Fosun Pharma's HLX13 enters liver cancer trial phase

Shanghai Fosun Pharmaceutical Group (SSE:600196) announced that its subsidiary, Shanghai Henlius Biotech, has begun a Phase I/III clinical trial in China for HLX13, a biosimilar of ipilimumab. HLX13, a recombinant anti-CTLA-4 fully human monoclonal antibody injection, aims to treat unresectable advanced hepatocellular carcinoma (HCC). Fosun Pharma has invested approximately CNY 104 million in the research and development of HLX13 as of April 2025. The company cautioned that the drug's development and eventual market launch are subject to various uncertainties and regulatory approvals, including potential safety or efficacy issues arising during clinical trials. Global sales of ipilimumab formulations reached USD 28.73 billion in 2024, according to IQVIA MIDAS™ data.