FDA Phase II Clinical Trials of Guizhi Capsules Start well

it is understood that in the first half of this year, Chinese medicine exports continued to grow, with exports reaching US$562 million, an increase of 10.69 percent over the same period last yearChina'sChinese medicineindustry is facing great opportunities for development in the world,the status of Chinese medicinein the world is quietly undergoing profound fundamental changes, but at present, china's internationalization of Chinese medicine is still in the form ofhealth care, food additives exported" In the field of internationalmedicinethe mainstream Chinese medicine is only covered with Chinese mark, if Chinese medicine does not in the form of finished medicine to the market, the internationalization of the market is not much to do, so I think we should consider the internationalization of Chinese medicine how to go the problem," said Xiao Wei, chairman of Kangyuan PharmaceuticalsWith the rapid rise of international plant medicine research, the modernization of Chinese medicine has also entered a complex and arduous stage, and entering the international mainstream market in the form ofmedicineis the real goal of the internationalization of Chinese medicineAs a modern Chinese medicine innovation enterprise, Kangyuan Pharmaceutical simen sits on the responsibility of internationalization of Chinese medicineAccording to reporters, from April this year, Kangyuan Pharmaceuticals' Guizhi-Yu capsule officially started the second phase of FDA clinical trials in the United States, is expected to become the first chinese medicine products in the form of drugs to enter the mainstream U.Sdrug market In the declaration of the U.S FDA project in contact with FDA experts for many years, Xiao Wei led Kangyuan Pharmaceutical sandinalization in the innovation of Chinese medicine and the internationalization of Chinese medicine gradually formed its unique way of thinking Recently, Chairman Xiao Wei in an interview with the media put forward the new ideas of Chinese medicine inheritance innovation, with international standards has been widely concerned by many pharmaceutical professionals For twenty years Kangyuan has been firmly innovative the road of Chinese medicine, in the history of thousands of years of Chinese medicine, there are many classical prescriptions of the efficacy proved to be very good, but there is no denying that the basic theory of traditional Chinese medicine and the current clinical theory of medicine have a great difference, although there are some permeability between the two, but between the two did not find a great decoding For 20 years Kangyuan has been firmly innovative chinese medicine road, Xiao Wei believes that innovation of Chinese medicine is to find common points of clinical theory of Chinese and Western medicine, to find the combination of modern Chinese medicine and Western medicine "password", so he and Kangyuan to do innovative Chinese medicine, is a "decoding" process, that is, "the core components of compound Chinese medicine screening out, the mechanism and action of the target to understand." FDA for the internationalization of Chinese medicine set the threshold, that is, the requirements of Chinese medicine to present a clear group composition and drug mechanism, do not understand this "decoding", the real internationalization of Chinese medicine is difficult to achieve Therefore, Kangyuan in innovative drug research and development and drug quality control standards , are striving to international drug safety standards in line Taking Chinese medicine injection products as an example, Kangyuan has always maintained a principle, with safety as the first standard Kangyuan to strengthen management, from the source of control, the establishment of GAP of medicinal base, in 4 control points to establish a strict SOP (standard operating procedures), with 9 fingerprints map control quality, from medicinal into the factory to separation extraction, mixed filtration, until the finished product, to maintain the product fingerprint map consistency So far, more than 500,000 people have been clinically used in the injection of hot virin, and no serious adverse reactions have Chinese medicine products to get the international mainstream market recognition, Xiao Wei believes that drug varieties and indications choice is also a key factor If a Chinese medicine product can be tested through an FDA clinical trial that can prove that it is effective for a disease in modern clinical treatment and can complement modern clinical medical treatment, the FDA considers the drug to be effective According to reporters, in 1998 Kangyuan to get the Ministry of Science and Technology support of 800,000 yuan of funds, and did not rush to the FDA to declare drugs, but spent three years in Beijing pilot hospital -selective, guizhi capsulecan can treat gynecological endocrine disorders for more than a dozen diseases screened against, and finally only screened an indication, is the gynecological primary pain The indications selected by guizhi capsules effectively fill a gap in the field of Western medicine in the United States At present, the FDA Phase II clinical trial of Guizhi-Yu capsules has started well, and the clinical response is also good, is a bright spot, very promising to become the first in China to obtain FDA approval of the compound Chinese medicine But the adverse factors mainly lie in the pressure of funds, according to the introduction, the second phase of clinical completion needs more than 80 million, the third phase of clinical work down the money is greater, probably need two hundred million, Kangyuan Pharmaceuticals to consider the future project to the capital market to raise Xiao Wei said, Guizhiyu capsule this compound Chinese medicine will do FDA clinical, in response to the call of the Ministry of Science and Technology that year At that time was selected to send 8 Chinese medicine, 7 have been sacrificed, and now only a variety of guizhi capsules continue to do, this is not only a product responsibility, a corporate responsibility, but also the responsibility of the nation