提高国产创新药的可及性：2010-2024 年中国获批药品的特点和趋势》。

IF 6.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Discovery Today Pub Date : 2024-11-13 DOI:10.1016/j.drudis.2024.104240

Yipeng Lan, Xiaofeng Lin, Yanmei Rao, Zhe Huang

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引用次数: 0

摘要

自 2015 年以来，中国启动了药品监管改革。在此，我们分析了 2010 年 1 月至 2024 年 5 月中国批准上市的国产创新药的特点和趋势，以探讨药品监管改革的成效。总体而言，共有219种药物获批，改革后化学药和治疗性生物药有所增长。单臂试验作为抗肿瘤药物临床试验设计的重要选择有所增加。改革后，从新药研究（IND）到新药申请（NDA）每个环节的时间都缩短了。此外，获批药品进入医保的时间缩短，降价幅度加大。中国的药品监管改革在提高国产创新药的可及性方面取得了进展。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Improving access to domestic innovative medicines: characteristics and trends of approved drugs in China 2010-2024.

China has initiated drug regulatory reforms since 2015. Here, we analyze the characteristics and trends of domestic innovative drugs approved for marketing in China from January 2010 to May 2024 to explore the effectiveness of drug regulatory reform. Overall, 219 drugs were approved, with growth in chemicals and therapeutic biologics post-reform. Single-arm trials as an important option for clinical trial design of antineoplastic agents increased. The time for each link from investigational new drug (IND) to new drug application (NDA) has been shortened post-reform. Moreover, the time for access to medical insurance for approved drugs has been shortened and price reductions have been increased. China's drug regulatory reforms have made progress in improving the accessibility of domestic innovative drugs.

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来源期刊

Drug Discovery Today 医学-药学

CiteScore

14.80

自引率

2.70%

发文量

293

审稿时长

6 months

期刊介绍： Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed. Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.