09/29 Taiwan BIO Weekly
2026-09-29 |
| Taiwan BIO Weekly |
| Next-Generation CAR-T Cell Therapies Gain Momentum as Companies Race to Invest in New Technologies |
| Stemchymal Receives Japanese Marketing Approval, H1 Marketing Authorization Targeted 26 September, 2026 Emerging biotech company Steminent Biotherapeutics (TW: 7729) announced on the 26th of September that its licensing partner, Reprocell, has officially obtained a Marketing Authorization Holder (MAH) license for regenerative medical products in Japan. The companies will continue working toward regulatory approval and commercialization of Stemchymal, a stem cell therapy for spinocerebellar ataxia, with the goal of obtaining conditional marketing authorization in Japan in the first half of next year. More... (in Chinese) |
| Enimmune Partners with Biogenetech to Enter Thailand's EV71 Vaccine Market 24 September, 2026 Enimmune (TW: 6564) announced that it has signed an exclusive distribution agreement with Thailand-based biopharmaceutical company Biogenetech for its self-developed enterovirus 71 (EV71) vaccine in Thailand. The partnership will jointly introduce the high-protection EV71 vaccine to the Thai market, with the potential to serve approximately 3 million infants and young children through both private-pay and public-sector procurement programs, helping address public health gaps in Southeast Asia. More... (in Chinese) |
| PharmaEssentia Establishes Australian Operations Hub to Strengthen Asia-Pacific Presence 23 September, 2026 PharmaEssentia (TW: 6446) will establish an Australian operations hub at the Centre for Eye Research Australia (CERA) in Melbourne on the 1st of October, strengthening its local clinical development and regulatory capabilities. The company has begun preparations to seek Australian marketing approval for Ropeg for polycythemia vera (PV) and essential thrombocythemia (ET), while building local partnerships and connections within Melbourne's biomedical R&D ecosystem to support its expansion into the Australian market. More... (in Chinese) |
| BRIM Biotech Accelerates Drug Licensing Efforts 23 September, 2026 BRIM Biotech (TW: 6885) reported during an investor conference on the 22nd of September strong licensing progress for its neurotrophic keratitis (NK) drug candidate BRM424 and glaucoma drug candidate BRM411, with both Phase II trials advancing smoothly. BRIM is actively pursuing global and regional licensing deals for the drugs, with more than 10 international pharmaceutical companies having signed non-disclosure agreements, seven currently conducting due diligence, with two already in term-sheet negotiations, according to the company. More... (in Chinese) |
| Taiwan's Adimmune expands drug, vaccine contract manufacturing 22 September, 2026 Adimmune Corp. (TW: 4142) is expanding its contract development and manufacturing organization (CDMO) business as it takes on more drug and vaccine work for international pharmaceutical companies, CTEE reported Tuesday. More... |
| Caliway Announces Positive Phase II Results of CBL-514 in Dercum's Disease, Achieving Primary Endpoint with Statistically Significant and Sustained Pain Reduction Press release 22 September, 2026 Caliway Biopharmaceuticals (TWSE: 6919) on September 21 announced final statistical results from its randomized, single-blind, placebo-controlled Phase II clinical trial (CBL-0202DD) evaluating CBL-514 for the treatment of Dercum's Disease (DD), a rare and debilitating disorder characterized by painful lipomas. The study successfully achieved its primary efficacy endpoint, with CBL-514 demonstrating clinically meaningful and statistically significant pain reduction in both the Full Analysis Set (FAS) and Per-Protocol (PP) populations. The results showed robust and durable efficacy, with treatment benefits consistently observed across multiple assessment time points and increasing over all treatment courses. More... |
| Elixiron Immunotherapeutics Files for Primary Listing on Taiwan's Innovation Board 22 September, 2026 Elixiron Immunotherapeutics (7871) formally submitted an application on the 22nd of September to be listed on the Taiwan Innovation Board (TIB). It is the sixth company to apply for a TIB listing this year, adding further momentum to Taiwan's biotech and healthcare capital market. Founded in January 2017 and headquartered in the Cayman Islands, Elixiron Immunotherapeutics operates in Taipei's Nangang District, Hong Kong, and Shanghai. The company focuses on developing innovative immunotherapies for diseases including immune disorders, neurodegenerative diseases, and cancer. More... (in Chinese) |
| From AI Diagnostics to Exoskeletons, Taiwan Targets the US Healthcare Market 21 September, 2026 he Taiwan External Trade Development Council (TAITRA) returns to Texas for a third consecutive year this September, hosting Taiwan Expo USA from September 24-26, 2026, at the Kay Bailey Hutchison Convention Center Dallas. More... |
| From Anti-Aging to Biotech: Taiwan Looks to Take Its Exosomes Global 21 September, 2026 The growing domestic medical aesthetics market has helped foster an increasingly sophisticated production ecosystem, creating opportunities in Taiwan and overseas. More... |
| Merry Life Biomedical Advances Global Phase II Trial of TML-6, Exploring Cellular Protein Clearance in Early Alzheimer's Disease Press release 21 September, 2026 Merry Life Biomedical today announced the advancement of TML-6, a Taiwan-developed investigational oral therapy for early Alzheimer's disease, into a global Phase II study spanning Taiwan, Sweden, and the United States. The study brings together 20 clinical sites, including nine medical centers in Taiwan, seven sites in Sweden, and four centers in the United States. It will evaluate TML-6 in approximately 210 participants with early Alzheimer's disease. More... |
| Taiwan's NTUH signs research pact with Johnson & Johnson 21 September, 2026 National Taiwan University Hospital and Johnson & Johnson have signed an agreement to expand cooperation on cancer, immune-mediated diseases, and innovative medical technology, per a press release. More... |
| New Drug Stocks Receive Regulatory Approval Wins 21 September, 2026 Preliminary data show that more than nine Taiwanese new drug companies are set to reach key milestones in the third quarter, including drug approvals, listings, and licensing developments. PharmaEssentia (TW: 6446), secured US and Japanese approvals for its novel drug Ropeg, while Handa Pharmaceuticals (TW: 6620) received final US FDA approval for its cancer drug candidate. Lotus Pharmaceutical (TW: 1795) obtained regulatory approval in South Korea for an oncology drug, while RenBio (TW: 6696) and TAHO Pharmaceuticals (TW: 6467) have entered the US regulatory review process. More... (in Chinese) |
| Pharmosa Biopharm's New Drug Receives US Approval for Phase II Clinical Trial Press release 21 September, 2026 Pharmosa Biopharm (TW: 6875) announced that its long-acting inhaled drug candidate L608 has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical trial. The company plans to conduct a multinational, multicenter clinical trial to further evaluate L608's potential for treating peripheral vascular complications associated with systemic sclerosis. More... (in Chinese) |
| AnBogen Therapeutics Targets Unmet Needs in Colorectal Cancer Immunotherapy with Triple-Drug Therapy 21 September, 2026 AnBogen Therapeutics (TW: 7784) shared the company's approach to cancer treatment innovation at the 2026 Health Trends Forum organized by the Central News Agency. AnBogen is developing a triple-drug combination therapy for advanced metastatic colorectal cancer, with clinical trials underway since November 2025. Nearly 20 patients in Taiwan and Australia have received treatment and undergone toxicity assessments, with the Phase I trial expected to be completed in November 2026 before advancing to Phase II. More... (in Chinese) |
| ========================================= |
| Please note that Taiwan BIO is not responsible for the accuracy of third-party news stories covered in this newsletter. |
| ========================================= |
| Taiwan Bio Industry Organization (Taiwan BIO) Tel: +886 2 27836028 Fax: +886 2 27836027 Email: biotaiwan@gmail.com BIO Asia-Taiwan 2027 (27-31 July, 2027) ========================================= Taiwan Bio Industry Organization (Taiwan BIO) Room C229, 2F, Bldg. C, No. 99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |