Abstract
Monoclonal antibodies (mAbs) have become increasingly important as human therapeutic agents. Yet, current research concentrates on technology itself and pays attention to developed countries. This paper aims to provide a comprehensive review of mAbs development in China through systematic analysis of drug registry, patent applications, clinical trials, academic publication, and ongoing R&D projects. The trends in therapeutic areas and industrialization process are also highlighted. Development and research trends of mAbs are analyzed to provide a future perspective of mAbs as therapeutic agents in China.
Highlights
Over the past three decades, monoclonal antibodies have achieved a dramatic development from scientific tools to powerful human therapeutic agents [1]
In 1975, Kohler and Milstein firstly described the in vitro production of murine monoclonal antibodies (mAbs) from hybridomas [3], which was an innovative step towards the development of human mAbs as therapeutic agents
In the following research exploration, human antibodies developed by phage display [9,10,11] and human Ig mice advanced the development of mAb greatly [12, 13]
Summary
Over the past three decades, monoclonal antibodies (mAbs) have achieved a dramatic development from scientific tools to powerful human therapeutic agents [1] (see Figure 1). In 1975, Kohler and Milstein firstly described the in vitro production of murine mAbs from hybridomas [3], which was an innovative step towards the development of human mAbs as therapeutic agents. Human mAbs are the fastest growing category of mAb therapeutics entering clinical study. Development of this class of therapeutic agents started as early as 1980s but achieved no clinical or commercial success until 2002 when adalimumab became the first human mAb approved by the US Food and Drug Administration (FDA) [14]
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