Domestic anti-Alzheimer's disease new drug to be released by the end of the year

　　Medicine Network November 4th, the treatment of Alzheimer's disease has a new domestic drug On November 2nd the State Drug Administration announced that it had approved the listing of a new drug for the treatment of Alzheimer's disease, glytosodium capsules (product name "Phase 9 One") this original Chinese, internationally first targeted brain-intestinal axis of Alzheimer's disease treatment new drug, can significantly improve the cognitive function of mild to moderate Alzheimer's patients The "Nine Phase One" market fills a 17-year gap in the global field of Alzheimer's treatment without new drugs the State Drug Administration said that the drug is based on marine brown algae extract as raw material, the preparation of obtained low-molecular acidic oligosaccharide compounds, is China's independent research and development and has independent intellectual property rights of innovative drugs, access to major national new drug creation technology major special support The pathogenesis of Alzheimer's disease is very complex, the course of disease is long and the cure is difficult, and the release of this medicine will provide patients with new drug options the State Drug Administration requires applicants to continue to study pharmacological mechanisms and long-term safety effectiveness after listing, improve analytical methods, and submit relevant test data on time reporters learned that since 1997 to the start of research to be approved for listing, "nine period one" before and after the advent of up to 22 years According to the official website of the Shanghai Institute of Pharmaceutical Research of the Chinese Academy of Sciences, "Phase 9 One" has been carried out by China Ocean University, the Shanghai Institute of Pharmaceutical Research of the Chinese Academy of Sciences and Shanghai Green Valley Pharmaceutical Co., Ltd for 22 years, and the research and development has been successful the Shanghai Drug Administration, the approval of the drug to fill the past 17 years in the field of Alzheimer's treatment no new drugs to the market gap, for the vast number of patients suffering from Alzheimer's disease to bring "good news." November 3, the Shanghai municipal government held a major results press conference revealed that "nine phase one" will be put into production on November 7, the first batch is expected to be launched nationwide by the end of December Production is planning to build a new factory, when completed to meet the annual production and sales of 2 million patients is also known as the "eraser in the mind" due to its severe impact on cognitive function Since its discovery in 1906, the pathogenesis and treatment of Alzheimer's disease has remained a world problem for more than a hundred years the world's major pharmaceutical companies over the past 20 years, has invested hundreds of billions of dollars in research and development of new drugs, more than 320 into clinical research drugs have failed 　　"Nine Phase 1" Phase 3 clinical lead researcher, Shanghai Jiaotong University School of Medicine affiliated mental health center Professor Xiao Shifu pointed out that Alzheimer's disease is currently the drug treatment, and there are not many drugs available, can not delay or prevent the progress of the disease 　　A total of 1,199 subjects participated in phases 1, 2 and 3 clinical trials of Phase se Three of the clinical trials were conducted by the Shanghai Jiaotong University Medical School Affiliated Mental Health Center and the Beijing Concord -led 34 tertiary Level A hospitals nationwide, and a total of 818 subjects were observed in a 36-week multicenter, randomized double-blind clinical phase 3 trial, "Phase 1" was able to significantly improve cognitive dysfunction in patients with mild and moderate Alzheimer's disease Compared to the placebo group, the cognitive function of the main therapeutic indicators improved significantly "Phase 9 Phase 1" has the characteristics of rapid effect, sustained and steady improvement of cognitive function, and good safety, adverse event incidence rate is comparable to the placebo group In recent years, the research of gut microbiology and disease has become a hot topic in the field of life science Zhu Shu, a professor at the China University of Science and Technology, points out that the link between intestinal microbiome disorders and a range of neurological disorders, including autism, depression, Parkinson's disease and Alzheimer's disease, is becoming clearer As a result, for these neurological disorders, the researchers' eyes have gradually shifted from the target-to-central nervous system to the study of targeted gut microbiomes or intestinal immune characteristics on September 6 this year, the "Nine One" research team published a paper in the academic journal Cell Research to reveal the research process The team first confirmed a correlation between changes in the gut flora during Alzheimer's disease and to immune cells that were invaded in the brain, and validated the effect of Phase 9 On Cognitive Impairment in Genetically Modified Mice with Alzheimer's Disease study found that in the course of Alzheimer's disease, accompanied by the deposition of A beta and the occurrence of phosphating of Tau protein, the composition of the intestinal flora changes, which in turn leads to abnormal metabolites, abnormal metabolites stimulate peripheral immune inflammation, promote inflammatory immune cells Th1 to the brain, causing the activation of small glial cells in the brain, leading to the occurrence of Alzheimer's-related neuroinflammation, eventually leading to cognitive dysfunction the drug's main inventor, the Chinese Academy of Sciences Shanghai Institute of Pharmaceutical Research, Geng Meiyu, "phase 1" by reshaping the balance of intestinal flora, inhibit the abnormal increase of specific metabolites of intestinal flora, reduce peripheral and central inflammation, reduce beta amyloid protein deposition and Tau protein excessive phosphorylation, thereby improving cognitive dysfunction the approval of the State Drug Administration is written on the "conditional approval" of the listing November 3 press conference, a reporter asked, this is the community is very much needed medicine, conditional approval of the listing is not some work is still in progress? Geng Meiyu introduced, conditional approval is because in the new drug declaration information, the rat long-term carcinogenicity test official report has not been submitted, but the test has been completed, the statistical results have been completed Generally speaking, all the information on a drug is completed before the completion of the concurrent new drug certificate, but the National Drug Administration considering the high demand for Alzheimer's patients, and especially based on the now completed rat cancer test results, indicating that the drug and carcinogenicity has no correlation, so we are allowed to first list, and within 3 months to make up the information she says new drug research is a long-term process that needs to be validated in more patients, and that basic research is now the tip of the iceberg Next will be in accordance with the requirements of the State Drug Administration, to do new drug market evaluation and real-world research, now Green Valley Pharmaceuticals is actively promoting the international phase iii multi-center research, the United States FDA and the European EMA have completed the first pre-defense communication work More than 100 years since the discovery of Alzheimer's disease, the clinical benefits of drugs used in clinical treatment around the world have been less visible 　　"Other drugs are targeted at a single target, and we've taken a completely different path, using a 'holistic view' rather than a headache and a head and foot Geng Meiyu, the main inventor of the "Nine Phase SI" and a researcher at the Shanghai Institute of Drug Research of the Chinese Academy of Sciences, used a picture of the elephant to illustrate the "whole view" innovation, is to do from 0 to 1 breakthrough Unlike the international focus on beta amyloid protein and Tau protein, Geng Meiyu's team revealed a new mechanism for the anti-Alzheimer's disease of the "Phase 9" target brain-intestinal axis "Phase 9 Phase 1" is a oligosaccharide drug extracted from seaweed, which can play its anti-Alzheimer's disease by inhibiting the accumulation of beta amyloid protein, regulating intestinal flora imbalance, and reducing nerve inflammation sugar, an important substance that makes up life, but it has been neglected in scientific research At first, sugar was thought to be an energy substance, it was later found to be a structural substance, and then it was discovered to be an important information substance, which played an important role in the development of some complex diseases Not only the activity of sperm eggs can not be separated from sugar, human body immunity can not be separated from sugar, many tumor patients have also been found in the sugar chain abnormality At the same time, the structure of sugar is very complex, four sugar molecules can form more than 30,000 different sequences, so it is very difficult to do medicine 　　"Since we extracted this oligosaccharides from seaweed in 1997 and established our first laboratory, what exactly is the mechanism of the 'nine-phase-one' mechanism?" We have been questioned by experts Geng Meiyu said Others are making small molecule drugs, and there is no precedent for using sugar drugs to treat Alzheimer's disease, whether it is structural determination, quality control, preparation process, or model building, evaluation system, in vivo metabolic process research, etc In July 2006, the new drug was approved for clinical trials in China, in December 2007, the first phase of clinical research was launched in China, in December 2009, Green Valley Pharmaceuticals was granted a "Phase 9 One" global development license, and in August 2013, "Nine" Phase I "Completed Phase II Clinical Research; In 2014, Green Valley Pharmaceuticals, in cooperation with Ai Kunwei (formerly Kuntai), brought together clinical researchers from 34 hospitals in Shanghai, including Shanghai Center and Beijing Concord Hospital, who have experience in international multi-center anti-AD drug research, and initiated clinical phase III research 　　In July 2018, the clinical phase III study was completed The 36-week Phase 3 clinical results showed that "Phase 9 Phase 1" significantly improved cognitive dysfunction in patients with mild and moderate Alzheimer's disease, and improved cognitive function significantly in the main therapeutic indicators compared to the placebo group, with a 2.54 point improvement in cognitive function scale scores, and a significant effect from the fourth week of treatment, and a sustained and steady improvement in October 2018, in China to submit a new drug market and production registration application Phase III clinical results were first disclosed at the 11th International AD Clinical Research Conference (CTAD) In November, applications for registration of new drugs were accepted by the State Drug Administration, and in October 2019, the results of the "Nine-Phase One" mechanism were published in the form of a cover article in Cell Research 　　"Ultimately, we have to talk with well-regulated clinical trial data Geng Meiyu said they reported to the State administration of of experimental data as many as 179 boxes, 530,000 pages of text Geng Meiyu's joint team found that in the course of Alzheimer's disease, intestinal microflora disorders can induce nerve inflammation in the brain, leading to cognitive impairment In recent years, people's awareness of gastrointestinal flora has gradually deepened Current studies have confirmed that intestinal flora imbalances are closely related to such as autism, depression, Parkinson's disease and Alzheimer's disease 　　The results of the phase-GV-971III clinical study are the closest to a successful anti-Alzheimer's drug in more than 10 years since cholinesterase inhibitors were marketed - Rachel Schindler, a member of the Scientific Committee of the 11th International Conference on Clinical Research on Alzheimer's Disease, has GV-971, with its unique mechanism of action and encouraging cognitive improvement, will hopefully provide a diverse range of treatment options for Alzheimer's patients It is expected that more clinical studies of the drug will be conducted to further verify its multi-target mechanism in clinical patients Eric Rehman, executive director of the , the Bannakind Alzheimer's Institute, a sustainable and stable improvement in patients' cognitive function provides a new approach to Alzheimer's disease treatment We look forward to conducting GV-971 clinical trials in many places around the world in the future, benefiting patients around the world as soon as possible - Jeffrey Cumming, Professor, Cleveland Clinic, USA