狂犬病是由狂犬病毒引起的急性傳染病，及時(shí)給予暴露后預(yù)防（PEP）可阻止臨床癥狀出現(xiàn)。PEP由清洗傷口、給予狂犬病疫苗和在傷口內(nèi)和周圍給予抗狂犬病病毒免疫球蛋白（RIG）3部分構(gòu)成。由于多種原因限制了RIG的使用，其全球使用率不到狂犬病病毒暴露的2%。因此，抗狂犬病病毒單克隆抗體雞尾酒正被開發(fā)為PEP被動(dòng)免疫成分RIG的替代品。美國(guó)食品藥品監(jiān)督管理局（FDA）于2021年7月發(fā)布了《狂犬?。簽楸┞逗箢A(yù)防的被動(dòng)免疫成分研制單克隆抗體雞尾酒供企業(yè)用指導(dǎo)原則》，旨在促進(jìn)抗狂犬病病毒單克隆抗體雞尾酒的開發(fā)，并對(duì)抗狂犬病病毒單克隆抗體雞尾酒的研究提出了詳細(xì)而具體的建議，其中包括臨床和非臨床研究的要點(diǎn)以及臨床III期療效試驗(yàn)設(shè)計(jì)。詳細(xì)介紹該指導(dǎo)原則主要內(nèi)容，期望對(duì)中國(guó)在此方面的研究和監(jiān)管提供幫助，對(duì)《抗狂犬病病毒單克隆抗體新藥臨床試驗(yàn)技術(shù)指導(dǎo)原則（征求意見稿）》的修訂有所啟示。

Rabies is an acute infectious disease caused by rabies virus, timely administration of rabies post-exposure prophylaxis (PEP) is effective in preventing clinical rabies. PEP consists of washing the wound, administrating rabies vaccine and administrating anti rabies virus immunoglobulin (RIG) in and around the wound. Due to various reasons, the use of RIG is limited, and its global use rate is less than 2% of rabies virus exposure. Therefore, anti-rabies virus monoclonal antibody cocktails are being developed as an alternative to RIG as the passive immunization component of PEP. FDA issued Rabies:Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry in July 2021, which aims to promote the development of monoclonal antibody cocktails against rabies virus. The guidelines put forward many detailed and specific suggestions for the study of monoclonal antibody cocktail against rabies virus, including the key points of clinical and non clinical research and the design of clinical phase III efficacy trial. This article details the guidelines, expected to be helpful to China's research and supervision in this regard. It also has enlightenment for the revision of Technical Guidence for Clinical Trials of New Anti-Rabies Virus Monoclonal Antibodies (Draft) in China.

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