普利製藥(300630.SZ):注射用比伐蘆定獲得藥品註冊批件
格隆匯 10 月 12日丨普利製藥(300630.SZ)公佈,公司於近日獲得國家藥品監督管理局簽發的注射用比伐蘆定的生產批件。
比伐蘆定是一種直接凝血酶抑制劑,作為抗凝劑用於以下患者:1、經皮腔內冠狀動脈成形術(PTCA):用於接受經皮腔內冠狀動脈成形術(PTCA)的不穩定型心絞痛患者;2、經皮冠狀動脈介入術(PCI):在REPLACE-2研究(見臨牀試驗項)所列舉情況下,與臨時使用的血小板糖蛋白IIb/IIIa受體拮抗劑(GPI)合用,用於進行經皮冠狀動脈介入治療(PCI)的患者。肝素誘導的血小板減少症(HIT)或肝素誘導的血小板減少並血栓形成綜合徵(HITTS)或存在上述風險的患者進行經皮冠狀動脈介入治療(PCI)。3、與阿司匹林聯合使用:在上述適應症中,比伐蘆定應與阿司匹林合用,而且僅在聯合使用阿司匹林的患者中進行過研究。4、在不進行PTCA或PCI的急性冠脈綜合徵患者中,比伐蘆定的安全性和療效尚未建立。
普利製藥的注射用比伐蘆定成功研發後,分別提交了歐洲、美國、中國和英國等多個國家和地區的仿製藥註冊申請,屬於共線生產品種。本品於2020年4月獲得了荷蘭藥物評價委員會(CBG)的批准,於2020年6月獲得了德國聯邦藥物和醫療器械管理局(BfArM)的批准;在美國,本品已進入美國食品藥品管理局(U.S.FDA)的技術審評程序,現處於審評中;在中國,本品於2020年1月在藥品審評中心(CDE)以“同一生產線生產,已在歐盟國家上市”為由納入優先審評程序,並於近日取得國家藥品監督管理局產品批件。公司注射用比伐蘆定其他市場的註冊工作仍在持續推進中。
公司注射用比伐蘆定以化學藥品新註冊分類4類獲批上市,標準着此產品視同通過仿製藥注射劑一致性評價,將對公司的市場拓展帶來積極地影響。
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