Chinese plant extracts have become the main force of Chinese medicine in the near American market!

Since 2001, China's import and export trade of traditional Chinese medicine products has maintained a relatively stable growth The import and export volume has increased from 640 million US dollars in 2001 to 3.37 billion US dollars in 2012 Among them, the export volume of traditional Chinese medicine products has increased from 460 million US dollars in 2001 to 2.5 billion US dollars in 2012, with an average annual growth rate of 16.6%, which is relatively stable In the global scope, more and more emerging markets begin to accept and use traditional Chinese medicine, which means that the influence of traditional Chinese medicine in China is further expanding However, the steady development of China's international trade in traditional Chinese medicine is still inseparable from the promotion of traditional markets such as Europe, North America and Asia Among them, the stable growth of the world's largest pharmaceutical consumer market, the U.S market, is indispensable Rigid domestic demand drives import and export trade The United States is the world's largest consumer market for medical and health products, and also the world's largest demand country for raw materials products The huge industrial demand requires us enterprises to continuously import raw materials from all over the world, including plant-based raw materials For a long time, the United States has been one of the main target markets for the export of Chinese traditional medicine products According to the statistics of China Customs, from 2001 to 2012, the import and export trade of Chinese traditional medicine products to the United States increased steadily, and the import and export volume has increased from US $100 million in 2001 to US $420 million in 2012 Among them, the export volume of Chinese traditional medicine products to the United States has increased from US $70 million in 2001 to US $350 million in 2012, with an average annual growth rate of 15.3%; while the import volume has increased from US $30 million to US $70 million, with an average annual growth rate of only 8.2% The export growth rate is significantly higher than the import From the perspective of export volume alone, from 2001 to 2012, the United States ranked third in the export market of Chinese traditional medicine products Although the emergence of the U.S financial crisis in 2008 has affected the export of Chinese traditional medicine products to the U.S to a certain extent, and the growth rate has slowed down, but from the data of 2011-2012, the import and export trade has seen a recovery growth with strong momentum From the perspective of product structure, China's exports of traditional Chinese medicine to the United States are mainly plant extracts, health care products, traditional Chinese medicine and decoction pieces and other raw materials, with the export volume accounting for about 95%; while the proportion of traditional Chinese medicine products is relatively small, about 4% - 6% Among them, plant extract is the main product category of China's export to the United States, and its export volume accounts for more than 60% in general, and the United States has been ranked first in the export market of China's plant extract products Taking 2012 data as an example, the largest product category of Chinese medicine exports to the United States is plant extracts, with an export volume of US $250 million, accounting for 73.1%; the export volume of health products is US $58.312 million, accounting for 16.8%, ranking the second; the export volume of Chinese medicine and decoction pieces is US $18.797 million, accounting for 5.4%, ranking the third; the export volume of Chinese patent medicine is US $16.306 million, accounting for only 4.7% From the perspective of enterprise composition, from 2001 to 2012, the number of enterprises participating in the export trade of traditional Chinese medicine to the United States has increased from about 500 in 2001 to nearly 631 in 2012 Among them, the number of private enterprises (up nearly six times, to 439) and the market share (up five times, to 50.1%) have increased year by year, the number of state-owned enterprises (down 72.6%, now 97) and the share (down 82.0%, only 12.6%) have continued to decline, while the number of three capital enterprises has only increased slightly (up 9.5%, to 93), accounting for 1.9 times (37.3%) On the whole, the state-owned enterprises once occupied more than 70% of the market share, which has been shared equally by private enterprises and foreign-funded enterprises I believe that in the future, with the further enhancement of domestic private enterprises' R & D and marketing capabilities, their market share is expected to further expand The advantages and disadvantages of dietary supplements are that the market of herbal dietary supplements in the United States has a large scale, and the plant extract products in China have become an important source of raw materials in the American supplement market For some varieties (such as green tea plant extract, resveratrol, ginkgo leaf plant extract, aloe Vera and other products), China occupies the advantages of resources, costs and so on According to the relevant laws of the United States, dietary supplements cannot be reimbursed in the national medical insurance of the United States, but the market access threshold of health products in the United States is low and the market space is large In the long run, the United States is still an ideal export target market for Chinese traditional medicine products, and the market capacity is expected to maintain stable growth In addition, as the history of the use of dietary supplements, it can be used as an important reference when the product is applied for approval of botanical drugs, and many traditional Chinese medicine preparation enterprises can also choose to sell the product as dietary supplements in the United States It should be noted that in recent years, the choice of herbal dietary supplements by American people is more rational Therefore, enterprises should actively understand the market demand and have a specific target in order to make great achievements in the American market From the perspective of the American market, the raw material enterprises in China can not only obtain a lot of profits, but also have no complicated procedures such as registration and approval from the operational level when they sell traditional Chinese medicine products in the form of dietary supplement raw materials in the United States At present, it is a better choice However, it is not a long-term plan for pharmaceutical enterprises to sell Chinese patent medicine products approved by Chinese pharmaceutical administration departments in the name of "dietary supplements" in the United States for a long time Most of the traditional Chinese medicine products exported from China to the United States are used as raw materials for dietary supplements, and the product application channels are relatively simple Therefore, the export volume of Chinese herbal medicine to the United States can be compared with the sales volume of American herbal dietary supplements, reflecting the contribution of Chinese export products in the American dietary supplement industry Data analysis shows that from 2001 to 2011, the proportion of Chinese herbal medicine products exported to the United States has increased from 1.7% in 2001 to 5.2% in 2011 However, it is not difficult to see from the data that Chinese enterprises only assume the role of raw material suppliers in the industrial chain, and more added value brought by dietary supplement products are enjoyed by American pharmaceutical enterprises Therefore, to speed up the pace of entering the field of preparations will be the inevitable choice for Chinese traditional medicine enterprises to seek long-term development in the United States Registration of plant medicine is not a dream With the increasingly prominent clinical therapeutic effect of plant medicine or natural medicine such as traditional Chinese medicine, many countries around the world have launched plant medicine legislation to open up a new channel for the research, development and marketing of plant medicine In June 2004, the FDA of the United States officially released the guidance document "guidelines for botanical products" (hereinafter referred to as the "guidelines"), which did not specifically stipulate or relax the specific requirements for the approval of botanical products, but opened the door for the entry of botanical drugs into the United States Medical and health systems In fact, as early as the FDA issued the guide, Chinese traditional medicine enterprises have begun to conduct beneficial exploration of product registration of traditional Chinese medicine as a "drug" in the United States Due to the strict control of drug approval policy and cautious approval by FDA in the United States, the experience of Chinese traditional medicine registration in the United States as a "drug" is relatively bumpy Huge investment in research and development, long clinical trial cycle and high risk of approval have become the biggest obstacles faced by Chinese Enterprises In this process, we also see that in order to support the continued development of registered projects in the United States, many enterprises have no choice but to carry out social financing, or equity transfer Some enterprises choose to suspend or delay the progress of the project due to capital or other reasons The industry also has doubts about whether the real purpose of project R & D is just "enterprise publicity" However, we should also be pleased to see that some domestic enterprises are still working hard for the registration of traditional Chinese medicine in the United States, and some enterprises have made some achievements For example, Tianshili (46.69, - 0.59, - 1.25%) group's Compound Danshen dropping pill has officially passed the FDA's ind application at the end of 1997 After ten years of efforts, compound Danshen dropping pill has completed phase II test in 2010, and has become the first clinical compound botanical drug in the United States FDA At present, the phase III Global Multi Center test of the drug is officially launched, and it is expected to complete the test by the end of 2013, which is expected to be the first case of compound modern Chinese medicine entering the mainstream market of western developed countries as a drug At the beginning of 2013, LVYE pharmaceutical also successfully completed the phase II clinical research of its main product zhizhikang in the United States, and has started the preparation of phase III clinical research In addition to compound Danshen dropping pills and zhizhikang, there are nearly 10 products in China that are also registered with FDA, such as Kangyuan Pharmaceutical (27.36, - 0.28, -1.01%) Guizhi Fuling Capsule, weimeining capsule of Huayi pharmaceutical, Kanglaite injection of Zhejiang Kanglaite pharmaceutical, longxuexie of Yunhe pharmaceutical, Fuzheng Huayu tablet of Shanghai Modern Chinese Medicine Co., Ltd and two plant medicine products of Hutchison Huangpu, etc I believe that with the enhancement of the strength of Chinese traditional medicine enterprises, more enterprises and more products will join the FDA drug registration and application team [Conclusion] as a whole, the American market is of great significance to the international development of Chinese traditional medicine products According to the current development characteristics of Chinese traditional medicine export enterprises to the United States, the market operation mode, which is dominated by raw material products and targeted at the dietary supplement market, will still exist for quite a long time Among them, the development of plant extract industry will become the main force of international trade of Chinese traditional medicine industry to the United States in the future The transformation from the production of plant extract raw materials to the production of plant extract preparation will also bring more development space for enterprises In addition, it is still a long way to go to further study the drug registration laws and regulations in the United States, and to make Chinese medicine really occupy a place in the mainstream drug market in the United States through the registration of botanical drugs However, many phenomena show that it is no longer a difficult dream for Chinese medicine to be registered as a "drug" and recognized in the United States We hope to see more powerful Chinese enterprises in the field of FDA registration of traditional Chinese medicine Raw material enterprises sell traditional Chinese medicine products in the form of dietary supplement raw materials in the United States, which is still a better choice at present, while Chinese patent medicine products of pharmaceutical enterprises have been sold in the United States for a long time in the name of "dietary supplement", which is not a long-term link > > American supplement management system Chinese traditional medicine products exported to the United States are mainly used as raw materials for dietary supplements, general food and pharmaceutical products Some Chinese patent medicines can be used as dietary supplements, and no preparation varieties have been approved for drug application In the United States, the use history of plant products can be pushed forward to the era of Native Americans (Indians) In the first half of the 19th century, the use of botanical drugs was still quite common In 1820, almost 66% of the medical methods listed in the United States Pharmacopoeia came from plants In the middle of the 19th century, with the establishment of the American Pharmaceutical Association, which focuses on chemical medicine therapy, the chemical synthetic medicine industry began to develop and grow, gradually becoming the leading medicine, and the plant products were gradually regarded as the outdated and outdated products by the American people If plant products are to be used as drugs, they need to be declared according to the registration requirements of chemical drugs, which further accelerates the disappearance of plant products from the market In 1994, in order to strengthen the management of various health care products and plant products such as vitamins on the market, the U.S government passed the dietary supplement health and Education Act (DSHEA), which prevented the FDA from regulating dietary supplements as "food additives" or "drugs", clarified the unclear nature of the previous concept of dietary supplements, and made it clear that plant products for non-medical purposes were Included in dietary supplement management