CSPC's SYS6041 receives U.S. clinical trial approval

CSPC Pharmaceutical Group Limited (HKEX: 1093) announced that its Investigational New Drug (IND) application for SYS6041 (Antibody-Drug Conjugate) has been approved by the U.S. Food and Drug Administration (FDA). This approval allows CSPC to conduct clinical trials for the drug in the United States. The product has also been approved by the National Medical Products Administration of the People's Republic of China in January 2025 to conduct clinical trials in China. SYS6041, developed by the Group, is a monoclonal antibody-drug conjugate designed to bind to specific receptors on tumor cells, releasing toxins to kill the cells. The indication for this approval is advanced solid tumors. Preclinical studies have demonstrated good anti-tumor effects on a variety of cancers. The company has filed multiple patent applications for the product in China and overseas.