Song Ruilin: running from heel to heel, the "second array" rises strongly

On the morning of July 16, song Ruilin, executive chairman of China pharmaceutical innovation promotion association, pointed out in his keynote speech that from a historical perspective, China's innovative drug research has stepped into the "parallel" phase of the second array from the "follow-up" of the third array in the past Although there is still a gap with the first front of "leading", China's pharmaceutical innovation is working in this direction Song Ruilin, executive chairman of China pharmaceutical innovation promotion association, made great efforts to integrate the vitality of small and medium-sized companies At present, major countries such as Europe, the United States and Japan have upgraded biomedical technology and its industrialization to national strategy It can be predicted that the biomedical market as a sunrise industry will continue to increase With the gradual change of human disease spectrum, the diseases that threaten human beings have gradually changed from infectious diseases to chronic complex diseases, and the innovation of pharmaceutical enterprises has to develop in this direction Song Ruilin pointed out at the meeting that we have noticed that the global investment in new drug research and development is increasing year by year, but the success rate of new drug research and development is declining According to statistics, the success rate of new drugs from phase I clinical research to final approval and listing is 9.6% on average, and the success rate of R & D of anti-tumor drugs is the lowest, only 5.1% The return rate of R & D of new drugs such as small pharmaceutical companies and bio cutting-edge companies is significantly higher than that of large pharmaceutical companies In view of this, large pharmaceutical companies also pay more and more attention to integrating the innovation vitality of small and medium-sized bio technology companies, which is the general trend Open innovation, capital extending to the front of R & D on the other hand, accelerating the regulatory policy of new drug review and approval to help innovative drug R & D In particular, he reminded, "the pharmaceutical innovation model has put more and more emphasis on open innovation and the innovation vitality of academic institutions and small biotechnology companies At present, there are some academic institutions and small biotech companies in the original research institutions that sell the top 20 drugs in the world " In this context, China's biomedical industry is booming, maintaining a double-digit high growth rate, far higher than the average growth rate of the whole industry At the same time, the intensity of R & D investment in Chinese pharmaceutical enterprises is increasing, such as Hengrui, Fosun, Shiyao, Xinda and other representative enterprises The proportion of R & D investment in revenue has exceeded 10% From the perspective of pharmaceutical innovation, R & D investment is limited by 10% Although the absolute value cannot be compared with Pfizer, Roche and other multinational pharmaceutical enterprises, the increasing R & D investment of local pharmaceutical enterprises brings new hope to the development of the industry, which witnesses the rise of local enterprises Since 2008, the implementation of major science and technology projects of "major new drug creation" has greatly promoted the enthusiasm of pharmaceutical research and innovation, and the approval rate of new drugs has significantly increased compared with that before 2008 Up to now, there are 44 first-class innovative drugs According to the statistics of CDE, the acceptance of various drug registration applications in 2018 is significantly higher than that in the past three years A total of 264 applications for registration of class I innovative drugs were accepted, an increase of 21% over 2017 The degree of globalization of innovation is also increasing Eight GLP platforms helped Chinese pharmaceutical enterprises submit more than 300 overseas ind applications Among them, a new class of drug, losartan capsule, was approved for marketing, which is the first "first in class" innovative drug developed and incubated in China and first approved by China The birth of a new class of new drugs, benwemod, as a "global new" initiative in China, means that the innovation driven biomedical industry is undergoing a leap forward development In particular, after China's drug regulatory authorities joined the ICH, the evaluation standards were connected with the international standards, which promoted the international cooperation and transfer of innovation projects In terms of capital, it gradually extends to the front-end of pharmaceutical research and development The reform of the capital market, such as the science and technology innovation board, has injected a strong impetus into the innovation of biomedicine, and effectively promoted the seamless docking of China's pharmaceutical innovation industry with domestic and foreign capital Song Ruilin concluded that in the above context, under the joint effect of "4 + 7" and other industrial policies, we have seen both huge market potential and potential innovation risks It can be seen that new changes are taking place in China's pharmaceutical industry.