06/30 Taiwan BIO Weekly
2025-06-30 |
| Taiwan BIO Weekly |
| CMUH and Shine-On Biomedical Lead Taiwan's Push into Global Exosome-Based Precision Medicine Press release 26 June, 2025 The NextGen EV Therapeutics Forum, hosted by China Medical University and Healthcare System, bringing together leading scientists, clinical experts, and biotech industry leaders from Taiwan and the United States to explore the forefront of extracellular vesicle (EV) research and translation. The forum showcased emerging EV-based applications in oncology, neurodegenerative disorders, immune modulation, and regenerative medicine, highlighting the rapid advances toward clinical implementation. More... |
| Andros Pharmaceuticals' APC201 shows positive Phase II clinical results, initiates global licensing 26 June, 2025 Andros Pharmaceuticals (TW: 6917) announced on behalf of its subsidiary that the Phase I/IIa clinical trial of APC201, a new drug for local knee osteoarthritis pain, in Australia has obtained Phase II clinical trial results. Both primary and secondary efficacy endpoints were positive, demonstrating good overall drug safety and tolerability, with preliminary evidence of pain score improvement in participants. More... (in Chinese) |
| Aprinoia Therapeutics targets early diagnosis market for dementia 26 June, 2025 Seizing the early diagnosis market for dementia, Aprinoia Therapeutics stated that the presence of Tau protein is highly correlated with neural damage and disease progression, making it the gold standard for early diagnosis. The company's product APN-1607 can visualize Tau protein deposits in the brain and is currently undergoing regulatory filings in Taiwan, China, the United States, and Japan. Taiwan has the opportunity to become the first market to launch this product. More... (in Chinese) |
| Medigen Biotech teams up with Oncolys to co-develop OBP-301 for Japan marketing approval 25 June May, 2025 Medigen Biotech (TW: 3176) announced that it is co-developing a novel oncolytic virus drug, OBP-301, with Japan's Oncolys for the treatment of locally advanced esophageal cancer for Japan market approval, the goal being to submit the approval application by the end of this year. OBP-301 is an oncolytic virus therapeutic drug based on a genetically modified adenovirus type 5. It selectively targets cancer cells without harming normal cells, replicating specifically inside cancer cells to cause their lysis, thereby achieving the goal of killing cancer cells. More... (in Chinese) |
| Senhwa Biosciences announces plan to enter HIV treatment drug development 25 June, 2025 Senhwa Biosciences (TW: 6492) during a recent shareholders' meeting revealing multiple drug development plans for the future. Among them, the new formulation of Silmitasertib (CX-4945) has found a new indication for HIV. Senhwa Biosciences stated that since HIV patients currently require lifelong medication, if the CX-4945 strategy proves successful, it could bring hope of a cure to tens of millions of HIV-infected patients worldwide. More... (in Chinese) |
| EpiSonica's targeted ultrasonic scalpel receives approval in Indonesia and Thailand 25 June, 2025 EpiSonica announced that its flagship product, the targeted ultrasonic scalpel (ArcBlate MRgHIFU), has received marketing approval from Thailand's Food and Drug Administration (Thai FDA) for the treatment of adenomyosis and uterine fibroids. This follows the product's approval from Indonesia's Ministry of Health at the end of August last year. EpiSonica's ultrasonic scalpel utilizes Magnetic Resonance-guided High-Intensity Focused Ultrasound (MRgHIFU) technology. It is a new non-invasive treatment method that features no incisions, no radiation, and precise thermal ablation through accurate targeting. More... (in Chinese) |
| BoYen Therapeutics announces IPO and drug development updates 24 June, 2025 BoYen Therapeutics, a company focused on drug development and drug repositioning, announced the official launch of its initial public offering (IPO) plan. The company aims to apply for listing on the Emerging Stock Board, with Taiwan Cooperative Securities serving as the underwriter. At the same time, BoYen Therapeutics announced that its core R&D oral drug candidate for the treatment of multiple sclerosis (MS), BY-102, had previously signed a CDMO agreement with Japan's SPERA PHARMA. Formulation development and production were completed in June this year. The company is currently in discussions with an Australian clinical research organization (CRO) to initiate international clinical trials. More... (in Chinese) |
| Companies energized in developing new Alzheimer's Disease drugs 24 June, 2025 With the diagnosis of former National Taiwan University Hospital director Lin Fang-Yu with dementia bringing the condition to the forefront of local attention, Taiwan is entering a new era in dementia treatment, with multiple domestic corporate groups quietly advancing new dementia drugs and diagnostics. Additionally, the world's only two approved new dementia drugs were recently approved for Taiwanese patients. Uni-President Group's invested biopharmaceutical company, Merry Life Biomedical, has announced that its Alzheimer's Disease drug candidate, TML-6, received FDA approval for Phase II clinical trials in May this year. The Phase II trial, involving 210 participants over 12 months, will be conducted starting in the first quarter of 2026 across 19 medical institutions in the US, Sweden, Taiwan, and other countries. More... (in Chinese) |
| OBI Pharma files for Phase I/II clinical trial of new TROP2 ADC dug OBI-902 23 June, 2025 On June 23, 2025, OBI Pharma (TW: 4174) announced that it has submitted an application to Taiwan's Ministry of Health and Welfare (TFDA) for a Phase I/II human clinical trial of its new drug, OBI-902, a TROP2-targeting antibody-drug conjugate (ADC). OBI-902 is the first drug independently developed by OBI Pharma using its proprietary GlycOBI ADC platform technology. Designed to target TROP2, the ADC has demonstrated strong anti-tumor activity across multiple animal models. The upcoming Phase I/II clinical trial will evaluate the safety, pharmacokinetics, and efficacy of OBI-902 in patients with advanced solid tumors. More... (in Chinese) |
| Formosa Laboratories' one-stop service and ADC expertise achieve global expansion milestone 23 June, 2025 Formosa Laboratories (TW: 4746) has long focused on supplying active pharmaceutical ingredients (APIs), especially in the fields of polymers (cholesterol and phosphate binders) and Vitamin D products, securing a key position in the global market. Through years of resource investment in antibody-drug conjugate (ADC) research and development as well as contract manufacturing services, the company has gradually transformed into a globally competitive contract development and manufacturing organization (CDMO) with customers worldwide. In recent years, Formosa Laboratories has actively pursued vertical integration by establishing an injection product production line. Leveraging extensive experience in raw material procurement, process development and scale-up, and final formulation manufacturing, the company aims to provide clients with comprehensive one-stop services. More... (in Chinese) |
| ACRO Biomedical's collagen corneal stroma brings new option for corneal reconstruction surgery 23 June, 2025 ACRO Biomedical (TW: 6748) is focused on developing applications in tissue repair and regenerative medicine. Utilizing its key technology, supercritical carbon dioxide decellularization, the company develops advanced medical devices centered on natural collagen scaffolds. These devices have broad applications in orthopedics, dentistry, ophthalmology, neurosurgery, plastic surgery, and wound care, demonstrating strong clinical potential. This technology effectively removes cells and impurities from animal tissues without damaging the natural tissue structure, preserving the intact triple-helix collagen structure without the need for chemical crosslinking agents. The resulting scaffold offers high biocompatibility and good biodegradability, significantly reducing the risks of allergic and rejection reactions while providing an optimal microenvironment for tissue regeneration. More... (in Chinese) |
| TaiMed Biologics' TMB-365/380 HIV combo therapy enters Phase IIb Trial 22 June, 2025 TaiMed Biologics (TW: 4147) announced that it will officially launch the Phase IIb clinical trial of its combination therapy TMB-365/380. The trial will enroll 75 participants and run for 48 weeks. In addition to the United States, Taiwan will also be included as one of the trial sites, demonstrating the company's ambition for global expansion. More... (in Chinese) |
| SPARK Taiwan reveals a decade of transformative impact on Biomedical Innovation 20 June, 2025 SPARK Taiwan marks a decade of remarkable achievements in advancing the nation's biomedical industry by successfully adapting and expanding the U.S. Stanford SPARK translational model. Over the past ten years, SPARK Taiwan has catalyzed innovation, commercialization, and talent development, solidifying Taiwan's position as a rising global leader in biotechnology. More... |
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