China Accepts Kelun-Biotech's Sacituzumab Tirumotecan for First-Line TNBC

The application’s acceptance follows positive results from the Phase III OptiTROP-Breast03 study, which compared the efficacy of the drug, also known as SKB264, against conventional chemotherapy. The trial focused on patients with unresectable recurrent or metastatic disease who had not received prior systemic therapy. Data indicated that the drug provided statistically significant clinical benefits, addressing a critical gap for patients with PD-L1-negative tumors where traditional treatment options remain limited.

This marks the sixth indication application for the drug to be accepted by the National Medical Products Administration. The agency has also granted the application priority review status, a designation intended to accelerate the drug's path to market. Kelun-Biotech CEO Dr. Michael Ge noted that the move reflects an urgent clinical requirement for safer and more effective first-line interventions in this patient population. The company continues to advance its global development strategy, including a partnership with MSD for territories outside of Greater China, while maintaining an extensive pipeline of over 30 innovative drug projects.