4/11 Taiwan Life Sciences Biweekly Newsletter
2022-04-11| | |
| 1. NTHU heading into a new ‘era of medicine’ 6 April, 2022 National Tsing Hua University (NTHU) is heading into a new “era of medicine” and looking to bring Taiwan’s medical prowess to the world with a new medical department and hospital. NTHU is to welcome its first class of medical students in August. A plan to build its own hospital was also approved by the Ministry of Health and Welfare’s Medical Review Committee on March 14.More... | |
| 2. Taiwan Launches Digital Submission System for Medical Devices 6 April, 2022 In the age of digital, having a digital submission is timely. The Taiwan Food and Drug Administration (TFDA) launched a new online pre-market application platform for medical devices. They named it the TFDA Medical Device Premarket E-submission System. The new online submission system is aimed to speed up the process. It provides manufacturers with an alternative way to submit pre-market application documents. This should improve the convenience of pre-market applications for medical devices.More... | |
| 3. Nvidia, Asus Cloud Team for Taiwanese Biomedical Supercomputer 5 April, 2022 The National Health Research Institutes (NHRI) in Taiwan has announced a partnership with Nvidia and Asus to deliver the nation’s first biomedical supercomputer. NHRI — a nonprofit foundation established by the Taiwanese government to promote biomedical research and health policy — says that the system will be used to support the NHRI’s application of AI in biomedical fields.More... | |
| 4. With record high revenue, Pharmagene announces new growth strategy 5 April, 2022 Taipei, Taiwan-based diagnostics firm Pharmagene’s (TW: 7595) booked record-high consolidated revenues of NT$129 million in 2021, an increase of over 27 percent over the previous year. However, due to increased R&D, marketing and promotion costs, the company still posted a net loss of NT$23.43 million. COO Chen Kuan-Chih said that in 2022 the company would forge ahead and pursue growth in several major directions. First, with its companion diagnostic of the gout drug Anleprinol approved in March this year, prospects look good particularly as the drug is considered a first-line drug and widely used in hospitals and clinics. Secondly, the company intends to strengthen its engagement with local medical associations, clinics, and pharmacists, and expand the marketing and promotion of its new products. Thirdly, in addition to OEM production, the company also intends to invest in the development of its own brands.More... (in Chinese) | |
| 5. Lin BioScience’s new drug for Stargardt disease approved for Phase III clinical trials 5 April, 2022 Taipei, Taiwan-based Lin BioScience (TW: 6696) announced on Tuesday that its US-based subsidiary Belite Bio's new drug LBS-008 has been approved by the Swiss Agency for Therapeutic Products (Swissmedic) for juvenile patients with Stargardt Disease, a rare condition. Phase III clinical trials and follow-up trials will involve 60 patients worldwide. Stargardt Disease is a rare hereditary disease with an incidence of about 1 in 10,000, and it tends to occur in children and adolescents, according to the announcement by Lin BioScience. This drug has also been granted orphan drug status by both the US FDA and the European EMA, along with pediatric rare disease certification by the FDA. More... (in Chinese) | |
| 6. Accord BioPharma, in Partnership with [Taiwan’s] Foresee Pharmaceuticals, Launches CAMCEVI™ (Leuprolide) Injection Emulsion in the US for the Treatment of Advanced Prostate Cancer in Adults 4 April, 2022 (Press release) Accord BioPharma, the US specialty division of Intas Pharmaceuticals, Ltd. focused on development of oncology, immunology, and critical care therapies, announced today, in partnership with Foresee Pharmaceuticals Co., Ltd., the US launch of CAMCEVI™ (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. The US Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021. CAMCEVI™ 42 mg injection is exclusively licensed to Accord BioPharma in the US for commercialization.More... | |
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| 7. Medigen Vaccine, TaiGen Biotechnology and PharmaEngine announce drug development progress 4 April, 2022 Three prominent Taiwan drug companies – Medigen Vaccine (TW: 6547), TaiGen Biotechnology (TW: 4157), and PharmaEngine (TW: 4162) – this week announced developments in the progress of some of their latest products. Medigen with its new COVID-19 vaccine was asked in 2021 to join the World Health Organization (WHO) Solidarity Trial Vaccines program which is developing next generation COVID vaccines for worldwide use. The vaccine is currently in Phase III trials, with the unbinding of data expected soon. TaiGen is on track to complete a Phase II trial of its new anti-influenza drug TG-1000 in China in the second quarter. The trial, which enrolled 202 patients at 30 centers, was completed in early February but the compilation of data is expected to take an additional three months. And PharmaEngine has the opportunity to obtain Chinese drug approval for its new pancreatic cancer drug, ONIVYDE, already available in Europe and Asia More... (in Chinese) | |
| 8. Orient EuroPharma gains rights to Contrave for Taiwan 1 April, 2022 Orient EuroPharma has signed a deal with the US branded and generic drugmaker Currax Pharmaceuticals to bring the weight control drug Contrave (naltrexone/bupropion) to the Taiwan market as soon as in the second half of 2022.More... | |
| 9. Taiwan, Somaliland to cooperate on health information management system project 30 March, 2022 Taiwan and Somaliland have agreed to cooperate on a new health information management system to digitize the East African nation’s patient and hospital records. The Health Information Management Efficiency Enhancement Project is a joint initiative between the Somaliland Ministry of Health Development, Taiwan ICDF, and Kaohsiung Medical University Chung-Ho Memorial Hospital, the Somaliland Chronicle reported. The system will initially be implemented at a few healthcare facilities. More... | |
| 10. Senhwa Biosciences presents clinical data on new skin cancer drug at international conference 28 March, 2022 Senhwa Biosciences (TW: 6492) announced last week that Silmitasertib (CX-4945), its new drug in development for the treatment of advanced basal cell carcinoma (BCC), has demonstrated positive early-stage efficacy and was selected for an online ePoster presentation at the 2022 American Academy of Dermatology (AAD) meeting held in Boston on March 27, 2022. Positive efficacy and safety data included: A. Two of 10 patients with locally advanced BCC achieved partial remission (PR) with 30% tumor shrinkage measured at 24 weeks of treatment. B. In the first biopsy analysis of patients with locally advanced disease, significant suppression of Gli1 protein gene expression was measured at week 8 of taking Silmitasertib, with a 90% reduction. C. More than 90% of the causes of basal cell carcinoma are associated with uncontrolled expression of the ‘Hedgehog signal pathway’ of DNA, which includes the Gli1, Gli2 and Gli3 proteins. More... (in Chinese) | |
| 11. Medical experts 3D print replicas of donated organs 27 March, 2022 Two medical institutions based in metropolitan Taipei yesterday held their first 3D organ replica printing workshop in the capital. Organ donation after death is relatively rare in Taiwan, as many people are reluctant to sign up to donate their organs after death. As some people fear that organ donation would affect the appearance of the corpse, replacing the organs with 3D-printed replicas would put families at ease over the appearance of their deceased family member, said the Taipei Medical University’s Innovation and Entrepreneurship Education Center, which organized the event with New Taipei City’s Shuang Ho Hospital.More... | |
| 12. Development Center for Biotechnology announces new anti-body drug, CHO-C cell production platform 26 March, 2022 Taiwan’s Development Center for Biotechnology (DCB) announced two recent drug development milestones. First, is anti-body ADC drug complex Tri-mannosy 1, which is expected to be licensed to local drug companies in the first half of the year for further development. The second is its new CHO-C cell mass production platform, which the DCB intends will be spun off as a new company later this year. In the announcement DCB CEO Wu Chung-hsiun said that over the past 15 years the DCB had successfully spawned five new ventures and licensed out 20 new drugs. More... (in Chinese) | |
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