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The development pattern of traditional Chinese medicine industry is becoming more and more internationalized

2018-12-29 17:09:17
China's Chemical Drug Development lags behind the West for 40 years

According to statistics, China's drug market will reach 755.6 billion yuan in 2010, an increase of 22% over the previous year. Next year, China is expected to become the third largest drug market in the world. However, in the face of this huge market, relevant data show that only 19 of the more than 6500 new drugs registered in China in 2006 truly belong to China's independent innovation. It is imperative to rapidly enhance the innovative capability of biomedicine in China. But how can we find a breakthrough in the transformation and upgrading of the biomedical industry?

At the 2010 Chinese Pharmaceutical Congress and the 10th Chinese Pharmacist Week held recently, 14 academicians from both academies and more than 2000 experts and scholars from home and abroad gathered together, and many experts focused on the Chinese medicine industry at the same time. Sun Hedao, vice president of Tianshili Group, explained the reasons for this. "The research of chemical drugs in China is about 40 to 50 years later than in the West, but now they have accumulated a lot of research experience and a very strong research team in the West. Even so, western medicine has gradually entered a bottleneck in research and development. It is relatively difficult for China to catch up with the West in chemical drugs." Because foreigners do not have Chinese medicine, and China has a lot of historical research experience, which gives us a very good opportunity, so China may indeed take the lead in the development of Chinese medicine.

Modernization and internationalization of traditional Chinese medicine (TCM) have gone through a long period of 10 years. Under the guidance of national policies, a large number of enterprises are committed to promoting the modernization of TCM, and have made remarkable achievements in the development of pharmaceutical enterprises with Chinese characteristics.

On August 7, 2010, the Tianjin Municipal People's Government and the Ministry of Health jointly convened in Beijing the "Report on the Initiation of the International Alliance of Production, Teaching and Research of Modern Chinese Medicine and the Phase II Clinical Test Results of the United States FDA for Compound Danshen Dropping Pills". They informed the whole country that Tianshili (37.27,-0.23,-0.61%) had successfully completed the Phase II clinical trial of Compound Danshen Dropping Pills in the United States. It is reported that Tianshili is actively preparing for the launch of phase III clinical trials of FDA on a global scale, and strives to make Compound Danshen Dropping Pills the first Chinese patent medicine to be listed as drugs in the mainstream pharmaceutical markets of Europe and the United States in the near future.

This not only opens a new chapter in the history of internationalization of traditional Chinese medicine, rewrites the history that no compound medicine has ever passed in the history of FDA in the United States, but also further proves to the world that modernization of traditional Chinese medicine is a successful way.

Zhuhai picks up shellfish, around the development of internationalization of traditional Chinese medicine, gathers opinions from all sides to feed readers.

Tianshili takes the first step in standardized control of traditional Chinese medicine

To achieve a qualitative leap in the development of traditional Chinese medicine and eventually enter the international market, one of the problems that must be overcome is the standardized production of traditional Chinese medicine preparations. Sun He, vice president of Tianshili Group, who has been engaged in drug development in the United States for many years, admits that there are many difficulties in the standardization of traditional Chinese medicine. Firstly, many enterprises have not established standardized production bases to control the quality of medicinal materials, and there is a lack of talents who are proficient in the administration of pharmaceuticals in different countries. In addition, the most important thing is that because of the multi-component components of traditional Chinese medicine, it also makes the mechanism analysis and experiment of traditional Chinese medicine face the danger which is difficult to control.



Sun He said that because traditional Chinese medicine is a multi-component rock mass, it is easy to handle those with wider therapeutic windows because of its high safety, so even if there is a 10% to 15% error, it does not matter. The so-called narrow therapeutic window means that the range of effective dose and poisoning dose is relatively close. Like digoxin, it is only twice as effective. That is to say, if one dose is effective, two doses of human life will be dangerous. "Individual components like this can be well controlled, but if the multi-component treatment window is also so narrow, it will be difficult to control."

However, the difficulties did not prevent the arduous standardization process of Chinese traditional medicine enterprises.

In August 2010, the compound Danshen dripping pills produced by Tianshili passed the phase II clinical trial of the Food and Drug Administration of the United States (FDA) after 13 years of strict examination and verification, and became the first Chinese traditional medicine preparation certified by the FDA of the United States to be safe and effective. Zhang Lihe, academician of Chinese Academy of Sciences and professor of Peking University School of Pharmacy, said that the success of Compound Danshen Dropping Pills has taken a solid step for Chinese medicine to enter the world. "Because the evaluation criteria of Western medicine are different from our evaluation of traditional Chinese medicine, Compound Danshen Dropping Pills is a good beginning, because many of its practices can be recognized by the FDA of the United States, which can accumulate a lot of experience and make more products more international, I think this is a trend."

Digging the Treasure of Traditional Chinese Medicine by Modern Means

Chen Kaixian, president of Shanghai University of Traditional Chinese Medicine and academician of Chinese Academy of Sciences, put forward on many occasions that we should pay attention to the preservation and inheritance of traditional Chinese medicine and the modernization of traditional Chinese medicine. As a scientist, his main research area is computer-aided drug molecular design. He has a deep research on the relationship between the structure and biological activity of small organic molecules and biological macromolecules.

Chen Kaixian said that Chinese medicine is the scientific treasure house of our country, and it has very important value to solve the health problems facing contemporary human beings. This is recognized by more and more people not only in China but also in the world. Faced with the challenges of many diseases, especially the complex diseases caused by many factors, the thinking of Western medicine has encountered many difficulties. Traditional Chinese medicine (TCM) has been receiving more and more attention because of a series of dialectical treatment ideas, such as advocating the treatment of both symptoms and symptoms, and holistic and systematic treatment.