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ROCKVILLE, Md., and BEIJING, Dec. 23, 2020 /PRNewswire/ CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announces that the Chinese Center for Drug Evaluation, a division of the China National Medical Products Association, has granted Breakthrough Therapy Designation ( Breakthrough Designation ) to its partner Juventas Cell Therapy Ltd. for CNCT19, a potential CD19 CAR-T therapy for the treatment of adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). CASI has co-commercial rights to CNCT19 and is a shareholder of Juventas.
The Breakthrough Designation for CNCT19 was granted based on initial data from the ongoing single arm, open-label, non-randomized, dose-escalation, Phase I study designed to determine the safety and efficacy of CNCT19 in B-ALL.