3/3 Taiwan BIO Weekly
2026-03-03 |
| Taiwan BIO Weekly |
| China Medical University Hospital earns US AABB cell therapy international accreditation 26 February, 2026 China Medical University Hospital (CMUH) announced that it has officially obtained international accreditation for cell therapy from US-based AABB (Association for the Advancement of Blood & Biotherapies), and is the first medical center in Taiwan to receive such accreditation. This achievement signifies that CMUH’s services in bone marrow and hematopoietic stem cell transplantation, as well as cell therapy for various solid tumors, including cell processing, cell selection and depletion, stem cell storage, and biotherapeutic product management, have met the highest international standards for quality and safety. The accreditation sets a new national record and places the hospital firmly on the global stage of regenerative medicine. Founded in 1947, AABB is one of the world's most authoritative international organizations in transfusion medicine, cord blood banking, and cell therapy quality management. AABB accreditation represents a "global passport" for cell quality, underscoring internationally recognized standards of excellence. More... (in Chinese) |
| Intech Biopharm receives Taiwan approval for combination nasal spray product 25 February, 2026 Intech Biopharm (TW: 6461) announced on 25th February that its combination nasal spray developed in-house has received Taiwan drug approval. This is the company's first nasal spray approval and the first product both developed and manufactured at Intech's facility with plans for domestic launch. The company will next apply for National Health Insurance (NHI) pricing, after which the product will be marketed in Taiwan. The nasal spray is indicated for moderate to severe allergic rhinitis symptoms in children aged six and above, as well as adults. The product was co-developed with a North American company for the US market. Based on US FDA clinical data, the combination formulation works faster and provides more significant symptom relief compared with single-component sprays. More... (in Chinese) |
| "From Taiwan with Care": Taiwan Excellence Pavilion Debuts at HIMSS 2026, Showcasing Deployment-Ready AI from 11 Taiwanese Brands Press release 25 February, 2026 Taiwan Excellence will make its first-ever appearance at HIMSS 2026, March 10-12, in Las Vegas, with a national pavilion themed "From Taiwan with Care." Located at Booth #6035, the pavilion will showcase deployment-ready AI, digital care platforms, and medical-grade computing designed for real-world clinical environments. Eleven leading Taiwanese innovators, exemplifying Taiwan's care-driven approach to healthcare innovation, will demo solutions that ease clinical workloads, strengthen care delivery, and support clinicians without added complexity. More... |
| Lotus Pharmaceuticals submits 505(b)(2) cancer drug for US FDA review 25 February, 2026 Lotus Pharmaceuticals (TW:1795) has submitted a 505(b)(2) New Drug Application (NDA) to the US FDA for its cancer drug LP757 (Cabozantinib), pending approval for US marketing. LP757 is Lotus' first oral oncology 505(b)(2) drug application in the US, marking an important milestone for the company. Cabozantinib is used to treat multiple advanced solid tumors, including renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and certain types of thyroid cancer. The drug has become a key standard therapy in the US for advanced RCC and HCC. More... (in Chinese) |
| Genomics' Innovation Board listing approved 25 February, 2026 Genomics (TW: 4195), a gene sequencing company, announced that the Taiwan Stock Exchange board approved its listing on the Innovation Board. With a paid-in capital of NT$724 million, Genomics has benefited from a diversified transformation strategy, achieving a record high revenue of NT$708 million last year, a 36.86% increase year-on-year. With new clients, expanded services, and growing contributions from overseas markets, Genomics is optimistic about full-year operations and aims to pursue profitability. Its instruments division has already received orders from academic research and biotech clients, and this year will actively target semiconductor and electronics companies. More... (in Chinese) |
| Taiwan's new drug developers face a decisive year 23 February, 2026 Taiwan's new drug sector is entering a decisive showdown year. At least 10 new drugs are set to compete on the global stage, with regulatory approvals expected to reach a record high. These include new indications for Ropeg from PharmaEssentia (TW: 6446); hopes that Belite Bio, a subsidiary of Lin BioScience (TW: 6696), will secure approval for the world's first therapy for juvenile-onset Stargardt disease; a countdown to Vietnamese approval for Medigen Vaccine Biologics's (TW: 6547) enterovirus vaccine; and closely watched regulatory progress for new drugs from TAHO Pharmaceuticals (TW: 6467) and Handa Pharmaceuticals (TW: 6620). More... (in Chinese) |
| GlycoNex adds second biosimilar development program, targeting US$35B global market 23 February, 2026 GlycoNex (TW: 4168) announced that following its biosimilar for osteoporosis, it plans to launch a second biosimilar development program in Q2 this year, focusing on immune-related diseases such as plaque psoriasis, aiming to capture the US$35 billion global biosimilar market. GlycoNex further stated that developing biosimilars in Taiwan can strengthen the local biologics supply chain, help reduce healthcare financial burdens, and lower treatment barriers for patients. More... (in Chinese) |
| Bora Pharmaceuticals and GSK Sign US$250M Five Year Global Manufacturing Contract Press release 23 February, 2026 Bora Pharmaceuticals Co., Ltd. (TW: 6472; OTCQX: BORAY), a global leader in pharmaceutical manufacturing, and GSK (LSE/NYSE: GSK) have signed a strategic agreement to renew a five-year manufacturing partnership. Bora purchased the Mississauga facility from GSK in 2020. This renewed collaboration reinforces the long-standing relationship between the two companies and expands the partnership, allowing GSK access to multiple sites within the Bora network, including its newest oral solid dose (OSD) site in Maple Grove, Minnesota. More... |
| Formosa Pharmaceuticals Announces Licensing Agreement with Arrotex, for Commercialization of Clobetasol Propionate Ophthalmic Suspension for the Treatment of Inflammation and Pain Following Ocular Surgery Press release 23 February, 2026 Taiwan-based Formosa Pharmaceuticals (TW: 6838) announced today that the company has entered into an exclusive licensing agreement with Arrotex Pharmaceuticals Pty Ltd., for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), an innovative topical eyedrop for the treatment of inflammation and pain following ocular surgery in Australia and New Zealand. Arrotex, 'Australia's Medicines Company', currently fulfills 50% of the country's total volume and is a leader in ophthalmology. The licensing arrangement includes upfront, regulatory milestones, sales milestones, and royalty considerations throughout the terms of the agreement. More... |
| Berkeley Dialogue highlights AI in drug development 12 February, 2026 The Berkeley Club of Taiwan hosted its annual Berkeley Dialogue on Wednesday (Feb. 11), focusing on biotechnology and drug development. The event brought together alumni, faculty deans, two Nobel Laureates, and Chancellor Richard K. Lyons to discuss global collaboration, innovation ecosystems, and AI-driven advancements in drug development. More... |
| MerryLife Biomedical Reports Positive Phase I Results and Plans for Global Phase II Trial for TML-6, an Oral Multi-Targeted Investigational Therapy for Alzheimer's Disease Press release 10 February, 2026 MerryLife Biomedical Inc., a clinical-stage biotechnology company focused on neurodegenerative diseases, today announced positive Phase I results for TML-6, its investigational oral therapy for Alzheimer's disease (AD). The study demonstrated that TML-6 was generally well tolerated with a favorable safety profile, supporting its continued clinical development. More... |
| PharmaEssentia Announces Plans to Establish New US Manufacturing Facility in Puerto Rico to Support Global Growth of BESREMi® Press release 9 February, 2026 PharmaEssentia Corporation (TW: 6446), a global biopharmaceutical company headquartered in Taiwan with deep expertise in the development of novel biologics for hematology and oncology, and its US subsidiary PharmaEssentia USA Corporation today announced that the global corporate Board of Directors has approved an investment of approximately US$46 million to establish a new, wholly owned manufacturing subsidiary in Puerto Rico. The planned investment supports the company's global manufacturing expansion strategy and is intended to serve as a future manufacturing center for the US market and long-term global demand for BESREMi® (ropeginterferon alfa-2b). More... |
| Taiwan researchers identify key protein in tracheal repair 5 February, 2026 Taiwanese researchers decoded the biological mechanism enabling cryopreserved donated aortas to regenerate cartilage during tracheal reconstruction, the National Science and Technology Council announced Wednesday (Feb. 4). The breakthrough could transform one of the world's most challenging surgical procedures. Tracheal surgery is considered extremely difficult because the organ's rigidity and position spanning from the neck to chest make reconnection impossible when damage is extensive. More... |
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