HENLIUS (02696) announced that the U.S. Food and Drug Administration (FDA) has recently approved the Investigational New Drug (IND) application for a Phase 1 clinical trial of HLX17, the company's proprietary pembrolizumab biosimilar (recombinant anti-PD-1 humanized monoclonal antibody injection), in patients with multiple resected solid tumors. The company plans to initiate this international multi-center clinical trial in the United States once conditions are met.

HLX17 is a proprietary pembrolizumab biosimilar developed by HENLIUS. Potential indications include melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair deficient tumors, gastric cancer, and other indications already approved for the original drug.

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. Some tumor cells upregulate PD-1 ligands, and signaling through this pathway can suppress activated T cell immune surveillance of tumors. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor, blocking the interaction between PD-1 and PD-L1/PD-L2, thereby relieving PD-1 pathway-mediated immune suppression, including anti-tumor immune responses, and enhancing the immune system's ability to eliminate tumor cells.

In September 2024, the clinical trial application for HLX17 was approved by the National Medical Products Administration (NMPA). According to IQVIA MIDAS data (IQVIA is a global provider of professional information and strategic consulting services for the pharmaceutical and healthcare industry), pembrolizumab generated approximately $32.056 billion in global sales in 2024.