2/9 Taiwan BIO Weekly
2026-02-09 |
| Taiwan BIO Weekly |
| BRIM Biotechnology's three ophthalmology drugs show clinical progress 5 February, 2026 BRIM Biotechnology (TW: 6885) announced that it is advancing Phase II clinical trials for its three ophthalmology drug candidates, all of which have recently shown notable progress. The Phase II trial of BRM424, a treatment for neurotrophic keratitis, has surpassed half of its planned enrollment, with most participants showing significant symptom improvement. For BRM411, a glaucoma drug, the Phase I high-dose human trial has been completed, and multiple Phase II trial sites are actively opening in Taiwan to accelerate patient enrollment. In addition, the Phase II dose-finding trial for BRM421, a treatment for dry eye disease, has successfully launched in Taiwan. The drug has also received US FDA agreement to proceed with a second Phase III clinical trial. More... (in Chinese) |
| Medigen Biotechnology partners with Singapore A*STAR BTI to develop technologies for commercializing cell therapies 5 February, 2026 Medigen Biotechnology (TW: 3176) announced that it has signed a collaborative research agreement with Singapore's Bioprocessing Technology Institute (BTI), part of A*STAR, to tackle key challenges in commercializing cell therapies. The partnership will focus on automated large-scale production and the development of off-the-shelf products, combining both parties’ expertise to accelerate clinical application and commercialization. Under the collaboration, Medigen Biotechnology will provide its ACE automated cell expansion system and related core technologies, while BTI contributes feeder-free NK cell culture methods and an iPSC expansion platform. Medigen Biotechnology has already advanced in the cell therapy field with its Magicell-NK technology, approved for cancer treatment under Taiwan's special regulatory pathway, and is currently conducting Phase I trials for autologous NK cell therapy in colorectal cancer and allogeneic NK cell therapy in pancreatic adenocarcinoma, steadily expanding its clinical presence in NK cell therapies. More... (in Chinese) |
| Foresee Pharmaceutical's Casppian Phase III trial passes fourth DSMB review, advances pediatric precocious puberty drug 4 February, 2026 Foresee Pharmaceuticals (TW: 6576) announced that its Phase III Casppian trial for treating children with central precocious puberty has successfully passed its fourth safety review by an independent Data and Safety Monitoring Board (DSMB). The committee recommended the study continue as planned with no changes, marking another important endorsement that strengthens the program's path toward future regulatory submissions. The Casppian study is an open-label, multinational Phase III trial evaluating the efficacy, safety, and pharmacokinetics of a six-month extended-release leuprolide formulation (FP-001, 42 mg) in pediatric patients. The repeated positive DSMB assessments point to a stable safety profile, while the drug's prior approval as CAMCEVI for advanced prostate cancer in adults provides a solid clinical foundation for expanding its use to pediatric indications. More... (in Chinese) |
| Concord Medical partners with Choninn Hospital to deploy DeepRad's medical imaging AI 4 February, 2026 Concord Medical (TW: 6518) announced that it has partnered with its long-term collaborator, Choninn Hospital, to launch a strategic collaboration with medical imaging AI startup DeepRad.AI, fully implementing its AI-assisted low-dose CT (LDCT) interpretation system. The initiative supports Taiwan's Ministry of Health and Welfare's early lung cancer detection program, enhancing screening accuracy and introducing AI-driven opportunistic screening. By analyzing a single lung LDCT scan, the system can simultaneously provide cardiovascular risk assessments, achieving a "dual-screen" approach for precision prevention. Lung cancer and heart disease remain the top two causes of death in Taiwan, with 23,000 deaths from heart disease in 2024 alone. By mid-2025, over 210,000 publicly funded LDCT screenings had been performed, with more than 80% of lung cancer cases detected at an early stage. With the growing demand for image interpretation, integrating AI helps accurately identify small lung nodules, alleviates clinical workload, and maximizes the preventive benefits of each screening. More... (in Chinese) |
| HanchorBio partners with WuXi Biologics to manufacture immuno-oncology fusion proteins 4 February, 2026 Global contract development and manufacturing organization (CDMO) WuXi Biologics announced a partnership with Taiwan-based biotechnology company HanchorBio. The collaboration will focus on the global manufacturing and commercialization of HanchorBio’s fusion protein pipeline, an immuno-oncology platform. As part of the agreement, WuXi Biologics will provide end-to-end manufacturing of cellular products to support scalable global development. HanchorBio expects this collaboration to shorten development timelines and allow flexibility across its clinical programs. More... |
| Taiwan's PharmaEssentia to expand US production with Puerto Rico plant 3 February, 2026 PharmaEssentia (TW: 6446) will invest NT$1.45 billion (US$46 million) to establish a subsidiary and manufacturing facility in Puerto Rico as part of the plan to strengthen its US production and supply chain presence. The company has developed protein-based medicines that work for a longer time to treat blood cancers and rare diseases. Its blood cancer drug Ropeg has been approved in nearly 50 countries, per CNA. More... |
| Taiwan's Biotech Leaders Double Down on AI and US Manufacturing: Inside Bora and EirGenix's Strategic Roadmaps 3 February, 2026 As the 44th Annual J.P. Morgan Healthcare Conference (JPM 2026) concluded in San Francisco, the focus of the global biotech community shifted from the excitement of the event to the substance of the strategic roadmaps revealed. For Taiwan’s leading biopharma companies, this year marked a definitive transition from establishing a presence to demonstrating advanced capabilities. Two key players, Bora Pharmaceuticals (Bora) and EirGenix, showcased a qualitative shift in their business models. Moving beyond traditional contract manufacturing, both companies highlighted aggressive moves into AI-driven production, supply chain localization in the US, and next-generation manufacturing technologies. More... |
| TaiRx advances to version 3.0, driving clinical progress, revenue growth, and strategic partnerships 2 February, 2026 TaiRx (TW: 6580), is officially entering its '3.0' era, according to General Manager Chien Du-Shieng. Chien stated that in 2026, the company will continue pursuing international licensing, formally enter the Chinese market, and simultaneously initiate plans for a public listing. Clinical development, revenue growth, and strategic partnerships will advance in parallel, aiming to submit listing applications in the second half of this year. More... |
| InnoPharmax submits Phase II Trial application in Taiwan for lung and pancreatic cancer drug, advances global Phase III biliary tract study 2 February, 2026 InnoPharmax (TW: 4172) announced that its investigational drug D07001 (GemOral) has submitted a Phase II clinical trial application to Taiwan's TFDA for advanced non-small cell lung cancer and pancreatic cancer, enrolling approximately 48 patients using a basket trial design to streamline evaluation and accelerate development decisions. Meanwhile, the company is advancing its FDA-approved Phase III trial of D07001-Softgel for biliary tract cancer, targeting 240 patients across the US, Taiwan, and South Korea, with submissions also made to the TFDA and Korea’s MFDS and plans to relocate former Indian sites to Europe, aiming to complete patient enrollment in time for a mid-2027 interim analysis. More... (in Chinese) |
| Great Novel Therapeutics Biotech & Medicals (GNTbm) submits US FDA IND application for anti-cancer drug GNTbm-38 2 February, 2026 Great Novel Therapeutics Biotech & Medicals (GNTbm) (TW: 7427) announced that its self-developed epigenetic immune-activating anti-cancer drug GNTbm-38 submitted an IND application for a Phase I clinical trial to the US FDA on January 30. GNTbm-38 is an oral anti-cancer drug with a dual mechanism of epigenetic regulation and immune activation. The company highlighted that the drug has undergone roughly five years of development, accumulating over 10,000 pages of research data and completing multiple preclinical evaluations of efficacy and safety. More... (in Chinese) |
| Oneness Biotech's wound care product enters Colombia 1 February, 2026 Oneness Biotech (TW: 4743) announced that its wound care product, Bonvadis topical cream, has been accepted by Colombia's regulatory authority INVIMA for a medical device registration application covering full wound indications. The product is positioned as a medical device wound dressing for acute and chronic wounds and scars, including burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds. If approval is granted and the product is commercialized, Oneness Biotech will pay sales royalties in accordance with its licensing agreement. More... (in Chinese) |
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