Changchun High-tech Subsidiary Receives FDA Orphan Drug Designation for GenSci128, Targeting Gastric Cancer

Changchun High-tech announced that its subsidiary, GenSci Pharmaceuticals, has received notification from the FDA granting orphan drug designation (ODD) for GenSci128, aimed at treating gastric cancer. According to Jin10, GenSci128 is classified as a new chemical drug under category 1 for therapeutic use and falls under the U.S. new drug registration category '505b1.' It is a selective reactivator targeting the TP53 Y220C mutation, intended for treating locally advanced or metastatic solid tumors carrying the TP53 Y220C mutation, including pancreatic cancer, gastric cancer, ovarian cancer, breast cancer, and colorectal cancer.