FOSUN PHARMA (600196.SH) announced that its controlling subsidiary Fosun Kerry (Shanghai) Biotechnology Co., Ltd. ("Fosun Kerry") has recently received approval from the National Medical Products Administration for its drug registration application of Brexucabtagene Autoleucel Injection (project code: FKC889, application registration category: therapeutic biological product category 3.2, hereinafter referred to as "the Product"). The indication for this application is for the treatment of adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).

The Product is a CD19-targeted CAR-T cell therapy product that Fosun Kerry developed and obtained authorization for development and localized production in China (including Hong Kong and Macau) based on Tecartus introduced from Kite Pharma, Inc. (a controlling subsidiary of Gilead Sciences, Inc.) through technology transfer. Tecartus was approved for market launch in the United States and Europe in July and December 2020, respectively.