Sichuan Kelun-Biotech Biopharmaceutical's (HKG:6990, SHE:002422) new indication application for TROP2 ADC sacituzumab tirumotecan was accepted for review by China's National Medical Products Administration.
The drug has been developed for the first-line treatment of patients with recurrent or metastatic triple-negative breast cancer, according to a Thursday Hong Kong bourse filing.
This is the sixth indication application accepted by the regulator for the product. The acceptance was based on positive results from a phase III registrational study.