Changchun High-tech: Subsidiary GenSci's 128-patch product receives Orphan Drug designation from the U.S. Food and Drug Administration

Changchun Gaoxin announced that its subsidiary, JinSai Pharmaceutical, received notification from the FDA, granting GenSci128 orphan drug designation (ODD) for the treatment of gastric cancer. GenSci128 is a Class 1 new chemical drug and falls under the “505b1” category for new drug registration in the United States. 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, and colorectal cancer.