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上海醫藥(601607.SH):鹽酸二甲雙胍片通過仿製藥一致性評價
格隆匯 03-16 16:19

格隆匯3月16日丨上海醫藥(601607.SH)公佈,近日,公司全資子公司上海上藥信誼藥廠有限公司(“上藥信誼”)收到國家藥品監督管理局(“國家藥監局”)頒發的關於鹽酸二甲雙胍片(0.5g)(“該藥品”)的《藥品補充申請批件》(批件號:2020B02515),該藥品通過仿製藥一致性評價。

鹽酸二甲雙胍片主要用於2型糖尿病的治療,由默克公司(Merck Santé S.A.S)研發,最早於1995年在美國上市。2019年1月,上藥信誼就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。截至公告日,公司針對該藥品的一致性評價已投入研發費用約人民幣720.52萬元。公司2019年未銷售該藥品。

截至公告日,該藥品在中國境內的主要生產廠家包括:中美上海施貴寶製藥有限公司、石藥集團歐意藥業有限公司等。IQVIA數據庫顯示,該藥品2019年醫院採購金額為人民幣14.76萬元。

根據國家相關政策,通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。因此,上藥信誼的鹽酸二甲雙胍片(0.5g)通過仿製藥一致性評價,有利於擴大該藥品的市場份額,提升市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。

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