New drug creation: there is an outbreak, but also has the potential

Source: Health Report 2016-10-11 as an important strategic layout of medical science and technology innovation in China, since 2008, China has officially implemented two major national science and technology projects, namely "major new drug development", "prevention and control of major infectious diseases such as AIDS and viral hepatitis" Up to now, the central government has invested nearly 20 billion yuan in two major projects On the basis of self-evaluation and phased supervision and evaluation over the years, the Department of science and education of the national health and Family Planning Commission commissioned a third-party non-governmental organization to conduct a comprehensive evaluation of the overall performance of the two major projects in the past eight years for the first time in 2016 What is the overall performance of the two major projects? Has the input-output ratio reached the ideal goal? By the end of 2015, 1595 National Science and technology major projects of "major new drug creation" had been approved, with central financial investment of nearly 12.8 billion yuan and supporting funds of nearly 20 billion yuan Entrusted by the science and Education Department of the national health and Family Planning Commission, China pharmaceutical innovation promotion association undertook the comprehensive performance evaluation of major new drug creation projects The society invites nearly 30 senior experts from clinical, pharmaceutical and pharmacoeconomics to evaluate the comprehensive benefits of new drugs since the implementation of the special project through systematic sorting, expert evaluation, field research and other forms Song Ruilin, director of the special evaluation of new drugs and President of China pharmaceutical innovation promotion association, said that the evaluation results showed that the special new drugs achieved the three major goals of improving China's pharmaceutical innovation ability, meeting major clinical needs and producing good economic and social benefits, which is of milestone significance The evaluation results of the explosive growth of original new drugs show that since the special implementation of new drugs, a number of original new drugs have stood out During the "11th Five Year Plan" and "12th Five Year Plan", 95 varieties have obtained new drug certificates, including the world's first hand, foot and mouth disease vaccine and 24 class 1 new drugs, involving infectious diseases, tumors, cardio cerebrovascular diseases, diabetes and immune system diseases, mental diseases and other fields Under the special support, 132 varieties have obtained the clinical approval documents of new drugs, 64% of which are class 1 new drugs "In the 50 years from the founding of the people's Republic of China to the implementation of the new drug program, China has approved 5 new drugs of category 1.1, while during the 12th Five Year Plan period, China has 21 new drugs of category 1.1 Song Ruilin said that since the implementation of the new drug program, the number of original new drugs has increased rapidly, and the more significant effect is to realize import substitution and benefit the public He said, for example, that after the launch of class 1.1 new drug for non-small cell lung cancer, exetane hydrochloride broke the monopoly of foreign drugs, and the cost of treatment was 30% lower than that of imported drugs "Because of the domestic drugs, we have more confidence in the national drug price negotiation this year At last, the corresponding drug price of foreign drug companies has dropped by 55% "After conbercept, a class 1 new biological product for the treatment of fundus diseases, went on the market, Novartis also took the initiative to reduce the price of imported drugs with a patent period of 10 years The technology content of new domestic medicine is higher, patient compliance is better than that of imported medicine, and the market coverage rate is faster than that of imported medicine, which greatly improves the accessibility of medicine At the same time, since the implementation of the special project, guided by clinical value, more than 200 large varieties of clinical application have been technically transformed to improve product quality and better benefit the people's livelihood (next to version 2) (last to version 1) the evaluation of significant improvement of pharmaceutical innovation shows that since the implementation of the special project, the pace of pharmaceutical research in China has accelerated from imitation to innovation and internationalization First, the innovation system has been constantly improved to build a comprehensive technology platform and professional technology platform for new drug research and development For example, the total sample stock of the national compound library in Shanghai has exceeded 1.776 million, ranking first in Asia, providing the basis for high-throughput screening The national Shanghai new drug safety evaluation and Research Center has passed the certification of the Netherlands, the United States and other countries Second, we will promote the technological innovation capacity of pharmaceutical enterprises and significantly increase the R & D investment of domestic enterprises A number of independent innovation patent products are licensed overseas, and the innovation ability and level of local enterprises are gradually recognized internationally Third, we will promote the development of the pharmaceutical industry and regional economy The average growth rate of the output value of the pharmaceutical industry in the past five years ranks first in all industrial sectors "The new drug program has produced a number of important results, but more importantly, it depends on whether we can improve our innovation ability and continue to produce more results Song Ruilin said that building a platform is a basic work, which can solve the technical bottleneck restricting the development of new drugs in China In the future, China will become the most potential pharmaceutical innovation country "Major projects are the embodiment of the will of the state, not only for money and projects, but also for the confidence of the pharmaceutical industry in full innovation Song Ruilin specially mentioned that the continuous rolling support of the state for new drug projects has greatly stimulated the enthusiasm of the pharmaceutical industry for innovation, and the R & D investment intensity of domestic enterprises has increased 5-6 times than before the implementation of major projects Domestic pharmaceutical enterprises have changed from having to innovate in the past to active innovation The implementation of the project shows the determination of the government to promote pharmaceutical innovation and attracts a large number of returnees As of May this year, 170 talents of the national "thousand talents plan" and more than 1000 senior talents at home and abroad have participated in special research projects, ranking first in all major projects "The dividend of Chinese scientific and technological personnel is on display "Song Ruilin said More supporting policies are needed to support new drug related research In 2015, NIH of the United States invested 8 billion US dollars to support new drug related research In 2015, major special projects spent 1 / 4 of NIH of the United States in 2015, which achieved such remarkable results The "cost performance" is very high In the just released 2016 plan for adjusting the medical insurance catalogue, new drugs with significant clinical value after 2009 are specially mentioned, many of which are major special products However, the evaluation also found that in the implementation process of the new drug project, there are too many management levels and too long chain, which affect the efficiency; the fund management system needs to be improved, and the effect of driving social capital investment is not obvious; the project selection value risk evaluation system has not been established, and the achievement conversion rate is low, for example, the science and technology fund is regarded as the financial fund, the fund allocation is later and the settlement in the same year, which has become The institutional shackles restricting the innovation of medicine "Promoting pharmaceutical innovation is a systematic project New drug projects cannot be unique, and need more support from supporting policies "Song Ruilin said It is understood that the annual sales volume of 16 new class 1 drugs in China is about US $1 billion, which is only equivalent to the annual sales volume of a single drug in the United States The current medical insurance mechanism, which focuses on basic medical needs, is still difficult to "digest" innovative drugs with relatively high prices Experts suggest that to promote pharmaceutical innovation, we need to continue to reform policies, systems and mechanisms, further break through all links of approval, use and reimbursement, better integrate government support with market mechanism, improve efficiency through reform, guide government funds to leverage social capital, improve market environment, supplement commercial insurance on the basis of social insurance, and provide better market for original new drugs Return.