It is learned from the GV-971 Global Strategic Launch and the First Gut-Brain Axis Forum hosted by Shanghai Institute of Materia Medica, Chinese Academy of Sciences (SIMM) on Dec. 29, 2019 that the innovative drug for Alzheimer’s disease (AD)-GV-971 (sodium oligomannurarate) has been officially marketed in China, which is priced at RMB895/box and has attracted much attention of the pharmaceutical practitioners. It is an original Class 1 new drug successfully developed by the research team led by Researcher Geng Meiyu from SIMM and through the joint efforts SIMM, Ocean University of China, and Shanghai Green Valley Pharmaceutical Co., Ltd. for a period of 22 years; it is the world’s first Class 1 new AD drug developed in China, which targets the gut-brain axis; it fills in gaps in the marketing of new drugs for AD for 17 years. This article sorts out the top 10 concerns of the AD patients and their families about this new AD drug.
I. Is the memory eraser a disease?
The memory eraser disease, i.e., senile dementia, also called AD, is a neurodegenerative cerebral disease that has a highly complex pathogenesis and is extremely difficult to cure.In 1906, Dr. Alois Alzheimer discovered the neurofibrillary tangles accompanied by neurodegeneration and many plaques on the cerebral cortex in the brain of senile dementia patients using brain slice staining techniques, therefore, such nervous system disease was later called Alzheimer’s disease. The research in recent years has proved that the imbalance of the intestinal flora is closely associated with AD and other nervous system diseases. According to scientists, AD has the following characteristic pathological changes: senile plaques deposited and formed by β-amyloid in the brain, and neurofibrillary tangles (NFTs) and neuron losses as a result of the hyperphosphorylation of the tau protein accompanied with glial cell proliferation. However, the pathogenesis and treatment of AD are still a global challenge.
II. How long did it take from the R&D to the marketing of the innovative drug GV-971?
From the time when the research team led by Researcher Geng Meiyu from SIMM started to research China’s first AD new drug GV-971 in 1997 to the official marketing of the drug in China on Dec. 29, 2019, it took 22 years. The R&D history of GV-971 is as shown in the following figure:
GV-971 R&D History
• 1997; The GV-971 research team led by Geng Meiyu discovered the active substance through drug screening
• July 2006; The research team received the clinical trial approval for GV-971
• Dec. 2007; The research team started Phase I clinical study of GV-971 in China
• Aug. 2013; The research team completed the Phase II clinical study of GV-971
• July 2018; The research team completed the Phase III clinical study of GV-971
• Nov. 2018; The new drug marketing application of GV-971 was accepted by the CDE
• Nov. 2, 2019; The NMPA officially approved the marketing of GV-971 (Sodium Oligomannurarate Capsules) in China
• Dec. 29, 2019; GV-971 is officially marketed in China
