2/26 Taiwan Life Sciences Biweekly Newsletter
2024-02-27 |
| Taiwan Life Sciences Biweekly |
| Taiwan FDA gains ICMRA associate membership Press release 22 February, 2024 The Taiwan Food and Drug Administration under the Ministry of Health and Welfare recently became an associate member of the EU-based International Coalition of Medicines Regulatory Authorities, the MOHW said in a statement Feb. 21. More... |
| Taiwan's AnHorn Medicines partners with European startups to develop protein degraders 21 February, 2024 AnHorn Medicines, a Taiwan-based start-up, announced on 20 February that it has teamed up with Czech start-up AI ffinity, Switzerland's NexMR and the Central European Institute of Technology (CEITEC) through a referral from Taiwan Capital to jointly research and develop prostate cancer drug candidates using artificial intelligence. This sets a precedent for R&D cooperation between Taiwanese pharmaceutical start-ups and EU partners and top research institutions. More... |
| Taiwan's biopharmaceutical industry sees a bright future with licensing and marketing approvals 19 February, 2024 The New Year's festivities for biotech stocks continue to unfold, with at least 17 companies sharing good news in just a month and a half to start the year, including Bora Pharmaceuticals, MegaPro Bio, PharmaEngine and Foresee Pharmaceuticals, Medigen Vaccine Biologics, Taimed Biologics, OBI Pharma Inc. and PharmaEssentia, NaviFUS Corp. and others. More... |
| NaviFUS Focused Ultrasound Therapy System receives US IDE Clinical Approval 18 February, 2024 NaviFUS (TW: 6872) announced that its NaviFUS Focused Ultrasound Therapy System had obtained Investigational Device Exemption (IDE) approval from the US FDA. The system will be used in conjunction with Bevacizumab (Avastin) in human trials for recurrent brain tumors at the University of Virginia Hospital in the United States. More... (in Chinese) |
| PharmaEssentia Applies for Phase II Clinical Trials in Japan for its Leukemia Drug 17 February, 2024 PharmaEssentia (TW: 6446) announced that its innovative long-acting interferon, Ropeginterferon alfa-2b (referred to as Ropeg, or P1101), intended for relapsed or refractory adult T-cell leukemia/lymphoma (ATL), has applied for Phase II clinical trials with Japan's PMDA. The trials will commence upon approval. More... (in Chinese) |
| China Medical University Hospital (CMUH) in Taiwan Upgrades Smart Healthcare with Gen AI Press release 17 February, 2024 China Medical University Hospital (CMUH) in Taiwan announced its collaboration with Google Cloud in mid-December 2023. Using Google Cloud's generative AI technology, including MedLM, which is a large language model built on Med-PaLM 2, CMUH has developed a comprehensive "AI-assisted Physician" system which aims to assist healthcare professionals in disease diagnosis, treatment planning, patient education, and medical research, etc. More... |
| PharmaEngine's New Drug Receives FDA Approval, Business Operations Set to Receive Significant Boost 15 February, 2024 PharmaEngine (TW: 4162) announced that it had obtained FDA approval for the new drug Onivyde (also known as nal-IRI, liposomal irinotecan injection) for the treatment of metastatic pancreatic cancer as a first-line combination therapy. This drug is licensed to IPSEN in France. While PharmaEngine cannot profit from the US market [for this drug], there is a chance to obtain approval in the EU and Taiwan in the first half of this year. In the future, this development is expected to significantly boost the company's operations. More... (in Chinese) |
| Andros Pharmaceuticals' New Arthritis Pain Drug, APC201, Enters Phase II Clinical Trial 15 February, 2024 Andros Pharmaceuticals (TW: 6917) announced that the Phase II clinical trial of APC201, a new drug for treating localized pain caused by knee osteoarthritis, has successfully admitted its first patient in Australia. The clinical trial is expected to enroll a total of 60 participants. More... (in Chinese) |
| AmCad BioMed Announces Dual-Track Development of Domestic and International Business 15 February, 2024 AmCad BioMed (TW: 4188), a medical device company specializing in ultrasound imaging, is accelerating the development of its domestic and international business this year, according to an announcement by the company. Among them, its product AmCAD-UO will begin operations at medical institutions such as National Taiwan University Hospital and the associated Good Liver Clinic. Additionally, it will introduce a new business model for corporate health checks and expand its application areas through clinical research. More... (in Chinese) |
| Foresee Pharmaceuticals announces progress in China clinicals trials for its prostate cancer drug 6 February, 2024 Foresee Pharmaceuticals (TW: 6576) announced that its CAMCEVI (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults has reached efficacy indicators in clinical trials in China. Subsequently, Foresee Pharmaceuticals' authorized partner in China, Changchun GeneScience Pharmaceutical, will submit a new drug inspection and registration application for the Chinese market in the second half of this year. More... (in Chinese) |
| Chang Gung Medical Foundation Teams Up with Janssen Pharmaceuticals for the Development of New Drugs for Common Cancers in Taiwan 6 February, 2024 Chang Gung Medical Foundation announced that it had signed a memorandum of clinical trial cooperation with Janssen Pharmaceuticals. Dr. Lin Yung-Chang, Vice President of Linkou Chang Gung Memorial Hospital, stated that Janssen has recently developed new drugs for blood cancer and head and neck cancer, and that through this collaboration with Chang Gung there is hope to include common cancers among Taiwanese and Asian populations, such as bile duct cancer and gastric cancer, in their global strategy. Additionally, Taiwanese physicians will also have the opportunity to further participate in international drug development. More... (in Chinese) |
| Pharmaceutical industry hits 100 billion mark for four consecutive years 6 February, 2024 Breaking down by product category, "Pharmaceuticals and chemical products" crossed the 100 billion mark for the first time in 2022, ending the year at TWD$117.3bn, up 9.8% year-on-year. More... |
| Taiwan biomanufacturer aims to be 'biotech TSMC' 5 February, 2024 Taiwan Bio-Manufacturing Corp (TBMC), a government-initiated biotech company, on Friday staged its first public event in Taipei, during which it outlined its business model as being similar to that of contract chipmaker Taiwan Semiconductor Manufacturing Co (TSMC) and highlighted its strategic alliance with a US technology-focused biomanufacturing company. More... |
| Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE2016, a First-in-Class Allogeneic Anti-EGFR Cell Therapy 5 February, 2024 Acepodia (TW: 6976), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 T-cell platforms to address gaps in cancer care, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for ACE2016, an allogeneic gamma delta 2 T-cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors. More... |
| ========================================= |
| 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 2024 (24-28 July, 2024) ========================================= Taiwan Bio Industry Organization (TBIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |