The fourth CAR T-cell theray, Inaticabtagene Autoleucel, approved in China for r/r B-ALL treatment

China National Medical Product Administration (NMPA) has approved the New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), a CD19-targeted autologous chimeric antigen receptor (CAR)-T cell therapy for adult relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product, featured with a unique CD19 scFv (HI19a) and advanced manufacturing processes. The pivotal study of Inaticabtagene Autoleucel has demonstrated high efficacy, durable remission, and substantially improved safety profile with adult r/r B-ALL. Inaticabtagene Autoleucel is the first proprietary CD19-targeted CAR-T product invented in China, and the first commercialized CAR-T cell therapy product for B-ALL in China.

This approval is based on the clinical results from a single-arm, multi-center, pivotal study for adult r/r B-ALL in China. The 9.3-month follow-up data demonstrated very high durable response (overall response rate (“ORR”) 82.1%, complete response rate (“CR”) 66.7% within 3 month post infusion, while median DOR hasn’t reached. The safety profile shown the decreased severity of CAR T-Cell related adverse events. Inaticabtagene Autoleucel will potentially be best-in-class CAR-T cell therapy for adult r/r B-ALL, meeting long-seeking unmet clinical need.

Prof. Wang Jianxiang, the Principal Investigator of the clinical study of Inaticabtagene Autoleucel (CNCT19 Injection) in China, deputy president of Institute of Hematology & Blood Diseases Hospital, Director of the National Clinical Research Center for Hematology commented:

Under traditional treatment strategies, adult r/r B-ALL patients usually end up with fatal situation within a few months after diagnosis. There is an enormous unmet clinical need for adult r/r B-ALL world-wide. Inaticabtagene Autoleucel has demonstrated outstanding clinical value, excellent efficacy, and sustained remission. This product will be the game-changer for adult r/r B-ALL treatment in China. The approval not only provides clinical physicians an effective treatment option, also offers a great hope of life for adult r/r B-ALL patients.

Dr. Lyv Lulu, CEO of Juventas Cell Therapy Ltd. remarked:

“Directed by the Clinical Value, Oriented by the Patients” has long been our principle. During clinical study, we have witnessed many patients who have received our product achieved long-term survival and returned normal life, not to mention the improvement of their life quality. This is the breakthrough in China leukemia treatment area. Looking at the future, as planned we will continuously join hands with all parties to alleviate patient accessibility of Inaticabtagene Autoleucel, and have more patients benefit from this China home-made innovative CAR-T cell therapy. Our mission is to Originate the Force of Health and Ignite the Hope of Strength!

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