11/04 Taiwan BIO Weekly
2025-11-04 |
| Taiwan BIO Weekly |
| Genomics signs MOU to advance new drug development 30 October, 2025 Genomics (TW: 4195) announced it has signed a tripartite MOU with Japan's Nippon Fine Chemical and its Taiwan subsidiary, Zillion Fine Chemicals, to jointly develop nucleic acid and pharmaceutical process technologies. The collaboration combines Genomics' expertise in gene sequencing and short-chain nucleic acid manufacturing, Nippon Fine Chemical's strength in lipid nanoparticle (LNP) formulation, and Zillion Fine Chemicals’ integration and market network to establish a one-stop platform from R&D to clinical application, aiming to accelerate innovative drug development and expand into global markets. More... (in Chinese) |
| AnHorn Medicines' AH-001 completes US Phase I clinical trial 30 October, 2025 AnHorn Medicines has successfully completed a US Phase I clinical trial for its AI-designed candidate drug AH-001. The trial showed that all dose groups were well-tolerated with no drug-related adverse events, marking Taiwan's first AI-generated drug to pass human clinical testing and validating the company's AI platform for efficient and clinically feasible drug design. AH-001 is a novel small-molecule protein degrader administered topically, selectively targeting androgen receptors (AR) involved in male pattern hair loss to block the underlying pathological mechanism. Preclinical studies demonstrated strong safety and efficacy potential, and the Phase I trial confirmed good local tolerability in both healthy volunteers and patients with hair loss, avoiding systemic side effects such as sexual dysfunction or hormonal imbalance. More... (in Chinese) |
| Repurgenesis partners with Altos Computing to build AI drug development platform 30 October, 2025 Repurgenesis, a wholly owned subsidiary of Energenesis Biomedical (TW: 6657), has officially signed a collaboration agreement with Altos Computing. The two companies will jointly develop a next-generation, high-performance AI drug development platform to accelerate the application and industrialization of precision and smart medicine, creating new cross-industry business opportunities. Energenesis Biomedical noted that to strengthen its presence in AI drug development and enhance competitiveness, it established the wholly owned subsidiary Repurgenesis in August, appointing Dr. Hsu Yin-Hsong, a leading domestic AI expert, as General Manager. More... (in Chinese) |
| TAHO Pharmaceuticals' new antithrombotic orally dissolving film drug seeks EMA authorization 30 October, 2025 TAHO Pharmaceuticals (TW: 6467) announced that it officially submitted a European marketing authorization application to the European Medicines Agency (EMA) on October 30 for its new antithrombotic orally dissolving film drug, TAH3311. TAH3311 is the world's first orally-dissolving film formulation using apixaban as the active ingredient. While apixaban is currently the world’s best-selling anticoagulant, it has only been available in tablet form, which can be inconvenient for elderly patients, children, or stroke patients with swallowing difficulties. More... (in Chinese) |
| Tainan demonstrates advances in AI-driven healthcare 29 October, 2025 The digital ministry brought hospitals and tech companies together in Tainan on Tuesday to find real-world uses for AI in healthcare and rehab, CNA reported. The event was called "Demo Day" and took place at National Cheng Kung University. Eight companies demonstrated tools such as group fitness software, smart care aids, fitness testing systems, and AI-driven dental imaging devices. More... |
| Taiwan talks evidence-driven TCM at CPHI Frankfurt 29 October, 2025 At CPHI Frankfurt 2025, speakers from Taiwan spotlighted its evidence?driven traditional Chinese medicine (TCM) ecosystem, backed by universal insurance coverage and a growing base of GMP?certified manufacturers, and invited partners to explore materials supply and OEM opportunities. More... |
| GlycoNex Announces Last Patient Dosed in Phase III Trial of SPD8, a Denosumab Biosimilar for Osteoporosis Press release 29 October, 2025 GlycoNex, Inc. (TW: 4168), announced that the last patient has received the final dose in its Phase III clinical study of SPD8, a biosimilar to denosumab for the treatment of osteoporosis. Developed in collaboration with Mitsubishi Gas Chemical (MGC), SPD8 is designed to address complications associated with bone metastases in patients with solid tumors and osteoporosis-related conditions. Dosing of the final patient marks a significant milestone for the program, positioning GNX to report top-line results from the study in the second quarter of 2026. More... |
| Serum made by Taiwan scientists regrows hair in 20 days in mice study 28 October, 2025 A topical serum developed by Taiwanese researchers has shown potential as a treatment for baldness after it restored hair in laboratory mice within 20 days. A research team at National Taiwan University, led by Lin Sung-jan from the Department of Biomedical Engineering, published a study on Oct. 22 demonstrating the serum's efficacy, per New Scientist. The mechanism for hair growth is naturally derived fatty acids that stimulate hair follicles. More... |
| AnBogen Therapeutics' ABT-301 receives clinical trial approval in US, Australia, and Taiwan 28 October, 2025 AnBogen Therapeutics (TW: 7784) announced that its orally administered HDAC1/2/3 inhibitor ABT-301, in combination with tislelizumab and bevacizumab, has received clinical trial approvals in the US, Australia, and Taiwan. Following US FDA IND clearance in July for Phase I/II trials in advanced metastatic colorectal cancer (mCRC), the therapy obtained clinical trial approvals from the Australian TGA and Taiwan TFDA in September and October respectively, with patient enrollment already underway in Australia. More... (in Chinese) |
| EirGenix's breast cancer biosimilar receives TFDA approval 28 October, 2025 EirGenix (TW: 6589) announced that its breast cancer biosimilar EIRGASUN (Yikangping) has received Taiwan Food and Drug Administration (TFDA) approval for the 420 mg dose, following the 150 mg approval in 2023. The drug is indicated for early HER2-positive breast cancer, metastatic breast cancer, and metastatic gastric cancer. EirGenix noted that EIRGASUN, a biosimilar of Roche's Herceptin (trastuzumab), has completed all required development and regulatory approvals in Taiwan, and the company is now preparing for local launch. According to Roche’s 2024 financial report, Herceptin achieved 1.38 billion Swiss francs in global sales, with 41% from European and US markets. More... (in Chinese) |
| Primo Biotechnology partners with GE Healthcare to develop radiopharmaceuticals 28 October, 2025 Primo Biotechnology announced a formal partnership with GE Healthcare to develop radiopharmaceuticals, covering licensing, R&D, technology transfer, and manufacturing. Under the agreement, GE's new radiopharmaceuticals will be prioritized for development, production, and sales by Primo Biotechnology in Taiwan, while jointly developed drugs will be supplied first to GE customers, aiming to bring innovative treatments to Taiwan's healthcare system. The collaboration builds on interactions since 2023, when Primo Biotechnology and GE introduced advanced radiopharmaceutical equipment and established a PIC/S GMP-compliant facility, laying the foundation for automated manufacturing and talent exchange in radiopharmaceuticals. More... (in Chinese) |
| Bora Pharmaceuticals reports success as its injectable drug factory reaches full-scale production 28 October, 2025 Bora Pharmaceuticals (TW: 6472) has launched commercial production at its Maryland, US, injectable facility with the new Groninger FlexPro 50 isolator line for vials and prefilled syringes. The state-of-the-art production line expands Bora's high-efficiency sterile filling capabilities, marking a key milestone in its global sterile formulation and CDMO operations. Built using Germany's Groninger precision automated systems, the line employs next-generation isolator technology to perform drug filling in an ultra-clean environment, minimizing contamination risks and ensuring stable, reliable production. More... (in Chinese) |
| Taiwan Biotechnology Industry Organization's 18th General Assembly draws 400 biotech professionals 27 October, 2025 The 2nd 18th General Assembly of Taiwan Bio Industry Organization, co-organized by PwC Taiwan, was held on October 14, 2025 at the NTUH International Convention Center, where the event drew nearly 400 professionals from the biotech sector. The day time forum featured insightful discussions on "Current Status and Trends in Global Digital Biomedicine" and "U.S. Reciprocal Tariffs and Most-Favored-Nation Drug Policy Analysis", and twi focus panel discussions on "The Value of Data and AI Applications in Biomedicine" and "Building Resilience in Taiwan's Biotech Financial Chain". More... |
| Anxo Pharmaceutical launches Taiwan's first generic oral drug for acne 27 October, 2025 Anxo Pharmaceutical (TW: 6677), a specialist in advanced drug delivery technologies, announced that its anti-acne drug has received market approval from Taiwan's TFDA. The product is not only Anxo Pharmaceutical's first approval based on its biphasic soft capsule platform but also Taiwan's first generic oral isotretinoin capsule. Co-developed with Sunny Pharmtech (TW: 6676), with Anxo Pharmaceutical in charge of formulation and marketing authorization and Sunny handling manufacturing, the product is set for official launch in the first half of next year through dermatology distributors in Taiwan. Anxo Pharmaceutical is also seeking partners in Southeast Asia to expand its overseas presence in the growing acne treatment market. More... (in Chinese) |
| TaiGen Biotechnology's new influenza drug approved to start pediatric Phase III clinical trial 27 October, 2025 TaiGen Biotechnology (TW: 4157) announced that its partner in China, Joincare Pharmaceutical Group, has received NMPA CDE approval for the pediatric formulation of the influenza antiviral Pixavir marboxil (TG-1000), allowing the drug to skip Phase II and proceed directly to Phase III trials. The oral suspension Phase III study will compare Pixavir with Oseltamivir in children aged 2–12 with influenza, assessing efficacy, safety, and pharmacokinetics. Enrollment is expected to complete this winter, with trial completion targeted in 2026 to support final marketing approval. More... (in Chinese) |
| Lumosa Therapeutics to start Phase III trial for stroke drug next year 27 October, 2025 Lumosa Therapeutics (TW: 6535), a key subsidiary of Center Laboratories (TW: 4123), recently reported Phase II results for its stroke drug LT3001 in China, though its stock hit the daily limit down for two consecutive days. Lumosa Therapeutics stated that Phase III trials in China are expected to start in 2026, aiming for completion in 2029 and potential market launch in 2030, with possible licensing opportunities in Europe and the US. Center Laboratories currently holds about 35% of Lumosa Therapeutics, making it the largest single shareholder. More... (in Chinese) |
| Pharmosa Biopharm debuts L608, first at-home treatment for SSc-DU, at American College of Rheumatology meeting 27 October, 2025 Pharmosa Biopharm (TW: 6875) presented Phase I data for its inhaled drug L608 (liposomal iloprost) at the 2025 American College of Rheumatology Annual Meeting. The results demonstrated strong safety and tolerability, with breakthrough pharmacokinetic advantages, positioning L608 as a potential first-in-class therapy for systemic sclerosis–related digital ulcers (SSc-DU), a condition with no approved US treatments. The company mentioned that L608, granted FDA orphan drug designation, could benefit from market exclusivity, tax credits, and accelerated review, as Pharmosa Biopharm accelerates further clinical trials to become the first US-approved therapy for SSc-DU, addressing unmet patient needs in this rare autoimmune disease. More... (in Chinese) |
| AusBiotech and Taiwan BIO sign MoU to strengthen global life sciences collaboration 27 October, 2025 AusBiotech, Australia's peak industry body representing more than 3,000 life sciences members, has formalised a new partnership with the Taiwan Bio Industry Organization (Taiwan BIO), which represents Taiwan's innovative life sciences and biotechnology sector and works to connect the Asian ecosystem globally to drive impactful innovation. More... |
| Taiwan Bio Therapeutics reports positive results from Phase II clinical trial 26 October, 2025 Taiwan Bio Therapeutics (TW: 6892) announced a major milestone for its regulatory T-cell (Treg) therapy TRK-001, having completed first-patient enrollment in a Phase II clinical trial at Northwestern Memorial Hospital in the US, positioning the company among global leaders in Treg-based clinical development. The company noted that this year's Nobel Prize in Physiology or Medicine honored three immunologists for their discoveries related to regulatory T-cells, underscoring the therapy's growing significance in advancing treatments for autoimmune diseases, cancer, and organ transplantation. More... (in Chinese) |
| 3D Global Biotech to build new US facility 26 October, 2025 3D Global Biotech (TW: 6808), a spin-off of Taipei Medical University, announced that its board has approved establishing a wholly owned subsidiary in San Diego, California, with a US$7 million investment to build a cell GMP manufacturing facility meeting US FDA standards. The new plant is expected to be completed by Q3 next year, with certification sought by year-end, marking the company's entry into the global regenerative medicine market. The company noted that the US is a key hub for regenerative medicine and cell therapy innovation. More... (in Chinese) |
| ========================================= |
| Taiwan Bio Industry Organization (Taiwan BIO) Tel: +886 2 27836028 Fax: +886 2 27836027 Email: biotaiwan@gmail.com BIO Asia-Taiwan 2026 (15-19 July, 2026) ========================================= Taiwan Bio Industry Organization (Taiwan BIO) Room C229, 2F, Bldg. C, No. 99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |