Public Health Emergency Center, Chinese Center for Disease Control and Prevention, Beijing, China.
School of Public Health, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
Infect Dis Poverty. 2020 Mar 13;9(1):27. doi: 10.1186/s40249-020-00643-0.
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.
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.
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.
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.
2014 年埃博拉疫情期间，中国成为全球医药研发的强大平台。长期以来，发展中国家在传染病暴发防控方面的研发影响力一直被低估，尤其是中国等新兴经济体。在此，我们按时间顺序、各研发阶段的投入和产出，研究了中国在应对埃博拉疫情方面的研发进展和政府支持。本研究将有助于更深入地了解中国在研发方面的差距和挑战，并为如何加速药物研发进程以满足未来疫情爆发时的迫切需求提供循证建议。
数据来自于 2006 年 1 月 1 日至 2017 年 12 月 31 日期间的中国国家自然科学基金数据库、PubMed 数据库、中国国家知识产权局专利检索系统、国家药品监督管理局、国家政策报告和文献。采用 Microsoft Excel 对研究资金、研究成果、药物产品专利和产品许可进行描述和分析。采用图表和图形绘制图表的描述性分析，并报告平均值±标准差。
中国在 26 个月内成功研发出埃博拉 Ad5-EBOV 疫苗，而临床试验的准备和实施则花费了相对较长的时间。中国国家自然科学基金为埃博拉相关研究提供了 4405 万元人民币（627 万美元）的资金，并强烈支持基础研究阶段（87.8%）。2014 年至 2015 年期间，文献数量呈爆炸式增长，药物研究增长了 1.7 倍，诊断研究增长了 2.5 倍，在埃博拉疫情爆发 3 年后，中国有 6 种埃博拉相关产品获得国家药品监督管理局批准。
中国已开始强调将医疗产品创新作为应对新发传染病的解决方案之一。继续研究监管和市场激励措施的发展，以及建立统一多渠道支持的多边合作机制，将有助于中国更有效地进入全球研发市场。
