3/3 Taiwan Life Sciences Biweekly Newsletter
2025-03-03 |
| Taiwan Life Sciences Biweekly |
| Standard Chem & Pharm Group companies achieve record-high earnings 26 February, 2025 Financial reports for last year have been released, with Standard Chem & Pharm Group, including Standard Chem & Pharm (TW: 1720), Syn-Tech Chem & Pharm (TW: 1777), and Syngen Biotech (TW: 8279), securing the top spot as the most profitable pharmaceutical group. All three firms achieved record-high revenues. More... (in Chinese) |
| Locus Cell set to complete cell therapy products plant 26 February, 2025 Locus Cell (TW: 6891) is set to complete its Zhubei plant in the Hsinchu Biomedical Science Park by August this year, with full-scale production starting in 2026. The company hosted a site visit at the Zhubei facility, with investors, major shareholders, and Locus Cell board members gathered to witness the imminent completion of Asia's largest and most advanced cell super factory. More... (in Chinese) |
| Chunghwa Telecom and Taiwan Medical Association team up for smart healthcare 25 February, 2025 Chunghwa Telecom and the Taiwan Medical Association have formed a "smart healthcare alliance," CNA reported on Tuesday. The alliance will use Chunghwa Telecom's network services to provide video consultations and at-home emergency care solutions for domestic medical institutions. Chunghwa Telecom President Lin Rong-syh said the company has supported more than 100 smart healthcare projects in Taiwan. The company will expand its video consultation platform, which complies with cybersecurity regulations and offers real-time recording. It said doctors only need to install simple settings to use the platform. More... (in Chinese) |
| UnicoCell Biomed targets exosome-based hair growth market opportunity 25 February, 2025 Unicocell Biotech (TW: 6794) announced that it has partnered with international hair salon chain MANDU International to enter the exosome-based hair growth and care market. Leveraging Unicocell's regenerative medicine stem cell-derived exosome products, the collaboration will combine the company's expertise with MANDU's network of approximately 250 stores. Unicocell specializes in stem cell-based drug development for age-related and degenerative diseases. Currently, the company is conducting Phase III clinical trials for degenerative arthritis at various partnered medical centers, with plans to complete patient enrollment by the end of this year. The observation period will last about a year, with the goal of submitting a new drug application by 2027. Unicocell's other clinical trial for stem cell treatment of chronic kidney disease has also completed Phase I/II trials, with plans to actively promote the next phases of clinical trials. More... (in Chinese) |
| Enimmune submits first registration application for EV71 vaccine in Macau 24 February, 2025 Adimmune's subsidiary, Enimmune (TW: 6564), has submitted its first registration application for the enterovirus 71 (EV71) vaccine (EnVAX-A71) to the Macau Pharmaceutical regulatory authority. Enimmune's EV71 vaccine completed its Phase III multicenter clinical trial in July 2024, with unblinding results confirming a vaccine efficacy (VE) of 99.21 percent, meeting trial indicators for protection and immune durability. In 2023, Enimmune received the first drug license in Taiwan for an enterovirus vaccine, with stable and growing sales. In July 2024, the vaccine's Phase III clinical trials in Taiwan and Vietnam were unblinded, showing a protection rate of 99.21 percent. More... (in Chinese) |
| Acer Medical pushes for transformation, expands into GenAI 24 February, 2025 Acer Medical (TW: 6857) is strengthening its AI-assisted medical device portfolio. Following the successful deployment of its flagship AI ophthalmology screening software in domestic and international markets, the company has now entered the field of chest X-ray imaging for osteoporosis screening. This year, it plans to accelerate the development of a new AI-assisted software for kidney disease, further expanding the clinical adoption of its AI-powered diagnostic tools. With the rapid advancement of generative AI (GenAI), Acer Medical is evaluating the development of specialized GenAI models tailored to different medical specialties as hospitals undergo digital transformation. More... (in Chinese) |
| NaviFUS Corp. Leverages Taiwan's Advanced Chip Technology to Lead Non-Invasive Precision Medicine for Brain Disorders Press release 20 February, 2025 NaviFUS Corp. is dedicated to advancing non-invasive treatments for complex brain disorders, a challenging area in medical innovation. By using ultrasound technology for both diagnosis and therapy, NaviFUS exceeds the signal processing capabilities of traditional medical devices. This is made possible by Taiwan's advanced chip technology, which positions NaviFUS as a global leader in focused ultrasound-based treatment solutions. This cutting-edge technology integrates ICT capabilities into high-end medical devices seamlessly. More... |
| Foresee Pharmaceuticals' prostate cancer drug enters substantive review in China 19 February, 2025 Foresee Pharmaceuticals (TW: 6576) announced that its new formulation of leuprolide acetate injectable emulsion for prostate cancer has been accepted for substantive review by China's National Medical Products Administration (NMPA). Foresee's Chinese licensing partner, Changchun GeneScience Pharmaceutical (GeneScience), submitted the marketing application for the drug on February 8, 2025. The company has since received official written confirmation from the NMPA that the application for the treatment of advanced prostate cancer has been accepted and entered the substantive review phase. More... (in Chinese) |
| Intelligene signs RNA drug co-development agreement with Australia's Kirby Institute 18 February, 2025 Intelligene Biotechnology, involved in developing innovative RNA nucleic acid drugs, has officially signed a co-development agreement with the Kirby Institute of Australia, a world-renowned research institution and organizer of Australia's BRIDGE Program (Nucleic Acid Drug Research and Development Program). Under this agreement, Intelligene will receive research resources equivalent to a maximum of AU$5 million (approximately NT$100 million) from the BRIDGE Program to accelerate the development of its new drug, IG-001. Intelligene also has plans for an initial public offering (IPO) and is expected to go public and list on the Emerging Stock Board in the first half of this year. More... (in Chinese) |
| Acepodia's cell therapy drug ACE2016 receives TFDA clinical trial approval 18 February, 2025 Acepodia-KY (TW: 6976), a next-generation allogeneic cell therapy developer, announced that its innovative cell therapy, ACE2016, designed to treat locally advanced and metastatic solid tumors expressing epidermal growth factor receptor (EGFR), has received Investigational New Drug (IND) approval from Taiwan’s Food and Drug Administration (TFDA). The company has officially initiated patient enrollment for a multinational, multi-center clinical trial aimed at evaluating the safety and tolerability of ACE2016. The company mentioned that while existing EGFR-targeted therapies face limitations due to acquired resistance and mutations, ACE2016 leverages Acepodia's proprietary Antibody-Cell Conjugation (ACC) platform to enhance treatment efficacy with allogeneic cell therapy, offering a scalable and more effective alternative. More... (in Chinese) |
| TAHO Pharma's apixaban oral strips equivalent to Eliquis in pivotal trial 18 February, 2025 TAHO Pharmaceuticals's (TW: 6467) apixaban-based oral dissolving strips were discovered to be a bioequivalent of Pfizer and Bristol-Myers Squibb's (BMS) Eliquis in a Phase II trial. The randomised open-label pivotal trial (NCT06689436) enrolled 60 healthy volunteers. Of those, 48 went on to complete the trial over four arms, two of who were made to fast for ten hours and the other two being fed. One group from each was given apixaban, dubbed TAH3311, with the other two given an Eliquis tablet. Results found the maximum plasma concentration in patients dosed with TAH3311 was equivalent to Eliquis, which is approved in the US and Europe. More... |
| Handa Pharmaceuticals' blood cancer drug attracts US licensing interest 17 February, 2025 Handa Pharmaceuticals (TW: 6620) is attracting strong interest from the US for the licensing of its FDA-approved oral blood cancer drug, Phyrago. A licensing deal, expected by late February, could bring in at least US$15 million (NT$490 million), with revenue reflected in Q1 financial reports. Phyrago is set to launch in the US in March, contributing to Q2 sales. As a generic version of a Bristol-Myers Squibb drug with a US$900 million annual market, Phyrago holds orphan drug designation (ODD), granting three years of market exclusivity. Handa Pharmaceuticals is also applying for Orphan Drug Exclusivity (ODE), which, if approved, could extend exclusivity to seven years. More... (in Chinese) |
| PharmaEssentia secures S&P Sustainability Yearbook spot, ranked in top 5 percent of global biotech industry 12 February, 2025 PharmaEssentia (TW: 6446) has been recognized for its ESG excellence, securing a spot in the S&P Global Sustainability Yearbook for the second consecutive year. The company ranked in the top 5 percent of the global biotech industry and received the "Industry Mover" award for significant progress. It remains the only Taiwanese biotech firm included, reflecting its strong sustainability and corporate governance performance. The S&P Global 2025 evaluation assessed 7,690 companies across 62 industries, with only 75 firms ranking in the top 5 percent and 12 in the biotech category. This achievement enhances PharmaEssentia's international visibility and credibility among global investors. More... (in Chinese) |
| Lotus Announces TFDA approval for Adcirca for PAH treatment 12 February, 2025 Lotus Pharmaceutical Co., Ltd. (TW: 1795), a leading global pharmaceutical company, announces that Adcirca (tadalafil) has been approved by the Taiwan Food and Drug Administration (TFDA) for treating pulmonary arterial hypertension (PAH). PAH is a rare, progressive disease with no cure. The 2022 ESC/ERS Guidelines recommend tadalafil as the only Class I therapy in combination with endothelin receptor antagonists (ERAs) for first-line treatment. Previously, cardiologists in Taiwan relied on another PDE5 inhibitor with weaker evidence in combination therapy. More... |
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