Fosun Pharma Pushes CD20-Targeted CAR-T Therapy FKC516 into Phase II Trial for r/r B-NHL in Mainland China

Bulletin Express11-12 18:21

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) reported that its subsidiary, Fosun Kairos (Shanghai) Biological Technology Co., Ltd., has commenced a Phase II clinical trial of FKC516 Injection in mainland China. The study targets patients with refractory or relapsed B-cell non-Hodgkin lymphoma (r/r B-NHL).

FKC516 is an autologous CAR-T cell therapy directed at the CD20 antigen. Under an existing licensing agreement, Fosun Pharma holds exclusive global development and commercialisation rights to the candidate across all disease areas.

R&D spend on FKC516 reached approximately RMB13.37 million (unaudited) as of September 2026.

No CD20-targeted CAR-T therapy has yet secured marketing approval in mainland China, positioning FKC516 as a potential first-in-class entrant, subject to successful trial outcomes and regulatory clearance.

Management emphasised that FKC516 must complete clinical evaluation and obtain approval from national drug review authorities before commercial launch, and highlighted the inherent uncertainties and long timelines associated with drug development. Investors were reminded of the attendant risks.

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