Driven by innovation, comparable to the top 100 pharmaceutical powers in the world

Source: according to the operation data of China's pharmaceutical industry in the first half of 2017 released by the Ministry of industry and information technology on September 1, 2017, the added value of the pharmaceutical industry above designated size increased by 11.3% year-on-year, 1 percentage point higher than that of the same period last year, 4.4 percentage points higher than that of the whole industry, ranking the top of the whole industry The high-level development of pharmaceutical industry, innovation driven strategy should be remembered "Green channel" is the acceleration of drug innovation "In the past, clinical approval documents for children's drug use usually took about two years to obtain Now, this time may be shortened to 4-6 months Since 2016, Bailey has obtained three clinical approval documents for children's drugs " Ding Yang, deputy general manager of R & D center of Sichuan Baili Pharmaceutical Co., Ltd., applauded China's priority review and approval policy Priority review and approval is a specific measure in the new round of medical review and approval reform in China Since the State Council's opinions on the reform of the review and approval system for pharmaceutical and medical devices was issued in August 2015, a new round of reform of the review and approval system for pharmaceuticals in China has begun, and the State Food and Drug Administration (CFDA) and relevant departments have made every effort to accelerate the reform In February 2016, CFDA issued the opinions on priority review and approval for solving the backlog of drug registration applications On the one hand, it accelerated the review and solved the backlog of review and approval; on the other hand, it opened up a "green channel" for innovative drugs and clinically urgent drugs for priority review According to the latest data of CFDA, China has basically eliminated the backlog of drug registration applications, and the number of drug registration applications waiting for review has decreased from 22000 at the peak in 2015 to 6000 The applications for clinical trials of chemical drugs and vaccines and various registration applications for traditional Chinese medicine have been reviewed within the time limit According to other data, as of July this year, more than 200 drugs have entered the priority review and approval process A number of innovative drugs and clinical urgently needed drugs have been put on the market with the help of "green channel" The treatment of systemic juvenile idiopathic arthritis (sJIA) with trodzumab injection (Roche) is one of the beneficiaries of the review and approval reform After entering the "green channel" in 2016, topuzumab injection obtained the priority approval of phase III clinical trial exemption, and was listed in advance eight months later, becoming the first biological preparation approved for the treatment of sJIA in China Priority review and approval has greatly stimulated the enthusiasm of enterprises in R & D Ding Yang said that considering the time of R & D, clinical application and production application, priority review and approval can squeeze out at least two years, and shorten the R & D cycle of children's drugs to 5-6 years, which greatly reduces the R & D cost of enterprises and helps products to be put on the market quickly "We currently have 17 children's drugs under research The current reform environment has strengthened our confidence in the research and development of children's drugs." Ding Yang said Mah pilot adds vitality to new drug research and development On August 21, CFDA issued the notice on promoting the pilot work of drug listing license holder system, which accelerated the work process of the pilot work of the holder system by means of the holder's multi-point entrusted production, allowing the holder to sell or sell drugs on his own, accelerating the review and approval of the pilot enterprise's declared registered varieties, and improving the drug regulatory responsibilities of the two places The policy dividend released by the regulatory authorities has injected new impetus into innovation research and development and achievement transformation On June 6, 2016, the general office of the State Council issued the notice on printing and distributing the pilot program of drug listing license holder system, and 10 provinces and cities including Beijing, Tianjin, Shanghai and Hebei started the pilot work of drug listing license holder system (MAH) As one of the policies of the new round of drug approval reform, MAH pilot work is highly expected by the industry The industry uses the words "new drug research and development ushered in the best era" to express the excitement As the MAH pilot is to untie the drug marketing license and production license, drug manufacturers, research and development institutions and scientific researchers can become the holders of drug marketing license, and the holders can realize production by means of entrusted production, avoiding the trouble of plant construction This greatly encouraged the enthusiasm of R & D units and drug R & D personnel According to some data, as of May 31 this year, CFDA has accepted 381 applications for registration of drug listing license holders from 10 pilot provinces and cities, of which 142 are research and development institutions, accounting for 37% of the total number of applications, a significant increase compared with previous years According to the data of Shanghai food and drug administration, 12 of the 16 applicants in Shanghai are R & D institutions, accounting for 75% of the total; 22 of the declared varieties are entrusted to 18 enterprises for production The incentive of MAH pilot to R & D institutions can be seen Applying MAH has also become one of the paths for pharmaceutical enterprises to choose innovative products Nanofloxacin malate API and its capsule of Zhejiang Pharmaceutical Co., Ltd and danorevir sodium API and its tablet, a new hepatitis C treatment drug developed by Zhejiang Geli Pharmaceutical Co., Ltd., have all applied to the holders of marketing license The former was approved in March this year, becoming the first innovative drug benefiting from MAH pilot in China "The speed of innovation and development of pharmaceutical industry in a country or a region depends not only on how much money the government and enterprises have invested, how many technology platforms have been established, but also on whether a policy environment conducive to innovation activities has been formed." Sang Guowei, academician of Chinese Academy of engineering, once said publicly that the competition of industry and innovative drug R & D is essentially the competition of innovation system environment To create a good atmosphere for drug innovation and R & D, we should combine multiple departments and policies to stimulate the enthusiasm of enterprises Recently, Zeng Yixin, deputy director of the national health and Family Planning Commission, revealed that the central government will invest 5 billion yuan in 2018 to support the "major new drug creation" major national science and technology special project (hereinafter referred to as the new drug special project), which is one third of the total investment in the 10 years since the implementation of the new drug special project Since the implementation in 2008, 94 varieties of new drug special support have obtained new drug certificates, 28 of which are class 1 new drugs for the first time on the market, 5 times of the number before the implementation of new drug special support These new drugs play an important role in filling clinical gaps and realizing import substitution in the treatment of 10 major diseases, such as malignant tumors, major viral infectious diseases and autoimmune diseases They are also a sign of the improvement of innovation ability in China Detailed "report card" of new drug special, many enterprises in the top 100 list of pharmaceutical industry are listed among them: Jiangsu Hengrui Pharmaceutical Co., Ltd which has developed apatinib for the treatment of advanced gastric cancer, Jiangsu Haosen Pharmaceutical Co., Ltd which has developed moroninazole for the treatment of viral infectious diseases, Jiangsu Xiansheng pharmaceutical Co., Ltd which has developed eramod for the treatment of rheumatoid arthritis Company The coincidence of this "honor list" and the top 100 list of industry highlights the driving force of innovation drive for national innovation, enterprise development and industrial construction Innovation driven sound policies have exploded in the past year From May 11 to 12 of this year, CFDA issued four documents for comments: relevant policies on encouraging innovation of medical devices to accelerate the review and approval of new medical devices on the market, relevant policies on encouraging innovation of medical devices to reform clinical trial management, relevant policies on encouraging innovation of medical devices to implement full life cycle management of medical devices, and relevant policies on encouraging innovation of medical devices to implement full life cycle management of medical devices Relevant policies to encourage innovation of pharmaceutical and medical devices to protect the rights and interests of innovators Four "incentives" directly refer to the acceleration of pharmaceutical innovation and evaluation, which are heartened by the whole industry China's innovation and R & D policies are also in full line with the world's pharmaceutical powers On the one hand, CFDA issued a document to encourage overseas unlisted new drugs to carry out clinical trials at home and abroad simultaneously, so as to shorten the time for new drugs to be listed at home and abroad; on the other hand, China's accession to the international human drug registration Technology Association (ICH) also requires China's pharmaceutical industry to implement the highest international standards This series of policies and measures to encourage innovation will benefit the industry and the people "Chinese pharmaceutical companies and foreign companies are on the same track," Sang said