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Recently, the Investigational New Drug (IND) application for "JWK002 Injection," a Class I innovative gene therapy drug independently developed by Chengdu Jinweike Biotechnology Co., Ltd. for X-linked retinoschisis, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). Previously, JWK002 Injection had received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation from the U.S. FDA.JWK002 Injection May Become the First Gene Therapy Drug in China to Enter Clinical Trials for X-Linked Retinoschisis.
About Jinweike Biotechnology
Jinweike Biotechnology is a biotech company dedicated to the development of AAV gene therapy new drugs for ophthalmic diseases, neuromuscular diseases, and genetic metabolic diseases. Currently, several of its AAV gene therapy products in the pipeline have entered the IIT clinical research stage.Source: Jinweike Biotechnology