Honya Medical received qualification approval under Taiwan's Act for the Development of Biotech and Pharmaceutical Industry: Deepening Roots in Taiwan and Advancing toward Global Clinical Standards

Honya Medical Co., Ltd. (hereinafter referred to as "Honya Medical"), a company dedicated to stem cell and regenerative medicine R&D, has recently achieved major milestones in both regulatory approval and clinical advancement. In addition to being certified under Taiwan’s Act for the Development of Biotech and Pharmaceutical Industry, the company has submitted an application to the Ministry of Health and Welfare (MOHW) for a multinational, multicenter Phase IIb clinical trial of its proprietary cell therapy product, MiSaver®, marking a pivotal step toward clinical validation, and on the way to roll out the Phase IIb clinical trial in multination and multicenter Milestone in Clinical Development

Clinical development of cell-based therapeutics must adhere to Good Tissue Practice (GTP) standards to ensure product quality and traceability. Despite facing recruitment delays due to the COVID-19 pandemic, Honya Medical successfully initiated its Phase I clinical trial of MiSaver® in 2020. The trial was approved by the Taiwan Food and Drug Administration (TFDA), and the company also secured GTP certification for its manufacturing facility dedicated to clinical-grade MiSaver® production—laying a critical foundation for clinical progress.

Following encouraging safety and efficacy data, Honya Medical formally submitted a Phase IIb multinational, multicenter clinical trial application in 2024. In the first half of 2025, the TFDA conducted site inspections at Honya Medical and its three collaborating hospitals.

Recognition under National Biotech Policy: Integrating Innovation, Compliance, and Operations

Honya Medical’s certification under the Act for the Development of Biotech and Pharmaceutical Industry in 2024 highlights its comprehensive strengths across innovation, clinical development, regulatory compliance, and operational excellence. This policy supports key areas such as tax incentives, funding access, and talent acquisition. It encourages both R&D and manufacturing, while also promoting emerging sectors such as regenerative and precision medicine.

Strategic Global Outreach: Showcasing at BIO Asia- Taiwan

2024 marked a strategic turning point for Honya Medical, with the appointment of Mr. Ming-Jen Hsu—founder of Elitegroup Computer Systems (ECS)—to the Board of Directors. A visionary entrepreneur known for anticipating the growth of Taiwan’s electronics industry, Mr. Hsu now sets his sights on the biotechnology field. Passionate about innovation since his youth, Mr. Hsu sees cell therapy as one of the most promising frontiers in modern healthcare, offering transformative potential in treating degenerative diseases, chronic conditions, and even cancer.

As regenerative medicine and personalized therapies rapidly advance, cell therapy is poised to reshape the future of medicine. Recognizing this opportunity, Mr. Hsu has been actively involved in biotech to position Taiwan as a leader in global medical innovation and to expand access to cutting-edge therapies.

To enhance international visibility, Honya Medical showcased its latest cell therapy innovations at the 2025 BIO Asia–Taiwan exhibition, as part of the National Science and Technology Council’s Southern Taiwan Science Park Pavilion. Mr. Hsu remarked, “Participating in BIO Asia 2025 is a strategic move in our global journey. This platform enables us to engage with leading biotech partners worldwide and unlock new opportunities for collaboration and market expansion.”

Looking Ahead: Accelerating  Progress in Clinics and Markets

Honya Medical remains committed to clinical evidence-based development, actively strengthening collaborations with hospitals, regulators, and industry partners both in Taiwan and globally. The company continues to advance MiSaver® through clinical trials and regulatory approvals with discipline and precision. While drug development demands significant expertise, innovation, targeted selection, and capital investment, it also holds vast medical impact and long-term commercial value. Honya is poised to further expand the applications of regenerative medicine and contribute to global health advancement.

About Honya Medical Co., Ltd.

Founded in 2011 and headquartered in the Southern Taiwan Science Park, Honya Medical specializes in the research, development, and commercialization of stem cell and regenerative therapies. With a proprietary cell therapy platform, the company offers end-to-end capabilities from R&D and GMP manufacturing to clinical trials and market deployment. Its core therapeutic areas include degenerative diseases, cardiovascular conditions, and neurological disorders—delivering translational solutions with strong clinical potential.

In adherence to international regulatory standards, Honya Medical actively collaborates with academic and healthcare institutions around the world. The company continues to expand its overseas clinical and commercial presence, aiming to become a globally competitive leader in cell therapy.