Thursday, January 24, 2013

China produces medicines and relies mainly on modelling The expert claims innovative medicine does not exceed 5 kinds

China produces medicines and relies mainly on modelling The expert claims innovative medicine does not exceed 5 kinds
The core is read at present, the medicines which our country produced, rely mainly on modelling more, autonomous innovation is like as rare as phoenix feathers and unicorn's hornly. China innovative medicine, little, first because scope of the enterprise little researching and developing funds to be limited; Two examine and approve the threshold higher and examining and approving time longly. Global natural medicine, medical plant are developed swiftly and violently, have a bright future, innovate and bring the opportunity to the Chinese medicine. The scientist of our country slaughters Hey Hey finds qinghaosu from the ancient book, and obtain the tallest and biggest award of the world, hope of letting people see traditional Chinese medicine innovates. Recently, a medicines get a kind of new medicine written instructions or comments in the country: The small molecule target is to antitumor medicine - -Eike takes the place of the Buddhist nun with hydrochloric acid. This is an innovative medicine with complete intellectual property right of our country, the insider inspires for it. Before this, the targets used in domestic vast lung cancer patient's treatment all rely on import to antitumor medicine. " eleven five " During this time, national great science and technology is special " great new medicine is formulated " Invest 6,600 million yuan, Chinese medicine innovates and is considered as and in historical best period. However, in national food medicines that were held a few days ago supervise systematic science and supervise and exchange the summit, a lot of experts regret to show, have new medicine of chemistry of the independent intellectual property right, it is still as rare as phoenix feathers and unicorn's horn in our country. How difficultly at present the medicine innovates, the medicines that our country produces rely mainly on modelling. The reporter consults the materials find, a kind of new medicine in the country is only about 20 kinds. The expert introduces, real innovative medicine which has the totally independent intellectual property right of our country, do not exceed 5 kinds. Registered commissioner, Yang Wei of department, of supervision bureau say, research and develop, succeed in a new medicine national food medicines in the world, need 8- 13 hundred million dollars, about 10 years. New medicine study high investment, risky, only about 1/5000 compound becomes medicines finally, medicine innovate somewhat like " Look for a needle in a haystack " . After drug development comes out, should be tested and die out many times. Animal's test result can't totally predict the clinical result, the miss ratio of the second stage of clinical trial of medicine is about 40%, three issues of success rate are 11%. Research and develop for the example with tumour medicine, only 5% can enter the market finally. The man of Shanghai Institute of Materia Medica, China Academy of Sciences is strong in the academician to think, it is a difficult problem in the world that medicines are researched and developed, reach our country specifically, insufficient because of researching and developing group's experience and ability, such difficult problems as the fund is limited, new medicine is difficult to grind and feel sleepy bigger. He says, about 4000 enterprises of pharmacy of our country, most scale is relatively small, it is limited to research and develop the funds. Global ten major pharmacy enterprises account for the global medical gross sales amount above 40%. Three major pharmacy enterprises in U.S.A. account for the medical market of 53% of U.S.A. and medical market of about 20% in the world. And the three medical enterprises of China account for the national medical market and is fewer than 10%. Nowadays, the new round of annexation upsurge has risen in the transnational medicine enterprise. 68 billion of Pfizer purchase favor, Luo 46,800 million dollar wholly-owned to control interest genetic Tyke, 41,100 million dollars of the east of silent sand annex Schering Plough,etc.. Someone predicts, present global ten major medicine enterprises will only have 7 left by 2017. The expert thinks, in the face of the annexation, purchase agitation of world, domestic enterprises should set up the medicine enterprise " super aircraft carrier " as soon as possible ,Lower costs, expand scale, raise new medicine and research and develop efficiency. How long new medicine is listed to examine and approve time, key a threshold is the registration of medicines, but declare and examine and approve time and is too condemned long in new medicine clinical trial of our country. Our country stipulate new medicine declare clinical trial, examine and approve time from 60 day to 90 day. But in fact, most enterprises should wait for one year and get the written instructions or comments. Because of declaring the guide clearly, opaqueness, new medicine researches and develops enterprises and can not " touch the head " . Some stipulate, find out, declare, want, increase newly or repeat, test while being a series of mostly when replying. In addition innovative medicine examine, comment, have inadequate experience and ability deficient, make to grind, leaven dough, face more difficulties of our country innovative medicine too. To registering the deficiency of the field, Yang Wei says: "We need to improve the risk control ability of each link, including researching and developing links, clinical trial links, examining and commenting links etc., the different fields communicate, strengthen cooperation, promote each other in the innovative process actively, strengthen the new medicine clinical trial reporting system to reform. " Fully realize innovative medicine and models medicine technology and examine the difference commented at first, will model medicines and examine and comment examining and commenting and carrying on appropriate differentiation to innovative medicine; Secondly, study and advance supplementarily and apply for the duties and responsibilities to transfer the work, on the premise of ensuring the quality of products, introduce the provincial human resources and handle the quantity enormously and supplementarily and apply for the item, model medicines and examine and comment and vacate the human resources for innovative medicine and high level; In addition, the ones that improved innovative medicine and researched and developed socialised the mechanism progressively. It socialises to be the intersection of medicines and registered applicant and medicines appraise organization discuss on questions of great decision, key technology in specific period that medicine research and develop, form and continue advancing decision of studying, suspending studying, delaying studying etc. to propose on this basis, it is significant to study to innovative medicine. Big vice chairman of Standing Committee of the National People's Congress Sang Guowei points out that there is traditional Chinese medicine potentiality more, "we must realize, 1,300 million Chinese ones take medicine the problem must be solved by China's pharmacy. " The innovative system of medicine of our country is taking shape progressively, combine closely through production, teaching, research, medicine of our country is researched and developed and gone through and improved from modelling to formulating great history that changes. Research and develop, have products of the independent intellectual property right to the national pharmaceutical industry of our country independently, strengthen the market development and research and development after going on the market, make great efforts to train innovative medicine to be the brand medicine of our country. Yang Wei thinks, what medicines of the western many countries innovated and is gone through is such a route: It is the ground floor that innovates first, secondly it is enterprises that innovate, it is the government that innovates again. And our country is just opposite, it is the innovation that government's leading factor makes the research institution first, secondly it is the innovation of state-owned enterprise under government's leading factor, it is the innovation of the small enterprise again, the whole people's innovation down and then. "Enterprise subject of innovation, if development model change, much practice of innovation may will become time and resource meaningless to loss, old way difficult to get rid of imitation medicine. " He says. Recently, Hey Hey finds from the ancient book, qinghaosu can be used for treating malaria that scientists of our country have slaughtered, and obtained the award of American Laske clinical medicine from this. This is up until now, the world-class tallest and biggest award that the biological medical circle of China obtains. Slaughter Hey award-winning that Hey, let people light the hope that traditional Chinese medicine innovate again. Ding Jian thinks, the domestic medicine enterprise is standing at the crossroad that is researching and developing in new medicine, there is innovative difficulty, also there is opportunity for development. The market of natural medicine will be a direction in which the domestic medicine will be researched and developed. It is reported, at present, global natural medicine, medical plant and market of products About 60 billion dollars, the development speed of its market is 10%- 20% of every year, are obviously higher than the growth rate of world medicines market. Yang Wei shows too, our country researches and develops the field in traditional Chinese medicine there are advantages. But he reminds, innovates as to traditional Chinese medicine, does not have good scientific theoretical foundation, enterprises should develop cautiously. Compound traditional Chinese medicine preparation should be summarized first from the clinical practice by the side, prove for being safe and effective, research and develop. Chen Zhu, minister of Ministry of Public Health, says, " closely related to health care industry of our country that new medicine is researched and developed. National great new medicine formulates the special research and development project that should support to ensure having great significance to the people of our country healthily more, especially specially research and develop to medicines of great prevention and cure of disease of the people of our country. "

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