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海正藥業(600267.SH):纈沙坦片獲得藥品註冊證書
格隆匯 08-23 18:11

格隆匯8月23日丨海正藥業(600267.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的纈沙坦片的《藥品註冊證書》。纈沙坦片適用於治療輕、中度原發性高血壓。公司纈沙坦片按新4類獲得國家藥監局批准上市,視同通過一致性評價。

纈沙坦片原研藥由瑞士諾華公司開發,目前,纈沙坦片國內主要生產廠家有浙江華海藥業股份有限公司、湖南千金湘江藥業股份有限公司等。經查詢IMS數據庫,纈沙坦片2020年全球銷售額約為60.79億美元,其中國內市場銷售額約為4.32億美元;2021年1-3月全球銷售額約為17.16億美元,其中國內市場銷售額約為1.42億美元。

2020年5月20日,國家藥監局受理了公司向其遞交的纈沙坦片藥品註冊申請。截至目前,公司在該藥品研發項目上已投入約1392萬元人民幣。

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