Shanghai, China, September 8, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for its HLX17, a proposed pembrolizumab biosimilar independently developed by the company, was approved by the U.S. Food and Drug Administration (FDA) as an adjuvant therapy for certain resected solid tumors,

HLX17 is a pembrolizumab biosimilar independently developed by Henlius in accordance with the NMPA, EMA, FDA and other international biosimilar guidelines. 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. In postoperative adjuvant therapy, this mechanism helps to eliminate residual cancer cells after surgery, thereby reducing the risk of cancer recurrence.

Leveraging its integrated platform advantages in antibody drugs and antibody-drug conjugates, Henlius is accelerating the development of immunotherapies and antibody-drug conjugates, building a diversified product pipeline with high potential immune checkpoints including PD-1/L1, CTLA-4, LAG-3, 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 disease areas, commit to bring high quality and affordable treatments for patients worldwide.