Fosun Pharma's Subsidiary Receives IND Approval for FKC289 Injection to Initiate Phase I/II Clinical Trials

Gelonghui April 14thFosun Pharmaceutical(600196.SH) announced that its holding subsidiary, Fosun Kite Biotechnology Co., Ltd. (Shanghai), and its holding subsidiary (collectively referred to as “Fosun Kite”) have received approval from the National Medical Products Administration (NMPA) to conduct Phase I/II clinical trials for FKC289 injection (hereinafter referred to as “FKC289”) for the treatment of (1) relapsed/refractory primary light chain amyloidosis and (2) relapsed/refractory membranous nephropathy. Fosun Kite plans to initiate relevant clinical research for this drug in China upon fulfilling the necessary conditions.

FKC289 is a gene-modified CAR-T cell product targeting BCMA and CD19, intended for use in (1) relapsed/refractory primary light chain amyloidosis and (2) relapsed/refractory membranous nephropathy. By simultaneously targeting two distinct surface antigens, BCMA and CD19, FKC289 achieves deep depletion of pathogenic plasma cells and B cells, thereby inhibiting disease progression. It is expected to demonstrate efficacy in the treatment of plasma cell disorders and B cell-mediated autoimmune diseases.