Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant advancement in the therapeutic landscape for this disease.
MRG003 is an innovative antibody-drug conjugate (ADC) that targets the epidermal growth factor receptor (EGFR), which is often overexpressed on the surface of tumor cells. The ADC is designed to deliver cytotoxic small molecules directly to cancer cells, enhancing the precision of treatment. Upon binding with EGFR, MRG003 can induce Fc segment-mediated immunotoxicity effects, such as antibody-dependent cell-mediated cytotoxicity (ADCC), thereby enhancing the body’s immune response against the cancer cells.- Flcube.com