12/22 Taiwan BIO Weekly
2025-12-22 |
| Taiwan BIO Weekly |
| LaunXP Biomedical's lung cancer drug to enter Phase III clinical trials in 2027 18 December, 2025 LaunXP Biomedical (TW: 6876) has announced that it has completed a full overhaul of its board and independent directors. Newly appointed Chairman Jeffrey Wang reported that LXP109, an in-licensed lung cancer drug, is scheduled to enter Phase III clinical trials in 2027 across Taiwan, Japan, and other Asian countries. Meanwhile, LXP103, a weight-loss and metabolic drug targeting the obesity market, is expected to be submitted for IND consideration by the end of 2026, the company mentioned. More... (in Chinese) |
| TaiMed Biologics reports clinical trial progress with long-acting bispecific antibody HIV therapy 18 December, 2025 TaiMed Biologics (TW: 4147) announced that its long-acting bispecific antibody HIV therapy, TMB-365/TMB-380, has enrolled its first participant in the US Phase IIb clinical trial, with full enrollment expected by the first half of 2026 and a six-month interim analysis by early 2027, around which time licensing agreements may also be finalized. CEO Jimmy Chang stated that the therapy is targeted for market launch in 2030, with peak sales projected between 2034 and 2035, and an annual treatment cost of USD50,000-60,000, comparable to current mainstream oral HIV therapies. The Phase IIb trial, to be conducted at multiple US sites, is focusing on HIV patients seeking longer-acting, more adherence-friendly treatment, with objectives including long-term safety, tolerability, sustained viral suppression, and a bi-monthly dosing regimen over one year. More... (in Chinese) |
| ASG Receives US FDA IND Approval to Initiate Phase I Clinical Trial of the Lead Drug Beta1 for Male Erectile Dysfunction Press release 17 December, 2025 [Taiwan's] Asia Scientific Global Inc. (ASG), a leader in the research and development of novel inhaled drugs, today announced that its lead product, Beta1, has received Investigational New Drug (IND) application clearance from the US Food and Drug Administration (FDA). Beta1 is currently the only inhaled investigational therapy for male erectile dysfunction to have received such approval and prepared to enter clinical trials. The FDA's clearance underscores ASG's capabilities in drug development and manufacturing technologies. ASG plans to initiate a Phase I clinical trial in Taiwan in the first half of 2026. More... |
| Caliway Biopharmaceuticals Presents Preclinical Research Supporting a Multi-Mechanism Approach to Weight Management at TMASO 2025 Press release 16 December, 2025 Caliway Biopharmaceuticals (TW: 6919), a clinical-stage biopharmaceutical company developing novel small-molecule therapeutics, announced that preclinical research involving CBL-514 was presented at the 25th Annual Congress of the Taiwan Medical Association for the Study of Obesity (TMASO 2025), held jointly with the 9th Japan-Korea-Taiwan Symposium on Obesity at National Taiwan University Hospital. More... |
| Top Innovators Compete in Taipei as 'Go Healthy with Taiwan' Finals Spotlight Health-Tech Advances 16 December, 2025 Six teams from around the world converged in Taipei on December 10, 2025, for the global finals of the "Go Healthy with Taiwan" Call for Proposals, culminating in the selection of three winning innovations poised to shape the future of global health. The competition--one of Taiwan's flagship international innovation initiatives--attracted 638 proposals from 55 countries, underscoring Taiwan's rising prominence as a hub for health technology and cross-border collaboration. More... |
| Taiwan-Japan team develops automated stem cell cultivation system 16 December, 2025 A collaborative research effort between Taiwanese and Japanese teams has led to the development of the world's first instrument capable of automatically culturing and differentiating stem cells, marking a breakthrough for regenerative medicine, according to CNA. More... |
| Nan Ya Plastics invests in AventaCell BioMedical, targeting high-value medical devices, regenerative medicine 16 December, 2025 Nan Ya Plastics' (TW: 1303) board has approved an investment in Taiwan's AventaCell BioMedical, with a total amount not exceeding NTD210 million, to explore related investment opportunities. Nanya stated that the investment aims to deepen the partnership, generating potential investment returns while expanding product sales channels and gaining real-time access to opportunities in the regenerative medicine industry, supporting the development and commercialization of medical device products. More... (in Chinese) |
| Taiwan opens new era in advancing kidney care 16 December, 2025 Taiwan's chronic disease care is once again at the forefront internationally, taking new strides with the release of the Asia-Pacific's first "Early Chronic Kidney Disease (CKD) Annual Report," jointly published by the Ministry of Health and Welfare, the National Health Research Institutes, and the Taiwan Society of Nephrology. More... |
| YD Bio to establish California operations center for diagnostic development 16 December, 2025 [Taiwan-based] YD Bio Limited (NASDAQ:YDES) announced Tuesday plans to establish a new operations center in California to advance its cancer detection and ophthalmologic technologies, according to a company press release. The biotech firm, currently valued at USD878.29 million despite generating just USD0.51 million in revenue over the last twelve months, is looking to expand its operational footprint in the US. More... |
| Gongwin Biopharm secures another foothold in Southeast Asia with Singapore signing 15 December, 2025 Gongwin Biopharm (TW: 6617) announced that its subsidiary Gongwin Medical Technology has signed a licensing and distribution agreement in Singapore for its lung cancer drug PTS302, expanding on its existing partnership in Malaysia, further strengthening its Southeast Asia presence. Gongwin noted that lung cancer is a high-incidence, high-mortality disease in Singapore, with an average of about 1,800 new cases annually from 2018 to 2022, of which roughly 25% develop malignant central airway obstruction (MCAO), representing an estimated 450 patients per year with potential treatment needs. Based on an estimated USD10,000 per patient per treatment course, the annual potential market for the MCAO indication in Singapore is about USD4.5 million, rising to USD22.5 million over five years. The company added that Singapore's strong healthcare accessibility and payment capacity make it a high-value market, and the new licensing deal is expected to support PTS302's entry into premium markets and enhance Gongwin's international growth potential. More... (in Chinese) |
| Medigen Biotechnology submits new drug OBP-301 to Japan's PMDA for approval 15 December, 2025 Medigen Biotechnology (TW: 3176) announced that, together with Japan's Oncolys BioPharma (also listed in Taiwan, TW: 4588), it has co-developed the oncolytic virus drug OBP-301 (Telomelysin) for esophageal cancer. Oncolys has submitted an NDA to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for manufacturing and marketing approval. Under the agreement, Medigen Biotechnology will receive one-third of the revenue once the drug is commercialized. The company plans to position OBP-301 as the world's first approved oncolytic adenovirus therapy for esophageal cancer, aiming to obtain manufacturing and marketing authorization from Japan's Ministry of Health, Labour and Welfare, and to begin sales in Japan from fiscal 2026 after pricing approval. More... (in Chinese) |
| Insilico Medicine, TaiGen collaborate for AI-driven PHD inhibitor for CKD-related anaemia 15 December, 2025 Insilico Medicine, a clinical-stage generative artificial intelligence (AI)-driven drug discovery company headquartered in Hong Kong, and Taiwan's TaiGen Biotechnology (TW: 4157), a listed discovery-based and market-focused pharmaceutical company, as well as TaiGen Biopharmaceuticals, its wholly-owned Beijing subsidiary, have announced an exclusive pipeline out-licensing collaboration. More... |
| Libo Pharma targeting defense medical market with new drug LIB-101 14 December, 2025 Libo Pharma (TW: 7888) stated in a recent announcement that its new drug LIB-101 is targeting the defense medical strategic market, making Libo Pharma not only the only Taiwanese company in this field but also one of the few globally among drug developers. The company added that a few firms in Asia are also exploring radiation countermeasure products, such as an Israeli company collaborating with Fukushima Medical University in Japan, primarily using cell therapy as the main approach. More... (in Chinese) |
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