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12月19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”)批准注射用比伐蘆定的技術審評報告通知。
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。於近日,公司收到了荷蘭藥物評價委員會的批准通知,該產品的技術審評已於2019年12月14日結束,結論為批准。目前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,預計在2個月左右可取得生產批件。之後該產品即可在荷蘭、德國市場進行上市銷售,將對公司拓展市場帶來積極的影響。
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