CSPC PHARMA (01093.HK): Phase III Trial of SYS6043 in First-Line Triple-Negative Breast Cancer Launched in China

NewTimeSpace News: On 22 October 2026, CSPC Pharmaceutical Group Limited (the "Company") voluntarily announced that the Phase III clinical trial of SYS6043 (the "Product"), developed by the Group for the first-line treatment of unresectable recurrent or metastatic triple-negative breast cancer, has been officially launched at the first research site in China.

The announcement disclosed that the Product is a B7-H3-targeting antibody-drug conjugate (ADC) developed by the Group, whose antibody portion can specifically bind to the surface of cells expressing B7-H3 and be internalised into the cells; its linker-drug comprises a tetrapeptide linker conjugated to a topoisomerase I inhibitor, which releases a small-molecule toxin after specific cleavage by proteases to kill tumour cells and exerts a bystander effect that non-specifically kills surrounding tumour tissue cells. Unlike antibodies using a conventional wild-type crystallisable fragment (Fc), the Product can reduce uptake by lymphocytes and lower the risk of off-target toxicity, thereby improving treatment safety.

The Company stated that the trial launched is a randomised, open-label, multicentre Phase III clinical trial designed to evaluate the clinical efficacy and safety of the Product compared with investigator's choice of chemotherapy in participants with unresectable recurrent or metastatic triple-negative breast cancer in the first-line setting. Patient recruitment and screening for the Phase III trial are currently progressing actively.