HENLIUS (02696) announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for Phase 1 clinical trials of HLX18, a self-developed nivolumab biosimilar (recombinant anti-PD-1 humanized monoclonal antibody injection), for the treatment of various solid tumors. The company plans to initiate the Phase 1 clinical trial in the U.S. once conditions are met.

HLX18 is a self-developed biosimilar to nivolumab, with potential indications including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, esophageal cancer, colorectal cancer, hepatocellular carcinoma, and other indications already approved for the reference drug.

The PD-1 receptor expressed on T cells binds to its ligands PD-L1 and PD-L2, inhibiting T-cell proliferation and cytokine production. Some tumor cells upregulate PD-1 ligands, which can suppress activated T-cell immune surveillance of tumors through this signaling pathway. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb) that binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2, thereby inhibiting PD-1 pathway-mediated immune suppression, including antitumor immune responses.