taiwan. To begin with,
spearheaded by NTU’s the companies will form an alliance with
Lee Kong Chian the Center for Biotechnology, the Institute
School of Medicine for Information Industry, and TUL
(LKCMedicine), Corporation to implement the “AI Digital
aims to address Health Talent Development Project” in
this pressing gap order to accelerate the integration of
in knowledge for cross-domain talent. Insilico Medicine
the Singaporean was selected by the well-known American
population and venture capital research organization CB
Asian patients. This Insights as one of the 100 companies
will allow medical in the world in the AI field in 2018, and
decisions, practices also named by NVIDIA as one of the
and interventions to be tailored to Asians and the individual top 5 most influential AI companies
rather than the disease. It will develop new DNA-based tests worldwide. Insilico Medicine, the
for common lung infections. TARIPH will also study the Center for Biotechnology, the Institute
economic and social costs of respiratory disease in Singapore for Information Industry, and TUL
and examine how to improve the ways chronic lung disease Corporation will jointly develop a series
patients’ access care. The findings from TARIPH could aid of courses related to AI biomedicine, in
policymakers and the healthcare sector in determining order to develop ICT and biomedical
strategies and implementation of medical interventions, talent, and accelerate the acquisition
healthcare delivery and access, health promotion and disease knowledge on how AI technology can
awareness in Singapore, and potentially throughout Asia. accelerate the development of drugs.

UTAR, CMU sign MoU to study traditional medicines

Universiti Tunku Abdul Rahman partnership and academic its planning stage and it will cater
(UTAR), Malaysia has signed a exchange between the two 250 beds for the western medical
memorandum of understanding universities so that students can treatment in the first phase as
(MoU) with China Medical enhance their knowledge as well well as separate facilities for the
University of Taiwan (CMU) as broaden their worldview. traditional Chinese medicine
to further develop the field of (TCM) and ayurvedic medicine.
Traditional Chinese Medicine UTAR hospital is currently in
(TCM).

The MoU was signed in the
presence of the Minister in fThe
Prime Minister’s Department Dr
Wee Ka Siong. Signing on behalf
of UTAR was its President Prof Dr
Chuah Hean Teik while CMU was
represented by its Vice President
Prof K. S. Clifford Chao.

The MoU is intended
to further strengthen the

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 43

Akonni, Righton enter SUPPLIER NEWS
into strategic partnership
WuXi
Akonni Biosystems Inc. and Chinese in vitro diagnostics company, Righton,
recently announced a commercial agreement that enables Righton to sell Biologics to
Akonni’s products for nucleic acid purification and molecular diagnostics
to researchers, clinical laboratories, and hospitals in China. install largest

The products to be sold include TruTip, Akonni’s best-in-class sample Single-Use
preparation technology, which is low-
cost and simple, yet highly effective Bioreactor
at purifying DNA and RNA from the
most difficult sample types. In addition, WuXi Biologics, a leading
for diagnostic applications, Righton global open-access
plans to commercialize Akonni’s biologics technology
TruDiagnosis system based on the platform company
proprietary TruArray multiplexed offering end-to-end
diagnostic solutions. Righton has made solutions for biologics
an equity investment of $7.5 million in discovery, development
Akonni’s series D fund raising bringing the total investments in the Series and manufacturing,
D round to $13.9 million. The two-way license agreement also grants announced that it has
Akonni exclusive rights to Righton’s extensive molecular diagnostic selected 4,000 liter
product portfolio outside of China. In addition to supporting Righton’s (L) Custom Single
core Oncology business, Righton will support the China launch of Akonni’s Run (CSR) disposable
highly anticipated Tuberculosis (TB) diagnostic product lines. bioreactors from ABEC
for its new commercial
Philips introduces advanced manufacturing facility
tele ultrasound solution (MFG4) in Wuxi city,
Jiangsu, China. The
Philips has unveiled a new and advanced tele-ultrasound solution partnership followed
designed to provide real-time connection between clinicians WuXi Biologics’ successful
across the world through two-way audio-visual calls with live testing and evaluation of
ultrasound streaming. The compatible, integrated tool is built on ABEC’s CSR bioreactor
Philips’ Lumify portable ultrasound system and backed by Reacts technology. The 4,000L
collaborative platform from Canada-based Innovative Imaging CSR is the largest
Technologies (IIT). Reacts platform comprises interactive tools single-use bioreactor
such as augmented reality designed to meet the demands of size available in the
various healthcare professionals and patients. Apart from virtual industry and potentially
guidance, the solution can be used to teach and train medical largest-ever design in
students and by emergency medical personnel, disaster relief conventional disposable
providers and hospitals with satellite clinics. bioreactors, resulting in
higher productivity and
significantly lowering
the cost of goods for
cell culture-based
biopharmaceuticals.
The system also delivers
performance comparable
to stainless steel systems
of that scale and can
be fully customized
for different products,
resulting in higher cell
culture productivity and
faster process transfer and
scale-up.

44 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

SUPPLIER NEWS

Thermo Fisher, Biocept collaborate on Liquid Biopsy Testing

Thermo Fisher Scientific laboratory. providing diagnostic testing
and Biocept have signed a Following that and other services for drug development,
non-binding memorandum companion diagnostic initiatives,
of understanding (MoU) to requirements, Thermo Fisher and to support clinical trials.
collaborate commercially. intends to designate Biocept as a
The companies initially plan Center of Excellence for oncology In addition, the companies
to validate Thermo Fisher’s liquid biopsy initiatives and to may develop new products that
Oncomine next-generation pursue commercial opportunities integrate Biocept’s Target Selector
sequencing liquid biopsy panels with the company. technology with Thermo Fisher’s
in Biocept’s CLIA-certified Ion Torrent NGS platforms and
The firms will initially target Oncomine liquid biopsy panels.
the pharmaceutical industry,

Roche launches immunoassay Quorum Tech
acquires Volocity
for Zika virus detection imaging platform

Roche has launched the first fully automated Zika Canadian owned scientific integrator and
IgG immunoassay to help detect Zika virus infection. developer, Quorum Technologies Inc. recently
The diagnostic test is called the Elecsys Zika IgG announced the acquisition of the highly respected
immunoassay and will be available in CE Mark Volocity software application from PerkinElmer
countries. Health Sciences, Inc. Volocity software has long
been recognized as a powerful, versatile and
As diagnostic testing enables healthcare agnostic image acquisition and analysis platform
professionals to assess the immune status of patients, and as such will bolster Quorum’s portfolio of
Roche’s immunoassay will be of particular importance imaging products. Volocity is the gold standard
to expectant mothers, their partners and travellers from which many other imaging software
in order to detect evidence of a recent Zika virus packages have been developed.
infection.
Volocity provides the most comprehensive
This new assay is part of a significant advancement and capable multi-dimensional imaging platform
from Roche for Zika virus screening. In 2017, the US on the market. Benefitting from its built-in library
Food and Drug Administration (FDA) granted IVD management system, the software provides
status to the cobas Zika test, for use with the cobas the most efficient means to capture, explore
6800/8800 systems, for the screening of blood and and analyze data. Volocity is currently used for
plasma donations in the US. digital image acquisition and analysis by research
scientists throughout the world. Quorum has
The rapid development of assays, including been distributing Volocity software since it was
cobas Zika NAT and Zika IgG antibodies, was first released by Improvision in January 2001.
part of the company-wide response to the World The Quorum team has an intimate understanding
Health Organisation’s declaration of a public health of this platform and can readily assist end users.
emergency during the Zika epidemic in 2016.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 45

PEOPLE NEWS

Pao to head drugs Kaiser Waheed joins
research at Roche
FPPCI Pharma body
Swiss drugmaker Roche has named U.S. cancer expert William
Pao head of its Pharma Research and Early Development President of the Federation of Pakistan
(pRED) business after John Reed decided to leave for certain Chambers of Commerce and Industry
personal reasons. Pao, now head of the oncology discovery and (FPCCI) Ghazanfar Bilour has appointed
translational area for pRED, assumed his new role on April Dr Shaikh Kaiser Waheed as chairman
2. Pao joined Roche pRED in May of the FPCCI standing committee on the
2014 as Global Head of Oncology. pharmaceutical industry for 2018. His
nomination is reflective of the confidence
He came to Roche pRED from reposed
Vanderbilt University Medical in him by
Center, where he was Professor of the FPCCI
Medicine, Director of the Division president, in
of Hematology and Oncology, and view of his
Director of Personalized Cancer contribution
Medicine. in the pharma
sector
He also played leadership during past
roles across a number of years, as an industrialist and business
other departments, including leader. Waheed previously served as
Cancer Biology and Pathology/ Pakistan Pharmaceutical Manufacturers
Microbiology/Immunology. He Association (PPMA) chairman. He
was previously a faculty member at Memorial Sloan-Kettering was elected as SITE Superhighway
Cancer Center in the Human Oncology and Pathogenesis Association of Industry president.
Program. William earned his MD and PhD degrees from Yale Waheed is currently serving as Medisure
University, where he investigated the role of gamma-delta T Pharma Karachi President and Chief
cells in mice. Executive and National Forum for
Environment and Health Chairman. He
Pao and his research team have contributed to over is actively involved in pharma and social
170 publications in fields including cancer biology, cancer welfare activities.
genomics and cancer treatment.

Taiwan researchers win Asian recognition

Huey-jen Jenny Su, president of National Cheng Technological University (NTU); Lam Khin Yong,
Kung University (NCKU) in Tainan, and Michael NTU’s vice-president for research; Chang Meeman
Ming-chiao Lai, a former NCKU president, have been of China’s Institute of Vertebrate Paleontology and
named among the top 100 prize-winning researchers, Paleoanthropology; and Ajoy Kumar Ray of the Indian
academicians, innovators and leaders in Asia Pacific Institute of Engineering Science and Technology.
region.

Su, a public health expert, was cited for her
outstanding leadership, after she received the
2017 Harvard T. H. Chan School of Public Health’s
Leadership Award for her timely and effective response
to two emergency events in Tainan City -- a dengue
fever outbreak in 2015 and a deadly magnitude 6.4
earthquake the following year.

Lai, cited by the Singapore magazine as a pioneer
in coronavirus research, is a famous scientist in his
field and a highly esteemed leader in the world of
higher education.

Also listed in the same leadership category were
Subra Suresh, president of Singapore’s Nanyang

46 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

PEOPLE NEWS

Varex Imaging appoints MD for China Mark Groper

Varex Imaging Corporation has experience in management, joins Orion

appointed Shaohua Liang as Vice manufacturing operations, Biotech as

President and Managing Director services, and sales of healthcare President,

for China. Liang equipment and CEO

reports directly components through Orion Biotechnology
Canada Ltd., a
to Sunny Sanyal, his roles at Elekta developer of novel
medical treatments,
President and Chief Instruments, Draeger has announced that
Mark Groper has joined
Executive Officer of Greater China and as the company’s new
President, CEO and a
Varex Imaging. Siemens Technology member of the board
of directors. Rudolf
In connection with Development Company. Bom, who served as the
company’s founder and
this key appointment, Prior to this, Liang CEO since 2011, will
assume the position of
Varex has consolidated worked at the Bureau of Chairman of the Board.
Groper is a veteran
all of its operations Quality and Standard of business executive
with more than 30
in China under the leadership of State Food & Drug Administration years’ experience in
the health industry
Liang, including the management of China (SFDA) and the China including the health
care, pharmaceutical
of all sales and operational teams, National Pharmaceutical Group and biotechnology
sectors. He has
as well as the shared responsibilities Corp. (Sinopharm) in a variety of previously held senior
executive positions with
of corporate functions of Human roles in China and internationally. Accenture, Emergis,
Telus Health and
Resources, Finance and Quality/ Liang graduated from Zhejiang DINMAR, a health care
company he founded,
Regulatory. University with a Bachelor’s Degree operated and grew
to become a highly
Liangbrings35years of extensive in Biomedical Engineering. success international
business. In addition to
NSF brings Frank Pan on board as MD his executive leadership
experience in both
Global public health organization NSF International has appointed Frank private and public-
Pan Managing Director of China Operations. Based in Shanghai, Frank sector organizations,
Pan is responsible for providing strategic and operational leadership for Groper brings a wealth
NSF International’s expanding programs in China, which include testing, of international product
auditing, certification, training and, separately, consulting services for the development experience
food, drinking water, health sciences and sustainability industries, as well as having served in North
America, Europe and the
ISO registrations. Pan will also ensure NSF’s strategies Asia-Pacific.
in China are aligned with the organization’s global
strategies.
Pan brings over 15 years of testing, inspection
and certification industry experience to NSF
International. Prior to joining NSF, Pan most
recently worked as Vice President for Bureau
Veritas’ CPS division, implementing global
strategies to expand its North American electrical
and electronics services, as well as drive new
business in the China market.
Pan also worked as Chief Executive of Intertek
Group’s Southeast Asia region and earlier as Chief
Operating Officer of the China region. In these roles,

he implemented strategic plans to strengthen and
expand the company’s businesses across Asia. He
holds a Bachelor of Engineering degree from
Northeast Heavy Machinery Institute in
China and an Executive MBA with
Honors from Massey University
in New Zealand.

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 47

BIO EVENT

Visitors listening to a talk at the tHIS 2018.

The Health Industry Summit (tHIS) 2018

China set for a higher
level of national health care
From microscopic needles to giant CT machines
and simple operation equipment to complex becoming China’s solution to promoting technology
diagnostic procedure machines, every component innovations and academic exchange on the grandest
scale. Now in its fourth edition, tHIS has been firmly

that is needed in healthcare at different steps was on established as the world’s largest health industry event.

display at The Health Industry Summit (tHIS) held in Key events of the summit included China’s top

China. medical equipment and pharmaceutical exhibitions

The Health Industry Summit (tHIS) 2018 hosted by CMEF, PHARMCHINA and API China, which featured

Reed Sinopharm, opened in Shanghai at the National cutting-edge technologies such as VR, AR, wearables

Exhibition and Convention Center on 11th April 2018. and AI as part of the new Intelligent Health exhibition,

This is the largest gathering of healthcare industry while traditional medicine was also highlighted at

professionals in the world with well over 200,000 the show as China’s own solution to treatment and

attendees from more than 150 countries and regions prevention which runs parallel to modern medicine

and over 7,000 exhibitors. The exhibitors ranged from and drug development. International Component

giants having footprints across the world to small ones Manufacturing and Design Show (ICMD), Intelligent

manufacturing may be one or two small products. Health China, Pharmpack Spring, Sinophex Spring and

Technology wise they ranged from diagnostics to Natural Health and Nutrition Expo were also part of the

robotics in healthcare, 3D printing, wearable and many event.

finer areas of healthcare. Leading companies with a major presence included

In accordance to the President Xi’s call for greater medical device giants like GE, United Imaging, Siemens,

promotion of the health industry at the Boao Forum Philips and Mindray as well as major pharmaceutical

for Asia, this leading health industry event covering groups in China including Sinopharm, Shanghai

the entire industry value chain to cover key segments Pharma and CR Pharmaceuticals. The majority of the

like medical devices, pharmaceutical production, most innovative companies in the medical field chose

drug distribution and natural health and nutrition is the show as their Global or Asia Pacific new product

48 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

BIO EVENT

launch platform and more than 600 new product papers. “The end to end solutions in women health,
launches took place during the 4-day show. infectious disease, tumor markers are displayed at the
expo”, pointed out Claudia Hu, senior sales supervisor,
The various companies displayed their products Hangzhou Alltest Biotech.
that included different types of giant machines like CT
scan. But more and more new types of small personal Shanghai Flower Medical Equipment presented
wearable or carry able machines for monitoring solutions for operations room and ICU, from beds &
personal health conditions are coming into the market. operations tables to operation lamps. “Our product
The rise of such small machines could be clearly manual at the expo gives details of the range of
witnessed in the summit. products we have and their technical descriptions,”
said Candy Guo, Shanghai Flower Medical Equipment.
In fact, tHIS is a place where many companies Marion Ma, Regional Sales Manager-International
launch their new products since “this is an apt place for Sales, Guangzhou Wondfo Biotech, said the company
attracting attention of thousands of interested visitors, focusses on rapid diagnostics in different areas and has
who could be the possible sellers of the products” said presented its diagnostic equipment from the qualitative
Alice Zou, Regional Manager, Wello tech for health. As rapid diagnostic family and quantitative detection
a result many companies, particularly in the med tech family. Sinocare was present with its PTS diagnostic
and devices category, choose tHIS as a platform for products. Dewei was present with a totally different
new product launch. Till now over 600 products and product. It displayed its range of chemicals which
technologies have been launched in the summit. The included haematology reagents, blood cell analyser
number got increased as some companies launched reagent, biochemistry analyser and urine reagents.
their new products and technologies this year too. Wisconic presented its range of bedside monitors,
transport monitor and central monitoring system.
Some of the new products launched this year Many packaging companies presented their different
included WellD’s D6 colour Doppler system. Chison’s types of packaging solutions from paper to plastics.
Sonobook, Hedy’s Healfusuion HDIS 50 plus infusion
management system. Helson technologies’ digital A separate section called Natural Health and
handheld probe-type ultrasound system can be Nutrition Expo displayed traditional Chinese foods
connected to laptop, tab or cellphone to see the results. as medicines and nutraceuticals. Over 700 producers
of nutraceuticals, natural & nutritional, dietary
Besides the expo, tHIS also put its focus on supplements and traditional Chinese products
conferences. Over 120 conferences were held participated in the expo, making it a complete
during the four days of the show. The international healthcare value chain, including wellness.
conferences included 3rd China International Clinical
Engineering forum for innovation and development; China seems to be interested in inviting more
IEC international medical equipment standard forum; and more investment in various sectors including
China-US summit seminar of medical device; Belt and healthcare. And at the same time it is also interested
road health symposium on rehabilitation sciences and in exporting China made products. No doubt, tHIS is
engineering. The conferences were organised by Reed the place for trade in healthcare sector and for global
Sinopharm with support from different organisations healthcare companies to demonstrate their product and
in respective areas. process excellence, and learn China’s regulations and
policies in the industry. Going a step ahead now, China is
During the expo, MD Pacific Biotechnology Ltd. planning a separate Import-Export show in the coming
presented its Protein analyser and fully automatic six months. Though the show will include import and
coagulation analyser. “The company has highly export opportunities in all sectors, healthcare will be a
qualified personnel to help the clients with design and major part of it. Announcement of the show was made
development of products to meet their requirements”, during the reception function of tHIS 2018.
commented Jesse Zhang, Overseas Manager. Kang Nai
Xin Zongshan Biotechnology presented its liquid based The Health Industry Summit (tHIS) was organized
cell sample preparation system and LCT liquid based by Reed Sinopharm, a joint venture between the
cell gradient centrifuge. world’s leading event organizer Reed Exhibitions and
China’s state-owned medical & pharmaceutical giant
Besides the Self-monitoring blood glucose meter, Sinopharm (ranked 199th on the Fortune 500 list). The
Trividia Health also displayed diabetic foot care cream, next edition of the event will be held in May 2019 in
intensive moisturizing cream, fast acting glucose Shanghai.
tablets, fibre tablets and glucose shot and gel.
(Milind Kokje was in Shanghai for tHIS
AMK displayed a whole range of mask airway 2018, on invitation from Reed Sinopharm
and different types of tubes required to be inserted in
nasal passageway, endotracheal and endobronchial Exhibitions)
tunes. Codonics displayed imaging solutions and

BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com 49

BIO EVENT

Visitors at MEDLAB Asia Exhibition

MEDLAB Asia 2018: 4000 industry
professionals visit 250 exhibitors

The fifth edition of MEDLAB Asia Pacific Philippine Society of Biochemistry and Molecular
Exhibition & Congress, featuring more than Biology, Philippine Society of Microbiology, Indonesian
250 international companies showcasing Association of Clinical Chemistry, Society of Infectious
the current cutting- edge technologies available in Disease Singapore, and Society of Cytology Singapore
healthcare and clever innovations in the field of and Diabetes Singapore.
medical laboratory and diagnostics, concluded on a
high note in Singapore. “MEDLAB Asia Pacific plays a key role in our global
MEDLAB Series of events and has quickly become
Held in the Suntec Singapore Convention and one of the most important medical laboratory and
Exhibition Centre, this year’s 3-day event attracted healthcare trade shows in the Asia Pacific region for
more than 4000 industry professionals (representing manufacturers, services providers, and dealers and
a 60 per cent increase over its 2016 edition) to discover distributers attending from across the globe. The success
a remarkable showcase presented by 250 global of the show as a business and educational platform
exhibitors from over 85 countries and 11 country is highlighted by the continued level of support that
pavilions, including Austria, Belgium, China, France, has been shown leading regional and global medical
Germany, Poland, South Korea, Spain, Switzerland, associations over the years”, quoted Tom Coleman,
UK and USA across the entire Pharma and Healthcare Group Exhibitions Director, MEDLAB Series.
sector.
Expanding and impressive
MEDLAB Asia Pacific has firmly established itself Following the huge success of MEDLAB Asia 2017,
as the region’s premier B2B business and educational this year’s event has been expanding and ever-
platform for the medical laboratory industry. impressive. With a mix of laboratory and healthcare
MEDLAB Asia Pacific continues to enjoy the support manufacturers, MEDLAB Asia Pacific & Asia Health
of a large number of key healthcare federations and welcomed dealers and distributors from across the
associations across the region including The Royal region as well as representatives from hospitals,
College of Pathologists of Australasia, Singapore consultancies and governments who took the
Society of Pathology, College of Pathologists, Academy opportunity
to meet, do business with exhibitors and
of Medicine of Malaysia, Indonesian Association learn from all professionals within the healthcare and
of Clinical Pathologist and Laboratory Medicine, medical laboratory marketplace.
Singapore Society of Haematology, College of American
Pathologists, Philippine Society of Pathologists, Inc., Tunkim Wong, Sales and Marketing Director,

50 BIOSPECTRUM | MAY 2018 | www.biospectrumasia.com

BIO EVENT

PorLab Scientific Co. Ltd, looked very content and middle-income countries. The Genedrive HCV ID Kit
positive about the event. “This year’s event has been was presented to key opinion leaders and distribution
very useful for us. The quality of attendees and their partners at the event. The Kit was presented and
heightened interest indicates good business for us. We demonstrated together with Sysmex Asia Pacific at the
hope to finalise some great deals”, he said. congress.

Scofield Duan, Regional Sales Director, SEA from 15 multi-track conferences
Snibe Diagnostic, who was also one of the platinum In line with Informa’s motto of “Exhibition with
sponsors of the event said, “We have been very Education”, MEDLAB Asia Pacific Congress also
happy with the outcome of the show. Our main idea hosted 15 multi-track, fully accredited conferences
was to increase awareness of the brand and gain with over 110 expert speakers providing unparalleled
visibility. The Asian region is a key market for pharma education as well as offering management solutions
and healthcare and we have accumulated further to help labs excel. The wide variety of plenaries and
understanding of the region.” panel discussions covered an array of topics including
laboratory management, infectious diseases, diabetes,
Dealers and distributors zone clinical chemistry, molecular diagnostics, cardiac
At the three-day event, attendees had the opportunity markers, haematology, gastrointestinal oncology,
to uncover latest laboratory management and R&D, Obs-Gynae and Women’s Health and point of
diagnostics technologies available in the market. The care testing. These new conferences helped in aiding
much-anticipated Dealers and Distributors Zone at value based diagnostics and cooperation between
MEDLAB Asia had a lot of buzz and was the main physicians and laboratorians. This year, Asia Health
highlight of the show. The zone provided an exclusive launched a free-to-attend Healthcare Procurement
platform to fast-track the process of exhibitors conference supported by PASIA under the theme of
sourcing new dealers and distributors free-of-charge. ‘Recent Asian trends in buying for hospitals and other
The event also provided the opportunity for visitors to healthcare facilities’. The conference tackled strategies
display their contact details, along with the products on procurement, regulations and trends in the medical
they were looking to source. This enabled exhibitors device industry.
and other visitors to identify which agents were
interested in their specific products/services, allowing Richard Lirio, COO, Tagaytay Center, The
for meetings to be set up directly onsite. Philippines, said, “Pharmacy itself is very complex
and has its own challenges. Each generic medicine
Primary sponsor, Lim Ai Tin, Head of Marketing, has several brand names, and we have to keep all of
Asia Pacific from Siemens Healthineers, noted, “This them in stock. The complexity increases many-folds
is our fourth year at the event. We are quite happy with the advent of instrument purchase. There are
with our association with MEDLAB Asia. It is a great numerous challenges that are not only in the software
platform to show leadership experience. Our presence and hardware but also with the equipment and sales.
at the event is also a great motivation for our regional MRIs, CAT Scans, and other vital instruments are
team and it will also help reinforce the quality of very difficult to purchase because there are many
our brand amongst the healthcare professionals.” technical complements that need to be taken care of.”
Talking about the event, she said, “MEDLAB also He was at the Healthcare Procurement conference to
serves as an excellent customer education program.” deliver a lecture on Challenges and best practices in
When asked about the pharma scenario in APAC, she procurement.
retrospectively said, “APAC is a mixed market for the
pharma and the healthcare industry, with countries Talking about the show, James Crilly, Quality
like Japan and Singapore who are a lot advanced in Control Marketing Executive, Randox Laboratories
innovation, research and infrastructure. According Ltd, said, “We are gold sponsors for the event. It is
to me, the future of pharma sector will primarily a great networking event, and we have been able to
involve a combination of healthcare and database make potential customers and end-users and have met
accumulation.” many distributors. People from different countries
have showed a lot of interest in working with Randox.
Unveiling new technologies We have managed some pretty good leads, especially
Molecular diagnostics company Genedrive premiered with the clinical chemistry divisions. We are definitely
its Genedrive hepatitis C virus (HCV) ID kit in the Asia coming back next year for the event.”
Pacific region at the Exhibition & Congress. The test
kit has been created to support the increasing number The sixth edition of MEDLAB Asia will be held
of direct-acting antiviral treatments in low and from 27- 29 March 2019 in the Suntec Singapore
Convention and Exhibition Centre, Singapore.