MRG003是一种由EGFR靶向单克隆抗体与强效的微管抑制有效载荷一甲基澳瑞他汀E分子通过缬氨酸-瓜氨酸链接体偶联而成的ADC。其以高亲和力特异性地结合肿瘤细胞表面的EGFR，通过内吞及溶酶体蛋白酶裂解后释放强效的有效载荷，从而导致肿瘤细胞死亡。Luoping Biological-B (02157) announced that the company has received the issuance of the National Medical Products Administration (NMPA) of China...
News from Wisdom Financial APP, Luoping Biological-B (02157) announced that the company has received the 'Acceptance Letter' issued by the National Medical Products Administration (NMPA) of China, and the new drug application (NDA) for the company's candidate drug MRG003 (an epidermal growth factor receptor (EGFR) targeted antibody-drug conjugate (ADC) candidate drug for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC)) has been accepted. MRG003 has also been given priority review by the NMPA Center for Drug Evaluation (CDE).
Previously, MRG003 has been granted Breakthrough Therapy Designation (BTD) by the CDE, and has been granted BTD, Orphan Drug Designation (ODD), and Fast Track Designation (FTD) by the Food and Drug Administration (FDA) of the United States for the treatment of R/M NPC.
MRG003 is an ADC composed of an EGFR-targeting monoclonal antibody linked to a potent microtubule inhibitor payload emtansine molecule through a valine-citrulline linker. It specifically binds to EGFR on the surface of tumor cells with high affinity, releasing the potent payload after internalization and lysosomal protease cleavage, leading to tumor cell death.
EGFR is highly expressed in various malignant solid tumors such as colorectal cancer, lung cancer, head and neck cancer, with 89% of advanced NPC cases demonstrating EGFR expression. Therefore, EGFR is an important target for cancer treatment.
The acceptance of MRG003's drug registration application by the NMPA and its inclusion in the priority review marks an important milestone in the commercialization process of MRG003. This, together with the BTD granted by the CDE, will accelerate the review process. In the future, the company will fully promote the commercialization of MRG003, which will have a positive impact on the company's business performance and further enhance its competitiveness.
After the acceptance of MRG003's drug registration application by the NMPA, MRG003 will still need to undergo technical review, on-site verification of clinical trials, on-site inspection of production facilities, and other procedures before it can be marketed for sale upon approval of the NDA.
