| Date |
Subject |
Media |
| 2025-07-02 |
Heron Neutron Medical Aims to Go Public by Year-End, Pushing Taiwan-Made BNCT onto the Global Stage
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Heron Neutron Medical, a subsidiary of the Hermes Technology Group, is accelerating its efforts to commercialize its accelerator-based boron neutron capture therapy (AB-BNCT). The company obtained medical device approval for its AB-BNCT system in 2024, and its companion drug B10 L-BPA for head and neck cancer is currently in Phase II clinical trials, with patient enrollment expected to be completed by the end of this year. General Manager Shen Leo emphasized that BNCT is Taiwan’s only domestically developed large-scale medical device, and with supportive government policy, it has the potential to represent Taiwan on the global stage—not only by advancing from late-line to second-line treatment locally, but also by facilitating international deployment through whole-plant exports. |
| 2025-07-02 |
Onyx Healthcare Builds Third Growth Engine, High-Margin Projects to Continue Shipping in H2 with Positive Outlook for the Year
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Onyx Healthcare is developing a third growth engine, according to General Manager Fu-Chun Chuang. The company’s two core businesses continue to advance steadily, while its new full-scale medical device contract manufacturing (CM) business is set to launch following GMP (now QMS) certification. This initiative focuses on mass production of existing, already-approved devices, aiming to begin contributing to revenue within four to six months. Although gross margin faced headwinds in the first quarter, high-margin project clients remain stable, with shipments expected in the second half of the year, supporting a cautiously optimistic full-year outlook. |
| 2025-07-02 |
UNICOCELL BIOMED Submits Listing Application, Eyes Board Transition in Q4
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UNICOCELL BIOMED has officially submitted its listing application to the Taiwan Stock Exchange, following the receipt of approval as a technology-based enterprise. With two of its allogeneic adipose-derived stem cell therapies already in mid- to late-stage clinical trials, and operations showing steady progress, the company is widely expected to complete its board transition by the fourth quarter. |
| 2025-07-02 |
Merry Life’s Alzheimer’s Drug TML-6 Receives FDA Approval for Global Phase II Clinical Trial
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Merry Life Biomedical announced on the 23rd that its investigational new drug for Alzheimer’s disease (AD), TML-6, has received FDA approval to initiate a global Phase II clinical trial. Following the launch of its Phase I trial in the U.S. in June last year, the FDA formally approved Merry Life’s Phase II clinical trial protocol in May this year. The trial is scheduled to begin in the first quarter of 2026, enrolling 210 participants for a 12-month study. |
| 2025-07-02 |
EU MDR Fully Enforced by 2028: Sixteen Taiwanese Companies, Including Qisda and United Orthopedic, Secure Early Market Access
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The European Union’s new Medical Device Regulation (MDR) is set to be fully implemented by the end of 2028. At present, only 16 Taiwanese manufacturers—including Qisda, AmCad BioMed, PACIFIC HOSPITAL SUPPLY, United Orthopedic, Avita, Wellell, and Visco Vision—have successfully obtained MDR certification, securing their entry into the EU market. Older certificates issued under the former MDD framework for invasive, moderate- to high-risk devices expired at the end of last year, posing a major challenge for companies seeking to maintain or expand their European market presence. |
| 2025-07-02 |
TaiMed Biologics Announces Phase IIb Clinical Trial of TMB-365/380, Marking a Major Milestone in Transforming HIV Treatment
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TaiMed Biologics announced on the 22nd the official launch of its Phase IIb clinical trial for the combination therapy TMB-365/380. The trial’s primary efficacy endpoint will evaluate the proportion of participants with HIV-1 RNA below 50 copies/mL at week 48, based on the Snapshot analysis method. In addition to expanding the number of participants, the trial will also extend its geographic scope beyond the United States to include Taiwan, with a total enrollment target of 75 subjects. |
| 2025-07-01 |
CHC Healthcare Group Targets Profit Growth with Three Strategic Initiatives
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CHC Healthcare Group is set to ramp up activity across its three major business divisions in the second half of the year. The company announced that, driven by a wave of equipment replacements at hospitals, many institutions are expanding their procurement of new medical devices, with revenue from these orders expected to be recognized starting in the third quarter. In addition, the appreciation of the New Taiwan dollar is favorable for equipment purchases, leading to a projected increase in both revenue contribution and profitability from the medical equipment segment this year. |
| 2025-07-01 |
Genomics BioSci & Tech. Targets Profitability and Launches IPO Plan for 2025
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Genomics BioSci & Tech. (Genomics) held its annual shareholders’ meeting on the 20th, approving a cash capital increase through public offering in preparation for its initial public offering (IPO). Shareholders also agreed to waive their preemptive rights, officially initiating the company’s IPO process. Chairman Meng-Hsien Chou stated that following a strategic business realignment, the company is now focused on revenue growth and aims to achieve profitability this year. |
| 2025-07-01 |
The 2026 World Congress of Internal Medicine to Be Held in Taiwan: Ming-Shiang Wu Hopes to Showcase Taiwan's Medical Strength
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In a major step toward elevating Taiwan’s global visibility in healthcare and realizing the vision of a “Healthy Taiwan,” the Taiwan Society of Internal Medicine has successfully secured the bid to host the 2026 World Congress of Internal Medicine. The Society announced that the event will bring together over 8,000 internists, scholars, and researchers from around the world to Taiwan. The congress will focus on the importance of preventive medicine in internal medicine, particularly the critical role of adult vaccination in enhancing public health. Through cross-sector collaboration and policy advocacy, the event aims to demonstrate Taiwan’s strong commitment to improving healthcare quality and extending healthy life expectancy. |
| 2025-07-01 |
Locus Cell Secures Another International Order, Partners with Japan’s CellFiber to Expand Global CDMO Footprint
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On the 19th, Locus Cell announced the signing of a CDMO (Contract Development and Manufacturing Organization) agreement with CellFiber, a leading regenerative medicine company in Japan. Under the agreement, Locus Cell will support the production of clinical-grade products, with the total value estimated to exceed tens of millions of New Taiwan dollars. With the company’s fully automated GMP-compliant smart facility in Zhubei set to be completed by the end of the year, Locus Cell expects to seamlessly scale up to mass production and sees strong potential for expanding its CDMO business. |
