Fosun Pharma receives NMPA green light for Phase I/II trials of dual-target CAR-T therapy FKC289

Bulletin Express04-14

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) announced that subsidiary Fosun Kairos (Shanghai) Biological Technology Co., Ltd. has obtained National Medical Products Administration approval to begin Phase I/II clinical studies of the investigational CAR-T cell product FKC289.

FKC289 is designed to simultaneously target BCMA and CD19 antigens, aiming to deliver deep depletion of pathogenic plasma cells and B cells. The upcoming trials will evaluate the therapy in two indications: (1) relapsed or refractory primary light-chain amyloidosis and (2) relapsed or refractory membranous nephropathy. No globally approved therapies share this dual-target mechanism.

Fosun Pharma disclosed cumulative research and development spending of approximately RMB59.00 million on FKC289 through March 2026. The company plans to start the China-based clinical programme once all preparatory conditions are satisfied.

Management emphasised that drug development remains subject to clinical and regulatory uncertainties, and the product must progress through further studies and approvals before any potential commercial launch.

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