Shiyao Group (01093): Phase I/II clinical trial of SYS6043 for the treatment of advanced solid tumors was officially launched at the first center in China

According to Zhitong Finance App, Shiyao Group (01093) announced that an open, multi-center phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and initial efficacy of SYS6043 (B7-H3-ADC) monotherapy or bevacizumab and/or chemotherapy developed by the Group in advanced solid tumor participants has been officially launched at the first center in China.

This product is an antibody-conjugated drug (ADC) targeting B7-H3 developed by the Group. The antibody part can specifically bind to the cell surface expressing B7-H3 and internalize it into the cell; its linker-drug (Linker-Drug) is a tetrapeptide ligand-conjugated topoisomerase I inhibitor, which can release small molecules of toxins to kill tumor cells through protease-specific cleavage, and exerts a bystander effect to kill surrounding tumor tissue cells without specificity. Unlike antibodies using traditional wild-type crystallizable fragments (Fc), this product can reduce lymphocyte uptake and reduce the risk of off-target toxicity, thereby improving the safety of treatment.

Previously, the group had received the “Drug Clinical Trial Approval Notice” issued by the State Drug Administration of the People's Republic of China in September 2026, and initiated the clinical trial after approval. The clinical trial initiated this time is an open, multicenter phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and initial efficacy of this product as a single agent or combination with bevacizumab and/or chemotherapy in advanced solid tumor participants. Currently, the recruitment and screening of participants for this clinical trial is being actively promoted.