Ge Long Hui·2025-09-24 10:21Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has received acceptance for the drug registration application of FKC889, a CAR-T cell therapy for adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) [1] Company Summary - Fosun Kairui is developing FKC889, a targeted CD19 CAR-T cell therapy, based on technology transferred from Kite Pharma, a subsidiary of Gilead Sciences [1] - The product has been authorized for development and local production in China, including Hong Kong and Macau [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020, respectively [1] Industry Summary - The application for FKC889 is classified as a therapeutic biological product (Category 3.2) [1] - Before commercial production, the product must pass GMP compliance checks and obtain drug registration approval [1] - The acceptance of the drug registration application is not expected to have a significant impact on the group's current performance [1]