Shanghai, China, December 19, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for its HLX18, a proposed nivolumab biosimilar independently developed by the company, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain resected solid tumors. Nivolumab has been approved in various countries and regions for a range of different indications, such as for the treatment of melanoma (MEL), malignant pleural mesothelioma (MPM), head and neck squamous cell carcinoma (HNSCC), and urinary tract cancer (urothelial carcinoma, UC). According to IQVIA, the sales volume of nivolumab worldwide for the year 2024 was approximately USD11.103 billion.
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 have been continuously validated. HLX18 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.
HLX18 is a nivolumab biosimilar developed by Henlius in accordance with the NMPA, EMA, FDA and other international biosimilar guidelines. Comparative pharmaceutical quality and non-clinical studies have demonstrated that HLX18 is similar to the reference nivolumab.
In the field of immuno-oncology, Henlius continues to deepen its strategic presence in immuno-oncology, establishing a multi-tiered product portfolio led by in-house innovation and complemented by biosimilars. Henlius’ self-developed anti-PD-1 monoclonal antibody, serplulimab, has demonstrated clear clinical value across multiple key indications, including small cell lung cancer and perioperative treatment of gastric cancer. Through the continued advancement of global clinical studies and combination therapy strategies, serplulimab is building a differentiated competitive profile.
Building on this foundation, Henlius leverages its integrated immuno-oncology R&D capabilities to advance a diversified portfolio covering multiple immune targets, including PD-1/L1 and CTLA-4. The company is developing complementary indication strategies across different tumour types and treatment settings, spanning MEL, urological cancers, breast cancer and lymphoma, while systematically addressing key clinical scenarios such as perioperative treatment, first-line therapy and combination regimens.
Among these programmes, the pembrolizumab biosimilar HLX17 and the ipilimumab biosimilar HLX13 have both initiated international multi-centre phase 1 clinical studies, with first patient dosing completed. Meanwhile, the nivolumab biosimilar HLX18 is focused on multiple solid tumour indications with well-established immunotherapy value. The coordinated advancement of multi-target immuno-oncology assets, differentiated by indication positioning and development pathways, further strengthens Henlius’ overall immuno-oncology portfolio and lays a solid foundation for future combination strategies and innovative therapeutic exploration.
Looking forward, Henlius will maintain its focus on unmet medical needs, further broaden the company’s layout in more disease areas, and strive to provide high-quality and affordable treatment options for patients worldwide.