How Chinese pharmaceutical companies face the internationalization of traditional Chinese medicine


Release time:

2017-03-02

At the end of 2016, Tianshili successfully completed the Phase III clinical trial of FDA in the United States, achieving a major breakthrough in the internationalization of traditional Chinese medicine. Tracing the course of internationalization of traditional Chinese medicine and visiting the track of Tasly's entry into FDA will give people a lot of enlightenment. It will tell people how to face the internationalization of traditional Chinese medicine and how to solve the problem of internationalization of traditional Chinese medicine.

Internationalization: the only way to make Chinese medicine bigger

Traditional Chinese medicine is a treasure of the Chinese nation and has made great contributions to the survival and reproduction of the Chinese nation. However, it is this treasure that has not been able to go to the world in the form of medicine and is recognized by the international pharmaceutical market. Even in China, the sales volume of traditional Chinese medicine is far less than that of western medicine. Statistics show that in 2005, there were nearly 10,000 kinds of traditional Chinese medicine products produced in China, but only 47 had an output value of more than 100 million yuan. Extensive production of traditional Chinese medicine, scattered and complex planting of traditional Chinese medicine, lack of strict and standardized standards of traditional Chinese medicine in the whole industry chain, and the mechanism of drug effect that can not be expressed in modern scientific and technological language and data have seriously restricted the development of traditional Chinese medicine industry. Some people even put forward: Chinese medicine destroyed in Chinese medicine.

Traditional Chinese medicine production mode and concept, so that Chinese medicine has been free in the international medical system, the scope of use is limited to the Chinese circle. In order to become a big medicine, traditional Chinese medicine must go to the world, take a road of internationalization, promote the internationalization of traditional Chinese medicine through the modernization of traditional Chinese medicine, realize the docking of traditional Chinese medicine with the international medical system through the modernization of traditional Chinese medicine, and finally realize the integration of Chinese and Western medicine.

As early as 1996, the State Science and Technology Commission put forward the strategy of internationalization of traditional Chinese medicine, and began to layout since then. As a firm executor and pioneer of the modernization and internationalization of traditional Chinese medicine, Tianshili has experienced hardships and reaped fruits on this road. Today, while Tianshili Compound Danshen Dripping Pills has been successful in the FDA Phase III clinical trial in the United States, its sales volume has also continued to rise from the original tens of millions, ranking first in the sales volume of single varieties of traditional Chinese medicine for many years in a row, and its annual sales volume exceeded 3.3 billion yuan in 2015. Industry experts believe that this phenomenon is no coincidence. It is the internationalization of traditional Chinese medicine that has promoted the continuous improvement of the quality of compound Danshen dripping pills, making the mechanism of its drug action clearer, so that the drug population is more assured and expanding.

The practice of Tianshili's internationalization of traditional Chinese medicine tells people that continuously improving the quality of drugs and interpreting the mechanism of drugs in accordance with international standards will definitely open the door to the international pharmaceutical market, and then make traditional Chinese medicine a world-leading medicine.

Internationalization: Need courage and commitment

As we all know, the current international mainstream drug system mainly includes chemical drugs and biological drugs, and its active ingredients are very clear single ingredients. To this end, the international drug evaluation standards are also set up in turn. However, most traditional Chinese medicines are made by the compatibility of several plants, with as few as a dozen or hundreds of ingredients. It is very difficult to evaluate compound traditional Chinese medicines completely according to the standards of chemical and biological drugs. A well-known pharmaceutical company in Japan once declared a Chinese medicine very close to traditional Chinese medicine to FDA for phase II clinical trials, which was withdrawn due to too much difficulty.

In 1996, the State Science and Technology Commission put forward the strategy of internationalization of traditional Chinese medicine and prepared to select a number of large traditional Chinese medicine enterprises to undertake this important task. At that time, almost no one dared to respond. A former female director of the State Science and Technology Commission recalled at a meeting at which compound Danshen dripping pills passed the FDA phase II clinical trial that at the end of 1996, she met Yan Xijun, chairman of Tianshili, and asked him whether compound Danshen dripping pills could be taken to the United States to try and see if they could withstand the FDA test. Yan Xijun readily agreed to her request at that time, and said: "isn't it just carrying explosive bags? I am a soldier, I will try." Decades have passed, and the director of the year still clearly remembered this incident and praised Tianshili's courage and responsibility at the meeting.

It was Yan Xijun, who compared entering the FDA to carrying explosive bags, who led his team on the road to entering the FDA for 20 years and finally successfully completed the FDA Phase III clinical trial of compound Danshen dripping pills today.

This example tells people that the internationalization of traditional Chinese medicine requires courage and responsibility, and requires a group of aspiring entrepreneurs to persevere through down-to-earth efforts to turn traditional Chinese medicine into a world-class medicine.

Internationalization: Patience and a relaxed atmosphere are required

It has been 20 years since the National Science and Technology Commission proposed the strategy of Chinese medicine going out in 1996, but so far no Chinese medicine has passed the FDA new drug certification and entered the US market. This is a long road, in spite of the twists and turns and hardships, we are glad to see that the enterprises on this road are quietly carrying out a revolution in the industry of traditional Chinese medicine. They describe the magic of traditional Chinese medicine to the world with scientific language and real experimental data. While the internationalization of traditional Chinese medicine is accelerating, we also see that the West is quietly opening a "door". In June 2004, the US FDA issued the "Plant Drug Industry Guide", recognizing the particularity of plant drugs. It is believed that it is necessary for compound Chinese medicine to adopt a policy different from that of chemical medicine.

The internationalization of traditional Chinese medicine is a long and arduous road, often met with some criticism. For the sake of their own interests, some people even do not hesitate to fabricate facts and confuse the public and describe the FDA as a scam. Although misunderstanding and criticism have not shaken our country's determination to adhere to the road of internationalization of traditional Chinese medicine, they have formed a bad influence in the society, so that some people who do not know the truth have doubts about the road of internationalization of traditional Chinese medicine.

The internationalization of traditional Chinese medicine is by no means a matter of any enterprise. It is related to the development of the traditional Chinese medicine industry and whether traditional Chinese medicine can become a major medicine in the world. Traditional Chinese medicine is the most advantageous industry in my country. If its huge medicinal value is excavated through the internationalization of traditional Chinese medicine, it will have practical significance for the rise of the Chinese nation and the spread of Chinese culture. For this reason, we look forward to more Chinese medicine companies taking the internationalization of Chinese medicine as a starting point, referring to international standards, to carry out a technological revolution in the entire Chinese medicine industry chain, so that our Chinese medicine production will be more standardized, the quality will be more controllable, and the efficacy will be clearer and more stable. Although Tianshili Compound Danshen Dropping Pills has successfully completed the FDA Phase III clinical trial, it is close to entering the mainstream pharmaceutical market in the United States. However, we must see that as a multi-component drug, the complexity of compound Chinese medicine is far more than that of general western medicine; although the FDA of the United States has recognized the particularity of plant medicine, there has never been a precedent for compound Chinese medicine to be approved. It should be expected that the collision of Eastern and Western medical concepts will continue, and various problems will be encountered on the road to the internationalization of Chinese medicine.

To this end, we look forward to: more patience, support and encouragement for the internationalization of traditional Chinese medicine.