全球碱基编辑药物专利技术发展现状分析  

Analysis of Development Status of Patented Technologies for Global Base-Editing Medicines

作　　者：沈晶晶 许龙 张彬[1] SHEN Jingjing;XU Long;ZHANG Bin(Patent Examination CooperationCenter of the Patent Office,China National Intellectual Property Administration,Beijing,China 100160;Certification Center for Licensed Pharmacist of National Medical Products Administration,Beijing,China 100061)

机构地区：[1]国家知识产权局专利局专利审查协作北京中心,北京100160 [2]国家药品监督管理局执业药师资格认证中心,北京100061

出　　处：《中国药业》2024年第22期13-19,共7页China Pharmaceuticals

基　　金：国家药品监督管理局资助课题项目[O201502]。

摘　　要：目的把握我国碱基编辑器(BE)技术的市场竞争地位,为碱基编辑药物产业发展实现新跨域提供参考,也为培育新质生产力和新经济增长点奠定基础。方法通过incoPat平台获取并分析BE技术的相关专利数据,通过ClinicalTrials.gov数据库、中国临床试验注册中心及美国食品和药物管理局、国家药品监督管理局、科研院校和企业官方网站查询碱基编辑药物的临床试验情况或进展。专利数据截至2023年12月31日,检索和查询日期截至2024年6月30日。结果BE专利技术首次出现于2016年,此后处于技术高速发展阶段,创新主体不断致力于新型BE的研发、递送方式的优化、药物临床试验的开展等。在发达国家和人口密集国家布局较多专利以为后期临床试验、药物上市等做出充分准备。结论在政策引领下,我国碱基编辑药物的创新活跃性显著增强,但专利产业化模式还存在优化空间。国内外的碱基编辑药物在种类上竞争性低,尚有可进行专利布局的空间。Objective To grasp the market competitive position of base editor(BE)technologies in China,to provide a reference for the cross-disciplinary development of base-editing medicine industry,and to lay the foundation for cultivating new-quality productive forces and new economic growth points.Methods The relevant patent data of BE technologies were obtained and analyzed by the IncoPat platform,the information on the clinical trias of base-editing medicines was obtained from the ClinicalTrials.gov,Chinese Clinical Trial Registry,the official websites of US Food and Drug Administration,National Medical Products Administration,research institutions and enterprises.The patent data deadline was December 31,2023,the search and query deadline was June 30,2024.Results BE-related patented technology emerged in 2016 and developed rapidly since that.Innovative entities focused on the research and development of new BEs,optimization of delivery methods,and development of drug clinical trials,etc.A large quantity of patents were deployed in developed and densely populated countries to make sufficient preparations for later clinical trials,drug launches,etc.Conclusion Based on policy guidance,the innovation activity of base-editing medicines in China has obviously increased,but the patent industrialization mode still needs to be optimized.Domestic and foreign base-editing medicines have low competition in terms of variety,and there is still room for patent layout.

关 键 词：基因编辑 碱基编辑器 碱基编辑药物 专利技术 药物临床试验 

分 类 号：R95[医药卫生—药学]