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恩華藥業(002262.SZ):收到1類化學藥品NH140068片的藥物臨牀試驗批準通知書
格隆匯 03-24 16:10

格隆匯3月24日丨恩華藥業(002262.SZ)公佈,公司於近日收到國家藥品監督管理局覈準簽發的1類化學藥品NH140068片4個規格的《藥物臨牀試驗批準通知書》,並將於近期開展臨牀試驗。

NH140068是一款適於口服的多種神經遞質受體激動劑,爲新一代治療精神分裂症的創新藥。臨牀前試驗結果表明,它可以激動多巴胺、5-羥色胺和痕量胺的相關受體,具有改善精神分裂症陽性和陰性症狀且副作用小的潛力。NH140068源於內部自主研發,公司獨家擁有其知識產權。根據我國藥品註冊相關的法律法規要求,藥物在獲得藥物臨牀試驗批準通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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