HENLIUS (02696) has announced that the investigational new drug application for a Phase 1 clinical trial of its self-developed HLX18, a biosimilar of nivolumab, has been approved by the National Medical Products Administration. The trial will evaluate HLX18 for the treatment of various solid tumors.
HLX18 is a recombinant anti-PD-1 humanized monoclonal antibody injection developed by HENLIUS. Its potential indications mirror those of the reference product and include 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, esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma.
The PD-1 receptor, expressed on T cells, binds to its ligands PD-L1 and PD-L2, leading to the suppression of T-cell proliferation and cytokine production. Some tumor cells upregulate these PD-1 ligands, exploiting this pathway to inhibit the immune system's ability to surveil and attack tumors. Nivolumab is a human immunoglobulin G4 monoclonal antibody that binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2. This action inhibits the PD-1 pathway-mediated immune suppression, thereby potentially restoring anti-tumor immune responses.
In December 2025, HLX18 received approval to commence a Phase 1 clinical trial for solid tumors in the United States. According to data from IQVIA MIDAS, a leading provider of healthcare information and strategic consulting services, global sales of nivolumab reached approximately $11.785 billion in 2025.
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