Changchun High-tech: Subsidiary GenSci 128 Tablets Obtains Orphan Drug Designation from the US Food and Drug Administration

Changchun High-tech announced that its subsidiary Golden Sai Pharmaceutical received a notification from the FDA granting GenSci128 tablets orphan drug status for the treatment of gastric cancer. GenSci128 tablets belong to the category of Class 1 new drugs for therapeutic use, registered in the United States under the category "505b1". It is a selective reactivator targeting the TP53 Y220C mutation, intended for the treatment of locally advanced or metastatic solid tumors carrying the TP53 Y220C mutation, including pancreatic cancer, gastric cancer, ovarian cancer, breast cancer, colorectal cancer, etc.