Fu Hong Han Lin (02696): The application for a phase 1 clinical trial of the Navuliumab biosimilar HLX18 for the treatment of various solid tumors was approved by the US Food and Drug Administration

Zhitong Finance App News, Fu Hong Han Lin (02696) issued an announcement. Recently, the US Food and Drug Administration (FDA) approved a phase 1 clinical trial application (IND) for the treatment of various solid tumors of the navulizumab biosimilar drug HLX18 (recombinant anti-PD-1 anthropogenic monoclonal antibody injection) (HLX18) independently developed by the company. The company plans to conduct relevant phase 1 clinical trials in the US when conditions are met.

HLX18 is a Navulyumab biosimilar drug independently developed by the company. Potential indications include melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classic Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial cancer, gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, esophageal cancer, esophageal cancer, hepatocellular carcinoma, etc. PD-1 receptors expressed in T cells bind to their ligands PD-L1 and PD-L2 to inhibit T cell proliferation and cytokine production. PD-1 ligands in some tumor cells are upregulated, and signaling through this pathway can inhibit immune monitoring of tumors by activated T cells. Navulizumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (hUMab) that binds to PD-1 receptors, blocks its interaction with PD-L1 and PD-L2, and blocks PD1 pathway-mediated immunosuppressive responses, including anti-tumor immune responses.