CSPC PHARMA (01093)'s SYS6043 for first-line treatment of unresectable recurrent or metastatic triple-negative breast cancer has officially launched its Phase III clinical trial in China.

CSPC PHARMA (01093) announced that the Phase III clinical trial of SYS6043, developed by the group, for the first-line treatment of unresectable recurrent or metastatic triple-negative breast cancer has officially been initiated at the first research center in China. The product is an antibody-drug conjugate (ADC) targeting B7-H3 developed by the group. Its antibody component can specifically bind to the surface of cells expressing B7-H3 and be internalized into the cells; its linker-drug is a tetrapeptide linker conjugated to a topoisomerase I inhibitor, which can release small-molecule toxins after specific cleavage by proteases to kill tumor cells and exert a bystander effect to non-specifically kill surrounding tumor tissue cells. Unlike antibodies using conventional wild-type crystallizable fragments (Fc), this product can reduce lymphocyte uptake and lower the risk of off-target toxicity, thereby improving treatment safety. The clinical trial initiated this time is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the clinical efficacy and safety of this product compared with investigator-selected chemotherapy in participants receiving first-line treatment for unresectable recurrent or metastatic triple-negative breast cancer. Currently, participant recruitment and screening for this Phase III clinical trial are being actively advanced.