Fosun Pharma subsidiary's leukemia drug application accepted in China

Fosun Kairos (Shanghai) Biological Technology Co., Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., has announced its drug registration application for Brexucabtagene Autoleucel Injection (FKC889) has been accepted by the National Medical Products Administration. This therapeutic biological product, a CD19-targeted CAR-T cell therapy, is intended for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The product, developed and locally produced in China through technology transfer from Kite Pharma, Inc. (a Gilead Sciences, Inc. subsidiary), is based on Tecartus, which received marketing approval in the United States and Europe in July and December 2020, respectively. As of August 2025, the group has invested approximately RMB183m in the research and development of the product. Another indication for the product, treating relapsed or refractory mantle cell lymphoma, is currently in bridging clinical trials in China.

The company cautioned that commercial production is contingent on passing GMP compliance inspection and obtaining drug registration approval. This acceptance does not currently have a material impact on the group's results. Investors should note the inherent uncertainties in pharmaceutical product sales performance due to factors like medication demand, market competition, and sales channels.