Deciphering the first innovative medicine for Alzheimer's disease in China

Ganlute sodium capsule, the first original new drug to treat Alzheimer's disease in China, has been approved for market recently, which fills the gap that there is no new drug in this field in the world for 17 years How difficult is the development of this new drug? What is the significance of breakthrough? What problems can be solved and to what extent can they bring good news to patients? The reporter made further interviews for this purpose Where's new? To re understand the pathogenesis of Alzheimer's disease, "nine phases one" is the first new drug targeting brain gut axis in China and the world Behind its research and development logic, it is a new understanding of the pathogenesis of Alzheimer's disease Previously, the treatment of Alzheimer's disease around the world mainly relies on the five drugs previously listed, and the clinical benefits are not obvious Over the past 20 years, the world's major pharmaceutical companies have invested hundreds of billions of dollars in research and development of new therapeutic drugs, but most of them have failed The theory supporting most of the above new drug trials of Alzheimer's disease suggests that the deposition of β - amyloid protein in the brain causes inflammation, and then damages neurons, leading to the onset of Alzheimer's disease However, the clinical trial results of targeting β - amyloid showed that its clinical efficacy was not obvious Geng Meiyu, the main inventor of "nine phases one" and researcher of Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences, said that after 22 years of research on "nine phases one", the research team came to a new understanding of the pathogenesis of Alzheimer's disease: the neuroinflammation induced by intestinal flora disorder is an important pathogenesis of Alzheimer's disease Ding Jian, academician of the Chinese Academy of engineering and former director of the Shanghai Institute of medicine of the Chinese Academy of Sciences, thinks that if the treatment of Alzheimer's disease is compared to killing mosquitoes, the original idea is to take pictures one by one in the room, and further close the windows at most "Nine phase one" adopts a new idea, to clean up the pollution sources inside and outside the house, so that mosquitoes can not breed Who benefits? For mild and moderate Alzheimer's disease according to the results of three phase clinical trials published, "nine phase one" can improve the cognitive dysfunction of patients with mild to moderate Alzheimer's disease, with the characteristics of rapid onset, continuous and stable improvement, and good safety Alzheimer's disease is commonly known as Alzheimer's disease, once the disease, people's memory, thinking and judgment ability will be like the "eraser" in the mind slowly wiped away According to statistics, there are about 48 million patients in the world With the rapid aging of population in China, the harm of Alzheimer's disease is more and more obvious According to the R & D team, the new drug's phase III clinical trial lasted 36 weeks, and compared with the placebo parallel control group, the cognitive function scale (ADAS COG) score improved by 2.54 points In view of this, some people in the pharmaceutical industry pointed out that, as the treatment of chronic diseases, the effect in a longer period of time remains to be tested In addition, the mechanism of new drugs is still worthy of further study According to the information on the website of the State Food and drug administration, the State Food and drug administration requires applicants to continue the research on pharmacological mechanism and long-term safety and effectiveness after listing, improve the analysis method of oligosaccharides, and submit relevant test data on time In response, Geng Meiyu explained that the team has not formally submitted the long-term carcinogenicity test report of rats, but the relevant data statistics have been completed, and the test has not found any carcinogenic risks related to the drug "According to the routine, the new drug can only be approved after all the materials are submitted However, considering the large and urgent demand for drugs for Alzheimer's patients in China, the State Food and drug administration currently allows the drug to be listed first and the materials to be supplemented within three months." How difficult is that? With the continuous efforts of Ocean University of China, Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences and Shanghai Green Valley Pharmaceutical Co., Ltd., the "nine phase one" R & D team took 22 years to tackle the original new drugs in the "relay run" for 22 years, and finally made a way Geng Meiyu said that for a long time, it was difficult for others to understand the R & D path chosen by the team Even after the "first stroke" in the laboratory, it was unknown whether enterprises could be found to undertake the follow-up huge R & D investment and bear the huge risk of clinical trial failure Lu Songtao, chairman of Shanghai Green Valley Pharmaceutical Co., Ltd., said that although at that time he did not dare to think about when he would succeed, since he was tackling key problems, he had to "fight back and forth" "Relay run" is not only at the R & D end, but also at the approval end The policy basis to achieve "conditional approval" is the drug listing license holder system launched in China since 2016 This is an important part of the reform of drug review and approval system, which speeds up the research and development of new drugs in China and gives new drugs the opportunity to complete and perfect first At the new drug conference, Wu Qing, member of the Standing Committee of the Shanghai Municipal Committee and vice mayor, said that "the success of new drug R & D and its approval for listing in the ninth phase I" is an important sign of the country's continuous strengthening of original innovation Shanghai will fully promote support and help more scientific research teams to put forward more "Chinese programs" and world standards on the way to tackle complex and difficult human diseases Editor in charge: 37