Sichuan Kelun-Biotech Biopharmaceutical Co Ltd (HK:6990) announced on Wednesday that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted a new indication application for the company's trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870).

This application relates to the treatment of adult patients with unresectable locally advanced, metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting.

The drug showed positive results in a registrational Phase 3 OptiTROP-Breast02 study.

This is the fourth indication application for sac-TMT that has been accepted by the NMPA, Kelun-Biotech said.