Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received FDA approval to conduct Phase I clinical trials for HLX18, a recombinant anti-PD-1 humanized monoclonal antibody injection for the treatment of various solid tumors [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved HLX18 for clinical trials, which is a biosimilar to Nivolumab [1] - The Phase I clinical trial will target multiple 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]
复星医药HLX18获美国FDA临床试验批准