Monday, 25 October 2021

CASI Pharma gets China approval Of CNCT19 Clinical Trial Applications

04 December 2019 | News

Registration Trials expected to eEnroll patients in early 2020

CASI Pharmaceuticals, Inc., a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announces that the China National Medical Product Administration (NMPA), has approved the clinical trial applications for CNCT19 (CD19 CAR-T) in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) submitted by its partner Juventas Cell Therapy Ltd., a biopharmaceutical company focused on cell therapy (Juventas).  CASI previously reported its acquisition of exclusive worldwide commercial rights to CNCT19 from Juventas. Juventas has responsibility for the clinical development of CNCT19.

Larry Zhang, CASI's President, commented, "This is a very exciting milestone for CASI.  CAR-T therapies were first approved in the United States in 2017; there are currently no CAR-T therapies marketed in China.  CNCT19 will be manufactured in China at a cost significantly less than the cost of imported therapies, which ultimately enables us to make it more widely available to the Chinese patient population.  We expect to start enrolling patients in early 2020."

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