GWOXI Stem Cell Seizes Opportunities under Taiwan’s Dual Regenerative Medicine Acts with a Dual-Track Strategy in Stem Cell Ther
GWOXI Stem Cell (TPEx: 6704) announced today that, following the Taiwan Legislative Yuan’s enactment of the Regenerative Medicine Act and the Regenerative Medicinal Product Act (collectively referred to as the "Dual Regenerative Medicine Acts"), which establish a legal framework for cell and gene therapies, the government has released 16 draft sub-regulations, with full implementation expected by the end of 2025. In response to these regulatory developments, GWOXI Stem Cell is actively positioning to capture emerging market opportunities by strengthening its intellectual property portfolio, progressing clinical trials of its cell therapy medicines, and enhancing the manufacturing capabilities while applying PIC/S GMP certification, which is also expected to obtain the certification by the end of 2025.
As of the end of March this year, Taiwan Ministry of Health and Welfare (MOHW) had issued 13 sub-regulations under the Dual Regenerative Medicine Acts. These address key areas such as the organization of the review committee, R&D incentives, technology management, adverse event reporting, product supply chain tracking, and informed consent procedures—laying the groundwork for the institutionalization and large-scale development of regenerative medicine in Taiwan.
GWOXI Stem Cell emphasized that its long-term commitments to intellectual property and clinical development have already let to four stem cell medicines entering human clinical trials. These patents not only safeguard its R&D achievements but also provide a strong foundation for future licensing transaction and international collaboration. Among them, GXNPC1®, the company’s stem cell medicine for treating chronic stroke, has secured both composition and manufacturing process patents, and has completed Phase II clinical trials. This positions GXNPC1® to be qualify for Taiwan’s conditional approval pathway, potentially becoming the first stem cell therapy product approved to be marketed in Taiwan, benefiting patients while accelerating commercialization for the
GXNPC1® has successfully completed Phase II clinical trials.
Meanwhile, GWOXI Stem Cell’s cell manufacturing facilities are in the process of obtaining PIC/S GMP certification. Together with its well-established commercial stem cell bank and dual production lines for autologous and allogeneic stem cell therapy products, the company is positioning itself as a strategic manufacturing and collaboration hub for international companies seeking entry into Taiwan’s regenerative medicine market.
Dr. Ming-Hsi Chuang, Chairman of GWOXI Stem Cell, stated that the company will continue to align with the global trend of integrating cell therapy productization and CDMO services. Leveraging its patent portfolio, clinical data, and pharmaceutical-grade manufacturing capabilities, GWOXI aims to advance the clinical development of its product pipeline, strengthen its intellectual property, expand production capacity, and actively pursue partnerships with domestic and international partners.
GWOXI Stem Cell’s cell manufacturing facilities are on track to achieve PIC/S GMP certification.