Lepu Biotechnology Co., Ltd (HKG: 2157), a Chinese pharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), MRG004A, which is being developed to treat pancreatic cancer. MRG004A is an innovative ADC that targets tissue factor, a protein that is over-expressed in various solid tumors.
The drug candidate is currently undergoing Phase I/II clinical studies in both the United States and China. Preclinical testing has demonstrated anti-tumor activities for MRG004A in pancreatic cancer, triple-negative breast cancer, and cervical cancer, highlighting its potential as a treatment for these aggressive malignancies.- Flcube.com
