The China NMPA has approved the New Drug Application (NDA) for Yorwida (Inaticabtagene Autoleucel Injection, CNCT19), a CD19-targeted autologous chimeric antigen receptor (CAR) T-cell therapy designed for adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
Yorwida features a unique CD19 single-chain variable fragment (scFv) known as HI19a and utilizes advanced manufacturing processes. The pivotal study results indicate that this therapy offers high efficacy, durable remission, and a significantly improved safety profile for adults with r/r B-ALL. It represents both the first proprietary CD19-targeted CAR-T product developed in China and the first CAR-T cell therapy approved for B-ALL in the country.
The approval is based on data from a single-arm, multi-center pivotal study involving adult patients with r/r B-ALL. Following a median follow-up of 9.3 months, the results demonstrated a remarkable overall response rate (ORR) of 82.1%, with a complete response (CR) rate of 66.7% observed within three months post-infusion. The median duration of response (DOR) has not yet been reached, and the safety profile reflects a reduced severity of CAR T-cell-related adverse events. Inaticabtagene Autoleucel is positioned to be a best-in-class CAR-T therapy for adult r/r B-ALL, addressing a critical unmet clinical need.
Professor Wang Jianxiang, Principal Investigator of the clinical study and Deputy President of the Institute of Hematology & Blood Diseases Hospital, noted, “Adult patients with r/r B-ALL typically face a dire prognosis within months of diagnosis. There is a significant unmet clinical need for effective treatments worldwide. Inaticabtagene Autoleucel has shown outstanding clinical value, excellent efficacy, and sustained remission, making it a potential game-changer for adult r/r B-ALL treatment in China. This approval not only offers clinicians a powerful new treatment option but also brings renewed hope to patients.”
