"13th five year plan" for new drug development is about to emerge

The new concrete reporter of new drug research and development learned from the meeting that from 2008 to 2014, there were 1501 projects for major new drug creation and development, and the central financial fund was approved to be 13.05 billion yuan, which has successfully completed the "11th Five Year Plan" target "After the mid-term assessment team's investigation, it expressed great affirmation to our achievements." Zhang Yongxiang mentioned that, taking the enterovirus 71 inactivated vaccine developed in China as an example, this vaccine is the first one, which has a good protective effect on the HFMD caused by EV71 At present, it is in the process of new drug approval, and three enterprises in China are applying for it Despite the rapid momentum of new drug research and development in the past year, Zhang Yongxiang pointed out that new drug research and development is becoming more and more difficult, with low success rate and insufficient research and development costs Only 30% of the total number of new drugs on the market are truly profitable At the meeting, experts listed several failed late clinical development new drugs in 2013 and analyzed the reasons for the failure In this regard, Zhang Yongxiang reminded: "in the research and development stage, the efficacy of drugs is always the most important." "At this stage, there are several research and development hotspots to focus on." Some experts put forward their own opinions on the spot First, the research of new drug targets has become the focus and hotspot of basic research The second is the rapid development of antibody drugs, including multi-functional antibodies, complex antibodies, antibody drug conjugates and so on Third, RNAi drugs enter a new round of competition Fourth, the fixed dose of new compound drugs for the treatment of diabetes, hypertension, cholesterol reduction, migraine and AIDS prevention is also one of the research focuses Fifth, the effect of personalized treatment drugs and their accompanying diagnostic reagents is obvious In addition, the new use of old drugs and the repositioning of drugs have also received due attention At the same time, a representative asked, some new drugs look promising, but they are easy to be ignored by the market What should we do? In Zhang Yongxiang's view, most of the foreign students engaged in drug research and development are mostly skilled in foreign countries and less in-depth in the field of circulation "To do research and development is not only to register new drugs, but also to know how to market new drugs Of course, with the improvement of China's international influence, this situation will be less and less " Strengthening the innovation of new drugs for enterprises can be led by two aspects: one is leading by large enterprises, mining and transforming the research power of small and medium-sized enterprises and scientific research institutions, and the other is leading by parks Many representatives expressed great concern about the park planning in the 13th five year plan Experts in the on-the-spot speech mentioned that since the end of the 11th five year plan, major new drug creation projects have added parks, forming three carriers: business incubation base, park and Industry University Alliance At present, a mechanism is needed to link them to undertake tasks together At the meeting, Zhang Yongxiang made a detailed interpretation of the 13th five year plan for the creation of major new drugs "Now, we must strengthen the dominant position of technological innovation of enterprises." He mentioned that the original scientific research system, from the government, university research institutions, enterprises to the market, should now be transformed into three parts: the government, enterprises and the market Universities and research institutions cooperate with enterprises as another branch It is reported that the 13th five year plan will continue to focus on the development strategy, focus on the development of major products, meet important needs, solve key problems of new drugs, and strengthen the combination of industrial chain and R & D chain Specific how to combine, in the end of November or December will be issued relevant draft At the same time, Zhang Yongxiang pointed out that the "13th five year plan" should carry out the cooperative mode of operation mechanism and service mechanism, so as to make these platforms interact The initial consideration for the deployment of key tasks is: first, strengthen the innovation driven development strategy and develop major innovative products The second is to solve the urgent need for access to medicines and serving the people's livelihood Third, we should attach importance to international quality standards and promote the international registration of domestic drugs Through technological breakthrough, we have broken through the technical barriers of international registration, developed new drugs that meet international standards, as well as chemical generic drugs and biological similar drugs, and carried out international multi center clinical research and registration research in developed countries such as Europe and the United States "A successful drug in the world, from the perspective of treatment, should follow the due international standards Only in this way can China go to the world." Shen Jingkang, deputy director of Shanghai Pharmaceutical Research Institute, pointed out In addition, the 13th five year plan for major new drug creation will also consider breaking through core key technologies and developing prospective new technologies Integrate and optimize technical resources, and build a national drug innovation system In addition, it is understood that four of the currently known projects in 2015 are about the research of Ebola virus, whose significance lies in strengthening the demand orientation, solving the strategic reserve of domestic urgent need and drug innovation, and having great significance in the fight against Ebola virus and the construction of China's prevention and control system