Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD) in the United States.
MRG004A is currently undergoing Phase I/II clinical trials in both the U.S. and China, demonstrating promising anti-tumor activity against pancreatic cancer, triple-negative breast cancer, and cervical cancer in preclinical studies. The Fast Track designation aims to expedite the development and review process for drugs addressing unmet medical needs.- Flcube.com
