普利製藥(300630.SZ):依替巴肽注射液獲得加拿大衞生部上市許可
格隆匯8月31日丨普利製藥(300630.SZ)公佈,公司於近日收到加拿大衞生部(Health Canada)簽發的依替巴肽注射液的上市許可。
依替巴肽是血小板糖蛋白IIb/IIIa受體拮抗劑。通過選擇性、可逆性抑制血小板聚集的最終共同通路,可逆轉因血栓形成而導致的缺血狀態。適用於急性冠狀動脈綜合徵患者的治療。依替巴肽注射液由COR Therapeutics,Inc.最初研發,於1998年5月在美獲准上市,現由默克公司負責銷售,1999年7月在歐洲獲准上市,現由葛蘭素史克公司負責銷售;商品名均為INTEGRILIN,目前已在全球廣泛上市銷售。
普利製藥的依替巴肽注射液成功研發後進行了多國註冊申報,已於2018年2月獲得了荷蘭上市許可,於2018年7月獲得了德國上市許可,於2019年1月獲得了美國上市許可,於2019年8月獲得了英國上市許可,於2021年7月獲得了國家藥品監督管理局頒發的藥品註冊批件,於2023年3月獲得了泰國上市許可。
近日,公司收到加拿大衞生部(Health Canada)簽發的上市許可,標誌着普利製藥具備了在加拿大銷售依替巴肽注射液的資格。
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