1/5 Taiwan BIO Weekly
2026-01-05 |
| Taiwan BIO Weekly |
| Regenerative medicine dual acts officially take effect, local firms poised to benefit 1 January, 2026 The Regenerative Medicine Act and the Regenerative Medicine Products Management Act officially took effect today, marking a major regulatory easing for Taiwan's regenerative medicine industry. With clearer rules and pathways, regenerative medicinal products are expected to reach the market faster, pushing the sector toward greater institutionalization and scale. Biotech companies are seizing the opportunity created by the dual laws to accelerate commercialization and capture emerging market opportunities. Several companies are already positioning for growth under the new laws. MetaTech (TW: 3224) raised NT$365 million via private placement to fund expansion in regenerative medicine. Lukas Biomedical (TW: 6814) is advancing its liver cancer cell therapy LuLym-T in Phase II trials and may be among the first to receive conditional approval. U-Neuron Biomedical (TW: 6973) has obtained dual fast-track designations for its amniotic fluid stem cell therapy UA002, potentially accelerating development and approval. Bionet (TW: 1784) is leveraging accumulated clinical data and compliance advantages, with 73 approved cell therapy programs, and its mesenchymal stem cell-derived exosomes have gained cosmetic ingredient approvals and international INCI names, enabling market access in Southeast Asia and Latin America. More... (in Chinese) |
| Microbio targets international markets 30 December, 2025 Microbio (TW: 4128) intends to focus on international commercialization of its Symbiota series next year, expanding from drugs into healthcare, personal care, and medical device markets. The company is planning to leverage existing clinical data to pursue global partnerships and licensing, targeting oncology and ulcerative colitis. Core product MS-20 has shown efficacy in reducing chemotherapy side effects, improving response in late-stage NSCLC, and increasing ulcerative colitis remission rates. MB701 received US FDA cosmetic approval, signaling readiness for international commercialization. Microbio is planning to adopt a diversified strategy across drugs, medical devices, cosmetics, medical foods, and health products, while pursuing Southeast Asian GMP and Halal certifications. First three-quarter revenue reached NT$1.383 billion, gross profit NT$536 million, both up over 10% YoY, with a net loss of NT$845 million (EPS -1.23). More... (in Chinese) |
| Steminent Biotherapeutics to apply for Japanese approval of stem cell drug Press release 30 December, 2025 Ahead of the planned implementation of Taiwan's Regenerative Medicine dual acts in 2026, Steminent Biotherapeutics (TW: 7729) said the company's flagship orphan stem cell product, Stemchymal, is undergoing pre-submission consultations with Japan's PMDA together with licensing partner REPROCELL. Steminent Biotherapeutics aims to become Taiwan's first cell therapy to expand overseas, while advancing regulatory plans in both Taiwan and Japan to accelerate treatment options for patients with spinocerebellar ataxia (SCA). Discussions with partners include the design of a Phase III clinical trial in Japan and a treatment and reimbursement plan under Japan's conditional approval system, with a formal submission targeted for the first quarter of 2026. Beyond Japan, Steminent Biotherapeutics is pursuing licensing opportunities in Southeast Asia, the Middle East, and South Korea, while the SNQ national quality award and certification for Stemchymal are expected to support future regulatory approvals and global market expansion. More... (in Chinese) |
| Senhwa Biosciences' CX-5461 to combine with blockbuster ADC drug to target global market 29 December, 2025 Senhwa Biosciences (TW: 6492) announced that its novel drug Pidnarulex (CX-5461) will be tested in combination with the blockbuster antibody-drug conjugate (ADC) trastuzumab deruxtecan (Enhertu) in a Phase Ib clinical trial. The study will target patients with HER2-positive solid tumors and breast cancer, with a particular focus on HER2-low expression and metastatic breast cancer. Supported by the US National Cancer Institute's NCI-NExT program, the trial marks CX-5461's entry into the fast-growing ADC therapeutic landscape. CX-5461 is the world's first and most advanced G-quadruplex (G4) stabilizer in clinical development and has previously shown therapeutic potential across multiple solid tumors, including breast cancer. The combination with Enhertu--co-developed by AstraZeneca and Daiichi Sankyo and the first approved ADC for HER2-low metastatic breast cancer--is expected to expand treatment options for patients with limited therapies. Meanwhile, the global ADC market is growing at a 28.4% CAGR and is projected to exceed US$47 billion by 2029. More... (in Chinese) |
| Mycenax Biotech becomes international commercial biologics supplier, builds plant in Japan 29 December, 2025 Mycenax Biotech (TW: 4726) marked 2025 as a milestone year in its globalization efforts, becoming a supplier for two internationally marketed drugs and establishing a joint venture, Alfenax, with three major Japanese partners including Alfresa to build a biopharmaceutical facility in Akita, Japan. With regulatory approvals progressing, Mycenax's first GMP plant has entered commercial-scale production of marketed biologics, transforming the company from a development-focused CDMO into a full-service CDMO capable of supplying international commercial drugs. Stable commercial production is expected to contribute substantial recurring revenue from late 2025, enhancing operational stability and visibility. In emerging biologics, Mycenax has expanded its ADC (antibody-drug conjugate) business since 2021, securing exclusive licensing of VLK linker technology from Japan's RIN Institute alongside its in-house technology. The Akita plant will focus on CMO manufacturing, with process development feeding back to Taiwan, further driving revenue and project momentum. Leveraging international-grade manufacturing capabilities and Japan as a strategic hub, Mycenax aims to strengthen global partnerships and expand its service capacity, positioning itself as a leading Bio-CDMO company. More... (in Chinese) |
| MegaPro Biomedical's anti-cancer drug MPB-1734 completes Phase I/IIa clinical trial 29 December, 2025 MegaPro Biomedical (TW: 6827) announced that the clinical Phase I/IIa trial report for its self-developed anti-cancer drug MPB-1734 (Tween-80-free Cabazitaxel) was approved for filing by Taiwan's Ministry of Health and Welfare on December 26. Following a meeting with the US FDA in May, MegaPro Biomedical confirmed that MPB-1734 could pursue regulatory approval via the 505(b)(2) pathway using a bioequivalence (BE) study, potentially shortening development timelines. Process scale-up and optimization are underway, with BE study design to be finalized with the US FDA next year to accelerate the approval process. According to Global Market Insights 2024, the prostate cancer drug market is currently valued at US$12.6 billion and is projected to reach US$29.9 billion by 2034. MPB-1734's Tween-80-free formulation reduces side effects and improves tolerability, positioning it for rapid market uptake. The company emphasized that it will continue leveraging its nano-microparticle platform to optimize hydrophobic drug formulations and work to accelerate regulatory approval for its other products. More... (in Chinese) |
| Taiwan's smart healthcare value chain is years ahead of global peers: Here's why 29 December, 2025 A defining feature of Taiwan's model is its ability to move AI from research environments into routine clinical use. Many countries produce world-class medical AI research but struggle to translate it into deployed systems. This study shows how Taiwan narrowed this gap by positioning universities and teaching hospitals as central nodes in the innovation pipeline. More... |
| Protect Animal Health's dual track strategy targets billion-dollar pet healthcare market 28 December, 2025 Protect Animal Health (TW: 7850) has unveiled its dual-track strategy to capture the rapidly growing global pet healthcare market. One track leverages the AIRS and AIOT product lines to quickly address high-return treatment areas and shorten time-to-market. The other builds its proprietary AIDE antibody platform for dogs and cats as a long-term value engine, enabling future development or licensing opportunities. The global pet healthcare market is projected to grow at an 8-10% CAGR, reaching hundreds of billions (NTD) in value. The company's three core platforms include AIRS for canine gene therapy, targeting common heart diseases (market >US$6B); AIOT for canine cancer immunotherapy (market >US$3B); and AIDE, a versatile antibody platform for multiple disease areas. This multi-platform approach differentiates Protect Animal Health from competitors focused on single areas, mitigates development risk, and creates synergistic potential to aggressively enter the global pet healthcare market. More... (in Chinese) |
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