| Date |
Subject |
Media |
| 2025-09-10 |
Foresee Pharmaceuticals’ Three-Month Prostate Cancer Therapy CAMCEVI Secures FDA Approval
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Commercial Times |
| 2025-09-10 |
Adimmune Corporation Secures Brazil GMP Certification Again, Paving the Way for Influenza Vaccine Market Entry in the Southern Hemisphere
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Adimmune Corporation announced yesterday (26th) that it has received official notification from Brazil’s National Health Surveillance Agency (ANVISA) confirming Good Manufacturing Practice (GMP) certification. The company stated that this certification marks a significant milestone in advancing its influenza vaccine registration process in Brazil. Adimmune expects to obtain regulatory approval for its influenza vaccine in Brazil by the end of 2026, enabling its formal entry into the Southern Hemisphere market. |
| 2025-09-10 |
OBI Pharma’s Subsidiary OBIGEN Pharma Reports Positive Phase II Trial Results for Next-Generation Botulinum Toxin; Plans Taiwan Emerging Stock Board Listing by Year-End
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OBIGEN Pharma, a subsidiary of Taiwan-based OBI Pharma, announced on the 26th that its independently developed next-generation botulinum toxin, OBI-858, has successfully met the primary efficacy endpoint with statistical significance in its first human Phase II clinical trial (OBI-858-002). Two pivotal Phase III trials for OBI-858 have recently been approved by the Taiwan Food and Drug Administration (TFDA). To support international expansion, OBIGEN plans to launch a cash capital increase in the fourth quarter of this year and aims to apply for listing on Taiwan’s Emerging Stock Board before year-end. |
| 2025-09-10 |
BioGend Turns Profit in July; Bone Growth Factor Clinical Trial Results to Be Unblinded in Q3
|
At the corporate briefing on the 25th, BioGend Therapeutics Chairman Te-Li Chen announced that the company’s operations are experiencing rapid growth, with several core technologies entering the harvest stage. Among them, results from the bone growth factor clinical trial will be unblinded in the third quarter, while licensing negotiations for RevoCart are expected to be completed within the year. |
| 2025-09-10 |
Gongwin Biopharm Holdings’ New Lung Cancer Drug Pirotinib (Proxanib) Passes Preliminary Review for China’s “Dual Reimbursement” Drug List
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Gongwin Biopharm Holdings’ new lung cancer drug Proxanib (PTS-302, Toluene Sulfonyl Urethane Injection) has taken another step forward in entering the Chinese market. On the 25th, the drug successfully passed the preliminary formal review for inclusion in the 2025 National Basic Medical Insurance Drug List in China. Notably, it is among the few drugs that also passed the preliminary formal review for the Commercial Health Insurance Innovative Drug List (“Commercial Insurance List”). According to the company, if the subsequent expert evaluations, negotiation, and pricing discussions proceed smoothly, Proxanib will be formally included in the “dual reimbursement” system, enabling rapid market expansion and potentially driving a significant surge in revenue. |
| 2025-09-10 |
Enimmune’s Kawasaki Disease Diagnostic Software Aims for Market Launch by End of 2026
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Enimmune Corporation yesterday (25) announced that its AI-powered Kawasaki disease risk assessment software, PEKAN, has successfully completed clinical performance studies at two major medical centers in Taiwan. Results showed that PEKAN demonstrated stable and highly accurate clinical differentiation, with an accuracy rate reaching 90%, laying a solid foundation for AI-based medical device applications in pediatrics. The company is now preparing for regulatory approval under Taiwan’s Medical Device Act as a Class II medical device, with the goal of securing TFDA registration and launching by the end of 2026. Enimmune also plans to accelerate international expansion, initially targeting Asian markets through clinical collaborations and licensing partnerships. |
| 2025-09-10 |
Government to Launch Health Data Service Company with Backing from Tech Giants and Major Medical Centers
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Wu, Cheng-Wen, Minister without Portfolio of the Executive Yuan, announced yesterday (25) that the government will follow through on the recommendations made during last year’s Biotechnology Industry Strategy and Advisory Council (BTC) meeting and establish a Health Data Service Company this year. This national-level company, combining artificial intelligence (AI) with health data, has already secured support from leading technology firms such as Quanta, Wistron, Catcher Technology, Delta Electronics, Elan Microelectronics, as well as from major medical centers including National Taiwan University Hospital, National Cheng Kung University Hospital, Taipei Veterans General Hospital, and Kaohsiung Medical University Hospital. |
| 2025-09-10 |
TaiMed Biologics Driven by Three Growth Engines; CEO: Major Business Transformation Expected by 2026
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TaiMed Biologics CEO Jin-Mei Chang said on August 22 that the company is focused on three major growth drivers: rising sales of Trogarzo and expanding CDMO revenues, accelerated Phase II clinical development and licensing of its next-generation HIV therapies TMB-365/TMB-380, and advances in its antibody-drug conjugate (ADC) platform. He projected that 2026 will mark a turning point for the company’s operations. |
| 2025-09-10 |
ABC-KY Posts NT$1 Loss Per Share in H1; New Diagnostic Target Expected to Enter Major Clients by Year-End
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Applied Biocode Corp. (ABC-KY) reported nearly 30% year-on-year revenue growth in the first half of 2025 but still posted a net loss of NT$103 million, equivalent to a loss of NT$1 per share. Management noted that a leading U.S. molecular diagnostics laboratory will begin adopting more of the company’s flagship products in the second half, alongside phased purchases of multiple MDx3000 fully automated molecular diagnostic systems, expected to provide significant growth momentum. Its new “STI+AMR” (Sexually Transmitted Infections plus Antimicrobial Resistance) assay is currently undergoing testing with three major clients and could enter routine clinical use before the end of the year. |
| 2025-09-10 |
Luo Lih-Fen Holding Q2 Gross Margin Surges, EPS at NT$1.38 Marks 18-Quarter High, Three Channels Drive Strong Outlook for H2
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Beauty channel operator Luo Lih-Fen Holding (羅麗芬-KY) saw simultaneous growth across its three major sales channels in the first half of the year, driving a sharp rebound in Q2 profitability. Gross margin jumped to 69.61%, up 6 percentage points year-on-year and 9 percentage points quarter-on-quarter, boosting core earnings. Earnings per share (EPS) reached NT$1.38, the highest in 18 quarters. Looking ahead, the company is targeting e-commerce demand during the “Double 11” shopping season, launching three new products under its namesake skincare brand in Q4. Combined with the opening of more community-based stores and seasonal demand in the second half, operations are expected to outperform the first half. |
