GWOXI Stem Cell (6704) announced today that since the Legislative Yuan passed the Regenerative Medicine Act and the Regulations for Regenerative Medicine Products (collectively, the "Regenerative Medicine Dual Laws"), which provide a legal framework for cell and gene therapies, 16 draft sub-regulations have been successively issued and are expected to be fully implemented by the end of this year. In response to this trend, GWOXI will target potential business opportunities by building its patent portfolio and advancing the clinical validation of its new cell drugs, while continuing to strengthen its cell manufacturing capabilities and actively obtaining PIC/S GMP certification.
As of the end of March, the Ministry of Health and Welfare (MOHW) has already announced 13 sub-regulations under the Regenerative Medicine Dual Laws, covering areas such as the organization of review committees, R&D incentives, technology management, adverse event reporting, supply chain tracking for preparations, and informed consent procedures. This is propelling Taiwan's regenerative medicine toward institutionalization and large-scale development.
GWOXI stated that its long-term focus on a patent portfolio and clinical validation has not only successfully advanced four new stem cell drugs into human trials but has also built a foundation for licensing negotiations and international collaboration through its patent strategy. Among these, the new stem cell drug for chronic stroke, GXNPC1, has not only obtained patents for its manufacturing method and composition but has also completed Phase II clinical trials. It is now qualified to apply for conditional approval, a pathway that is expected to make it the first product in Taiwan to receive market approval, benefiting patients and accelerating the commercialization process.
Concurrently, GWOXI's cell manufacturing facility is actively applying for PIC/S GMP certification. It is expected to be paired with a commercial stem cell bank with comprehensive data, integrating dual production lines for autologous and allogeneic cell production. In the future, this facility is poised to become a key collaboration platform for foreign companies entering the Taiwanese market.
GWOXI Stem Cell Chairman Chuang Ming-hsi pointed out that GWOXI will follow the global trend of cell therapy becoming a drug and CDMO integration. By leveraging its patent portfolio, clinical evidence, and international-grade manufacturing capabilities, the company will continue to strengthen its clinical development, enhance its patents, and expand production capacity while actively collaborating with both domestic and international partners.
