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山東新華製藥股份(00719.HK)獲得《藥品補充申請批準通知書》

格隆匯4月28日丨山東新華製藥股份(00719.HK)公佈,近日,公司收到國家藥品監督管理局覈準簽發的甲鈷胺片(以下簡稱“本品”)《藥品補充申請批準通知書》,批準本品上市許可持有人轉讓補充申請。

甲鈷胺片適應症爲周圍神經病。本品屬於《國家基本醫療保險、工傷保險和生育保險藥品目錄》乙類品種。根據有關統計數據顯示,2023年中國公立醫療機構甲鈷胺片的銷售額約爲人民幣14.31億元。

甲鈷胺片於2025年4月通過國家藥品監督管理局審批,新華製藥成爲本品的上市許可持有人。該產品的上市,有利於豐富公司神經系統藥物產品線,提升公司綜合競爭優勢。

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