Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced the completion of subject enrollment in its Phase IIb clinical study for MRG003, its flagship product targeting recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The randomized, open-label, multi-center pivotal study aims to evaluate the efficacy and safety of this epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) in patients with R/M NPC.
MRG003 functions by targeting EGFR on the surface of tumor cells, delivering cytotoxic small molecules directly to the cancer cells. Upon binding to EGFR, MRG003 can trigger Fc segment-mediated immunotoxicity, including antibody-dependent cell-mediated cytotoxicity (ADCC). The drug has already received breakthrough therapy designation (BTD) in China, along with fast-track status and orphan drug designation (ODD) in the United States for the same indication of R/M NPC.- Flcube.com
