Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that the National Medical Products Administration (NMPA) of China has accepted a new indication application for its core product, sacituzumab tirumotecan (sac-TMT), a novel TROP2-directed antibody-drug conjugate. The application pertains to the treatment of adult patients with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer who have previously received endocrine therapy and other treatments. This marks the fourth indication of sac-TMT to be reviewed via the priority review and approval process by the Center for Drug Evaluation $(CDE)$ of the NMPA. The company has initiated eight registrational clinical studies in China, while MSD has conducted 14 ongoing Phase 3 global clinical studies of sac-TMT in combination with pembrolizumab or other agents for various cancer types.
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