It has been more than three decades since the first monoclonal antibody was approved by the United States Food and Drug Administration (US FDA) in 1986, and during this time, antibody engineering has dramatically evolved. Current antibody drugs have increasingly fewer adverse effects due to their high specificity. As a result, therapeutic antibodies have become the predominant class of new drugs developed in recent years. Over the past five years, antibodies have become the best-selling drugs in the pharmaceutical market, and in 2018, eight of the top ten bestselling drugs worldwide were biologics. The global therapeutic monoclonal antibody market was valued at approximately US$115.2 billion in 2018 and is expected to generate revenue of $150 billion by the end of 2019 and $300 billion by 2025. Thus, the market for therapeutic antibody drugs has experienced explosive growth as new drugs have been approved for treating various human diseases, including many cancers, autoimmune, metabolic and infectious diseases. As of December 2019, 79 therapeutic mAbs have been approved by the US FDA, but there is still significant growth potential. This review summarizes the latest market trends and outlines the preeminent antibody engineering technologies used in the development of therapeutic antibody drugs, such as humanization of monoclonal antibodies, phage display, the human antibody mouse, single B cell antibody technology, and affinity maturation. Finally, future applications and perspectives are also discussed.

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开发用于治疗疾病的治疗性抗体

自从第一种单克隆抗体于1986年获得美国食品和药物管理局（US FDA）批准以来，已经过去了三十多年，在此期间，抗体工程技术得到了长足的发展。当前的抗体药物由于其高特异性而具有越来越少的副作用。结果，治疗性抗体已成为近年来开发的新药的主要类别。在过去的五年中，抗体已成为制药市场上最畅销的药物，2018年，全球十大最畅销药物中有八种是生物制剂。2018年，全球治疗性单克隆抗体市场价值约为1152亿美元，预计到2019年底将产生1500亿美元的收入，到2025年将产生3000亿美元的收入。随着新药被批准用于治疗各种人类疾病，包括许多癌症，自身免疫性疾病，代谢性疾病和传染性疾病，治疗性抗体药物市场经历了爆炸性增长。截至2019年12月，美国FDA批准了79种治疗性单抗，但仍有巨大的增长潜力。这篇综述总结了最新的市场趋势，并概述了治疗性抗体药物开发中使用的卓越抗体工程技术，例如单克隆抗体的人源化，噬菌体展示，人抗体小鼠，单B细胞抗体技术以及亲和力成熟。最后，还将讨论未来的应用程序和前景。代谢和传染病。截至2019年12月，美国FDA批准了79种治疗性单克隆抗体，但仍有巨大的增长潜力。这篇综述总结了最新的市场趋势，并概述了治疗性抗体药物开发中使用的卓越抗体工程技术，例如单克隆抗体的人源化，噬菌体展示，人抗体小鼠，单B细胞抗体技术以及亲和力成熟。最后，还将讨论未来的应用程序和前景。代谢和传染病。截至2019年12月，美国FDA批准了79种治疗性单抗，但仍有巨大的增长潜力。这篇综述总结了最新的市场趋势，并概述了治疗性抗体药物开发中使用的卓越抗体工程技术，例如单克隆抗体的人源化，噬菌体展示，人抗体小鼠，单B细胞抗体技术以及亲和力成熟。最后，还将讨论未来的应用程序和前景。例如单克隆抗体的人源化，噬菌体展示，人类抗体小鼠，单B细胞抗体技术以及亲和力成熟。最后，还将讨论未来的应用程序和前景。例如单克隆抗体的人源化，噬菌体展示，人类抗体小鼠，单B细胞抗体技术以及亲和力成熟。最后，还将讨论未来的应用程序和前景。