复星医药子公司HLX18获美国FDA临床试验批准

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval to conduct Phase I clinical trials for HLX18, a biosimilar to Nivolumab, targeting various solid tumors [1] Group 1: FDA Approval - The FDA has approved HLX18 for clinical trials, marking a significant milestone for the company [1] - HLX18 is a recombinant humanized monoclonal antibody injection targeting PD-1 [1] Group 2: Indications - HLX18 is intended for the treatment of multiple solid tumors, including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classic 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]