(??? 2020? 4? 28? PRNewswire=????) ?? 8?, Shanghai Green Valley Pharmaceuticals, China? ?? ?????(FDA)??? GV-971 ?? ??? ?3? ?? ??? ?? ?? ???(Investigational New Drug, IND) ??? ?? ?? ?? ??? ????. ? ??? ?????? ?? ???? ??? ????? "???? ??(Study May Proceed)"? ???? ??. IND ???? 2020? 4? 3???.

GV-971? ?? ?????, ?? ????? ??? ??? ?? ???? ?????. ? ?? ??? ?? ?? ? ?? ??, GV-971? ?? ????? ??? ???, ? ?? ?????? ???? ????? ?????? ???? ?? ????, ?? ? ?? ??, β-????? ?? ? ?? ???? ????? ????? ?? ??? ????? ??? ????. ?? ?????? ????, ???, ??? ? ?? ????? ?? ??? ??? ????? ??? ??? ?? ???? ??. GV-971? 2019? 11? 2? ??~??? ?????? ??? ?? ??? ???? ??? ????????????(NMPA)? ??? ??? ???, ?? 12? 29? ???? ????.

GV-971? ???, ??, ??, ??? ??(GMC) ? ?? NMPA??? NDA ??? ?? ? ??? ?? ?3? ?? ??? ??? ??? ??? ??? ??? ???? ????, Green Valley? ?? ??? ?3? ????? ?? IND ???? FDA? ?? ????, ?? ??? ???. ?? ?? ? ?? ?????? ???? ??? ??? ?? ? ?? ?? ??? ??? ????.

GV-971 ?3? ????? ???? ?? Green Valley? ???? ??? ???? ?? ??? ???? ?? ??(contract research organization, CRO)? IQVIA(? Quntile)? ??? ??? ????. ??-??? ?????? ?? 2,000? ??? ????, 12??? ???? ?? ??? 6???? ?? ??? ??? ?? ??? ??? ? ????? ??, ?? ? ??? ???? ?????? ?? ? 200? ???? ??? ????. ?? ??????????? Bengt Winblad ?? ???(2018?)? ????, ????? ?? ??? ????? ????? ?? ?? ??? ???? Jeffrey Cummings ??? ???? ??? ????, Green Valley? ???????(Scientific Innovation Committee, SIC) ???? ?? ????. ? ??? ?? ???(principal investigator, PI)?? Martin Farlow, Roy Jones, Bruno Vellas ? ? ? ????? ??? ????? ??. ?? ? ?? PI? ??? ?????? ????(Xuanwu Hospital of Capital Medical University)? Jia Jianping ??? ??? ??????(Shanghai Mental Health Center)? Xiao Shifu ??? ???.

?3? ????? 2024?? ??? ????, ?? ?????(NDA)? 2025?? ??? ????.

??: Shanghai Green Valley Pharmaceuticals