HENLIUS (02696) has announced a significant milestone in its clinical development program. The company has dosed the first patient in the United States for its international multi-center Phase 1 clinical study. This trial is evaluating HLX13, a self-developed biosimilar of ipilimumab, as a first-line treatment for patients with unresectable advanced hepatocellular carcinoma (HCC).
Study Design and Objectives
This international study is a randomized, double-blind, parallel-controlled Phase 1 trial. Its primary goal is to assess the pharmacokinetic (PK) profile, safety, efficacy, and immunogenicity of HLX13 compared to its reference product, YERVOY®. Both are being evaluated in combination with OPDIVO® (nivolumab) in previously untreated patients with unresectable advanced HCC. Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. For the initial four cycles, patients will receive either HLX13 or YERVOY® in combination with OPDIVO® every three weeks. This will be followed by OPDIVO® monotherapy as maintenance treatment every four weeks.
The main objective of the research is to compare the PK similarity between HLX13 and YERVOY® within the target patient population. Key endpoints include the area under the serum concentration-time curve from pre-dose to 21 days after the first dose (AUC0-21d), and the area under the curve at steady state within the dosing interval after the fourth dose (AUCss), or the area under the curve from time zero to infinity at steady state after the fourth dose (AUCinf). Secondary endpoints will cover additional PK parameters, effectiveness assessments, safety, and immunogenicity.
About HLX13 and Its Development
HLX13 is a biosimilar candidate for ipilimumab, developed internally by HENLIUS. It is intended for use in indications where the reference product is already approved, including melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma. Ipilimumab is a fully human, IgG1 monoclonal antibody targeting CTLA-4 (cytotoxic T-lymphocyte-associated antigen 4, also known as CD152). It works by blocking the interaction between CTLA-4 and its ligands, thereby enhancing the immune response to target and destroy tumor cells.
The clinical development of HLX13 has progressed through several key stages. In September 2025, the Investigational New Drug (IND) application for the Phase 1 trial in first-line unresectable HCC received approval from the U.S. Food and Drug Administration (FDA). Subsequently, in November 2025, the first patient in China (excluding Hong Kong, Macao, and Taiwan) was dosed in this international multi-center Phase 1 study. Furthermore, in April 2025, HENLIUS entered into a licensing agreement with Sandoz AG. This agreement grants Sandoz AG exclusive rights to commercialize HLX13 in the United States, specified European regions, Japan, Australia, and Canada.
Market Context
According to data from IQVIA MIDASTM, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, the global sales of ipilimumab reached approximately $3.277 billion in 2025.
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