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健友股份(603707.SH):苯磺順阿曲庫銨注射液獲臨牀試驗通知書
格隆匯 01-06 16:08

格隆匯1月6日丨健友股份(603707.SH)公佈,公司於近日收到國家藥監局核准簽發的《臨牀試驗通知書》。

苯磺順阿曲庫銨注射液,由Aspen/GSK開發,後被Glaxo Wellcome收購,並於1995年12月獲得FDA批准,商品名為Nimbex?,劑型為注射液。雅培公司於1999年11月獲得Glaxo Wellcome麻醉藥品的美國市場經營權,因此現由雅培公司在美國上市該品種。1996年1月,Nimbex®首次在丹麥獲批上市。苯磺順阿曲庫銨注射液(Cisatracurium Besylate Injection)屬於肌鬆劑,具有通過非肝非腎途徑代謝的特點,肌鬆作用比苯磺酸阿曲庫銨作用強3倍。其具有起效快、作用強、恢復迅速、不釋放組胺、對心血管影響小、無蓄積、代謝產物無肌鬆效應也無毒性的臨牀優勢。主要適用於全身麻醉,並能廣泛應用在氣管插管、肝腎功能障礙、心血管手術及老年和兒科病人。

苯磺順阿曲庫銨注射液已於2000年在國內上市,商品名為NIMBEX和賽機寧,目前上市規格(以順阿曲庫銨計)為2.5ml:5mg、5ml:10mg、10ml:20mg。公司研製的苯磺順阿曲庫銨注射液為20ml:200mg。2019年4月,公司10mg/5mL、200mg/20mL、20mg/10mL三個規格已在美國獲FDA批准上市。截至目前,該產品項目已投入研發費用約為1157.6萬元人民幣。

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