Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma, a type of cancer that arises in the urinary system.
SHR-A2102 is an innovative antibody-drug conjugate (ADC) that targets Nectin-4, a protein that is highly expressed in certain cancers and is associated with tumor development and a poor prognosis. The ADC is equipped with a topoisomerase inhibitor (TOPi) as its payload, which is designed to be delivered directly to cancer cells, minimizing damage to healthy cells. SHR-A2102 is currently in Phase II clinical trials, marking an advanced stage in its development.
Globally, Pfizer/Seagen’s Padcev (enfortumab vedotin) is a comparable ADC that also targets Nectin-4 and has been approved for certain uses. The FDA’s Fast Track Designation for SHR-A2102 signifies that the agency has identified a potential to fill an unmet medical need and may expedite the review process for the drug.- Flcube.com
