恩華藥業(002262.SZ):收到1類化學藥品NH104片的藥物臨牀試驗批準通知書
格隆匯6月4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NH104片2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。
NH104爲新一代治療失眠及抑鬱症伴失眠的創新藥。臨牀前試驗結果表明,它具有較強的抗失眠及輔助抗抑鬱藥效,安全性和藥代動力學特性良好。NH104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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