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恆瑞醫藥(600276.SH):3類化藥鹽酸艾司氯胺酮注射液獲註冊批件
格隆匯 11-28 15:38

格隆匯11月28日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的《藥品註冊批件》。該藥品名稱:鹽酸艾司氯胺酮注射液,劑型:注射劑,規格:2ml:50mg(按C13H16ClNO計),註冊分類:化學藥品3類。

2017年11月30日,恆瑞醫藥向江蘇省食品藥品監督管理局遞交的藥品註冊申請獲得受理。鹽酸艾司氯胺酮是具有鎮痛和增加劑量引起麻醉作用的手性環己酮衍生物,主要通過阻滯N-甲基-D-天冬氨酸(NMDA)受體來發揮鎮痛作用。適用於與安眠藥聯用誘導和實施全身麻醉,作為局部麻醉的補充,兒童麻醉,以及在急救護理中用於麻醉和鎮痛。

鹽酸氯胺酮由ParkeDavis公司於1962年首先研發,輝瑞製藥收購該公司後,繼續開發了氯胺酮的右旋拆分體——右旋氯胺酮,即艾司氯胺酮,鹽酸艾司氯胺酮目前已分別在澳大利亞、德國、荷蘭等國家上市。目前,國內已批准恆瑞醫藥、山西太原藥業、山東方明藥業等多家企業生產氯胺酮原料及注射液,尚無其他企業申報或生產艾司氯胺酮注射液。

經查詢IMS數據庫,2018年鹽酸艾司氯胺酮注射液全球銷售額約為1321萬美元。

截至目前,公司在該研發項目上已投入研發費用約為1951萬元人民幣。

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