Fosun Pharma Subsidiary Secures NMPA Approval to Launch Phase I Trial of FXB0871 for Advanced Solid Tumors

Bulletin Express
03/31

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) announced that its wholly owned unit, Shanghai Fosun Pharmaceutical Industrial Development, has obtained National Medical Products Administration clearance to begin a Phase I clinical trial of FXB0871 in mainland China for patients with locally advanced or metastatic solid tumors.

FXB0871 is an anti-PD-1–targeted IL-2 fusion protein co-developed by Fosun Pharma and Teva Pharmaceutical Industries. Under the collaboration, Fosun Pharma holds exclusive rights to develop, manufacture and commercialise the therapy in China and selected Southeast Asian markets.

Mechanistically, FXB0871 is engineered to deliver interleukin-2 selectively to PD-1–expressing T cells, aiming to enhance anti-tumor immune responses while limiting systemic toxicity. A parallel first-in-human Phase I study (TEV-56278) led by Teva is already under way in the United States and Canada.

Fosun Pharma reported cumulative research and development spending of approximately RMB6.28 million (unaudited) on FXB0871 as of February 2026. To date, no anti-PD-1/IL-2 targeted therapy has received global regulatory approval, highlighting both the drug’s potential and the inherent uncertainties of clinical development.

The company cautioned that FXB0871 must successfully complete multiple clinical stages and obtain final regulatory approvals before potential commercialisation, and noted the usual risks associated with drug R&D, including possible termination for safety or efficacy reasons.

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