2021年度中美注册新药的结构分析

摘要/Abstract

摘要： 近年来，我国新药创制的系统性水平（包括注册审评）正在逐步提升，药品审评体系和审评能力现代化建设亦是持续推进，医药产业创新能力和高质量发展进一步增强。本研究以美国食品药品管理局（FDA）药品审评与研究中心（CDER）发布的《2021年新药审批总结报告》，以及我国国家药品监督管理局药品审评中心（CDE）发布的《2021年度药品审评报告》为基础，比较了中美两国2021年度所批准新药的结构组成。我国药品创新取得了历史性的成绩，但与美国同行相比还有较大差距，在首创性新药、罕见病新药等方面的差距更为突出；我国创新药的临床适应证与威胁我国民众健康的疾病分布还有较大的脱节；建议关注相关领域的学科进展，加大科技投入，加快转化研究，开发新产品。

关键词: font-size:medium, ">新药；药品注册；结构分析

Abstract: In recent years， the systematic level of new drug development (including drug evaluation) in China has been gradually improved， and the modernization of drug evaluation system and evaluation ability has also been continuously promoted. The innovation ability and high-quality development of the pharmaceutical industry have been further enhanced. Based on the annual reports released respectively by US FDA and CDE of China NMPA， this article compares the structural composition of new drugs approved in China and the United States in 2021. The article pointed out that China′s drug innovation has made historic achievements， however， there is still a gap compared with the counterparts in the United States. The gap is more prominent in the aspects of First-in-Class drugs and new drugs for rare diseases. In addition， there is a disconnect between the clinical indications of new drugs in China and the distribution of diseases that threaten the health of Chinese people. It is suggested to pay attention to the progress of the disciplines in related fields， increase investment in science and technology， accelerate translational research， and develop new products.

Key words: font-size:medium, ">New drugs； Drug registration； Structural comparison

中图分类号:

唐辉, 汤立达. 2021年度中美注册新药的结构分析[J]. 中国医药导刊, 2023, 25(6): 559-564.

TANG Hui, TANG Lida. Structural Comparison of New Drugs Registered in China and the United States in 2021[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2023, 25(6): 559-564.

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