Ge Long Hui·2025-12-19 09:58Core 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 various 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 multiple 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 Development and Market Potential - HLX18 is developed by the group and is intended for use in indications where the original drug has been approved, including melanoma, non-small cell lung cancer, and several other cancers [1] - As of November 2025, the group's cumulative R&D investment in 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]