博雅生物(300294.SZ)人凝血酶原複合物納入優先審評程序
格隆匯8月15日丨博雅生物(300294.SZ)公佈,近日,公司的藥品人凝血酶原複合物被國家藥品監督管理局藥品審評中心納入優先審評品種公示名單,現公示期滿,正式進入優先審評程序。
藥品名稱為人凝血酶原複合物;劑型為注射劑;規格為每瓶含人凝血因子IX400IU;專家審核意見:經審核,本申請符合《總局關於鼓勵藥品創新實行優先審評審批的意見》(食藥監藥化管[2017]126號)規定的優先審評審批範圍,同意按優先審評範圍(二)4款罕見病納入優先審評程序。
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。該藥品主要用於治療先天性和獲得性凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ缺乏症,如乙型血友病等。
人凝血酶原複合物屬治療用生物製品 15類(已有國家標準的生物製品),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。
公司自 2016年12月獲得該藥品的《藥物臨牀試驗批件》,積極推進藥品的臨牀研究。此次公司人凝血酶原複合物納入優先審評程序僅是藥物開發進展的階段性步驟,後續能否獲得國家藥品監督管理局的批准尚存在不確定。
公司人凝血酶原複合物納入優先審評程序,有利於提高公司研發積極性,進一步提升公司的核心競爭力,不會對公司2019年度業績產生重大影響。
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