Ten years after Entry into WTO Witness the Number

12/02/2014

[December 26, 2012, Beijing] According to the statistical presentation of R&D-based Pharmaceutical Association Committee of CAEFI (RDPAC), among 37 RDPAC member companies, 17 of them have set up R&D Centers inChina, with number up to 22. Among others, 2 R&D Centers were set up before 2000, 4 between 2001-2005, 16 newly-established R&D Centers from 2006 till now, demonstrating a momentum of geometric growth and growing by 10 times over the past ten years after Chinas entry into WTO.

 

R&D input and growth amplitude of RDPAC member companies are in the forefront of various industries

Research and development are not easy, even at later stage of clinical trial, and many products have to face bitter pill of failure: The investment up billions of US dollars over ten years has come to nothing. To take Alzheimer’s Disease for an example, over the past decade, more than 20 kinds of new drugs have encountered failure in the clinical trial of later stage. Even after the products came into the market, only two among 10 products can recover the investment on average, but it has not been able to prevent pharmaceutical industry from innovation. In 2001, the drugs under study reached2,040 inpharmaceutical industry while the figure jumped to 3,050 by 2010. Meanwhile, R&D input of pharmaceutical industry is still in the forefront of various sectors. According to the data display of Booz&Co. and Bloomberg, among the list of top 20 companies in global R&D investment, 8 RDPAC member companies were chosen and 4 of 5 top companies were member companies. In 2010, the total R&D investment reached 60.847 billion US dollars, 7.606 billion US dollars for each on average, making up 15.9% in sales amount on average. Besides, compared with the previous year, the average growth was 13.85%, which was higher than the average value of other sectors selected in the list.

 

R&D in China will benefit Chinese patients and pharmaceutical industry

Generally speaking, the mankinds major threats facing infectious diseases have been gradually transformed to increasingly severe challenge of chronic diseases, however, due to existence of factors in region, race and economic development level of different areas, there still exist obvious difference with disease pattern. Only when R&D is close to these different markets can it serve the patients in a better way. 

Mr. Zhuo Yongqing, president of RDPAC said, "Joint response to disease challenge with a country which has a population of 1.3 billion is a bounden duty of RDPAC member companies. To set up a R&D center in China can not only speed up Chinese patients to obtain innovative drugs, but also spur the improvement of R&D capacity of Chinese medical industry: First, 22 R&D centers set up by RDPAC member companies cover various links of drug research and development. At present, there are 3,300 full-time employees. The business interaction and knowledge sharing between these persons and local scientific research institutions, CROs and pharmaceutical enterprises will foster and aggregate a great number of talents for Chinese medical industry; second, the clinical trial performed by R&D center in China will be helpful to improving the capacity of Chinese doctor clinical trial. For local enterprises, implementation of world-level clinical trial in the only way marching towards international market and R&D of high quality drugs; finally, launching of R&D in China can bring considerable economic benefit to China. As a rule, R&D cost of an innovative drug is about several billion yuan. This figure is still rising while the operation of R&D center inChinawill bring plenty of revenue for local market no doubt.

 

Realization of Chinese pharmaceutical industry from imitation to creation depends on the elimination of “innovation bottleneck”

“The 12th Five-Year Plan of Chinese pharmaceutical industry is exciting since we can see the nation’s confidence and resolution in improving the innovative capacity of Chinese pharmaceutical industry, but we also take note of realizing the objective of such plan. There are some key bottlenecks to be eliminated,” Zhuo Yongqing said, “Drug research and development is out of the question without clinical trial, but new drug clinical trial evaluation in China is generally above 8 months; for new biological products, even more than one year, new drug clinical trial evaluation in USA, Europe, Japan, Korea, India and other countries is around 1 to 2 months. Due to slow clinical trial evaluation, it is difficult for many international clinical trials to be launched in China, even some domestic pharmaceutical enterprises transfer the clinical test to other countries for quickening the progress. The root cause to such a phenomenon lies in the serious shortage of Chinese drug evaluation registered resource -- the number of people engaging in drug registration and approval is only 120 approximately; more than 2,000 people in American FDA are responsible for the work, but the drug registration and approval amount is far lower than that in China, which has not only affected the R&D speed and quality of Chinese innovative drugs, but also brought potential risk for safe use of new drugs after coming into the market. We are expecting that China can increase the investment of drug evaluation resources as quickly as possible, which is of utmost importance for safe drug use of 1.3 billion people and industrial development of output value up to billion yuan.”

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