上海醫藥(601607.SH):上藥信誼的華法林鈉片通過仿製藥一致性評價
格隆匯9月26日丨上海醫藥(601607.SH)公佈,近日,上海醫藥集團股份有限公司控股子公司上海上藥信誼藥廠有限公司(簡稱“上藥信誼”)收到國家藥品監督管理局頒發的關於華法林鈉片(簡稱“該藥品”)的《藥品補充申請批准通知書》(批件號:2022B03876),該藥品通過仿製藥一致性評價。
華法林鈉片主要用於深靜脈血栓形成(DVT)和肺栓塞(PE)、心房顫動(AF)和/或心臟瓣膜置換術後血栓栓塞併發症的預防和治療,降低心肌梗死後死亡、復發和血栓栓塞事件(如卒中或體循環栓塞)的風險。由百時美施貴寶研發,最早於1954年在美國上市。2021年01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。IQVIA數據庫顯示,2021年該產品片劑醫院採購金額為人民幣10,086萬元。2021年,公司該藥品的銷售收入為人民幣7564萬元。
截至公吿日,中國境內該藥品的主要生產廠家有芬蘭奧利安藥廠、齊魯製藥有限公司等。截至公吿日,公司針對該藥品的一致性評價已投入研發費用約人民幣1332萬元。
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