Shanghai Fosun Pharmaceutical (Group) Co.,Ltd. (600196.SH) announced that its controlled subsidiary Shanghai Henlius Biotech, Inc. and its controlled subsidiaries (collectively "Henlius") recently received approval from the US FDA (Food and Drug Administration) to conduct a Phase I clinical trial of HLX17 (recombinant anti-PD-1 humanized monoclonal antibody injection) for the treatment of various resected solid tumor patients. Henlius plans to initiate this international multicenter clinical study in the United States once conditions are met.

HLX17 is a pembrolizumab biosimilar drug independently developed by the Group (the company and its controlled subsidiaries/entities). The potential indications include melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair-deficient tumors, gastric cancer, and other indications already approved for the original drug.

In September 2024, the clinical trial application for HLX17's related indications received approval from China's National Medical Products Administration.