New Alzheimer's disease drug "nine-phase one" market still needs international phase 3 clinical trials
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Science and Technology Daily, Beijing, December 29 (Reporter Cui Shuang) On the 29th, reporters learned from the "Nine Phase One" global strategy release ceremony that Alzheimer's disease drug "Nine Phase One" was officially launched in China. Patients can purchase from doctors in major specialty pharmacies (DTP pharmacies) nationwide for 895 yuan per box.
According to Xiao Shifu, the lead investigator of the Phase 9 clinical trial in China and professor of mental health center affiliated to the Shanghai Jiao Tong University School of Medicine, 1199 Chinese subjects have participated in Phase 1, 2 and 3 clinical trials respectively; Phase 3 clinical trials were carried out by Peking Union Medical College Hospital and Shanghai Mental Health Center Affiliated to Shanghai Jiao Tong University School of Medicine in 34 tertiary first-class hospitals across the country. A total of 818 subjects have been monitored for medication.
A pure placebo-controlled study of the "Nine Phase One" drug was 9 months. Clinical trial results show that the drug effectiveness rate is 78%, which can continuously and significantly improve patients' cognitive function, and the incidence of adverse events is comparable to that of the placebo group.
After approval, there are many controversies surrounding the mechanism of action. In response, Geng Meiyu, a researcher at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, responded that the research on the mechanism of the "nine-phase one" mechanism has been conducted for more than 20 years. 23 experiments were performed with more than 2,700 mice (referring to a paper published in the Cell Research in September this year). Although the theory of intestinal flora and neurological diseases was not their first proposal, they actually carried out A very important mechanism research.
Geng Meiyu revealed that on December 26, they had submitted the results of the rat's 104-week carcinogenicity toxicity test required for "conditional approval to the market" to the State Food and Drug Administration, and the results showed no rat carcinogenic risk.
Shanghai Green Valley Pharmaceutical Co., Ltd. announced that it plans to invest US $ 3 billion in the future to support real-world research after the "nine-phase one" market launch, international multi-center phase 3 clinical research "green memory", expanded indication research and mechanism in-depth research, etc .; plans Complete international multi-center clinical trials in 2024, and strive to complete the global registration of new drugs in 2025.