Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has had its New Drug Application (NDA) for SKB264 accepted for review by China’s National Medical Products Administration (NMPA). This application is based on results from the OptiTROP-Breast01 study, a multi-center, randomized, controlled Phase III trial evaluating SKB264 as a treatment for previously treated irresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). If approved, Kelun’s product will be the first domestically developed TROP2-targeted antibody-drug conjugate (ADC) to receive regulatory clearance in China.
In addition to mTNBC, SKB264 is also being developed for non-small cell lung cancer (NSCLC) and HR+/HER2- breast cancer, among other indications. The drug has received breakthrough therapy designation (BTD) in China for its use in TNBC, NSCLC, and breast cancer. Notably, the molecule was the subject of a licensing agreement with Merck, Sharp & Dohme (MSD) in May 2022 for markets outside Greater China.- Flcube.com
