复星医药(02196)控股子公司药品注册申请获受理
智通财经网·2025-09-24 10:17

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has had its drug registration application for FKC889 accepted by the National Medical Products Administration for treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adult patients [1] Group 1: Product Development - FKC889 is a CAR-T cell therapy product targeting CD19, developed through technology transfer from Kite Pharma, a subsidiary of Gilead Sciences [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020 respectively [1] - As of September 24, 2025, FKC889 is in the bridging clinical trial phase for another indication, treating adult patients with relapsed or refractory mantle cell lymphoma after second-line treatment [1] Group 2: Financial Investment - The cumulative R&D investment for FKC889 as of August 2025 is approximately RMB 183 million (unaudited) [2]