06/24 Taiwan BIO Weekly
2025-06-24 |
| Taiwan BIO Weekly |
| EirGenix submits additional data to US FDA for Sandoz-licensed biosimilar EG12014 19 June, 2025 EirGenix (TW: 6589) announced that its licensing partner, Sandoz, has submitted a biosimilar drug EG12014 (Trastuzumab biosimilar) 150 mg lyophilized injection for a regulatory review with the US FDA. More... (in Chinese) |
| Locus Cell secures multi-million NTD CDMO order, partners with Japan's CellFiber for cell manufacturing scale-up Press release 19 June, 2025 Locus Cell (TW: 6891) announced that it has secured a CDMO order by signing a cooperation agreement with Japanese regenerative medicine company CellFiber. Locus Cell will assist in producing clinical-grade products to achieve large-scale cell manufacturing, with the total contract value estimated to exceed tens of millions of New Taiwan Dollars. More... (in Chinese) |
| TAHO Pharmaceuticals releases pivotal trial data for antithrombotic in oral film form 18 June, 2025 TAHO Pharmaceuticals (TW: 6467) has presented the final results of its pivotal trial for TAH3311 Apixaban antithrombotic oral dissolving film (ODF) at BIO 2025 in Boston, USA. The trial successfully met its endpoints, showcasing TAHO's innovation in cardiovascular drug development through oral film formulations designed to address the unmet clinical needs of patients with swallowing difficulties. TAHO noted that Apixaban is the world's best-selling anticoagulant, yet currently only available in tablet form. TAH3311 utilizes the company's Transepithelial Delivery System (TDS) to develop Apixaban into an oral dissolving film (ODF), classified as a 505(b)(2) new dosage form drug. More... (in Chinese) |
| Jyong Biotech Ltd. closes US$20 million initial public offering on Nasdaq 18 June May, 2025 Jyong Biotech Ltd., a Taiwan-based biotechnology company focused on developing innovative plant-derived drugs for urinary system diseases, announced the closing of its initial public offering (IPO) on June 18, 2025. The IPO raised approximately $20 million by offering 2,666,667 ordinary shares at $7.50 each, with trading commencing on Nasdaq under the ticker symbol "MENS." The company plans to allocate the proceeds for various clinical trials and general corporate purposes. More... |
| Instant NanoBiosensors' ultra-sensitive blood test for dementia and precision leukemia therapy showcased at BIO 2025 18 June, 2025 The Taipei City Government led six Taipei-based biotech companies to participate in BIO 2025, held this year in Boston, USA. Among them, Instant NanoBiosensors, focused on dementia and precision diagnostics, showcased its core technology in embedded precision medicine, including an ultra-sensitive blood test for Alzheimer's disease proteins and a precision medicine solution for leukemia. More... (in Chinese) |
| JUN ZHI Biomedical signs MOU with University of South Australia to globalize nano mass spectrometry platform technology 18 June, 2025 JUN ZHI Biomedical has signed a Memorandum of Understanding (MOU) with the University of South Australia for the two parties to jointly promote the clinical application of JUN ZHI Biomedical's innovative Nano Mass Spectrometry Detection Platform in Australia and collaborate to expand its presence in the international market. More... (in Chinese) |
| PharmaEssentia's new drug Ropeg wins regulatory approval in Argentina, following Brazil success 18 June, 2025 PharmaEssentia (TW: 6446) announced that its new drug Ropeginterferon alfa-2b (Ropeg) has been approved by Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) for the treatment of polycythemia vera (PV). Following the PV drug approval in Brazil in March, this marks another milestone in PharmaEssentia's expansion into the Latin American market, further extending its global business footprint. Ropeg is a next-generation, long-acting innovative interferon developed and manufactured in-house. It has already been approved for PV treatment and launched in about 40 countries worldwide, including major pharmaceutical markets such as the EU, US, and Japan. Global patient usage and sales of the drug continue to grow steadily. More... (in Chinese) |
| Brain Navi achieves US FDA approval for neurosurgical robot NaoTrac Press release 17 June, 2025 Brain Navi Biotechnology, a medical robotics company founded in 2015 in Taiwan by surgeon and serial entrepreneur Jerry Chen, has reached another major milestone. Following previous approvals from the Taiwan Food and Drug Administration (TFDA) and the CE Mark for Europe, Brain Navi has now received FDA 510(k) clearance for its stereotaxic guiding surgical device, NaoTrac -- reinforcing our commitment to innovation, patient safety, and continuous improvement in the neurosurgical field. More... |
| GlycoNex to submit clinical trial application for new drug GNX1021 in Q1 next year 17 June, 2025 GlycoNex (TW: 4168) announced that its antibody-drug conjugate (ADC) GNX1021 has demonstrated outstanding efficacy in animal studies. In addition to showing strong tumor suppression activity in gastric cancer models, the drug also holds promise as a novel treatment option for patients with gastric cancer who are ineligible for HER2 or CLDN18 targeted therapies. The company plans to submit a Phase I clinical trial application in Taiwan and Japan in Q1 next year. More... (in Chinese) |
| HanchorBio to debut on Emerging Stock Board June 20, focused on immuno-oncology drug development 17 June, 2025 HanchorBio-KY (TW: 7827), a biotech company focused on the development of innovative immuno-oncology biologics, will debut on Taiwan's Emerging Stock Board on June 20. Building on its proprietary FBDB platform, HanchorBio is developing fusion protein biologics targeting specific immune evasion pathways in tumor cells, with the potential to surpass current PD-1/PD-L1 immunotherapies. In a press briefing, the company stated that its FBDB (Function-Based Design of Biologics) platform enables the flexible construction of multifunctional biologics. By assembling multiple anti-cancer molecules into a single biologic, the platform facilitates multi-target mechanisms that activate both the innate and adaptive immune systems, thereby enhancing tumor-killing efficacy. More... (in Chinese) |
| Arce Therapeutics enrolls first patient in US Phase I/II trial for ARD103 CAR-T therapy 17 June, 2025 Arce Therapeutics, a subsidiary of Compal Group, specializing in cell and gene therapy development, announced that its new cell therapy drug ARD103 CAR-T for treating the rare disease acute myeloid leukemia (AML) has enrolled its first patient in a Phase I/II clinical trial at Novant Health Cancer Center in Charlotte, North Carolina, USA. The patient has received CAR-T infusion. More... (in Chinese) |
| MegaPro Biomedical's New Drug Receives FDA Approval for Accelerated Approval Pathway 16 June, 2025 MegaPro Biomedical (TW: 6827) announced that the company's new drug formulation MPB-1734, developed for the treatment of prostate cancer, has received approval from the US FDA to pursue registration via a bioequivalence (BE) bridging study under the 505(b)(2) regulatory pathway. In addition, its diagnostic agent for hepatocellular carcinoma, MPB-1523, is on track to file for Phase III clinical trials in the US and China by the end of this year, along with plans to initiate out-licensing discussions. Both new drug candidates are aiming for New Drug Application (NDA) submissions in 2028. 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 (Taiwan BIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |