08.11.2023 13:53:22

CASI : Juventas' CNCT 19 Approved In China For R/R B-cell Acute Lymphoblastic Leukemia Treatment

(RTTNews) - The China National Medical Products Administration or NMPA has granted market approval for Juventas Cell Therapy Ltd's investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19), for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia or r/r B-ALL in China, CASI Pharmaceuticals Inc. (CASI) said in a statement on Wednesday.

The approval was based on the clinical results from a single-arm, multi-center, pivotal study of 39 adult patients with r/r B-ALL in China.

The 9.3-month follow up data demonstrated very high durable response, overall response rate 82.1%, complete response rate, 66.7% within 3 month after infusion and median duration of response has not reached.

CASI Pharma announced a major milestone in its partnership with Juventas Cell Therapy Ltd.

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