摘要
双特异性抗体(bispecific antibody,BsAb)是具有两个特异性抗原结合位点的人工抗体,能够在靶细胞的两个功能分子之间或靶细胞与其他细胞类型之间发挥桥接作用,在抗血管生成、清除肿瘤细胞、调节肿瘤微环境和增强抗肿瘤免疫反应等方面具有广阔的应用前景,是生物医药领域重要的研究方向之一。全球已有近200种BsAb药物进入临床试验,其中7款药物已获批上市。我国有60余种BsAb药物,但大多数BsAb药物处于临床Ⅰ期或者Ⅱ期阶段,仅有Cadonilimab已获批上市以及KN046和AK112处于临床Ⅲ期。综述了BsAb药物的前沿进展及其在研发和转化过程中所面临的难点与挑战,并提出了合理可行的解决方案,以期为我国在BsAb药物的研发与布局提供参考。
Bispecific antibody(BsAb)is an artificial antibody with two specific antigen-binding sites,playing a bridging role between two functional molecules of target cells or between a target cell and another cell type.It has broad application prospects in anti-angiogenesis,clearance of tumor cells,regulation of tumor microenvironment and enhancement of anti-tumor immune response,etc.The research and development of BsAb is one of the important research directions in the field of biomedicine.Approximately two hundred BsAb drugs are entering clinical trials worldwide,and seven of them have been approved for marketing.More than 60 BsAb drugs are being investigated in China.However,most of them are in phaseⅠ/Ⅱclinical trials.Only Cadonilimab has been approved for marketing,and KN046 and AK112 are in phaseⅢclinical trials.This paper summarized the research progress,difficulties and challenges of the development and transformation of BsAb drugs,and proposed the reasonable and feasible solutions,which was expected to provide a reference for the development and strategic layout of BsAb drugs in China.
作者
李永超
杨昭
LI Yongchao;YANG Zhao(Key Laboratory of Protection and Utilization of Biological Resources in Tarim Basin of Xinjiang Production and Construction Corps,College of Life Science and Technology,Tarim University,Xinjiang Alar 843300,China;Innovation Center of Molecular Diagnostics,College of Life Science and Technology,Beijing University of Chemical Technology,Beijing 100029,China)
出处
《生物技术进展》
2023年第3期353-358,共6页
Current Biotechnology
基金
中央高校基本科研业务费(201910)
2021年新疆科协青年人才托举工程项目
京津冀基础研究合作专项(19JCZDJC65800〔Z〕)
新疆生产建设兵团重点领域科技攻关计划项目(2022AB022)。
