偏頭痛是一種常見的神經(jīng)系統(tǒng)疾病，以單側(cè)搏動(dòng)性頭痛為主要特征。降鈣素基因相關(guān)肽（CGRP）在偏頭痛的發(fā)病機(jī)制中發(fā)揮重要作用，并由此開發(fā)了用于偏頭痛的CGRP拮抗藥物，近期有3個(gè)以CGRP單抗或CGRP受體的單抗藥物Aimovig^®、Ajovy^®和Emgality^®被FDA批準(zhǔn)上市。概述了這3個(gè)單抗新藥的非臨床研究?jī)?nèi)容，并結(jié)合ICH S6（R1）分析了生物制品類新藥非臨床研究的要點(diǎn)，以期為國(guó)內(nèi)該類藥物的研發(fā)提供參考。

Migraine is a common neurologic disorder characterized by attacks consisting of unilateral, throbbing headache. Calcitonin gene-related peptide (CGRP) has been shown to play causative role in induction of migraine attacks. Therefore, drugs blocking CGRP for migraine have been developed. Currently, three mAbs for CGRP or CGRP canonical receptor (Aimovig^®, Ajovy^® and Emgality^®) have been approved by FDA. This article summarizes the nonclinical study of the three mAbs and analyzes the key points of the nonclinical research of biotechnology-derived pharmaceuticals according to ICH S6(R1) guideline to provide information for drug development in China.