JW Therapeutics announced that the NMPA of China has approved the NDA for its anti-CD19 autologous CAR-T cell immunotherapy product relmacabtagene autoleucel injection for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy and has released the drug registration certificate.
Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally. The product was independently developed based on a CAR-T cell process platform of Juno Therapeutics to meet the needs of the Chinese market. Currently, it is the only approved CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted Priority Review and Breakthrough Therapy designations (in follicular lymphoma).