09/14 Taiwan BIO Weekly
2026-09-14 |
| Taiwan BIO Weekly |
| Formosa Pharmaceuticals to Initiate Clinical Trials of TSY-110 While Advancing Licensing Discussions 10 September, 2026 Formosa Pharmaceuticals (TW: 6838) has resumed production and shipments of BYQLOVI, with Taiwan self-pay sales expected to begin in late September and continued deliveries to the US and Canada. Its ADC biosimilar TSY-110 has been submitted for a CTA, with clinical trials targeted to begin this year, while the company pursues licensing opportunities in major markets. Its bispecific ADC candidate TSY-310 is expected to enter clinical development by the end of next year. More... (in Chinese) |
| EirGenix Expands CDMO Capabilities to Capture Opportunities from Regulatory Changes 10 September, 2026 Amid biosimilar regulatory changes overseas, EirGenix (TW: 6589) is expected to see renewed growth in its CDMO business. The company continues to expand capacity and strengthen its end-to-end capabilities, with analysts expecting double-digit annual CDMO growth from this year. Meanwhile, its proprietary products are expected to gain regulatory approvals, supporting both businesses and improving capacity utilization. More... (in Chinese) |
| Applied BioCode's Revenue Rises 70%, In Vitro Diagnostics Enters High-Growth Phase 10 September, 2026 Applied BioCode (TW: 6598) reported August revenue of NT$61 million, bringing first-eight-month revenue to NT$530 million, up 70% year on year and exceeding total revenue for all of last year. The company expects continued expansion of the in vitro diagnostics market to drive growth, while seasonal demand for respiratory infection testing in the Northern Hemisphere's fall and winter is expected to boost sales of its multiplex molecular respiratory testing products. More... (in Chinese) |
| Andros Pharmaceuticals Signs MOU with China's BIONNA Medicine to Collaborate on Topical Formulation Market 10 September, 2026 Andros Pharmaceuticals (TW: 6917) has signed an MOU with China's BIONNA Medicine to collaborate on novel topical formulations, combining Andros Pharmaceuticals' formulation development expertise with BIONNA Medicine's clinical, regulatory, and commercialization resources in China. The companies will evaluate opportunities for technology development, clinical validation, and commercialization, including niche generic drugs and novel dosage-form products. More... (in Chinese) |
| Medigen Vaccine Biologics Develops New Enterovirus Vaccine 9 September, 2026 Medigen Vaccine Biologics (TW: 6547) is developing a next-generation multivalent enterovirus vaccine based on its existing monovalent EV71 vaccine, with Charles River Laboratories handling key overseas CMC activities and Taiwan Bio-Manufacturing Corporation and TFBS Bioscience supporting domestic antigen manufacturing process development at BSL-2 facilities. The company is establishing analytical methods, regulatory documentation, and manufacturing conditions from the early development stage to facilitate a smooth transition to clinical trials and commercial-scale production. More... (in Chinese) |
| Synmosa Biopharma's August Revenue Rises 50% YoY, Hormone Plant Passes PMDA Inspection 8 September, 2026 Synmosa Biopharma (TW: 4114) reported August 2026 revenue of NT$750 million, up 50% year on year, bringing January-August revenue to NT$5.096 billion, up 26%. Oncology, cardiovascular and metabolic, and women's healthcare products grew 43%, 48%, and 23%, respectively. The company recently secured a Vietnam distribution partnership, while its hormone plant passed a Japan PMDA inspection, supporting further Asian expansion. Allergic rhinitis nasal spray sales rose 21% in August, with a key product growing 61%, while its combination therapy received a priority recommendation in the latest ARIA guidelines. More... (in Chinese) |
| Lin BioScience's Belite Bio Ophthalmic Drug Advances on Dual US and Japan Approval Tracks 8 September, 2026 Lin BioScience (TW: 6696), through its subsidiary Belite Bio, has submitted a New Drug Application (NDA) in Japan for Tinlarebant (LBS-008) to treat Stargardt disease (STGD1). The drug has received Japan's SAKIGAKE designation and is expected to undergo accelerated review, while its U.S. NDA has already been accepted with a PDUFA target action date of February 12, 2027. With no treatments currently approved for STGD1 worldwide, Tinlarebant could become the world's first approved treatment for the disease. More... (in Chinese) |
| Taiwan's HORIEN Accelerates Global Footprint: Achieves Three Thai FDA Class 4 Approvals and Secures US Patent for Biodegradable Ureteral Stent Press release 8 September, 2026 HORIEN Biochemical Technology Co., Ltd. (TW: 7814) today announced a major double milestone in its global expansion strategy: the formal entry into the Thai market following Thai Food and Drug Administration (Thai FDA) Class 4 approvals for three advanced regenerative medical devices, alongside securing a prestigious U.S. invention patent for its innovative biodegradable ureteral stent. More... |
| TAHO's Antithrombotic Drug Nears US Market Launch 7 September, 2026 TAHO Pharmaceuticals (TW: 6467) announced on the 6th of September that its flagship drug, the antithrombotic orally dissolving film BEQIA (TAH3311), has received confirmation from the US FDA that its New Drug Application (NDA) has been accepted and formally entered the standard review process. Under the Prescription Drug User Fee Act (PDUFA), the target action date is April 22, 2027, marking another major milestone toward BEQIA's US market launch. More... (in Chinese) |
| HANDA Pharmaceuticals' New Drug Receives Final US FDA Approval 7 September, 2026 HANDA Pharmaceuticals (TW: 6620) announced on the 6th of September that its 505(b)(2) new drug HND-039 (OMCAZIO) has received final approval from the US FDA, making it eligible for commercial sale in the United States. The US FDA also rejected a Citizen Petition filed by the originator company in April this year. With the regulatory hurdles cleared, HANDA will accelerate its evaluation of two commercialization options, marketing the product independently or out-licensing it, with the goal of launching OMCAZIO in the US as soon as possible. More... (in Chinese) |
| Gongwin Biopharm's Veterinary Cancer Drug Set for Launch 7 September, 2026 Gongwin Biopharm (TW: 6617) announced that it has received notification from Taiwan's Ministry of Agriculture that the technical dossier review for its new targeted tumor ablation drug for animals, Gwa103, for the treatment of canine melanoma, has been approved. The approval heralds a new era of anti-tumor treatment for pets in Taiwan. More... (in Chinese) |
| Obigen Pharma's OBI-858 Botulinum Toxin Successfully Meets Phase II Repeat-Dose Safety Trial Endpoint 7 September, 2026 Obigen Pharma (TW: 7876) announced on the 7th of September that its proprietary novel botulinum toxin OBI-858 has successfully met the predefined criteria in the analysis of its Phase II repeat-dose safety clinical trial, potentially positioning the company to target the US$10 billion medical aesthetics market. Obigen Pharma said OBI-858 is a novel botulinum toxin developed using a proprietary bacterial strain and is intended for both aesthetic and medical applications. More... (in Chinese) |
| NTU Finds GLP-1 Drugs Slash Cancer Risk Press release 7 September, 2026 A multinational research team led by National Taiwan University (NTU) Hospital recently achieved a significant breakthrough, publishing their findings in the top-tier oncology journal Annals of Oncology. The study reveals that non-diabetic obese adults using GLP-1 receptor agonists--commonly known as weight-loss injections like Semaglutide and Tirzepatide--experience a remarkable 41% reduction in the risk of developing obesity-associated cancers (OACs) compared to those receiving only diet and exercise counseling. More... |
| Taiwan's Bora Pharmaceuticals Posts Second-Highest Monthly Revenue of NT$2.18 Billion in August; Sale-Leaseback Deal to Add Over NT$16 Million in Annual Cash Flow 7 September, 2026 Bora Pharmaceuticals (TW: 6472) reported August consolidated revenue of NT$2.18 billion, up 15% month-over-month and 59.22% year-over-year, marking its second-highest monthly figure on record, driven primarily by the shipment of CDMO orders deferred from July. More... |
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