12/29 Taiwan BIO Weekly
2025-12-29 |
| Taiwan BIO Weekly |
| ITRI Wins Three R&D 100 Awards for Breakthroughs in Biotech and Sustainability 24 December, 2025 ITRI has been recognized with three 2025 R&D 100 Awards for its Bio-Inspired Ligament Scaffold (BILS), Circu-Texfilm, and AI-WaJe. These technologies showcase exceptional novelty, impact, and practical applications in the analytical/test, mechanical/materials, and process/prototyping categories, respectively. More... |
| Bio-Inspired Ligament Scaffold 24 December, 2025 Taiwan's Industrial Technology Research Institute (ITRI) has developed the Bio-Inspired Ligament Scaffold (BILS), a bioengineered artificial ligament designed to accelerate healing in ligament repair procedures and provide multiple therapeutic advantages over conventional approaches. More... |
| Caliway's Fat Reduction Drug Candidate CBL-514 Completes US FDA IND Submission for Phase II Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies Press release 24 December, 2025 Caliway Biopharmaceuticals (TW: 6919) today announced that it has completed the submission of an Investigational New Drug (IND) application to the US FDA for a Phase II clinical study of its world's first large-area localized fat reduction drug candidate, CBL-514, for the weight management indication. This submission accelerates the clinical development of CBL-514 in combination with GLP-1R agonist (GLP-1RA) therapies and expands the Company's R&D footprint in the global weight management field. More... |
| Foresee Pharmaceuticals' long-acting GnRH agonist FP-001 progresses in Phase III trials 24 December, 2025 Foresee Pharmaceuticals (TW: 6576) announced that its FP-001 (CAMCEVI) 42 mg new drug, a long-acting GnRH agonist administered once every six months for central precocious puberty (CPP) in children, successfully met the primary endpoint in its Phase III clinical trial. The company plans to submit a New Drug Application (NDA) to the US FDA around mid-2026. More... (in Chinese) |
| TCI benefits from global weight-loss trend as new customers boost orders 24 December, 2025 TCI (TW: 8436) is seeing increased demand for its health-focused formulation contract manufacturing as global interest in weight management and GLP-1–related products rises. With the market expanding from pharmaceuticals into broader health and wellness segments, brand customers are increasingly adopting functional formulas for metabolism, blood sugar control, and weight regulation. The company has also attracted new customers recently, further strengthening order momentum. More... (in Chinese) |
| Ambassador Douglas Hsu Highlights Integrated and Value-added Diplomacy at AusBiotech 2025 23 December, 2025 Ambassador Douglas Hsu underscored Taiwan's commitment to deepening Taiwan-Australia biotechnology cooperation while attending the opening of the 2025 Australian International Biotech Conference (AusBiotech 2025) in Melbourne. In his remarks, Ambassador Hsu emphasised that the Taiwan Pavilion exemplifies Taiwan's approach to integrated diplomacy, combining industrial strengths, innovation capacity and shared values to advance mutually beneficial partnerships with Australia. More... |
| Senhwa Biosciences advances two drug candidates with novel anticancer mechanism 23 December, 2025 Senhwa Biosciences (TW: 6492) held an investor meeting recently highlighting its R&D and commercialization strategy focused on AI validation, clinical development, and international collaboration, with a novel anticancer mechanism as its cornerstone. The company is advancing two drug candidates: CX-4945 (Silmitasertib), identified using its C2S-Scale AI model as having immune-sensitizing potential to enhance antigen presentation, and CX-5461, which is being developed in combination with BeOne Medicines' PD-1 inhibitor tislelizumab for advanced solid tumors such as pancreatic cancer and immunotherapy-resistant melanoma. The CX-5461 collaboration targets early combination therapy trials, which could open access to a global immuno-oncology market worth hundreds of billions of US dollars. Senhwa Biosciences plans to produce multiple clinical studies for both CX-4945 and CX-5461 over the next 1-3 years, while furthering international collaborations, exploring licensing opportunities, and increasing visibility in global scientific and investment communities. More... (in Chinese) |
| Genomics BioSci applies for listing on Taiwan's Innovation Board 23 December, 2025 Taiwan Stock Exchange announced that Genomics BioSci (TW: 4195) has submitted its application for listing on the Taiwan Innovation Board. The company, with a paid-in capital of approximately NT$724 million, focuses on genomics, offering services such as gene sequencing and multi-omics innovation, prenatal and cancer NGS clinical testing, and bioinformatics and AI-driven analysis. Genomics BioSci is also expanding into biopharmaceutical manufacturing, providing CRDMO services for peptides, nucleic acid adjuvants, and nucleic acid drugs, along with agency and distribution of related laboratory reagents and equipment. More... (in Chinese) |
| Biomedical sector sees wave of new drug licensing deals 22 December, 2025 Taiwan's biomedical sector is poised for a new wave of international licensing deals next year, following a strong year of clinical and regulatory progress. Multiple Taiwanese companies have achieved key milestones, including successful Phase II/III trial readouts or regulatory approvals, setting the stage for investment momentum. Based on company disclosures, eight firms are expected to complete licensing agreements in the first half of next year: Oneness Biotech (TW: 4743), TAHO Pharmaceuticals (TW: 6467), AP Biosciences (TW: 6945), BRIM Biotech (TW: 6885), AnnJi Pharmaceutical (TW: 7754), Taimed Biologics (TW: 4147), Medeon Biodesign (TW: 6499), and HanchorBio (TW: 7827). Among them, Oneness Biotech aims to license its US FDA-approved wound-care cream Bonvadis (ON101) to US partners, while TAHO Pharmaceuticals' anticoagulant oral film TAH3311 (BEQIA) is advancing in both European and US regulatory pathways, with Europe expected to see licensing completion in the second quarter. Medeon Biodesign's Urocross Expander System, a minimally invasive prostate device, is under US FDA review, and other first-quarter licensing targets include AnnJi Pharmaceutical's Kennedy disease drug AJ201 and AP Biosciences' bispecific antibody IBI302 for wet age-related macular degeneration. BRIM Biotech, Taimed Biologics, and HanchorBio are also expected to finalize international deals, reflecting a strategic focus on outward licensing to penetrate global markets rather than pursuing end-to-end commercialization. More... (in Chinese) |
| Five companies to launch new products in the US 22 December, 2025 In 2026, Taiwan's biotech sector is set to advance not only licensing deals for new drugs and innovative medical devices but also US market launches. Five companies--PharmaEssentia (TW: 6446), Lin BioScience (TW: 6696), Medeon Biodesign (TW: 6499), Tanvex BioPharma (TW: 6541), and Handa Pharma (TW: 6620)--are expected to start selling their new drugs and innovative medical products in the US starting from the second quarter. PharmaEssentia's Ropeg, already marketed internationally for polycythemia vera (PV), helped drive the company's consolidated revenue to NT$13.71 billion through November, up 59.38% year-over-year. The company is pursuing a second indication, essential thrombocythemia (ET), with an US FDA pre-submission meeting (AOM) on December 8, potentially enabling approval in the first half of next year. Lin BioScience's US subsidiary Belite Bio reported successful Phase III readout of LBS-008 for adolescents with Stargardt disease, targeting US approval by year-end with plans to commercialize independently. Tanvex BioPharma aims to secure US FDA approval in the first half of 2026 for its breast cancer biosimilar TX-05 following previous unsuccessful attempts, while Handa Pharma plans to obtain US approval in July for its new formulation anticancer drug HND-039. More... (in Chinese) |
| U-Neuron Biomedical's UA002 gains dual fast-track approval from TFDA and CDE 22 December, 2025 Taiwan’s regenerative medicine sector is set for a growth boost as the new dual regenerative medicine regulations are expected to take effect in 2026. U-Neuron Biomedical (TW: 6973) announced that its stem cell-based erectile dysfunction drug UA002 has received dual fast-track recognition: inclusion in the TFDA's special project-based consultation cases and designation as a CDE key project. These designations provide one-stop guidance covering regulatory strategy, clinical trial design, manufacturing, quality control, and market application, which can accelerate development, shorten review timelines, and reduce costs. UA002, developed in-house using amniotic stem cells, targets patients unresponsive to oral treatments, with preclinical models showing dual mechanisms of nerve and vascular repair. Phase I trials confirmed safety and preliminary efficacy, and Phase IIa trials are ongoing. The dual fast-track status highlights the drug's innovation and therapeutic potential, enabling closer collaboration with regulators under Taiwan's new regenerative medicine framework. More... (in Chinese) |
| EverFortune.ai's dual AI medical devices approved by TFDA 22 December, 2025 EverFortune.ai (TW: 6841) announced that two of its artificial intelligence medical devices--AutoSeg, an automatic organ contouring system for radiotherapy, and the EFAI Computer-Assisted Detection Platform for TRODAT-1 Dopamine Transporter Scan--have both received medical device approval from Taiwan's Food and Drug Administration (TFDA), marking a major milestone in the expansion of its smart healthcare portfolio. The newly approved AutoSeg employs a closed-loop AI algorithm to integrate CT and MRI images and automatically delineate and analyze 182 organs at risk (OARs) across the head and neck, thoracic-abdominal, and pelvic regions. Meanwhile, the EFAI Computer-Assisted Detection Platform for TRODAT-1 Dopamine Transporter Scan analyzes Tc-99m TRODAT-1 SPECT images via DICOM input to evaluate striatal dopamine transporter uptake to support physicians' clinical interpretation. More... (in Chinese) |
| OBI Pharma's glycoprotein ADC drug licensed to US-based TegMine 20 December, 2025 Taiwan's OBI Pharma (TW: 4174) has signed a global exclusive licensing agreement with US biopharmaceutical company TegMine for a glycoprotein ADC (antibody-drug conjugate). Under the deal, OBI Pharma will receive upfront, R&D, and sales milestone payments, as well as royalties based on a percentage of annual net sales once the product is commercialized. The agreement builds on a research collaboration launched in June, during which OBI Pharma successfully developed a glycoprotein ADC candidate commissioned by TegMine, which the company assessed as having strong potential for further clinical development. More... (in Chinese) |
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