Great news for Alzheimer! China's original therapeutic new drugs, phase 9 and phase 1, have been approved for marketing. There is no new drug market in this field for 17 years

November 3, 2019 / BIOON / -- on November 2, 2019, the State Drug Administration approved the listing application of Shanghai Green Valley Pharmaceutical Co., Ltd., a new drug for Alzheimer's disease, phase 9-1 (mannose sodium, code: gv-971), "for mild to moderate Alzheimer's disease, to improve patients' cognitive function" The listing of phase 9-1 in mainland China through the priority review and approval process is the first time in the world, filling the gap of no new drug listing in this field for 17 years This Chinese original and the first new Alzheimer's treatment drug targeting brain gut axis in the world will provide a new treatment scheme for the vast number of Alzheimer's patients Alzheimer's disease (AD) is the third leading cause of disability and death in the elderly after cardiovascular and cerebrovascular diseases and malignant tumors There are at least 50 million Alzheimer's patients in the world, and by 2050, the number is expected to reach about 150 million In 2018, the global cost of treatment and care has reached trillions of dollars, which brings a heavy burden to families and society of patients There are about 10 million people with Alzheimer's disease in China, which is the largest number of patients in the world With the acceleration of population aging, it is estimated that the number of patients in China will reach 40 million by 2050 Since the discovery of Alzheimer's disease more than 100 years ago, there are only five drugs for clinical treatment in the world In the past 20 years, the world's major pharmaceutical companies have invested hundreds of billions of dollars in the research and development of new Alzheimer's disease treatment drugs, and more than 320 drugs entering clinical research have failed Nine phase one ® is a research team led by researcher Geng Meiyu of Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences It has been working hard to develop successful original new drugs in Ocean University of China, Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences and Shanghai Green Valley Pharmaceutical Co., Ltd for 22 years A total of 1199 subjects participated in the phase I, phase II and phase III clinical trials Among them, the three phase clinical trials were carried out by 34 third class A hospitals in China led by the mental health center affiliated to Shanghai Jiaotong University Medical College and Beijing Union Medical College A total of 818 subjects were observed The whole clinical trial is managed by AI kunwei (formerly Kuntai), the world's largest new drug R & D outsourcing service organization The results of a 36 week three-stage clinical study showed that nine stage one ® can significantly improve the cognitive dysfunction of patients with mild and moderate Alzheimer's disease Compared with placebo group, the main efficacy index cognitive function improved significantly, and the cognitive function scale (ADAS COG) score improved by 2.54 points (P < 0.0001) Phase 9 and phase 1 have the characteristics of rapid onset, continuous and stable improvement of cognitive function, good safety, and the incidence of adverse events is similar to that of placebo group According to Geng Meiyu, the main inventor of the drug and researcher of Shanghai Institute of medicine, Chinese Academy of Sciences, the preclinical mechanism of action shows that nine phase one ® can inhibit the abnormal increase of specific metabolites of intestinal flora, reduce peripheral and central inflammation, reduce β amyloid deposition and tau protein hyperphosphorylation, and improve cognitive dysfunction by reshaping the balance of intestinal flora This unique mechanism of action targeting the brain gut axis provides an important scientific basis for the deep understanding of the clinical efficacy of the nine phase one Professor Xiao Shifu, the main lead researcher of phase 9, phase 1, phase 3 clinic and the mental health center affiliated to Shanghai Jiaotong University School of medicine, said: "the current drug treatment of Alzheimer's disease is symptomatic treatment, and there are not many drugs available, which can not delay or prevent the progress of the disease course Based on the new mechanism of action and unique clinical efficacy characteristics of nine phases one, it is believed that the drug can provide a new scheme for Alzheimer's disease treatment " Professor Zhang Zhenxin, the leading researcher of phase IX, phase III and neurologist of Peking Union Medical College Hospital, said: "I have been engaged in the research of Alzheimer's disease for 50 years, participated in the international multi center research of many drugs, and have never found a satisfactory treatment drug for Alzheimer's disease The phase IX, phase III, 36 week clinical trial The results are exciting, and finally let us see the hope and dawn, and feel heartfelt joy for patients and families around the world " Lu Songtao, chairman of Shanghai Green Valley Pharmaceutical Co., Ltd., said: "it is our eternal mission to" only be the most desired drug for human beings " We are very looking forward to the long-awaited clinical benefits of phase IX, phase I, for Alzheimer's treatment The successful R & D of phase IX and phase I can not be separated from the strong support of the state and research institutions at all levels, especially the perseverance and hard work of the R & D personnel represented by researcher Geng Meiyu over the past 22 years " According to reports, Shanghai Green Valley Pharmaceutical Co., Ltd has made preparations for production and sales, and the drugs will be put on the market within the year At the same time, green valley will launch phase 9 post Market Research and real world research, and is actively promoting international multi center clinical research projects, hoping to benefit patients around the world as soon as possible The R & D of phase IX project 1 has been supported by the National 863 program, the National Natural Science Foundation, the national 973 program, the national science and technology major project of major new drug creation, the strategic leading science and technology special project of the Chinese Academy of Sciences (Class A), Shanghai Science and technology plan and other projects Original source: State Drug Administration, Green Valley pharmaceutical