BioSpectrum Asia November 2018

ternational
stant
cisive
formative

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4 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

BIO EDIT

Milind Kokje NEXT DESTINATION
FOR CLINICAL TRIALS
Chief Editor
China has done it second time in a year. Its list of products exempted from the
[email protected] clinical trials requirements in the country is expanding as the National Medical
Products Administration (NMPA) added more medical devices and IVD type
products to the exemption list in October. Earlier, just three months back in July 2018,
NMPA had announced the list of products exempted from the clinical trials requirement.

With the recent addition of 84 medical devices and 277 IVD product types, in all now
855 medical devices type and 393 IVD type products now do not need any clinical trial
in China before their usage. This is considered a significant move as it is loosening entry
restrictions.

Apart from loosening entry restrictions, China is also simplifying the processes for
approvals. It has developed a system for more comprehensive electronic submissions of
Chinese market application materials. Along with the devices, China is also easing the
entry for clinical trials by relaxing the process and reducing the process duration.

Just two months back, China National Drug Administration (CNDA) introduced a
new policy. It changed the clinical trial authorisation official review and approval process.
As like US Food and Drug Administration’s (FDA) investigational new drug period,
CNDA introduced 60-day window for clinical trial approvals. It has introduced a time
table making it mandatory for the authorities to complete each step in the prescribed
time frame, bringing down the total number of days.

China not only prescribed time frame for approvals but also initiated some other key
changes to streamline the approval process. It started accepting data generated from
the clinical trials outside China for approval of new drugs. The most important change
China introduced was Market Authorisation Holders system (MAH). This system will be
fully responsible for all liabilities right from preclinical research to reporting of adverse
drug reactions. This process of simplifying the approval process has begun since 2016 by
initiating some changes in stages and still continues.

China is obviously implementing the significant changes to streamline the processes
to attract more clinical trials to boost its clinical research industry. China is as it is ahead
in clinical trials. With the world’s largest population China recorded more clinical trials
than any other Asian country, except South Korea, from 2001 to 2012. But it appears that
it wants to further grow in this industry. It has advantages like large population and an
equally large network of hospitals, skilled professionals, changed regulatory environment
and support from the government.

Despite so many initiatives from the regulator, some quarters feel that China is still
not ready for conducting clinical trials as there are several challenges. These include
protecting the participants, poor transparency and inadequate infrastructure. Experts
claim that trial participants are treated like regular patients as the staff do not have
experience to comply with good clinical practices, risking trial’s integrity. Some other
experts are of the opinion that with these changes the cost of clinical research will increase
when China was having cost advantage over some other countries. But on the other hand
it will also increase the quality, the experts hope.

Regarding the transparency, the experts point out that in 2015 when China FDA
inspected over 1600 pending new drug applications over 90 per cent of them were rejected
due to unauthentic data. All these issues have not yet made China ready for developing a
huge clinical trial market despite having some advantages.

Despite all these challenges and whatever experts may feel, one thing is for sure that
China is not only willing to change, but has already started changing steadily and fast for
clear guidelines. Improving regulatory transparency and fixed time frame for approvals,
may soon be making it an important destination for global clinical trials.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 5

BIO MAIL

CRO on Rise Women’s Healthcare
It is amazing to know that startups
A rather comprehensive article on the
growth of the CRO market in Asia. targeting women’s healthcare have
Increased R&D activity and a shift
towards outsourcing have gradually multiplied in BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com
emerged as key factors contributing to recent years. 36
this growth. Write more details about the A number of
evolution of this market. innovations S TA R T U P S
are taking
- John Wend, Singapore place in this IwtnhAdoriomaunegnshthainer tnauoltpvhsa&taiodhnvya!gniecninegWAwrbwerooaoamo(mtsuaWcaramoirnoaemhacreSeniHfcRderncneeencoettoeerco’TTOflnxdrhscne7xihuaaedtnwecuonoIhcepa)thWgstcsin0Oipthtuocrfa,nsegfhencisrththir‘tdeeosownotylirrigcrhictonbtoeiopwalorloefcmpodebrgrrmregohuyaldraiortawtivtentpdaiIupemiarosuhselriylmiinsuemftloeentsdncoeidrosisekonir,rerteeigrrfdmnlciefta,aoovokimtunortbiynigaecdtteiiHtoavsnwgakswsouiedohrnitlninnnesinenee’dmecfnakoev,etnsferuiigoratotisb,toes(ttinnswntegeaaaofadwhitrincmaroaimRiafraodyimcRnnornltoeelclctieouaentfvningrthft.deTsipIfnoWnoicadeTrhogtmhmiavtnIegitepaihn.sbioulInnnrwahtnecteIefmclasIbdsaeeduHeneeosaplhttendtaso)s.sanatedatnigtndspaeroiOdaetillxfeleomaeidetartan,littu.shnhseaarcsrirc,hreocdt.epeeeis.anansiapArrsstcreahofeaoled,lrkawubnlcaatohtsywi,ivsPcAlwelsiweubevnupsnofddrIheeoartuemaenitaiPoigctlenfnovnwBsicdrhhuesemehenoaPidtaseeieewaolnn“euputsioacteeitauWrsadsmiBarannaiefaAipuntedophonnebcpusssrskcnedguBmptlnwreopylhtddtdhcteoAenolehleiDisdwdooCseanugom-teePee-sfaheminid,ynes,hldiddrninarnfp,dfnheosiepwe2mpiteeettegsekyumeuledRndpoieiuaim-inslve0reaoncerrloc,neenc-FneyampedepoisabrellBntge1samtdscangls,tdddcheosts5nhIaNod,m2atceoapekuBdeohnssuaoeeeaeilutaaalhh.udnpiitionenwuthrvhi9dadencnasnpmpcrnmegenatdcaenmtirnee6suhet”dhidjwagesdcPlevrrnatsdoplas,yucaw.iiiedaehmeepyshoce,openlnialslojelldtertsruaeesf.aeatr,thrfgimsycfroehisBekltnsvorusswauo.pilc,irewma.etfndagupasorTruelruaotrieeueeindatcicahirnanmlnfftesnsancde.trlcreaegadinaseehttodsiyBeyentmussitaapimnheniehnsdaskbslouesgdiiyagsl.ennkbie.ssdIedailstnnientocwosbleoaoceywhttlcepyohocatgo2fsaroutin0iwtooosSncenwPofirr1rinWteirodcanrteeene7tpebroehatmlinrehter-itpsoaiyHosspaimsa2Behnbetonliorheidasrtm0TwateSuelmtbekrh2oesnerdawgm1hasdtmritish0eeaav8ebosatnlgtaeid,oiiolrwi1eedsrnl.ethrranga,tslynoe6rertirrhdTkpitraecat,keuuoees-tPtwomi,tihnsaunh2sddheonnclahytRr,uatSlosdweu0aieanluideHalDanssntyiueuvuaelr1ilntokln,eApnohweadandaCidnnetage7fnenilemPntotidrsmymtenlcatihwwoa-bpraNdRasaeianoeesagMpl,plnmtveiuolmuvtaniata.teInnenhsesteLmrilreehhhgmnsBzbyBdaEoeldowobesonereir2rii5akoeedluemtda.innun-ritnrettneeU.ilw.ophalnecasohihji5cUseacdgeTeeiatSaaTdrfiocrem.ptharoreosastbdittpiSitncjKeoyttgRmhsnenrEarrnspms,rpeovrystouos.ldoeEodd,eas,ersohno,dgrtpoetmAriDcne(dmhogaseinUoysrnorege,du1rTcgc,tnotsfuaie.eedteolrseflopaeginhLmtrdtdddlcaeaorwougsiinihheieutcemneirrlnfsurrvca2petdtireen,fsaIdetss-dolt0reedh.namlrhenemdp1sifdaanapot8mirsubestnetiytrzyseeusoe,ars).
field that have
Vaccine Scandal the potential
in becoming
This revelation has come across as the landmarks for
one of the largest public health scandals influencing
to hit China. It should be probed further
unless a suitable vaccine law or vaccine women’s health. A
safety criteria gets developed.
regular column for such developments
- Dr Renni Dutta, New Delhi
should be carried out.
- Smita Bedi, Mumbai

Vol 13; Issue 11; November 2018 MM Activ Singapore Pte. Ltd. India
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6 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

BIO CONTENT

COVERStory 18

SOUTH KOREA – LEADING
BIOSIMILARS OPPORTUNITIES FOR ASIA

Historically, Asia has led in generics adoption and now, with more than 300 biosimilars under development, Asia
is one of the leading regions for global biosimilars development. The foundations have been laid for the biosimilar
industry in Korea, providing an opportunity for the region to become a global center for manufacturing and adoption
of biosimilars in the next few decades. Just as Indian companies have carved out a leading position in the generic drug
market, South Korean companies are poised to take leading positions in the biosimilars industry in the coming years.

24 BIO SPECIAL 28 HEALTHCARE

The Changing API Industry Ayushman Bharat-
Reaching out to Indian poor

31 BIO SPECIAL 33 Q&A

Achieving Universal “Vietnam – a potential
Healthcare in India for growth of pharma
imports in next few years”
Sanjeev Gupta,
Managing Director, Kusum Group of Companies, India Joelle Chia,
Co-director Asia, Pharma To Market, Singapore

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 7

BIO CONTENT

35 Q&A CONNECT
ENGAGE
“Diabetic kidney disease could SHARE
overwhelm our health systems”

Dr Richard Lipscombe,
CEO, Proteomics International, Australia

37

“New innovations create
meaningful barriers for competition”

Julie Tay,
Managing Director and Senior Vice President- Asia Pacific, Align Technology, Singapore

39

“Robotic medical technologies can
change the future of healthcare”

Jane Wang,
CEO and Co-Founder, Roceso Technologies, Singapore

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8 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

REGULATORY NEWS

India bans 328 combination drugs

The central government in India has banned 328 In 2016, the government had banned about 350 such
combination drugs leading to a blow for both domestic FDCs, but the industry mounted various legal challenges
and foreign pharmaceutical firms. At the same time, that prompted the Supreme Court to call for a review by
the ban has been cheered by health activists worried an advisory board.
about growing antibiotic resistance due to the misuse
of medicines. The technical and advisory board According to the president of the Indian Drug
formed by the government has found that there was no Manufacturers’ Association (IDMA), Deepnath
therapeutic justification for the ingredients contained Roychowdhury, the order would have an impact on a
in 328 fixed-dose combinations (FDCs) and these FDCs market worth an estimated Rs 16 billion a year for such
may involve risk to human beings. drugs, which are produced by both small and large
pharmaceutical companies.

Cancer Australia Korea approves Opdivo-Yervoy
releases new for renal cell carcinoma
diagnostic data
The Korean government has approved Ono Pharma
For the first time, national data on Korea and Bristol-Myers Squibb Korea to sell Opdivo
childhood cancer stage at diagnosis (nivolumab)-Yervoy (ipilimumab) combination therapy
has been released, showing that a as the first-line immunotherapy to treat renal cell
high proportion of the most common carcinoma (RCC).
childhood cancers are diagnosed at a
limited stage, before they have spread to The approval is based on a clinical trial called
other parts of the body. CheckMate-214, which evaluated the Opdivo-Yervoy
combo in patients with moderate- and high-risk
The new data published by Cancer advanced RCC who did not have any treatment
Australia covers the 16 most common experience.
childhood cancers, which represent
approximately three-quarters of all The study showed the combined therapy proved
childhood cancers diagnosed in Australia. effective in achieving improved survival compared
to sunitinib (under trade name Sutent by Pfizer),
The release of the data on childhood regardless of PD-L1 (programmed death-ligand 1)
cancer stage at diagnosis is the result of expression.
a collaboration between Cancer Australia
and the Australian Childhood Cancer L-R- Liu Baochun, Director-General Guangzhou Foreign Affairs Office, China exchanging
Registry at Cancer Council Queensland, document with Pene Baleinabuli, Official Secretary to the Fiji’s President- Jioji Konrote.
with involvement of all states and
territories, and was supported as part of
the Australian Government’s investing in
Medical Research – Fighting Childhood
Cancer initiative.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 9

REGULATORY NEWS

OBI Pharma receives Kyorin secures
FDA ODD for OBI-3424
approval from
OBI Pharma, Inc., a Taiwan Carcinoma (HCC). A Phase 1/2
biopharma company, recently study of OBI-3424 in patients Japan Health
announced that the US Food and with solid tumors, including HCC
Drug Administration (FDA) has and castrate-resistant prostate Ministry
granted Orphan Drug Designation cancer (CRPC), has commenced
(ODD) for OBI-3424 for the enrollment at the University of Urovant Sciences, a clinical-
treatment of Acute Lymphoblastic Texas M.D. Anderson Cancer stage biopharmaceutical
Leukemia (ALL). OBI-3424 is Centre. According to Amy company focused on
a first in class DNA alkylating Huang, General Manager of OBI developing novel therapies
cancer therapeutic agent Pharma, this additional orphan for urologic conditions,
targeting aldo-keto reductase 1C3 drug designation for OBI-3424 recently announced that
(AKR1C3) overexpressing cancers. by the FDA is a significant step Kyorin Pharmaceutical
This is the second FDA orphan in the development of this drug Co., Ltd. has received
drug designation for OBI-3424. candidate in ALL, including marketing approval from
On July 9, 2018 OBI-3424 was T-ALL, an unmet medical need Japan’s Ministry of Health,
granted orphan drug status for disease with limited treatment Labour and Welfare for
the treatment of Hepatocellular options. vibegron for the treatment
of adults with overactive
China, Fiji ink pact bladder (OAB) in Japan.
for health and wellness Kyorin licensed vibegron
for Japan from Merck &
A new agreement has been signed between the Fijian and Chinese Co., Inc. in 2014, and later
governments that will see the construction of a health and wellness expanded the license to
centre at the State House compound in Suva. include certain other Asian
countries in 2017. Urovant
The agreement in the form of a Memorandum of Understanding licensed rights to vibegron
(MoU) was signed by the Official Secretary to the President Pene for the United States and
Baleinabuli and the Director-General Guangzhou Foreign Affairs Office the rest of the world from
Liu Baochun. Merck, Sharp & Dohme
Corp., a subsidiary of Merck
Liu is part of a 19-member Delegation from Guangdong Province & Co., Inc. in 2017 and
in China, which is visiting Fiji to help strengthen bilateral relations subsequently entered into
between the two countries. a collaboration agreement
with Kyorin later that year.
Following the MoU signing, Fiji’s President Jioji Konrote renewed Under the collaboration
the call for a healthy, productive nation and for all Fijians to live a agreement, Urovant and
healthy lifestyle to be more productive. Kyorin share information
related to the development
of vibegron, including
clinical trial and nonclinical
study data. In Kyorin’s Phase
3 clinical trial, vibegron
demonstrated a significant
reduction in frequency,
urgency episodes, urinary
urge incontinence episodes
and total incontinence
episodes. Vibegron also was
observed to be well tolerated
in Kyorin’s Phase 3 program.

10 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

COMPANY NEWS

Accuron Merck opens S$20M lab in Singapore
unveils
S$10M German biopharmaceutical consumers the assurance of more
technology speedily available and validated
centre in company Merck has officially next-generation drugs for
Singapore treatment. Time taken to validate
opened a S$20 million lab near critical processes, test and release a
Singapore headquartered drug to market will be significantly
medical device company Pasir Panjang, Singapore. The reduced. According to Dr Koh Poh
Accuron MedTech Group has Koon, Senior Minister of State
officially opened a new S$10 Merck Singapore Lab offers for Trade and Industry, Merck’s
million technology centre investment in Singapore is timely
in Singapore. Located in services such as cell culture media as global and regional healthcare
Tuas, the 22,000 sq ftcentre demands continue to grow. The
provides incubator facilities development, purification process Government has invested in
and business services for the infrastructure, technology and
companies in which Accuron optimisation and biologics drug talent to help propel the industry’s
MedTech invests, which are growth and will continue to do so.
highly-innovative, category- safety testing.
disrupting technology firms
that are complementary to The 3,800 sq m facility will also
its core urology business.
Accuron MedTech has done house Merck’s first BioReliance
more than 10 strategic
transactions in the last four laboratory in the region, to provide
years, including investments
in renal companies AWAK pharmaceutical firms in Asia
Technologies and Advent
Access, and Nasdaq-listed with quicker, more accessible
Aslan Pharmaceuticals. It
is an independent division testing services for biological
of Accuron Technologies,
a subsidiary of Temasek drug products. The new lab offers
Holdings. The centre is
located next to the global Celltrion signs agreement for
headquarters of AMT, atherosclerosis drugs development
Accuron MedTech’s
medical technology contract Celltrion, a leading University and Georgia Institute
manufacturing business. biopharmaceutical company of Technology, and provide
Portfolio companies will headquartered in Incheon, research costs and manufacturing
be able to access AMT’s Korea has signed an Incubation materials of new drug candidates
44,000 sq ft of advanced agreement with Emory University for atherosclerosis. Celltrion
manufacturing capabilities in Atlanta to support the research will have a preferential right to
such as rapid prototyping, and development of new drug acquire a license for inventions
turnkey manufacturing, candidates for atherosclerosis. resulting from the agreement.
clean-room manufacturing Under the agreement, Celltrion
and assembly, 3D printing, will share its accumulated
and medical device biologics development expertise
sterilisation. with Emory University School
of Medicine and the Wallace
H. Coulter Department of
Biomedical Engineering at Emory

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 11

COMPANY NEWS

Microsoft, SRL to use AI for cancer detection

Tech giant Microsoft has early detection of blindness in
collaborated with SRL people suffering from diabetes
Diagnostics to train its artificial and assessing cardiovascular
intelligence (AI) system in health of patients. According to
detecting cancer. Microsoft Microsoft, this cancer-detecting
plans to teach its AI system to solution will not replace the
find the traits of cancerous cells need of an oncologist, but the
that trained pathologists do goal is for the AI system to speed
manually by looking at a slice up, make more accurate and
of the patient’s tissue on a glass give valid pointers to the doctor
slide. SRL’s bank of more than to make the right diagnosis. This
one million such slides from will reduce the cost of treatment,
past diagnosis will be used as better utilise the time of trained
the training material for the AI specialists to reach more
system. Microsoft has already patients and make healthcare in
deployed its AI system for general more patient-centric.

Mundipharma, Novartis WuXi, I-Mab
collaborate to develop
to distribute pain 3 bispecific antibodies

medicine in SE Asia WuXi Biologics, a leading global open-access

International healthcare organizations, Novartis biologics technology platform company offering end-
and Mundipharma, have signed an agreement
for the marketing, sales and distribution of well- to-end solutions for biologics discovery, development
known pain medicine brands Voltaren (diclofenac
sodium) and Cataflam (diclofenac potassium) in and manufacturing and I-Mab
Malaysia, Thailand, and the Philippines.
Diclofenac is a non-steroidal anti-inflammatory Biopharma, a biotech company
drug (NSAID) used to relieve pain, swelling
(inflammation), and joint stiffness caused by focusing exclusively on
arthritis. It is available as a tablet, injectable and
liquid capsule. innovative biologics in
According to Novartis, the company’s
commitment to enhance healthcare providers immuno-oncology
and institutions’ access to effective medicines
will be complemented by Mundipharma’s core and auto-immune
strengths in anesthesia and surgicals in
Southeast Asia. Novartis will diseases, have
retain all international
development jointly announced
responsibility, as well as
clinical development that I-Mab has
activities. The
company will expanded strategic
also continue
to manufacture collaboration with WuXi
and supply
Voltaren and Biologics and licensed
Cataflam for
commercial use. proprietary WuXiBody Platform to develop

three bispecific antibodies. WuXi Biologics will also

be the exclusive partner to develop and manufacture

these bispecifics.

Under the terms of the agreement, I-Mab has

rights to use the proprietary WuXiBody Platform to

research, develop and commercialize three bispecific

antibodies generated from I-MAB’s proprietary

pipeline. WuXi Biologics will receive an upfront

payment as well as development, regulatory and

commercial milestone payments, and will be entitled

to royalties based on global sales of these bispecific

antibodies.

12 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

FINANCE NEWS

IFC invests $40M in Fullerton Health

The International Finance improve the provision of affordable,
Corporation (IFC), a member of the
World Bank Group, has committed quality healthcare in the Philippines
a $40-million loan facility to the
Philippine subsidiaries of Singapore- and enhance efficiencies in the
based integrated healthcare platform
Fullerton Health – Fullerton Health health maintenance organization
Philippine Holdings and Fullerton
Health Philippines Pte Ltd. IFC’s market through increased
investment comes four months after
Fullerton Health officially entered integration between the financing
the Philippine healthcare market
through its acquisition of a 60 per and provision of healthcare.
cent stake in the Intellicare Group.
Fullerton Health sees the
The IFC investment will help
Philippines as an important market

in the Asia Pacific for the company

due to its market being underpinned

by attractive underlying growth

drivers. This acquisition grants

Fullerton Health a presence in eight

Asian countries.

Changchun High, New
Technology form $200M JV

China’s biopharma firm an agreement to set up a joint General Atlantic
Changchun High & New venture (JV) with a registered
Technology Industries have capital of $200 million. invests $150M
teamed up with Iceland’s Changchun will fund the
drugmaker Alvotech to JV with $100 million while in Asia Medical
develop and sell biosimilars Alvotech will contribute $10
in China. Alvotech, founded million plus six drug licenses Global growth equity firm General
in 2013, is a sister company valued at $90 million. The Atlantic has invested $150 million
to Alvogen, a US generic permits to use these products in Chinese healthcare services
pharma. Alvogen is majority will last for five years. provider and hospital operator
owned by CVC Capital Hong Kong Asia Medical Holding
Partners, an EU-Asian PE The JV will have an Limited (Asia Medical), marking
firm, and Temasek, the exclusive right to develop, its expansion into the healthcare
sovereign wealth fund of import and sell these and biotechnology sector in China.
Singapore. six drugs in China’s Founded in 1999, Asia Medical
mainland, while looking for specialises in heart surgery and
The parties have signed international opportunities. cardiology and operates under
the brand name Asia Heart. It
currently operates two hospitals
in Wuhan and Xinjiang and co-
manages four additional heart
centres. This year, Asia Medical
opened a co-managed heart centre
in Hong Kong and completed the
acquisition of a Japanese heart
centre. It will also open its second
branch in Wuhan this November.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 13

START-UP NEWS

MedPlanner to raise $362K through Holmusk
equity crowdfunding campaign
secures $9.75M
Malaysian medtech startup MedPlanner Sdn Bhd recently
announced the crowdfunding campaign in Ata Plus’ platform, in Pre-Series
with the goal to raise $362,000. The funds will be used for the
company’s growth and expansion plans. Backed with data worth of A financing

10 years research from Holmusk, a Singapore-
its UK’s early users, headquartered digital health
the platform provides and data analytics company
clinicians and patients with a global presence, recently
with tech-enabled announced closing of $9.75
solution that helps million in Pre-Series A financing.
combating healthcare The financing round included
inefficiency due to poor funding from Heritas Venture
communication. Using Fund as well as participation from
blockchain technology, new and existing investors. The
MedPlanner app is secure and compliant with regulators. The app funds allow Holmusk to expand
also incorporates a bulletin featuring information from health its footprint in USA and Europe.
authorities, organisations and professional bodies. Holmusk leverages technology
and data science to accelerate
PharmEasy gathers $50M research and improve outcomes
in series C funding for people with chronic diseases
and behavioral health disorders.
Indian online pharmacy expand warehouses and Partnering with pharma and
startup PharmEasy has raised fulfillment centres, among healthcare providers, Holmusk
$50 million in series C round other things. It already has informs predictive algorithms and
led by Eight Roads Ventures 8 existing warehouses in the provides actionable insights for
India, the proprietary country, and plans to open 12 personalized medicine through its
investment arm of Fidelity by 2019. PharmEasy provides proprietary modelling platform.
International Limited a technology platform to offer Alongside this, it has an innovative
(FIL), F-Prime Capital, various healthcare services digital health platform for patient
Fundamentum Advisors, an like medicine delivery, engagement. Holmusk is also
investment firm backed expanding its assets in behavioral
by Nandan Nilekani medicine refills & reminders, health. Having acquired
and Sanjeev along with MindLinc, a behavioral health
Aggarwal, and teleconsultation. It EHR, it now holds one of the
San Francisco- further integrates largest behavioral health databases
based hedge fund in the world. Combining system
Think Investments. diagnostics centres, dynamics with deep learning
The funds will in order to help neural networks and quantitative
reportedly be systems pharmacology, Holmusk
used to increase provide a is developing MindLinc 2.0 which
customer base, comprehensive will include predictive disease
medical models based on longitudinal
solution to its patient data.
clients.

14 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

START-UP NEWS

SigTuple Tech receives Israeli startup
recognition at Demo Day Asia
receives $29M
Indian startup SigTuple (AI)-based solutions to automate
healthcare screening. It has built for cancer
Technologies was given the Judges’ intelligent screening solutions
to aid diagnosis through AI- therapy
Choice’ award at the Google’s powered analysis of visual medical
data. The start-up also has an AI Alpha Tau Medical, an
first Demo Day Asia programme platform called Manthana, which Israeli medical technology
helps analyse visual medical company that developed
held in Shanghai recently. Out data efficiently. Manthana has a breakthrough alpha
enabled the company to work radiation cancer therapy,
of hundreds of applications on five high-volume screening has secured $29 million
processes - analysis of peripheral in private financing. The
from entrepreneurs across Asia- blood smears, urine microscopy, funding round was led by
semen, fundus and OCT (optical Shavit Capital, an Israeli
Pacific, 10 outstanding founders coherence tomography) scans and private equity firm that
chest X-rays. specializes in funding late-
were chosen as finalists. After stage investments, with
participation from leading
this win, the startup will have global equity crowdfunding
platform OurCrowd,
an opportunity to be mentored and Medison Ventures,
the venture capital arm
by Google executives on product of Medison Pharma.
Additional private investors
development and will get access included Sir Ronald Cohen
and Alan Patricof, the
to the Google for Entrepreneurs founders of Apax Partners.
Alpha Tau Medical was
global partner network. SigTuple founded in 2016 to focus on
R&D and commercialization
creates Artifical Intelligence of its breakthrough cancer
treatment, Alpha DaRT
Cyclops Medtech raises (Dіffusіng Alpha-emіtters
$1M as fresh capital Radіatіon Therapy). The
technology delivers high-
Indian medical technology company Cyclops Medtech Pvt Ltd has raised $1 precision alpha radiation
million in fresh capital from impact investment fund Unitus Ventures and that is released when
existing investor CP Bothra, chairman and managing director of generic radioactive substances
drug manufacturer Medreich Pharma. The investment was facilitated decay inside the tumor.
by dealmaking platform LetsVenture. Cyclops According to the company,
designs and develops diagnostic and rehabilitation the alpha particles
products for neuro vestibular disorders using eye- effectively kill the cancer
tracking technology. It focuses on a group of 20 cells while sparing the
diseases including vertigo, epilepsy, migraine, and surrounding healthy tissue,
concussions, among others. According to Cyclops, the and preliminary clinical
latest investment will help it to increase installations results showed that Alpha
of its product BalanceEye, which diagnoses neuro- DaRT was effective for
vestibular conditions, across Tier-2 and 3 cities apart treating squamous cell
from entering new markets in Asia. It has a target of carcinoma tumors, with
1,000 installations over the next five years. The money all patients’ tumor sizes
will also be utilised to develop three other products in reducing.
the neuro-vestibular space. BalanceEye is based on a
non-invasive method tracking pupil movement. The company has so far
made 100 installations, facilitating 10,000 tests so far.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 15

WORLD NEWS

Emergex signs MoU with Fiocruz to develop viral vaccines

Emergex Vaccines Holding Limited could be expanded to include the under which Emergex and Fiocruz
(Emergex), a biotechnology development of vaccines to target will co-develop vaccines to viruses
company pioneering a new other viral families that are endemic that are of specific importance
approach to synthetic vaccine to the region. The MoU consists to the Brazilian government and
development in the field of of three parts. The first part is a are prevalent and endemic in the
infectious diseases, has signed a Collaboration Agreement under region. Emergex and Fiocruz will
Memorandum of Understanding which Fiocruz and Emergex will develop vaccines collaboratively to
(MoU) with Brazil-based Oswaldo initially carry out a Phase I clinical find solutions for various diseases
Cruz Foundation- Fiocruz for the trial to demonstrate flavivirus that have not yet been resolved
development of viral vaccines. vaccine safety. Thereafter, the two using conventional vaccine
The MoU initially covers the parties expect to carry out further approaches. The third part of the
development of a vaccine that clinical studies to test the vaccine MoU covers a vaccine technology
universally targets diseases within in the field. transfer agreement for vaccines
the flavivirus family such as Dengue that will be used within Brazil’s
Fever, Zika and Yellow Fever but The second part of the MoU National Health Service.
is an umbrella R&D agreement

Roche launches NIH to accelerate genetic
blood test for
cancer detection therapies for sickle cell disease

Roche has launched a blood test that can The National Institutes of Health (NIH) has announced the
identify 70 of the most commonly mutated launch of a new initiative to help speed the development
genes in solid tumours, as the company of cures for sickle cell disease, a group of inherited blood
seeks to make more personalised medicines. disorders affecting at least 100,000 people in the United
The test known as FoundationOne Liquid States and 20 million worldwide. The Cure Sickle Cell
can identify circulating tumour DNA in Initiative will take advantage of the latest genetic discoveries
the blood of people living with cancer and and technological advances to move the most promising
identify the genes including microsatellite genetic-based curative therapies safely into clinical trials
instability, a genomic signature that can within five to 10 years. The initiative and its research
help inform decisions about treatments partners will establish a national data warehouse of genetic
based on cancer immunotherapy. therapies for sickle cell disease and conduct comparative
FoundationOne Liquid complements analyses of therapeutic approaches to assess both clinical
Roche’s FoundationOne CDx, a tissue- and cost effectiveness. They will also establish national
based genomic profiling test launched networks to make it easier for patients and providers to
in the US earlier this year, as part of a learn and engage with the research, clinical trials, and other
portfolio of genomic tests. While Roche has activities happening across the country. The Cure Sickle Cell
used circulating tumour DNA released by Initiative seeks to develop cures for a far broader group of
tumours into the bloodstream as they grow individuals with the disease, and it is initially focusing on
to test cancers that doctors have already gene therapies that modify the patient’s own hematopoietic
spotted, the hope is that the technology stem cells (HSCs), which make red and other blood cells.
could be used to screen for cancer before These modified HSCs can then be given back to the patient
symptoms have appeared. via a bone marrow transplant, making a cure available to
more patients who lack a matched donor.

16 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

WORLD NEWS

SA health authority approves Egypt healthcare
startup raises $12M
Aurobindo’s HIV drug
Egypt based digital health startup, Vezeeta, recently
Aurobindo Pharma has received approval from the announced a Series C investment of $12 million led
South African Health Products Regulatory Authority by Saudi Technology Ventures, the largest VC fund in
(SAHPRA) for its Dolutegravir, Lamivudine and the region. Joining the round are existing investors:
Tenofovir Disoproxil Fumarate (DLT) tablets, BECO Capital (UAE), Vostok New Ventures (Sweden)
50mg/300mg/300mg, the first-line preferred regimen and Silicon Badia (Jordan), along with new investor
for HIV patients as per latest WHO guidelines. Crescent Enterprises’ CE-Ventures (UAE). According
Aurobindo is now among the first few companies to the startup, the financing will be used to fund its
which have received approval for this product. This continued expansion primarily in Saudi Arabia and
approval demonstrates its commitment towards HIV for further investments in key new products. Vezeeta
patients and enables the company to participate in connects patients and doctors through an online
South African HIV tender as well as launch in private platform. It also provides SaaS (Software as a service)
market. The approval further strengthens Aurobindo’s solutions that utilize cloud computing and big data to
HIV product basket in South Africa, which has the empower doctors, building the infrastructure for the
potential to improve the lives of millions of patients. development of the broader healthcare ecosystem.
Prior to SAHPRA’s approval, Aurobindo has received
tentative approval for the drug from USFDA and
launched in Sub-Saharan African markets as part
of its commitment to bring affordable HIV drugs to
millions of patients globally.

Cancer detection device proves effective in Uganda

The Tiny Isothermal from the National
Nucleic acid Institutes of Health.
quantification sYstem The team is planning
(TINY) has shown expanded testing
promise as a point-of- over the next several
care detector of Kaposi years. Future work
sarcoma-associated on TINY will include
herpesvirus (KSHV) expanding testing to
in resource-limited more locations in Africa,
settings such as sub- South America and the
Saharan Africa. US, and developing a
commercialization plan.
Developed by a team The group has applied
of researchers at Cornell for patent protection
Engineering and Weill through Cornell’s
Cornell Medicine, US, Center for Technology
TINY met its goals in the Licensing.
first round of funding

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 17

WHO NEWS

WHO calls for
urgent action to end TB

Fewer people fell ill and died political leaders gathering for WHO launches first
from tuberculosis (TB) last the first-ever United Nations
year but countries are still High-level Meeting on TB to investment case
not doing enough to end TB take decisive action, building
by 2030, warns the World on recent moves by the WHO recently published its first
Health Organization (WHO). leaders of India, the Russian investment case, setting out the
Although global efforts Federation, Rwanda, and transformative impacts on global
have averted an estimated South Africa. Nearly 50 Heads health and sustainable development
54 million TB deaths since of State and Government that a fully-financed WHO could
2000, TB remains the world’s are expected to attend the deliver over the next five years. The
deadliest infectious disease. meeting. To meet the global investment case describes how WHO,
target of ending TB by 2030, working together with its Member
WHO’s 2018 Global TB countries need to urgently States and partners, will help to
Report, released in New accelerate their response save up to 30 million lives, add
York recently, calls for an – including by increasing up to 100 million years of healthy
unprecedented mobilization domestic and international living to the world’s population and
of national and international funding to fight the disease. add up to 4 per cent of economic
commitments. It urges growth in low and middle-income
countries by 2023. Achieving these
WHO reappoints Bloomberg as results would require an investment
Global Ambassador for NCDs of $14.1 billion from 2019 to 2023,
representing a 14 per cent increase
Dr Tedros Adhanom Ghebreyesus, Director-General of the World in WHO’s base budget over the
Health Organization (WHO), has renewed the appointment of previous five-year period. These
Michael R. Bloomberg as WHO Global Ambassador for Non- investments would help achieve
communicable diseases (NCDs) and Injuries. the triple billion targets of WHO’s
General Programme of Work- 1
During his second term as Global billion more people benefitting from
Ambassador, Bloomberg will continue universal health coverage; 1 billion
to support global, national, and local more people better protected from
efforts to protect people from NCDs health emergencies; and 1 billion
and injuries. Many of the work streams more people enjoying better health
from the first appointment will continue, and well-being. The investment case
including building the Partnership for shows how a stronger, more efficient,
Healthy Cities and promoting investment and results-oriented WHO will serve
in NCD and injury prevention. and guide governments and partners
in their efforts to improve the health
Bloomberg served as the 108th Mayor of their populations. It highlights
of the City of New York, from 2002 new mechanisms to measure
to 2013. He launched his foundation, success, ensuring a strict model of
Bloomberg Philanthropies, in 2006. Most accountability, and sets ambitious
recently at the 17th World Conference targets for savings and efficiencies.
on Tobacco or Health in March
2018, Bloomberg Philanthropies
announced the global tobacco
industry watchdog STOP – Stopping
Tobacco Organizations and
Products – which will
aggressively monitor
deceptive practices
to undermine public
health.

18 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

COVER STORY

Historically, Asia has led in generics
adoption and now, with more than 300
biosimilars under development, Asia
is one of the leading regions for global
biosimilars development. The foundations
have been laid for the biosimilar industry
in Korea, providing an opportunity for
the region to become a global center for
manufacturing and adoption of biosimilars
in the next few decades. Just as Indian
companies have carved out a leading
position in the generic drug market,
South Korean companies are poised to
take leading positions in the biosimilars
industry in the coming years.

SOUTH KOREA:

leading biosimilars
opportunities for Asia

In the last four decades after the Korean War, to be one of the most promising nations where
South Korea has evolved from one of the most pharmaceutical companies have identified huge
abject states in the region to one of the most investment potentials for the biosimilar development
vibrant manufacturing powerhouses in Asia. From and commercialization. In 2017, two out of three
electronic devices to smartphones, the country’s biosimilars sold worldwide were Korean products,
manufacturing groups have driven extraordinary reports Business Korea. The report further articulates
economic growth over the past 50 years making the that global revenues of top four biosimilar medicines
region one of the strongest developed economies amounted to 2.65 trillion won ($2.38 billion) in 2017,
in the world. And healthcare is no exception. A and of the total, South Korean products accounted for
growing market, ageing society, favorable regulatory 1.76 trillion won ($1.58 billion), or 66.4 per cent.
policies and investments, a new global competitive
environment have made the region one of Asia’s The South Korean Ministry’s figures paint a
biggest pharma, biotech manufacturing and similar picture. The country’s leading Korean news
innovation hubs. agency-The Korean Herald provided an elaborate
coverage of Ministry’s report. The article states that
For Korea, much of this growth in the biopharma pharmaceutical export volume for 2017 rose to 30
space has come from biosimilars. With over per cent to reach $4.07 billion, riding on strong sales
hundred biosimilars under development (as per of biosimilars and botulinum toxin drugs. Exports of
Statista’s latest data) South Korea has emerged as biologic drugs in 2017 stood at $1.37 billion, up 28.6
one of the strategic location for the development of per cent on-year, and accounted for 33.6 per cent of
biosimilars on the global level. The country is proving the country’s total pharmaceutical exports.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 19

COVER STORY

Japan, the article says, was the biggest export JAPAN, WAS THE BIGGEST EXPORT
destination for Korea’s pharmaceutical products, DESTINATION FOR KOREA’S
importing $497 million worth. The ministry PHARMACEUTICAL PRODUCTS, IMPORTING
attributed the sharp growth of Korea’s biologic drug $497 MILLION WORTH. THE MINISTRY
exports to robust overseas sales of biosimilar drugs. ATTRIBUTED THE SHARP GROWTH OF
KOREA’S BIOLOGIC DRUG EXPORTS TO
Last year, Korea’s top export biosimilars were ROBUST OVERSEAS SALES OF BIOSIMILAR
Celltrion’s Remisma and Truxima for which export DRUGS. LAST YEAR, KOREA’S TOP EXPORT
volume reached $564 million and $348 million BIOSIMILARS WERE CELLTRION’S REMISMA
respectively. AND TRUXIMA FOR WHICH EXPORT
VOLUME REACHED $564 MILLION AND $348
Founded in 2002, Celltrion has been at the MILLION RESPECTIVELY. FOUNDED IN 2002,
forefront of biosimilar development in Korea. CELLTRION HAS BEEN AT THE FOREFRONT
Unlike generics, biosimilar development is a long OF BIOSIMILAR DEVELOPMENT IN KOREA.
and tedious process involving huge investments and SAMSUNG BIOEPIS, KOREA’S ANOTHER
failure risks. Yet Celltrion overcame these hurdles MAJOR BIOSIMILAR GIANT.
to develop the first copy of Johnson & Johnson’s
rheumatoid arthritis drug Remicade, which was the Remicade, Humira, and Herceptin – Benepali,
world’s third best-selling drug last year, with sales of Flixabi, Imraldi, and Ontruzant – approved in
$10 billion. This was seen as a landmark achievement Europe.
in biosimilar development. The Celltrion version,
known as Remsima or Inflectra, was launched in Apart from these giants few other Korean firms
Europe and is now sold in 40 countries worldwide. like LG Chem, GC Green Cross, Chong Kun Dang,
Celltrion, currently, has 6 independent pipelines CJ Healthcare, and Dong-A ST have also jumped
for developing therapeutic agents against cancer, into the bandwagon. Chong Kun Dang has been busy
respiratory diseases and autoimmune diseases. developing biosimilar CKD-11101 for anaemia and if
approved, CKD-11101 will be launched as the world’s
Samsung Bioepis, Korea’s another major first NESP biosimilar next year. LG Chem recently got
biosimilar giant, also put up a good show in the nod from the Ministry of Food and Drug Safety
biosimilar sales last year. The company’s Benepali
recorded 531.8 billion won ($478 million) in sales,
accounting for 98.4 per cent of the global Enbrel
sales (a biosimilar of Pfizer-produced autoimmune
disorder drug). The company currently has more than
six drugs focussed on immunology, oncology and
metabolic diseases. The firm has grown to become
the only company to get four biosimilars of Enbrel,

20 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

COVER STORY

Q&A

« How strong is the biosimilar industry in Korea?
South Korea is becoming a fast-growing market, with
Sanjeev Kumar, R&D centres for biosimilars, driven by investments
Industry Manager, and strong government initiatives to foster the
Transformational development of the biotechnology industry.
Health, Frost &
Sullivan Of all the categories of drugs in the South Korean
pharmaceuticals market, biosimilars show the best
“SOUTH growth prospects. Some of the factors supporting
KOREA – this are free trade agreements (FTAs) with India and
EMERGING China. The South Korean government entered into an
FTA with India in 2010 and with China in 2015. As
AS THE both India and China focus largely on generics, these
BIOSIMILARS FTAs threaten to further intensify competition in the
generics market in South Korea, whereas biologics is
BOWL OF highly specialised and presents a huge opportunity
THE WORLD” for local growth.

Another major factor for biosimilars growth in
the country is the rapidly growing demand in the
global market, which local companies are aiming
to capitalise. For example, Samsung Bioepis and
Celltrion are 2 major companies with several
biosimilars approved in different regions

Please elaborate on some of the region’s efforts

to advance the biosimilar industry?
APAC is the fastest-growing market for biosimilars,
owing to favourable government policies and
growing harmonisation in the region. South Korea is
becoming a fast-growing market, with R&D centres for
biosimilars, owing to healthy investments and strong
government initiatives to foster the development of the
biotechnology industry. Companies such as Celltrion
and Samsung Bioepis have already taken lead with

to sell Eucept, an Enbrel biosimilar, to treat a range share by 2020. “The local generic pharmaceutical
of autoimmune diseases. The approval of Eucept industry failed to advance to the global market
marks the second Enbrel biosimilar to get regulatory because it just settled for the domestic market.
approval in Korea. The majority of mAb biosimilars We need to make this an opportunity for Korea to
are being developed in Asia (44 per cent) and Europe become a leader in the global bio and pharmaceutical
(36 per cent), with South Korea being the global industry,” said, the Minister of Knowledge Economy
leader with 17 mAb portfolio products from nine Choi Kyung-hwan at a meeting with chiefs of local
different biopharmacompanies. pharmaceutical firms, as quoted by a leading Korean
daily.
Government support
Since then South Korean government has rolled
It all began in 2010, when the Ministry of Knowledge out many favorable policies and capital investments
& Economy announced unprecedented capital and to foster Korea’s biotech sector. There are many
regulatory support to boost the industry and set favorable steps undertaken by the government in
an ambitious target for Korean pharmaceuticals to this regard, some of them being tax holidays, tax
capture 22 per cent of the global biosimilars market concessions, cash grant, site location support and

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 21

COVER STORY

multiple biosimilars in their pipeline. Samsung Biologics and Celltrion are building
huge capacity for biosimilars manufacturing,
Last year, 2 out of the three biosimilars sold mainly for export.

worldwide were Korean products. What Strong and Clear Biosimilars
Regulation: Establishment of clear biosimilar
according to you are some of the key factors guidelines and strong support by the South
Korean FDA have been playing major roles in the
driving this growth of the biosimilar industry in development of the biosimilars market.

Korea? By 2020, how do you see the biosimilar
South Korea is emerging as a powerhouse for
biosimilars R&D and manufacturing. Two of its industry in Korea grow, through launch of
companies, Samsung Bioepis and Celltrion, have
emerged as top global participants with several new biosimilars?
of their biosimilars molecules at various stages As blockbuster drugs near patent expiry,
of development and commercialisation. Celltrion numerous companies are betting on the
and Samsung Bioepis are in an aggressive mode of exponential growth expected in the biosimilars
investment in biosimilars development. Both the market. Biosimilars are particularly relevant for
companies have several key biosimilars in their APAC, as countries in the region strive to reduce
development pipeline and are disrupting the global their expenditure on pharmaceutical drugs.
biosimilars market. In just two years, Samsung South Korea is positioning itself to emerge as
Bioepis gained European regulatory approval for four the biosimilars bowl of the world, contributing
biosimilars(BS), setting an Industry record. Several to more than 20 per cent of the global market
of these molecules are expected to get FDA approval revenues. Many new Asian companies, along with
soon. Its Insulin glargine BS candidate has already established market participants such as Celltrion
got US FDA’s tentative approval in Jul 2017. and Samsung Bioepis, are expected to launch
biosimilar versions for most of the top biologics in
Growth Drivers for Korea will include 5–10 years, targeting a market size of more than
Strong and Clear Biosimilars Regulation: $20 billion.
Establishment of clear biosimilar guidelines and
strong support by the South Korean FDA have Government support programmes, such as
been playing major roles in the development of the fast approval time by the Korea Food and Drug
biosimilars market. Administration (KFDA), will enhance biosimilars’
Export-driven Market: The South Korean market growth, as this will enable more
market is expected to be largely export driven. biosimilars to be introduced to the market in a
Exports are expected to contribute as much as 50% given period of time.
of the total revenue. Bio-CMO companies such as

financial support for pharmaceutical companies
investing in Korea etc.

Thus, with all the government policies and
frameworks, the biosimilars market in South
Korea has become one of the most promising
growth engines of the nation and is attracting huge
investments from public and private companies
located in and outside Korea.

Investments by
Korean companies in biosimilars

Responding to rising demand for antibody biosimilar
Remsima, Celltrion has decided to invest 325.1 billion
won ($275 million) to ramp up current 140,000-liter
capacity to 310,000 liters by 2019 by expanding

22 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

COVER STORY

South Korea Biosmilars Market 173
190

USD Million 170 CAGR: 12-14% 153
150 135
130
110 106 120

94
90

70

5O 2017E 2018F 2019F 2020F 2021F
2016

Sources: bigmoleculewatch.com, Beroe Analysis

Top Biosimilar Drugs, Past Five Years (2013-2017)

Percentage of Total Deal Value
0% 1% 2% 3% 4% 5% 6%

rituximab biosimilar 5.9%
etanercept biosimilar 5.8%
trastuzumab blosimilar 5.4%
bevacizumab biosimilar 4.7%
adalimurnab biosimilar 3.6%
infliximab blosimilar

3.4%
Note: completed strategic alliance deals only
Source: GlobalData, Deals Database (Accessed 13 February2018)

Estimated costs for biosimilar manufacturing established facilities and building a new plant.
Sample analysis of manufacturing costs in the U.S. and South Korea With capacity expansion, industry experts say,
Estimated costs for a monoclonal antibody
manufactured in U.S. and South Korea* (2015) Celltrion will beat rival contract manufacturing
USD per gram organizations -- Germany’s Boehringer Ingelheim
(300,000 liters) and Switzerland’s Lonza (280,000
100 98 Directional liters). Samsung Bioepis, also expects to reap a
windfall from its drugs, targeting revenues worth
90 08 1 trillion won (~$872 million) by 2020. Samsung
BioLogics, the parent company of Samsung Bioepis
80 19 63 said it is on track to complete its third manufacturing
70 07 Others** plant in Songdo, Incheon, this year, which when
60 26 12 Labor completed will make the South Korean company the
50 largest “pure play” biologics contract manufacturer
40 Materials & in the world. With the completion of this plant, the
30 26 Consumables company will have the total production capacity of
20 45 362,000 liters and will have invested $2.6 billion
(3 trillion won), in manufacturing capabilities.
10 18 CAPEX Commercial production is expected to begin at this
plant in 2020.
0 South Korea
U.S. Challenges

Notes: *ASSurneS 5 g mAb/L titer, 90kL plant capacity, 10-year linear depreciation of capital Biosimilars have hit the market at a time when the
investment, output of 1 metric ton (MT) of mAbs per year and scaled manufacturing labor global pharmaceutical industry is bearing the brunt
costs (e.g., South Korea Labor at 58% of U.S. costs). One gram can provide between two and of two important events-unprecedented patent
10 vials of finished product. ** Others includes overheads such as utilities cost. expirations on the world’s top pharma brands along

Source: L.E.K. Analysis.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 23

COVER STORY

THERE IS AN INCREASE IN THE NUMBER OF
INTERNATIONAL PHARMACEUTICAL COMPANIES
ENTERING THE BIOSIMILAR MARKET. THE RISE
OF CHINESE AND INDIAN COMPANIES, WHO LEAD
WITH PRICE COMPETITIVENESS MAY HINDER
THE FUTURE GROWTH OF KOREAN COMPANIES.
ALSO, DESPITE PROGRESS, THERE REMAIN
SEVERAL CHALLENGES, INCLUDING STRINGENT
REGULATORY REQUIREMENTS, CONTINUED
EDUCATION OF PATIENTS AND PHYSICIANS, THE
PROBLEM OF SWITCHING BETWEEN ORIGINATOR
REFERENCE PRODUCTS AND BIOSIMILAR
PRICING ISSUES. MOREOVER, BIOSIMILARS
HAVE HIGHER REGULATORY BARRIERS THAN
TRADITIONAL GENERICS, THE MANUFACTURING
PROCESSES FOR BIOLOGICS INVOLVE GROWING
CELLS, WHICH ARE VERY DIFFICULT TO
REPLICATE. ALSO, GENERIC DRUGS DO NOT
REQUIRE CLINICAL TRIALS WHILE BIOSIMILARS
DO. AS A RESULT, DEVELOPMENT OF A
BIOSIMILAR IS AN EXPENSIVE UNDERTAKING.

with the increasing healthcare burden and an ageing A bright future ahead
society. Thus an increasing number of international
pharmaceutical companies are entering the market, As biologics with $79 billion of revenue lose patent
and the rise of Chinese and Indian companies who protection over the next four years, biosimilars
lead with price competitiveness may hinder the will emerge and change the biotechnology
future growth of Korean companies. Also, despite industry’s competitive dynamics. While the
progress, there remain several challenges, including biosimilars market is still in its early years, many
stringent regulatory requirements, continued industry watchers expect it to grow faster than
education of patients and physicians, the problem of all other pharma segments. The FDA approved
switching between originator reference products and five biosimilars in 2017, doubling the number
biosimilar pricing issues. Moreover, biosimilars have from what was approved until 2016. Historically,
higher regulatory barriers than traditional generics, Asia has led in generics adoption and now, with
the manufacturing processes for biologics involve more than 300 biosimilars under development,
growing cells, which are very difficult to replicate. Asia is one of the leading regions for global
Also, generic drugs do not require clinical trials biosimilars development. The foundations have
while biosimilars do. As a result, development of a been laid for the biosimilar industry in Korea,
biosimilar is an expensive undertaking. providing an opportunity for the region to become
a global center for manufacturing and adoption of
Earlier, in an interview with a Korean news biosimilars in the next few decades.
agency an official from the Korea Economic Research
Institute had said, “Although domestic biosimilar Just as Indian companies have carved out a
companies have the capacity for mass production, leading position in the generic drug industry,
they are weak in terms of global sales networks. South Korean companies are poised to take
They need to cooperate with global pharmaceutical leading positions in the biosimilars industry, opine
companies to strengthen their international analysts.
operations.”
Aishwarya Venkatesh
[email protected]

24 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

BIO SPECIAL

THE CHANGING
API INDUSTRY

The spending on healthcare has grown at a rapid

pace in recent years worldwide and this has directly

benefited the Active Pharmaceutical Ingredients (API)

market. According to Stratistics MRC, the Global

Active Pharmaceutical Ingredients market is expected

to grow from $129.12 billion in 2015 to reach $198.8

billion by 2022 with a CAGR of 6.4 per cent.

Growth in healthcare adoption has benefited the API market
immensely. There is greater focus on accessibility to affordable
healthcare and this has led to increased surge for access to
medicines, in turn driving the growth of the market as a whole. Sanjeev
Kumar, Industry Manager, Transformational Health, Frost & Sullivan,
Asia Pacific says, “Innovator APIs which were traditionally the largest
segment are continuing to grow much more slowly in comparison
with generic APIs, which constitute the fastest growing segment. With
several key brands going off-patent, and as and consolidation in the
pharmaceutical industry, the demand for branded APIs has gone down
significantly over the years. Consequently, generic APIs have witnessed

a boom, and are expected to continue growing steadily, with further
expected patent expiries and a subsequent increase in generic
production capacities globally.”

Trends in API market

Patent expiration of prominent drugs, government
initiatives, regional penetration and increasing aged
population are some of the factors that are driving
the market growth. Strict validation and safety
guidelines stated by World Health Organisation
(WHO) and fragmented market are the factors that
are hampering the API market growth. “The trend
is shifting towards outsourcing
the manufacturing of advanced
APIs, such as biotech-based
APIs, biopharmaceuticals, and
advanced bulk drugs
required
for the
production of
dosage forms of new
chemical entities
in high-end

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BIO SPECIAL

therapy areas, such as oncology”, says Kumar. Over are key outsourcing allies for pharmaceutical
the next five years, the global market for APIs will companies that supply their wares to North
be driven by increased demand for pharmaceutical America and Europe. With increased competition,
products such as generics and biological drugs. pricing pressures and regulatory changes, drug
manufacturers are resorting to outsourcing raw
Specialty medicines material procurement and manufacturing activities.
driving the market
Asia-Pacific and Rest of the World are the fastest-
A higher generic adoption rate in developed countries growing markets for APIs (8 per cent and 7.2 per cent
that ranges from 27 per cent to 32 per cent is driving CAGRs, respectively) due to increases in consumption,
global medicine spending and aiding greater access to healthcare expenditures and access to medicines. In
improved, lifesaving healthcare services. The adoption the global API and intermediates industry, Asia-Pacific
of branded generic drugs is predicted to be higher accounted for 27.9 per cent of the market share by
in emerging economies such as China and India and revenue in 2015, and this is expected to grow to more
generic drugs accounted for nearly 80 per cent of the than 33.2 per cent by 2020. Sanjeev Kumar says,
total drugs sold by value in these fast-growing nations “Although the overall cases of poor quality and unsafe
in 2016. Increase in the use of specialty medicines APIs are relatively low, an increase in the number of
is anticipated to grow the pharmaceutical spending cases is likely to have a negative impact on the entire
worldwide with quicker growth in richer, developed region. However, with generics accounting for over
nations as compared to their emerging counterparts. 50 per cent of the overall API production, contract
This is primarily because the former have adequate manufacturers in Asia are estimated to account for
manufacturing units, a higher spending power, and
greater emphasis on transparent pricing by assessing Key Players in Global API Market
measuring effects on the population.
● Albemarle ● DuPont
Karen Wai, Chief Operating Officer, Biofourmis Corporation ● Elanco Animal
says, “In general in developed markets the
regulations are clearly defined or there are ● Allergan Plc Health (U.S.)
ample resources to keep regulations relevant to ● Ampac Fine ● Fabbrica Italiana
technological advances. In developed markets due
to the reduced ability to spend on healthcare in Chemicals LLC Sintetici
general you are looking at places that are playing ● Aptuit, Inc ● Heska Co. (U.S.)
on the ability to manufacture at a cost effective ● Aurobindo Pharma ● Koninklijke DSM
price point versus a market that will drive revenue
from the sales of the product.” Sanjeev adds, “Due Ltd. N.V.
to the current restructuring of the pharmaceutical ● BASF SE ● Lonza Group AG
industry, API Contract Manufacturing Organisations ● Bayer Healthcare ● Lupin Limited
(CMOs) are expected to witness a strong upsurge in ● Medtronic Plc
demand, particularly in the generics sector. However, (Germany) ● Merck Animal
in the innovator drugs segment, a major portion of ● Biocon Limited
the manufacturing process is still controlled by big ● Bioniche Animal Health (U.S.)
pharma and the role of CMOs is limited.” ● Merial Inc. (Sanofi)
Health (Canada)
API market in Asia-Pacific ● Boehringer (France)
● Mylan Inc
Asia-Pacific is an important geographical region Ingelheim ● Novartis
and has a number of emerging countries in terms (Germany)
of API manufacturing. Even though the proportion ● Bristol Myers International AG
of healthcare spending in the APAC region is Squibb Company ● Novasep Holding
comparatively low, the growth rate in this strategic ● Cambrex ● Pfizer Inc
region has outpaced that of mature markets in North Corporation ● Ranbaxy
America and Europe. Rising healthcare spending has ● Ceva Animal
led to quality healthcare becoming accessible along Health, Inc. Laboratories
with a higher demand for pharmaceutical products ● Cipla Limited ● Sigma-Aldrich
across APAC. The pharmaceuticals consumed here ● Dishman
are mostly produced in onshore manufacturing units. Pharmaceuticals & Corporation
Furthermore, contract manufacturing organizations Chemicals Ltd. ● Sun
● Dow Chemicals
● Dr. Reddy’s Pharmaceutical
Laboratories Ltd. Industries Ltd.
● Teva
Pharmaceutical
Industries Limited

26 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

BIO SPECIAL

over 80 per cent of the overall small molecule API API market. The large patient population base that
production globally. In addition, India features consumes non-controlled drugs over the counter is
the highest number of FDA-approved units next also a key factor leading to the boom in APAC in-
only to the United States, and several hundreds of house API consumption.
companies are involved in the production and supply
of APIs, formulations and finished dosage forms to Patent cliff and API
the regulated markets. The challenge for regulatory
authorities from advanced markets is the continuous Apart from increased healthcare expenditure by
physical inspection of hundreds of these units to the urban populations across the world and rapid
ensure product quality and safety.” increment people aged over 60 years, the global
API market stands to gain addition traction from
The vast majority of anti-inflammatory and the increase in drug master file (DMF) filing from
antibiotic drugs are manufactured in Asian nations pharma companies. That being said, patent expiry
such as China and India. The low labour cost and of lucrative biological drugs is expected to open new
abundant raw material availability needed to make opportunities in API market in the coming five years
API are the critical factors responsible for the massive (business intelligence study).
growth in the APAC API market. In addition to this,
regulatory support and government encouragement There has been an increasing emphasis on
to establish API manufacturing hubs by way of biopharmaceuticals API. Manufacturing of
favourable tax policies are helping drive the APAC biopharmaceuticals is a capital-intensive, complex
and highly technical process in comparison
“Cost effectiveness might not be the to that of small molecules. The outsourcing of
only key sales & marketing points with biopharmaceuticals manufacturing is becoming
the tightening of regulations, higher increasingly attractive, driven by the lack of
cost for compliance. Now they must captive manufacturing capacity with mid and small
biotechnology companies that drive the research
look at differentiation and development pipeline. Talking about the
through potentially niche business strategy for pharma companies to respond
specialization due to the to API industry landscape given the patent cliff and
changes in the healthcare opportunities it has opened up for generics, Wai says,
environment where due “Some have gone the way of developing biosimilars
to increased knowledge (e.g. Novartis through Sandoz) to combat the erosion
of diseases there are by generics. Some have built generic arms (with
better molecular targets varied success) Merck, Sanofi. Others have increased
and we can now get into the value proposition for their drugs by chasing
the subtype of a disease patient related outcomes on top of the standard
and make an impact clinical trial safety and efficacy. Another new value
there.” differentiation is incorporating digital technologies
- Karen Wai, Chief that are tied to the demonstration of outcomes for the
Operating Officer, pharma brand and aid in medication adherence and
Biofourmis monitoring – e.g. through digital biomarkers.”

Kumar adds, “The business model of contract
manufacturing organisations (CMOs) is rapidly
evolving to suit the changing demands of
biopharmaceutical innovation, with over 50 per cent
of biopharmaceutical companies outsourcing some
form of their biopharmaceutical production. CMOs
have also adapted well to the change by offering
value-added services such as packaging, logistics
and anti-counterfeiting in addition to traditional
manufacturing, making outsourcing increasingly
attractive option.”

Quality Control and API

The ICH guidelines and FDA recommendations
about how to effectively manage quality risk in drug

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BIO SPECIAL

manufacturing are clear and plentiful. However, the “In the pharmaceutical industry, API
amount of qualification and validation that take place sourcing is increasingly being considered
is really left to the discretion of drug manufacturers as a highly critical strategic decision.
and their CMOs. Believing in the process, Kumar While most of the demand in value terms
says, “In 2016, warning letters were issued by for APIs is still from the United States
the US FDA to several Chinese pharmaceutical
manufacturers for GMP non-compliance, resulting and Europe, the role of
in a denial of entry of the latter’s products into the Asia Pacific region
the United States. Following this, the US FDA as a key location
has opened affiliate offices in Chinese cities such for API sourcing
as Beijing, Shanghai and Guangzhou to conduct is becoming more
periodical inspections to ensure that standards are prominent. “
met. Recent efforts have been made by the CFDA to - Sanjeev Kumar,
address issues of IP protection and development of Industry Manager,
innovative drugs which will have a positive impact Transformational
on innovative API manufacturing”. Similarly, during Health, Frost
2015-2016 Indian manufacturers have faced quality & Sullivan,
issues, which have raised regulatory concerns from Asia
importers. The issues are being addressed by both the Pacific
Indian governing bodies and FDA. The governments
in APAC are implementing favourable funding garner greater market share in different regions.
regulations that promote the development of high- Kumar, looks at the potential and says, “As the API
quality pharmaceutical products. manufacturing industry becomes more competitive,
there is an increasing onus on technologies that
Product-Offering Expansion enhance manufacturing efficiencies. Several leading
and Cost Reduction API participants, particularly those in the Asia-Pacific
region, are taking measures to improve equipment
For the drugs manufacturers, APIs are of great utilisation and product yield, as well as to reduce
essence as their quality defines the effectiveness process time and harmful emissions and increase
of the products. However, not all pharmaceutical reuse and recycling. From a geographical perspective,
companies possess in-house API manufacturing Europe-based participants cater to the innovator
capabilities and it is not feasible for a single company sector in the US and Western European markets
to produce all the APIs required for their formulation because of their proven capabilities. On the other
offerings. An intense focus on commercializing hand, Asian companies are major suppliers to the
drugs and reducing operating costs by outsourcing generics industry in the Western markets.”
R&D activities can improve the organizational
efficiency substantially. Outsourcing at later stages Looking into the future
of development through the appointment of strategic
partners can potentially improve operational In order to keep pace with the industry, many
efficiencies throughout the value chain. A balanced generics-focused companies will continue to
portfolio approach goes a long way in expanding gain capabilities through acquisition. Innovator
sales and simultaneously reducing risk. Karen Wai companies are building their own facilities to pursue
notes, “Cost effectiveness might not be the only new therapeutic areas of interest while others are
key sales & marketing points with the tightening of trending toward outsourcing the development, scale-
regulations, higher cost for compliance. Now they up and commercial production of API to custom
must look at differentiation through potentially niche development and manufacturing organizations with
specialization due to the changes in the healthcare diverse capabilities that can offer a one-stop shop.
environment where due to increased knowledge of
diseases there are better molecular targets and we With the continuous growth and shift in the
can now get into the subtype of a disease and make market, we can expect more mergers, acquisitions
an impact there.” and investment as companies strategize in order to
be competitive and relevant in the industry.
This could be by possessing branded generic
drugs, branded drugs, and unbranded drugs Priyanka Bajpai
within the same portfolio. In addition, clearly [email protected]
defined forward linkages in the supply chain can

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HE ALTHCARE

Ayushman Bharat-

REACHING OUT
TO INDIAN POOR

In India, it has been observed that if Rs 100 is spent on an individual for treatment, of that the burden of more

than Rs 60 is borne by the family or that individual. The entire savings is spent on medical expenses. As most

part of their income is spent on medical expenses, every year lakhs of families that are on the verge of coming

out of poverty are again pushed back into poverty due to some or the other disease. Thus, government of India

has taken the responsibility of changing this scenario by launching Ayushman Bharat scheme.

On September 23, India took a giant The Prime Minister of India, Narendra Modi addressing the
leap towards providing accessible and gathering at the launch of the Pradhan Mantri Jan Arogya Yojana
affordable healthcare to the common man (PMJAY), at Ranchi, in Jharkhand on September 23, 2018.
by launching Ayushman Bharat – Pradhan Mantri
Jan AarogyaYojana (AB-PMJAY), the “world’s equal to the population of the European Union, or the
largest government funded healthcare programme” population of America, Canada and Mexico, taken
targeting more than 500 million beneficiaries. With together and 85 times that of Singapore.
this scheme, the government is taking healthcare
protection to a new aspirational level. Explaining how comprehensive the AB-PMJAY is,
the Prime Minister said it would cover 1300 illnesses,
Narendra Modi, the Prime Minister of India said including serious illnesses such as heart diseases,
that this launch has been done with a vision to provide kidney and liver diseases and diabetes. The private
the poorest of the poor, and the underprivileged hospitals too would be part of this scheme. The
sections of society, with better healthcare and amount of Rs 5 lakh would cover all investigations,
treatment. He said this scheme, which envisions medicine, pre-hospitalization expenses etc. He said
health assurance of Rs 5 lakh (about $7000) per family it would also cover pre-existing illnesses. The people
per year, will benefit over 500 million people, and is can learn more about the scheme by dialling 14555, or
the world’s biggest health assurance scheme. He said through their Common Service Centre. The States that
the number of beneficiaries of this scheme is roughly are a part of PMJAY, people can get the benefit of the
scheme in whichever of these States they go to.
“The PMJAY is clearly
a massive leap towards The Prime Minister said “I believe that in the
universal health coverage near future, the people associated with the medical
that could transform the sector, or those concerned with health schemes, those
healthcare landscape in associated with economics or modern treatment
India. We believe that techniques, or those thinking of bringing about a
digital infrastructure will
be key to a seamless and transparent system
of transacting the costs of drugs, diagnostics
and therapeutic interventions. We are keenly
monitoring the operating models to be followed
by empanelled hospitals and will continue to
serve communities with the highest quality of
care and commitment possible.”
- Dr Dharminder Nagar,

MD, Paras Healthcare

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HEALTHCARE

transformation in the lives of the common man like Features of AB-PMJAY
social scientists, medical scientists, economists will
have to study and think on the lines of India’s scheme ● A progression towards promotive, preventive,
of Ayushman Bharat. And sooner or later, based on it, curative, palliative and rehabilitative aspects of
they will have to devise future models for the world.” Universal Healthcare through access of Health
and Wellness Centres (HWCs) at the primary
The Ayushman Bharat Mission strengthens the level and provision of financial protection for
environment of ‘One India, One treatment’ in true accessing curative care at the secondary and
sense. The people of one state that have joined the tertiary levels through engagement with both
Ayushman Bharat Mission can also avail the benefits of public and private sector.
the scheme in some other state in case of emergency.
Till date, more than 13,000 hospitals across the ● Adopts a continuum of care approach,
country have joined this mission. In the near future, comprising of two inter-related components:
more hospitals will be part of this mission. Moreover, Creation of 1, 50,000 Health and Wellness
the well performing hospitals, especially the rural Centres, which will bring health care closer to
hospitals will get incentives from the government. The the homes of the people.
aim of Ayushman Bharat Mission is not only to provide
financial aid but also to develop a system that will ● HWCs will provide Comprehensive Primary
ensure best treatment facilities just close to your house. Health Care (CPHC), covering both
maternal and child health services and
The Prime Minister also inaugurated 10 health and non-communicable diseases, including free
wellness centres on the day. At present the number of essential drugs and diagnostic services.
such centres across the country has reached 2300. The
aim of the government is to have 1.5 lakh such centres ● The second component is the Pradhan Mantri
in India within four years. The health and wellness Jan ArogyaYojana (PMJAY), which provides
centres are important part of Ayushman Bharat health protection cover to poor and vulnerable
Mission. These centres will not only have treatment families for secondary and tertiary care.
and medicines for common diseases but will also have
facilities for conducting several free tests. This will ● HWCs will play a critical role in creating
help in early detection of serious diseases. awareness about PMJAY, screening for
non-communicable diseases, follow-up of
The government is working holistically instead hospitalization cases among others.
of working in bits and pieces. Every decision and law
is interlinked. The government is focusing on both AB-PMJAY (Financial protection from
affordable healthcare and preventive healthcare. Yoga, catastrophic expenditure)
campaigns like “Swachh Bharat Mission”, making ● 71st Round of National Sample Survey

“The announcement of Organization (NSSO) has found 85.9 per cent
Jan Arogya Abhiyan is of rural households and 82 per cent of urban
a landmark scheme and households have no access to healthcare
a much needed boost to insurance/assurance. More than 17 per cent
India’s healthcare system. of Indian population spend at least 10 per
Till now at least 27 per cent cent of household budgets for health services.
people around the poverty Catastrophic healthcare related expenditure
line who could not have afforded healthcare pushes families into debt, with more than 24
would hit by the high cost of treatment. With per cent households in rural India and 18 per
a promise of a transparent, IT-enabled system, cent population in urban area have met their
the initiative promises to benefit 500 million healthcare expenses through some sort of
plus population is indeed laudable. Another borrowings.
aspect that stands out is the integration of ● PMJAY primarily targets the poor, deprived
the wellness centres, the first pillar - with rural families and identified occupational
Ayushman Bharat and the second pillar - category of urban workers’ families as per
government healthcare delivery.” the latest Socio-Economic Caste Census
- Ajoy Khandheria, Founder, (SECC) data for both rural and urban areas
as well as the active families under the
Gramin Healthcare RashtriyaSwasthyaBimaYojana (RSBY).
● Approximately 10.74 crore identified families
(approximately 50 crore beneficiaries) will be

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HE ALTHCARE

entitled to get the benefits. There is no cap on “Ayushman Bharat is a
family size and age as well as restriction on very ambitious scheme and
pre-existing conditions. would be the largest state
sponsored scheme in the
AB-PMJAY (Hospitalization cover from world. The success of this
inpatient care to post hospitalisation care) scheme would depend upon
● Objectives are to reduce out of pocket the effective implementation
of this scheme. This scheme would definitely
hospitalisation expenses, fulfil unmet needs increase awareness among the population and
and improve access of identified families to help set in some standards of care especially in
quality inpatient care and day care surgeries. rural areas.”
● Provides a coverage up to Rs 5 lakh (about - Shreeraj Deshpande, Head
$7000) per family per year, for secondary Health Insurance,
and tertiary care hospitalization through a Future Generali India Insurance
network of Empanelled Health Care Providers
(EHCP). villages “Open Defecation Free” etc. are aimed at
● The EHCP network will provide cashless eradicating the root cause of serious diseases. With
and paperless access to services for the launch of “Swachh Bharat Mission” saving the lives of 3
beneficiaries at the both public and private lakh children have increased in the country. Whether it
hospitals. is the statistics pertaining to saving the lives of newborn
● Includes 1350 procedures covering pre and babies or the lives of pregnant mothers, the country is
post hospitalization, diagnostics, medicines striding ahead at a rapid pace to make India healthy.
etc.
● Beneficiaries will be able to move across The government has started schemes like Poshan
borders and access services across the country Mission so that malnutrition can be prevented right at
through the provider network seamlessly. the nascent stage of development of the body. At the
same time, relentless efforts are being made to increase
Progress of AB-PMJAY in States: 30 states the human resources in the medical field. According to
and Union Territories have signed the MoU and an estimate, there will be about 2500 good quality and
have started working on implementation of the modern hospitals due to Ayushman Bharat in the coming
mission. 3 years. Most of these hospitals will be concentrated
Pilot launch of PMJAY: in tier-2, tier-3 cities and small towns. As a result, new
● The focus of the mission is to test and enhance employment opportunities and opportunities for new
profession will open up for middle class families.
the developed IT systems and streamline the
state preparedness for a comprehensive launch Moreover, employment opportunities will also
● Done in around 22 States / UTs come up in the form of technical expertise, call centre
● Taking place in specific hospitals to test the jobs, management, pharmaceutical production,
Beneficiary Identification System (BIS) and equipment manufacturing along with medical
Transaction Management System (TMS) services. There will be a huge demand for paramedical
systems. staff and trained doctors. Simultaneously, there will
● Involved over 1280 hospitals. also be new opportunities for start-ups related to the
medical field. Lakhs of doctors, nurses and people
Hospital Empanelment: So far 15,686 associated with hospital management will get the
applications for hospital empanelment have been opportunity to be associated with it. This means that
received. a great opportunity awaits the country’s middle class
Fraud detection and Data privacy: and lower middle class.
● Detailed guidelines have been prepared to
The Prime Minister expressed confidence that
address the issues around potential fraudulent through the efforts of all those involved with the
activities that could be committed by any scheme, and the dedication of the doctors, nurses,
individual or organization. healthcare providers, ASHAs, ANMs etc, the scheme
● Anti-fraud cells will be established at the would become a success.
national and state level, and strong IT tools will
be deployed to prevent and detect fraud. Narayan Kulkarni
[email protected]

(Inputs from Prapti Shah)

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BIO SPECIAL

Achieving Universal
Healthcare in India

India, the largest provider of generics «
worldwide, has the potential to contribute
to country’s Universal Healthcare Coverage Sanjeev Gupta,
program as well as those of other developing Managing Director,
and less developed economies because of Kusum Group of
the strength of its generic industry, which is Companies, India
able to use low manufacturing costs in this
country to the advantage of consumers who

are most in need of it.

The World Health Organization (WHO) defines Hospitals, too, are understaffed or undersized due
Universal Healthcare to include all practices to paucity of funds. At the same time, poor quality
that promote, prevent, cure, rehabilitate and of care contributes to the spread of infections and
palliate quality health care with efficacy that does not epidemics. There is also the problem of oversupply
cause undue financial strain on the suffering victim. of certain preferred medical equipment, diagnostic
It is estimated that between one-fifth to three-fifth of investigations and other procedures. Public
the national health budgets in low and middle income healthcare workers tend to be less motivated or have
countries go toward expenditures on essential drugs unbalanced staffing of expensive departments while
and medicines. Further, in these countries, up to 90 private institutions may practice uncommon hospital
per cent of the costs on medicines are borne by the admissions or extension of stay. In short, there exists
patients themselves through out-of-pocket expenses. wastage of resources, leakages in health initiatives
In developed countries, these expenses are managed including corruption and fraud and poor strategies as
through compulsory insurance schemes that help well as poorly implemented strategies.
keep health costs low without destabilizing individual
finances. These findings are directly substantiated by
WHO studies and form part of its report on Access
Reducing Out-of-Pocket to Essential Medicines and Universal Health
Expenditure on Medicines Coverage, 2015. Any good public strategy should
always consider who the health policy interventions
The overall costs of treatment, such as doctor’s are meant to target, which services can be covered
consultation fees, laboratory testing, hospitalization under its ambit and how much of the costs can be
charges and medication make up more than half apportioned to the state. If a health technology is
of all spending on healthcare. Underuse of generic understood to be an expression of knowledge and
drugs and overpricing is resulting in pushing skill to medicine, medical equipment, vaccines
an increasing percentage of the most vulnerable and other frameworks and processes developed to
disadvantaged communities, in developing and resolve a health challenge, then a health technology
less developing countries, toward absolute poverty. assessment properly planned and implemented
Public spending backed by a responsive yet would go a long way in helping policy makers reach a
affordable insurance mechanism can ensure equal decision in regard to a particular strategy.
access to healthcare for all.
Which Healthcare coverage
Reducing Wasteful Public Expenditure models should India follow?

The availability of spurious and/or sub-standard Governments are faced with dilemmas in deciding
medication and inappropriate or ineffective use of the type of basic health initiatives that need to be
available medication is yet another impediment to promoted and also in exploring ways to extend their
the reach of safe and effective drugs to the masses. reach to hitherto neglected groups across geographies

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BIO SPECIAL

INDIAN PHARMA INDUSTRY HAS THE Already Rs 1200 crore have been allocated toward
these programs through the Union Budget 2018. Cost
POTENTIAL TO CONTRIBUTE TO INDIA’S sharing is to be performed jointly by the Center and
the States. A vision encompassing contributions from
UNIVERSAL HEALTHCARE COVERAGE the private sector through voluntary initiatives and
CSR activities has also been recorded.
PROGRAM AS WELL AS THOSE OF OTHER
Huge Domestic Disease Burden
DEVELOPING AND LESS DEVELOPED
This approach would cover some of the costs toward
ECONOMIES BECAUSE OF THE STRENGTH expensive medication for rising incidences of NCDs
in India. However, communicable diseases continue
OF ITS GENERIC INDUSTRY, WHICH IS ABLE to persist more than half a century since the first
steps to eliminate them began. Old diseases have
TO USE LOW MANUFACTURING COSTS TO reemerged with greater virulence most notably due
to inappropriate usage and abuse of commonly
THE ADVANTAGE OF CONSUMERS WHO ARE available antibiotics. New infections due to
environmental degradation and poor hygiene due to
MOST IN NEED OF IT. human congestion in urban slums continue to fester
and current measures to deal with them may be
and social barriers. It is these incremental decisions inadequate.
at the margins that help in taking a policy approach
forward and increase its efficacy. Countries Incorporating a culture of
particularly vulnerable to political or social strife Quality healthcare for all
should plan for contingencies affecting large groups
of people such as hurricanes or earthquakes that India produces one-fifth of the world’s generic
leave a flood of diseases and epidemics in their wake. medicine exports and is easily the largest provider
of generics worldwide. The domestic pharmaceutical
The high cost of healthcare market itself is set to become the third largest in
and Ayushman Bharat the world by 2020 based on incremental growth
with turnovers predicted between $ 45 billion to $
Essential medication cannot be denied to those who 70 billion within the same period. Penetration of
need it the most on the flimsy grounds of inability registered pharmacists into remote villages is on
to pay. One of the grimmest challenges to universal the rise and over-the-counter drugs will steadily
facilitation of healthcare is its prohibitive cost. increase. Local companies are keen to expand into
For a country with the size of India’s population, rural markets as health centers and roads develop.
guaranteeing health solutions for everybody requires Insurance coverage also guarantees payment to
trillions of Rupees each year for sustenance. The medical suppliers including pharma. Indigenous R&D
newly conceived Ayushman Bharat cum National is sufficiently encouraged by allowing price control
Health Protection Scheme which promises a two exemptions for them for the first five years. However,
pronged strategy to tackle access to medical services concrete policies that ensure uniform enforcement of
is a step in the right direction. The first component quality imperatives to ensure intended target delivery
will increase the number of Health and Wellness are crucial.
centers by 1.5 lakh across the country. The second
will provide an insurance cover of Rs 5 lakh per Indian pharma industry has the potential to
household covering non communicable diseases and contribute to India’s Universal Healthcare Coverage
gynecological healthcare to about 10 crore of the most program as well as those of other developing and
vulnerable and poor sections of India’s population. less developed economies because of the strength
of its generic industry, which is able to use low
manufacturing costs in this country to the advantage
of consumers who are most in need of it. However,
to maximize the participation of the $30 billion
dollar industry in achieving the national dream
would first and foremost require a policy framework
which reward maintenance of quality initiatives with
incentives and inject appropriate capital into the
system for the movement to sustain.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 33

Q&A

“Vietnam – a potential for growth of
pharma imports in next few years”

« overseas manufacturers would have to re-write
certain documents or generate extra data for inclusion
Joelle Chia, into the registration dossier. This could be due to
unique patient populations in the country as well as
Co-director Asia, for political reasons to protect their own domestic
pharmaceutical manufacturers.
Pharma To Market,
Another major complaint we hear from our clients
Singapore is the unpredictable timelines to obtain a product’s
registration approval. Published timelines are seldom
Founded by ex-Therapeutic Goods followed and regulatory agencies do not have the
Administration (TGA) evaluators and industry capacity to process the large number of received
specialists, Pharma To Market is a leading applications. The problem is further compounded each
regulatory affairs consulting company that operates time the local regulations or guidelines are updated to
in the Asia-Pacific (APAC) region. The firm assists include even more requirements from the applicant.
pharmaceutical, biotech, medical device and other In an effort to meet the published timelines, agencies
life science companies to register their products have been known to turn away applications once any
and access the diverse and rapidly growing markets slight deficiency is spotted during the first screening
throughout Australia, New Zealand and APAC region. of the dossier so that these applications will not enter
Pharma to Market established their new entity in the queue and count towards the Key Performance
Malaysia, further strengthening their foothold in the Indicators (KPIs).
APAC region. Joelle Chia, Co-director Asia, Pharma
To Market has over 12 years’ experience in regulatory What, in your opinion, can be done to address
affairs in Asia working with biotechnology companies
and pharmaceutical companies. In conversation with these concerns?
BioSpectrum Asia she shared her views on quality and Pharmaceutical companies should maintain regulatory
compliance issues being faced by pharma companies staff or engage consultants that demonstrate the
in APAC and growth of the pharma market in the relevant expertise and knowledge required to
region. Edited excerpts; understand the various quirks of each agency of the
country that they would like to pursue a registration
What are the most pressing business issues that in. Because of the differences in economic standing,
companies face today while registering their demographics and culture, every agency in the Asian
products in the Asia Pacific region? region is unique. It is generally challenging for
One major regulatory hurdle for pharmaceutical companies without experienced local regulatory staff
companies wanting to enter the Asian markets is or a competent local partner to keep up with frequent
the differing regulatory requirements for product changes to the local requirements, which in many
registration across different countries. Most cases, are announced without many implementation
regulatory authorities in this region have their local details.
guidelines adapted from international ones (e.g. ICH,
WHO). However, despite harmonisation efforts (e.g. Organisations need to maintain channels to
such as the ASEAN Harmonisation of ACTD and readily communicate and clarify requirements with
ACTR), the interpretation of the requirements is in the officers in regulatory agencies in order to prepare
practice not consistent between agencies and even data required for submission more efficiently and also
within the same agency. It is common for authorities assist their R&D departments evaluate options for
to also impose other complex requirements for which justifications if the required data is unavailable.

Supporting the education of regulatory personnel
in charge of gathering registration data in the form
of training, workshops, etc. will also allow the
company to enjoy an advantage in understanding the
complexity and differences in regulatory requirements
as compared to other major regulatory agencies.

34 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

Q&A

Pharma To Market has established their new the next few years. A fast-growing young population
with increasing income, widespread preference for
entity in Malaysia. How do you see Malaysia’s imported branded drugs for chronic conditions and
government upgrading in infrastructure and facilities
pharma market progressing in the next five and being more open to foreign investment are some
of the reasons.
years?
Malaysia’s government has increased its national Other larger and more prominent ASEAN countries
healthcare budget, some of which will be allocated (Indonesia, Thailand, Philippines and Malaysia) also
to building new hospitals and medical centres. The hold potential due to their large populations but may
allocation to the Ministry of Health in the year 2018 be challenging because of the political situation, more
is a 9.5 per cent increase from the 2017 budget. The competitive marketplaces and less straightforward
government has also identified healthcare travel as regulation.
one of the National Key Economic Areas to drive the
country towards a high-income nation by 2020. In China and India are also countries with significant
line with this announcement, the government has potential for growth due to the sheer size of their
allocated a portion of the total health budget to spur populations and their fast-growing economies.
further growth of the medical tourism industry, with Currently, China is the world’s second largest market
the aim to achieve a year-on-year growth of 20-30 per for pharmaceuticals and the fastest emerging market
cent. for this sector.

Several other factors will contribute to the Many companies in APAC struggle with quality
increased need of healthcare and even demand for
more expensive health products - increasing life and compliance issues. What in your opinion
expectancy, increasing affluence of citizens, and the
surge in the rate of non-communicable diseases due to could be some of the reasons?
prevalence of sedentary lifestyles, unhealthy diets and These issues are mostly seen in countries with
use of tobacco and alcohol. less developed regulatory frameworks. The overall
trend of pharmaceutical globalisation has seen drug
The aforementioned reasons will spur an increase companies setting up manufacturing sites in the
in the demand of pharmaceutical products and developing countries of Asia due to cheap labour
increase in the investments in the pharmaceutical and low operational costs. Although laws exist in
market, contributing to a general growth of the these countries to govern compliance and the quality
pharmaceutical market, which foreign companies can of pharmaceutical products, it is difficult for the
take advantage of. government to enforce the laws due to lack of budget,
infrastructure or manpower. Lack of budget may even
Imported medicines form about 63 per cent of lead to corruption.
the pharmaceutical market in 2016. Most of the
domestic pharmaceutical companies produce only There is also a general lack of expertise and
generic products and are not focused on research training regarding GMP in the countries, resulting
and development activities. Hence, Malaysia is still in manufacturing plants and their quality control
reliant on imported patented products from foreign laboratories having lax adherence to standard operating
companies. procedures and hygiene issues, and other GMP non-
compliances. This lack of expertise also applies to
In which markets of APAC do you see maximum the inspectors at the regulatory agencies that audit
GMP compliance. Without expertise in the country’s
growth for pharma sector and why? regulatory agency, it is difficult to ensure that their
The Vietnam market has been widely expected to be of local manufacturers are producing safe and efficacious
the greatest potential for growth of pharma imports in drugs. To facilitate pharmaceutical exports, the
regulatory agencies have been working on enhancing
their inspectorate functions in recent years, by setting
inspection protocols and training their inspectors.
For some ASEAN countries it meant achieving an
accession into Pharmaceutical Inspection Convention
and Pharmaceutical Inspection Co-operation Scheme
(PIC/S) (e.g Indonesia in 2012, Thailand in 2016 and
Philippines, applied but pending).

Aishwarya Venkatesh
[email protected]

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 35

Q&A

“Diabetic kidney disease could
overwhelm our health systems”

« kidney disease using our technology. Working with
our clinical team, we followed the progression of the
Dr Richard disease over a four year timeframe in a community
based study of people with diabetes. At the end of this,
Lipscombe, we looked at all the variables that changed and were
able to hone in on a small subset of biomarkers that
CEO, Proteomics correlated with the disease.

International, Australia Can you tell us more about your lead product,
PromarkerD? How does it work to detect
Diabetic kidney disease, also known as diabetic Diabetic Kidney Disease in patients? What
nephropathy is one of the most significant is the successful ratio in people with pre-
complications in terms of mortality and diabetes?
morbidity for patients with diabetes. Globally, PromarkerD is a blood test that measures a panel of
the diabetic nephropathy market is witnessing three proteins found in the circulation. This protein
significant growth due to rise in the incidence of fingerprint is combined with clinical parameters
diabetes and obesity in different regions of the such as age and cholesterol levels and then the
world. The global diabetic nephropathy market is PromarkerD algorithm calculates a risk score
likely to reach $3,145.9 million by 2020 (Persistence showing who is likely to get diabetic kidney disease
Market Research). At such rate, monitoring and in the near future. In clinical studies, PromarkerD
management becomes crucial for diabetic patients. correctly predicted 86 per ent of otherwise healthy
Recently, Proteomics International licensed their diabetics who went on to develop chronic kidney
diabetic kidney disease predictor test (PromarkerD) disease within four years. The test is yet to be
in the USA and Mexico. During his interaction with evaluated in people with pre-diabetes, however,
BioSpectrum Asia, Dr Richard Lipscombe, CEO clinical studies published by others have suggested
of Proteomics International, Australia talks about kidney disease may begin at the pre-diabetes stage,
their star product, plans to launch in other countries hence PromarkerD may be useful for this group too.
and the future of diabetic kidney diagnosis. Edited
excerpts; Are there any unique challenges to managing
diabetic kidney in Australia, where your
Diabetic Kidney management and monitoring company is based?
is becoming a huge problem around the world. The problem with managing kidney disease in
What brought Proteomics International to Australia is no different from other parts of the
translate into creating PromarkerD? world – with one-third of all adults with diabetes
Proteomics International has focused on applying our having chronic kidney disease. The risk is that health
technology to precision and personalised medicine systems will soon be overwhelmed by the numbers
since 2007. The standard tests for diagnosing kidney requiring dialysis or a kidney transplant.
disease have been around for over 50 years and can
only diagnose problems once they are already present. Proteomics International has just licensed the
The existing tests cannot predict who will get sick into PromarkerD test kit in the USA and Mexico. Can
the future. Consequently the diabetes consultants you talk about the data that you have developed
connected to our research network were seeing an ever over the course?
increasing number of people who already had chronic The results from the clinical studies on PromarkerD
symptoms. Proteomics International was approached were presented at the American Diabetes Association
to see if we could find better biomarkers for diabetic Annual Scientific Sessions last year and published in
the prestigious journal Diabetes Care in November
2017. The data covers two independent cohorts and
over 1000 participants followed for four years.

36 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

Q&A

What are the plans of launching the product Does Proteomics International aims to develop

in other parts of the world? Have you faced blood tests for other diseases as well? What is

any regulatory challenges while licensing in the pipeline? Are there any big milestones

contracts? coming up on the company’s roadmap?
Following the licences in the USA and Mexico, and Yes, we have an ongoing biomarker discovery and
the launch in the Dominican Republic early this year, diagnostics development programme, that employs
PromarkerD is attracting attention from around the the same Promarker technology platform used to
world. Proteomics International is now targeting create PromarkerD.
the major healthcare markets of Japan, Europe
and China. For new technologies there are special The pipeline is targeting new diagnostic tests for
regulatory pathways called Laboratory Developed chronic diseases with unmet medical need including
Tests or “LDT”s, and Proteomics International endometriosis, infections from the Giardia parasite,
is following this route for PromarkerD in target asthma and chronic obstructive pulmonary disease
countries. (COPD). Endometriosis affects one in ten women
in their reproductive years and both incidence
Now a days, personalised medicine and its and health burden are comparable with diabetes.
The current gold standard for detection is invasive
extensive use is highly prevalent. How do you surgery. Giardia affects about 280 million people
worldwide, and the risk for human health is to detect
expect Proteomics International to benefit from human infective strains of the Giardia parasite that
can jump across from animals. Milestones - both
this trend? these tests are at the proof of concept stage and we
Indeed, we see the personalised medicine market expect key results over the next six months.
more than doubling in size within the next 4 years.
This is exactly where Proteomics International’s How do you think the future of diabetic kidney
technology platform is focused, both for developing
new tests or helping to monitor drug therapies. diagnosis will develop?
If nothing is done, diabetic kidney disease could
For example, diagnostic tests can be essential overwhelm our health systems across the Asia region,
for the safe and effective use of therapeutics USA and Australia and Europe.
(companion diagnostic), or may help weigh up the
risks and benefits of a treatment without restricting According to the International Diabetes
drug access (complementary diagnostic). A test Federation there are now 425 million adults
like PromarkerD could act as a complementary with diabetes. Kidney disease is one of the
diagnostic for more than 20 new drugs
being developed for diabetic kidney major complications of the disease and affects
disease. Proteomics International’s approximately one-third of all diabetics.
diagnostics development is made Since 1990, chronic kidney disease (CKD)
possible by the company’s due to diabetes alone has climbed from
proprietary biomarker 35th to now the 16th leading cause of death
discovery platform called and years of life lost due to premature
Promarker, which searches mortality in the USA. Kidney disease
for protein ‘fingerprints’ in
a sample. This disruptive not specifically attributed to diabetes
technology can identify (although this could still be the cause)
proteins that distinguish is ranked 9th, with the combined US
between people, who healthcare spending attributed to CKD
have a disease and people exceeding $100 billion annually. These
who do not, using only statistics are only going to get worse.
a simple blood test. It Better diagnosis means early intervention
is a powerful alternative and the potential to stop the disease
to genetic progressing to a dangerous and or fatal
testing. stage. PromarkerD could help transform
diabetes management globally.

Priyanka Bajpai
priyanka.
bajpai@
mmactiv.
com

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 37

Q&A

“New innovations create
meaningful barriers for competition”

« extending desirable features across the entire portfolio
and creating new Invisalign Treatment Packages,
Julie Tay, as well as new options to treat young patients with
early mixed dentition. The new end-to-end Invisalign
Managing Director and portfolio now includes clear aligner product offerings
for almost every patient age group and case complexity
Senior Vice President- to make it easier for doctors to tailor treatment
planning to the needs of each unique patient.
Asia Pacific, Align
iTero scanners: iTero scanner is part of the
Technology, Singapore Invisalign digital workflow and has been purpose-
built to support our advanced clear aligner technology
Digital orthodontics is rapidly becoming the with enhanced features that are not available with
industry standard and is changing the way other scanner product lines.
orthodontics is viewed currently. Digital
orthodontics as a tool has the potential to replace Digital services: Product development is one of
the conventional methods in the future, because of our competitive advantages. We believe we have the
its many business advantages including the ability only end to end digital clear aligner system that delivers
to significantly shorten delivery times, increase the outcomes, efficiency and experience that doctors,
production capacity and eliminate bulky model storage. and patients want - and doctors will see our significant
The orthodontists are looking at the opportunity to be value when they try other products. We continue to
a part of the revolution as it could be seen in the high remain committed to providing our customers with
adoption rate across major economies. According to the most comprehensive tools in digital dentistry.
report by IndustryARC, the global digital orthodontics
market will grow at a CAGR of 18 per cent and reach Market by market, which regions you think to
$3.6 billion by 2020. Recently, Julie Tay, Managing
Director and Senior Vice President Asia Pacific of grow in?
Align Technology spoke to BioSpectrum Asia about China is the #2 global market for Align and represents
the current trends, potential and future of digital an enormous opportunity. We will be opening a
orthodontics industry. Edited Excerpts; manufacturing facility in Ziyang, China in the 2H18
for both Invisalign clear aligners and iTero scanner
Where do you see the largest potential for manufacturing. Initially, we will use the facility to
growth in digital orthodontics? What are the supply our customers in China, but over time, we will
advancements in technology evolution? look to leverage the facility to supply our customers
Align Technology is firmly rooted in the belief that across Asia Pacific. We continue to add new doctors
innovation extends its competitive edge and therefore – especially outside North America – and have seen
drives growth and adoption. We will continue to utilization growth among existing Invisalign practices.
innovate through R&D and combine the power of
software, biometrics, machine learning and 3D In Asia Pacific (APAC), Q1 Invisalign volumes were
printing to ensure that we deliver the products and up 56.1 per cent year-over-year led by China, Japan
services to help our doctors and their patients achieve and Australia, with China solidifying as our 2nd largest
the smiles they dream of. At Align, we are always market worldwide. Our Q1 results reflect continued
thinking of new and innovative ways to reach the more strong growth overall and especially from teen cases,
than 300 million consumers globally who can benefit which were up 73 per cent year-over-year. In addition,
from straightening their teeth. we saw strong growth from our GP channel which was
up over 70 per cent compared to last year.
Invisalign clear aligners: The new Invisalign
product portfolio offers doctors more choices by We also continue to see positive uplift from Invisalign
customers with iTero scanners. For Q1, Japan had a
record quarter and showed very strong growth from
doctors who have previously purchased iTero Element
scanners. Finally, Q1 was an all-time high for Invisalign
volume in our smaller expansion markets in Thailand,

38 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

Q&A

THERE IS A LARGE OPPORTUNITY FOR EXPANSION
AND ACCELERATED GROWTH AMONG BOTH
ADULT AND TEEN CONSUMERS INTERESTED
IN THE INVISALIGN TREATMENT IN THE APAC
REGION. WITH MORE THAN 300 MILLION
CONSUMERS GLOBALLY (100 MILLION OF THEM IN
APAC) WHO CAN BENEFIT FROM STRAIGHTENING
THEIR TEETH, WE ARE FOCUSED ON PROVIDING
BETTER CUSTOMER EXPERIENCES WORLDWIDE.

Singapore, and Korea - where we are still very early in of the year developing for Align Technology?
their development and adoption cycle. One of the key focus areas for Align is to improve
our consumer experience. We want to service our
How does Align Technology plan in improving the consumers beyond the product. To connect people
with their ideal smile, Align plans to deliver superior
patient experience? What is it that gives you an consumer and customer experience. We will also
continue with growing our presence globally and to
edge over your competitors in the orthodontics reiterate our position as the leader and pioneer of
clear aligners. Another area of growth is in digital
sector? platforms across eCommerce and retail. We want to
We have had competition for many years in the clear develop consumer-driven products and solutions that
aligner market – competition is not new. We believe can fulfil the specific needs of our consumers.
that we have put into place and continue to put into
place new innovations (with many new patents and What are Align Technology’s plans in APAC
trade secrets) that have created and will continue to
create meaningful barriers for competition. region for the future? What is the growth strategy

We understand that doctors do try and will try that company is planning to follow?
competing aligner products, especially new products In 2017, the Asia Pacific region represented 14 per
coming to market. But we believe we have the only cent of Align’s business and has been the fastest
end to end digital clear aligner system that delivers growing region overall. There is a large opportunity
the outcomes, efficiency and experience that doctors, for expansion and accelerated growth among both
and patients want - and doctors will see our significant adult and teen consumers interested in the Invisalign
value when they try other products. treatment in the APAC region. With more than 300
million consumers globally (100 million of them
SmartTrack material is one of the best examples in APAC) who can benefit from straightening their
– no other clear aligner has SmartTrack material teeth, we are focused on providing better customer
and can deliver the performance that it does – we experiences worldwide. China is the largest country
believe that will be apparent to doctors to as well. Our market for Align outside of the US and represents an
earliest patents that expired last year relate to CAD/ enormous opportunity. One of the benefits of having
CAM, but those patents do not teach how to move the treatment planning facility in Chengdu is that we
teeth predictably and reliably with a polymer (plastic). have reduced the cycle time because there is not as
Someone may try to manufacture clear aligners, but much back and forth between doctor and Align Treat
we believe that would be similar to the technology that technicians caused by language translation. The Treat
we had 10 plus years ago, before the introduction of technicians in Chengdu speak the local language and
Invisalign G3, G4, G5, G6, G7 and SmartTrack aligner there is no need to translate. They are also in the same
material which are significant differentiators for the time zone which makes it more efficient.
Invisalign system. Many of these innovations are
patented and many more are patent pending. We are still significantly underpenetrated when
compared to traditional metal braces, so there is much
Having said that, we are confident we can extend a room for continued growth.
highly differentiated product while competing across
all segments. Priyanka Bajpai
[email protected]
How do you see the future of the market and

your own systems? And how do you see the rest

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 39

Q&A

“Robotic medical technologies can
change the future of healthcare”

« When and how was the company established?

Jane Wang, What inspired you to start the company?
After working in multinational corporations for
CEO and Co-Founder, almost 8 years, I decided to go back to school
to pursue Masters in Intellectual Property and
Roceso Technologies, Technology Management. I met my co-founders
Dr Yap Hong Kai and Dr Raye Yeow at a tech
Singapore commercialization module called TechLaunch
in the year 2015. Dr Yap Hong Kai and Dr Raye
UOB economist Francis Tan had said in a research Yeow have been developing a unique soft robotics
note: “Singapore’s population will reach a actuator technology at NUS, Faculty of Biomedical
critical juncture next year, as the number of Engineering. I would like to say that I fell in love
people above 65 will equal those under 15 for the first with the technology immediately and saw the
time in history.” By 2030, the gap between the young potential in various sectors especially in healthcare.
and old in Singapore is expected to widen considerably; After spending months to validate the soft robotic
the percentage of seniors will rise to 27 per cent, and technology with experts from various industries,
that of youths will fall to 10.8 per cent. This will put we decided to focus on medical industry, especially
Singapore on a similar footing with current-day Japan, rehabilitation and assistive functions. Eventually, the
the oldest society in the world with 26.6 per cent of its company was registered in 2016.
population above 65 years old.
Starting a healthcare related startup was always
While younger generations till now are serving as a dream and now it is a dream-come-true. With all
caregivers, the rapid rate at which the world’s aging the interviews we have conducted with doctors and
population is alarming and in this fast pacing world therapists, we can see that soft robotic technology
availability of human caregivers have become scarce. can help both hospitals and patients. Improving
Many researchers are trying to address this issue
with unique robotic inventions. Robotics is providing
increasingly viable ways to complement healthcare
technology trends such as smart monitoring systems
and mobile applications, thus easing the reliance on
human caregivers. Disability to perform daily tasks does
not come from old-age alone. Loss of muscle control,
impairment, activity restrictions, as well as disabilities
due to stroke, cancer, accidents, and injuries impairs
independence which creates a huge impact on one’s life.

One such unique invention is a smart robotic glove
to assist and rehabilitate patients who have lost hand
functions due to injuries or nerve-related conditions.
Created by Singapore-based Roceso Technologies
EsoGlove is a soft robotic hand rehabilitation system
that helps patients gain self-reliance in the most natural
and efficient way. Speaking to Aishwarya Venkatesh of
BioSpectrum Asia, Jane Wang, CEO and Co-Founder,
Roceso Technologies shares her insights on EsoGlove,
role of soft robotics in healthcare and challenges in
setting up a medtech startup in Asia. Edited experts;

40 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

Q&A

healthcare with technology is the main motivation training, short setup time (less than 3 minutes),
that drove us to start the journey. portable (1 kg) and more affordable. With all these
advantages, soft robotics technology will enable home
Please tell us more about EsoGlove therapy and improve rehabilitation tremendously.
EsoGlove is a soft robotic hand rehabilitation system
helping patients gain self-reliance in the most As a startup that designs robotic solutions for
natural and efficient way. EsoGlove system consists
of a glove with soft robotic actuators, a pump-valve healthcare, what are the challenges you faced
control system with touch panel and actuating the
soft robotic glove, and an external device GUI. The in setting up business in Asia?
soft robotic actuators are activated based on air I have to say that developing a startup alone is very
pressurization. The EsoGlove system can be operated challenging, not mention a medical robotics startup.
in two modes: passive mobilization and functional
task-specific training. In passive mobilization mode, The first challenge we have is a common challenge
it allows high intensity and repetitive finger joint faced by all hardware or deep-tech companies -
mobilization exercises, including cyclic flexion talents. In the past 10-20 years, the Engineering
and extension or individual finger mobilization, to sector has been losing top engineering talents to
prevent the development of spasticity and edema. banking, oil & gas and other industries with better
welfare. This is partially caused by our economic
In functional task-specific training, it allows the structure and lack of focus on corporate innovation.
training of important tasks such as power grip and With the support on startups from our government
key pinch that are required for conducting activities and change of mindset of young people, we will see
of daily living. Task-specific training and intensity improvements slowly in terms of talent attraction
of repetition have been proven to be key strategies and acquisition. And Singapore is a talent magnet;
for facilitating neuroplastic changes and recovery I believe we are able to manage it with supportive
after suffering from neurological disorders such as manpower policies to startups and tech talents.
stroke. All exercises can be pre-programmed via the
software system or programmable buttons. Roceso The second challenge we are facing is the lack of
Technologies have also developed an intention a strong tech startup ecosystem, and this consists
detection function that can detect the intention of of both partners and funding. In Singapore, it can
patients while they want to start the pre-selected take 9 months to 1 year to finish a prototype design
functional task training. The intention detection while it may only take half of the time in other
feature has been validated by various neurologists, places. We have seen engineering partners changing
rehab doctors and occupational therapists to be business direction due to the lack of fast monetary
critical in creating neuroplasticity. return working for startups on design services. In
terms of funding, it is no news that raising fund for
Please highlight the uniqueness of this hardware startups is challenging despite the fact that
there is abundant capital in Singapore. However,
technology and what difference it can create in despite all challenges, we are grateful to receive
tremendous support from various parties such as
medical industry? Enterprise Singapore, NHIC, JUMPSTART and NUS
Soft robotics is made of soft materials such as Enterprise. All of them are working so hard to make
polymer, rubber and fabric. It is a relatively new entrepreneurs’ life easier.
domain of study that has gained popularity in recent
years due to the possibility of filling the gaps of In your opinion, how can robotic medical
traditional robotic technologies. Due to the lack of
trained manpower in rehabilitation and the ageing technologies change the future of
population, rehabilitation robots are in high demand
to improve healthcare productivity and help patients healthcare?
recover faster with high intensity training. However, Robotic medical technologies
most of the hand rehabilitation devices are made of can change the future of
rigid components, which bring many limitations such healthcare in various
as discomfort, limited range of motions/exercises, ways. One is by
long setup time (10-25 minutes), bulkiness and high reducing
price. With soft robotic technologies, we are able burden for
to create a device which is comfortable, supporting the whole
both passive and active exercises including functional
healthcare
system by managing the
manpower challenge and enabling

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 41

Q&A

patients receive care faster without compromising stroke market, in the long run; we have planned to
quality. The other is offering better precision and design devices to help other groups of patients such
accuracy by reducing human errors. With the as cerebral palsy, spinal cord injury and arthritis.
development of AI, machine learning and hardware
technologies, robotics can be more reliable and What are the challenges that you see in the
intelligent in supporting clinicians in various tasks
with minimal supervision. To achieve all these, success path of the company?
medical robotics companies need to invest heavily in One challenge that most entrepreneurs are facing is
research, talents and the implementation of quality to find the right resources to meet milestones. These
system to ensure the safety and efficacy of the devices. resources generally include partners, talents and
money. Successful entrepreneurs have to be very
What are your future plans in terms of resourceful. As a company based out of Singapore,
marketing/product/profile expansion? we have to look at international markets at a very
We position ourselves as a soft robotics expert and early stage. Therefore, finding the right international
would like to develop a range of devices with soft partners is critical and it requires a lot of time and
robotics as platform. That means soft robotic devices efforts to get it right. The other challenge is the ever-
for various parts of the body will be researched rising number of competitors. Rehabilitation and
and created to improve rehabilitation and patient mobility is a fast-growing market, and this attracts
mobility. At the same time, research will be done on many new players joining the competition on a
add-on features such as brain computer interface, regular basis. Keeping up with the competition is
sensing/IoT and gamification to improve the not easy, but we don’t let it distract us from our final
performance of the devices. Our current focus is the goal and company’s vision. Competition does not
necessarily have to be a negative factor. We believe
ONE CHALLENGE THAT MOST that healthy competition helps in the growth of the
ENTREPRENEURS ARE FACING IS TO industry and leads to new avenues.
FIND THE RIGHT RESOURCES TO MEET
What are the other products that the company
MILESTONES. THESE RESOURCES
GENERALLY INCLUDE PARTNERS, is working on?
TALENTS AND MONEY. SUCCESSFUL In addition to EsoGlove Pro (rehabilitation device),
ENTREPRENEURS HAVE TO BE VERY we are also developing an assistive glove which can
RESOURCEFUL. AS A COMPANY BASED assist hand-impaired patients in daily living activities
OUT OF SINGAPORE, WE HAVE TO LOOK such as eating, drinking and wearing clothes.
AT INTERNATIONAL MARKETS AT A VERY The device will be sold to individual patients at
EARLY STAGE. THEREFORE, FINDING THE reasonable pricing and it will be highly portable and
RIGHT INTERNATIONAL PARTNERS IS easy to operate. Compared to EsoGlove Pro, it will
CRITICAL AND IT REQUIRES A LOT OF TIME cater to a wider range of patients such as stroke, SCI,
AND EFFORTS TO GET IT RIGHT. THE OTHER MS, and elderly people with wake hands.
CHALLENGE IS THE EVER- RISING NUMBER
The other device in the pipeline is Esock, which
OF COMPETITORS. is a soft robotic sock technology to prevent deep
vein thrombosis (DVT) and joint contracture for
bedridden patients. The existing product in the
market can prevent DVT by compressing the calf
muscles to improve blood circulation; however, it
cannot prevent joint contracture being developed.
Esock will be able to fulfill both needs of the patients.
It is currently under clinical trial and we have seen
some very positive results.

What are your future plans for the company ?
EsoGlove is set to receive FDA clearance by
November 2018, which means we will launch the
product in the US market by end of this year. We will
be able to launch in ASEAN and EU in mid-2019. At
the same time, we are setting up our Chinese entity to
plan for CFDA approval.

42 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

SCIENCE NEWS

Canadian team to convert any blood group to Type O

A team of researchers from the snapshot of all the DNA found in the
University of British Columbia, gut. The team then isolated bacterial
Canada has isolated an enzyme in genomes from the sample and tested
the gut that reliably converts any thousands of enzymes against sugary
type of blood into type O, which is proxies that resembled A and B
compatible with nearly everyone. antigens. One enzyme was found to
be particularly effective at stripping
There are four basic types of away A antigens from red blood cells.
blood group, AB, A, B and O, and
each group is characterised by the Researchers were then able to
presence of antigens, which are combine their new enzyme with one
sugars on the surface of the cells. that is already known to remove B
Type A blood has A antigens, type antigens from blood cells, providing
B blood has B antigens, type AB has a way to convert AB, A and B blood
both, and type O has no antigens. into type O. The researchers hope
to continue exploring their new
Using a technique called approach to blood-type conversion
metagenomics, the team was able to in clinical trials to test the effects on
take a large amount of microbes from the human body.
a sample of human faeces and get a

KKH creates rapid Chinese scientists
diagnostic test for rare diseases
design new
A multi-disciplinary team at KK Women’s and Children’s
Hospital (KKH), Singapore has developed a test to enable photoacoustic
faster diagnosis of rare diseases to help critically ill children.
Rapid Genomic Sequencing or RapidSeq of critically ill imaging technology
children in the neonatal and children’s intensive care units
is a test, the first of its kind in Singapore, to help families by Researchers from Jinan University
providing information on the underlying genetic diagnosis of in China have developed a smart
these critically ill children. The RapidSeq test is being launched photoacoustic imaging approach by
under the first phase of the BRIDGES programme. In 2014, the using a combination of laser light and
team collaborated with genomic research institutes (including ultrasound. The new technique is believed
Duke-NUS and A*Star) to create an integrated approach to have the potential for application in
and developed a programme known as BRIDGES (Bringing medical diagnostics, wearable devices
Research Innovations for the Diagnosis of GEnetic diseases in and instrumentation. By leveraging
Singapore). Tapping on innovations in genomic technologies, optical fibre technology, the researchers
BRIDGES incorporated the sequencing service into routine devised new sensors for photoacoustic
clinical care to directly benefit patients and families and imaging. The team developed a unique
improve their health outcomes. ultrasound sensor comprising a compact
laser built within 8 microns diameter
core of a single-mode optical fibre, which
is doped with ytterbium and erbium to
get necessary optical gain. It is expected
that the fibre laser-based ultrasound
sensors will be helpful in photoacoustic
microscopy. The laser sensor could also
be used for endoscopes and has wearable
applications. As it has an 8 microns
diameter, the new sensor may offer
an alternative for current commercial
endoscopic products with larger
dimensions.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 43

Biologists in Singapore SCIENCE NEWS
discover new diagnostic device
Korean
A multidisciplinary team of researchers at the National University of
Singapore (NUS) has developed a portable, easy-to-use device for quick researchers
and accurate screening of diseases. This versatile technology platform
called enVision (enzyme-assisted nanocomplexes for visual identification develop device
of nucleic acids) can be designed to detect a wide range of diseases - from
emerging infectious diseases (e.g. Zika and Ebola) and high-prevalence for flexible drug
infections (e.g. hepatitis, dengue, and malaria) to various types of cancers
and genetic diseases. enVision takes from 30 minutes to one hour to detect delivery
the presence of diseases, which is two to four times faster than existing
infection diagnostics methods. In addition, each test kit costs under S$1 - A team of researchers at the
100 times lower than the current cost of conducting similar tests. Building Korea Advanced Institute
on the current work, the research team is developing a sample preparation of Science and Technology
module for extraction and treatment of DNA material to be integrated with (KAIST) in South Korea has
the enVision platform to enhance point-of-care application. In addition, developed a flexible drug
the research team foresees that the smartphone app could include more delivery device. The team has
advanced image correction and analysis algorithms to further improve its fabricated a device consisting
performance for real-world application. of a substrate onto which
a 50 µm-thick active drug
NUS scientists harness delivery layer was transferred.
AI platform for advanced cancer They used a method called
inorganic laser lift off to
A translational research team led by National University of Singapore apply the drug delivery layer.
(NUS) has harnessed CURATE.AI, a powerful artificial intelligence (AI) The fabricated device was
platform, to successfully treat a patient with advanced cancer, completely mechanically flexible while
halting disease progression. This new development represents a big step maintaining its capability
forward in personalized medicine. During the clinical study, a patient to administer exact dosages
with metastatic castration-resistant prostate cancer (MCRPC) was given a of drugs at desired times.
novel drug combination consisting of investigational drug ZEN-3694 and The flexible drug delivery
enzalutamide, an approved system can be applied to
prostate cancer drug. The smart contact lenses or by
research team successfully implanting it inside the body.
utilized CURATE.AI to A wireless power transfer
continuously identify the system was also built into the
optimal doses of each device to allow continuous
drug to result in a durable and stable operation over
response, allowing the prolonged periods of time.
patient to resume a The researchers were also able
completely normal and to dispense an anti-epileptic
active lifestyle. According medication via the device to
to the scientific team, the appropriate brain regions.
CURATE.AI is applicable
to all diseases and all
patients, and a first
generation of the platform was previously validated in the clinic for
single drug optimization in post-transplant immunosuppression. This
new study demonstrates that CURATE.AI can optimize multi-drug
regimens. The CURATE.AI team expects to broadly deploy the platform
for the prevention of transplant rejection, adult and pediatric cancers,
cardiovascular medicine, diabetes management, infectious diseases, and
many other applications.

44 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

SUPPLIER NEWS

BeiGene picks GE’s facility Agilent to
to boost antibody production expand
portfolio in
BeiGene, Ltd., a commercial-stage biotechnology company focused on cell analysis

developing and commercializing innovative molecularly-targeted and Agilent Technologies Inc.
has signed a definitive
immuno-oncology drugs for the treatment of cancer, has selected GE agreement to acquire
privately-owned ACEA
Healthcare Life Sciences’ off-the-shelf biomanufacturing facility, KUBio Biosciences Inc., a
developer of cutting-edge
for large-scale production of its cancer monoclonal antibodies (mAbs). cell analysis instruments
for life science research
The KUBio will be located in Guangzhou, the capital city of Guangdong and clinical diagnostics,
for $250 million in cash.
Province, China, where an increasing number of biotech firms are Since its inception in
2002, ACEA has launched
establishing operations. The first phase of the facility is expected to two ground-breaking,
highly differentiated
be completed and operational in 2019. BeiGene is already using GE platforms. ACEA is
revolutionizing the field
Healthcare’s FlexFactory, an integrated biomanufacturing platform in of flow cytometry with
its high-performance,
its existing manufacturing plant in Suzhou, China to manufacture mAbs customizable line of
NovoCyte benchtop flow
for clinical trials. The facility is based on the single-use technologies cytometers. ACEA’s
xCELLigence instruments
that bring flexibility and are designed to yield higher productivity by enable label-free, real-time
monitoring of cell growth,
increasing the number of lots manufactured, reducing cell function, and cellular
responses to a variety of
maintenance requirements and shortening treatments, providing
scientists information-
downtime between rich cellular assays.
ACEA instruments are
batches and used worldwide in both
academia and industry
products. GE across a wide range of
life science applications
Healthcare Life from basic research
to clinical diagnostics
Sciences has including preclinical
drug discovery and
delivered three development, toxicology &
safety pharmacology, and
KUBios to China various disease studies.
ACEA is headquartered in
and over 50 San Diego and has a large
manufacturing and R&D
FlexFactories footprint in Hangzhou,
China.
globally.

BioBright, Beckman Coulter
announce strategic partnership

BioBright and Beckman Coulter have recently announced a strategic
partnership to bring enhanced technical support capabilities to
instruments. BioBright’s DarwinSync platform gives Beckman Coulter
access to a large amount of precise data about deployed instrument logs,
enabling faster troubleshooting, reduced equipment downtime, and
predictive analytics. Beckman Coulter will deploy BioBright’s DarwinSync
platform to multiple instrument categories, expecting to reach close to
200 instruments before the end of the year. The direct integration of

BioBright’s platform with Beckman
Coulter provides a reliability
advantage for both the end-user
and the equipment vendor. The
advanced data capabilities of the
integrated platform enable Beckman
Coulter to develop new analytics to
address errors before they happen. The BioBright tool seamlessly collects
instrument performance information from equipment outputs, including
complex diagnostic information that is difficult and time intensive to
obtain. The tool automates the data analysis to provide meaningful
insights for users and equipment vendors. This information informs
product development, service efficacy, and business strategy.

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 45

SUPPLIER NEWS

Sartorius, Repligen to introduce Next-Gen perfusion-enabled bioreactors

Sartorius Stedim Biotech, a leading international supplier for the
biopharmaceutical industry, and Repligen Corporation, a global life
sciences company focused on bioprocessing technologies, have entered
into a collaboration agreement to integrate Repligen’s XCell ATF cell
retention control technology into SSB’s BIOSTAT STR large-scale
single-use bioreactors to create novel perfusion-enabled bioreactors.

As a result of this collaboration, end users will stand to benefit
from a single control system for 50 L to 2,000 L bioreactors used in
perfusion cell culture applications. This single interface is designed
to control cell growth, fluid management and cell retention in
continuous and intensified bioprocessing and, ultimately, simplify the
development and cGMP manufacture of biological drugs.

Through the partnership, Sartorius Stedim Biotech and Repligen
will further collaborate to equip SSB’s recently launched ambr 250ht
perfusion single-use mini bioreactor system with Repligen’s KrosFlo
hollow fiber filter technology. The bioreactor system will be sold by
SSB as a complete single-use assembly. This optimal design conserves
hollow fiber filter technology across scales, enabling customers to fast
track development and scale up their cell culture perfusion processes.

Thermo Fisher releases Hitachi to supply
first Compact Proton
GeneArt products in China Therapy System

Asia Pacific is predicted to be the fastest growing Hitachi, Ltd. has recently received an order for the
market for synthetic biology from 2018 to 2025, compact proton therapy system from Tokushukai
driving increased demand for genome editing and Medical Group, and the system will be installed
gene synthesis technologies. To fulfill researchers’ at Shonan Kamakura Advanced Medical Centre,
needs, Thermo Fisher Scientific Inc., the world leader which is planned to be built near Shonan
in serving science, is now offering its portfolio of Kamakura General Hospital. This is the first order
Invitrogen GeneArt products and services in China. for Hitachi’s dedicated compact proton therapy
system. Following the expansion of demand for
According to the company, in response to the proton therapy system with minimized footprint
growing customer demand for more efficient, reliable worldwide, Hitachi has developed dedicated
gene synthesis and genome editing technologies, the single room proton therapy system (Single
line of GeneArt products has been launched in China. Room Solution). Single Room Solution features
GeneArt products will not only enable the customers to optimized system configuration, reducing the
continually enhance the understanding of how biology footprint to 70 per cent of conventional solution,
works, it will also help them accelerate the path from realizing installation in urban limited areas
planning experiments to executing them in the lab. and contributing to lower the initial cost and
With the Invitrogen GeneArt product line, researchers shorten the lead time. Other features include spot
in China now have access to: Invitrogen GeneArt Gene scanning technology for treating certain forms of
Synthesis Service, GeneArt Strings DNA Fragments cancer and full rotating gantry with cone beam CT
and Libraries, and GeneArt Genome Editing Tools. for precise patient positioning, sustaining high
performance technologies in minimized footprint.
Hitachi has been proactively promoting particle
therapy business worldwide, supplying world-
class facilities around the world with its highly
reliable and proven particle therapy systems,
which have treated more than 16,000 patients.

46 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

NOBEL AWARDS

CHEMISTRY

Chemistry Frances Arnold of the California Institute of Technology,
Nobel for
George Smith from the University of Missouri and
work on
antibody Gregory Winter of Britain’s MRC Laboratory of

drugs, Molecular Biology have been awarded 2018 Nobel Prize
enzymes
for Chemistry for pioneering science in enzymes and
MEDICINE
antibodies. According to the Royal Swedish Academy

of Sciences, Arnold had transformed science by using

the principles of evolution, genetic change

and selection, and to evolve new types

of proteins very fast. Smith developed a

method using a virus that infects bacteria

to produce new proteins while Winter

used the same phage display technique

to engineer the evolution of antibodies,

George Smith with the aim of producing more effective
medicines. The fruits of this work include

the world’s top-selling prescription

medicine, the antibody injection

Humira sold by AbbVie for

treating rheumatoid arthritis

and other autoimmune

diseases. Humira,

or adalimumab,

was the first

drug based on

Winter’s work

to win regulatory

Gregory Winter approval in 2002. Frances Arnold

James Allison, Tasuku Honjo win Nobel in medicine

James P Allison of the US and Tasuku Honjo of to suppress immunity led to the development of
Nivolumab, a drug marketed as Opdivo and used
Japan have won the 2018 Nobel Medicine against lung cancer and melanoma.

Prize for research that has revolutionised In 2006, his research was tested in a clinical
trial before Opdivo was finally approved in Japan,
the treatment of cancer. in July 2014, and subsequently in the United
States and Europe. The work led to a fourth class
Japanese scientist Tasuku Honjo of treatment alongside surgery, chemotherapy and
radiation that harnesses the immune system.
has been awarded the Nobel Prize
Allison, chair of Immunology and executive
for his discovery of a protein that director of the Immunotherapy Platform at the
University of Texas MD Anderson Cancer Center,
contributed to the development of studied a protein that functions as a brake on
the immune system. He found that releasing the
an immunotherapeutic drug against brake allowed immune cells to attack tumors. The
discovery led to effective treatments, specifically
cancer. Honjo, a 76-year-old professor some called immune checkpoint blockade
therapies.
at Kyoto University, opened a pathway for

a new cancer treatment by discovering the

PD-1 protein, which is responsible

for suppressing immune

response.

His method of treating

cancer by controlling

Tasuku Honjo the protein’s function

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 47

PEOPLE NEWS

PHYSICS Lupin announces new

Arthur Ashkin chief executive of US market
receives Nobel for
Optical Tweezers Indian pharma major Lupin Limited has announced the
appointment of Alok Sonig as CEO – US Generics and
The American scientist Arthur Ashkin, 96 who Global Head – Generics R&D & Biosimilars. Alok will
invented optical tweezers will share the 2018 lead and have overall responsibility for the US Generics
Nobel Prize in physics with two other scientists, business including Research & Development in India
Gerard Mourou and Donna Strickland. Ashkin and the US and the Commercial side of the business in
will be honored for devising the US. He will also be responsible for Lupin’s global
optical tweezers that grab Biosimilars business.
particles, atoms, viruses and
other living cells with their With over 23 years of experience in the industry,
laser beam fingers. This Alok brings an established track record of success in
new tool allowed Ashkin the Pharmaceutical and Healthcare sectors to Lupin.
to realise an old dream of Most recently, Alok was CEO of Developed Markets
science fiction using the (US, Canada, Europe and Japan) at Dr. Reddy’s.
radiation pressure of light He joined Dr. Reddy’s in 2012 and ran their India
to move physical objects. He succeeded in getting business till 2015 before moving back to the US to
laser light to push small particles towards the run their North America business. Prior
centre of the beam and to hold them there. A major to Dr. Reddy’s, Alok spent nearly
breakthrough came in 1987, when Ashkin used the 15 years at Bristol-Myers Squibb,
tweezers to capture living bacteria without harming where he held several positions of
them. He immediately began studying biological increasing responsibilities in General
systems and optical tweezers are now widely used Management, Country leadership
to investigate the machinery of life. Ashkin also has roles, Global Strategy and Marketing.
the distinction of being the oldest Nobel laureate. Alok holds a Bachelor’s of Engineering
from Punjab Engineering
College in India, and an MBA
from American University,
Washington, D.C.

Allison’s work led to the development of the Dr G R Reyes joins Benitec

first immune checkpoint inhibitor drug, according as Senior Scientific Advisor

to MD Anderson Cancer Centre. Ipilimumab, Benitec Biopharma Limited, a Sydney based clinical-
stage biotechnology company developing novel
which has the brand name Yervoy, was approved genetic medicines via the proprietary DNA-directed
RNA interference (ddRNAi) platform combining RNA
for late-stage melanoma by interference with gene therapy, recently announced that
Gregory R. Reyes, M.D., Ph.D., has joined the company
the US Food and Drug as Senior Scientific Advisor. As the Senior Scientific
Advisor, Dr Reyes will lead the company’s efforts
Administration in 2011 to advance and expand its portfolio of gene therapy
products. His leadership and vision will be integral to
and became the first the achievement of the operational and strategic goals
regarding the Company’s key indications and research
to extend the survival programmes. Dr Reyes will also oversee the expansion
of the company’s scientific operations to facilitate the
of patients with late- successful execution of the Company’s broad based
research collaboration with Axovant, comprising five
stage melanoma. additional, fully funded research programmes targeting
neurological disorders. Dr Reyes brings over 30 years
Now, ipilimumab is of successful R&D leadership experience in major
biotechnology and pharmaceutical companies.
also approved to treat

colorectal cancer and

a type of kidney cancer

called renal cell

carcinoma, and is

being studied in

the treatment of

other types of

cancer. James Allison

48 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

ACADEMICS NEWS

BI partners with Tsinghua Queen Mary establishes
for immuno therapies
collaboration with A*STAR
Boehringer Ingelheim (BI) and Tsinghua University in
Beijing have announced a collaboration aiming to research Queen Mary University of London has
and develop immunological therapies for infectious cemented a partnership with Singapore
diseases. Scientists will work in the BI-Tsinghua University through a new collaboration with its
Joint Research Centre for Immuno-Infection to harness the leading research agency, the Agency
mechanisms of immune modulation to combat infectious for Science, Technology and Research
diseases. The collaboration brings together the leading (A*STAR). The Queen Mary-A*STAR
expertise of Tsinghua University in infectious disease partnership will develop joint research
across medicine, health, science and
research and engineering. This will include funding
immunology a number of PhD scholarships through
with Boehringer A*STAR’s prestigious Research
Ingelheim’s Attachment Programme (ARAP), where
experience in the PhD students can develop their research
development of in both the UK and Singapore. In the
novel therapies for first instance, Queen Mary is committed
patients suffering to co-funding six students across several
from diseases areas of medical research. The first PhD
with high unmet students are expected to join Queen Mary
medical need and in 2019. They will then spend at least a
its comprehensive year in Singapore from 2020.
research and development programs in cancer immunology
and immune modulation. This collaboration is an initiative
of Boehringer Ingelheim’s Research Beyond Borders
(RBB) and Cancer Immunology and Immune Modulation
Research Departments. Immuno-infection is a new
focus area for BI’s RBB department, which also focuses
on gene therapy, regenerative medicine and the role of
the microbiome in human health and disease. With the
new collaboration, BI further expands its activities in
the growing biomedical innovation hot spot of China. By
combining a focus on cutting-edge science with a long-term
view, the company aspires to develop the next generation
of medical breakthroughs to improve the lives of patients
suffering from diseases with high unmet medical needs.

Academia Sinica signs MoU for translational medicine development

Taiwan’s Academia Sinica three months aiming to build up the collaborative efforts will also
has signed a memorandum a cooperation model between the work to integrate related services
of understanding (MoU) with two parties from early research of the National Laboratory Animal
government-backed Development and development to product Centre of the National Applied
Centre for Biotechnology (DCB) commercialization, and facilitate Research Laboratories (NARLabs);
calling for collaborative efforts to cooperation in order to better to coordinate the regulatory
accelerate the commercialization respond to rapidly changing review processes at Taiwan’s Food
of translational medicine. market trend and technology and Drug Administration (FDA);
advancements. and to provide industry startups
Following the signing of the with business support from
MoU, the two sides also look While focusing on the DCB’s incubation centre, BioHub
to ink an R&D and promotion development of new drugs as Taiwan.
cooperation agreement within well as translational medicine,

BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com 49

BIO EVENT

3rd Edition of IoT India Congress

“IoT is on brink of revolutionizing

health care industry in India”
“Whether it’s smart
gadgets, wearable enterprise, public financing, corporate hospitals across
technology or enabling regulatory environment, India, connected care would
remote monitoring and diagnosis, public health management cadres give doctors access to a patient’s
the Internet of Things (IoT) is on and building trust among health longitudinal history. In addition,
the brink of revolutionizing the professionals and public. they would have data that can
health care industry in India,” help them see the treatment
said Neeraj Jain, Country Head, In his address, Ravi decisions that have been made
PATH, India. Ramaswamy, Senior Director & in the past and the prognosis
Head - Health Systems, Philips of those decisions. Clinical care
Speaking at the third Innovation Campus & Chair, would evolve from experience-
edition of IoT India Congress in Healthcare Working Group, IET based to evidence-based care.
Bengaluru, Jain said “There is a IoT Panel said “Preventive health The reliability and validity of
strong need for the government initiatives have the potential to clinical data in a connected care
to form a legal framework. deliver value by increasing access ecosystem can improve diagnosis
The lack of a regulatory body to care, improving outcomes, which in turn improves care
raises concerns for privacy and and increasing the standard of outcomes.
security.” health for citizens, patients and
healthcare providers. As we Dr Kishore Kumar, CEO
Jain further said that greater look at the Indian healthcare & MD, Cloud Nine, Ashvanni
spending on ensuring availability ecosystem, we clearly see that Srivastava, Founder & Managing
and accessibility healthcare multiple changes are necessary to Partner, Synergie Group,
through integration of IoT the edifice that holds the system Rajagopal Rudraraju, Senior Vice
technologies into public health together. It is easy to assume President & Product Head, Tata
systems by the governments that technologies like IoT might AIG, Dino M Martino, General
will help reduce out of pocket solve this problem but in our Manager, PerformSpecialty, USA
expenditure and reduce the observation we have seen that the and Dr Shyam Prasad Rajan,
number of people being pushed biggest opportunities for change Exponential Market Growth
into poverty due to high may come with process and Solutions Leader, GE Global
medical costs. He also added people.” Research Centre participated in
that empowering and enabling a panel discussion on IoT and
technology to help revitalize the A preventive health ecosystem Affordable Healthcare moderated
Indian health care environment will provide a holistic approach to by Dr Vikram Venkateswaran,
will lead to more citizens managing a patient’s health. How Director- Digital Risk, Risk
receiving care, improved quality the various parts of the system Advisory, Deloitte Touche
of care and reduced cost of care will get incentivized is something Tohmatsu India LLP. Dr Vikram
and lead to the development and that we would need to look at. The Venkateswaran, who is also the
well-being of India’s population. other major area that we need to Founder of Healthcare India
take a very strong look at is the said that Preventive Health will
Prof. K. Srinath Reddy, issue of privacy, he added. create the right situation to move
President, Public Health from Experience-based care to
Foundation of India (PHFI) Dileep Mangsuli, Chief Evidence -based care.
addressing the gathering on Technology Officer (CTO),
‘IoT as Enabler for Healthcare: Wipro-GE said that preventive Institution of Engineering and
Health Systems Perspectives’ health would clearly aid the
said that Incubation, Insertion healthcare providers. Availability Technology (IET), has released a
& Expansion of Innovations in of data would ensure that they white paper on healthcare titled
IoT need- multi-disciplinary would be able to make data ‘Preventive Health 4.0 The future
technical expertise, private sector driven decisions. While this model of care for a Digital India’
is already in place in many on the occasion.

50 BIOSPECTRUM | NOVEMBER 2018 | www.biospectrumasia.com

BIO EVENT

National Dialogue on Protecting Communities: Vector Control in Action

“Malaria cases are down in India
by 60% in 2018 compared to 2017”

Vector diseases such as malaria still plague
India. Malaria treatment should, therefore, be
a compulsory part of training to all doctors and
public health workers, suggested the Principal Advisor

(Public Health), Directorate General of Health Services,

Ministry of Health & Family Welfare, Government of

India– Dr N. S. Dharmshaktu.

He was speaking at ASSOCHAM’s National Dialogue

on Protecting Communities: Vector Control in Action Dr N. S. Dharmshaktu, Principal Advisor (Public Health),
in New Delhi on September 26, 2018. Describing the Directorate General of Health Services, Ministry of Health &
hurdles to Vector-Borne Disease control in India, Dr Family Welfare, Government of India addressing the gathering at
Dharmshaktu suggested several other measures to put the ASSOCHAM’s National Dialogue on Protecting Communities:
a stop to the problem. His suggestions included vector Vector Control in Action in New Delhi on September 26, 2018.

control components in smart cities and web-based

reporting of all Vector Borne Diseases (VBD) cases. between 2015 and 2017 reaching 1.88 lakh cases, he

The conference was also graced by the presence noted. VBDs are outcomes of developmental issues he

of Director, National Vector Borne Disease Control observed adding that they need to be addressed through

Programme, Ministry of Health & Family Welfare – multiple approaches.

Dr P. K. Sen who outlined the danger posed by Vector The actions taken to combat VBDs must be scientific

Borne Diseases to India. The government is taking andevidence-basedassertedtheCountryLead–Routine

steps to control VBDs he assured the gathering, adding Immunization and Neglected Tropical Diseases, Bill &

that Malaria cases are down by 60 per cent in 2018 Melinda Gates Foundation – Dr Bhupendra Tripathi.

compared to the same in 2017. He also batted for a Public Private Partnerships are essential to restrict the

more efficient surveillance and reporting mechanism, spread of VBDs in India he noted.

deployment of efficient human resources and increased The event also witnessed the release of a knowledge

coordination between different stakeholders. paper jointly prepared by ASSOCHAM and Azoth

Dr Sen said that technology will be crucial in Analytics Pvt Ltd titled “Controlling Vector-Borne

stemming the tide of vector-borne disease epidemics. Diseases: An Indian Perspective.”

Technologies such as disease surveillance system and The inaugural sessions was followed by extensive

web-based reporting need to be strengthened to tackle discussions on the themes: “Managing Diseases: How

the sporadic epidemics that are endemic to India. Such can Vector Control play a pivotal role?” And “Vector

technologies will help track diseases in real time and help Control Challenges in Urban India: Novel Approaches &

policymakers devise optimum strategies to fight them. Community Driven Tools”, both moderated by Dr Ranju

“India is endemic to vector-borne diseases. We must Anthony, Managing Director, TRK Consultants Pvt Ltd.

all, therefore, work together to combat the problem and The conference was graced by the presence

here Public-Private partnerships can play a major role,” of dignitaries such as Head of South Asia, Bayer

observed Dr Arun Kumar, Head of South Asia, Bayer Environmental Science – Dr Arun Kumar; Director,

Environmental Science. Azoth Analytics Pvt Ltd – Matloob Hasan; Director

“Diseases do not just cause sickness but also become (Health), NITI Aayog – Dr. S. Rajesh; Joint Director,

an economic burden to the families. Endemic to India, National Vector Borne Disease Control Programme

vector-borne diseases are therefore serious health and – Dr. Kalpana Baruah; Additional Director General,

financial issue for India,” stated Dr Sunil M. Raheja, Public health – IV, NVBDCP Waterborne Diseases

Additional Director General, Public Health-IV, IDSP, Control – Dr Sunil M. Raheja; US Health Attache,

NVBDCP, Government of NCT of Delhi. India & Regional Representative – South Asia, US

In his Welcome Remarks at the conference Uday Department of Health and Human Services – Dr

Kumar Varma, Secretary-General, ASSOCHAM dwelt Preetha Rajaraman; and the Assistant Secretary

on the reasons behind the surge in VBDs in India. While General, ASSOCHAM – Dr Om S. Tyagi, besides many

cases of malaria are decreasing, dengue cases doubled others.