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www.biospectrumasia.com S$ 5.00 BioSpectrum ASIA EDITION INCUBATORS IGNITING BIOSCIENCE ECOSYSTEM Volume 17 | Issue 9 | September 2022 “Asia is constantly strengthening its digitisation and connectivity, making it an attractive market to invest in.” -Eva van Pelt, Co-Chief Executive Officer, Eppendorf SE -33 Taming the Enemy Within -31 BioSpectrum is an MIM AACTLY publication; MCI (P) 020/06/2022 Biospectrum BioSoectrum ASIA EDITION Asia Excellence j Awards 2022 Brought to yOu Dy: —_ThermoFisher BIO RAD Technology Partners: "y¥"¥ MasterControl - Announcing Jury Panel 2022 - THE 2022 AWARDS ARE JUDGED BY AN ESTEEMED PANEL OF INDUSTRY LEADERS AND EXPERTS! The Executive Director of the Genome Institute of Singapore, Professor at Duke-NUS Medical School Singapore and Executive Director of PRECISE, Prof. Patrick Tan is also an elected member of the American Society for Clinical Investigation (ASCD and a Board Member of the International Gastric Cancer Association from Singapore. Clare Blain, Chief Executive Officer of Life Sciences Queensland, Australia (LSQ) is passionate about highlighting the integral role life science innovation plays in Queensland's diverse economy. She has been a Chief Operating Officer and Operations Manager at LSQ from Marketing Manager at Queensland Clinical Trials Network. A Physician Scientist, Professor at Christian Medical College, Vellore (India) and Laboratory Director, Gagandeep Kang. Is the first Indian woman to be elected to the Fellowship of the American Academy of Microbiology and to the Royal Society and the only physician-scientist to receive the Infosys Award in Life Sciences. Dario Heymann, founding member and Chief Research Officer of Galen Growth, Singapore has also successfully built HealthTech Alpha; the world's only analytics platform dedicated to Digital Health, delivering accurate and regularly Curated information to investors, industry innovation leaders and startup CxOs. The Director at Hello Tomorrow Asia Pacific, Xin Yi Tow from Singapore was also an investment banker. Her expertise in investment, private equity, capital, and asset management inspired her to co-found Slate Alt, an ecosystem of alternative investors, future-forward innovators, and curious tech experts. Dr. Satya Dash is a national innovation ecosystem designer, technology strategist, policy and implementation expert, Board Member at Venture Center, Pune, India's largest S&T incubator. He contributed to the growth of the Indian biotech & medtech innovation landscape as the founding Head Strategy at DBT-BIRAC & In-Charge Head of IP & TT. Recently, he joined as the Founding CEO of BITS BioCyTiH Foundation, funded by the Department of S & T, Government of India. Haven't Filled Your Entries Yet? _ Nominate Now — For more information, visit: www. biospectrumasia.com/bsa-awards BIO EDIT BIOSPECTRUM | SEPTEMBER 2022 | www.biospectrumasia.com A DEFICIENT PROPOSITION T: keep pace with the changing needs, time and technology, the Government of India is proposing a totally revamped new Act for drugs that will replace the 82-year-old Drugs and Cosmetics Act 1940. For this, the Ministry of Health and Family Welfare (MoHFW) has drafted the ‘Drugs, Medical Devices and Cosmetics Bill, 2022’, which is published on its website to seek opinions and suggestions from stakeholders. Although the existing legislation along with its rules made in 1945, were repeatedly amended to stay relevant, several parts of the Act became obsolete, requiring a modern version. The Draft Bill deals with medical devices, clinical trials, e-pharmacies and import of drugs. It empowers the government to waive the requirement of clinical trials for Dr Milind Kokje importing a new drug in case of extreme urgency. If there is an emergency induced by Chief Editor an epidemic, the government may regulate or restrict the import of drugs. In case of rating eekieisiremagieom risks involving a new drug, the government has been empowered to stop its import. The new Bill includes an elaborate description of what constitutes misbranded, adulterated and spurious drugs. In line with emerging developments in healthcare and medicine, the introduction of provisions for ‘Medical Devices’ in the Draft Bill is quite crucial. From robotics, used in complicated surgeries, to simple and common ‘home-use’ devices like pulse oximeters, blood pressure/ sugar level monitoring gadgets and high-level artificial intelligence (AI) to machine learning, various devices are now deployed in monitoring, controlling and improving health. It’s no surprise, the medical devices market in India is estimated to reach $50 billion in just the next three years, growing at 37 per cent CAGR. The field of medicines and healthcare is being revolutionised by developments like the introduction of new techniques, new diagnostics and treatment procedures, the concept of big corporate hospitals, widespread use of private and public medical insurance, and in general, privatisation of healthcare. The Bill makes two important proposals- setting up of technical advisory boards for medical devices and testing centres for medical devices, like the drug laboratories in states and at the central level. The key difference is that unlike in the old Act, the medical devices will not be regulated on par with the drugs. Although medical devices have been given their due recognition in the Draft Bill, the Association of Indian Medical Devices Industry (AiMeD) is disappointed, as its aspiration for a separate Act for devices is not addressed. Its argument has some merit given the sector is growing so fast, it would have been prudent to bifurcate drugs and devices at this juncture, rather than revisiting this issue again, just a few years later. It is important to note here that Malaysia has had two separate Acts in force since 2012 - the Medical Devices Act and the Medical Device Authority Act, to regulate the manufacturing and distribution of medical devices. Taiwan also recently introduced the Medical Devices Management Law, separating pharma products and medical devices. On the clinical trial front, the Bill has provisions for penalties and imprisonment for failing to pay compensation to trial victims. Currently, all matters related to clinical trials are regulated through the clinical trial rules. However, one glaring lacuna is the absence of good manufacturing practices (GMPs) and the transparency in new drug approvals. GMPs were included in India in the rules drafted by the government in 1988. But the required corrective measure to incorporate GMPs in the Act itself has not been done even now. The Bill is silent about the GMPs. The Bill also fails to address the issue of uneven enforcement of the Act. Each state has its own enforcing agency, which has created a problem of uneven enforcement. Way back in 2003, the Mashelkar Committee had recommended centralising drug licensing with the central regulator. Although this is the most opportune time to introduce this change, the Bill remains silent over the issue. The government may consider it while presenting the Bill in Parliament. BIOSPECTRUM | SEPTEMBER 2022 | www.biospectrumasia.com BIO MAIL 35500 Keeping Pace with Mutating Viruses Acknowledgements/ Feedback Rise in pharmaceutical R&D has led to develop cost-effective and efficient cell and gene therapies (CGTs) while focusing on biomanufacturing innovations. Thank you BioSpectrum Asia for featuring insights by Avantor on Asia’s CGT Biomanufacturing ecosystem. - Narayana Rao, Singapore One of the key objectives of GE Healthcare’s spinoff to become an independent company is to meet the demands of our markets with greater speed and agility. Thank you BioSpectrum Asia for publishing my ue 9; September 2022 insights on advancing precision health and strengthening digital healthcare in the Asia-Pacific region. - Chris Khang, Singapore The information captured in the story on drones in the August edition was very well aligned with the current industry trends. Including ongoing industry facts and figures supported by industry experts’ quotes makes the story very crisp, informative and at the same time an easy read for anyone who may not possess prior knowledge of the subject. - Aarti Chitale, India Publisher & Managing Editor: Ravindra Boratkar Editorial: Chief Editor: Dr Milind Kokje [email protected] Advisor - Content: Vijay Thombre Editor: Narayan Kulkarni [email protected] Executive Editor: Dr Manbeena Chawla [email protected] Assistant Editor: Nitesh Pillai [email protected] Assistant Editor (Digital): Sanjiv Das [email protected] Asst. Manager Content Creation and Coordination- APAC Region: Hithaishi C. Bhaskar [email protected] Social Media Communications: Ankit Kankar [email protected] CFO & Special Correspondent: Manasee Kurlekar [email protected] Operations and HR: Asmita Thakar [email protected] Production & Design: MM Activ Sci-Tech Communications Anil Walunj Cover Design: Dominix Strategic Design Pvt. Ltd. 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Mobile: +91-9579069369 [email protected] USA BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +91-9579069369 [email protected] Europe BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +91-9579069369 [email protected] Printed and published by Ravindra Boratkar on behalf of MM ACTIV Singapore Pte Ltd. Printed at Times Printers Private Limited 16 Tuas Avenue 5, Singapore 639340 Tel : +65-63112888 Reprinted in India for private Circulation Taiwan Media Representative: Ms Christine Wu Image Media Services Company 2F-2, No. 35, Sec. 2, Flushing South Road, Taipei 10665, Taiwan Tel: +886-2-87734199 Fax:+886-2-87734200 Mobile: 886-937890533 E-mail: christine @imagemediatw.com website: www.imagemediatw.com China Erika Cheng RFCOMMS E101, East Lake Villas, 35 Dongzhimenwai Main Street, Dongcheng District, Beijing 100027, P. R. China Mobile: +86 17375668063 E-mail: [email protected] India Apoorva Mahajan Key Account Executive “NITON”, Block B, First Floor, 1173, Palace Road, Bangalore 560001 Tel: +91-80-41131912/13 Mobile: +91-7724025888 [email protected] Photo: Shutterstock Go Digital: To request subscription email: [email protected] Chief Editor: Dr Milind Kokje MCI (P) 020/06/2022 Copyright: MMaActiv Singapore Pte Ltd. BIO CONTENT BIOSPECTRUM | SEPTEMBER 2022 | www “COVER STORY 24M ' INCU BATORS IGNITING BIOSCIENCE ECOSYSTEM Incubators and accelerators are driving small and medium enterprises (SMEs) in Asia through the development of novel therapeutics and encouraging innovations and commercialisation. Biotechnology incubators provide a stimulating environment that attracts investors, talent, and companies to collaborate on research, thereby fostering industry growth. While the appetite for laboratory space is constantly growing among biotech ventures, countries in the Asia Pacific (APAC) region are actively investing to construct life science hubs that foster innovation strategies and strengthen R&D capabilities. Let's explore prominent startup incubators and accelerators in key APAC economies that are cultivating biotech innovations to create unicorns. BIOSPECTRUM | SEPTEMBER 2022 | www.biospectrumasia.com AUTOIMMUNE DISEASES Taming the Enemy Within SPEAKING WITH 33 “Asia is constantly strengthening its digitisation and connectivity, making it an attractive market to invest in’ Eva van Pelt, Co-Chief Executive Officer, Eppendorf SE 36 “Growing demand for low-cost remote patient monitoring services, CIS & EMRs will propel digital healthcare platform adoption" Suresh Venkatachari, Chairman and CEO, Healthcare Triangle 38 “Lack of sufficient capacity is a greatest challenge facing the biomanufacturing industry today” Mathias Garny, Chief Executive Officer, Univercells Technologies BIO CONTENT BioSpectrum ASIA Un Scan QR code to access BioSpectrum Asia Digizine SYNTHETIC BIOLOGY @ EL yy \S tu mh 1 ow nT ly Expanding Toolbox Spurring Opportunities Ruplekha Choudhurie, Senior Industry Analyst/ Team Lead (Health & Wellness), TechVision, Frost & Sullivan REGULARS BiOE ite... eee ce eeeecececsecseseesteseeseeseeseetestesecresteseeseesens 04 BiOMALL eee eecceeee eee eee ects eee ceeeeteeesteseseeeteseees 05 Policy and Regulatory NEWS. ........ccccceeeeeee 08 COMPaNy NEWS sessevseeueemmncemneern 10 FINANCE NWS... cececcceceeseseseeeseseeteeeeseneneneeeeeenees Te Start-Up N@WS wo... cece csc eecsetetetseteteestsessnseees 13 P@OBIEINGWS scenes ner anemia 43 R&D NOWS we. ceccccececeeseseseseesescsesnsneseseseenensneneeneneneneees 46 Supplier NWS .....cccccecccccceceescseeescseestetetsneeesseeseeee 48 Lets Talk Health o.o..cccccccccccccccsescesesesessesestssseeseeees 50 REGULATORY NEWS BIOSPECTRUM | SEPTEMBER 2022 | www.biospectrumasia.com 17 EVUSHELD Injection India approves Corbevax as first heterologous COVID-19 booster shot for 18+ Indian firm Biological E has announced that its COVID-19 vaccine Corbevax has been approved by the Union Health Ministry as a heterologous COVID-19 booster dose under emergency use authorisation for individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of Covaxin or Covishield Biological E. Limited vaccine. The Union Health Ministry’s ‘a approvalis based ontherecommendations CORBEVAX made recently by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI). This ue = approval came after the Drug Controller General of India (DCGI) approved the vaccine for emergency use as a heterologous COVID-19 booster dose for individuals aged 18 years on June 4, 2022. Corbevax had received emergency use authorisation as a primary two-dose vaccination regimen in adults, adolescents and children five years and above, in a series of approvals from December ’21 to April '22. Corbevax is expected to be available as a precautionary dose on the CoWIN App in public and private vaccination centres. The price of Corbevax for private COVID-19 vaccination centres is Rs 250, inclusive of GST. For the end- user, the price is Rs 400, including taxes and administrative charges. Singapore grants interim authorisation for AstraZeneca’s antiviral mAb Evusheld The Health Sciences Authority (HSA) in Singapore, in consultation with its Medicines Advisory Committee, has granted an interim authorisation under the Pandemic Special Access Route (PSAR) for AstraZeneca’s antiviral monoclonal antibody, Evusheld. Evusheld comprises two monoclonal antibodies, namely tixagevimab co-packaged with cilgavimab, & is administered by intramuscular injection. It is authorised to be used for the prevention of COVID-19 in adults who have not had a known recent exposure to an individual with COVID-19 infection (pre- exposure prophylaxis) & are unlikely to mount an adequate immune response to COVID-19 vaccination due to a medical condition or are taking immunosuppressive medications or treatments or for whom COVID-19 vaccination is not recommended. Examples of such people include those who are in an immunocompromised state from blood or bone marrow transplants or have human immunodeficiency virus (HIV) infections. However, pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. The treatment must be prescribed by a doctor and the suitability of use on the individual patient will require a careful clinical assessment by the prescribing doctor. pos eg yeaa Australia's new ‘missing link’ lab to boost local vaccine capability Commonwealth Scientific and Industrial Research Organisation (CSIRO), an Australian Government agency responsible for scientific research, has opened a new $23.1 million national lab in Melbourne that will bolster the nation’s ability to produce vaccines & drug treatments locally. Researchers at CSIRO’s National Vaccine and Therapeutics Lab will turn vaccine & drug candidates into products that can be manufactured in large quantities for clinical trials. The ability to do this within Australia, rather than needing to go overseas, has been the ‘missing link’ in the country’s biomedical science sector being able to produce vaccines & drugs. The new lab follows asuccessful pilot facility in the early stages of the COVID-19 pandemic, when CSIRO scaled up vaccine candidates that had been developed onshore as part of a national strategy to combat this emerging threat. The facility was completed with funding from the Federal and Victorian Governments & was officially opened on August |1, by Federal Minister for Industry and Science Edham Nurredin Husic. BIOSPECTRUM | SEPTEMBER 2022 | www.biospectrumasia.com REGULATORY NEWS UNOPS partners with Japan to aid COVID-19 preparedness in Indonesia In collaboration with the Government of Japan, the United Nations Office for Project Services (UNOPS) has delivered essential medical equipment, medical supplies and personal protective equipment to support the Government of Indonesia’s COVID-19 preparedness and response. Since May 2020, UNOPS and the Government of Japan have been working with the Ministry of Health of the Republic of Indonesia to equip hospitals with medical equipment, and medical supplies for COVID-19 patients, as well as strengthen the health preparedness and COVID-19 response of the country’s healthcare system. With $4 million in funding from the Government of Japan, UNOPS delivered medicines and medical equipment - including ICU Ventilators, COVID-19 testing kits, PCR machines, an ambulance and other items aimed at preventing and treating COVID-19 cases in an effective and timely manner. Since the start of the project, the joint partnership is estimated to have helped over 16,000 critically-ill patients, as well as supported the work of 1,750 health workers across 30 hospitals. Novavax’s COVID-19 vaccine receives approval for adolescents in Asian region US-based Novavax, Inc., a biotechnology company dedicated to developing and commercialising next- generation vaccines for serious infectious diseases, has announced that Nuvaxovid (NVX-CoV2373) COVID-19 vaccine has received expanded manufacturing and marketing approval from Japan, expanded emergency use authorisation in Thailand, post approval change application by South Korea, provisional registration in Australia, and expanded provisional approval in New Zealand, for primary immunisation to prevent COVID-19) in adolescents aged 12 through 17. The company has also filed for expanded emergency use authorisation in Taiwan. Novavax has partnered with Takeda to develop, manufacture, and distribute Nuvaxovid in Japan, and partnered with SK bioscience to provide the first protein-based COVID-19 vaccine approved for use in adolescents aged 12 through 17 years in South Korea. Novavax has established partnerships for the manufacture, commercialisation and distribution of its COVID-19 vaccine worldwide. Existing authorisations leverage Novavax’s manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. NZ evaluates Maori Influenza and Measles vaccination programme of 2021 The Ministry of Health in New Zealand, which oversees’. the Maori Influenza and Measles Vaccination Programme (MIMVP) has released a report on its findings for 2021, identifying which initiatives worked and what could be improved in future. The report finds that while the vaccination rates. Its 2021 report finds that providers built on the learnings and capacity developed through MIVP 2020, applied these strategies to their COVID-19 activities as relevant, and new relationships and ways of working emerged. The report makes a series of recommendations overall flu vaccination rates and equity rates amongst the Maori community were lower than 2020, the rates achieved were still a notable improvement on 2019 and previous years. The MIMVP programme provides funding to providers around the country for initiatives designed to boost Maori influenza and measles around how immunisation and vaccination rates could be further bolstered, some of which are being addressed by the establishment of the Maori Health Agency. COMPANY NEWS BIOSPECTRUM | SEPTEMBER 2022 | www.biospectrumasia.com AstraZeneca signs MoU to empower breast cancer community in Singapore AstraZeneca Singapore has signed a Memorandum of Understanding (MoU) with Breast Cancer Foundation (BCF) to improve the overall breast cancer awareness, detection rates, and _ patients’ access to breast cancer treatment in Singapore. The MoU creates a new partnership to address the rising incidence of cancer and the cost-savings and lives saved that would result from early cancer detection. It also aligns with the Healthier Singapore _ strategy which supports the nation’s goal to breast cancer shift from acute care to preventive care. Under the MoU, AstraZeneca and _ diagnosis, Moderna to debut mRNA production & research facility in Australia Australia’s Monash University has announced that US- based firm Moderna will be joining other world-leading research and technology companies in the Monash Technology Precinct, under an agreement signed with the Victorian government. Moderna will build its first mRNA production facility in the Southern Hemisphere at Clayton in Melbourne’s south-east, and is expected to produce up to 100 million vaccine doses each year in Australia, including COVID-19, influenza and respiratory syncytial virus (RSV). It comes six months after Moderna, the Australian Government and the Victorian Government reached an _ in-principle agreement to build the facility, and will be the world’s first mRNA production facility to be located on a university campus. Not only will it secure the production of mRNA vaccines on Australian shores and ensure Australians have quick and easy access to vaccines, it will boost the country’s medical research and development, clinical trials and global supply chain access. In addition to the Moderna manufacturing site, Monash University is partnering with the Victorian government to establish the Monash Centre for Advanced mRNA Medicines Manufacturing and Workforce Training. Singapore and BCF aim to bridge existing knowledge gaps about identification and encourage regular screenings to help with early detection among targeted communities and the wider public in Singapore. A comprehensive care management plan will be established in partnership with healthcare professionals and -_ patient groups to give advice and “? -_ support on cancer management to breast cancer patients and caregivers in the community. This includes exploring the feasibility of a patient navigator programme to guide breast cancer patients in negotiating the healthcare system and providing a range of support such as psychosocial, diet, and nutritional interventions. ROKIT Healthcare deploys Al & 3D bioprinting for diabetes foot, osteoarthritis treatment South Korea-based ROKIT Healthcare will provide a hyper-personalised medical platform that uses 3D bioprinting and artificial intelligent (AI) technology built on Google Cloud, to innovate the treatment of osteoarthritis and diabetic foot lesion ulcer. ROKIT Healthcare's AI solution accurately recognises the affected area of the patient, using computer vision and deep-learning technology, and then outputs a patch with the same size and shape as the affected area to a 3D printer. The goal for this platform is to increase the treatment rate for chronic and complex diseases, improve access to medically underprivileged areas, and lower medical expenses. The company moved its existing infrastructure to Google Cloud and used Google Cloud’s AI tools to expand its medical platform. ROKIT Healthcare has established a system that can reliably expand and operate medical platforms in various regions using Google Cloud’s scalable, high-performance load-balancing service Cloud Load Balancing and Google Kubernetes Engine (GKE), which provide a fully managed Kubernetes service.