Henlius Biotech doses first patient in HLX13 international clinical trial

Shanghai Henlius Biotech, Inc. announced the first patient has been dosed in an international multicenter Phase 1 clinical study for its Ipilimumab biosimilar, HLX13. This study evaluates HLX13 as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC) in mainland China, in combination with OPDIVO®. The study aims to assess similarity in pharmacokinetic profiles, safety, efficacy, and immunogenicity between HLX13 and the reference product YERVOY® (US-sourced).

The study involves two groups receiving HLX13 or YERVOY® with OPDIVO® for four cycles, followed by OPDIVO® monotherapy. Primary endpoints include the area under the serum concentration-time curve after the first and fourth doses. HLX13, a fully human anti-CTLA-4 monoclonal antibody, is being developed for various indications, including melanoma, renal cell carcinoma, and HCC.

Regulatory approvals for HLX13 clinical trials in HCC were secured in mainland China in June 2023 and in the United States in September 2025. In April 2025, Henlius granted Sandoz AG an exclusive license to commercialize HLX13 in the United States, Europe, Japan, Australia, and Canada. Worldwide sales of Ipilimumab were approximately $2.873 bn in 2024.