06/29 Taiwan BIO Weekly
2026-06-29 |
| Taiwan BIO Weekly |
| TBIO Secretary General Wallace Lin elected ICBA Chair 26 June, 2026 The Taiwan Bio Industry Organization (Taiwan BIO) is pleased to announce that Secretary General Wallace Lin has been elected Chair of the International Council of Biotechnology Associations (ICBA) by its member organizations. The election took place during the annual BIO Convention currently being held in San Diego, USA. Lin becomes the first representative from Taiwan to assume this position, underscoring the growing standing of Taiwan's biotechnology industry and its continued international recognition. More... |
| BoYen Therapeutics files Australian Phase I clinical trial application for BYT-1007 18 June, 2026 BoYen Therapeutics (TW: 7891) has submitted a Phase I clinical trial application in Australia to the Human Research Ethics Committee (HREC) for its oral investigational drug BYT-1007. Upon regulatory approval, the company plans to begin enrolling acute myeloid leukemia (AML) patients at The Alfred Hospital in Melbourne in the third quarter of 2026 to assess the drug's safety and tolerability. BYT-1007 is a multi-purpose oral small-molecule candidate developed using a prodrug and drug repositioning strategy, with potential applications in hematologic cancers and neuroimmune diseases. More... (in Chinese) |
| Taiwan Bio Therapeutics approves private placement capital increase to advance cell therapy drug and CDMO strategy 25 June, 2026 Taiwan Bio Therapeutics (TW: 6892) at its recent AGM said it will continue advancing its cell therapy pipeline and expanding its CDMO business while strengthening strategic partnerships in the US and Japan, following shareholder approval of a private placement capital increase of up to 30,000 units. Although 2025 performance fell short of expectations, the company reported progress in R&D and international expansion, including Taiwan approval to initiate Phase III enrollment for its knee osteoarthritis cell therapy Chondrochymal and the full acquisition of US-based TRACT, securing global IP rights for its regulatory T-cell therapy candidate TRK-001. More... (in Chinese) |
| U-Neuron Biomedical completes Phase IIa enrollment for amniotic stem cell therapy for erectile dysfunction 25 June, 2026 U-Neuron Biomedical (TW: 6973) announced on the 24th of June that its Phase IIa clinical trial of the allogeneic amniotic fluid stem cell drug UA002, for the treatment of male erectile dysfunction (ED) unresponsive to oral medications, has completed enrollment of the last patient (Last Patient In, LPI). All enrolled subjects have completed one-month post-dosing safety follow-up assessments and meet evaluable criteria, with key interim data expected to be analyzed by the end of 2026. More... (in Chinese) |
| Tanvex BioPharma receives US FDA information request for breast cancer biosimilar 25 June, 2026 Tanvex BioPharma (TW: 6541) announced that its US marketing authorization application for the breast cancer biosimilar TX05 has completed the current review cycle by the US FDA. However, the US FDA has requested that the contract manufacturing organization (CMO) responsible for drug product formulation make facility improvements and submit additional information before approval can be granted. The company said the US FDA's review did not raise any concerns related to the safety, efficacy, or biosimilarity of TX05, nor did it identify any deficiencies or required improvements at Tanvex's drug substance manufacturing facilities. More... (in Chinese) |
| AnnJi Pharmaceutical's AJ201 showcased at BIO, Kennedy's disease drug advances to Phase III 25 June, 2026 AnnJi Pharmaceutical (TW: 7754) showcased its first-in-class small-molecule drug AJ201 for Kennedy's disease at BIO 2026, held in San Diego, June 22 to 25, focusing on advancing global licensing discussions and expanding its HDAC6 inhibitor pipeline. AJ201, which has shown favorable safety and tolerability as well as positive signals in Phase II trials, is expected to initiate multinational Phase III patient enrollment in the second half of 2026. The company continues to target unmet medical needs in global markets and is leveraging strong patient engagement to support trial recruitment and accelerate development progress. More... (in Chinese) |
| Vacino Biotech selected for BIO start-up competition, showcases brain drug delivery platform 23 June, 2026 At this year's BIO International Convention in San Diego, 49 biotech startups and teams from around the world were selected to deliver pitches at the BIO Start-up Stadium, with only three companies from Asia making the shortlist. Taiwan's sole representative, Vacino Biotech, was personally represented on the international stage by founder Dr. Jia-Ming Chang, where he showcased the company's breakthrough brain drug delivery platform designed to overcome the blood-brain barrier (BBB). The presentation drew strong attention from on-site judges and industry experts, and it is reported that two venture capital firms have already expressed interest in investing after the event. More... (in Chinese) |
| AnHorn Medicines CEO: Taiwan has the capability to participate in global AI-driven drug innovation 23 June, 2026 AnHorn Medicines, an AI-driven drug discovery company, participated in the BIO International Convention, where CEO Dr. Lin Chu-Chiang highlighted Taiwan's strength in translating AI capabilities into globally competitive new drug development, describing the company as part of Taiwan's "AI New Drug National Team." Founded in 2020, AnHorn has built an AI-powered drug discovery platform and advanced two first-in-class drug candidates into clinical development, including AH-001, a protein degradation-based therapy for androgenic alopecia that targets the disease's underlying cause and has the potential to provide a safer, disease-modifying treatment for both men and women. More... (in Chinese) |
| GlycoNex launches Phase I clinical trial for ADC drug candidate 23 June, 2026 GlycoNex Pharmaceuticals (TW: 4168) announced that its first-in-class anti-glycan antibody-drug conjugate (ADC) candidate, GNX1021, has entered the execution phase of its multinational Phase I clinical trial following Taiwan FDA approval, with patient enrollment expected to begin in the third quarter of 2026. With regulatory and IRB approvals in Japan already secured, the company will conduct the study concurrently in Taiwan and Japan to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of GNX1021 in patients with advanced gastrointestinal cancers, while determining the recommended dose for future clinical development. More... (in Chinese) |
| Taiwan Biotech Delegation Heads to BIO 2026 to Advance Global Partnerships and Innovation 22 June, 2026 Taiwan is showcasing the strength of its biotechnology ecosystem at BIO International Convention 2026 in San Diego from June 22-25, bringing together 33 biotechnology companies and more than 40 innovative technologies as it seeks to deepen global partnerships, attract investment and reinforce its position as one of Asia's leading biotechnology hubs. More... |
| 2026 Taiwan Biotech Forum Shines in San Diego, Spotlighting Precision Medicine Innovations 22 June, 2026 On June 21, 2026, the highly anticipated Taiwan Biotech Forum officially opened its doors in San Diego, shedding a bright light on the future of healthcare. Hosted by the Development Center for Biotechnology (DCB), primarily sponsored by the Department of Industrial Technology (DoIT), and co-organized with GeneOnline and Biocom, the event focused deeply on "Innovative Therapeutic Modalities in Precision Medicine". More... |
| Steminent Biotherapeutics submits Japanese manufacturing and marketing approval application for Stemchymal cell therapy 21 June, 2026 Steminent Biotherapeutics (TW: 7729) announced that its stem cell therapy candidate Stemchymal has entered the Japanese regulatory review process through a submitted application for a Marketing Authorization Holder (MAH) license. The application, filed via its partner REPROCELL to Japan's Kanagawa Prefectural Government, marks a key step toward potential conditional approval and future commercialization of the therapy in Japan. The review is expected to take about three months, with approval potentially coming as early as the third quarter of this year, advancing Steminent's efforts to bring Stemchymal closer to market. More... (in Chinese) |
| TAHO Pharmaceuticals resubmits TAH3311 antithrombotic oral film NDA to the US FDA, aims for launch next year 21 June, 2026 TAHO Pharmaceuticals (TW: 6467) announced on the 20th of June that its 505(b)(2) novel dosage form drug TAH3311 antithrombotic oral film has resubmitted a New Drug Application (NDA) to the US FDA. The company aims to launch the product in the US by mid-next year, targeting a potential market opportunity worth US$29.2 billion. In addition, TAH3311 was also submitted for regulatory approval in the European Union in the second half of last year, with approval in the EU potentially arriving in the third quarter of this year, possibly ahead of the US authorization. More... (in Chinese) |
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| 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) ========================================= |