恩華藥業(002262.SZ):1類化學藥品NH600001乳狀注射液獲批臨牀
格隆匯12月13日丨恩華藥業(002262.SZ)公佈,公司於近日收到國家藥監局核准簽發的1類化學藥品NH600001乳狀注射液的《藥物臨牀試驗批准通知書》。經審查,2021年10月11日受理的NH600001乳狀注射液符合藥品註冊的有關要求,同意該藥品開展用於麻醉誘導和短時手術麻醉的臨牀試驗。
NH600001分子結構與依託咪酯相似,擬開發成與依託咪酯相比具有明顯優勢的短效靜脈麻醉1類新藥。臨牀前研究結果表明,NH600001乳狀注射液保留了依託咪酯麻醉起效快、甦醒迅速、安全窗大、對呼吸和循環系統影響小等優點。同時克服了依託咪酯抑制腎上腺皮質功能的缺點,對腎上腺皮質激素沒有明顯的抑制作用。
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