First Indigenous CD19 CAR-T Therapy Approved for Market in China, National CAR-T Research Enters a Boom Period!

On November 8, 2023, we have received another major piece of good news! According to the official website of the National Medical Products Administration (NMPA) of China, the new drug application (NDA) for Inaticabtagene Autoleucel Injection (CNCT19 Cell Injection), a CAR-T therapy product developed by Hegen Biotech, has been officially approved for market. This therapy is indicated for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). Inaticabtagene Autoleucel Injection is the first CAR-T cell therapy product with complete independent intellectual property rights in China. It is also the first CAR-T therapy product for leukemia that has been approved and made available in the Chinese market!