How to deal with the transfer of new drug R & D business from multinational pharmaceutical companies to China?

Learn from foreign companies, develop their own technology, and strengthen themselves -- to undertake the analysis and suggestions on the transfer of new drug R & D business from multinational pharmaceutical companies to China After the "production transfer" in China, international pharmaceutical companies began to "R & D test water" They set up R & D centers in China, transfer their R & D business, or outsource their research business to Chinese R & D outsourcing enterprises Based on the analysis of the mode and characteristics of international pharmaceutical enterprises' transfer of R & D business to China, this paper further analyzes the essence of their transfer of R & D business, and puts forward a positive and appropriate development policy environment for Chinese government, pharmaceutical enterprises, investment and R & D institutions, and improves the intellectual property protection system; Make full use of cro strategic cooperation mode, accelerate the implementation of localization industry of innovative drug technology and other relevant countermeasures and suggestions This edition will publish this article in two journals, hoping to enlighten the relevant people In recent years, large international pharmaceutical companies have established R & D centers in China or outsourced new drug R & D business to China, which has promoted the development of R & D outsourcing service industry in China Beijing and Shanghai, as the concentration of talents and technologies in China, have also become one of the first choices for international pharmaceutical enterprises to transfer R & D business There are various modes for international pharmaceutical enterprises to transfer R & D business to China, or to establish their own R & D center, or to cooperate with domestic universities, research institutes, R & D service enterprises, etc But even if it is a self built R & D center, its positioning and goal are different 1 It is an important form for international pharmaceutical enterprises to transfer their R & D business to China to build their own R & D center at the same time of self research and cooperative R & D In the past 10 years, international pharmaceutical companies have set up R & D centers in China, and transferred part of their R & D business to Chinese R & D centers Due to the different development strategies of enterprises, these R & D centers also have their own characteristics It is the work of most international pharmaceutical companies in China's R & D center to screen compounds and active substances of Chinese herbal extracts However, it has become more and more difficult to screen active compounds from synthetic organic compounds As China has rich resources of traditional Chinese medicine and natural medicine, Chinese traditional medicine has thousands of years of research experience and achievements, which has a good guiding significance for the world's new drug research and development Some foreign companies with strategic vision began to select active substances from them, which has become a new way for some international pharmaceutical companies to carry out R & D business in China in recent years For example, Novartis cooperates with Shanghai Pharmaceutical Institute to screen active ingredients from traditional Chinese medicine for the development of new drugs According to a person in charge of AstraZeneca, it is "to dig out the effective ingredients and compounds of the East for the R & D centers around the world to develop drugs suitable for them; to transplant mature drug research and development experience from the west to China to develop drugs needed by Chinese and Asians" The development of innovative drugs transfers the preliminary screening of innovative drugs to China, which is the key point for international pharmaceutical companies to transfer their R & D business in recent years Innovative drug research and development is a scientific research with high risk and investment At present, the more advanced drug screening technology is high-throughput drug screening, but its research cycle is long and cost is large This is a heavy burden for the western countries which have gradually high human cost to carry out this business for a long time In the past, international pharmaceutical companies were skeptical of the development level of China's pharmaceutical science and technology Now, with the increasing proportion of Chinese R & D personnel in R & D centers of major international pharmaceutical enterprises and a large number of Chinese studying abroad to start their own businesses, international pharmaceutical enterprises gradually realize that China's R & D capacity has developed rapidly, and China's human resources, raw materials and other resources are much cheaper than those in western countries Therefore, the international pharmaceutical enterprises have paid more and more attention to the research of innovative drugs in the R & D center of China The representative enterprises include Roche, Bayer, Johnson & Johnson, etc Because of the differences between the eastern and western ethnic groups, the symptoms of the same diseases may be different, which provides a scientific basis for international pharmaceutical companies to carry out basic research, reveal the differences between the eastern and western ethnic groups, and develop new drugs or enter the Asian market Therefore, some international pharmaceutical enterprises have carried out corresponding work in China's R & D center, such as AstraZeneca, Novo Nordisk, GlaxoSmithKline, etc With the promulgation and implementation of GLP and GCP in various countries, the demand for drug safety evaluation is increasing, and the market scale is expanding At present, there are more than 84 institutions engaged in drug safety evaluation research in China, of which 1 / 3 have passed the GLP certification of the State Food and drug administration In 2007, the above institutions conducted safety evaluation on 701 drugs, and the total number of test items completed was 2216, including 1156 under GLP Five units, including the experimental animal room of the national drug safety evaluation center, the animal center of Peking University, and Zhaoyan New Drug Research Center Co., Ltd., have passed the AAALAC certification Wuxi apptec, Shanghai Pharmaceutical Institute and other units are also building an international standard drug safety evaluation research center to provide international pharmaceutical enterprises with international standard drug safety evaluation research services Therefore, in recent years, international pharmaceutical companies have gradually transferred the drug safety evaluation business to China The international pharmaceutical enterprises that enter China for clinical research will basically carry out clinical research in China, because according to the provisions of the State Food and drug administration, the drugs they produce need to be registered and managed when entering the Chinese market In order to verify their efficacy and drug safety, they must carry out clinical research The R & D centers set up by some international pharmaceutical companies in China should therefore undertake the corresponding clinical research work In addition, China has a large population and rich clinical resources, which can quickly recruit subjects for clinical trials, facilitate multi center clinical trials, shorten clinical research time, and promote the listing of new drugs For example, the incidence rate of hepatitis B, cancer, diabetes and other diseases is high in China, and the population base of our country is large For the international pharmaceutical companies that develop and treat these diseases, choosing to carry out clinical research in China can easily collect appropriate cases, which is difficult to do in the United States and Europe 2 Risk sharing and revenue sharing in August 2007, Huang pharmaceutical and Eli Lilly signed a cooperation agreement on the development of multi-target drugs in cancer and inflammatory diseases, with an amount of up to $100 million, the highest in China In November 2008, the two sides once again signed a high-level joint development and cooperation plan in new drug research and development According to the agreement, Lilly will work with Hehuang pharmaceutical to develop new cancer drug targets in the future Lilly will pay a higher signing fee than the previous contract, a deposit for potential candidate drugs and a mileage fee for each important research and development stage He and Huang will also receive a commission on the global sales revenue of the products generated by the cooperation between the two sides Subsequently, Huang pharmaceutical and other companies such as Johnson & Johnson, Merck and P & G signed strategic cooperation agreements 3 Technology and resource sharing the mode of cooperation between Novartis and Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences is technology and resource sharing Shanghai Pharmaceutical Research Institute has isolated and purified natural ingredients from extracts of medicinal plants Through the screening of Novartis, more than ten kinds of active substances have been found for further research and development The research plan for the cooperation period was successfully completed in July 2004, and at the end of the same year, the two sides signed a second round of three year cooperation agreement The characteristics of the above cooperation are: Taking the natural chemical ingredients in Chinese herbal medicine as the research object, focusing on technology transfer; improving the separation speed and quality of natural compounds, and sharing intellectual property rights; realizing the industrialization of scientific and technological achievements through international enterprises, and constantly expanding new areas of cooperation through mutual communication The cooperation between the two sides has formed good interaction and mutual trust, and the depth of cooperation has been increasingly strengthened 4 R & D management cooperation the mode of cooperation between Eli Lilly and Shanghai Pioneer Chemical Research Management Co., Ltd is R & D management cooperation, which is also called exclusive outsourcing In 2003, Lilly cooperated with Shanghai pioneer chemistry and established Shanghai pioneer Chemistry Research Management Co., Ltd - Lilly laboratory The research direction of the laboratory is the synthesis of early compounds, which is funded and supported by Eli Lilly China is responsible for organizing scientific research team and implementing scientific research plan Lilly regards China as a strategic R & D partner and integrates R & D projects in China into its global drug R & D system, which helps the company reduce R & D costs and enhance its global competitiveness For China, participating in the R & D of multinational pharmaceutical companies is conducive to learning international advanced R & D models and processes, improving its own level, reserving domestic talents, and promoting China's participation in global drug R & D 5 Contract R & D service contract R & D service is the most common mode of cooperation between international pharmaceutical enterprises such as Pfizer, Novartis, Lilly, Merck and domestic R & D outsourcing service enterprises such as Wuxi apptec, smart chemical, KANGLONG chemical, Baonuo technology, Medici, etc., also known as contract R & D According to the requirements of the contract, both parties shall complete corresponding R & D services for customers within the time specified in the contract Many international pharmaceutical companies choose this cooperation mode However, most of these cooperation are low value cooperation 6 The R & D outsourcing services transferred to China by international pharmaceutical enterprises with high concentration are mainly concentrated in several R & D outsourcing service enterprises, such as Wuxi apptec, pioneer chemistry, Medici, pilot chemistry, Huiyuan biotechnology, etc From the analysis of the contract registered in the technology market, we can see that the R & D outsourcing business undertaken by Wuxi apptec accounts for about 50% of the total R & D outsourcing business in Shanghai, followed by several enterprises such as Medici, Pioneer chemical, and wisdom chemical Through the analysis of enterprises, we can see that most of these enterprises are founded by Chinese who have been engaged in research and development for many years in international pharmaceutical enterprises They have excellent professional technology and international management experience, build enterprises according to international standards, and gradually become the main contractor for international pharmaceutical enterprises to transfer R & D business to China by virtue of their high-level reputation in international pharmaceutical enterprises 7 Outsourcing is not the core business According to the data analysis of the contract database of the technology market, from 2006 to 2008, the total contract value of 21 international pharmaceutical enterprises entrusted Shanghai R & D outsourcing services was RMB 665 million, RMB 1.056 billion and RMB 771 million respectively, accounting for 39.71%, 63.65% and 37.94% of the total R & D outsourcing services of Shanghai in the same period; The total contract value of the three years is 2.492 billion yuan, accounting for 46.44% of the total R & D outsourcing services of Shanghai in the same period It can be seen that the R & D business transferred by international pharmaceutical enterprises accounts for a large proportion 2007 is the year with the largest R & D investment in the world The proportion of R & D investment in sales of most international pharmaceutical enterprises is between 15% and 25% Take AstraZeneca as an example In 2007, its global sales reached US $28.709 billion, its global R & D investment was US $4.737 billion, accounting for 16.50% of the sales, and its R & D business transferred to China accounted for 1.14% The R & D investment of other international pharmaceutical companies in China is lower than that of AstraZeneca It can be seen that