China national medical product administration approves casi pharmaceuticals's cnct19 (cd19 car-t) clinical trial applications

Casi pharmaceuticals, inc. announced that the china national medical product administration, 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. cnct19 targets cd19, a b-cell surface protein widely expressed during all phases of b-cell development and a validated target for b-cell driven hematological malignancies. cd19-targeted car constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed b-cell acute lymphoblastic leukemia (b-all), chronic lymphocytic leukemia (cll), and b-cell non-hodgkin lymphoma (b-nhl). cd19 antigen is the most frequently used target in the car-t cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. casi holds the worldwide commercial rights to cnct19. juventas is responsible for the development of cnct19 with casi's participation on the program's steering committee. juventas cell therapy ltd. is a china-based domestic biopharmaceutical company established in 2018 focused on r&d, clinical translation and commercialization of innovative immune cell therapy. juventas' r&d operations are based in beijing and its gmp facility is located in tianjin city.
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