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作 者:武刚[1] 王军志[1] WU Gang;WANG Jun-zhi(Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Product,National Institute for Food and Drug Control,Bejing 102629,China)
机构地区:[1]中国食品药品检定研究院卫生部生物技术产品检定及标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629
出 处:《中国新药杂志》2022年第21期2073-2081,共9页Chinese Journal of New Drugs
基 金:国家重点研发计划蛋白类生物制品主成分及其相关成分精准定量检测技术研究(2021YFF0600804-C02-05)。
摘 要:抗体类生物制品已逐渐成为传染病治疗的一项新策略。自2019年新型冠状病毒肺炎(corona virus disease 2019,COVID-19)疫情暴发后的几年里,治疗性新型冠状病毒(以下简称新冠病毒)抗体药物研究取得了极大的发展,全世界科研人员以极高效率开发出了一系列抗体治疗方案来对抗新冠病毒。疫情初期,新冠病毒抗体仅应用于紧急治疗临床重症患者,如今既可以用于暴露前预防又可用于感染后治疗。本文概述了新冠病毒治疗性抗体药物的研究进展,包括患者恢复期血清疗法、动物抗血清疗法、已上市新冠病毒单抗药物、非靶向治疗性单抗药物、双特异新冠抗体药物等,并讨论了新冠病毒治疗性单抗药物的局限性及未来应用前景。Antibody-based biological products have gradually become a new strategy for the treatment of infectious diseases. In the past few years, especially after the outbreak of the COVID-19 in 2019, researches on therapeutic SARS-CoV-2 antibodies have greatly developed. Researchers around the world have developed a series of antibody treatment programs with extremely high efficiency to fight against COVID-19. From the early days of the pandemic, therapeutic antibodies were only used for emergency treatment of clinically severe patients, now they can be used for both pre-exposure prophylaxis and post-infection treatment. We summarize the research progress of therapeutic antibodies for SARS-CoV-2, including convalescent plasma, animal antiserum, marketed mAbs, non-targeted therapeutic mAbs, and bispecific antibodies, etc. The limitations and future application prospects of the SARS-CoV-2 therapeutic mAbs are also discussed.
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