HK Stock Market Move | LEPU BIO-B(02157) opens more than 14% lower and will resubmit the application for MRG003 new drug listing today

LEPU BIO-B(02157) opened more than 14% lower, and as of the time of writing, it has fallen by 14.73% to HKD 3.01, with a trading volume of 4.8792 million Hong Kong dollars. On the news front, Lepu Biopharma announced that it had received a Notice of Acceptance from the National Medical Products Administration (NMPA) in September last year. The notice is related to the new drug application (NDA) for MRG003, which has been accepted and prioritized for review by the NMPA's Center for Drug Evaluation (CDE). The regulatory agency is currently conducting clinical and pharmaceutical reviews of MRG003 in an orderly manner. In order to supplement the relevant data, the company proactively withdrew the previous NDA for MRG003. The company has supplemented the application materials and prepared the eCTD submission documents, and will resubmit the NDA for MRG003 on March 4th. The company will make every effort to cooperate with regulatory agencies to complete the subsequent review process and obtain approval for the NDA. The announcement notes that the approval process for the commercialization of MRG003 may be delayed due to the supplementary submission of relevant data. It is reported that MRG003 is an antibody-drug conjugate (ADC) consisting of EGFR-targeting monoclonal antibody linked to a potent microtubule inhibitory payload, one-methyl eosin E, via a valine-glycine linker. It binds specifically to EGFR on the surface of tumor cells with high affinity, releasing the potent payload after internalization and lysosomal proteolytic 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, with 89% of advanced NPC patients showing EGFR expression. Therefore, EGFR is an important target for cancer treatment.