Internationalization of traditional Chinese medicine is breaking through

There is a new breakthrough for traditional Chinese medicine to enter the international market Recently, Fuzheng Huayu tablet successfully completed the phase II clinical trial in the United States, and is closer to the goal of entering the prescription drug market Facing the situation that traditional Chinese medicine with unique advantages is hard to find a place in the world pharmaceutical market, more and more domestic traditional Chinese medicine enterprises begin to realize that traditional Chinese medicine must adapt to the "discourse system" of modern medicine and actively explore the way of "modern" traditional Chinese medicine internationalization that can be understood and accepted by all countries in the world, especially western people—— Recently, Fuzheng Huayu tablet, a Chinese patent medicine, has successfully completed phase II clinical trials in the United States, and has been highly recognized by the U.S Food and Drug Administration (FDA) It is expected to become the first compound Chinese medicine approved to enter the mainstream pharmaceutical market in the United States, adding a lot of color to the modernization and internationalization of traditional Chinese medicine In the past 10 years, traditional Chinese medicine has made remarkable achievements in the process of internationalization The standard of Salvia miltiorrhiza developed by China Pharmaceutical [0.10% capital research report] company was included in the US pharmacopoeia, and 5 varieties including Panax notoginseng were included in the European Pharmacopoeia Recently, Xinxuekang produced by Chengdu Di'ao has also completed its registration in the EU In addition, the FDA registration of Chinese patent medicine has also made important progress After the completion of FDA registration of Compound Danshen dropping pill of Tianshili [0.79% capital research report], the phase II clinical experiment of Fuzheng Huayu tablet developed by Shanghai Modern Chinese Medicine Co., Ltd has also been highly recognized by FDA of the United States The international market of water testing has broken through the dialectical treatment ideas of TCM focusing on the whole, treating both the symptoms and the symptoms, and regulating the balance of the body It has been paid more and more attention by the international community "Facing the challenges of many contemporary diseases, especially the complex diseases caused by many factors, western medicine has encountered many difficulties Chinese medicine pays more and more attention to a series of dialectical treatment ideas, such as the whole, treating both the symptoms and the symptoms, adjusting the balance of the body, etc It can be said that the development of Chinese medicine has entered a new period of strategic opportunities " Academician Chen Kaixian, President of China Association of integrated traditional Chinese and Western medicine, told reporters It is understood that the US FDA is organizing experts to study the multi-target therapeutic effect of traditional Chinese medicine Hassanein, a famous liver disease expert of FDA and professor of the University of California, recently came to China to say, "after the success of Fuzheng Huayu tablet test, FDA hired a number of Chinese medicine experts to actively request Chinese medicine enterprises applying for certification to submit Chinese application materials, so as to increase their understanding of Chinese medicine and pharmacology." Some traditional Chinese medicines have successfully entered the mainstream pharmaceutical market abroad Taking Beijing Tongrentang [0.31% capital research report] as an example, 90% of its exports of traditional Chinese medicine are proprietary Chinese medicine Relying on the mode of "taking medicine with medicine", this century old store has opened 74 retail pharmacies in 16 overseas countries and regions, almost every one of which has TCM doctors stationed in the store Through TCM treatment business, TCM sales are driven, and TCM and traditional Chinese medicine have successfully entered the international market "Fuzheng Huayu tablet will start a more rigorous phase III clinical trial as soon as possible It is expected to be sold in the United States as a prescription drug within four to five years " Professor Liu Ping, the inventor of Fuzheng Huayu formula and vice president of Shanghai University of traditional Chinese medicine, told reporters The lack of "traditional Chinese medicine version" in the international standard has hindered the integration of traditional Chinese medicine with the international standard At present, traditional Chinese medicine is mostly registered as a healthy food overseas, and has no drug status as a whole According to the statistics of the State Food and drug administration, the annual sales volume of the world's botanical medicine market has exceeded 20 billion US dollars However, China, as the origin of traditional Chinese medicine, has no corresponding international status In 2012, the export amount of traditional Chinese medicine extracts was only US $1.13 billion, accounting for 48.5% of the export amount of traditional Chinese medicine The export of traditional Chinese medicine and decoction pieces is 700 million US dollars, accounting for only 33% of the export of traditional Chinese medicine Why is it so hard for traditional Chinese medicine to go abroad? "Modernization of traditional Chinese medicine is not easy." Li Daning, former deputy director of the State Administration of traditional Chinese medicine, believes that "traditional Chinese medicine has the unique advantage of multiple targets in clinical treatment, but the backward quality standards, unclear effective ingredients and mechanism of action, poor controllability and other problems also hinder the process of traditional Chinese medicine's integration with the world." According to the directive on traditional plant registration procedure issued by the European Union in 2004, pharmaceutical enterprises need to provide at least 30 years of medical history and at least 15 years of use history in the European Union before they can register and enter the European Union market as drugs The therapeutic effect of traditional Chinese medicine has not been recognized by the international standards and the research methods vary from person to person The concentration of traditional Chinese medicine industry in China is not high, there are no flagship enterprises with the scale of 10 billion yuan, and there are few enterprises with the scale of more than 1 billion yuan "Lack of innovation, low level of repetition, small scale, poor industrial concentration and other problems are the main reasons that hinder the internationalization process of traditional Chinese medicine, so it is necessary to establish a scientific standard of traditional Chinese medicine that can meet international standards as soon as possible." Zhang Boli, academician of the Chinese Academy of engineering and President of the Chinese Academy of traditional Chinese medicine, said In addition, the uneven resources and quality of traditional Chinese medicine are not conducive to the formation of its own international standards In recent years, the supply crisis and quality decline of Chinese herbal medicine resources have aroused widespread concern, the reason is excessive exploitation Zhang Boli suggested that traditional Chinese medicine should be listed as a national strategic resource, to strengthen protection, research and development and rational utilization, to cultivate rare and endangered traditional Chinese medicine artificially, to promote resource recovery; to conduct a general survey of traditional Chinese medicine resources, to strengthen the monitoring of traditional Chinese medicine resources and information network construction; to strictly control the exploitation of traditional Chinese medicine resources, and to strictly export traditional Chinese medicine and extracts according to the degree of scarcity Only when the domestic demand is met, can the products be exported The export of rare products is prohibited At the same time, we should vigorously promote the standardized cultivation of traditional Chinese medicine, and carry out the large-scale standardized cultivation of key traditional Chinese medicine varieties, national essential drug catalog and national medical insurance catalog varieties, so as to ensure the sustainable supply of traditional Chinese medicine and ensure the quality and safety of products Cross border cooperative R & D is a shortcut for domestic pharmaceutical companies to start international cooperation in new drug R & D, promoting cross-disciplinary and even cross-border R & D of traditional Chinese medicine products has become a consensus Nowadays, many domestic pharmaceutical companies have begun to try international cooperation in new drug R & D, and promoting cross-disciplinary and even cross-border R & D of traditional Chinese medicine products has become a consensus in the industry It is understood that the clinical research of Fuzheng Huayu tablet is led by the University of California in the United States, with the participation of 9 American clinical centers The operation of the project follows the international clinical research norms, which can be regarded as the starting point of international cooperation of traditional Chinese medicine According to Zhang Boli, the advantages of traditional Chinese medicine lie in clinical efficacy However, clinical efficacy needs to be expressed with scientific data to be recognized by the international community Chinese traditional medicine enterprises should actively seek interdisciplinary and transnational cooperation, and strive for the international discourse power of Chinese traditional medicine Ren Dequan, former deputy director of the State Administration of traditional Chinese medicine, believed that in order for traditional Chinese medicine to enter the world, modern science and technology must be fully used on the basis of traditional Chinese medicine theory, modern scientific and technological methods should be absorbed, modern research methods, dosage forms and language expressions should be used, so that the western people can understand it and accept it The State Administration of traditional Chinese medicine will also intensify efforts in the standardization construction of traditional Chinese medicine, and provide continuous support for pharmaceutical enterprises in scientific research funds, taxes, price protection, bidding, access to relevant directories, etc Industry insiders said that with the rapid pace of internationalization of traditional Chinese medicine, there are still hidden dangers in low added value, trade barriers, intellectual property rights and other aspects At the same time of strengthening research and development, Chinese medicine enterprises should improve the awareness of intellectual property protection, such as patent application, so as to better go to the international market.