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華潤雙鶴(600062.SH):旗下商丘雙鶴「替格瑞洛」原料藥通過藥監局技術審評
華潤醫藥(03320.HK)子公司華潤雙鶴(600062.SH)公佈,旗下商丘雙鶴研發的「替格瑞洛原料藥」,近日通過國家藥品監督管理局藥品審評中心(CDE)技術審評,在CDE原料藥、藥用輔料和藥包材登記信息公示平臺上顯示登記號轉爲「A」狀態。 該產品爲抗血小板聚集藥,與阿司匹林合用可用於急性冠脈綜合症(ACS)患者或有心肌梗死病史且伴有至少一種動脈粥樣硬化血栓形成事件高危因素的患者,可降低心血管死亡、心肌梗死和卒中的發生率。 公司表示,此次商丘雙鶴替格瑞洛原料藥通過CDE技術審評,表明其已符合國家相關藥品審評技術標準,待通過GMP符合性檢查後可生產銷售至內地市場,爲公司帶來可觀的投資回報,並將進一步豐富華潤醫藥產品線,提升集團市場綜合競爭力及市場銷售份額,對經營業績產生積極正面的影響。
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