Kelun-Biotech's TROP2 ADC Sacituzumab tirumotecan (sac-TMT) Approved For Marketing By NMPA Of China For 2L+ Advanced or Metastatic TNBC [Yahoo! Finance]
Merck & Company, Inc. (new) (MRK)
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Source: Yahoo! Finance
marketing authorization in China from National Medical Products Administration (NMPA) for the first domestically developed trophoblast cell-surface antigen 2 (TROP2)-directed antibody–drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-287 for adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) 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 ADC approved for marketing in China and the first domestically developed ADC fully approved for marketing in China The approval is based on the positive results from a randomized, controlled, phase 3 OptiTROP-Breast01 study in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). Sac-TMT demonstrated statistically significant and clinic
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