偏头痛是一种常见的神经系统疾病，以单侧搏动性头痛为主要特征。降钙素基因相关肽（CGRP）在偏头痛的发病机制中发挥重要作用，并由此开发了用于偏头痛的CGRP拮抗药物，近期有3个以CGRP单抗或CGRP受体的单抗药物Aimovig^®、Ajovy^®和Emgality^®被FDA批准上市。概述了这3个单抗新药的非临床研究内容，并结合ICH S6（R1）分析了生物制品类新药非临床研究的要点，以期为国内该类药物的研发提供参考。

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.