It has been announced that CSPC PHARMA (SEHK: 01093) has seen its independently developed B7-H3-targeting humanized monoclonal antibody-drug conjugate, SYS6043, included in the Breakthrough Therapy Designation list by the National Medical Products Administration of China. The intended indication is for monotherapy in platinum-resistant ovarian cancer, primary peritoneal cancer, and fallopian tube cancer.

Clinical study data for treating these specific cancers indicates that, compared to non-platinum monotherapy chemotherapy and the treatment regimen involving mirvetuximab soravtansine, SYS6043 demonstrates more durable anti-tumor efficacy. It has doubled patients' progression-free survival (PFS) while maintaining a favorable overall safety profile.

The company has now officially initiated a Phase III confirmatory clinical trial for this product targeting the aforementioned indication, fully advancing its development and regulatory approval pathway.

In addition, clinical trials for this product as a first-line and second-line treatment for small cell lung cancer, as well as for breast cancer and various other solid tumors, are concurrently underway, steadily progressing the multi-tumor research and development strategy.

The inclusion of SYS6043 in the Breakthrough Therapy list is expected to significantly accelerate its clinical development and regulatory review timelines across the various tumor types, facilitating earlier approval and market access for this innovative drug. This provides a new, high-quality treatment option for patients with advanced gynecological cancers.

Simultaneously, this milestone further enriches the company's oncology drug development pipeline, continuously strengthening its differentiated R&D advantages and core market competitiveness in the Antibody-Drug Conjugate (ADC) field. This supports the company's ongoing commitment and development within the innovative oncology therapeutics sector.