Tea polyphenols: the first herbal medicine to become a prescription drug in the United States

at the International Conference on Scientific and Technological Cooperation of theChinese Medicineon November 28th, cheng Shuxuan of the Chinese Academy of Medical Sciences gave a speech entitled "The first FDA-approved plant medicine Veregen (Tea Polyphenol) ——— basic research to clinical applications" was highly anticipatedHe walked down from the podium, and then by the crowd "blocked", these people have like me want to ask him to "talk" reporters, but also a few years ago in the United States with him has a side of the peer, but also the Beijing Municipal Science and Technology Commission with him to discuss cooperation with the leadership, more hope to communicate with him, negotiate the enterpriseIn October 2006, the U.SFood and Drug Administration (FDA) approved tea polyphenols as a new prescription drug for topical (external) treatment of genital warts caused by the human papillomavirusIt is the first plant (herb) drug approved for the fda under the 1962DrugAmendment Act"This approval proves that the FDA does not just use plants as food and food supplements, but also as a drug," said Freddy Ann Hoffman, M.D., a plant-based drug expert and former FDA officialThis paved the way for the establishment of a new drug industryHe called it "a historic milestone."From Cheng Shuxuan began to study tea polyphenols, to the creation of this "milestone" has been more than 20 yearsUp to now, most people's main concern is: How did tea polyphenols win FDA approval? What's the trick?" There's really no knack"It's the result of a long, complex international cooperation, but every step is natural, and I've never asked for it"
" 1984, we began to study green tea catechins anti-mutation, anti-cancer effect and its mechanism, the results show that green tea catechins have a clear inhibition of skin inflammation, growth, inhibittheed the occurrence of skin papillomas and other effects Later, I presented my findings at an international conference in Hangzhou, and Mitsui Agroforestry Co., Ltd was very interested In 1990, we signed a cooperation agreement with Mitsui to conduct further clinical studies with their support "
lucky, Cheng and his colleagues have had a great success in their clinical studies, and they have started to apply for patents in various countries However, new problems soon arose: patent applications required significant costs, and in the circumstances, Cheng's laboratory simply could not afford it In the following period, Cheng Shuxuan through cooperation with Mitsui Agriculture and Forestry Co., Ltd., in 1998, tea polyphenols applied for and obtained a U.S patent It was subsequently granted patents in many developed countries Recalling this process, Cheng Shuxuan is glad that he has a little "very crude" patent common sense, "so always adhere to: we are not only patent inventors, but also one of the patent holders." By 1999, tea polyphenols had a very critical partnership: a cooperation agreement was signed with MediGene, a German biopharmaceutical listed company, which funded the Clinical Phase II and III trials From 1999 to 2004, MediGene conducted clinical trials of 500 people in Europe and North America, and the results were strikingly similar to those of Cheng and his colleagues in domestic clinical trials Finally, the FDA's complex and rigorous approval process was announced on October 31, 2006, when the FDA approved the listing of tea polyphenols for the treatment of peripheral genital and warts Cheng's co-workers first passed the happy news to him "It's been 17 years since I first met you, 14 years after your first experiment at Hospital, and it's been a long process, and you've finally succeeded," Hara, a Japanese collaborator, said in the letter Reading this letter, Cheng Also is full of emotion "More than 20 years ago, it was just one of my thoughts, and I didn't think it would go all the way to where it comes to success," he said In fact, when MediGene began clinical trials in Europe and North America, I didn't expect it to succeed "
" for more than 20 years, it is a long time, a very complex process, which is mixed with a lot of difficult negotiations, but I have been following the principle of the natural, never strong, do what is of interest to them Cheng said that if there is a knack, "go with the flow" is the know-how Cheng Shuxuan, who calls himself a "bookworm", doesn't understand the "business operation problem" at all "My philosophy is simple, everything is a process of coordination, it's like a bike chain, we're just one of them, and it's the best thing to do well," he said I'm a nerd, only doing research, business problems others come to "
" to this day, everything has succeeded Many people ask me, why don't you all come by yourself, " said the book here, laughing, "say it makes sense, that I also want to make it myself." Where does the funding for long-term research come from? How are clinical trials in Europe and North America completed? 1000 people clinical trials need so much money, where come from? How can we convince the FDA that tea polyphenols are safe and effective without clinical trials in Europe and North America? It's all about it! finally, he summed up the complex process in a very simple paragraph: "This is a combination drug we developed in the 1990s to treat warts, transferred to MediGene, Germany, after years of international cooperation and development, and finally applied for a new drug at the FDA." The invention of this drug stems from our series of experimental and clinical studies for more than 20 years " (Li Yan)