Inaticabtagene Autoleucel Injection，纳基奥仑赛注射液

It is used to treat relapsed or refractory acute lymphoblastic leukemia in adults, relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma, and relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia in children and adolescents. It has been recognized as a “breakthrough therapy” by the Center for Drug Evaluation of the National Medical Products Administration and has been recognized as an orphan drug by the U.S. FDA (Orphan Drug Designation, ODD). In December 2022, the National Medical Products Administration (NMPA) officially accepted the new drug application (NDA) for Nacioren injection for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in adults and included it in the priority review. In March 2023, the clinical trial application for Nacioren injection for the treatment of adult r/r B-ALL was approved by the U.S. Food and Drug Administration (U.S.FDA).