HLX18

HLX18 is a recombinant humanized monoclonal antibody developed by Shanghai Henlius Biotech as a biosimilar to nivolumab (Opdivo). It functions as an immune checkpoint inhibitor by specifically binding to the programmed death-1 (PD-1) receptor on T cells. This binding blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby preventing the downregulation of T-cell activity and enhancing the immune system's ability to recognize and attack tumor cells. HLX18 is being developed for the treatment of various solid tumors and has entered Phase 1 clinical trials to evaluate its pharmacokinetic profile, safety, and efficacy compared to the reference product. The drug is designed to meet biosimilar regulatory guidelines in major markets including China (NMPA), the European Union (EMA), and the United States (FDA).

Other names

nivolumab biosimilar