We should reduce drug consumption by more than 5 billion yuan every year! More than 10 innovative drugs will be industrialized in 3 years!

Source: from December 26, 2017 to December 27, 2017, the national development and Reform Commission issued the notice on the implementation plan of key technology industrialization in key areas of the three-year action plan for enhancing the core competitiveness of the manufacturing industry (2018-2020), and formulated the implementation plan for the industrialization of high-end medical devices and key technology of drugs   Innovation driven, market-oriented, quality first and key breakthrough are the basic principles of the three-year action plan To achieve industrialization by breaking through a number of major key technologies, to form a group of leading enterprises with international influence, to create a number of well-known brands made in China, to create a number of internationally recognized Chinese standards, and to significantly improve the innovation ability and product quality of the manufacturing industry The overall goal of the action plan is to significantly enhance the comprehensive quality During the 12th Five Year Plan period for the industrialization of innovative drugs, major special projects for new drug creation and development in China supported the development of 30 new drugs and completed the transformation and technological innovation of 200 large drug varieties With the continuous promotion of drug trial reform, the process of innovative drugs is also accelerating, and innovative drugs and high-end imitation become the key content in the next stage According to the requirements of the plan, in terms of the industrialization of key technologies of high-end new drugs, more than 10 innovative drugs should be industrialized in three years; through the listing of domestic first generic drugs or biological similar drugs, the drug consumption expenditure should be reduced by more than 5 billion yuan / year; the sales volume of preparations in the European and American markets should reach more than 1 billion US dollars, and the new drug registration should achieve zero breakthrough In the treatment of major diseases such as tumor, cardio cerebrovascular disease, diabetes, immune system, virus and drug-resistant bacteria infection, we will promote the development and industrialization of targeted, highly selective and innovative drugs with new mechanism of action Promote the industrialization of chemical drugs of category 1-2 (new compounds and improved drugs), traditional Chinese medicine of category 1-6 (including ethnic medicine) and new classic famous formula products that have obtained new drug certificates or applied for new drug production since 2015, and the first bio medicine on the market in China In terms of major generic drugs, we will encourage the development and industrialization of the first chemical generic drugs and biological similar drugs with great market potential and high clinical value when their patents expire, promote the industrial upgrading of products through the consistency evaluation of quality and efficacy of generic drugs, improve the level of production process intelligence and green manufacturing, improve production efficiency and product quality, and reduce medical expenses As of December 6, 45 acceptance numbers had applied to CFDA for conformity assessment through bioequivalence test, 10 applications had been transferred from local drug administration to General Administration, 15 applications had been transferred from overseas listing to domestic listing, and 9 applications for withdrawing generic drugs had been reported again according to conformity assessment standard Not long ago, chinda Tianqing's tenofovir dipivoxil was approved as a chronic hepatitis B indication, becoming the first preparation variety in China to pass the consistency evaluation, and two first imitations of colun were also approved during this period At the end of November, the on-site inspection of the first batch of generic drug conformity evaluation varieties has also started Some securities institutions predict that 87 products in the first batch will be certified for conformity assessment of generic drugs It can be seen that under the support of policy change, generic drugs have gradually entered the realization period In addition, for internationalization, it is planned to build an international standard production base for new drugs and major generic drugs according to the requirements of drug registration and production in European and American markets We should develop one belt, one road market and encourage vaccine enterprises to build international production bases according to the requirements of WHO quality certification Accelerating the import of high-end medical devices and drugs is one of the nine key areas For high-end medical devices, through the implementation of the plan, more than 10 innovative medical devices should be achieved to fill the domestic gap; more than 10 domestic high-end medical device brands should be upgraded, with significantly improved quality and performance, and the sales volume of the same products should be in the top three market shares; leading medical device enterprises should be cultivated, with sales revenue of more than 2 billion reaching more than 10   Focusing on the construction requirements of healthy China and the development direction of medical device technology, we will focus on high-end medical devices with large usage, wide application and high technology content, encourage the industrialization of innovative products mastering core technology, promote the transformation of scientific and technological achievements, fill in domestic gaps, promote the upgrading and upgrading of a number of key medical devices, improve the quality and performance, improve the stability and reliability of products, and give full play to The leading role of large-scale enterprises and the cultivation of domestic famous brands In the field of high-end medical equipment, the pace of import substitution has not stopped From the national policy level, including healthy China 2030 and made in China 2025, key requirements for localization of high-end medical equipment have been put forward The three-year action plan is the five main development aspects of high-end medical equipment, including imaging equipment, treatment equipment, in vitro diagnostic products, implant intervention products and specialized technical service platform It is encouraged to fill in the gaps in China, including PET-MRI, ultrasound endoscope, laparoscopic surgery robot, neurosurgery surgery robot and laboratory wide automated inspection and analysis pipeline (TLA) In fact, with the help of domestic policies in recent years, the support for local medical equipment enterprises has been increasing, which is gradually becoming a new favorite of investors According to incomplete statistics of e drug managers, from October 1, 2016 to September 30, 2017, the number of disclosed medical device financing cases was 136, with a cumulative amount of 10.77 billion yuan In terms of quantity, it is second only to biotechnology and medical services And the cumulative financing amount follows biotechnology, ranking the second in all pharmaceutical sub industries Insiders told E drug managers that the quality of domestic medical equipment enterprises is scarce, and the entire primary market has already seen a relatively large bubble Some investment institutions are less involved in the field of medical and health industry, and they believe that medical equipment will be easier to understand than more complex new drug projects