Fosun Pharma subsidiary gains US FDA nod for solid tumor drug trial

Shanghai Fosun Pharmaceutical Group Co., Ltd. announced that its controlling subsidiary, Shanghai Henlius Biotech, Inc., has received US FDA approval to commence Phase I clinical trials for HLX18 (recombinant anti-PD-1 humanized monoclonal antibody injection). This drug is intended for the treatment of various solid tumors. Henlius Biotech plans to initiate the US clinical trials for HLX18 once conditions are met.

HLX18 is a self-developed nivolumab biosimilar, targeting indications such as melanoma, non-small cell lung cancer, and gastric cancer, among others. As of November 2025, the group's cumulative research and development investment for HLX18 totals approximately RMB 52.53 million (unaudited). According to IQVIA MIDAS™ data, nivolumab achieved global sales of approximately $11.1 billion in 2024.

The company cautioned that the drug's development and eventual market launch remain a long-term endeavor with inherent uncertainties. Future clinical trials and regulatory approvals are required, and there is a risk that the trials may be terminated due to safety or efficacy concerns.