10/27 Taiwan BIO Weekly
2025-10-27 |
| Taiwan BIO Weekly |
| Foxconn partners with Taipei hospital to enhance tech integration in healthcare 23 October, 2025 Foxconn has partnered with Taipei Veterans General Hospital to promote AI, robotics, and smart technologies in healthcare, aiming to create a leading smart hospital model in Taiwan. Hospital Director Chen Wei-ming and Foxconn Chair Young Liu signed the partnership agreement on Thursday, per CNA. Liu said the medical care industry is undergoing rapid transformation with the fast development of AI and robotics. He praised the hospital’s efforts in clinical medicine, smart healthcare, and research innovation, noting that these align with Foxconn's goal to strengthen technology applications in the sector. More... |
| Taiwan Precision Medicine Initiative (TPMI) publishes two research findings in Nature 22 October, 2025 The Taiwan Precision Medicine Initiative (TPMI), led by Academia Sinica in collaboration with 33 hospitals across 16 healthcare centers, has built the world's largest genetic and clinical database focused on the Han Chinese population, enrolling over 500,000 participants. Integrating genetic and medical data, the team has developed risk prediction models for diseases including diabetes, cardiovascular disease, autoimmune disorders, and cancer. This groundbreaking work is featured in two papers published simultaneously in the international journal Nature, highlighting both the establishment of the large-scale cohort and the application of biomedical big data to advance disease risk assessment. More... (in Chinese) |
| AnnJi Pharmaceutical's AJ201 granted US FDA Fast Track designation 22 October, 2025 AnnJi Pharmaceutical (TW: 7754) announced that the US FDA has granted Fast Track designation for AJ201, its investigational drug for treating spinal and bulbar muscular atrophy (SBMA, also known as Kennedy's disease). This designation allows AJ201 to benefit from more frequent FDA meetings and written communications, potential Accelerated Approval and Priority Review if relevant conditions are met, and the ability to submit NDA documents for rolling review during Phase III clinical trials, all of which can help accelerate future US drug approval timelines. More... (in Chinese) |
| SynbioTech Brings Taiwan's Biotech Excellence to the Global Stage with TWK10 for Muscle Performance and Healthy Aging Press release 22 October, 2025 In a field where scientific validation defines credibility, Synbio Tech Inc., a biotechnology company from Taiwan, is gaining international recognition with its proprietary probiotic Lactiplantibacillus plantarum TWK10. The clinically proven strain, which will be featured at SupplySide Global 2025 from October 27-30 (Booth #6253F), has shown measurable benefits on muscle strength, endurance, and balance--offering a new microbiome-based approach to healthy aging and active living. More... |
| Energenesis Biomedical applies for Phase II clinical trial for hereditary epidermolysis bullosa (EB) treatment 22 October, 2025 Energenesis Biomedical (TW: 6657) announced it has submitted a Phase II clinical trial application to the US FDA for its hereditary epidermolysis bullosa (EB) cream, F703EB. With no current cure for EB, F703EB's mechanism of action aims to accelerate wound healing, positioning it as a potential first-line therapy for this rare disease, which represents a US$2.4 billion global market. EB is a severe genetic skin disorder causing extreme fragility of skin and mucous membranes, leading to blistering, anemia, deformities, and life-threatening complications in severe cases. More... |
| TaiMed Biologics presents pioneering global results of immune cell–based ADC for HIV treatment 22 October, 2025 Taimed Biologics (TW: 4147) announced that the company presented its innovative immune cell-targeting antibody-drug conjugate (ADC) and its prospective results in HIV treatment at ID Week 2025, the annual global conference on infectious diseases. The company stated that its R&D team successfully developed the world's first TMB-365-ADC, a novel ADC demonstrating highly precise targeting of CD4 immune cells and significant antiviral activity, offering a new strategy for precision HIV therapy, functional cure, and long-term safety management. More... (in Chinese) |
| HanchorBio's new drug HCB101 granted US patent 22 October, 2025 HanchorBio (TW: 7827) announced that its independently-developed immunotherapy drug HCB101 has been officially granted a patent by the US Patent and Trademark Office (USPTO). The patent approval highlights the high originality of HanchorBio's R&D achievements and lays the foundation for future international licensing collaborations. HCB101 was developed using HanchorBio's proprietary multifunctional fusion protein platform. The molecule precisely regulates certain immune system functions to clear cancer cells and effectively overcome tumor immune evasion. More... (in Chinese) |
| Regenerative medicine dual regulations take effect next year; Bionet and Formosa Biomedical Technology accelerate deployment 21 October, 2025 Taiwan's dual regenerative medicine regulations are expected to take effect next year. For life-threatening or severely disabling conditions, therapies with Phase II clinical trial results could apply for provisional drug approval, effectively gaining early commercial access alongside standard treatments. Bionet (TW: 1784) and Formosa Biomedical Technology are accelerating their deployment strategies. Bionet leads under the Special Regulation framework with autologous adipose-derived stem cell therapies for degenerative arthritis, cartilage defects, chronic wounds, and soft tissue repair. Patient enrollment for degenerative arthritis is expected to exceed 200, supporting a potential provisional drug application. Its umbilical mesenchymal stem cell therapy for pulmonary fibrosis is in Phase II trials. Formosa Biomedical Technology's Ivy IKC immune cell therapy has completed Phase II trials for lung cancer, with GMP certification expected by year-end and a provisional application planned next year. More... (in Chinese) |
| Adimmune's Influenza, tetanus, and Enimmune's enterovirus vaccines listed on WHO Prequalification List 21 October, 2025 Adimmune (TW: 4142) announced that in September, the World Health Organization (WHO) released its global vaccine product list, with Adimmune's influenza vaccine, tetanus vaccine, and its subsidiary Enimmune's enterovirus vaccine all included. This WHO list serves as a procurement reference for countries to strengthen national and regional epidemic prevention capabilities, signaling that Adimmune has joined the global pandemic prevention supply chain and is accelerating its international expansion. According to Adimmune's press release, the WHO's latest vaccine product list includes over 1,000 globally available vaccines. The list aims to provide insight into vaccine demand, supply, and price fluctuations, helping countries assess affordability and shortage risks. This initiative seeks to enhance national and regional capacities, improve vaccine accessibility, and support WHO goals of global health promotion and increased vaccine coverage. More... (in Chinese) |
| TWi Biotechnology submits new antidepressant drug application to the US FDA 20 October, 2025 TWi Biotechnology (TW: 6610) announced that its oral prodrug candidate NORA520, developed for the treatment of postpartum depression (PPD) and major depressive disorder (MDD), completed a Type C meeting with the US FDA in September, and received the official meeting minutes on October 16. The FDA agreed that if the results of the Phase II clinical trial meet expectations, they could serve as a pivotal trial submission, marking a key milestone in the drug’s clinical development. More... (in Chinese) |
| PharmaEngine's new drug PEP08 begins Phase I clinical trial with first patient dosed 20 October, 2025 PharmaEngine (TW: 4162) has initiated dosing of the first patient in the Phase I clinical trial for its investigational new drug PEP08 in solid tumors. PEP08 is a second-generation PRMT5 inhibitor. PRMT5 plays a critical role in maintaining cell survival, including gene replication, cell growth, DNA damage response, and immune regulation, making it a promising target for cancer therapy. Compared with first-generation PRMT5 inhibitors, PEP08 selectively targets tumor cells with MTAP gene deletion, exploiting synthetic lethality to inhibit PRMT5 function without affecting normal cell growth. This selectivity results in lower toxicity and improved safety compared with first-generation inhibitors. More... (in Chinese) |
| YD Bio Ltd. Rings Nasdaq Opening Bell to Celebrate Listing under Ticker YDES Press release 20 October, 2025 [Taiwan's] YD Bio Limited (NasdaqGM: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today rang the Opening Bell at Nasdaq MarketSite in New York to celebrate its public listing on the Nasdaq Global Market. This milestone strengthens YD Bio's capital base, elevates its global profile and accelerates the commercialization of its next-generation diagnostic and regenerative medicine platforms. More... |
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