China News Service, Beijing, April 27th (Reporter Sun Zifa) China's original Alzheimer's disease new drug "Nine Phase One" (Ganlut sodium capsule) has been officially launched in China at the end of 2019, and has recently made new progress-American Food The Food and Drug Administration (FDA) has approved the application of "Nine One One" to conduct an international multi-center Phase III clinical trial in the United States.
The latest news from the "Nine Phase One" R & D cooperation company Green Valley Pharmaceuticals said that on April 8th, Green Valley Pharmaceuticals received an official document from the US FDA that it had approved the original new drug Ganrut sodium capsule (brand name) for the treatment of Alzheimer's disease. "Nine Phase One") International multi-center phase III clinical trial, the approval form will take effect on April 3.
According to industry insiders, a new drug is directly approved for Phase III clinical trials in the United States, which is relatively rare in the past operations of the US FDA. Based on the data of Phase III clinical trials in China, “Phase I Phase I” directly applied to the US FDA for the development of an international multi-center Phase III clinical trial and was approved, which will shorten the drug marketing process and provide more overseas Alzheimer ’s Sick patients bring new hope.
According to the introduction of Green Valley Pharmaceuticals, according to the latest clinical trial plan, the "Nine Phase One" international multi-center Phase III clinical trial plan will be in 12 countries in North America, the European Union, Eastern Europe, Asia-Pacific, and 200 clinical centers in Hong Kong and Taiwan. A 12-month double-blind trial followed by an open trial of 6 months in more than 2000 patients with mild to moderate Alzheimer's disease. The entire clinical study will skip Phase I and Phase II and directly enter the international Phase III clinical trial. It is expected to be completed in 2024 and submit a new drug registration application in 2025.
Jeffrey Cummings, the winner of the Bent Weinbrard Lifetime Achievement Award from the Alzheimer's Disease Association and Professor of the Cleveland Medical Center The trial plan was designed and served as the chairman of the Scientific Decision Committee. IQVIA, the world's largest pharmaceutical clinical trial business company, is responsible for clinical trial management.
Regarding the prospects of Phase III clinical trials of the "Nine Phase One" international multi-center, Ren Zhengjie, CEO of Green Valley Pharmaceuticals, believes that the new coronary pneumonia epidemic will definitely affect clinical trials in the short term, but in the long run, it will not have much impact. Based on the good performance of "Nine Phase One" in China's domestic clinical trials, Ren Zhengjie believes that "Nine Phase One" will eventually be successfully listed globally, benefiting more patients.
"Nine Phase One" is a scientific and technological innovation achievement supported by China's major science and technology special project "Major New Drug Creation". The results of the completed Phase I, II, and III clinical trials in China show that it can continuously and significantly improve patients' cognitive functions. And the safety is good, and the incidence of adverse events is comparable to the placebo group. In early November 2019, the "Nine Phase One" was conditionally approved by the China National Drug Administration for listing, and was officially launched in China at the end of December, becoming the world's first approved new drug for Alzheimer's disease since 2003. (Finish)