09/01 Taiwan BIO Weekly
2025-09-01 |
| Taiwan BIO Weekly |
| Oneness Biotech to start clinical trials in Q4 of weight-loss drug SNS851 29 August, 2025 Oneness Biotech (TW: 4743) is advancing its weight-loss nucleic acid drug SNS851, which can increase weight reduction by 40 percent when combined with GLP-1 drugs and shows half the post-treatment rebound rate. A Phase I trial is planned in Australia in Q4, alongside international partnership discussions. Following the successful Phase II readout of COVID-19 drug SNS812, Oneness is prioritizing SNS851, pausing another Phase I liver cancer program to focus on more promising projects. SNS851 accelerates fat metabolism, complementing GLP-1 therapy, and is administered monthly via intramuscular injection. The company is also progressing commercialization of its wound care drugs and medical devices, supported by 33 publications and clinical evidence for insurance reimbursement. More... (in Chinese) |
| Exosomes boost U-Neuron Biomedical's performance this year 28 August, 2025 U-Neuron Biomedical has launched its Exosome Pioneer Manufacturing Center, announcing that the first commercial-scale product, an exosome-based skincare line co-developed with Clé de Peau Beauté, will debut in October. Driven by strong demand for its exosome skincare products, the company's July revenue rose 69.2 percent year-on-year to NT$6 million, bringing cumulative revenue for the first seven months to NT$46.08 million, almost matching last year's total, ensuring a new record high in 2025. More... (in Chinese) |
| TFBS Bioscience expands in Northeast Asia, secures first viral vector order from South Korea 28 August, 2025 TFBS Bioscience (TW: 6939), a viral vector manufacturer in Taiwan, recently announced two international collaborations, highlighting its key role in the Asia-Pacific cell and gene therapy (CGT) industry. South Korean innovative cancer therapy company artiCure selected TFBS Bioscience as its manufacturing partner for retroviral vectors, accelerating clinical trials and global commercialization. At the same time, TFBS established a strategic partnership with Japan's advanced analytics firm U-medico, targeting the Japanese gene testing market. These collaborations expand TFBS's biologics testing and viral vector manufacturing business from Japan into South Korea, strengthening its influence across the Northeast Asian and broader Asia-Pacific markets. More... (in Chinese) |
| Unicocell Biomed teams up with Japan company to target South Korean market 28 August, 2025 Unicocell Biomed (TW: 6794) announced that it has signed a collaboration agreement with Japan's New Cell Bio (NCB) to jointly enter the South Korean regenerative medicine market, focusing on stem cell and exosome-related product promotion. Unicocell Biomed noted that NCB, a stem cell-based biotech company headquartered in Chuo-ku, Tokyo, with a branch in Busan, South Korea, specializes in regenerative medicine. NCB has established partnerships with Korea University Hospital and is recognized by the Japan Society for Regenerative Medicine, providing strong academic and clinical resources, making it an ideal partner for Unicocell Biomed’s expansion into the South Korean market. More... (in Chinese) |
| Taiwan Pushes AI-Driven Biomedicine: From Health Data Companies to Global Precision Health Ambitions 28 August, 2025 "Sharpen the knife before cutting wood. " With this proverb, Executive Yuan Minister without Portfolio Wu Cheng-wen opened the Bio-Taiwan Committee (BTC 2025) on August 25, 2025, by calling for the creation of a Health Data Service Company. His vision: to integrate Taiwan's semiconductor + AI strengths into the biomedical sector, first solidifying the domestic market, then expanding abroad. More... |
| From AI to Precision Medicine: Taiwan's Smart Healthcare Pavilion Showcases 10 Global-Ready Innovators at Taiwan Expo USA 2025 28 August, 2025 At Taiwan Expo USA 2025 in Dallas, the Smart Healthcare Pavilion showcased Taiwan’s growing strength in digital health innovation. Organized by the International Trade Administration (TITA) and the Taiwan External Trade Development Council (TAITRA), the pavilion featured 10 leading organizations that revealed new approaches in telemedicine, artificial intelligence (AI), precision medicine, and medical services. The exhibition declared Taiwan's ambition to position itself as a global partner in advancing smart healthcare solutions. More... |
| "Taiwan and India can strengthen health-tech collaboration by establishing structured platforms for regulatory dialogue" 27 August, 2025 As Taiwan is leading global conversations around health, wellness, and medical innovation through its flagship initiative -- "Go Healthy with Taiwan 2025", India has been identified as a key partner. Through this initiative, Taiwan expects to unlock multi-million dollar trade opportunities in areas like fitness & sport, cycling and smart healthcare. Shu-Han Lin, Director of TAITRA Mumbai (Taiwan External Trade Development Council) interacted with BioSpectrum Asia to share more details about this initiative. More... |
| Panion & BF Biotech submits drug application for PBF-1681 new formulation, new indication 27 August, 2025 Panion & BF Biotech (TW: 1760) has submitted an NDA to Taiwan's TFDA for PBF-1681 tablet, a new formulation and indication targeting iron deficiency anemia and high serum phosphate in adult chronic kidney disease (CKD) patients. The drug, based on a ferric citrate coordination complex with dual iron-supplementing and phosphate-binding mechanisms, aims to provide an integrated treatment option for complications common in CKD. With over 2 million CKD patients in Taiwan, including 80,000-90,000 on dialysis and annual dialysis-related costs of NT$46 billion, the therapy is positioned to address a significant unmet medical need and is planned for commercialization upon approval. More... (in Chinese) |
| TCM Biotech's U101 aims for Phase III interim results in Q2 next year, accelerating US drug approval 27 August, 2025 Drug developer TCM Biotech (TW: 4169) is advancing U101, a new drug for a novel indication in recurrent urinary tract infections. The Phase III trial is expected to meet its enrollment target of 208 patients by Q4, with interim results anticipated in Q2 next year. The company has also launched its US market strategy, securing FDA agreement to use the Taiwan Phase III trial as a pivotal study for its US drug application, aiming to accelerate approval in both Taiwan and the US. More... (in Chinese) |
| Asia-Pacific health event invites cancer screening experts 27 August, 2025 The 2025 Asia-Pacific Health Promotion and Non-Communicable Disease Prevention Workshop was held on August 26 and 27 at the College of Public Health, National Taiwan University. The focus was on in-depth exchanges on health promotion and cancer screening strategies, with specific reference to colorectal cancer. More... |
| Foresee Pharmaceuticals' new prostate cancer drug receives US FDA approval for market launch 27 August, 2025 On August 26, Foresee Pharmaceuticals (TW: 6576) announced that its new three-month injection formulation of CAMCEVI, a prostate cancer drug, has received US FDA approval. The company expects formal market launch and revenue contribution by the end of this year. The drug will be marketed in the US by Accord, a subsidiary of its licensing partner Intas. Foresee is eligible for milestone payments upon approval and launch, as well as future sales royalties. The six-month formulation of CAMCEVI has already been approved in the US, Canada, Europe, Taiwan, Israel, and the UK, and is commercially available in the US, Germany, and Canada. The drug is estimated to have captured about a 15 percent market share in the US so far. More... (in Chinese) |
| OBI Pharma's locally-developed botulinum toxin meets Phase II endpoints, Phase III trials for frown lines to begin 26 August, 2025 OBI Pharma's subsidiary Obigen Pharma announced that its self-developed botulinum toxin, OBI-858, achieved the primary efficacy endpoint in its first Phase II human clinical trial (OBI-858-002). Obigen plans to prepare the IND filing for a Phase II trial submission in the US. The company stated that in this Phase II trial of 200 participants, more than half observed efficacy as early as Day 3, with effects lasting over six months. Based on the data, the 20U dose was selected for Phase III trials. Two pivotal Phase III clinical trials, enrolling 600 participants, were approved by Taiwan's TFDA on August 22. To further expand internationally, Obigen Pharma is planning a cash capital increase in Q4 and aims to apply for listing on Taiwan's Taipei Exchange before year-end. More... (in Chinese) |
| MOEA Launches Three AI Robotics Initiatives to Capture New Opportunities in Smart Healthcare and Manufacturing Press release 25 August, 2025 Artificial intelligence is accelerating the transformation of Taiwan's robotics industry. The Ministry of Economic Affairs (MOEA) Department of Industrial Technology (DoIT) has partnered with China Steel Machinery, National Taiwan University Hospital, and Changhua Christian Hospital to introduce three cutting-edge applications: Taiwan's first AI endoscopic robot that improves diagnostic safety and efficiency; medical logistics and instrument preparation robots that ease healthcare workloads by 20%; and a digital twin welding robot that doubles efficiency while halving costs. More... |
| BioPhoenix aims to list on Taipei Exchange by year-end 25 August, 2025 BioPhoenix, a subsidiary of electronic and specialty chemical firm San Fu Chemical (TW: 4755) has advanced three new drugs targeting bone marrow disorders, glaucoma, brain cancer, and ovarian cancer, now at various stages of clinical and animal studies. Progress this year has been steady, with goals to complete a public offering in the second half and list on the Taipei Exchange by year-end. More... (in Chinese) |
| Calling for greater government support of the pharmaceutical industry, Taiwan Bio Industry Association Chairman Liu Lee-Cheng presents seven key policy recommendations 25 August, 2025 The annual Executive Yuan Biotechnology Industry Strategy Advisory Committee (BTC) meeting was held on August 25. At Taiwan's largest government biotech policy consultation, Taiwan Bio Industry Association (Taiwan BIO) Chairman Liu Lee-Cheng, together with five other biomedical industry associations, presented seven key recommendations to the government. The proposals aim to advance the Healthy Taiwan initiative and accelerate the adoption of new drugs and domestically produced pharmaceuticals by exploring reimbursement mechanisms aligned with differential drug pricing. These seven are: A new reimbursement mechanism for differential drug pricing; a pharmaceutical and medical resilience fund; a translational medicine venture fund; a new medical-assisted industrialization policy; a regulatory sandbox for emerging biotech; AI-driven biomedical sovereignty; and personal health expenditure tax incentives. More... (in Chinese) |
| Enimmune Biotech's Kawasaki Disease adjunct diagnostic software aiming for approval and market launch by end of 2026 25 August, 2025 Enimmune Biotech (TW: 6564) announced today that its Kawasaki disease risk analysis software, PEKAN, has completed clinical performance studies at two major medical centers in Taiwan. The results show an accuracy of 90.9 percent, demonstrating the model's stability and broad applicability. Enimmune emphasized plans to pursue regulatory certification, aiming to register the software with TFDA as a Class II medical device under Taiwan's Medical Devices Act, with a target market launch by the end of 2026. The company stated that PEKAN is not just an AI-assisted diagnostic tool for a single disease, but the starting point of Enimmune's smart healthcare platform. By combining data-driven insights with artificial intelligence algorithms, Enimmune aims to deliver long-term value to clinicians, patient families, and investors. More... (in Chinese) |
| NSTC: Health Data Service Company to be established, sights set on five major goals 25 August, 2025 The Executive Yuan plans to establish a Health Data Service Company, with companies such as Wistron and Quanta set to participate. The National Science and Technology Council (NSTC) stated that by leveraging cross-hospital medical and health data, while ensuring personal data security, the company will perform data storage and analysis, aiming to achieve five major goals, including providing personalized medical services and building sovereign AI. Wu Cheng-wen, Minister without Portfolio of the Executive Yuan, said in his opening remarks at the Executive Yuan's Biotech Taiwan Committee (BTC) meeting that the Health Data Service Company will be launched this year to stimulate private-sector development of health data services. Companies including Wistron, Quanta, Catcher Technology, and Etron Technology will participate, and medical centers such as National Taiwan University, National Cheng Kung University, Taipei Veterans General Hospital, and Kaohsiung Medical University Hospital have also expressed interest in joining. More... (in Chinese) |
| Taiwan ramps up generic drug R&D to boost pharma sector 25 August, 2025 Taiwan is intensifying efforts in generic drug development to strengthen the global competitiveness of its pharmaceutical industry, with 11 local firms currently participating in an Industrial Development Administration program. More... |
| Pioneering the Next Wave of Bioscience Innovations & Opportunities: Trends & Dynamics at BIO Asia-Taiwan 2025 22 August, 2025 Taiwan is poised to play a pivotal role in advancing the global bioscience arena, emphasizing collaboration, innovation, and resilience. The country strives to promote early-stage research, secure funding, and improve supply chain stability to achieve progress in the global healthcare sector. With its growing influence, Taiwan is strengthening its efforts in the global healthcare sphere, where a number of locally developed drugs have successfully entered international markets. More... |
| Applied BioCode's digital bio-barcode testing platform enters five major US laboratories, expands into the animal health market 22 July, 2025 Applied BioCode (TW: 6598) leverages its digital bio-barcode (BMB) technology and automated testing systems to offer two flagship in vitro diagnostic (IVD) products: a gastrointestinal pathogen panel (GPP) covering 17 pathogens and a respiratory pathogen panel (RPP) covering 20 pathogens, both of which have received FDA 510(k) clearance. More... (in Chinese) |
| Genomics Corp builds a CRDMO platform integrating whole-genome research and emerging therapies 22 July, 2025 Genomics Corp. (TW: 4195), a gene sequencing company, has over 20 years of genomics expertise and 10 years of nucleic acid synthesis experience. Recently the company has been focusing on providing gene research, key raw materials, and process services for emerging therapies such as cell therapy, gene therapy, and nucleic acid drugs. By building an integrated and highly flexible CRDMO platform, Genomics Corp. has successfully established a distinct position in the highly competitive CDMO market. More... (in Chinese) |
| AP Biosciences' T-cube platform develops bispecific antibodies to tackle solid tumors 22 July, 2025 AP Biosciences (TW: 6945), Taiwan's first company dedicated to bispecific antibody drug development, was listed on the Taipei Exchange in 2023. The company has established an antibody phage display library and the T-cube bispecific antibody platform, advancing five product pipelines. Two have already been licensed to publicly listed companies Innovent Biologics and Tasly Biopharmaceuticals, while the remaining three are in or nearing clinical development. More... (in Chinese) |
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