CSPC obtains U.S. clinical trial approval for SYS6040

CSPC Pharmaceutical Group Limited (HKEX:1093) announced that its Investigational New Drug (IND) application for SYS6040, an antibody-drug conjugate, has been approved by the U.S. Food and Drug Administration (FDA). This approval allows CSPC to conduct clinical trials of SYS6040 in the U.S. The "Product" also obtained approval from the National Medical Products Administration of the People's Republic of China in March 2025 to conduct clinical trials in China. SYS6040 is a monoclonal antibody-drug conjugate designed to target specific receptors on tumor cells, inducing cell death. The clinical trial will focus on advanced solid tumors. Preclinical studies have demonstrated promising anti-tumor effects across a range of cancers. The Group has submitted a number of patent applications of the Product in China and overseas.