The reality of China's pharmaceutical industry: the vast majority of chemicals are imitations

Source: China Youth Daily 2016-03-01 is to strengthen R & D or improve the level of imitation? Is it to concentrate on the domestic market or to explore the international market? In front of Chinese pharmaceutical enterprises, not only the huge market potential in the future, but also the puzzle of how to innovate At the first executive meeting of the State Council after the Spring Festival this year, promoting innovation and upgrading of the pharmaceutical industry became a key content Among the four promotion measures determined at the meeting, the first one is to focus on the urgent needs of the masses, strengthen the R & D and innovation of the original research medicine, the first generic medicine, traditional Chinese medicine, new preparations, high-end medical devices, and accelerate the industrialization of major drugs for frequently occurring and rare diseases such as tumors, diabetes, cardiovascular and cerebrovascular diseases Support domestic original research drugs and brand generic drugs that have obtained patents to carry out international registration and certification "China's pharmaceutical industry should enter the stage of innovation and development." Shen Jingwang, deputy director of the information and Publicity Department of the State Food and drug administration, said that since last year, the state has successively issued some major deployments and decisions, providing a good opportunity for the innovation of the pharmaceutical industry The gap between 2% and 8% was just at the first "made in China" drug innovation communication forum recently held Officials and enterprises from various government departments sat together and "innovation" became the focus of their discussion "What kind of mechanism is more conducive to innovation?" Zhang Wei, Secretary General of the State Pharmacopoeia Commission, asked at the forum In his view, the development of China's pharmaceutical industry has gone through the stage of self-sufficiency Now, in addition to providing sufficient drugs to the domestic market, we need to make good drugs and export good drugs from China At present, China's drug production is mainly based on imitation Is it possible to focus on innovative drugs in the future? In China's drug production industry, a rather awkward reality is that the vast majority of chemical drugs are imitated Although there are trillions of drug consumption markets, there are not many innovative drugs in China that dominate this market Wu Haidong, deputy director of the Department of consumer industrial products of the Ministry of industry and information technology of the people's Republic of China, said that 95% of China's chemicals are generic drugs, and the level is uneven According to the data provided by Wu Yifang, President of Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., from 2010 to 2014, the average number of innovative drugs on the market in the world is 42, the average R & D cycle of innovative drugs is 13.5 years, and the average investment is more than 800 million US dollars At present, it is still the global multinational drug manufacturers that lead the innovation and research of drugs "For these innovative R & D companies, the highest R & D investment is more than 20% of sales revenue, and the lowest is 12% Drug R & D is high investment, innovation driven and high value." Wu said that the main products sold and profited by these multinational companies are basically innovative drugs Innovation brings great value In 2015, the 10 drugs with the highest sales volume in the world were all developed by multinational drug manufacturers, none of which belonged to China The annual reports of the top 10 multinational drug manufacturers in the world in recent five years confirm the above views Just last year, the R & D investment of Amgen, Lilly and AstraZeneca accounted for more than 20% of the sales revenue But in Chinese drug manufacturers, that's only 2% In other words, the average R & D investment of Chinese pharmaceutical manufacturers accounts for only 2% of sales revenue Xu Ming, vice president of China Chamber of Commerce for the import and export of medical and health products, said that internationally, the average proportion is 8% An expert, who asked not to be named, told reporters that innovation in the pharmaceutical industry is talked about every year, but to achieve real innovation, it needs to be implemented into the actions of enterprises In addition to a few enterprises, most domestic pharmaceutical companies are reluctant to spend more money on innovation and R & D Shen Lingjia, deputy general manager of Jiangsu Hengrui Pharmaceutical Co., Ltd., told reporters that China's pharmaceutical industry is characterized by large scale, with thousands of domestic enterprises, many more than developed countries However, the investment in innovation is insufficient Many enterprises invest less than 2% or even less in R & D, some of which have little R & D investment The result is that without investment, nothing can be done and innovation ability can hardly be improved Enterprise strategy: in the view of many enterprises, to increase investment in drug research and development is a very risky thing From research and development to the emergence of new compounds, not only is the cycle long, but also the probability of failure is large, and the enterprise investment is likely to drift Ye Zhengliang, CEO of manufacturing business group of Tianshili Holding Group Co., Ltd., tells a story In 1997, the Ministry of science and Technology launched a plan to introduce 10 kinds of drugs into western developed countries in several years "At that time, many enterprises did not dare to do it." Ye Zhengliang said that Tianshili was not a big enterprise at that time, but had the courage to do it At present, there are 6 drugs in 8 countries in the form of prescription drugs Tianshili's main product is compound Danshen dropping pill, which is a Chinese patent medicine However, the drug has been in the United States and other 9 countries, 120 clinical centers to start phase III clinical If the phase III clinical data are good, it means that there is only one last step to go to the market in the corresponding country Ye Zhengliang said that the internationalization of traditional Chinese medicine has driven the innovation of traditional Chinese medicine technology and equipment In order to meet the requirements of the drug regulatory authorities in the United States and the European Union, the compound Danshen dropping pill has been made into a new dosage form of micro dropping pill capsule On January 6, the product was approved by EU Danshen capsule But for more domestic pharmaceutical companies, such innovation seems far away An official from the State Food and Drug Administration told reporters that the most fundamental system to encourage innovation is the patent system, which encourages innovation by giving enterprises market monopoly However, it has also been suggested that there is no innovation without imitation On the surface, imitation and innovation are contradictory, but in fact, they promote each other This official believes that innovation has vitality, innovation has development momentum, and innovation has development sustainability, which needs to be promoted by imitation This view may adapt to the development stage of China's pharmaceutical industry In the interview, many pharmaceutical companies, famous for their large R & D investment, said that the long-term corporate goal must be innovation oriented, but at this stage, imitation is still needed According to the data provided by Wu Yifang, during the 12th Five Year Plan period, Fosun Pharmaceutical's R & D investment accounted for more than 20% of sales, with a compound annual growth rate of more than 20%, and the R & D investment continued to rise "At present, imitation is still our basic survival mode." Wu Yifang said that breakthroughs must be achieved through innovation, but if generic drugs are not made, they may not survive, so generic drugs still need to be made The development of Wu Yifang's idea is divided into three stages In the near future, enterprises will build up their innovation ability on the basis of imitation In the medium term, they will develop both imitation and innovation, and in the long term, they will be completely innovative "In 10 to 15 years, most of Fosun's profits will probably come from innovation." Shen Lingjia told reporters that Jiangsu Hengrui pharmaceutical has insisted on putting 8% to 10% of its sales into R & D in recent years Even so, the company hopes to become a multinational company with international influence based on generic drugs, driven by innovation and internationalization "We say that it is impossible to give up imitation Whether the combination of imitation and innovation is based on generic drugs, we are gradually turning to innovation." Shen Lingjia said that through 5 to 10 years, the company plans to achieve international integration in areas where enterprises are strong, and finally achieve the listing of patent drugs overseas In the pharmaceutical industry, it is a more stable path to start with generic drugs, occupy the international market through generic drugs, and gradually realize the transition to innovation on the premise of sufficient capital and enhanced market operation ability Xu Ming said that at present, China only has more than 40 generic drugs entering the European, American and Japanese markets, while neighboring India has already broken through 100 Market return is the driving force of innovation Recently, Xu Ming proposed at the working conference on foreign trade situation held by the Ministry of commerce that China's foreign trade development must be driven by innovation, not transformation, but also transformation, and the medium and high speed should move forward to the medium and high end "In the 1930s Austria put forward the theory of technological innovation industry upgrading." Xu Ming said that this theory believes that the development of industry must rely on innovation To carry out high-end learning through a large number of practices is the only way for developing countries to improve their international competitiveness, that is, innovation driven In his view, the pharmaceutical industry is in such a transformation stage "What is innovation in the end? To do something high is called innovation or to develop on the basis of application is called innovation? Innovation must be multi-level." Xu Ming said that Chinese products now face a severe challenge, that is, high-end products do not compete with European and American enterprises, and low-end products are more and more difficult to compete with developing countries In Xu Ming's opinion, the purpose of innovation is to realize the market return of product and technology development, which is the real driving force of leading innovation If there is no market return, innovation is ineffective innovation According to the data provided by Xu Ming, the scale of the global pharmaceutical market (excluding medical devices) in 2015 is about 1068.8 billion US dollars, and the global pharmaceutical sales will maintain a growth of 4% - 7% in the next five years At present, Chinese pharmaceutical enterprises are transforming from bulk low value-added products to characteristic raw materials, patent pharmaceuticals and biological pharmaceuticals A huge market is placed in front of the pharmaceutical industry, and to achieve the growth of this market, innovation cannot be avoided Wu Haidong, deputy director general of the Department of consumer industrial products of the Ministry of industry and information technology, told the China Youth Daily that the first national special plan for the pharmaceutical industry was seeking social opinions, which was jointly prepared by the Ministry of industry and information technology, the development and Reform Commission, the health and Family Planning Commission, the State Food and Drug Administration and the Ministry of Commerce The data shows that under the background of increasing economic pressure in 2015, the main economic and technical indicators of the pharmaceutical industry are among the best in all industries For example, the growth rate of added value of the pharmaceutical industry is 9.8%, 3.7 percentage points higher than the overall level of the whole industry The growth rate of main business income is 9%, while that of all industries is only 1.2% Wu Haidong said that in the future, the pharmaceutical industry should make full efforts in independent innovation During the 13th Five Year Plan period, it is necessary to enhance the innovation ability, first, increase investment, second, improve efficiency, and actively promote China's strategic transformation from tracking imitation to independent innovation There are eight key tasks in the special plan of the pharmaceutical industry The first is to enhance the ability of independent innovation First, promote product innovation, increase the research and development of original drugs, and realize the upgrading of drug research and development from imitation to creation, so as to meet the needs of prevention and control of major clinical diseases in China; second, build a platform, build a pharmaceutical medical device innovation center, develop key generic technologies around the industry, tackle key problems, break through the bottleneck of industrialization technology, and promote the transformation of innovation results Third, support the development of small and medium-sized innovative enterprises, build innovation and entrepreneurship service platform, implement the pharmaceutical industry venture capital plan, support the development of a number of small enterprises engaged in new drug innovation, and make them become an important source of pharmaceutical innovation in China On December 3 last year, the CPPCC National Committee held a two-week Symposium Many members suggested