Sichuan Kelun-Biotech Biopharmaceutical Co Ltd (HK:6990), a holding subsidiary of China-based Kelun Pharmaceutical (SZ:002422), announced on Wednesday that it has received marketing authorisation from China's National Medical Products Administration (NMPA) for its trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870), for adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting).

This is the first domestically developed TROP2 ADC approved for marketing in China and the first domestically developed ADC fully approved for marketing in China.

The approval was based on positive results from the randomised, controlled, phase 3 OptiTROP-Breast01 study in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). Sac-TMT demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. The results were presented at the special clinical science symposium for next-generation ADCs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2024.