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A Chinese biotech company has secured approval to begin clinical trials in both China and the U.S. for a groundbreaking cell therapy targeting intractable epilepsy, marking the first time a drug in this field has advanced to clinical testing simultaneously in both countries.
The therapy, known as UX-GIP001, is an allogeneic treatment derived from induced pluripotent stem cells (iPSCs), and was authorized by China’s National Medical Products Administration today for clinical trials. Earlier, on March 12, the U.S. Food and Drug Administration granted approval to initiate trials there as well.
Worldwide, approximately 70 million people live with epilepsy—a neurological disorder caused by abnormal electrical activity in the brain, resulting in sudden loss of consciousness and uncontrollable movements. About a third of these individuals have treatment-resistant epilepsy, which often remains unresponsive to medications, surgery, or neurostimulation.
This innovative therapy developed by the Shanghai-based company offers a novel approach: implanting stem cells capable of developing into specific inhibitory neurons into damaged areas of the brain. This aims to repair neural circuits and potentially cure epilepsy.
Animal studies have shown encouraging results. Six months after implanting the stem cells into mice, roughly 90% of seizure-related brain activity subsided. Eight months into the study, epileptic waves were nearly undetectable.
Founded in 2021 by a leading researcher from the Chinese Academy of Sciences specializing in stem cell neural development, this company recently raised CNY 140 million (about $20.5 million) in an Series A+ funding round. The capital will further support clinical trials for epilepsy and Parkinson’s disease treatments.
The firm operates a research and development center along with a Good Manufacturing Practice facility spanning 4,000 square meters in the China (Shanghai) Pilot Free Trade Zone. Its iPSC-derived therapy for Parkinson’s disease entered Phase I clinical trials last year.
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