China NMPA grants breakthrough therapy designation to JW Therapeutics

JW Therapeutics, an independent, innovative biotechnology company, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China granted Breakthrough Therapy Designation for Carteyva (relmacabtagene autoleucel injection) in patients with mantle cell lymphoma (MCL). Carteyva is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics. The Breakthrough Therapy Designation was supported by the results from the clinical study of Carteyva in relapsed or refractory MCL (r/r MCL), which aimed to assess the efficacy and safety of Carteyva in adults with r/r MCL in China. This is the first clinical result obtained in Chinese patients. MCL is a non-Hodgkin lymphoma, which is highly aggressive and can

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