Development History Of GV-971

- Dec 31, 2019-

Development history

In 1997, geng meiyu GV-971 R&D team found effective substances through drug screening .

In July 2006, it obtained the approval of Chinese drug clinical trial .

In December 2007, start Ⅰ period clinical research in China .

In December 2009, green valley was awarded the global development license for phase 971® .

In August 2013, Complete Ⅱ period clinical research for 971®.

In 2014, cooperating with iqvia , Shanghai mental health center, Peking union medical college hospital, such as 34 of 3 armour hospital for international multicenter drug AD research experience of clinical researchers, start the clinical Ⅲ phase of the study.

In July 2018, the complete clinical Ⅲ study .

In October 2018, China submitted the application for new drug listing and production registration.Ⅲ period clinical results in the 11th international conference on AD clinical research (CTAD) disclosed for the first time.

In November 2018, the application for listing registration of new drugs was accepted by CDE.

In October 2019, the results of the mechanism of action study in issue 971 ® were published as a cover article in Cell Research .

In November 2019, the state drug administration (NMPA) officially approved the launch of phase 971 ® (mannose sodium capsule) in China.

China's original drug for treating alzheimer's disease, phase 971, officially went on sale in the country on DEC 29, 2019.


Innovative features

This drug is the first Chinese and international new drug for alzheimer's disease treatment targeting the brain-gut axis. Behind the logic of its development is a new understanding of the pathogenesis of alzheimer's disease. The theory behind most of the new alzheimer's drug trials, backed up by five drugs previously on the market, is that beta-amyloid deposits in the brain trigger inflammation that damages neurons and leads to alzheimer's. However, clinical trials of drugs developed to target beta-amyloid showed that their clinical efficacy was not significant.

The team has come up with a new understanding of the pathogenesis of alzheimer's disease: neuroinflammation caused by intestinal flora disorders is an important pathogenesis of alzheimer's disease.


Geng meiyu (front row, first left) from Shanghai institute of materia medica, Chinese academy of sciences, takes a photo with researchers from green valley pharmaceutical research institute

Geng meiyu (front row, first left) from Shanghai institute of materia medica, Chinese academy of sciences, takes a photo with researchers from green valley pharmaceutical research institute.