美国FDA紧急使用授权（EUA）批准的新冠病毒抗体药物研发进展

摘要/Abstract

摘要： 新型冠状病毒（SARS-CoV-2）引发的急性呼吸道传染性疾病在全球大规模流行，严重威胁人类生命安全，全世界迫切需要有效、安全的新冠肺炎（COVID-19）治疗及预防药物。疫苗、抗体和小分子药物成为战胜疫情的关键。由于抗体药物特异性强、安全性好等优点，现已成为开发抗COVID-19特效药的焦点。目前，全球已有美国礼来公司（Eli Lilly and Company）的巴尼韦单抗/埃特司韦单抗（Bamlanivimab/Etesevimab）鸡尾酒疗法、再生元制药公司的REGEN-COV抗体鸡尾酒疗法、Vir公司与GSK公司共同开发的索曲韦单抗（Sotrovimab）、阿斯利康制药有限公司的Evusheld抗体鸡尾酒疗法共计4款针对SARS-CoV-2的抗体药物获得美国FDA的紧急使用授权（EUA），用于治疗早期轻症COVID-19患者、暴露前预防或暴露后预防，这为COVID-19患者的治疗和预防打了一剂强效“加强针”。本研究基于这4款抗体药物研究和发展现状，梳理总结其临床治疗效果、作用特点及作用机制，以期为针对SARS-CoV-2抗体药物的开发提供一定借鉴和参考。

关键词: font-size:medium, ">新冠病毒；新冠肺炎；中和抗体药物；紧急批准授权

Abstract: Corona virus disease 2019 (COVID-19) caused by the sever acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are spreading worldwide on a large scale， seriously threatening the human life and safety. The world urgently needs effective drugs against SARS-CoV-2. Vaccines， antibodies and small molecule drugs are the key to defeating the epidemic of COVID-19. Due to the advantages of strong specificity and good safety， antibodies have become the focus of the development of anti-SARS-Cov-2 treatment. Up to now, four antibody therapies against SARS-CoV-2 have received emergency use authorization (EUA) of US FDA for the treatment of early mild COVID-19 patients， pre-exposure prophylaxis or post-exposure prophylaxis，i.e. 4Bamlanivimab/Etesevimab cocktail therapy from Eli Lilly and Company， REGEN-COV antibody cocktail therapy from Regeneron Pharmaceuticals， Vir and GSK co-developed Sotrovimab and AstraZeneca′s Evusheld antibody cocktail therapy. These antibody therapies can provide treatment and prevention for COVID-19 patients worldwide. Based on the research and development of these antibody therapies， this study summarizes their clinical therapeutic effects， acting characteristics and mechanism， and to provide a reference for the development of antibody therapies against SARS-CoV-2.

Key words: font-size:medium, ">SARS-CoV-2；COVID-19；Neutralizing antibodies；Emergency use authorization

中图分类号:

单思思, 杨子卿, 张林琦. 美国FDA紧急使用授权（EUA）批准的新冠病毒抗体药物研发进展[J]. 中国医药导刊, 2022, 24(1): 9-15.

SHAN Sisi, YANG Ziqing, ZHANG Linqi. Research Progress on Antibody Therapies Against SARS-CoV-2 Received US FDA Emergency Use Authorization[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2022, 24(1): 9-15.

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