GWOXI Stem Cell Capitalizes on Super-Aged Society and Taiwan’s Regenerative Medicine Act; Stem Cell Therapy Product for Chronic
Gwo Xi Stem Cell Chairman, Dr. Ming-Hsi Chuang
With the passage of Taiwan’s dual regenerative medicine laws this June, the biotech sector is closely watching which domestic company will first obtain marketing approval and advance into international markets as a unicorn in cell therapy. As one of the earliest Taiwanese stem cell therapy companies, Gwo Xi Stem Cell (TPEx: 6704) has, over the past decades, secured more than 100 patents across Taiwan, China, the United States, and other five countries. Among its four pipeline stem cell therapies, several are advancing toward commercialization, with its chronic stroke therapy GXNPC1® emerging as the frontrunner, potentially accelerating marketing approval through conditional approval.
Chairman Dr. Ming-Hsi Chuang stated that since Gwo Xi Stem Cell established its operations in the Hsinchu Biomedical Science Park in 2011, the company has consistently advanced cell therapy technologies. Within its five-story facility, Gwo Xi Stem Cell has independently developed a GMP-grade stem cell manufacturing platform and the core technology named Nigiro-Med®, both of which are applied to address unmet medical needs. Building on its academic research foundation and close collaborations with medical institutions, Gwo Xi Stem Cell has developed four stem cell medicines, targeting liver cirrhosis, chronic stroke, osteoarthritis, and diabetes—disease areas with rapidly increasing healthcare demand in Taiwan.
Gwo Xi Stem Cell Builds a Strong Patent Portfolio to Advance Stem Cell-Based Therapeutics: Leading in Stroke, Expanding Internationally in Diabetes
Dr. Ming-Hsi Chuang emphasized, “Gwo Xi Stem Cell’s positioning within the cell therapy industry chain has always been very clear: we approach stem cells with the mindset of pharmaceutical drug development. During preclinical research, we do not simply adopt a single specialized process for broad applications; rather, we focus on the underlying mechanisms to develop products, with each indication supported by its corresponding stem cell processing protocol.” Dr. Migh-His Chuang further noted that, given Gwo Xi Stem Cell’s strong emphasis on the continuum from research and development to clinical translation, the company has secured more than 100 patents across Taiwan, China, the United States, and other 5 countries, thereby reinforcing its comprehensive intellectual property strategy.
Gwo Xi Stem Cell’s four stem cell therapy products are undergoing clinical development.
Among Gwo Xi Stem Cell’s four investigational cell therapies, the most advanced are GXCPC1®, for which a Phase III clinical trial application was submitted in September this year, and GXNPC1®, which, in collaboration with Dr. Shinn-Zong Lin, Superintendent of Hualien Tzu Chi Hospital, successfully completed its Phase II clinical trial report in September and is now preparing to advance into Phase III. GXNPC1® is expected to become Gwo Xi Stem Cell’s first independently developed and commercialized cell therapy. This therapy is based on autologous adipose-derived stem cells and administered through intracerebral injection. In the Phase II clinical trial, 15 stroke patients treated with GXNPC1® exhibited therapeutic effects within two weeks. In particular, patients in the high-dose cohort demonstrated a mean improvement of 1.2 points on the NIHSS neurological function scale at week two, with continued improvement reaching a mean of 2.7 points by week 24. Notably, 89% of patients showed post-treatment neurological functional improvement.
Dr. Ming-Hsi Chuang noted that the indication for GXNPC1® falls under the “Dual Regenerative Act” criteria for severe disability or life-threatening conditions. Following regulatory review and confirmation of safety and preliminary efficacy, the stem cell therapy product could be granted a conditional approval for up to five years, thereby addressing the growing domestic demand for stroke treatments.
Another significant milestone for Gwo Xi is its allogeneic stem cell therapy for diabetes, GXIPC1®. According to Dr. Chuang, through collaboration with VINMEC Medical Center in Vietnam, Gwo Xi has completed the cell manufacturing process in Taiwan and transported the cell products via cold-chain logistics to Vietnam for a Phase I clinical trial. The trial has successfully enrolled and treated 10 patients, with clinical outcomes pending completion of follow-up assessments.
Vertical Integration of Cell Supply Chain and PIC/S GMP Expansion
Dr. Chuang also highlighted that the clinical results of Gwo Xi Stem Cell’s stem cell medicines for liver cirrhosis, chronic stroke, and osteoarthritis have been published in journals including Cell Transplantation and the Journal of Tissue Engineering and Regenerative Medicine, in addition to patent filings. Beyond drug R&D, the company has established a GTP cell processing center (CPC), offering services in clinical cell storage, cell product QC testing, and clinical grade cell bank sharing for use as starting material in clinical therapies.
Furthermore, Gwo Xi Stem Cell is upgrading its second facility into a PIC/S GMP-compliant cell factory, providing contract manufacturing services while supporting the translation of its own product pipeline. Leveraging its strong foundation in cell therapy, Gwo Xi Stem Cell has expanded into exosome innovation, offering product development, testing, and CDMO services. The company has already applied for an INCI name for its exosome products and submitted a Drug Master File (DMF) to the U.S. FDA. Collaborations with National Tsing Hua University and National Yang Ming Chiao Tung University are also advancing automation in cell processing technologies. With Taiwan’s exosome sector rapidly growing, Gwo Xi Stem Cell is positioning itself as an active participant, engaging in multiple CDMO service discussions.
Gwo Xi Stem Cell’s GTP cell processing center (CPC), offering clinical storage, testing, and clinical grade cell bank sharing service.
Looking ahead, Dr. Ming-His Chuang explained that Gwo Xi Stem Cell’s primary strategy is to prioritize domestic drug approval, while pursuing out-licensing and strategic partnerships internationally. Over the next three to five years, the company aims to secure conditional approvals for rapid market entry, achieve formal GMP certification for production facilities, and conduct multi-center Phase III trials. These steps will further strengthen Gwo Xi Stem Cell’s capacity and competitiveness in cell therapy industry.