GWOXI's GXCPC1 Enters Phase III Clinical Trials

Yesterday evening, GWOXI Stem Cell (6704) issued a significant announcement stating that the Phase III clinical trial for its allogeneic adipose stem cell drug, GXCPC1, for the treatment of osteoarthritis, has been approved by Taiwan's Ministry of Health and Welfare (MOHW). This makes it one of the few stem cell new drugs in Taiwan to successfully advance to this late-stage clinical trial.

GWOXI Stem Cell stated that GXCPC1 is an allogeneic adipose stem cell therapy with the dual properties of immunomodulation and cartilage repair. Administered via a simple knee joint injection, it can quickly relieve pain and improve function. The therapy doesn't require hospitalization or surgery, which increases patient acceptance and convenience.

According to the results of the Phase I/II clinical trials, patients showed a significant reduction in pain within one week of receiving GXCPC1 treatment. After 24 weeks, their improvement reached 42.29 points, which significantly enhanced their quality of life. No major side effects were observed.

Chairman Chuang Ming-hsi stated that GXCPC1 overcomes the limitations of traditional autologous cell therapy, which requires long waiting times and high costs. With the potential for immediate use and commercial mass production, and a focus on repair and regeneration, GXCPC1 can provide patients with osteoarthritis a more lasting and fundamental treatment option compared to traditional hyaluronic acid therapy.

Chairman Chuang also noted that GWOXI's new factory in the Zhubei Biomedical Science Park is fully implementing PIC/S GMP standards, which will not only support its own product production but also provide CDMO capacity. In the future, the company will continue to deepen its clinical validation and patent portfolio, combining its automated mass production capabilities with strategic international partnerships to accelerate its expansion into the global elderly health and medical market.

According to statistics from the Ministry of Health and Welfare, the number of outpatient and inpatient visits for knee osteoarthritis in Taiwan has exceeded 4.01 million, with annual medical costs exceeding NT$6.1 billion. Furthermore, with the increase in people exercising and improper exercise habits, knee degeneration is showing a younger-onset trend, which continues to expand the potential medical demand.