StoryRegulatory
China approves sac-TMT for EGFR-mutant lung cancer, the first TROP2 conjugate approved in lung cancer
Merck & Co.Sacituzumab tirumotecan (sac-TMT)
Kelun-Biotech won Chinese approval for sac-TMT as second-line treatment of EGFR-mutant lung cancer, its second indication in China. The approval rested on the OptiTROP-Lung03 trial, which beat docetaxel chemotherapy on response, progression-free survival and overall survival. Merck holds the rights everywhere outside Greater China.
- Brand name in China: Jiatailai; disclosed by Sichuan Kelun Pharmaceutical on 10 Mar 2025.
- Described as the first TROP2 conjugate approved for lung cancer anywhere.
- Merck licensed ex-China rights in May 2022.