Shanghai, China, March 20, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for HLX18, a proposed nivolumab biosimilar independently developed by the company, has been approved by the China National Medical Products Administration (NMPA) for the treatment of certain resected solid tumors. Previously, the IND application for HLX18 was also cleared by the U.S. Food and Drug Administration (FDA).
HLX18 is a nivolumab biosimilar developed by Henlius in accordance with biosimilar regulatory guidelines in China, the European Union, and the United States. Comparative pharmaceutical quality and non-clinical studies have demonstrated that HLX18 is similar to the reference product nivolumab.
Nivolumab has been approved in multiple countries and regions for a range of indications, including melanoma (MEL), malignant pleural mesothelioma (MPM), head and neck squamous cell carcinoma (HNSCC), and urothelial carcinoma (UC). According to IQVIA, global sales of nivolumab reached approximately USD11.103 billion in 2024.
Leveraging its integrated R&D capabilities in immuno-oncology, Henlius continues 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 lung cancer, gastrointestinal cancers, melanoma, urological cancers, breast cancer, and lymphoma, while systematically addressing key clinical scenarios such as perioperative treatment, first-line therapy, and combination regimens.
Henlius’ self-developed anti-PD-1 monoclonal antibody, serplulimab, has demonstrated clear clinical value in 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.
In addition, HLX43, a potentially best-in-class pan-tumour antibody-drug conjugate (ADC) candidate targeting PD-L1, has shown promising preliminary clinical efficacy characterized by encouraging efficacy and manageable safety profile in solid tumors including non-small cell lung cancer (NSCLC). Recently, a global multicenter phase 2/3 clinical study evaluating HLX43 for advanced or metastatic squamous NSCLC (sqNSCLC) has been initiated in the United States.
Beyond HLX18, the pembrolizumab biosimilar HLX17 and the ipilimumab biosimilar HLX13 have both completed first patient dosing in their respective international multicenter phase 1 clinical studies. Meanwhile, the investigational new drug application for HLX15-SC, a subcutaneous formulation of the daratumumab biosimilar HLX15 (a recombinant anti-CD38 fully human monoclonal antibody), has also been cleared by both the NMPA and the FDA.
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 ahead, Henlius will continue to focus on unmet medical needs, expand its forward-looking pipeline across more disease areas, and strive to provide high-quality and affordable treatment options for patients worldwide.
