Latest Breaking News On - Juventas cell therapy - Page 5 : comparemela.com

Share this article Share this article 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.

United statesJennifer porcelliInstitute of hematologyChinese centerChina national medical products associationPharmaceuticals china co ltdJuventas cell therapy ltdPharmaceuticals incChinese academy of medical sciencesDrug evaluationBreakthrough therapy designationJuventas cell therapyBreakthrough designationDrug registration regulationReceiving breakthrough designationCell therapy