07/14 Taiwan BIO Weekly
2025-07-14 |
| Taiwan BIO Weekly |
| International Symposium on Medical Technology and Biotechnology Industry Collaboration Held at NCKU -- Health Data Governance and Japan's PFI Hospital Operations in Focus 11 July, 2025 On June 21, National Cheng Kung University (NCKU) hosted the International Symposium on Medical Technology and Biotechnology Industry Collaboration at Macronix Hall. The event brought together experts from Taiwan and Japan across the medical, technology, and industrial sectors. Participants engaged in in-depth discussions on cutting-edge topics such as smart healthcare, data governance, biotechnology innovation, and international collaboration. The symposium aimed to draw lessons from the Kobe Biomedical Innovation Cluster (KBIC) in Japan, with the goal of further internationalizing NCKU Shalun Healthcare and Innovation Park. More than 100 students, faculty members, and industry representatives took part in the event. More... |
| Innopharmax's oral orphan drug for cholangiocarcinoma enters global Phase III clinical trials 10 July, 2025 Innopharmax (TW: 4172) announced that its oral orphan drug for cholangiocarcinoma, D07001-Softgel, has officially entered a global Phase III pivotal clinical trial. The trial plans to enroll approximately 240 participants, with the first subject in the US trial site expected to be enrolled by the end of 2025, and interim analysis enrollment completed by the end of 2026. More... (in Chinese) |
| Asia's Largest Biotech Event, BIO Asia-Taiwan 2025, Kicks Off July 23 10 July, 2025 The premier annual event for Asia's biotech industry, BIO Asia-Taiwan 2025, will take place from July 23 to 27 at the Taipei Nangang Exhibition Center, TaiNEX 1 and 2, with the theme "Next Wave of Biotech Opportunities", highlighting innovations and exciting new opportunities emerging in this sector. More... |
| Genetics Generation Advancement supports TMU startup in building AI platform to develop cancer drugs 9 July May, 2025 Genetics Generation Advancement (TW: 4160) announced that its AI drug development platform has successfully supported a team from the College of Medical Science and Technology at Taipei Medical University in developing 20 novel small-molecule drugs. These new drugs target diseases such as glioblastoma, pancreatic cancer, Alzheimer's disease, and pulmonary fibrosis. Among them, six innovative small-molecule inhibitors have been selected for further development, with brain cancer and pancreatic cancer candidates already advancing into preclinical trials. More... (in Chinese) |
| Adimmune implements Quality by Design (QbD) to enhance process and product development 9 July, 2025 Adimmune (TW: 4142) announced that it will implement Quality by Design (QbD), with the approach to be applied from process design through all stages of product development, from preclinical to post-marketing, in a comprehensive effort to improve process and product development capabilities. Quality by Design (QbD) is a global regulatory initiative in the biopharmaceutical industry. Its primary goal is to drive biopharmaceutical development through proactive design and control of the manufacturing process, thereby consistently delivering high-quality products that meet expectations and ensuring the safety and efficacy of every batch. QbD is also a conceptual framework promoted by both the US FDA and the International Council for Harmonisation (ICH) for the biopharmaceutical industry. More... (in Chinese) |
| EverFortune.ai's smart hair growth cap receives TFDA medical device certification 9 July, 2025 EverFortune.ai (TW: 6841) announced that its RENEHS hair growth cap, jointly developed with its subsidiary Ever Wynn Technologies, has received medical device certification from Taiwan's Food and Drug Administration (TFDA). With this milestone, the company has successfully built a hair care technology platform and plans to apply for US FDA certification in the future to expand its hair growth technology into international markets. To date, Ever Fortune AI has obtained a total of 49 medical device certifications globally, including 13 from the US FDA, 20 from Taiwan's TFDA, 5 from Thailand, 5 from Malaysia, 5 from Vietnam, and 1 from Singapore. More... (in Chinese) |
| Andros Pharmaceuticals reports breakthrough for new osteoarthritis drug 7 July, 2025 Andros Pharmaceuticals (TW: 6917) has announced encouraging results from the Phase I/IIa clinical trial of its new drug APC201, developed to treat localized knee osteoarthritis pain, conducted in Australia. The trial met both its primary and secondary efficacy endpoints. The company announced that it is now actively planning a global multi-center Phase IIb/III trial, while also initiating licensing negotiations to accelerate the drug's commercialization. More... (in Chinese) |
| Orient EuroPharma introduces photoimmunotherapy, aims for Taiwan drug approval next year 7 July, 2025 Orient EuroPharma (TW: 4120) recently announced the licensing and introduction of Rakuten Medical's Alluminox platform photodynamic immunotherapy products for commercialization in Taiwan, Singapore, Malaysia, and the Philippines. This therapy obtained approval from Japan's Ministry of Health, Labour and Welfare in 2021, with nearly 1,000 treatments performed to date. Currently, a Phase III clinical trial is underway in Taiwan, targeting regulatory approval next year. Additionally, Rakuten Medical will conduct combined Phase III clinical trials across Taiwan, the US, and Japan, enrolling over 400 patients, aiming to apply for FDA approval in the US and expand the innovative therapy market. More... (in Chinese) |
| CHO Pharma's partners with Amaran Biotech CDMO to advance innovative vaccine into Phase I clinical trials 7 July, 2025 CHO Pharma (TW: 6586) announced that its preventive bacterial vaccine CHO-V08--developed to target Klebsiella pneumoniae, a highly pathogenic bacterium commonly associated with hospital-acquired infections--received approval from the Taiwan Food and Drug Administration (TFDA) in late March to initiate Phase I clinical trials in Taiwan. CHO Pharma noted that bacterial vaccines represent the most successful application of glycoscience in pharmaceutical development to date. CHO-V08 is not only the company's first bacterial vaccine product but also a landmark case in Taiwan's vaccine development landscape. Considering Amaran Biotech's practical experience in glycoscience and biologics, and following on-site facility evaluations, CHO Pharma began its collaboration with Amaran Biotech in 2022. In less than a year, the two companies completed GMP production of both CHO-V08's active pharmaceutical ingredient and final product, passing quality controls and submitting Investigational New Drug (IND) applications in both the US and Taiwan. More... (in Chinese) |
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| Taiwan Bio Industry Organization (Taiwan BIO) Contact: Daisy Tsai Tel: +886 2 27836028 ext 14 FAX : +886 2 27836027 Mobile: +886 933-139647 | Line ID : daisy222 Email: daisy@taiwanbio.org.tw BIO Asia-Taiwan 2025 (23-27 July, 2025) ========================================= Taiwan Bio Industry Organization (Taiwan BIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |