Zhang Yongxiang: comprehensive analysis of the 13th five year plan of "major new drug creation"

Source: bioexploration 2015-6-17 June 8-10, the 17th Shanghai International Biotechnology and Medicine Symposium themed "win win cooperation, building a biomedical innovation center with global influence" was held in Shanghai International Conference Center Hundreds of business, government, investment and academic circles from all over the world discussed the future development trend and achievement transformation of life science At the opening ceremony, Yi Chengdong, deputy director general of Shanghai food and drug administration, delivered a wonderful speech According to Yi Chengdong, the Shanghai food and drug administration is working hard to implement the "one initiative, three strives" put forward in the "opinions on accelerating the construction of a science and technology innovation center with global influence" How to transform technology and information advantages into industrial advantages is one of the challenges for Shanghai biomedical industry Four keynote speeches have been arranged in this conference, among which Professor Zhang Yongxiang, a member of the national "major new drug creation" special expert group, takes the implementation progress of major new drug creation and development ideas of the 13th five year plan as the theme, and makes major new drug creation of the national science and technology major special project from three aspects of overview, implementation progress and development ideas of the 13th five year plan“ The overall situation is analyzed and introduced in detail Innovation is the eternal theme of pharmaceutical enterprises Since 2000, the scale of global pharmaceutical market has been growing gradually, reaching US $1014.2 billion in 2014 With the rapid development of the world economy, human beings have higher and higher requirements for health care and disease prevention and control, which has become one of the powerful driving forces for the sustainable development of the pharmaceutical industry Although new drug R & D has the characteristics of low success rate, high cost and long cycle, innovation has always been the eternal theme of pharmaceutical enterprises and the fundamental way for enterprises to continuously improve market competitiveness In 2014, the number of new drug projects under research in the world has increased from 5995 in 2001 to 11622, with an annual growth rate of 4.76% In the history of the necessity of carrying out the major project of "major new drug creation", the major projects represented by "two bombs and one star" and "hybrid rice", as well as the implementation of "Three Gorges Project", "Qinghai Tibet Railway" and other major projects, have played a crucial role in improving the overall national strength The United States, Europe and other developed countries take the implementation of major special plans around national goals as an important measure to improve national competitiveness In 2008, 10 major projects of minkou science and technology were launched, with the implementation period of 2008-2020 It is the largest and most invested science and technology plan since the founding of the people's Republic of China Three of the 10 major projects are related to the field of life science, including the cultivation of new varieties of genetically modified organisms, the creation of major new drugs, and the prevention and control of major infectious diseases such as AIDS and viral hepatitis On the one hand, the establishment of the major project of "major new drug creation" is to meet the major needs of people's health, 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 build a strong pharmaceutical country On this basis, the major project of "major new drug creation" has set three goals: 1 For major diseases, develop drugs with good efficacy, small side effects and low price to provide people with safe, effective, convenient and cheap medical and health services, and basically meet the people's growing health and medical requirements; 2 To build a national drug innovation technology system, to provide technical support for innovative drug research and development; 3 To explore and establish a new model and mechanism of innovative drug research and development in line with China's national conditions and effective Professor Zhang Yongxiang said that how to establish an innovation mechanism in line with China's national conditions has always been one of the key points in the implementation of the major project "major new drug creation" The state hopes that through the implementation of special projects, China will realize the transformation from a "big country of generic drugs" to a "big country of innovative drugs" and from a "big country of medicine" to a "big country of medicine" Since the implementation of the major project of "major new drug creation" in 2008, "five outstanding achievements" of the major tasks and major projects of "major new drug creation", as of 2014, 1501 projects have been approved accumulatively, and the central financial fund of 13.05 billion yuan has been approved, and five important achievements have been achieved: 1 A batch of new drugs have been independently developed A total of 85 new drug certificates and 119 clinical approvals were obtained, which exceeded the target of "12th Five Year Plan" variety research and development; 2 Significant achievements were made in the technological transformation of large drug varieties A large number of technical transformation and upgrading of varieties of drugs have been completed Of the 520 varieties in the national essential drugs catalogue (2012 version), 15.3% are specially supported 3 The construction of technical platform is gradually in line with international standards A total of 8 GLP platforms have passed the certification of the International Committee for the assessment and Accreditation of experimental animals, and two of them have obtained the certification of GLP of OECD CFDA has been approved by who as the first cooperation center for standardization and evaluation of biological products in developing countries; 4 The internationalization process is developing rapidly Many chemical agents such as tacrolimus and lamotrigine have passed the FDA certification; Compound Danshen dropping pill, Xuezhikang Capsule and other traditional Chinese medicine varieties have completed the second phase of clinical trials; Danshen medicine and powder and other traditional Chinese medicine standards have entered the United States Pharmacopoeia, and 17 herbal monographs have been listed in the European Pharmacopoeia; 5 The technological innovation ability of enterprises has been continuously improved Under the special support, a number of enterprises have significantly enhanced their innovation ability; in the past five years, the average growth rate of the output value of China's pharmaceutical industry is 20.1%, 4.5 percentage points higher than the national industrial average The "13th five year plan" is a key period for China to build a well-off society in an all-round way, accelerate the construction of an innovative country, and also a decisive period for major science and technology projects to complete the overall strategic objectives At present, profound changes have taken place in the global scientific and technological innovation, industrial development and competition pattern, bringing new challenges and development opportunities to China's development The 13th five year plan for major special projects was launched on June 16, 2014, and the guiding ideology of "major demand oriented, product and technology as the main line, collaborative innovation as the driving force, complete system and mechanism as the support, and landmark as the goal" was formulated "13th five year plan" key tasks layout the "13th five year plan" development plan takes products and technologies as the main line, three tasks as the focus, and focuses on 10 Major diseases, including malignant tumors, cardiovascular and cerebrovascular diseases, neurodegenerative diseases, diabetes, mental diseases, autoimmune diseases, drug-resistant pathogens infection, hepatitis B, AIDS and human infection with avian influenza In recent years, there have been obvious changes in the death spectrum of Chinese people; cardiovascular disease, cerebrovascular disease, malignant tumor and chronic obstructive pulmonary disease are the four major diseases threatening the life and health of the people; the mortality of chronic kidney disease and Alzheimer's disease has increased significantly In the aspect of drug research and development, the 13th five year plan of major special projects points out that in view of the urgent need for clinical drug use such as prevention and control of major diseases and response to sudden diseases, through the combination of imitation and innovation, technological transformation and other ways, we need to develop and improve the quality of drugs to meet the requirements of clinical drug use In the aspect of building the national drug innovation system, the major development plan of 13th Five-Year requires relying on the various technical platforms, industry university research alliance, bio medicine technology innovation park and other carriers to further strengthen the research and development of new drugs, key technologies and new technologies, advanced and standardized construction, and strengthen functional links and organic links of technical links.