12/23 Taiwan Life Sciences Biweekly Newsletter
2024-12-23 |
| Taiwan Life Sciences Biweekly |
| EirGenix, Mitsubishi Gas Chemical, and GlycoNex forge partnership to advance SPD8 in global markets 18 December, 2024 EirGenix (TW: 6589), Mitsubishi Gas Chemical (MGC), and GlycoNex (TW: 4168) have signed a production agreement for SPD8, a denosumab biosimilar for treating osteoporosis, positioning it for the Japanese and international markets. SPD8, co-developed by GlycoNex and MGC, is currently in Phase 3 clinical trials after completing Phase 1 and receiving regulatory approval from Japan's PMDA, with results expected by Q2 2026. EirGenix will handle commercial API production. The development aligns with Taiwan's NHIA policies favoring domestically produced biosimilars, offering pricing incentives and parity with originator drugs, enhancing SPD8's competitiveness and facilitating its market entry and expansion globally. More... (in Chinese) |
| Research and Innovation at Academia Sinica: Taiwan's Hub for Interdisciplinary Integration in Science and Technology 18 December, 2024 Academia Sinica, a renowned research academy in Taipei, Taiwan, has launched a range of cutting-edge research facilities designed to push the boundaries of biotechnology, pharmaceuticals, and medical science. These facilities cover a wide spectrum of research, including gene editing, RNA technology, preclinical testing, and the development of nucleic acid vaccines. Among the key resources are Taiwan's only RNA Technology Platform, the Taiwan Mouse Clinic for preclinical trials, and the BioTReC Nucleic Acid Pilot Plant, which specializes in mRNA vaccine production. Additionally, Taiwan Biobank provides valuable biological data for research into precision medicine. Together, these facilities support both academic and industry research, helping to speed up discoveries that could shape the future of healthcare. More... |
| Taiwan's CDMO strength shines as local firms expand overseas reach 18 December, 2024 Taiwan's CDMO industry demonstrates strong global competitiveness, with Bora Pharmaceuticals (TW: 6472), EirGenix (TW: 6589), and Mycenax Biotech (TW: 4726) leveraging their unique advantages to secure orders from the US, Europe, and Japan. Bora Pharmaceuticals has expanded its North American presence through three US acquisitions this year, including a fully utilized injectable drug facility set to increase capacity by 30 percent. EirGenix has supported over 50 complex biologics projects and filed over 30 global IND/BLA submissions, with significant growth in the Japanese market accounting for 45 percent of its contracts, alongside rapid US market expansion driven by the Biomanufacturing Safety Act. Mycenax Biotech has achieved revenue growth through CDMO projects initiated post-2019 transformation, with a Korean ophthalmic drug client completing Phase 3 trials and preparing for market entry in South Korea, Canada, and the EU next year. More... (in Chinese) |
| Sunny Pharmtech expands partnership with US company, secures exclusive US market licenses for two products 16 December, 2024 Sunny Pharmtech (TW: 6676) announced that it has signed exclusive US market licensing agreements with 'S Company' for its two developing drugs: the cancer treatment TMN-T and the ulcerative colitis drug MSL-T. Sunny Pharmtech will receive a total of US$2.6 million (approximately NT$83.2 million) in signing and milestone payments based on the development progress of these two drugs. Additionally, after the drugs are launched, both companies will share sales revenue. According to the agreement, Sunny Pharmtech will be responsible for the R&D and production of TMN-T and MSL-T, as well as assisting with related regulatory filings, while the US company will acquire the marketing authorization for the US market and handle post-launch promotion and sales. More... (in Chinese) |
| StreamTeck's mmWave enables accurate non-contact physiological monitoring 13 December, 2024 Founded in 2018, Taiwan-based startup StreamTeck is leveraging millimeter-wave radar technology combined with IoT solutions to develop a non-contact physiological monitoring system for chronic patients and the elderly. The goal is to alleviate the pressure on nursing staff while avoiding the inconvenience and discomfort associated with traditional monitoring devices. The company's first product, SmartCaring T60 Intelligent Remote Care System, has already received Taiwan FDA Class II medical device certification, and its market outlook is promising. More... |
| Protect Animal Health partners with US startup Rejuvenate Bio to develop gene therapy for canine heart disease 12 December, 2024 Protect Animal Health has signed a licensing agreement with US-based Rejuvenate Bio to introduce a gene therapy for treating myxomatous mitral valve disease (MMVD), a common heart condition in dogs. Developed by Harvard Medical School's Wyss Institute, this therapy aims for US FDA approval by 2027, with exploratory preclinical trials in Taiwan planned for late 2024. Protect Animal Health will handle the development, distribution, and marketing in the Asia-Pacific region, targeting the US$70 billion global pet healthcare market. The company also has a broad product portfolio, including cancer-fighting vaccines and early-stage antibody drugs for pets. More... (in Chinese) |
| Fighting the Good Fight: Global Experts Unite to Share Oncology Breakthroughs at Asia-Pacific Precision Cancer Treatment Forum 12 December, 2024 Cancer remains the second leading cause of death globally, and improving survival rates has become a worldwide priority. Precision medicine is seen as the key to breakthroughs in this field. The 4th Asia-Pacific Cancer Precision Medicine Forum brought together top experts from around the world to discuss precision diagnostics for breast and lung cancers, personalized treatments, and international collaboration models to enhance the accuracy and effectiveness of cancer diagnosis and treatment. More... |
| Academia Sinica: An R&D Powerhouse Fueling Advancements in Biotech, Pharma, and Medical Research 12 December, 2024 Academia Sinica provides advanced core facilities that support research and development in biotechnology, pharmaceuticals, and medical science. These facilities integrate tools and expertise across disciplines to enable drug discovery, precision medicine, and translational research. Key areas include medicinal chemistry, antibody development, RNA technologies, and infectious disease research, with applications ranging from high-throughput gene editing and vaccine development to preclinical testing and biobanking. By offering resources for both academic and industry projects, these facilities play a significant role in advancing research and addressing challenges in healthcare and biomedical fields. More... |
| Syncell announces US$15M Series A funding to Accelerate the Global Commercial Growth of Its Protein Purification and Spatial Proteomics Technology Press release 11 December, 2024 Syncell, a leader in next-generation subcellular protein purification and spatial proteomics analysis, today announced the close of a US$15 million Series A funding round, bringing its total raised to US$30 million. The investment will be used to expand and accelerate the global commercialization and commercial support for the company's groundbreaking Microscoop platform. The round was led by Taiwania Capital, with participation from new and existing investors. More... |
| Caliway Announces Successful Study Results from CBL-0204, a CBL-514 Phase 2b Study for Reducing Abdominal Subcutaneous Fat, Met All Primary and Secondary Efficacy Endpoints Press release 11 December, 2024 Caliway Biopharmaceuticals announced the study results of the CBL-514 Phase 2b study for subcutaneous fat reduction (CBL-0204 Phase 2b study, NCT05736107), which met all the primary and secondary efficacy endpoints in the FAS (Full analysis set) and PP (Per-protocol) population analysis. Notably, the primary endpoint in the FAS population analysis showed that, at 12 weeks after the final treatment, 76.7 percent of patients treated with CBL-514 compared with placebo (18.9 percent) achieved at least 1-grade improvement reported by the Investigator using the Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS) (p=0.00004). Additionally, the study results demonstrated a favorable safety and tolerability profile, paving its way to a global muti-center Pivotal Phase 3 study in 2025, shading light of becoming the first approved injectable for large area fat reduction. More... |
| Yonglirong Biomedical Develops New Advances in Velvet Antler Regenerative Medicine, Expands into Southeast Asian Market 11 December, 2024 Yonglirong Biomedical (TW: 6973), specializing in the development of amniotic stem cell regenerative medicine and medical aesthetic products, has unveiled new velvet antler peptide health supplements and velvet antler stem cell skincare products. These products combine cutting-edge amniotic stem cell and patented cellular technologies for tissue repair and regeneration. The company stated that distribution channels have already been established in Southeast Asian markets, including Malaysia, Indonesia, and Vietnam. More... (in Chinese) |
| Andros Pharmaceuticals' new drug APC201 completes Phase II clinical enrollment, targets global market licensing next year 11 December, 2024 Andros Pharmaceuticals (TW: 6917) announced that Phase II clinical trials for the new drug APC201, developed for the treatment of knee osteoarthritis, have completed enrollment of the final participant. Preliminary data results are expected in Q1 next year, after which the company plans to initiate a global multicenter Phase III clinical trial. Concurrently, efforts will be made to license the drug to global markets, aiming to secure milestone payments and royalties to boost the company's revenue. APC201 received approval last year to conduct Phase I/II human clinical trials in Australia for the treatment of knee osteoarthritis. Phase I trials were completed in December of the same year, and Phase II trials have now successfully enrolled 60 participants. Upon completion of treatment, data analysis will commence, with clinical statistical results anticipated in Q1 next year. More... (in Chinese) |
| Microbio announces positive results from clinical unblinding of new drug Theralux 11 December, 2024 Microbio (TW: 4128) has announced the latest clinical trial unblinding results for its new drug Theralux. The exploratory human trial combining Theralux with the world's leading cancer immunotherapy drug Keytruda (pembrolizumab) yielded positive results, demonstrating potential to extend survival in patients with advanced lung cancer. More... (in Chinese) |
| BioTReC, AIT, BPIPO, and Taiwan BIO Collaborate to leverage US biotech resources and support Taiwan’s global market expansion 9 December, 2024 Wu Han-Chung, Director of the Biomedical Translation Research Center (BioTReC) at Academia Sinica, stated during his remarks at the US-Taiwan Biotech Day business matchmaking event held on 9 December that the event represents years of Taiwan's participation in the BIO International Convention in the US. Through the American Institute in Taiwan (AIT), representatives from various US states were invited to share insights on US market trends and strategies for helping Taiwanese companies enter the American market. The goal is to connect Taiwan's promising startups with the world's largest market - the United States - and propel these potential ventures onto the global stage. More... (in Chinese) |
| Foresee Pharmaceuticals reports strong revenue growth; expects international licensing of new drug FP-020 next year 9 December, 2024 Foresee Pharmaceuticals (TW: 6576) announced its consolidated revenue for November was approximately NT$9.68 million, with total consolidated revenue for the first 11 months of the year reaching NT$404 million, marking significant 143 percent year-on-year growth. This is the first time annual revenue has surpassed NT$400 million. Looking ahead to next year, in addition to expected licensing revenue from its prostate cancer drug CAMCEVI, which is anticipated to receive US regulatory approval for the three-month dosage form, the company aims to complete international licensing for its new drug FP-020, developed for immune-fibrotic diseases, with a major global pharmaceutical partner. More... (in Chinese) |
| EverFortune.AI's smart brain midline shift detection system receives US FDA medical device approval letter 9 December, 2024 EverFortune.AI (TW: 6841) announced that its brain midline sShift detection system had received approval from the US FDA as a medical device. This detection system uses deep learning algorithms to automatically analyze non-contrast head CT images of adults, identifying features of midline shift (MLS) and quickly sending alerts to PACS/RIS workstations. This allows clinical staff to intervene in a timely manner, improving the quality of care. To date, EverFortune.AI has obtained 42 medical device approvals domestically and internationally, including 12 from the US FDA, 15 from Taiwan, five from Thailand, five from Malaysia, four from Vietnam, and one from Singapore. More... (in Chinese) |
| Biotech diplomacy heats up! Canada-Taiwan Life Sciences Forum and Medical Expo kick off with six companies seeking opportunities in Taiwan 7 December, 2024 The "Canada-Taiwan Life Sciences Cooperation Forum," organized by the Canadian Trade Office in Taipei and the Development Center for Biotechnology (DCB) and co-organized by the Taiwan Bio Industry Association and the British Columbia Taiwan Office, took place recently during the Taiwan Healthcare+ Expo. The forum featured an overview of Canada's biotechnology industry, with presentations by six Canadian companies specializing in precision medicine and digital health, fostering discussions and business matchmaking opportunities. More... (in Chinese) |
| PharmaEssentia reports NT$1B revenue for November; Ropeg new indication to begin global regulatory submissions next year 5 December, 2024 PharmaEssentia (TW: 6446) announced that its revenue for November reached NT$1.02 billion, marking both month-on-month and year-on-year growth, with an annual increase of 139 percent, setting a new all-time high. Cumulative revenue from January to November this year totaled NT$8.6 billion, representing a 94.15 percent year-on-year increase. The company attributed the strong November performance primarily to US sales of its rare disease drug Ropeg, with consistent growth in both the US and global markets The company also shared updates on the expansion of new indications for Ropeginterferon alfa-2b (Ropeg), with plans to begin submitting regulatory applications in various countries early next year following the release of trial results. More... (in Chinese) |
| ACRO Biomedical Collagen ADM Scaffold obtains FDA clearance, new tech featured on int. journal cover 5 December, 2024 ACRO Biomedical (TW: 6748) recently achieved two significant milestones. First, its advanced medical device Collagen ADM Scaffold has obtained FDA 510(k) clearance in the US, enabling its application in wound care and potential hair growth treatments. Second, its Bio-Brain-Machine interface chip, developed using a collagen biofilm combined with semiconductor technology, has been featured on the cover of a renowned international journal. More... (in Chinese) |
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| Taiwan Bio Industry Organization (Taiwan BIO) Contact: Daisy Tsai Tel: +886 2 27836028 ext 14 FAX : +886 2 27836027 Mobile: +886 933-139647 | Line ID : daisy222 Email: daisy@taiwanbio.org.tw BIO Asia-Taiwan 2025 (23-27 July, 2025) ========================================= Taiwan Bio Industry Organization (TBIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |