博雅生物(300294.SZ):獲得“人凝血酶原複合物”《藥品註冊證書》
格隆匯 12 月 8日丨博雅生物(300294.SZ)公佈,近日,公司收到國家藥品監督管理局簽發的“人凝血酶原複合物”《藥品註冊證書》。
人凝血酶原複合物系由健康人血漿經分離、提純,並經病毒去除和滅活處理等工藝製成的血漿蛋白製品。該產品含有維生素K依賴的在肝臟合成的四種凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ。維生素K缺乏和嚴重肝臟疾患均可造成這四個因子的缺乏,而上述任何一個因子的缺乏都可導致凝血障礙。
人凝血酶原複合物主要用於治療先天性和獲得性凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ缺乏症(單獨或聯合缺乏)包括:1、凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ缺乏症,包括B型血友病;2、抗凝劑過量、維生素K缺乏症;3、因肝病導致的凝血機制紊亂,肝病導致的出血患者需要糾正凝血功能障礙時;4、各種原因所致的凝血酶原時間延長而擬作外科手術患者,但對凝血因子V缺乏者可能無效;5、治療已產生因子Ⅷ抑制物的A型血友病患者的出血症狀;6、逆轉香豆素類抗凝劑誘導的出血。
人凝血酶原複合物屬治療用生物製品(已上市生物製品),目前國內企業上海萊士血液製品股份有限公司、山東泰邦生物製品有限公司、華蘭生物工程股份有限公司等擁有該藥品的生產註冊批件。
公司於 2016年12月獲得該產品的《藥物臨牀試驗批件》,2019年6月獲得該產品申報生產註冊的《受理通知書》。公司此次獲得“人凝血酶原複合物”《藥品註冊證書》,是對公司產品的進一步補充,豐富了公司產品線,有利於提升公司原料血漿綜合利用率,提高每噸血漿產值。
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