12/1 Taiwan BIO Weekly
2025-12-01 |
| Taiwan BIO Weekly |
| SPOT-MAS Launches in Taiwan: AI-Powered Multi-Cancer Early Detection Ushers in a New Era of Precision Medicine Press release 28 November, 2025 Precision medicine is entering a new era, driven by breakthroughs in genetic technology and Artificial Intelligence (AI). Multi-Cancer Early Detection (MCED) has become a global trend, and Taiwan joins this movement with the introduction of SPOT-MAS--an advanced screening solution developed by Gene Solutions, a global leader in precision oncology and genomics, in collaboration with local partner Gene Health. More... |
| TTY Biopharm's three major strategies beginning to bear fruit 27 November, 2025 TTY Biopharm (TW: 4105) announced that its three-pronged operational strategy is beginning to yield results, with strong growth expected this year and next. The company will continue expanding exports of complex generics, advancing international new drug licensing, and broadening its vaccine portfolio to sustain momentum. Among its key drivers, the liposomal antibiotic Lipo-AB has gained over one-third market share in the US, and combined with sales in Vietnam, South Korea, and other regions, exports now approach 20% of revenue. TTY is also seeking approvals in the Middle East and Australia while expanding into Southeast Asia and South America, aiming to lift export contribution above 20% in the coming years to support the next phase of expansion. More... (in Chinese) |
| Energenesis Biomedical's new drug for Epidermolysis Bullosa begins Phase II clinical trial in US 26 November, 2025 Energenesis Biomedical (TW: 6657) announced that its independently-developed topical cream for hereditary Epidermolysis Bullosa (EB), F703EB, has received US FDA approval to proceed with a Phase II clinical trial. The trial will begin patient enrollment, targeting 20 moderate-to-severe EB patients to evaluate the drug's preliminary efficacy and safety, with enrollment and data readout expected next year. EB currently has no curative treatment, and Energenesis Biomedical noted that F703EB, with its superior mechanism of action, is expected to serve as a first-line therapy to accelerate wound healing in EB patients. More... (in Chinese) |
| Taiwan's Jyong Biotech announces partnership in Korea to evaluate in-licensing of plant-derived MCS drugs 26 November, 2025 Jyong Biotech, a science-driven biotechnology company based in Taiwan committed to developing and commercialising innovative and differentiated new drugs (plant-derived) mainly specialising in the treatment of urinary system diseases, has entered into a non-binding letter of intent (the LOI) with a South Korean pharmaceutical company to review and evaluate the potential in-licensing and development of Jyong Biotech's plant-derived new drug MCS-2for the Korean market. More... |
| Mycenax Partners with three major Japanese firms to focus on local market 25 November, 2025 Mycenax (TW: 4726) announced it is partnering with Japanese firms Alfresa, Kidswell, and Chiome to form the joint venture Alfenax Biologics, which will build a biologics manufacturing base in Japan and focus on CDMO and pharmaceutical distribution. Following MHLW subsidy approval in May and an investment framework agreement in October, the shareholders' agreement was signed this month, with Alfresa and Mycenax each holding 45%. Alfresa, Japan's largest prescription drug distributor, brings extensive industry experience and influence to the venture. More... (in Chinese) |
| Biotech newcomer Pharmasaga debuts on OTC market at NT$120, developing PS1 for diabetes 25 November, 2025 Biotech newcomer Pharmasaga (TW: 7878) will debut on the OTC market on November 27 at a reference price of NT$120 per share. The company is developing its flagship small-molecule drug PS1, currently in Phase I trials, to reverse diabetes by targeting PDIA4, a key protein involved in pancreatic islet cell dysfunction. Unlike traditional glucose-control treatments, PS1 aims to preserve islet cell function and mass, with potential applications in Type 1, Type 2, and other forms of diabetes, while Pharmasaga plans to accelerate both clinical development and global licensing. More... (in Chinese) |
| HanchorBio applies for stock market listing, focuses on developing immunotherapy cancer drugs 24 November, 2025 The Taiwan Stock Exchange announced that HanchorBio (TW: 7827) has submitted its application for a primary listing on the Innovation Board in Taiwan. According to its prospectus summary, the company's main products focus on developing immunotherapy biologics for cancer treatment. HanchorBio operates multiple entities globally, including in Taipei, Taiwan; Hong Kong; California, USA; and Shanghai and Guangzhou, China. More... (in Chinese) |
| Genovate Biotechnology and NaviFUS report clinical progress in Australia 24 November, 2025 Genovate Biotechnology (TW: 4130) and its investee NaviFUS Biomed (TW: 6872) announced that their pre-market pilot study at Alfred Hospital in Australia using the NaviFUS focused navigation ultrasound system for drug-resistant epilepsy (DRE) successfully completed treatment of the first cohort. The Safety Monitoring Committee confirmed no major safety concerns and recommended advancing to the second cohort, which will receive more treatment sessions, while the two-stage trial design differs only in total session numbers. More... (in Chinese) |
| NatureWise Biotech & Medicals' new drug for melanoma granted Orphan Drug Designation by US FDA 24 November, 2025 NatureWise Biotech & Medicals (TW: 4732) announced that its subsidiary NovelWise Pharmaceutical's independently developed next-generation selective HDAC8 inhibitor NBM-BMX for the treatment of uveal melanoma (UM) has officially received Orphan Drug Designation from the US FDA. The company noted that uveal melanoma is a highly aggressive cancer with very limited effective treatments worldwide. NBM-BMX, by selectively inhibiting HDAC8, regulates tumor cell DNA repair and survival pathways, potentially delaying drug resistance and providing clinical benefit. More... (in Chinese) |
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