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苑東生物(688513.SH):獲得硫酸氫氯吡格雷片藥品註冊證書
格隆匯 12-28 18:18

格隆匯 12 月 28日丨苑東生物(688513.SH)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的硫酸氫氯吡格雷片《藥品注冊證書》。

硫酸氫氯吡格雷片是一種血小板聚集抑制,主要用於預防動脈粥樣硬化血栓形成事件,如近期缺血性卒中、近期心肌梗死、急性冠脈綜合徵等。根據國家藥監局網站數據查詢,目前國內硫酸氫氯吡格雷片廠家主要有:賽諾菲(杭州)製藥有限公司、樂普藥業股份有限公司、石藥集團歐意藥業有限公司、深圳信立泰藥業股份有限公司等。此外,另有北京四環製藥有限公司、揚子江藥業集團廣州海瑞藥業有限公司等公司提交仿製藥申請。米內網數據顯示,2019年硫酸氫氯吡格雷片在重點省市公立醫院終端銷售額約為17.43億元。

201972日,公司向國家藥監局提交的硫酸氫氯吡格雷片註冊申請獲得受理。截止公吿日,該產品累計已投入研發費用2460.54萬元。

公司硫酸氫氯吡格雷片按照化藥新註冊分類4類申報,按照與原研藥品質量和療效一致的技術要求審評並獲批,因此批准後視為通過仿製藥質量和療效一致性評價。硫酸氫氯吡格雷片獲批上市後,標誌着公司具備在國內市場銷售該藥品的資格,進一步豐富了公司心血管領域的產品線對公司經營發展具有一定的積極作用

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