China-based Juventas Cell Therapy Ltd announced that its chimeric antigen receptor (CAR)-T cell therapy, inaticabtagene autoleucel (CNCT 19), has received clinical approval from the National Medical Products Administration (NMPA) for the treatment of refractory lupus nephritis (LN). This marks a significant milestone in the development of innovative therapies for autoimmune diseases.
Clinical Approval and Previous Indications
CNCT 19 previously secured NMPA investigational approvals for relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL), r/r B-cell non-Hodgkin lymphoma (B-NHL), r/r acute lymphocytic leukemia, and autoimmune hemolytic anemia (AIHA). The therapy became China’s first commercially approved CD19 CAR-T product in November 2023, initially indicated for r/r B-ALL.-Fineline Info & Tech