HENLIUS Doses First U.S. Patient in Global Phase 1 Trial of Ipilimumab Biosimilar HLX13 for Unresectable Advanced HCC

Shanghai Henlius Biotech, Inc. (HENLIUS) has administered the first U.S. dose in its international, multicenter Phase 1 clinical study of HLX13, a biosimilar to Bristol Myers Squibb’s Ipilimumab (YERVOY). The trial evaluates HLX13 in combination with nivolumab (OPDIVO) as first-line therapy for patients with unresectable advanced hepatocellular carcinoma (HCC).

The randomized, double-blind study assigns treatment-naïve HCC patients to either HLX13 plus nivolumab or U.S.-sourced YERVOY plus EU-sourced nivolumab in a 1:1 ratio. Participants receive combination dosing every three weeks for four cycles, followed by nivolumab monotherapy every four weeks. Primary endpoints focus on pharmacokinetic similarity—specifically AUC0-21d after the first dose and steady-state AUC measures after the fourth dose. Secondary assessments include additional PK parameters, efficacy, safety and immunogenicity.

HLX13 is designed to mirror Ipilimumab’s mechanism of action as a fully human anti-CTLA-4 IgG1 monoclonal antibody. Beyond HCC, the candidate targets indications corresponding to the reference drug, including melanoma, renal cell carcinoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma and esophageal squamous cell carcinoma.

Regulatory and partnership milestones underpin HLX13’s development trajectory. The U.S. Food and Drug Administration cleared an Investigational New Drug application for this Phase 1 HCC study in September 2025, and the first patient in Mainland China was dosed in November 2025. In April 2025 HENLIUS granted Sandoz AG exclusive commercialization rights for HLX13 in the United States, selected European countries, Japan, Australia and Canada.

Market data from IQVIA MIDAS indicate that global sales of Ipilimumab reached approximately USD 3.28 billion in 2025, highlighting significant commercial potential for competitively priced biosimilars. HENLIUS emphasizes that clinical development and eventual commercialization of HLX13 remain subject to study outcomes and regulatory review.