China NMPA Accepts Clinical Trial Application For CASI’s CD19 CAR-T-Product
ROCKVILLE, Md., Sept. 16, 2019 - CASI Pharmaceuticals, Inc. (CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products, announces that the Chinese National Medical Product Administration (NMPA), the Chinese FDA, has accepted the clinical trial application for CNCT19 (CD19 CAR-T) for investigation in relapsed B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). CASI owns the exclusive worldwide license and commercial rights to CNCT19.
Wei-Wu He, Ph.D., CASI’s Chairman and CEO, commented, “CAR-T therapies were first approved in the United States in 2017, and have dramatically improved survival rates for patients suffering from varying B-cell malignancies. The efficacy data generated by the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China, for our CNCT19 technology to date is comparable to the current CAR-T therapies available in the U.S. This drug will be manufactured locally in China at a cost significantly less than the cost of imported therapies from outside of China, ultimately making CNCT19 more widely available to the Chinese patient population. With exclusive global rights, we intend to partner outside of China so that we can similarly make this drug accessible to even more patients.”
About 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 license and commercialization rights to CNCT19. Juventas is responsible for the development of CNCT19 with CASI’s participation on the program’s steering committee.
About Juventas
Juventas Cell Therapy Ltd. is a China-based domestic company located in Tianjin City, China focused on cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.
