The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd’s (HKG: 6990) drug candidate, SKB264, is on track to obtain priority review status for the treatment of unresectable, locally advanced, or metastatic triple negative breast cancer (TNBC) in China. This development is particularly significant for patients who have previously received at least two kinds of systematic treatment, including at least one for the advanced/metastatic stage of cancer.
SKB264’s Target and Development
SKB264 is an antibody drug conjugate (ADC) that targets TROP2 and is under development for the treatment of TNBC, non-small cell lung cancer (NSCLC), and HR+/HER2- breast cancer, among other types of cancer. The drug has already been granted breakthrough therapy designation (BTD) status in China for use in TNBC, highlighting its potential to address significant unmet medical needs.
Global Partnership and Clinical Progress
In May 2022, Merck, Sharp & Dohme (MSD) entered into a licensing deal for SKB264 for territories outside Greater China, recognizing the drug’s potential in the global market. A Phase III study for SKB264 in TNBC reached its primary endpoints in August of this year, further validating the drug’s efficacy and safety profile.-Fineline Info & Tech
