Shanghai Biotech's Cell Therapy for Epilepsy Cleared for Clinical Trial

​A staff member of UniXell Biotechnology works in laboratory. [Photo/Shanghai Observer]

Shanghai-based UniXell Biotechnology has become the first company to secure clinical trial clearance in both China and the United States for an epilepsy cell therapy, marking a major milestone for the country's stem cell drug development.

The therapy, UX-GIP001, received Investigational New Drug, or IND, approval from the US Food and Drug Administration on March 12. The drug later got approval for clinical testing from China's National Medical Products Administration on April 8.

Epilepsy is a chronic neurological disorder caused by sudden, excessive electrical discharges in brain cells and affects nearly 70 million people globally. It can be triggered by events like brain injury or surgical trauma.

UniXell noted that current epilepsy treatments, though helpful to some patients, carry "significant side effects," so there's an urgent need for novel therapies that can not only target the root source of the seizure, but also preserve healthy tissues and avoid safety issues.

UX-GIP001 is designed to suppress the excessive electrical activity that triggers seizures. Through directed differentiation, the therapy generates inhibitory neural progenitor cells to repair damaged neural circuits in the brain.

Animal studies have demonstrated that about 90 percent of epileptic waves had disappeared six months after cell implantation in the brains of mice.

Founded in 2021, UniXell specializes in the research and development of cell therapy drugs for neurological diseases, including Parkinson's disease and epilepsy.

Founder Chen Yuejun said Shanghai's strengths in scientific research and development, and industrialization have been crucial for innovative pharmaceutical companies like UniXell. He noted that all key supporting services required for the company's clinical research are available within a five-kilometer radius.

In November, UniXell completed a Series A+ round of financing, raising nearly 100 million yuan ($14.64 million).

The company has established an R&D center and a good manufacturing practice facility covering approximately 4,000 square meters in the China (Shanghai) Pilot Free Trade Zone.