Shanghai, China, July 16, 2026 – Henlius (2696.HK) announced that the first patient in China has been dosed in the international multicenter Phase 1 clinical trial (HLX18-MRST001) of its self-developed nivolumab biosimilar HLX18 (recombinant anti-PD-1 humanized monoclonal antibody injection) in patients with resected solid tumors. Previously, the Investigational New Drug (IND) application for HLX18 was also cleared by the U.S. Food and Drug Administration (FDA).  To date, no nivolumab biosimilar has been approved in China or other major global biologics markets, including the United States, Europe, and Japan.

HLX18 is a nivolumab biosimilar developed by Henlius in strict accordance with biosimilar regulatory guidelines in China, the European Union, and the United States. Analytical and non-clinical comparability studies have demonstrated similarity between HLX18 and reference nivolumab. Nivolumab has been approved in multiple countries and regions for a broad range of indications, including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma. According to IQVIA data, global sales of nivolumab reached USD 11.785 billion in 2025.

Looking ahead, Henlius will continue to focus on unmet medical needs, leveraging its integrated global R&D and clinical development capabilities to expand its presence across therapeutic areas and deliver more treatment options to patients worldwide.