Ge Long Hui·2025-12-19 10:01Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX18, a biosimilar to Nivolumab, targeting multiple solid tumors [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved the initiation of Phase I clinical trials for HLX18, a recombinant anti-PD-1 humanized monoclonal antibody injection, for the treatment of various solid tumors [1] - Fuhong Hanlin plans to conduct the Phase I clinical trial in the United States once conditions are met [1] Group 2: Product Details and Market Potential - HLX18 is a biosimilar to Nivolumab, intended for 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, esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma [1] - As of November 2025, the cumulative R&D investment for HLX18 is approximately RMB 52.53 million (unaudited) [1] - According to IQVIA MIDAS data, global sales of Nivolumab are projected to be around USD 11.1 billion in 2024 [1]