Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX18, a recombinant anti-PD-1 humanized monoclonal antibody, for use in various solid tumors, indicating a significant advancement in its clinical development pipeline [1] Group 1: Product Development - HLX18 is a 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, esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma [1] - The company plans to conduct Phase 1 clinical trials in the United States once conditions are met [1] Group 2: Mechanism of Action - The PD-1 receptor expressed on T cells binds to its ligands PD-L1 and PD-L2, which can inhibit T cell proliferation and cytokine production [1] - Tumor cells can upregulate PD-1 ligands, leading to the suppression of activated T cells' immune surveillance against tumors [1] - Nivolumab, as a human immunoglobulin G4 (IgG4) monoclonal antibody, binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2, thereby inhibiting the immune suppressive response mediated by the PD-1 pathway, including anti-tumor immune responses [1]
复宏汉霖：纳武利尤单抗生物类似药HLX18用于多种实体瘤治疗的1期临床试验申请获美国食品药品管理局批准