恆瑞醫藥(600276.SH):苯磺順阿曲庫銨注射液通過仿製藥一致性評價
格隆匯 4 月 9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(“國家藥監局”)核准簽發的關於苯磺順阿曲庫銨注射液的《藥品補充申請批准通知書》,公司苯磺順阿曲庫銨注射液通過仿製藥質量和療效一致性評價。
苯磺順阿曲庫銨是一種神經肌肉阻滯劑,它在運動終板上與膽鹼能受體結合,以拮抗乙酰膽鹼的作用,從而產生競爭性的神經肌肉傳導阻滯作用,適用於手術和其他操作以及重症監護治療。作為全麻的輔助用藥或在重症監護病房(ICU)起鎮靜作用,它可以鬆弛骨骼肌,使氣管插管和器械通氣易於進行。
苯磺順阿曲庫銨注射液由Aspen公司開發,後被GlaxoWellcome收購,並於1995年12月獲得FDA批准,商品名為Nimbex®。1999年11月GSK將Nimbex®在美國市場的業務許可給美國雅培(Abbott Laboratories),後者獲得了該品種的美國市場開發和銷售權利。截至目前,本品已在全球多個國家上市銷售。2000年5月,GlaxoWellcome的苯磺順阿曲庫銨注射液獲批進口。
截至目前,除公司外,國內已有南京健友生化製藥、北京泰德製藥2家企業化4類獲批生產,均等同於通過一致性評價。另有湖南科倫、浙江仙琚等多家申報生產,目前未見獲批信息。公司苯磺順阿曲庫銨注射液已於2017年獲得美國FDA批准文號,ANDA號分別為209334、204960。
經查詢,苯磺順阿曲庫銨注射液2019年全球銷售額約為3.27億美元。截至目前,苯磺順阿曲庫銨注射液一致性評價項目累計已投入研發費用約541萬元。
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