灵北公司提交Vyepti在中国的上市许可申请

Core Viewpoint - Lingbei Company has submitted a New Drug Application (NDA) for Vyepti (eptinezumab) to the China National Medical Products Administration (NMPA) for the preventive treatment of migraines in adults, marking its first introduction of a biological product in mainland China and key Asian markets [1][2] Group 1: Drug Details - Vyepti is a humanized monoclonal antibody that specifically targets calcitonin gene-related peptide (CGRP) and is administered via intravenous injection [1] - The SUNRISE study, a phase III trial conducted primarily among chronic migraine patients in Asia, demonstrated significant advantages of Vyepti over placebo in reducing the frequency of migraine attacks, decreasing the proportion of severe pain episodes, and alleviating disease burden [1] Group 2: Market Potential - The introduction of Vyepti in China is expected to provide a new treatment option for migraine patients, addressing the need for improved accessibility to effective preventive treatments in the country [2] - Lingbei Company aims to accelerate the approval process for Vyepti in China and expedite its nationwide launch to enhance brain health and improve the quality of life for a large number of migraine patients [2]