億帆醫藥(002019.SZ):拉考沙胺片獲批上市
格隆匯2月24日丨億帆醫藥(002019.SZ)公佈,公司全資子公司合肥億帆生物製藥有限公司於2023年2月24日收到國家藥品監督管理局核准簽發的拉考沙胺片《藥品註冊證書》。
拉考沙胺片適用於4歲及以上癲癇患者部分性發作的單藥治療和聯合治療。最早由UCB Pharma S.A.研發,於2008年在歐洲上市。公司於2021年3月向國家藥品監督管理局藥品審評中心遞交了藥品註冊申請,於2021年4月獲得受理,並於2023年2月24日收到拉考沙胺片《藥品註冊證書》,此次拉考沙胺片以化學藥品註冊分類4類獲批上市,標誌着此產品視同通過仿製藥一致性評價。
截止報吿披露日,除公司外,中國境內拉考沙胺片有包括陝西步長製藥有限公司、石藥集團歐意藥業有限公司在內的9家企業獲批,3家企業處於報產階段。
根據IQVIA數據顯示,2022年拉考沙胺片國內市場規模約9428萬元,全球市場約16億美元。截止公吿披露日,公司對該產品已投入研發費用約525萬元。
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