Kelun-Biotech announces fourth indication for Sacituzumab Tirumotecan (sac-TMT) approved by NMPA in HR+/HER2- breast cancer

CAR-T Digest - August 2020

06 February 2026: Kelun-Biotech announces fourth indication for Sacituzumab Tirumotecan (sac-TMT) approved by NMPA in HR+/HER2- breast cancer

Sichuan Kelun-Biotech announced that China’s National Medical Products Administration has approved a new indication for its TROP2-directed ADC sacituzumab tirumotecan for the treatment of adults with unresectable or metastatic HR+/HER2- breast cancer who have received prior endocrine therapy and at least one line of chemotherapy in the advanced setting
This latest approval marks the fourth indication for sac-TMT in China and is supported by results from the Phase 3 OptiTROP-Breast02 study, which was presented as a late-breaking abstract at the 2025 ESMO Congress
In the study, sac-TMT demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with investigator’s choice of chemotherapy, delivering a median PFS of 8.3 months versus 4.1 months and reducing the risk of disease progression or death by 65%
The benefit was consistent across key subgroups, including patients with HER2-zero and HER2-low expression, those with visceral and liver metastases, and individuals previously treated with CDK4/6 inhibitors and multiple lines of chemotherapy, alongside a higher objective response rate compared with chemotherapy
Building on this momentum, global and China-based Phase 3 trials are now underway to evaluate sac-TMT with or without pembrolizumab in chemotherapy-naïve HR+/HER2- metastatic breast cancer, further expanding its development in earlier treatment settings