Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it has been granted Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), SHR-A1921. This designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
SHR-A1921, developed in-house, targets TROP2, a protein overexpressed on various solid tumor cells. The ADC works by binding to the target antigen on the tumor cell surface, facilitating endocytosis of the drug into the cell, and subsequently releasing small-molecule toxins to eliminate the cancer cells. Currently undergoing a Phase II study in China for the treatment of platinum-sensitive recurrent epithelial ovarian cancer as a monotherapy or in combination with chemotherapy, SHR-A1921 has also received clinical trial approval in the U.S. for platinum-resistant recurrent epithelial ovarian cancer.
This Fast-Track Designation underscores the potential of SHR-A1921 to address a significant unmet medical need and highlights Hengrui’s commitment to advancing novel therapeutics for cancer treatment.- Flcube.com
