The strange circle of "model" thinking of drug innovation needs to be broken

Source: the 13th five year plan of the national major new drug development project was recently approved by the expert group in Beijing by the pharmaceutical economic news on July 14, 2015 According to authorities, during the 13th Five Year Plan period, the pharmaceutical industry will develop 30 new drugs, develop and promote 20-30 chemical drugs and high-end preparations, develop 20-30 clinically urgent important varieties, break through 10-15 major core key technologies, and develop 10-15 prospective new technologies This means that the pharmaceutical innovation system and collaborative innovation mode that are in line with the national conditions and with characteristics will gradually form In recent years, the number of approved clinical acceptance numbers has gradually increased Among them, the registration and application of three kinds of new drugs rose in a straight line As the main category of drug development in China, the phenomenon of over declaration of medium level is in the ascendant Under the national strategy of vigorously promoting drug innovation, how to wake up in the dilemma of self-restraint and develop real innovative drugs has become a practical test in front of the industry "The most important thing is to change thinking," Dr Su Yong, executive director and deputy general manager of Shanghai Fudan Zhangjiang biomedical Co., Ltd., told reporters Pharmaceutical innovation is an economic function which contains technical and economic factors It is difficult to achieve good results without changing the mode of innovation thinking to encourage enterprises to change from imitation to innovation " Breaking the path dependence can not be ignored, most of the ideas of drug innovation are still the research and development logic of generic drugs In the first half of 2015, there were 938 application numbers for new drugs in China, including 871 chemical drugs, only 17 traditional Chinese medicines, all of which were oral drugs, and 32 biological products for treatment There are a large number of new drug registrations, but there are not many independent innovations Experts believe that the over application of three kinds of new drugs, although meeting the clinical needs, should be strictly in line with generic drugs in technology Dr Su Yong pointed out that "the most important thing for the state to encourage innovation is thinking For example, under the condition that domestic basic research is not enough to carry out batch original innovation, the R & D strategy of advocating me too drugs is very suitable for the national conditions But if it is not done until the patent expires, at this time, all patent drugs have been reduced in price, and me too drugs need to recover cost through high price, and the time is wrong " Moreover, repeated declaration makes a good R & D strategy face many problems in practice According to Su Yong, "the essence of the massive backlog of drug registration is that there are too few real innovations In my opinion, projects with enough innovation must be based on the global market, and innovation should be reflected in thinking reconstruction and economic transformation " It is reported that by the end of December 2014, of the 16738 drug varieties approved by CFDA, 610 had approved more than 50 drugs, accounting for only 3.64% of all drug varieties, but 56.44% of the total number of approval documents The registration approval of the same drug variety is over repeated, while the overall utilization rate of the approval on sale at the terminal is low Li Dongjiu, senior vice president of Fosun Pharmaceutical Group, said, "if we still follow the drug development strategy of follow-up and imitation, low-level imitation will only further kill the firm's real innovation perseverance and destroy the whole innovation pattern In my opinion, focusing on R & D and efficient innovation are the driving force of enterprise development " In 2014, Fosun Pharmaceutical's R & D investment accounted for more than 6% of the pharmaceutical business revenue, with 125 research projects under development, including 7 registered class 1.1 new drugs and 9 monoclonal antibody drugs under development, he said From the perspective of the R & D mode of Fosun Pharmaceutical, its route is to hold shares by the team of scientists, develop innovation funds, and improve the quality of innovation by cooperating with domestic and foreign advantageous enterprises through an open platform In terms of the number of clinical acceptance numbers approved in the first half of this year, the innovation momentum of enterprises has not decreased Some pessimists think that "at present, there is no way out for drug innovation in China." It is true that pharmaceutical innovation is facing a test, but there are more distinctive views that only innovation can survive "The development of high-quality drugs will promote the price reduction of original research drugs and improve the accessibility of high-quality drugs." Lou Shi, general manager of Bairui Dinghui pharmaceutical research (Beijing) Co., Ltd., previously said that the cost of safe and ineffective drugs is actually more than the actual cost of high-quality drugs What we need to face up to is that many enterprises have an impulse to innovate, which also causes the congestion of drug registration applications The competent department guides the enterprises to declare rationally by increasing the establishment, purchasing services, increasing the registration application fees and other measures "These measures have a positive effect, but they are difficult to cure." The head of a pharmaceutical company said they would prefer to raise the threshold through high standards If the production of 10 enterprises of one variety can meet the market demand, the bidding mode of "one product and two specifications" in many places will make the application more rational The question to be discussed is, if the standards of 10 enterprises are higher, how to deal with it? In order to avoid congestion, it is also a way to report first and review first, but what is better for those who report later than those who report first? All these test the wisdom of reform After drug approval and marketing, we have to face the impact of bidding, admission and prescription Experts said, "drug prices should be classified according to drug characteristics, market competition and government management." Due to the lack of competition in the market for patented drugs and exclusive drugs, the commonly used international negotiation method can be adopted The drugs with high price and large quantity and produced by many companies can return to a reasonable price range through market regulation, which can not only reduce the price of drugs, but also guarantee the supply of drugs Based on this, the same common name adopts the same payment price For different varieties of different enterprises, the service, quality, reputation and other factors are all handed over to the market, doctors and patients for selection The same name varieties are grouped according to the price " In the second half of the year, if the payment price of medical insurance and the price management measures related to generic drugs determine the price difference of generic drugs according to the time of approval one by one, Su Yong judges, "the competition for generic drugs declaration will be more intense, and some small and medium-sized enterprises will choose products declaration more cautiously."