The research team led by Prof. Meiyu Geng found the potential carbohydrate compound with drug activity.
Clinical trial registration was completed in China on July, 2006
Launched phase I clinical study in China on December, 2007
Green Valley acquired licensing rights for development of GV-971.
GV-971 Phase II clinical trial was accomplished on August.
In 2014, the phase 3 clinical trial was conducted in 34 tier-1 hospitals in China led by Shanghai Jiaotong University Medical School Mental Health Center and Peking Union Hospital, with 818 patients completed the study. The trial was conducted in collaboration with IQVIA (formally Quintiles) and Bracket among other partners.
The ground-breaking of carbohydrate drug manufacturing site in Laoning Province, China, marks a significant milestone for Green Valley’s further development of carbohydrate drug innovation.
Completed phase III clinical trial on July, 2018.
Submitted new drug applications and market authorization to the National Medical Products Administration (NMPA) and Phase 3 clinical trial data was disclosed at the conference of 11th Clinical Trials on Alzheimer's Disease (CTAD) for the first time by Professor Meiyu Geng on October, 2018.
Center for Drug Evaluation, NMPA accepted the application of new drug on November, 2018
Findings of mechanisms of action study were published on the peer-review journal Cell Research as cover story.
GV-971 was approved conditionally by NMPA on November.
GV-971 officially launched the Chinese market on December.
GV-971 received approval by FDA on the IND application for a global multi-center Phase III clinical study on April.
GV-971 received approval by FDA on the IND application for a global multi-center Phase III clinical trial on April and kicked off patient-enrollment process on October.
GV-971 Global Phase III Clinical Trial completed first patient dosed globally on February, initiated in Greater China on May, and completed first patient dosed in Greater China on August.
GV-971 Gets Included in China National Reimbursement Drug List.