The current situation of new drug research and development in China is mixed. To solve the dilemma, we need to start from many aspects

[market analysis of China Pharmaceutical network] a new drug was born under the driving of real market demand, the guidance of national new drug policy, the continuous influx of capital and the painstaking research of scientists On the one hand, the development of Chinese medicine industry is restricted, resulting in the lack of innovation power; on the other hand, many domestic drugs and generic drugs are difficult to reach the treatment level of foreign original drugs, so patients have to resort to imported drugs (the current situation of new drug research and development in China is mixed To solve the dilemma, we need to start from many sources Picture source: chinapharma Com.) as far as the current situation of new drug research and development in China is concerned, it can be said that the situation is mixed Fortunately, with the acceleration of CFDA's new drug approval process, the seamless connection of overseas cooperation projects, the shortening of clinical application and listing time, CFDA has provided a longer profit period for local pharmaceutical enterprises At the same time, the green light will be given to local pharmaceutical enterprises, and it will be more relaxed to apply for approval and enter the medical insurance catalogue The worry is that compared with the new drug research and development situation in developed countries such as Europe and the United States, China's new drug research and development really has a lot of room for growth For example, at the same time, the research and development of some drugs of the same type, even some countries started later, but could be listed earlier than China The reason is that European and American countries have relatively perfect R & D investment mechanism and complete intellectual property protection system In China, the researchers of innovative drugs have to face the pain points of long research and development cycle, high investment and high failure rate, especially in clinical trials All these make many drugs look forward to and fear, unable to resist the huge cost of developing new drugs New drug research and development is a "comprehensive project", a class 1 new drug, from project initiation to market, needs continuous capital investment "In all links, clinical trial is a long-term, large investment and high risk link." The head of a new drug R & D enterprise in China said that with the design of clinical trials becoming more and more complex, the cost of clinical research is also rising However, there are still a number of enterprises emerging in China, such as Hengrui, Zhengda Tianqing, Baiji Shenzhou, etc Taking Baiji Shenzhou as an example, three products have entered the third phase of clinical trials: PD-1 mAb, Btk inhibitor and PARP inhibitor However, Btk inhibitors were approved by FDA in November 2013 and PARP inhibitors were approved by FDA in December 2014, which also reflected the strength of Baiji Shenzhou in new drug research and development Not only that, the relevant fields in the pharmaceutical industry have also become the goal of many powerful enterprises competing for R & D For example, tumor drug research and development, the author understands that the traditional model of tumor research and development is limited by the genetic factors, biomarkers and other differences between patients, resulting in a high failure rate in the later stage of tumor drug development The biomarker driven drug development model, starting from a large number of cancer patients' genome big data, guided by biomarkers, guides drug development and improves the success rate of clinical trials In addition, after the new drug projects of local pharmaceutical enterprises have sprung up, limited clinical trial resources have become the indisputable place for pharmaceutical enterprises, which is also the key to the success of pharmaceutical enterprises Professionals said that to fundamentally break through the difficulties of domestic new drug research and development, we need to start from many aspects Second, we need to improve and perfect the law and system of intellectual property protection in China to protect the domestic innovative drugs; Third, in terms of investment, we should not only advocate investors to understand the long-term and high-risk characteristics of new drug research and development, reduce the illusion of making fast money and hot money, invest scientifically and reasonably, but also provide long-term support for new drug research and development by relevant departments, including funds and policies In fact, new drug research and development is also an important part of the upgrading from made in China to created in China The current situation that new drug R & D often dies due to lack of funds and guarantee requires us to constantly stimulate innovation power, so that only innovators win and innovators are strong Only in this way can we make the researchers more motivated and the patients spend less money on better drugs.