The internationalization of Chinese medicine

Recently, Fuzheng Huayu Tablets produced by Shanghai Modern Traditional Chinese Medicine Co., Ltd. have passed the US Food and Drug Administration's clinical trials to give Chinese people confidence in the modernization of Chinese medicine. This is the second Chinese patent medicine after the successful completion of the US FDA Phase II clinical trial for the first time.

Before the completion of the US FDA-phase clinical trials, Fuzheng Huayu tablets have been on the market for 10 years in China and accumulated a large amount of clinical data. It is these data that have attracted the attention of the FDA.

In the face of the dilemma of chronic liver disease treatment, American medical researchers have come up with the best medical research resources in their country and have worked with Chinese medical researchers to tackle the world's problems in reversing liver fibrosis. This cooperation has apparently accelerated the The US passed the FDA phase II clinical trial process and also provided a sample for the Chinese pharmaceutical companies in domestic pharmaceutical companies to attack the US FDA.

In this regard, the analysis of the industry, the internationalization of Fuzheng Huayu film has gone so smoothly, and its key point is the help of American medical scientific research peers. The driving force behind its assistance in China's completion of the trial came from the drug's targeting of the blank spots of liver disease drugs and the selection of blank areas that are difficult to break through in the field of Western chemical drugs. The key figure that contributed to the successful conduct of this study in the United States is Professor Hassanni of the University of California, San Diego.

It is understood that the entire testing process was conducted under strict FDA supervision. In addition to the University of California, San Diego, it also includes nine well-known medical institutions such as the Southern California Liver Disease Research Center, University of California, Davis, and Stanford University Medical School.

Stanley Fushi, general manager of Shanghai Modern Traditional Chinese Medicine Co., Ltd., believes that Fuzheng Huayu Tablets is aimed at the blank field that can not be broken by Western chemical drugs—hepatic fibrosis. The United States now has more than 25 million patients with chronic liver disease. Each year, 500,000 people are hospitalized due to complications. In addition to limited liver transplants, Americans are unable to do this. The fossilization of research interests and challenges is the driving force of these high-end scientists. The blank areas where Chinese medicine companies want to quickly open the international market for Chinese medicines and the chemical drugs are difficult to compete are the main directions for Chinese medicine companies to make a breakthrough.

It has been an indisputable fact that traditional Chinese medicine has been difficult to enter the mainstream markets in Europe and America. This also has its own reasons, mainly due to the ambiguous mechanism of traditional Chinese medicine in treating diseases, and it is controversial in the international medical community. It is understood that currently there are 10 prescription medicines including Compound Danshen Dripping Pills and Xuezhikang in China. They formally apply to the US FDA for testing and certification. Seven of them have entered Phase II clinical trials, and the remaining three are starting Phase I clinical trials.

Even if it is the compound Danshen Dripping Pill that is about to succeed in “eating crabs”, its course of attack is also quite difficult. On December 9, 1997, the drug was officially approved by the FDA's new drug clinical research review (ie, IND review) and entered the phase II and phase III clinical trials. Until 2010, the drug successfully completed the US FDA phase II clinical trial. This process not only cost the researchers 13 years, but Tasly also spent hundreds of millions of dollars to obtain the success of Phase II clinical trials.

In addition, among the other FDA-approved prescription drug products in the United States, except for the successful passage of Fuzheng Huayu Tablets, the other 8 drugs are still not heard.

In the internationalization of Chinese medicine, it is necessary to adopt the strategy of misaligning the development of chemical and biological drugs that are mainstream in Western medicine. Internationally, from the R&D to the market, general new drugs for chemical drugs have to invest billions of dollars and take several decades, and the likelihood of success is only one in six thousandth.

For thousands of years, Chinese medicine has proved clinically effective and non-toxic. It has the advantage that Western medicine does not have in some areas. If companies can fully explore this treasure, they must be strictly and uniformly verified and provide a large number of internationally recognized clinical evidence. It may greatly shorten the time to enter the international market and expand the national pharmaceutical industry.