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    Home > Active Ingredient News > Drugs Articles > The situation and challenges of new drug research and development in China in 2017

    The situation and challenges of new drug research and development in China in 2017

    • Last Update: 2017-03-03
    • Source: Internet
    • Author: User
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    Source: innovation and development achievements of Bio Valley in 2017-3-3 During the "12th Five Year Plan" period, China's major new drug creation projects supported the development of 30 new drugs, completed the transformation and technological innovation of 200 drug varieties, and basically established a world-class drug innovation system, nurtured new drug incubation base, industry university research alliance and high-tech park, focusing on the research and development of drugs for ten major diseases such as malignant tumors, cardio cerebrovascular diseases and diabetes The pharmaceutical industry has implemented the special proposal to enhance the ability of independent innovation, build a research platform for efficacy, drug generation and toxicology around the breakthrough of key common technologies in the industry We will support the development of small and medium-sized innovative enterprises, provide innovative and entrepreneurial services, and implement venture capital plans for the pharmaceutical industry and new drug innovation and development However, the research institutes of quite a number of domestic enterprises are not worthy of the name, and the capital investment and capacity-building need to be strengthened urgently According to Roche's research and development investment of 8 billion euros (about 80 billion yuan) in 2016, the sum of the annual investment of all enterprises in China is also less than 1 / 10 of that of this enterprise (the total investment of national enterprises in the 12th Five Year Plan is no more than 40 billion yuan) During the 12th Five Year Plan period, in order to meet the needs of people's livelihood, realize industrial adjustment, and encourage "breakthrough innovation", some major new drug creation projects will enter the accelerated review, which will be conducive to innovative research and development The first ADC drug (rc48) approved by China to enter human clinical trials is expected to become the most effective weapon to conquer HER2 positive tumors; the anti hepatitis B antigen recombinant hepatitis B vaccine, the new structure Y01 and paladofovir are expected to make new progress this year; the hepatitis C treatment, which is composed of two direct antiviral drugs (DAA), asc16 and asc08, is expected to be the core New drugs are in clinical trials On the basis of 10 years of innovation and development, it is expected that China will usher in the rising period of new drug listing this year This year, we should pay attention to the research and development of new drug delivery system and give full play to the leading role of national key laboratories of enterprises In view of the short board of research and development theory, technology, excipients, technology, equipment, etc., strengthen the research and development and industrialization of pharmaceutical excipients, and provide high-end excipients for the production of slow controlled release and intelligent preparations No matter what form of going out, we must recognize the short board of development in order to meet the challenges: first, the long-time, high-cost and low-efficiency closed type new drug R & D mode urgently needs to be reformed to realize enterprise cooperation and establish an open and efficient innovation concept of the pharmaceutical innovation ecological environment; second, to enhance China's global competitiveness and set up a new concept of meeting the immediate needs with an international perspective of R & D innovation The concept of multi-channel matching degree of bed demand research and development forms a competitive advantage in the world and develops innovative cutting-edge science and disciplines; the third is that "personalized medicine" for the purpose of "precision medicine" should adapt to the needs of China, and pay attention to the differences between the clinical research and development of European and American people and the patient's disease spectrum, genetics and living environment of China, so as to adapt to the needs of domestic disease spectrum; the fourth is how to start the rapid review Comment on beneficial innovation and R & D Therefore, we should change the research and development mode of new drugs in order to speed up the research and development of national major innovative drugs The development of high-end innovative preparations is the best policy because of the impact of quality consistency, China's chemical API surplus, export downturn From the perspective of energy conservation, emission reduction and drug resource utilization, it is the best policy to digest more than 50% of the excess chemical API manufacturing capacity to the global market, combine with the development frontier of preparations, adopt a variety of flexible cooperation mechanisms, and develop high-end innovative preparations The internationalization of pharmaceutical preparations has become an important way to transfer and optimize the export of APIs in China From the perspective of market demand, the development of pharmaceutical preparations is an important stage for China's pharmaceutical industry to extend to the world in the next 10 years According to the latest data of China Customs in 2016, the export of chemical drugs to Europe, the United States and Japan is nearly 35 billion yuan, of which the export to the United States has grown by more than 40% Its development momentum is related to encouraging the transformation of excellent enterprise preparations At present, hundreds of pharmaceutical products of 75 pharmaceutical companies in China are registered and listed in South America, Russia, Eastern Europe, ASEAN and Africa, and more than 100 pharmaceutical products have passed the FDA review In 2016, the export of preparations of the top 100 pharmaceutical enterprises in China was far more than 4%, reaching a growth rate of more than 12%, and the growth rate of the top 10 pharmaceutical enterprises was as high as 100% It is expected that Huahai, Hengrui, Haizheng and LVYE will increase more this year The development strategy of pharmaceutical industry should be put on the development of high-end innovative pharmaceutical products with core competitiveness, adopt various flexible cooperation methods, make full use of domestic and foreign resources and cost advantages, and find new development direction and ideas In combination with the international pharmaceutical development frontier, the development of new preparations in China should pay attention to transformation, and enterprises should pay attention to the development of new high-end drug delivery system (DDS), which is obviously superior to the research and development of new entity drugs in terms of improving research and development speed, reducing cycle, reducing risk and improving efficiency The law on traditional Chinese Medicine published in 2016 provides policy guarantee for the development of traditional Chinese medicine industry, and will promote traditional Chinese medicine to the world For example, Hutchison Whampoa, Qixing pharmaceutical, Xiangxue pharmaceutical, Tianshi pharmaceutical and other enterprises are optimistic about listing abroad In the research of application foundation and industrialization development of new preparations, enterprises with foundation should be encouraged to go out and give full play to the leading role of national key laboratories of enterprises We should also strengthen the R & D and industrialization of pharmaceutical excipients At present, there are few domestic enterprises that produce high-end products such as sustained-release, controlled-release and intelligent preparations, few enterprises that produce children's preparations, and few professional institutions engaged in research and development In 2017, the state listed high-end preparations and pediatric preparations in the key R & D plan, which will surely promote the preparation innovation and development, and will produce innovative R & D effect The key year to meet the challenge of generic drug conformity evaluation in 2016, the center of a series of documents of CFDA is the challenge of quality standard system construction and supply side reform After the top-level design of nearly three years' consistency evaluation research, we sorted out the varieties of essential drugs, put forward a batch of reference drug directories, and established an expert committee for consistency evaluation Some policies that benefit people's livelihood and promote development are related to the completion of the consistency evaluation of quality and efficacy of nearly 300 essential drugs in 2018 It is expected that this year will be the key year to meet the challenge of generic drug consistency evaluation Some of the competent pioneers have passed the consistency evaluation, and some enterprises with international vision and ability will "flow back" the products approved for listing in Europe and the United States In the reform, we should pay attention to the strict review and approval of drug listing and optimize the review and approval procedures We will give policy support to accelerate the consistency evaluation of drugs and orderly promote the system of listing license holders We will increase efforts to adjust the structure of the pharmaceutical industry and push backward enterprises to exit We will improve industrial and commercial supervision, and ensure the supply of medicines in short supply and at low prices, as well as monitoring and early warning mechanisms According to the implementation problems and time limit of the released documents, it is very difficult to complete the re evaluation of generic drugs The consistency evaluation may cause the chain effect of industry and supply: the production cost increases, the supply price increases, the government burden, the medical insurance payment and the people's drug burden increases In the consistency evaluation of generic drugs, the enterprise's main strategy and variety strategy are the basis for winning Therefore, the number of manufacturers, products or production reduction, production suspension and supply interruption may occur in the selection of products, which will inevitably affect the structural changes of effective varieties with low price and small quantity, while non consistency evaluation varieties will have greater opportunities Finally, the influence of patients' medication habits Due to the withdrawal of a large number of approvals, doctors' prescriptions may face the situation that there is no medicine to match The brands or varieties that patients are familiar with will disappear and need to be supplemented by new drugs (BIOON Com)
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