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Revolutionizing the treatment landscape for refractory epilepsy, Shanghai companies launch the world's first drug to receive both China and U.S. IND approvals.
Shanghai Yuesai Biotechnology Co., Ltd.'s independently developed world’s first allogeneic cell drug derived from induced pluripotent stem cells (iPSC) for refractory epilepsy has consecutively received clinical trial approvals within a month from the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration’s Center for Drug Evaluation (CDE), making it currently the only innovative product in the global iPSC-based epilepsy treatment field to achieve both U.S. and Chinese IND (Investigational New Drug) approvals. (The Paper)