中国青蒿素类药物的生产与出口：现状与现存挑战

The production and exportation of artemisinin-derived drugs in China: current status and existing challenges.

作者信息

Huang Yangmu, Li Hui, Peng Danlu, Wang Yu, Ren Qiaomeng, Guo Yan

机构信息

School of Public Health, Peking University, Xueyuan Road 38, Haidian District, Beijing, 100191, China.

China Chamber of Commerce for Import & Export of Medicines & Health Products, Floor11-12, Building 3, Beijing INN, No.6 Nanzhugan Hutong, Dongcheng District, Beijing, 100191, China.

出版信息

Malar J. 2016 Jul 15;15:365. doi: 10.1186/s12936-016-1422-3.

DOI:10.1186/s12936-016-1422-3

PMID:27421885

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4947284/

Abstract

BACKGROUND

As the discoverer and a major manufacturer of artemisinin, China has made valuable contributions to malaria control and the global market of artemisinin-derived drugs. This study aims to explore the production and export status of artemisinin-derived drugs in China during 2011 and 2014 to provide a clear understanding of China's participation in this field and also to provide guidance for its future role on global malaria control.

METHODS

Production and exportation data were obtained from the Ministry of Industry and Information Technology (MIIT) database of the People's Republic China and monthly reports of the General Administration of Customs of China, respectively. The production volume, export volume, export value, and export area of artemisinin and its derivatives (artemether, artesunate, dihydroartemisinin), including both active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), were descripted and analysed by Microsoft Excel.

RESULTS

Between 2011 and 2013, the total production volume of artemisinin-derived APIs and FPPs reached 543.41 metric tons (MT) and 14.79 MT, respectively. The total export value and volume of artemisinin-derived APIs during 2012 and 2014 was US$ 211.39 million and 338.53 MT; the total export value and volume of FPPs was US$ 227.17 million and 4401.44 MT. Compared with the sharply decreasing trend of API exports each year, the export value of FPPs kept at a more stable level, with 14.66 % increase in 2013 and 5.31 % decrease in 2014. As for exportation areas, India was the largest purchaser of APIs, accounting for nearly a half of the total amount, while FPPs mainly exported to African countries.

CONCLUSIONS

Exports of artemisinin derivatives for China have been transforming from API-dominated to FPP-dominated. However, the exportation of artemisinin-derived drugs in China still face the challenges of small market share in the global FPP market and indirect sale of FPPs through a third country due to the deficiency in obtaining relevant certification into global market.

摘要

背景

作为青蒿素的发现者和主要生产国，中国为疟疾防治以及青蒿素类药物的全球市场做出了宝贵贡献。本研究旨在探讨2011年至2014年期间中国青蒿素类药物的生产和出口状况，以便清晰了解中国在该领域的参与情况，并为其未来在全球疟疾防治中发挥的作用提供指导。

方法

生产和出口数据分别取自中华人民共和国工业和信息化部数据库以及中国海关总署月报。青蒿素及其衍生物（蒿甲醚、青蒿琥酯、双氢青蒿素）的产量、出口量、出口额和出口地区，包括活性药物成分（API）和成品药（FPP），均通过Microsoft Excel进行描述和分析。

结果

2011年至2013年期间，青蒿素类API和FPP的总产量分别达到543.41公吨和14.79公吨。2012年至2014年期间，青蒿素类API的出口总额和总量分别为2.1139亿美元和338.53公吨；FPP的出口总额和总量分别为2.2717亿美元和4401.44公吨。与API出口量逐年急剧下降的趋势相比，FPP的出口额保持在较为稳定的水平，2013年增长了14.66%，2014年下降了5.31%。在出口地区方面，印度是API的最大购买国，占总量近一半，而FPP主要出口到非洲国家。