Posted by Michael Wonder on 05 Dec 2024
Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan approved for marketing by NMPA of China for second-line advanced or metastatic triple negative breast cancer
27 November 2024 - Sichuan Kelun-Biotech Biopharmaceutical announced that the Company received marketing authorisation in China from the NMPA for the first domestically developed trophoblast cell-surface antigen 2 (TROP2)-directed antibody–drug conjugate sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) for adult patients with unresectable locally advanced or metastatic triple negative breast cancer 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 antibody drug conjugate approved for marketing in China and the first domestically developed antibody drug conjugate fully approved for marketing in China.
