Chinese NMPA approves Alzheimer drug based on gut microbiota improvement

Oligomannate (GV-971: sodium oligomannurarate) developed by Shanghai Green Valley Pharmaceuticals was approved by the NMPA as a drug to improve cognitive improvement of patients with moderate Alzheimer disease (AD). The multi-center randomized Phase III study which led to the approval was done for 36 weeks at 34 first-class hospitals in China on a total of 818 patients with mild to moderate AD between ages 50 to 85. The results showed that oligomannate produced a statistically significant improvement in cognitive function after 4 weeks of administration, and the effect persisted. Oligomannate is thought to improve cognitive function by improving dysbiosis of intestinal microbiota, suppressing abnormal increase of intestinal bacterial metabolites, regulating inflammation of the peripheral and central nervous system, and by reducing excessive phosphorylation of tau, resulting in less deposits of amyloid protein. GV-971 was co-developed by Ocean University of China, CAS Shanghai Institute of Materia Medica (PI GENG Meiyuand Green Valley Pharmaceutical Co.

Japan JST China news, November 12, 2019

Xinhua news release, November 5, 2019

Chinese NMPA approves Alzheimer drug based on gut microbiota improvement
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