The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China.
Inaticabtagene Autoleucel’s Unique Structure and Manufacturing Techniques
Inaticabtagene autoleucel is a CD19 CAR-T cell therapy product that features a unique CD19 scFv (HI19a) structure and employs leading current good manufacturing practices (CMC) techniques. The therapy has shown a high level of efficacy, with patients experiencing durable remission and an improved safety profile, characterized by reduced CAR-T related toxicities in the pivotal clinical study for the treatment of adults with r/r B-ALL.
Market Entry of China’s Fourth CAR-T Therapy
The approval of inaticabtagene autoleucel marks it as the fourth CAR-T therapy to enter the Chinese market and the third CD19-targeted therapy, further expanding the treatment options for patients with r/r B-ALL.- Flcube.com
