11/24 Taiwan BIO Weekly
2025-11-24 |
| Taiwan BIO Weekly |
| Medigen Biotechnology's OBP-301 receives preliminary orphan drug designation in Japan 21 November, 2025 Medigen Biotechnology (TW: 3176) announced that its new drug for esophageal cancer OBP-301 has received preliminary orphan drug designation from Japan's Ministry of Health, Labour and Welfare. The company plans to submit a market application for OBP-301 to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) by the end of December 2025. More... (in Chinese) |
| TCM Biotech International passes stock listing review 21 November, 2025 The Taiwan Stock Exchange Securities Listing Review Committee has approved TCM Biotech International (TW: 4169) for its initial stock listing application, subject to final approval. From 2022 to 2024, the company reported pre-tax net profits of NT$23 million, NT$22 million, and NT$25 million, with earnings per share of NT$0.38, NT$0.35, and NT$0.36, respectively. For the first three quarters of this year, pre-tax net profit reached NT$27 million, with earnings per share of NT$0.40. TCM Biotech International primarily engages in biotech drug development, pharmaceuticals and medical devices sales, and the production and sale of functional foods and raw materials. More... (in Chinese) |
| Standard Chem & Pharm sales grow in both Taiwan and Japan, building momentum for 2026 21 November, 2025 Standard Chem & Pharm (TW: 1720) announced at a recent earnings briefing that Taiwan and Japan will be the core markets driving the company's future growth. In Taiwan, five new products are expected to launch next year, including two first-to-market generic drugs. In Japan, two CDMO collaboration projects have entered regulatory review, which is expected to add momentum to operations in 2026. For the first three quarters of this year, Standard Chem & Pharm reported net profit after tax of NT$698 million, with earnings per share of NT$3.91, setting a record high for the same period. More... (in Chinese) |
| Handa Pharmaceuticals plans to list on Taiwan's OTC market in late December 20 November, 2025 Handa Biotech plans to list on Taiwan's OTC market in late December, with operations driven by improved new drugs and high-technology generics. The company also stated that it aims to secure FDA approval for at least one drug annually. This year, the company has already launched a leukemia drug and obtained generic drug approval. After a previous listing attempt was withdrawn due to reporting issues, Handa resubmitted its OTC application in August, which was approved by the Taiwan OTC Exchange in October. More... (in Chinese) |
| Ever Supreme Bio and Shine-On BioMedical receive National Drug Technology R&D Awards 20 November, 2025 Ever Supreme Bio Technology (TW: 6712) and Shine-On BioMedical (TW: 6926) have received recognition in the 2025 National Drug Technology R&D Awards, in the pharmaceuticals category. Ever Supreme Bio received bronze for CAR001, a CAR-T therapy using non-viral CAR technology and dual-targeting HLA-G/PD-L1, currently in Phase I/IIa trials in Taiwan and the US. Shine-On BioMedical won silver for tri-specific nanobody SOA101, targeting PD-L1/HLA-G to boost T-cell activation and tumor penetration, also in Phase I/IIa trials. The awards highlight Taiwan's strengths in cell therapy and antibody drug development, combining R&D, clinical progress, and global collaboration. More... (in Chinese) |
| GlycoNex partners with Japan's Hokkaido University Hospital to conduct GNX1021 gastric cancer R&D 20 November, 2025 GlycoNex (TW: 4168) has signed a collaborative research agreement with Japan's Hokkaido University Hospital to conduct precision-medicine studies on its next-generation ADC, GNX1021, marking a key milestone ahead of its planned Phase I trial in Japan in 2026. The partnership will analyze the expression of the GNX1021-targeted glycan antigen in Japanese gastric cancer tissues and compare it with biomarkers such as HER2, CLDN18, and PD-L1, aiming to identify patients most likely to benefit and strengthen GNX1021's clinical development strategy. More... (in Chinese) |
| PharmaEssentia to invest US$50 million to build manufacturing plant in the US 20 November, 2025 PharmaEssentia (TW: 6446) plans to expand its manufacturing footprint by investing over US$50 million (around NT$1.56 billion) in a new protein API plant in the US, alongside its Taiwan base, with construction starting in the first half of next year and completion expected by year-end. The company has applied to the US FDA for a new indication in essential thrombocythemia (ET) for its Ropeginterferon alfa-2b (Ropeg) drug, targeting approval in late 2026. More... (in Chinese) |
| Taiwan CareTech Alliance Enters Japan's Aging Market with Smart Elderly Care Products 18 November, 2025 As Japan transitions into a super-aged society, the demand for long-term care and assistive technologies is growing rapidly. Therefore, Taiwan's smart assistive device SME, Netown Corporation, has partnered with 9 Taiwanese manufacturers, software developers, and service providers to establish the Taiwan CareTech Alliance [English translation of the Japanese]. The alliance aims to bring Taiwan's high-quality smart elderly care solutions to Japan. More... |
| Taiwan Advances AI-Powered Precision Medicine 17 November, 2025 Taiwan is highlighting its strong position in global medical technology at MEDICA, one of the world's largest medical trade fairs. As one of the leading exhibiting nations, Taiwan is showcasing its innovation and industrial expertise at this year's event. More than 250 Taiwanese companies are presenting state-of-the-art solutions for intelligent diagnostics, robotics, and digital healthcare from November 17 to 20 at Messe Dusseldorf. More... (in Chinese) |
| OBI-902 has been granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma Press release 17 November, 2025 OBI Pharma (TW: 4174), a clinical-stage oncology company, received notification from the US FDA stating that the request for Orphan Drug Designation of OBI-902 TROP2 ADC for the treatment of Cholangiocarcinoma has been granted. OBI-902 is the first OBI-developed ADC that incorporates our proprietary site-specific glycan-conjugated ADC enabling technology. Cholangiocarcinoma is a rare and lethal malignancy with fewer than 50,000 patients in the United States and a 5-year survival rate ranging from 2% and 23% depending on disease stage, histological subtype, and localization. At present, there are no FDA approved ADC therapies for cholangiocarcinoma. More... |
| Taiwan's CMUH Completes HIMSS "Grand Slam," Achieving DIAM Stage 7 Certification Press release 17 November, 2025 China Medical University Hospital (CMUH) has secured one of the world's highest honors in digital health, becoming the first hospital in Taiwan to achieve Stage 7 certification under the HIMSS Digital Imaging Adoption Model (DIAM). The designation, awarded by the U.S.-based Healthcare Information and Management Systems Society (HIMSS), represents the pinnacle of excellence in medical imaging worldwide. More... |
| Taiwan's Adimmune to expand enterovirus vaccine into Vietnam 13 November, 2025 Adimmune Corp. (TW: 4142) will launch its enterovirus vaccine in Vietnam by the end of next year, marking its first entry into the Southeast Asian market for this vaccine. Adimmune Chair Steve Chan said the company's Taichung cell culture plant has received Thailand's Good Manufacturing Practice certification, paving the way for the expansion of its enterovirus vaccine into Southeast Asia. More... |
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