4/14 Taiwan Life Sciences Weekly Newsletter
2025-04-14 |
| Taiwan Life Sciences Weekly |
| Taiwan's ACRO Biomedical Gains Regulatory Approval for Its Collagen Ophthalmic Matrix, Offering New Hope for Corneal Transplant Patients Press release 13 April, 2025 ACRO Biomedical Co., Ltd. (TW: 6748) announced today that its ABCcolla Collagen Ophthalmic Matrix has received regulatory approval from Taiwan's Ministry of Health and Welfare (MOHW), with registration number: MOHW Medical Device No. 008155. This milestone marks a significant advancement in regenerative medicine and provides new hope for millions awaiting corneal transplants worldwide. More... |
| Savior Lifetec's antibiotic Ertapenem receives drug approval in China 8 April, 2025 Savior Lifetec (TW: 4167) announced today that its antibiotic product, Ertapenem Injection, has been approved for market launch by China's National Medical Products Administration (NMPA). The drug has passed China's generic drug quality and efficacy consistency evaluation and will officially enter the Chinese carbapenem antibiotics market. More... (in Chinese) |
| U-Neuron Biomedical's new ED drug passes Phase I safety review, advances to Phase II trials 7 April, 2025 U-Neuron Biomedical (TW: 6973) announced that its amniotic stem cell new drug UA002, developed for the treatment of erectile dysfunction, has passed the Phase I clinical trial safety evaluation in Taiwan. The Data and Safety Monitoring Board (DSMB) determined that the safety profile is satisfactory and recommended advancing to Phase IIa clinical trials as planned. U-Neuron stated that in preclinical animal studies, UA002 demonstrated the ability to repair both nerve and vascular tissues, offering a potential new treatment option for patients who do not respond to current standard therapies. The company plans to actively pursue licensing and partnership opportunities to accelerate the drug’s path to market. More... (in Chinese) |
| EirGenix aims for breast cancer drug approval in Mexico 7 April, 2025 EirGenix (TW: 6589) announced that it will submit a Phase III clinical trial protocol for its investigational breast cancer drug EG1206A (pertuzumab biosimilar) to Mexico's Federal Commission for the Protection against Sanitary Risk (COFEPRIS). The company is aiming to secure market approval for its second-generation breast cancer therapy in Mexico. More... (in Chinese) |
| University, hospital team develop 'brain scanner' 6 April, 2025 National Yang Ming Chiao Tong University (NYCU) and the Taipei Veterans General Hospital hailed a new milestone for disease diagnosis in the medical industry with a brain imaging system they jointly developed that could isolate levels of cerebral regression suffered by patients with mental diseases at different stages of their lives. The system, named Brain Probe, won this year's Edison Awards' Gold award in the Advancements in Neurological Treatments subcategory. More... |
| PharmaEssentia announces application for market approval for Ropeg in Vietnam 2 April, 2025 PharmaEssentia (TW: 6446) announced that it has applied for marketing approval in Vietnam for its new drug Ropeg for the treatment of Polycythemia Vera (PV). Since Ropeg has already received PV drug approvals in Singapore and Malaysia, this application for approval in Vietnam will further expand its influence in the Southeast Asian market. According to market research estimates, there are approximately 15,000 PV patients in Vietnam, with current clinical treatments including phlebotomy, Hydroxyurea (HU) capsules, interferon, and JAK2 inhibitors. PharmaEssentia stated that Ropeg is a next-generation, innovative long-acting interferon developed and manufactured by PharmaEssentia. It has been approved for use in adult PV patients in over 40 countries worldwide, including major new drug markets such as the European Union, the US, and Japan, with global sales continuing to grow steadily. More... (in Chinese) |
| StemCyte advances cord blood therapy REGENECYTE toward Phase III pivotal trial following successful FDA EOP2 meeting 31 March, 2025 StemCyte (TW: 4178) announced today (31st) that its cord blood-derived cell therapy, REGENECYTE, has successfully completed an End-of-Phase 2 (EOP2) meeting with the US FDA. The discussions focused on the design of the pivotal Phase III clinical trial and the regulatory pathway for its Biologics License Application (BLA). StemCyte received the official meeting minutes from the FDA March 28, and is planning to initiate the Phase III pivotal trial ahead of schedule. More... (in Chinese) |
| Acer Medical announces expansion, partners with Intel to launch AI-powered ophthalmology screening solution 31 March, 2025 Acer's (TW: 2353) subsidiary Acer Medical (TW: 6857) announced that its VeriSee AI ophthalmology screening software series, VeriSee DR for diabetic retinopathy and VeriSee AMD for age-related macular degeneration, will be showcased at the Malaysia Society of Ophthalmology (MSO) Annual Scientific Meeting from April 25–27. These solutions aim to bring innovative AI-assisted screening technologies to local ophthalmology institutions. At the same time, Acer Medical will partner with Intel to run the VeriSee series, powered by OpenVINO technology, on laptops equipped with Intel Core Ultra processors. More... (in Chinese) |
| AnHorn Medicines launches US Phase I trial for innovative protein degradation therapy for male pattern baldness 27 March, 2025 AnHorn Medicines, an AI-driven drug development company specializing in protein degraders, announced that its innovative protein degrader for male pattern baldness, AH-001, has officially entered Phase I clinical trials in the United States, with the first patient dosed earlier this week. AnHorn Medicines explained that AH-001 is a novel, topically applied small-molecule drug designed to specifically degrade androgen receptors (AR), which are responsible for hair loss in male pattern baldness. More... (in Chinese) |
| ========================================= |
| 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 (TBIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |