4 December, 2023, Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is pleased to announce that, our drug candidate MRG003, an antibody drug conjugate (“ADC”) drug candidate targeting epidermal growth factor receptor (“EGFR”) and a core product of the Company, has been granted the Fast Track Designation (the “FTD”) by the Food and Drug Administration of the United States (the “FDA”) for the treatment of recurrent or metastatic nasopharyngeal cancer (“R/M NPC”) recently.

Previously, MRG003 has already been granted breakthrough therapy designation (the “BTD”) by the Center for Drug Evaluation (the “CDE”) of the National Medical Products Administration of the People’s Republic of China (the “PRC”) and the Orphan-drug Designation (the "ODD") by the FDA for the treatment of R/M NPC.

The FTD is established to facilitate and expedite the clinical development and review process of drugs with a view to meeting the unmet medical demands of serious diseases. According to the regulations, the obtainment of FTD status for drug candidates would provide the opportunity to accelerate the review process in various forms. MRG003 is an advanced EGFR-targeted ADC in clinical-stage development in China and has the potential to seize market opportunities. This obtainment of the FTD marks another important milestone for the Company, which comes shortly after MRG003 was granted the ODD from the FDA and BTD from the CDE.

ABOUT MRG003

MRG003 is an ADC comprised of an EGFR-targeted monoclonal antibody conjugated with the potent microtubulin inhibiting payload monomethyl auristatin E via a valine-citrulline linker. It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment.