Shanghai, China, September 2, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for clinical trial of HLX17, a pembrolizumab biosimilar independently developed by the company, was approved by the National Medical Products Administration (NMPA) for the treatment of indications that reference pembrolizumab has been approved, including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell cancer, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair deficient cancer, and gastric cancer, etc.

HLX17 is a pembrolizumab biosimilar independently developed by Henlius in accordance with the relevant guiding principles on biosimilar issued by the NMPA, and referencing the guidelines of European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The pharmacologic comparative study, and preclinical pharmacology study, pharmacodynamics, pharmacokinetics and immunogenicity studies have demonstrated that HLX17 is similar to the reference pembrolizumab.

Immune checkpoint inhibitors are playing a crucial part in immunotherapy, which has emerged in recent years as a novel approach to combating tumor cells and their distinct advantages and enormous potential has been continuously validated. HLX17 is a monoclonal antibody that binds to the PD-1 receptor expressed on T cells and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, thus restoring the T-cell immune surveillance of tumors and increasing its anti-tumour efficacy. Based on the competitive edge of an integrated antibody drug R&D platform, Henlius has accelerated the development of immunotherapies and built a diversified product pipeline with high potential immune checkpoints including PD-1/L1, CTLA-4, LAG-3, TIGIT, etc., which are expected to show efficacy in multiple indications while laying a foundation for the synergy with in-house products of the company and other innovative therapies.

Looking forward, Henlius will maintain its focus on unmet medical needs and further broaden the company’s layout in more diseases areas, commit to bring high quality and affordable treatments for patients worldwide.