LEPU BIO-B(02157) will resubmit the NDA for MRG003 on March 4, 2025.

LEPU BIO-B (02157) announced that the company has received a "Acceptance Notification Letter" from the China National Medical Products Administration (NMPA) in September 2024, regarding the acceptance of the NDA for MRG003, and it has been included in the priority review by the NMPA Drug Evaluation Center (CDE). The regulatory agency is currently conducting orderly clinical and pharmacological reviews of MRG003. According to the company's latest communication with the regulatory agency, the company voluntarily withdrew the previous NDA for MRG003 in order to supplement the relevant data. The company has supplemented the application materials and prepared the eCTD application documents, and will resubmit the NDA for MRG003 on March 4, 2025. The company will make every effort to cooperate with the regulatory agency to complete the subsequent review process and obtain the NDA approval for market launch. It is reported that MRG003 is an ADC composed of an EGFR-targeting monoclonal antibody and a potent microtubule inhibitory payload, E-monomethyl auristatin F, linked to a valine-citrulline linker. It specifically binds to EGFR on the surface of tumor cells with high affinity, releases the potent payload through endocytosis and lysosomal protease cleavage, leading to tumor cell death. EGFR is highly expressed in various malignant solid tumors such as colorectal cancer, lung cancer, and head and neck cancer, and 89% of late-stage NPC cases have EGFR expression. Therefore, EGFR is an important target for cancer treatment.