Jingu Finance | Lupe Biotechnology (02157) announced that the company's candidate drug MRG003 (an epidermal growth factor receptor (EGFR) targeted antibody drug conjugate (ADC) candidate drug and the company's core product) has recently been granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/MNPC).
It is reported that BTD aims to promote and accelerate the development and evaluation of new drugs for the treatment of serious diseases with preliminary evidence indicating significant clinical advantages over existing therapeutic drugs.
MRG003 is an ADC composed of an EGFR-targeted monoclonal antibody and a potent microtubule inhibitor payload one methyl auristatin E molecule linked by a valine-glycine linker. It specifically binds to the EGFR on the surface of tumor cells with high affinity and releases the potent payload after internalization and lysosomal protease cleavage, thereby causing tumor cell death.
