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First Chinese CAR-T clinical trial approved by CFDA

On March 13, Nanjing's GenScript Biotech Co. announced that it officially received a clinical trial approval from the State Food and Drug Administration (CFDA) for autologous reinfusion of LCAR-B38M. The CFDA received a total of 15 clinical applications for CAR-T cell therapy. Among them are Anke Biotechnology, Hengrui Pharmaceutical, Galaxy Biological, Fosun Pharma and other listed companies. Chinese pharmaceutical companies are struggling to catch up with the United States in the clinical study of CAR-T therapy. Currently, over hundred CAR-T clinical research projects have been registered. Precision biology companies such as Zhongyuan Concord, Pu Ruijin, and Zhifei Bio are actively involved in the deployment of CAR-T immunotherapy, as are the People's Liberation Army General Hospital, Beijing Cancer Hospital, Tongji Hospital and other medical services.

Source: China Bio news release, March 14, 2018

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