Behind Tu Youyou's Nobel Prize: Chinese Medicine Approval Now Marginal Risk

On the evening of October 5, Sweden's Karolin Medical College announced in Stockholm that it would award the 2015 Nobel Prize in physiology or medicine to Tu Youyou, a Chinese female pharmacist, as well as two other scientists, William Campbell and Da Cunzhi, for their achievements in the research of parasite disease treatment Tu youyou's award is undoubtedly a good thing for the traditional Chinese medicine industry, but the reporter of "daily economic news" noted that the approval of traditional Chinese medicine is on the edge of marginalization "In recent years, the proportion of approved traditional Chinese medicine in the number of new drugs has declined, accounting for only 2.19% last year," Guangyao group said in an interview From the national level to the local government, we should make a combination of efforts to promote the development of traditional Chinese medicine from top-level design, approval process to popularization and promotion " Tu youyou and her artemisinin research attracted a lot of attention for a while after becoming the first native Chinese scientist to win the Nobel Prize for natural science "Artemisinin is a gift from traditional Chinese medicine to the people of the world." Tu youyou said in an interview with the media on October 6, "artemisinin research shows that traditional Chinese medicine is indeed a great treasure house and has precious wealth, which needs us to discover, excavate and research." However, the reporter of "daily economic news" noted that due to the lack of evidence-based basis in the source of raw materials, efficacy mechanism, targeting principle and other aspects for a long time, traditional Chinese medicine has been controversial and questioned in the process of going to the world Opponents believe that whether a drug is effective or not should be based on clinical data, rather than on oral communication and inaccurate standard work What's more, in recent years, the examination and approval of traditional Chinese medicine is on the verge According to a group of data provided by Guangyao group to reporters, currently, there are 165000 drug production approvals approved nationwide, of which only 36% are Chinese medicine From 2012 to 2013, the number of approved traditional Chinese medicine accounted for only 6% of the total number of new drugs in that year Among the 501 new drug approvals approved in 2014, there were only 11 Traditional Chinese medicines, accounting for only 2.19% "The status of traditional Chinese medicine is declining." "But now many foreign pharmaceutical companies attach great importance to traditional Chinese medicine and have started research and development It is hoped that through Tu youyou's award, the central government, regulatory authorities and local governments at all levels will attach importance to traditional Chinese medicine and increase the proportion of new Chinese medicine on the market from the policy level, especially the top-level design " In fact, it is difficult to approve new drugs for a long time A general manager of a pharmaceutical listed company in Guangdong Province, who did not want to be named, confessed to the reporter of the daily economic news that whether it is chemical medicine or traditional Chinese medicine, it is about a year before a new drug R & D application is submitted to the State Food and drug administration, and then to the staff of the drug evaluation center to open the documents for trial It will take at least eight years from drug research and development to marketing "It's not something that ordinary small businesses can do Sometimes it doesn't work out in a few years." The general manager said that at present, there are two main types of research and development of traditional Chinese medicine in China, one is scientific research institutions supported by state funds, the other is large enterprises with financial strength, and small and medium-sized enterprises are more willing to produce generic drugs The reporter learned that the R & D of a new drug must consider many factors, such as the feasibility of project approval, approval rate, clinical utilization rate and market prospect, with high investment and risk The general manager said that, if not sure, even if drug companies get new drug approval after a lot of setbacks, the market environment may have changed, and even there are more advantageous drugs In the field of traditional Chinese medicine, authentic raw materials and standardized active ingredients are another key factor affecting drug research and development Mr Wan, a dealer of traditional Chinese medicine in Qingping market, Guangzhou, told the daily economic news that the effective ingredients of traditional Chinese medicine are affected by places of origin, growth cycle, harvest season, processing, storage and other links Now many large enterprises have started to build raw material bases, hoping to solve this problem through unified and standardized management