背景:在2014年埃博拉疫情爆发期间,中国已成为全球药物研发(R&D)的强大平台。发展中国家的研究和发展对预防和控制传染病暴发的影响长期被低估,尤其是像中国这样的新兴经济体。这里,我们根据时间表研究了其研发进展和政府对应对埃博拉疫情的支持,输入,以及每个研发阶段的产出。这项研究将有助于更深入地了解中国的研发差距和面临的挑战,以及就如何加快药物开发进程以满足未来疫情期间的紧急需求提供循证建议。
方法:数据来源于国家自然科学基金数据库,PubMed数据库,国家知识产权局专利检索系统,国家医药产品管理局,1月1日之间的国家政策报告和文献2006年和12月31日,2017.研究经费概述,研究成果,医药产品专利,和许可的产品由MicrosoftExcel描述和分析。通过报告平均值±标准偏差来进行具有绘制图表和图形的可视化的描述性分析。
结果:中国在26个月内成功完成了埃博拉Ad5-EBOV疫苗的研发,而临床试验的准备和实施需要相对较长的时间。中国国家自然科学基金委员会资助4405万元人民币(627万美元)用于埃博拉相关研究,并大力致力于基础研究阶段(87.8%)。在2014年至2015年之间,文献激增,药物研究增加了1.7倍,诊断研究在1年内增加了2.5倍。埃博拉病毒爆发三年后,中国有6种与埃博拉相关的产品获得了国家药品监督管理局的批准。
结论:中国已经开始强调医疗产品创新作为应对新发传染病的解决方案之一的重要性。继续研究制定监管和市场激励机制,以及统一跨渠道支持的多边合作机制,将更有效地推进中国进入全球研发市场的进程。
BACKGROUND: China has emerged as a powerful platform for global pharmaceutical research and development (R&D) amid the 2014 Ebola outbreak. The research and development impact of developing countries on prevention and control of infectious disease outbreaks has long been underestimated, particularly for emerging economies like China. Here, we studied its research and development progress and government support in response to Ebola outbreak by timeline, input, and output at each research and development stage. This study will contribute to a deeper understanding of the research and development gaps and challenges faced by China, as well as providing evidence-based suggestions on how to accelerate the drug development process to meet urgent needs during future outbreaks.
METHODS: Data were obtained from the National Nature Science Foundation of China database, PubMed database, Patent Search System of the State Intellectual Property Office of China, National Medical Products Administration, national policy
reports and literature between Jan 1st, 2006 and Dec 31st, 2017. An overview of research funding, research output, pharmaceutical product patent, and product licensed was described and analyzed by Microsoft Excel. A descriptive analysis with a visualization of plotting charts and graphs was conducted by reporting the mean ± standard deviation.
RESULTS: China has successfully completed the research and development of the Ebola Ad5-EBOV vaccine within 26 months, while the preparation and implementation of clinical trials took relative long time. The National Nature Science Foundation of China funded CNY 44.05 million (USD 6.27 million) for Ebola-related researches and committed strongly to the phase of basic research (87.8%). A proliferation of literature arose between 2014 and 2015, with a 1.7-fold increase in drug research and a 2.5-fold increase in diagnostic research within 1 year. Three years on from the Ebola outbreak, six Ebola-related products in China were approved by the National Medical Products Administration.
CONCLUSIONS: China has started to emphasize the importance of medical product innovation as one of the solutions for tackling emerging infectious diseases. Continuing research on the development of regulatory and market incentives, as well as a multilateral collaboration mechanism that unifies cross-channel supports, would advance the process for China to enter global R&D market more effectively.