Henlius begins international phase 1 trial for pembrolizumab biosimilar

Shanghai Henlius Biotech, Inc. announced the dosing of the first patient in an international multi-center Phase 1 clinical study for HLX17, its recombinant humanized anti-PD-1 monoclonal antibody injection. This trial, a biosimilar of pembrolizumab, is underway in mainland China and targets patients with multiple resected solid tumors. The company plans to expand this study to the United States, Europe, Australia, and other regions.

The Phase 1 study is designed to assess the pharmacokinetic profile, efficacy, safety, and immunogenicity of HLX17 against US-sourced KEYTRUDA®. HLX17 received approval for clinical trial application from the National Medical Products Administration (NMPA) in September 2024, followed by Investigational New Drug (IND) application approval from the United States Food and Drug Administration (FDA) in September 2025.

Globally, pembrolizumab recorded sales of approximately $32.056 bn for the year 2024, according to IQVIA MIDAS™ statistics. Henlius's HLX17 aims to address indications similar to the original drug, including various cancers such as melanoma, non-small cell lung cancer, and gastric cancer.