Fosun Pharma subsidiary's gastric cancer drug application accepted for priority review

Shanghai Fosun Pharmaceutical Group announced that its controlled subsidiary, Shanghai Henlius Biotech, had its drug registration application for an additional indication of its anti-PD-1 monoclonal antibody, HANSIZHUANG® (serplulimab injection), accepted by the National Medical Products Administration. This new indication is for the perioperative treatment of resectable gastric cancer, in combination with platinum-based chemotherapy. The application has been granted priority review.

This innovative anti-PD-1 monoclonal antibody has already been approved in several countries and regions, including China, the EU, and the UK, for various indications such as non-small cell lung cancer and esophageal squamous cell carcinoma. As of October 2025, the group's cumulative R&D investment for this drug was approximately 3.495 billion yuan.

The acceptance of this application does not immediately impact the group's current financial performance. Commercialization in China is contingent on further regulatory approvals.