Research Of Chinese Pharmaceutical Enterprise Novel Drug Development Strategy

Since twentieth century,the world's pharmaceutical industry is developing very fast. The global new drug R&D cost has rapidly increased along with the enlarging of the pharmaceutical market volume. In 1990, the world's new drug R&D cost was $8.4 billion, but $26.4 billion in 2000, more than 3 times higher in 10 years'period. Average time for developing one successful new drug is 12 years and $350 to $850 million investment cost. Definitively it is a key advantage fact to own innovative new drugs for a pharmaceutical company in this high investment, high risk and high return industry. The globalization of the pharmaceutical industry comes with to be a member of WTO for China is obviously. To be survival and development in such a critical competitive situations, the pharmaceutical enterprise must develop the innovative new drugs which has the own intellectual property and make the R&D process comply with the global standard. Currently the stage of new drug R&D in our country sticks on the copy model which can only produce generic drugs. How to break through on the new drug R&D and improve the research ability for our pharmaceutical company, the purpose of this thesis is trying to seek a R&D strategy of the new drug which suit to the characteristics of China itself. Firstly the paper defines the innovative new drug, then use the tool of PEST and SWOT to analyse the macroscopical and microcosmic situation, advantage and disadvantage of local pharmaceutical enterprises. Furthermore it tries to compare with the advanced country such as U.S and similar level as China such as India through comparative analysis. Base on these analysis, the paper make the position, mission and vision for the strategy of Chinese pharmaceutical enterprise new drug development. At last it gives the further explanation of the strategy making and implementation.The Break through new drug strategy could try to execute in traditional Chinese medicine and biopharmaceutics fields where China has comparative advantages. The most of Chinese pharmaceutical enterprises could use Copy strategy (Me-too) and Extend development strategy (Me-better) which utilizing each one's advantage through a cost effective short cut. How to succeed these strategy, the thesis provides four different protocols for different Chinese pharmaceutical enterprises reference.