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泰恩康(301263.SZ):吡非尼酮片境內註冊上市許可申請獲受理
格隆匯 04-03 17:27

格隆匯4月3日丨泰恩康(301263.SZ)公佈,公司全資子公司山東華鉑凱盛生物科技有限公司於近日收到國家藥品監督管理局簽發的吡非尼酮片境內註冊上市許可申請《受理通知書》,國家藥監局根據《中華人民共和國行政許可法》第三十二條的規定,對上述藥品的藥品註冊申請進行了審查,決定予以受理。

吡非尼酮是一種具有抗纖維化、抗炎、抗氧化作用的小分子化合物,是全球首個上市治療特發性肺纖維化(Idiopathic pulmonary fibrosis)(IPF)的藥物,最初由美國Marnac公司開發,原研藥Pirespa由日本鹽野義製藥株式會社於2008年10月申請上市,先後在美國、歐盟、中國等批准用於治療IPF,吡非尼酮已被列入《國家基本醫療保險、工傷保險和生育保險藥品目錄(2022年)》。米內網數據顯示,2020年吡非尼酮的全球銷售額達到11.08億瑞士法郎。

經查詢國家藥監局網站數據,截至目前,吡非尼酮片在國內共有1家企業獲得藥品註冊批件。

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