Henlius' HLX13 biosimilar gets FDA nod for liver cancer trial

Shanghai Henlius Biotech, Inc. announced the United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its ipilimumab biosimilar, HLX13. This approval allows for a phase 1 clinical trial of HLX13 as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). The company plans to initiate this international multi-center clinical trial in the United States.

HLX13 is a recombinant anti-CTLA-4 fully human monoclonal antibody injection, developed by Henlius as a biosimilar to ipilimumab. The reference drug targets various indications, including melanoma, renal cell carcinoma, and colorectal cancer. According to IQVIA MIDAS™ data, worldwide sales of ipilimumab are projected to reach approximately $2.873 bn in 2024.

In April 2025, Henlius entered a license agreement with Sandoz AG, granting exclusive commercialization rights for HLX13 in the United States, agreed European countries, Japan, Australia, and Canada. The company has also received approvals for clinical trials of HLX13 for HCC, melanoma, renal cell carcinoma, and other cancers from China's National Medical Products Administration in 2023.