"Nine Phase One" is conditionally approved for listing, and the global Alzheimer's disease treatment field welcomes new drugs after 17 years.

On November 2, 2019, the State Drug Administration conditionally approved the launch of China's original and international first new drug for the treatment of Alzheimer's disease targeting the brain-gut axis, "Phase One", and the global Alzheimer's disease treatment field finally Welcome new drugs after 17 years.

Alzheimer's disease, commonly known as Alzheimer's disease, is a neurodegenerative brain disease. At present, there are up to 50 million patients in the world, and about 20% of Chinese patients. Once sick, people's memory, thinking and judgment ability will be slowly erased by the "eraser" in their minds, which will not only affect their thinking ability, but also affect their life span. The disease is the third leading cause of death for people over the age of 65, after cancer and heart disease.

However, since the discovery of Alzheimer's disease more than 100 years ago, there are only five drugs used in clinical treatment in the world, and the clinical benefit is not obvious. In the past 20 years, major pharmaceutical companies around the world have invested hundreds of billions of dollars in the development of new Alzheimer's disease treatment drugs, but more than 320 drugs that have entered clinical research have failed, and many large companies have announced that they will temporarily withdraw from research and development. Related drugs. The theory that underpins most trials of new drugs against Alzheimer's disease is that beta-amyloid deposits in the brain trigger inflammation, which in turn damages neurons and contributes to the onset of Alzheimer's disease. However, the results of clinical trials of drugs targeting β-amyloid have shown that their clinical efficacy is not obvious.

The "Nine Phase One" research team took a new approach and gained a new understanding of the pathogenesis of Alzheimer's disease: neuroinflammation induced by intestinal flora disorder is an important pathogenesis of Alzheimer's disease. On November 2, the State Drug Administration conditionally approved the application for the listing of a new drug for the treatment of Alzheimer's disease, "for mild to moderate Alzheimer's disease and improving patients' cognitive function". The listing of "Phase 9 and Phase 1" in Chinese mainland 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, and providing a new scheme for the treatment of Alzheimer's disease.

"Jiuzha I" (Sumum mannat, code: GV-971).

"Nine one" is a homophonic sound of 971. The development of the drug began in 1997 and is the first active molecule obtained since the formation of the research team, so it is called 971. "Nine Phase One" is an original new drug that has been successfully developed for 22 years under the continuous efforts of Ocean University of China, Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Shanghai Green Valley Pharmaceutical Co., Ltd.

A total of 1199 subjects participated in the "nine one" phase 1, 2, 3 clinical trials. Among them, the phase 3 clinical trial was carried out by 34 tertiary A hospitals in the country led by the Mental Health Center affiliated to the School of Medicine of Shanghai Jiaotong University and Peking Union Medical College Hospital, and a total of 818 subjects were observed.

The results of a 36-week phase 3 clinical study showed that "Nine Phase I" can significantly improve cognitive dysfunction in patients with mild and moderate Alzheimer's disease. Compared with the placebo group, the main efficacy indicator cognitive function improved significantly. The cognitive function scale (ADAS-Cog) score improved by 2.54 points (p<0.0001). "Nine phase one" has the characteristics of rapid effect, continuous and steady improvement on the cognitive function of patients, and the safety is good, and the incidence of adverse events is similar to that of placebo group.

According to Geng Meiyu, the main inventor of the drug and a researcher at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, the study of the mechanism of drug action shows that the "Nine Phase One" inhibits the abnormal increase of specific metabolites of the intestinal flora by reshaping the balance of the intestinal flora. Peripheral and central inflammation, reduce β-amyloid deposition and Tau protein hyperphosphorylation, thereby improving cognitive dysfunction. This unique mechanism of targeting the brain-gut axis provides an important scientific basis for a deep understanding of the clinical efficacy of "nine phases and one.

We have noticed that the information on the website of the State Food and Drug Administration shows that the State Food and Drug Administration requires applicants to continue research on pharmacological mechanisms and long-term safety and effectiveness after listing, improve the analysis methods of oligosaccharides, and submit relevant test data on time. In this regard, Geng Meiyu explained that the team has not formally submitted a long-term carcinogenicity test report in 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 regular, new drugs need to submit all the materials before they can be approved. However, considering the large and urgent demand for drugs from patients with Alzheimer's disease in China, the State Food and Drug Administration currently allows them to go on the market first and submit supplementary materials within 3 months."

It is understood that Shanghai Green Valley Pharmaceutical Co., Ltd. has made various preparations for production and sales, and the drugs will be put on the domestic market within the year. At the same time, the approval of the "Nine Phase One" quickly gained global attention in this field. The Science (Science) website published the latest report online on the conditional approval of the drug in China on November 5, pointing out that Alzheimer's disease experts The new drug should be greeted with caution and hope. Green Valley will launch a "nine-phase one" post-marketing study and is actively promoting an international multi-center clinical research project, hoping to benefit patients around the world as soon as possible.

"Nine Phase One" is a global original new drug with completely independent intellectual property rights. It has been approved for listing conditionally, making the global Alzheimer's disease treatment field finally usher in a new drug after 17 years, which will be suffered by the majority of people around the world. Alzheimer's disease patients bring good news.