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Current Status and Future Suggestions for Innovative Drug Research and Development in China
- Affiliations：
Institute of Medical Information, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing100020, China
- Author bio：
E-mail: xumeimei2005@163.com
- Funds：
DOI：10.24920/004363
CLC：Received：11 April 2024，
Accepted：2024-10-25，
Published Online：23 December 2024，
Published：31 December 2024
- Accepted：
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刘曙霞,王琰,杨爽等.中国创新药物研发现状与发展建议[J].中国医学科学杂志（英文）,2024,39(04):288-296.
Liu Shu-Xia,Wang Yan,Yang Shuang,et al.Current Status and Future Suggestions for Innovative Drug Research and Development in China[J].Chinese Medical Sciences Journal,2024,39(04):288-296.
刘曙霞,王琰,杨爽等.中国创新药物研发现状与发展建议[J].中国医学科学杂志（英文）,2024,39(04):288-296. DOI： 10.24920/004363.
Liu Shu-Xia,Wang Yan,Yang Shuang,et al.Current Status and Future Suggestions for Innovative Drug Research and Development in China[J].Chinese Medical Sciences Journal,2024,39(04):288-296. DOI： 10.24920/004363.
摘要
近年来，随着新药审评审批政策改革，我国迎来了创新药研发的热潮。基于药融云数据库和医药魔方数据库，我们分析了中国创新药物数据，包含已获批上市和进入临床试验阶段的创新药的数据，梳理了主要研发机构和企业、创新药靶点类型分布以及获批创新药的主要治疗领域等，并与全球创新药研发格局进行了比较。2020年以来，我国创新药物研发呈现出快速增长趋势，生物制药公司之间竞争激烈。在竞争中，涌现出一批生物医药龙头企业。我国临床试验阶段和已获批药物的热门靶点包括酪氨酸蛋白激酶、表皮生长因子受体、血管内皮生长因子受体等。肿瘤疾病是中国新药研发最活跃的领域，其次是感染和神经系统疾病。基于研究结果，我们提出加大政策扶持力度、增加研发创新投入、优化产品管线布局、加强国际合作以及聚焦创新靶点等建议。本综述能为制药研发企业、科研人员和政府管理人员等提供决策参考。
Abstract
In recent years
with the policy reform of new drug review and approval
China has ushered in a surge of innovative drug development. Based on the Pharnexcloud database and the Pharmcube database
we analyzed the innovative drugs approved for marketing and entered clinical trials in China
sorted out the major research and development (R&D) institutions and enterprises
the distribution of innovative drug target types
and the primary therapeutic areas of the approved innovative drugs
and compared with the global innovative drug R&D landscape. Since 2020
China's innovative drug development has shown a rapid growth trend
with intense competition among biopharmaceutical companies
and the emergence of a number of leading biopharmaceutical enterprises. Popular targets for clinical-stage and approved drugs include protein tyrosine kinase
epidermal growth factor receptor
vascular endothelial growth factor receptor
and others. Oncological diseases are the most active domain for new drug R&D in China
followed by infectious diseases and neurological diseases. Suggestions for future development are proposed to increase policy support
enhance R&D innovation investment
optimize pipeline layout
strengthen international cooperation
and focus on innovative targets. This review provides a reference for pharmaceutical R&D enterprises
scientific researchers
and government administrators.
关键词
Keywords
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