Henlius HLX17 biosimilar gets FDA green light for clinical trial

Shanghai Henlius Biotech, Inc. announced that its investigational new drug (IND) application for a biosimilar of pembrolizumab, HLX17, has been approved by the United States Food and Drug Administration (FDA) for a Phase 1 clinical trial. The trial will focus on patients with multiple resected solid tumors, and the company intends to initiate this international multi-center clinical trial in the United States.

HLX17 is a recombinant humanised anti-PD-1 monoclonal antibody injection, independently developed by Henlius. Its potential indications align with the original drug, pembrolizumab, including melanoma, non-small cell lung cancer, and various other solid tumors. The application for a clinical trial of HLX17 was also approved by the National Medical Products Administration (NMPA) in September 2024.

The global market for pembrolizumab is substantial, with worldwide sales reaching approximately $32.056 bn for the year 2024, according to IQVIA MIDAS statistics. Henlius advises shareholders and potential investors to exercise caution, as there is no guarantee of successful development or commercialization of HLX17.