08/31 Taiwan BIO Weekly
2026-08-31 |
| Taiwan BIO Weekly |
| Immunwork's Novel Drug Advances to Phase II Clinical Trials 28 August, 2026 Immunwork announced on the 27th of August that its next-generation long-acting octreotide analog, TE-8214, has been featured in the international journal Frontiers in Endocrinology. The drug has completed a Phase I clinical trial in Australia, with Phase II trials expected to begin simultaneously in Taiwan and Australia in the fourth quarter of this year. The company is targeting indications including acromegaly and neuroendocrine tumors (NETs), while continuing to pursue international partnerships and global market opportunities. More... (in Chinese) |
| Bio Taiwan Committee Approves 27 Recommendations, Pushes for CIT Implementation 27 August, 2026 The annual meeting of the Bio Taiwan Committee concluded successfully after three days of discussions focused on three key areas--technology applications, regulatory frameworks, and industry sustainability--covering six major issues and resulting in 27 policy recommendations. The recommendations call for accelerated regulatory review of AI-driven drug development and smart medical devices, greater commercial use of health data, and government priority procurement of domestically developed AI healthcare products. The goal is to build a national 'Smart Biotech' team and help Taiwan transition from "Made in Taiwan" to "Created in Taiwan. " More... (in Chinese) |
| Medeon Biodesign's Three Growth Engines Drive Growth 26 August, 2026 Medeon Biodesign (TW: 6499) is entering a key inflection point in its operations, with three major business engines advancing in parallel. Following US FDA clearance for its minimally invasive prostate medical device Urocross, the company is preparing for commercialization through a dual strategy of direct sales and international licensing. Its Taiwan regulatory application is also in the final stage of review, with approval targeted for this year. Meanwhile, enrollment in the US pivotal trial for its Duett thoracic aortic repair system has surpassed 50%, while revenue from its contract development and manufacturing services (CDMO) business has nearly tripled over the past three years. More... (in Chinese) |
| BRIM Biotechnology's Ophthalmic Orphan Drug Shows Strong Phase II Results, Targets Licensing by Year-End 25 August, 2026 BRIM Biotechnology (TW: 6885) announced that its investigational drug BRM424 for neurotrophic keratitis (NK) has completed dosing of all participants in its Phase II clinical trial in the US and Brazil, with topline data expected in September 2026 and the full clinical study report due in the fourth quarter. The company aims to secure global or regional licensing by year-end. NK is a rare, degenerative eye disease that can cause corneal ulcers, perforation and blindness, with the global market projected to grow from US$396 million in 2026 to US$764 million by 2035, underscoring significant unmet medical needs and market potential. More... (in Chinese) |
| Taiwan's Lotus Pharma inks biosimilars agreement with Alvotech for US and selected Asian markets 25 August, 2026 Taiwan-based Lotus Pharmaceutical Co. (TW: 1795) has announced a strategic licensing and commercialisation agreement with Alvotech, covering two of Alvotech's candidates in the United States and selected Asian markets: AVT34, a proposed biosimilar to Imfinzi (durvalumab), and AVT87, a proposed biosimilar to Hemlibra (emicizumab). More... |
| Precision healthcare could be Taiwan's strength 25 August, 2026 Taiwan has an opportunity to become a global innovation hub for precision health by taking advantage of its strengths in biotechnology and information and communications technology, an academic said at an annual biotech meeting in Taipei yesterday. More... |
| Ever Fortune.AI's Appendicitis Detection System Receives TFDA Approval 25 August, 2026 Ever Fortune.AI (TW: 6841) announced on the 24th of August that its proprietary AI medical device software has received medical device approval from the Taiwan FDA. The approval follows the system's US FDA 510(k) clearance in April, marking another milestone in the company's global commercialization efforts. Ever Fortune.AI has now secured a total of 57 medical device approvals and certifications in Taiwan and overseas. More... (in Chinese) |
| PharmaEssentia's Ropeg Secures Japanese ET Approval 25 August, 2026 PharmaEssentia (TW: 6446) announced on the 24th of August that its drug Ropeg has been approved by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of essential thrombocythemia (ET), with the approval covering all ET patients. This marks Ropeg's first global approval for the treatment of the full ET patient population. Attention now turns to the US FDA's PDUFA action date of the 30th of August. If approved, Ropeg could further expand its presence in the global myeloproliferative neoplasm (MPN) market. More... (in Chinese) |
| Engineering the Future of Healthcare with Artificial Intelligence: Taiwan to lead the Forefront in Asia 24 August, 2026 As healthcare systems across Southeast Asia embrace smarter technologies and new models of care, Taiwan is looking to deepen its role as a technology and innovation partner for the region. At Medical Fair Asia 2026, Taiwan Excellence will bring together award-winning companies and solutions spanning smart medicine, precision healthcare and medical innovation. More... |
| Taiwan premier touts biotech growth at annual policy meeting 24 August, 2026 Premier Cho Jung-tai said Monday that Taiwan's biotechnology and medical industry generated more than NT$805 billion (US$25.32 billion) in revenue and attracted NT$55.08 billion in investment last year, CTEE reported. More... |
| Charles River Laboratories collaborates with Taiwan's Medigen Vaccine Biologics Corp 24 August, 2026 US-based Charles River Laboratories International, and Medigen Vaccine Biologics Corp. (TW: 6547)), headquartered in Taiwan, have collaborated on the characterisation and validation of the virus seed bank for MVC's next-generation multivalent enterovirus vaccine. More... |
| Taiwan's TAHO Pharmaceuticals' Antithrombotic Oral Film Clears FDA Acceptance Hurdle, Targets World's Second-Largest Drug Market 24 August, 2026 TAHO Pharmaceuticals (TW: 6467), a Taiwanese emerging biotech company, announced that its antithrombotic oral film drug BEQIA has officially entered substantive review by the US Food and Drug Administration (FDA) as of August 21. BEQIA is the world's first Apixaban antithrombotic oral film, developed using the company's proprietary TDS (Transepithelial Delivery System) platform, targeting elderly patients and those with swallowing difficulties. More... |
| HanchorBio's New Drug Scores a Major Win 24 August, 2026 HanchorBio (TW: 7827) is leveraging its proprietary FBDB multifunctional biologics platform to develop next-generation myeloid cell-directed immunotherapies. Its first-in-class drug candidate HCB101 has demonstrated a higher objective response rate than conventional therapies in early-stage clinical trials for second-line colorectal cancer and gastric cancer. More... (in Chinese) |
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