5/19 Taiwan Life Sciences Weekly Newsletter
2025-05-19 |
| Taiwan Life Sciences Weekly |
| Gene Solutions and NEWCL Forge Strategic Partnership to Advance Genetic Testing in Taiwan Press release 16 May, 2025 In a groundbreaking move, Gene Solutions, a leader in prenatal and oncology genetic testing, and NEWCL Biomedical Laboratory, Taiwan's pioneering clinical laboratory with LDTs certification, have joined forces to establish an advanced Next-Generation Sequencing (NGS) laboratory in Taiwan. This collaboration was sealed with the signing of a Memorandum of Understanding (MoU) at NEWCL's state-of-the-art facility in New Taipei City. More... |
| Taiwan's Bora Pharma appoints industry veteran JB Agnus as Chief Commercial Officer 14 May, 2025 Taiwan-based Bora Pharmaceuticals, a global leader in pharmaceutical manufacturing, has announced the appointment of Jean-Baptiste (JB) Agnus as Chief Commercial Officer. In this role, he will lead Bora’s commercial strategy for its sterile injectables and complex small molecule offerings, as well as playing a key role in its M&A and strategic partnership initiatives. More... |
| Caliway Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat Press release 14 May, 2025 Caliway Biopharmaceuticals (TW: 6919) today announced the successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for CBL-514, the company's proprietary first-in-class injectable drug candidate for large-area subcutaneous fat reduction. Caliway has received the official meeting minutes, confirming the pivotal Phase 3 design to support the New Drug Application (NDA) filing, including the primary endpoints and proposed indication. A key outcome of the meeting was the FDA's support for the proposed indication of "reduction of abdominal subcutaneous fat" for CBL-514 in its upcoming New Drug Application (NDA). Previous aesthetic drugs have been approved solely on the "improvement in appearance." In contrast, CBL-514 targets the actual reduction of fat volume--a measurable physiological change. More... |
| Acer Medical signs MOU with ZEISS to launch fundus photography AI screening 14 May, 2025 Smart healthcare firm Acer Medical (TW: 6857) is set to sign a memorandum of understanding (MOU) with ZEISS Taiwan, the local branch of the global optics and optoelectronics company. The two parties will launch a collaborative clinical validation project that integrates ultra-widefield fundus imaging systems with AI-based disease screening software, aiming to promote the application of early diagnostic technologies in ophthalmology. Acer Medical stated that the collaboration with ZEISS Taiwan's Medical Technology division marks a significant step forward in expanding the application of AI-assisted diagnostic tools in ophthalmology. More... (in Chinese) |
| Taiwan's Lotus Pharma inks $125 M deal with LENZ Therapeutics to commercialize presbyopia treatment 13 May, 2025 US-based LENZ Therapeutics and Taiwan's Lotus Pharmaceutical have announced an exclusive license and commercialization agreement for Lotus to commercialize LNZ100 for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia. Under the terms of the licensing and commercialization agreement, LENZ will receive up to US$125 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales. Lotus will have exclusive development, manufacturing, registration and commercialization rights for LNZ100 for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia and Singapore. More... |
| Sunny Pharmtech's gynecological drug CPT-I approved in China 13 May, 2025 Sunny Pharmtech (TW: 6676) announced that its gynecological drug, Carboprost Tromethamine Injection, has received official approval from China's National Medical Products Administration (NMPA). According to previous disclosures, the company is actively in talks with potential sales partners in China. The product contains the same active ingredient as Sunny Pharmtech's US-marketed product CPT-I, and is indicated for postpartum hemorrhage, as well as for inducing uterine cervical ripening and labor in cases of mid-trimester abortion or full-term pregnancy. More... (in Chinese) |
| AmCad BioMed's smart sleep diagnostic technology featured in international journal 13 May, 2025 AmCad BioMed (TW: 4188) continues to focus on expanding the clinical value of its products. In a recent collaboration with the University Hospital of Bern in Switzerland, the company successfully broadened the application of its AmCAD-UO system for obstructive sleep apnea (OSA), advancing it from a disease risk screening tool to a key clinical aid in treatment decision-making. This achievement was recently published in the official journal of the American Academy of Otolaryngology--Otolaryngology, Head and Neck Surgery. The study confirmed that AmCAD-UO can enhance the suitability assessment for hypoglossal nerve stimulation (HNS), paving the way for more precise treatment. More... (in Chinese) |
| United Orthopedic receives Asia's first BSI certification for Class III high-risk orthopedic medical device 12 May, 2025 United Orthopedic Corporation (TW: 4129) has announced that its U2 Total Knee System has successfully obtained the first-ever EU MDR (Medical Device Regulation) certification issued by BSI in Asia for a Class III high-risk orthopedic medical device. According to the company, this achievement demonstrates that the product meets the highest international standards for quality and safety. In addition to the certified knee system, its other products are expected to gradually obtain MDR certification between 2025 and 2027. 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 (TBIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |