GWOXI Stem Cell announced that it submitted a Phase III clinical trial application (IND) to the Taiwan Food and Drug Administration (TFDA) for its new cell drug for osteoarthritis. In August, the company also secured a Taiwan invention patent for a pharmaceutical composition to treat osteoarthritis. This makes the company's overall patent portfolio for osteoarthritis stem cell drugs more complete and will help accelerate its commercialization timeline.
There are approximately 355 million people worldwide suffering from arthritis, with over 100 million in China. In the United States, one in five people experiences the pain and discomfort of arthritis, while in Asia, one in six people develops the disease at some point in their lifetime. Moreover, the age group affected by osteoarthritis is getting younger—once considered a condition mainly for those over 50, in recent years it has increasingly appeared among people in their 30s and 40s, making it no longer an illness exclusive to the elderly.
The stem cell analysis platform and the “Nigiro-Med” activation technology are the core strengths of Guoxi. Leveraging these two platforms, the company has developed the novel stem cell therapy GXCPC1 for osteoarthritis. This therapy enables stem cells to stably produce extracellular vesicles (EVs) and growth factors, which work synergistically with the cells to alleviate pain, stiffness, and impaired physical function caused by osteoarthritis, while also showing potential to increase cartilage thickness.
After being granted a Taiwan invention patent in August this year, the company has begun actively pursuing international patent filings. The announced Phase I/II clinical trial results of the novel stem cell therapy GXCPC1 showed positive outcomes. This innovative treatment demonstrated superior improvements in pain assessment and quality of life compared to the control group, with no serious adverse events (SAEs) and no suspected unexpected serious adverse reactions (SUSARs) reported, confirming its favorable safety profile.
Guoxi Stem Cell has recently submitted an IND application to the Taiwan Ministry of Health and Welfare for a Phase III clinical trial. According to the National Health Insurance Medical Statistics Annual Report published by the Statistics Department of the Ministry, there were 4,014,745 outpatient and inpatient visits for knee osteoarthritis in Taiwan, with medical expenses reaching NT$6.11 billion and a prevalence rate of approximately 15%. These figures highlight the urgent unmet medical need for patients suffering from osteoarthritis.
Guoxi Stem Cell noted that current treatments for osteoarthritis primarily involve physical therapy, pain-relieving medications, and hyaluronic acid injections. However, when pain severely interferes with daily life and significant functional deterioration occurs, patients often require surgical interventions such as partial joint replacement or total knee arthroplasty to restore quality of life. In contrast, GXCPC1 is developed as an injectable therapy, administered directly into the affected area, offering a less invasive alternative.