Speech by Vice Chairman sang Guowei at 2012 International Pharmaceutical Innovation Summit

Source: Mr sang Guowei, vice chairman of the China Council for the promotion of drugs, delivered a speech at the 2012 International Pharmaceutical Innovation Summit Dear Dr Lechleiter, ladies and gentlemen, friends, good morning! First of all, I would like to extend my heartfelt congratulations on the "2012 International Pharmaceutical Innovation Summit" jointly held by rdpac, pharma and the China Council for the promotion of drugs, and extend a warm welcome to the domestic and foreign pharmaceutical friends who have come to attend this summit! I am very happy to participate in this summit and work with all colleagues in the pharmaceutical industry to study and discuss the theme of "pharmaceutical innovation" Pharmaceutical industry is an important livelihood industry related to national health and well-being Pharmaceutical scientific and technological innovation is the core competitiveness and fundamental driving force to promote the healthy and sustainable development of pharmaceutical industry It has become a global consensus to promote the innovation of pharmaceutical technology and accelerate the cultivation of healthy and sustainable pharmaceutical industry The Chinese government has always attached great importance to scientific and technological innovation, including pharmaceutical technology, and has repeatedly stressed the great strategic significance of scientific and technological innovation for China's economic and social development At the national science and Technology Innovation Conference held in July this year, President Hu Jintao clearly put forward the strategic task of adhering to the path of independent innovation with Chinese characteristics and building an innovative country in the new era, and made a comprehensive deployment for deepening the reform of the science and technology system and accelerating the construction of the national innovation system He proposed that we should focus on solving the outstanding problems restricting scientific and technological innovation, optimize the innovation environment, improve the innovation efficiency, and strengthen the innovation subject position of enterprises The report of the 18th National Congress of the Communist Party of China, which was held not long ago, also clearly pointed out that "scientific and technological innovation is the strategic support to improve social productivity and comprehensive national strength, and must be placed at the core of the overall national development." "Gather the wisdom and strength of the whole society into innovative development" Biomedical industry has been listed as one of the seven strategic emerging industries supported by the state for a long time With the great attention of the government and the joint efforts of all sectors of society, China's pharmaceutical industry has made great progress since the reform and opening up for more than 30 years In 2011, there were 6154 enterprises in China's pharmaceutical industry, with a total asset of 1376.2 billion yuan, an increase of 23% year on year In 2011, the output value reached 1577.7 billion yuan, a year-on-year increase of 28.5% In 2011, the added value of the pharmaceutical industry increased by 17.9%, 4 percentage points higher than the industrial growth rate It is estimated that during the 12th Five Year Plan period, the total output value of China's pharmaceutical industry will grow by 20% annually, and the industrial added value will grow by 16% annually According to IMS, China has become the second largest pharmaceutical market in the world At present, the environment for the development of China's pharmaceutical industry is good, especially in the growth of the pharmaceutical market, the increase of government investment in basic research and infrastructure construction, and the introduction of talents The rapid development of China's pharmaceutical industry benefits from the comprehensive favorable factors of China's innovative drug R & D and market development Over the years, the sustained and stable development of China's economy, the improvement of national income and consumption level, the rapid formation of the middle class, and the acceleration of the aging and urbanization of the population constitute the objective basis for the development of China's pharmaceutical market The country attaches great importance to the people's livelihood, increases the investment in health and new drug research and development, and deepens the pharmaceutical and health reform, which is the innovation of Chinese medicine Strong driving force for market expansion In the past five years, the Chinese government has successively issued a series of important policies and measures, listing the biological industry as seven strategic emerging industries, and clearly proposed that the biological medicine should be regarded as a new growth point of the strategic emerging industries; encourage the innovation of the biological medicine industry, and improve the domestic standards in various fields including medical treatment, food and drug safety A major national science and technology special project of "major new drug creation" has been set up, which has greatly promoted the research and development of innovative drugs with independent intellectual property rights and high-quality generic drugs in China The major science and technology project of "major new drug creation" is a support project specially set up by China to promote the innovation and development of the pharmaceutical industry Since the "11th Five Year Plan" and the "major new drug creation" project, China has made a number of landmark achievements in drug innovation I'm glad to see that in the "2012 annual report on global drug research and development" published by citeline, the world's largest clinical data provider, products such as small molecule targeted anticancer drug "exetinib hydrochloride" and "linagliptin" for type 2 diabetes developed by Lida pharmaceutical, a member of China Association for the promotion of drugs, are listed in 2011 The new active substances listed in the world in There are also a number of innovative drugs with obvious characteristics entering clinical trials in China, and a number of potential drug targets with good prospects have been independently discovered During the 11th Five Year Plan period, China's application for foreign drug-related patents exceeded the original plan by 192% and obtained foreign authorization by 125% over the original plan; 40 new drug certificates and applications were obtained and remarkable achievements were made in the field of new drug innovation In drug research and development, we need to pay attention to the ultimate purpose of drug research and development, which is to benefit patients and meet the growing clinical needs; at the same time, we need to pay more attention to the early detection and prevention of diseases, pay attention to the changes of disease spectrum of different gender, population and race, and formulate different prevention and control strategies and drug research and development programs Therefore, the focus and strategy of drug research and development in various countries must be based on evidence-based medicine, which is consistent with the needs of the clients With the rapid development of transformation science, a close combination of basic research, clinical research, gene technology and pharmaceutical innovation is forming in the work of disease prevention and treatment For example, the results of 11 clinical trials of hypertension in the world show that the ratio of stroke incidence and myocardial infarction incidence in hypertension patients is between 1.02 and 1.63 in European and American countries, 5.00 in Japan, and 6.56 to 13.00 in China This suggests that stroke is the most important complication of hypertension in China Therefore, it is necessary to adjust the stroke prevention and control strategy of Chinese hypertension patients according to the evidence-based medicine of our country Enalapril folate tablet, a national class 1 drug supported by the national major new drug program, and individualized medical gene diagnostic reagent for H-type hypertension treatment can better prevent and treat hypertension, and can screen out possible high-risk stroke patients among existing hypertension patients, so as to achieve early prevention Looking forward to the future, the huge market demand for affordable bio generic drugs will be the main driving force for the rapid development of the industry However, China lacks relevant policies on biosimilars, which are difficult to develop and produce, with high technical requirements Pharmaceutical enterprises need to produce qualified biosimilars through continuous investment and technology upgrading and customer service From the perspective of generic drug policy, it will be a challenge for governments and drug regulatory departments to reduce the application procedures, save the time and cost of R & D and clinic, and ensure the consistency of generic drugs and generic drugs in terms of effectiveness and safety Looking at the global trend of drug research and development, it has become an objective fact that the cost of drug research and development is rising and the efficiency is decreasing We are facing serious challenges in terms of R & D output rate This shows that the development model of heavy bomb level cannot be the most important factor leading the development of enterprises, and other new strategies need to be explored We need to pay more attention to the reorientation of existing drugs, that is, to develop the R & D strategy of new indications of existing compounds Repositioning drugs have the characteristics of low risk, low cost and short time For example, aspirin is found to be able to treat thrombosis on the basis of the original inflammation and pain indications; gemcitabine is found to be able to treat cancer on the basis of the original treatment of virus infection, etc Of course, drug repositioning is not zero risk However, it has been proved that drug repositioning can be a successful strategy At present, a large number of drugs do not have the opportunity to push the market, but are put in the company's assets It is estimated that there are more than 2000 failed drugs that can be used for relocation, and the annual growth rate is 150-200 drugs During the 11th Five Year Plan period, 704 innovative drug research and development projects, including clinical research, preclinical and candidate drug research, have been established for major new drug projects in China, involving 40 first-class new drugs In addition, many research projects have been established in the aspects of large variety technology transformation, technology platform construction, new drug incubation base construction and key technology research At present, with the support and efforts of all parties, we have successfully completed the tasks of the 11th five year plan, achieved the expected goals and achieved a number of landmark results For example, Antofloxacin, the first class 1 new chemical drug with independent intellectual property rights in China, has a half-life of up to 20 hours in human body, and its clinical efficacy and safety are superior to levofloxacin Iricoxib, a new anti-inflammatory drug, is the first selective cyclooxygenase-2 (COX-2) inhibitor in China Ckip-1, a potential drug target for osteoporosis treatment, has been found to be a new protein with specific regulatory function, which may become a candidate target for osteoporosis treatment The first international nucleic acid delivery system targeting osteoblasts has been established Shanghai Pharmaceutical Institute of Chinese Academy of Sciences has passed the international GLP certification of OECD At present, it is urgent to establish a market-oriented promotion mechanism for the transformation of innovative achievements On the basis of government guidance and market mechanism, a complete value chain of biomedical industry should be built An investment chain supported by angel / government early investment and scientific research funding, innovative drug venture capital funds and industry giants should be established to achieve sustainable financial support and industrialization promotion Strengthen close cooperation between domestic and foreign innovative R & D enterprises and production and marketing enterprises, and promote R & D enterprises to move from innovation success to market success The cost and risk of drug research and development will further promote the cooperation between enterprises, especially between Chinese enterprises and multinational pharmaceutical groups The overall goal of major new drug projects in China is to build China into a pharmaceutical power by 2020, so as to meet the needs of safeguarding the health of Chinese people, safeguarding the national strategic security and social stability The Chinese government has always been committed to building a good policy environment conducive to the innovation and development of the pharmaceutical industry, striving to improve the level of national health security, so that all citizens can share the development results Over the years, China has built a relatively complete pharmaceutical policy system in drug registration review, drug pricing, drug bidding, drug intellectual property protection and other related aspects, which has greatly guaranteed and promoted the development of the pharmaceutical industry At present, there are still some problems and challenges to be solved in this policy system, which need to be further improved in order to better protect the innovation enthusiasm of the market subjects and ensure that the innovation of medical science and technology can better serve the public health and benefit the people's livelihood Pharmaceutical innovation is not only the business of pharmaceutical enterprises, but also needs the joint efforts of industry, academia, clinical institutions, media and government departments Finally, the social value of drugs should be reflected in the clinical efficacy Transformation medicine and model-based drug research and development will be the main mode of pharmaceutical innovation in the 21st century At the same time, innovative medicine and market environment can not be divorced In the process of medical reform, the