[heavyweight] China's new drug has emerged

Two photon microscope displayed by Suzhou Institute of biomedical engineering technology, Chinese Academy of Sciences The researchers of Wuhan Youzhi biopharmaceutical Co., Ltd are conducting experiments "There is a high incidence of tumor Why don't we have our own medicine?" "Foreign medicine is too expensive Can cheap domestic medicine achieve therapeutic effect?" "Are these drugs safe?" These questions that doctors often hear best reflect the long-standing concerns of the common people Innovation, effectiveness and safety have become the three questions in front of the development of Chinese medicine Nowadays, with the implementation of major national science and technology projects for new drug creation, the pattern of new drug creation has changed, a number of key technologies and production processes for drug creation have been broken, and innovative drugs independently developed in China have appeared on the stage, not only breaking the monopoly of foreign patent drugs in some fields, but also improving the safety and reliability of drugs Pharmaceutical research and development is gradually moving from imitation to creation, and China is moving forward from a pharmaceutical power to a pharmaceutical power The R & D capacity of new drugs has been greatly improved A number of key technologies for drug creation have made breakthroughs, and the quality of drugs has been significantly improved The innovation capacity of new drugs in China has been internationally recognized as a major national science and technology major project for new drug creation for eight years, with fruitful results Qin Huaijin, director of the office of new drug special implementation management and director of the science and Education Department of the national health and Family Planning Commission, told the Economic Daily that by the end of the 12th Five Year Plan, 90 varieties had obtained new drug certificates, including 24 class 1 new drugs such as EV71 vaccine for HFMD, Sabin polio inactivated vaccine, xidaban and apatinib, five times of the total before the special implementation At the same time, a number of core key technologies have made breakthroughs Qin Huaijin introduced that China has broken through a number of bottleneck key technologies such as preparation of antibody and protein drugs, administration of biomacromolecule drugs, delayed and controlled release preparations of drugs, secondary development of Chinese patent medicine, etc., and gradually realized the transformation from "follow-up" to "parallel" in pre clinical evaluation, vaccine development and other technologies The continuous introduction of new drugs has benefited the Chinese people After breaking the monopoly of foreign patent drugs in the fields of lung cancer, leukaemia, drug-resistant bacteria prevention and control, China has the bargaining power in the face of expensive foreign drugs "The listing of domestic small molecule targeted anticancer drug exetane hydrochloride prompted the price reduction of foreign patented drugs by more than 50%, significantly reducing the burden of drug use for patients." Qin Huaijin said that not only that, China's technological transformation of more than 200 kinds of clinically urgently needed varieties, involving 15.3% of the national essential drugs, significantly improved the quality of drugs to meet the needs of the domestic people Since Tu Youyou, a Chinese scientist, won the Nobel Prize, the name of artemisinin has entered the public field of vision This magical Chinese medicine has obvious curative effect on malaria Now, Chinese scientists have extracted artesunate, an extension of artemisinin, which has stronger effect and longer-term curative effect Artesunate, certified by the World Health Organization, has been used abroad to treat 15 million malaria patients China's new drugs not only fill the gaps in China, but also go to the world and make outstanding contributions to human health Chinese medicine is no longer a synonym for "low-end medicine" The R & D and innovation ability of new drugs in China has been internationally recognized, lamotrigine has been approved by the US FDA for listing, risperidone microsphere injection has been approved by the US FDA, and new drug applications have been directly submitted, and di'aoxinxuekang and Danshen capsule have been approved by the EU for listing The emergency drugs, such as palamivir, oseltamivir phosphate, therapeutic antibody of Ebola virus mil77 and recombinant vaccine of Ebola virus, provide important biological safety guarantee for coping with the global emergency - epidemic of infectious diseases The continuous improvement of technological innovation ability also makes the rapid development of China's pharmaceutical industry According to preliminary statistics, the direct economic benefit of new drug projects is 160 billion yuan, which promotes the continuous enhancement of the main position of enterprise innovation In 2015, the R & D investment of Enterprises above designated size is about 45 billion yuan It promotes the formation of relatively concentrated and distinctive biomedical industry clusters in Beijing, Tianjin and Hebei, Bohai rim, Yangtze River Delta, Pearl River Delta and other regions, and accelerates the regional economic development and industrial transformation and upgrading Safety evaluation is in line with the international standards The compliance of Chinese drug non clinical safety evaluation platform is further improved, and the pace of domestic new drugs entering the international mainstream market is accelerated "New drug R & D involves various disciplines, with many links, long cycle and complex innovation activities In the whole chain of R & D process from target determination to product development and marketing, drug non clinical safety evaluation (GLP) is an extremely important link in the necessary stage of new drug R & D." Said sang Guowei, chief engineer of new drug special technology and academician of Chinese Academy of engineering Under the special support of new drugs, a series of major breakthroughs have been made in the construction of China's drug non clinical safety evaluation platform (GLP) The regulatory compliance of GLP platform has been further improved, the management level of the platform has been internationally recognized, and the pre clinical safety evaluation of new drugs has been in line with international standards According to Sang Guowei, 11 platforms in China have passed the AAALAC certification, 4 platforms have accepted and passed the GLP inspection of FDA, 5 platforms have passed the official GLP inspection of OECD member countries, 3 platforms have passed the cap certification, and 9 platforms have been established in accordance with international standards Is / IT system, provantis GLP tox software and LIMS system for data collection and management in laboratory These platforms aim at the forefront of international new technology and methods development, further improve the technical system of non clinical safety evaluation of drugs, and the core key technologies reach the international advanced level Sangguowei said that GLP platform provides standardized technical services for drug R & D enterprises at home and abroad, and has carried out more than 3500 non clinical safety evaluation studies on drugs, providing an important guarantee for innovative drug R & D with independent intellectual property rights in China In addition, eight GLP platforms helped Chinese pharmaceutical enterprises submit more than 300 overseas clinical research applications for new drugs, and promoted a batch of domestic R & D drugs to carry out clinical trials in the United States, the European Union and other places, greatly accelerating the pace of domestic new drugs entering the international mainstream market At the same time, driven by the new drug project, 63 GLP laboratories in China have passed the certification of the State Food and drug administration These flourishing GLP laboratories play an increasingly important role in China's new drug R & D industry chain Some GLP platforms not only carry out the safety evaluation of drugs, but also expand the GLP platform technology to the safety research of pesticides, animal food, veterinary drugs and environmental poisons, which promotes and promotes the normative development of other industries During the 13th Five Year Plan period, the new drug project will continue to focus on the strategic needs of "new drug delivery" and "safety protection", aiming at the current weak links of domestic drug toxicology research, further comprehensively improve the innovation ability and international competitiveness of China's GLP platform, so as to give full play to the "leading" service of new drug R & D innovation chain To grasp the key of consistency evaluation, China should do a better job in consistency evaluation, ensure that generic drugs are consistent with the original drugs in quality and efficacy According to the degree of innovation, drugs can be divided into two levels: innovative drugs and generic drugs China is a big country of generic drugs, but not a big country of generic drugs The phenomenon of low-level generic drugs is serious Some generic drugs have problems such as low quality and weak efficacy Safe use of drugs and meeting clinical needs are the special objectives of new drugs China should invest more in innovative drugs and generic drugs, especially through strict consistency evaluation to obtain high-quality generic drugs In 2015, consistency evaluation was carried out and relevant policy documents were released intensively Li Bo, President of CFDA, said, "consistency evaluation is a hot topic that everyone pays attention to The purpose of consistency evaluation is to keep the quality and efficacy of generic drugs on the market in China consistent with the original drugs, and to replace the original drugs in clinical practice, so as to meet the public's demand for high-quality generic drugs; at the same time, reduce the total expenditure of drugs and eliminate them Backward production capacity, improve the international competitiveness of domestic generic drugs " The "big test" of consistency evaluation has accelerated the pace of survival of the fittest, transformation and upgrading of China's pharmaceutical industry At present, more than 5000 domestic pharmaceutical enterprises that have passed the new GLP certification need platform support except for large enterprises with strong R & D strength The platform advantage of major special support has been fully exerted It uses the technical reserves to support the consistency evaluation work On the one hand, it provides the support for the key technologies and problems needed by the consistency evaluation work of new drugs and generic drugs, and on the other hand, it builds bridges between major domestic scientific research institutes, special support platforms and enterprises to accelerate the promotion of consistency evaluation Price work "In addition, the preclinical safety evaluation platform not only undertakes the important responsibility of the safety evaluation of national innovative drugs, but also undertakes the important responsibility of in-depth study on the toxic effects and toxic mechanisms caused or possibly caused by drugs." Ren Jin, director of the center for drug safety evaluation and research, Shanghai Institute of medicine, Chinese Academy of Sciences, said This year, the consistency evaluation of generic drugs involving thousands of pharmaceutical companies will enter the stage of comprehensive supervision and evaluation Many pharmaceutical companies, such as Sinopharm, Cr Shuanghe and Luoxin pharmaceutical, have said that they are accelerating the evaluation process of quality and efficacy consistency of generic drugs "Whether it's a new drug project or a biomedical industry, it's going through the process from imitation based to the combination of creation and imitation." "The key to innovative drugs lies in innovation, including new targets, new structures and new mechanisms of action, as well as innovation in drug research caused by changes in disease spectrum," said sang The key to generic drug research and development is to strictly do a good job in consistency evaluation Although the task is arduous, we are confident " (economic daily · China economic net reporter Du Fang) (Liang Jingxue)