Gu Jinhui: "major new drug creation project" will promote flexible pricing of new drugs after listing

Source: on November 23, 2016, innovation momentum of pharmaceutical economic news is surging! From government, society, scientific research institutions to enterprises, Chinese pharmaceutical industry pays more and more attention to the research and development of new drugs from the top to the bottom A series of favorable policies have been issued successively, and the era of industrial chain value transferring to the upstream of R & D innovation is coming quietly Among them, the "major new drug creation project" issued by the state in 2008 has a far-reaching impact on the innovation and upgrading of the pharmaceutical industry In the 28th national pharmaceutical economic information conference and 2016 National pharmacy week, 11th Gu Jinhui, director of the Department of science and education of the national health and Family Planning Commission, pointed out at the annual meeting of the top 100 pharmaceutical industry in China that through the development of major innovative and clinically urgent varieties, breaking the monopoly of foreign patents, speeding up the internationalization process of domestic drugs, improving the construction of drug innovation technology system, and promoting the realization of China's pharmaceutical industry from generic to innovative drugs, and from a pharmaceutical country to a pharmaceutical country With the transformation, the pharmaceutical industry is facing unprecedented strategic opportunities Gu Jinhui, director of the major special department of the science and Education Department of the national health and Family Planning Commission, deeply focuses on the clinical needs Although the new drug research and development has the characteristics of low success rate, high cost and long cycle, it is not only the permanent theme of industrial development, but also the fundamental way for enterprises to continuously improve their competitiveness to adhere to product innovation and meet the needs of the market and clinic that are not fully met For this reason, "major new drug creation project" in 2008 At the beginning of the launch, three goals were defined: to develop drugs with good efficacy, small side effects and low price for major diseases, to provide people with safe, effective, convenient and cheap medical and health services, to basically meet people's growing health and medical needs; to build a national drug innovation technology system, to provide technical support for innovative drug research and development; to explore and establish compliance It is an effective and innovative drug development model and mechanism in line with China's national conditions Since the launch of the "major new drug creation project", the scale and investment of new drug projects will reach 20 billion yuan by 2020 Now, the central government has arranged more than 10 billion yuan of financial expenditure and more than 1500 projects have been approved It is mainly aimed at 10 major diseases such as malignant tumor, cardiovascular and cerebrovascular diseases, neurodegenerative diseases, mental diseases, diabetes, autoimmune diseases, drug-resistant pathogens infection, tuberculosis, major viral infectious diseases and other common and frequently occurring diseases Gu Jinhui pointed out:“ In terms of innovative varieties, we should promote the research and development of chemical drugs, make innovative drugs gradually enter the international mainstream pharmaceutical market, research and develop new products of traditional Chinese medicine, make the research of innovative traditional Chinese medicine stay at the international leading level, and strive to make breakthroughs in many aspects to reach the world's advanced level; in terms of system construction, we should build a national comprehensive technology platform and enterprise new drug incubation base as the backbone, and a specialized unit technology platform As an important part of the national drug innovation system, in terms of new models, we will explore and establish new models and mechanisms for innovative drug research and development that are in line with China's national conditions, have Chinese characteristics, operate scientifically and efficiently under the market mechanism " During the 11th Five Year Plan and the 12th Five Year Plan, the new drug creation policy has reserved huge resources for the new drug research and development in China "Up to now, 1329 new drug projects in different research and development stages have been specially deployed and supported, forming a relatively complete product line, of which chemical drugs are still the key support, with a total of 649 projects, 237 traditional Chinese medicine projects and 443 biological medicine projects." In addition, according to the statistics of CFDA drug review center, 90 varieties of major innovation have obtained new drug certificates, 135 varieties have obtained clinical approval documents, 24 new drugs of category 1 have been approved, and the new drugs of category 1.1 developed and approved for marketing in China from 2009 to 2015 are all special support projects "In combination with clinical drug demand, a number of large varieties urgently needed in clinical research, development and technical transformation have been completed, with a total of more than 200 varieties involving more than 80 national essential drugs, accounting for 15.3% of the national essential drugs catalogue (2012 version)." Accelerate the integration of production, teaching, research and application of "major new drug creation and development project" On the one hand, the project establishment is to meet the major requirements of safeguarding people's health, safeguarding national security and social stability; on the other hand, it is a major strategic choice to promote the leapfrog development of the pharmaceutical industry and the construction of a powerful pharmaceutical country The investment of special funds has fully played the leading and upgrading functions, promoted the enterprise to become the innovation subject of new drug R & D and industrial development, and promoted the depth of production, learning, research and application Integration "More than 60 business innovation incubation bases, 26 biomedical industrial parks and industry university research alliances, and more than 340 participating enterprises have been built with special support, which directly and indirectly promote the development of local economy, forming a distinctive biomedical industry cluster area, gradually forming a new trend of industrial development with enterprises as the main body, government policy funds as the guide, and programs as the goal." Gu Jinhui further said that relying on various technical platforms, national key laboratories, engineering technology centers and other institutions, we should enhance the ability to drive by key tasks, strengthen the advanced technology, open service, talent training and radiation driving role of the technical platform, enhance the transfer and transformation ability of new drug innovation achievements, cultivate major varieties and large backbone enterprises, and promote the transformation and development of the pharmaceutical industry 。 A number of national drug innovation platforms, the largest compound library in Asia, the national compound sample library, and the internationally certified GLP platform have all reached the international advanced level By breaking through a number of key technical bottlenecks, domestic enterprises have achieved international "parallel" in vaccine, antibody research and development and other technical fields 51 National Science and technology awards have been awarded for special projects, and nearly 200 talents of "thousand talents plan" have been introduced, ranking first in major projects; biomedical industry clusters such as Beijing Tianjin Hebei, Bohai rim, Yangtze River Delta and Pearl River Delta have taken shape, with an average annual increase of 13.4% in added value of pharmaceutical industry above Designated Size, ranking first in all industrial categories With the support of major new drug projects, the pace of internationalization of domestic pharmaceutical industry is accelerating At present, there are more than 20 domestic pharmaceutical enterprises with GMP certification in developed countries, 200 More than varieties of APIs and preparations have obtained international certification Local enterprises such as Shenzhen micro core, Zhengda Tianqing and Suzhou Xinda have successfully provided patent licenses to the pharmaceutical industry of developed countries in Europe and the United States Some pharmaceutical enterprises such as Hengrui pharmaceutical, Hutchison Huangpu and Baiji Shenzhou have obtained international recognition for their innovation ability and level, and the cooperative transfer of innovative drugs to large foreign enterprises has achieved zero breakthrough Who The Cooperation Center for biological product standards and evaluation was established in China; conbercept was directly approved by the US FDA to enter phase III clinical trials; more than 50 new drugs, such as compound Danshen dropping pills and bergistine, were launched in European and American countries for clinical research; lamotrigine was approved by the FDA for marketing; risperidone microspheres were approved by the US FDA to directly submit new drug application (NDA ）The standards of Salvia miltiorrhiza and other Chinese herbal medicines researched and formulated by Chinese experts have entered the US pharmacopoeia, and Uncaria, Polygonum cuspidatum, Platycodon grandiflorum have been listed in the EU Pharmacopoeia It is expected that the "13th five year plan" and "major new drug development projects" will be further advanced in an orderly manner Gu Jinhui introduced that the special key tasks will be deployed in the first three years In 2016, the "12th Five Year Plan" will be strengthened and 10% of the projects will be launched In 2017, the main tasks will be implemented and the top-down and bottom-up combination will be adopted to organize the project 60% of the projects will be launched in this period 2018-2020 In, we will improve the layout and make up for the missing "During the 13th five year plan, major new drug creation will continue to focus on the development of major varieties and key technologies, strengthen the original new drugs and transformation research around 10 major diseases, and accelerate the 200% of the clinical research stage We will continue to optimize the special organization and management mechanism, establish and improve policies and regulations related to incentive innovation, and actively coordinate and promote policies such as accelerating the review and approval of new drugs, flexible pricing and promoting the use of new drugs after they go on the market "