HENLIUS (02696)Naluriyou monoclonal anti-drug similar to drug HLX18 (recombinant humanized monoclonal antibody injection) for the treatment of various solid tumors has received approval from the National Medical Products Administration for phase 1 clinical trial application.

HENLIUS (02696) announced that recently, the company's independently developed biosimilar to Nivolumab, HLX18 (recombinant anti-PD-1 humanized monoclonal antibody injection), for the treatment of various solid tumors has received approval for Phase 1 clinical trial application (IND) from the National Medical Products Administration (NMPA). HLX18 is the company's independently 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 adenocarcinoma or esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma, among others. The PD-1 receptor expressed in T cells binds to its ligands PD-L1 and PD-L2, inhibiting T cell proliferation and cytokine production. Upregulation of PD-1 ligands on some tumor cells can suppress the immune surveillance of activated T cells against tumors. Nivolumab is a human IgG4 monoclonal antibody that can bind to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2, thereby blocking the immunosuppressive response mediated by the PD-1 pathway, including anti-tumor immune response. In December 2025, HLX18 received approval in the United States to conduct Phase 1 clinical trials for the treatment of various solid tumors. According to data from IQVIA MIDAS (IQVIA is a global provider of professional information and strategic consulting services for the healthcare industry), in 2025, global sales of Nivolumab were approximately $11.785 billion.