普利製藥(300630.SZ)：注射用比伐蘆定獲得荷蘭藥物評價委員會上市許可
格隆匯4月21日丨普利製藥(300630.SZ)公佈，公司於近日收到了荷蘭藥物評價委員會(“CBG”)簽發的注射用比伐蘆定的上市許可。
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(見説明書中臨牀研究章節)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/肝素誘導的血小板減少並血栓形成綜合徵(HIT/HITTS)患者或存在上述風險的患者進行經皮冠狀動脈介入治療(PCI)。
3、在上述適應症中，比伐蘆定應與阿司匹林合用，而且僅在合用阿司匹林的病人中進行過研究。
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。
比伐蘆定是一種人工合成的抗凝血藥物，其注射劑由The Medicine Company研發，於2000年12月獲美國食品藥品監督管理局(FDA)批准上市，2004年9月獲歐洲藥物管理局(EMA)批准上市，2019年2月獲國家藥品監督管理局(NMPA)批准上市。
普利製藥的注射用比伐蘆定成功研發後，分別遞交歐洲、美國和中國的仿製藥註冊申請，屬於共線產品。本品於2020年1月在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，正在技術發補中；美國現處於審評中；歐洲於2019年12月14日結束技術審評，進入荷蘭和德國國家階段的產品特性概要，説明書和標籤的審核和批件發放階段，於近日收到了荷蘭的上市許可。
公司收到荷蘭藥物評價委員會的上市許可，標誌着普利製藥具備了在荷蘭銷售注射用比伐蘆定的資格，將對公司拓展市場帶來積極的影響。
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