CSPC PHARMA (ASX: 01093) has announced the official initiation of a Phase III clinical trial at its first Chinese center for its investigational drug, SYS 6043 (B7-H3-ADC).

This randomized, multicenter, open-label trial is designed to evaluate SYS 6043 against chemotherapy chosen by investigators for the treatment of patients with platinum-resistant advanced ovarian cancer, primary peritoneal cancer, and fallopian tube cancer.

SYS 6043 is an antibody-drug conjugate (ADC) developed by the company that targets B7-H3.

The antibody component of the drug specifically binds to B7-H3-expressing cells on the surface and is internalized.

The linker-drug component consists of a tetrapeptide linker coupled with a topoisomerase I inhibitor, which is released upon specific protease cleavage to deliver the cytotoxic agent, killing tumor cells and exerting a bystander effect to non-specifically eliminate surrounding tumor tissue.

Unlike antibodies using a traditional wild-type Fc fragment, this product is designed to reduce lymphocyte uptake, potentially lowering off-target toxicity risks and thereby enhancing treatment safety.

The company received a clinical trial approval notice from China's National Medical Products Administration in July 2026, authorizing the start of this randomized, multicenter, open-label, active-controlled Phase III study.

The primary objectives of this Phase III trial are to assess the clinical efficacy and safety of SYS 6043 compared to investigator-chosen chemotherapy regimens in the specified patient population.

Subject recruitment and screening for the trial are currently being actively advanced.