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Yesterday afternoon, the Chinese Academy of Sciences and the Shanghai municipal government held a press conference to introduce the research and development of the new drug “phase I” (mannate sodium, code named gv-971). The reporter learned that the drug belongs to the “conditionally approved” drug among the urgently needed drugs and rare disease drugs in China, and is expected to be put on the market within this year, which will bring good news to patients with Alzheimer’s disease (commonly known as Alzheimer’s disease). Where is the new drug? Our reporter interviewed relevant experts. Geng Meiyu, the main inventor of “phase 9-1” and a researcher of Shanghai Institute of pharmacy, Chinese Academy of Sciences, demonstrated the new drug action mechanism model in Green Valley Research Institute. Jin liwang, a reporter from Xinhua news agency, took a picture and asked: “how to treat Alzheimer’s disease in phase 9-1” According to reports, “phase 9-1” can improve cognitive dysfunction by reshaping the balance of intestinal flora, inhibiting the abnormal increase of specific metabolites of intestinal flora, reducing peripheral and central inflammation, and reducing β – amyloid protein deposition and tau protein hyperphosphorylation (both of which are closely related to the pathogenesis of Alzheimer’s disease), so as to improve cognitive dysfunction. This unique mechanism of targeting brain gut axis provides an important scientific basis for the deep understanding of the clinical efficacy of “phase 9-1”. Q: how many patients participated in the clinical trial? A: there were 50 cases in Peking Union Medical College Hospital, 1199 cases in China, and 1199 cases participated in the phase I, II and III clinical trials of “phase I”. The phase III clinical trial was organized by the mental health center affiliated to Shanghai Jiaotong University School of medicine and Peking Union Medical College Hospital. It was carried out by 34 Grade-A hospitals in China. These hospitals ranked among the top ten general hospitals and various specialized hospitals in China, with 269 clinical researchers involved. A total of 818 subjects were observed. Professor Zhang Zhenxin, the main lead researcher of phase 9, phase 1 and phase 3, neurology expert of Peking Union Medical College Hospital, introduced that there were 50 subjects in Beijing Union Medical College Hospital, including 26 in the effective treatment group and 24 in the placebo group. Q: what is the effect of the clinical trial? A: the results of a nine month (36 week) phase III clinical study showed that “phase 9-1” could significantly improve cognitive dysfunction in patients with mild to moderate Alzheimer’s disease. Compared with placebo group, the main efficacy index cognitive function was significantly improved, and the score of cognitive function scale was improved by 2.54 points. “Nine phase one” has the characteristics of rapid onset, continuous and steady improvement, and good safety. The incidence of adverse events is similar to that of placebo group. “All the standards for phase III clinical trials are consistent with international standards.” Zhang Zhenxin said that as the main lead researcher of phase III clinical practice, she should personally understand the situation of each subject, and check the subjects herself every three months. The clinical trial was a randomized double-blind trial. Zhang Zhenxin analyzed the score changes of the subjects when the experiment was still in the blind state. The data roughly divided the subjects into three groups, one group was the score deteriorated, the other group was unchanged, and the other one third of the subjects had obvious improvement. Among them, the score difference of the improved patients is very large, and the maximum difference is as much as 8 points, “this has strengthened my confidence.” Zhang Zhenxin said, “the deposition of amyloid beta protein and hyperphosphorylation of tau protein have been reduced, and the inflammation and immune function have also been improved. The results are really very good.” Q: how long does “phase nine one” take effect? A: there is a significant effect in the fourth week. The “phase 9-1” extremely significantly improves the cognitive impairment function of patients with Alzheimer’s disease. The clinical trial patients have significant curative effect in the fourth week of treatment, and continue to improve steadily. Zhang Zhenxin said that at six months (24 weeks), the scale score curves of the effective treatment group and the placebo group showed a significant difference, just like a “bell mouth”. The score of the effective treatment group showed a straight-line upward trend, while the score of the placebo group decreased linearly. “This can prove that our drug not only works quickly, but also can play a role in regulating the disease, and continuously and steadily improve the cognitive function of patients.” Zhang Zhenxin said. Q: what’s the change in the patient’s condition? A: the 79 year old professor’s brain power has improved significantly. What’s the effect of “phase nine one”. There is a 79 year old professor who often forgets what he has said when giving lectures to his students. He often fails to get to the point when talking to others. He is very stubborn and difficult to communicate with others. After the treatment, his thinking became agile, and the feedback from students improved. He was able to send more than a dozen e-mails every day by using the computer, and he was more concerned about his lover. His memory ability, executive ability, ability to analyze and judge, sense of direction, ability of daily life have improved significantly, the scores of various indicators have been significantly improved, and the evaluation of his family members has also improved significantly. “Although he only took the medicine for nine months during the experiment, his condition continued to improve in two to three years. We have been following up the subjects, and his comprehensive score has increased from 26 points at the time of enrollment to 29 points (out of 30 points) Q: when can general patients use phase 9? A: the drug will be put on the market within the year. According to the introduction, 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 the “nine phase one” listing

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