Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced that its flagship product MRG003 has received fast-track status from the U.S. FDA for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The antibody-drug conjugate (ADC), which targets the epidermal growth factor receptor (EGFR), was previously granted orphan drug designation (ODD) by the FDA.
MRG003 operates by specifically targeting EGFR on tumor cells, delivering cytotoxic small molecules directly to the affected cells. Upon binding to EGFR, MRG003 can induce Fc segment-mediated immunotoxicity, including antibody-dependent cell-mediated cytotoxicity (ADCC). The drug has also received breakthrough therapy designation (BTD) in China for the same indication of R/M NPC.- Flcube.com
