中文摘要
对于药品生产企业来说，新产品的开发是企业向前发展的不竭动力，也是保
持企业利润增长的关键。新药开发是研发项目中的一种，也是相对比较特殊的一
种。新药开发的特点是周期长、高投入、高风险、涉及面广、操作复杂。因此，
引用项目管理来管理新药开发，提高效率、降低风险。

2009年4月深化医药卫生体制改革启动实施，我国进入医疗体制转型的关键时期。

如何在这一时期更好的进行新药项目开发是本文研究的重点。

《医药工业“十二五”发展规划》中提出“加强医药创新体系建设。进一步
发挥企业在技术创新体系中的主体作用，支持骨干企业技术中心建设，提高企业
承担国家科技项目的比重，增强新药创制和科研成果转化能力”。本文以
K制药公司B新药项目为例，对医疗体制转型中的新药项目开发进行研究。本文通过
这一个案的总结，为我国医药开发科学管理化道路提供参考借鉴。

关键词：医改；医药管理；药物开发；新药项目
ABSTRACT
For the pharmaceutical companies, the development of new products has always
been the driving force of enterprise development, and it is crucial to maintain
profitable growth. Pharmaceutical development is quite special among R&D projects.
The characteristics of new pharmaceutical development are long period, high input,
high risk, large involvement and complex operation. Therefore, project management
is used to manage the new pharmaceutical development which can enhance efficiency
and decrease risk. The medical and health system start to implement in April 2009,
and China has entered a critical period of transformation of medical mechanism.
The Pharmaceutical Industry 12th Five-Year development plan indicates to
strengthen the medical innovation system, which have enterprises play a more
important role in the technological innovation system, increasing the proportion of
enterprises undertaking the national science and technology projects, enhancing the
capabilities of new pharmaceutical creation and scientific R&D. This thesis will take
B new pharmaceutical project of K pharmaceutical company as an example, to
research in R&D of pharmaceutical project facing to transformation of medical
mechanism. The thesis hopes this case study could provide reference for the scientific
management of pharmaceutical development of our local pharmaceutical industry.
Key words
：
Medical System Reform; Pharmaceutical and Medicine Management;
Pharmaceutical Development; New Pharmaceutical Project;