Song Ruilin, President of China pharmaceutical promotion association: great potential for Chinese pharmaceutical innovation

The "4 + 7" volume procurement implemented in 2018 is like a scalpel to reshape the pattern of China's pharmaceutical market and reshape the domestic pharmaceutical industry At the end of September this year, the second batch of bulk procurement was opened, and the nationwide procurement of 25 "4 + 7" pilot drugs was completed, and the price of multiple drugs was lowered again Compared with the lowest purchase price in 2018 in the alliance region, the price to be selected in the pilot project will decrease by an average of 59%; compared with the price level of "4 + 7" pilot project, the price will decrease by an average of 25% This means that the era of high gross profit of generic drugs has gone, and the development of innovative drugs is ushering in the tuyere "The" 4 + 7 "volume procurement has suddenly changed China's inherent procurement mode for more than 30 years, but China's pharmaceutical industry has to face such a form of restructuring In the future, it must be innovators who can take the lead," Song Ruilin, President of China pharmaceutical innovation promotion association, said in an interview with China News Weekly Song Ruilin, President of China pharmaceutical innovation promotion association According to song Ruilin, there are two kinds of pharmaceutical innovation, one is "global new", the other is "improved new" He believes that under the current capacity and environment of China's pharmaceutical innovation, China's "global new" should strive to be on the list, and is expected to produce more "improved new" These "improved new" can not only fill the clinical gap, but also achieve effective drug substitution China News Weekly: "4 + 7" volume procurement has a great stimulating effect on the development of innovative drugs What are the opportunities and challenges for R & D innovation? Song Ruilin: actually, innovative medicine is a challenge to the world To innovate, we must follow the road that our predecessors have not gone through and do what they have not done before From the current pattern of global pharmaceutical innovation, China has been upgraded from the third to the second, but there is still a big gap between China and Europe and the United States This gap comes from many reasons and challenges China's pharmaceutical innovation China is a big country of generic drugs Since 2005, China has incorporated biomedicine into seven strategic emerging industries, especially since the country established the "innovation driven" development strategy, the development of domestic innovative drugs has made rapid progress Since 2008, the establishment of the "major new drug creation" project by the state has greatly promoted the innovation of Chinese medicine and opened a valve for the development of Chinese innovative drugs At present, opportunities outweigh challenges in the development of innovative drugs in China First of all, the 40 years of reform and opening up and the rise of China's economy have created a material, technological and talent foundation for the development of China's innovative drugs Secondly, China adheres to the strategy of opening up to the outside world, that is, global cooperation and diversification, which provides better opportunities for the development of China's innovative drugs; all advanced technologies in the world can come to China at the first time China Newsweek: at present, there is still a big gap between China and foreign countries in pharmaceutical innovation What kind of international cooperation mode is there? Song Ruilin: China is not a strong country in pharmaceutical innovation, so the cooperation mode must be diverse, and there is no fixed mode Cooperation can be technology transfer, merger and reorganization or market share Quoting Comrade Xiaoping's words in those days, no matter the white cat or the black cat, catching a mouse is a good cat So we don't have to worry about what kind of model to use and whether we can succeed or not China Newsweek: the new drug administration law will be officially implemented on December 1, 2019 How will its promulgation affect future pharmaceutical innovation? Song Ruilin: the newly revised Drug Administration Law will play a great role in promoting China's pharmaceutical innovation The main reform highlights in the revision of the drug management law are clearly stipulated in the "two office documents" (opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices) jointly issued by the general office of the CPC Central Committee and the general office of the State Council in October 2017 The new drug administration law has legalized and cultured one of the achievements of China's pharmaceutical regulatory system reform in the past four years, which is a major progress China Newsweek: both the report of the 19th National Congress of the Communist Party of China and the central economic working conference pointed out that China's economy has changed from a stage of high-speed growth to a stage of high-quality development For the pharmaceutical industry, what are the elements of high-quality development? Song Ruilin: as an integral part of China's economic development, the pharmaceutical industry should be as refined as other industries The development of China's pharmaceutical industry must change from a simple quantitative growth to a high-quality growth In the past, clinical drugs in China were not satisfied We vigorously developed the pharmaceutical industry, but we did generic drugs, even low-end generic drugs Now that China has become the world's second largest economy, of course, our goals will change, and the needs and cognitive standards of ordinary people will also change, so we must move towards the track of high-quality development To achieve high-quality development of China's pharmaceutical industry, we need to do two things: first, generic drugs should be equivalent to the original research drugs, and second, innovative drugs should be able to take the lead in the world China's pharmaceutical industry needs to have Chinese enterprises like Huawei as soon as possible, or a group of multinational enterprises headquartered in China, which is the symbol of the high-quality development of China's real pharmaceutical industry In Song Ruilin's view, China is expected to step into the first camp in the world in terms of natural medicine, because traditional Chinese medicine has a unique cultural heritage and foundation in China If it can be successfully transformed into modern natural medicine, it can even lead the world China Newsweek: what innovation trends do you think the biomedical industry has at present, and what direction will innovation develop? Song Ruilin: innovation is like a wave Each wave is higher than the other The content and standards of each wave have changed Our current observation may not be accurate Now immunotherapy has become a focus of the whole pharmaceutical innovation Immunotherapy belongs to biological medicine, but not only biological medicine can do immunity, natural medicine can also From the perspective of natural medicine, chemical medicine and biological medicine, the discovery of artificial compounds (chemical medicine) is becoming more and more difficult There is a foundation for using natural medicine to treat diseases in China, which can be transformed from Chinese herbal medicine, traditional medicine to modern natural medicine Artemisinin is a very successful case From the current research results, a considerable part of natural drugs have immune mechanism, which is in fact the same as PD-1, PD-L1 and cart we heard, and it is worth further exploration In fact, China has the foundation and cultural heritage of traditional Chinese medicine If we find more natural drugs on the basis of traditional Chinese medicine, we can take the lead in the world China News Weekly: what do you think of the innovation of traditional Chinese medicine? Song Ruilin: when we talk about traditional Chinese medicine, we hope that we can draw a line and talk about two things, one is the concept of traditional medicine, the other is the concept of modern medicine If it is traditional medicine, it should be inherited well and conform to the theory of traditional Chinese medicine; if it is to innovate, it must be verified according to the standard of modern medicine, with clinical evidence and evidence-based medicine evidence China Newsweek: what kind of state do you think China's pharmaceutical industry has reached, which is a relatively healthy and balanced state? Song Ruilin: at present, the global pharmaceutical industry has been divided into two groups, one is specialized in making innovative drugs, such as Pfizer, Johnson & Johnson, Bayer, which are specialized in making innovative drugs or patent drugs; the other is to make generic drugs At present, China's pharmaceutical industry is constantly evolving under the new market situation China will not leave generics, but more importantly, it should vigorously promote innovative research and development Editor in charge: Guo Huifen