海正藥業(600267.SH):替格瑞洛片獲得藥品註冊證書
格隆匯 8 月 19日丨海正藥業(600267.SH)公佈,2020年8月19日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的替格瑞洛片的《藥品註冊證書》。
替格瑞洛片主要適用於急性冠狀動脈綜合徵(ACS)的治療,降低ACS患者或有心肌梗塞(MI)病史患者的心血管死亡、心肌梗死和卒中的發生率。在ACS後至少12個月的治療中,與氯吡格雷相比,替格瑞洛片作用更優。公司替格瑞洛片按新4類獲得國家藥監局批准上市,視同通過一致性評價。
替格瑞洛片原研藥Brilinta片(90mg)由阿斯利康研發,國內外生產廠商主要有阿斯利康、深圳信立泰藥業股份有限公司、石藥集團歐意藥業有限公司等。經查詢IMS數據庫,替格瑞洛片2019年全球銷售額為191538.28萬美元,其中中國銷售額為17860萬美元;2020年1-3月全球銷售額為52305.07萬美元,其中中國銷售額為5455.2萬美元。公司於2018年01月29日向國家藥監局遞交藥品註冊申請並獲得受理。截至目前,公司在該藥品研發項目已投入2814萬元人民幣左右。
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