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中國同輻(01763.HK):原子高科取得治療用碘化鈉膠囊藥品註冊證書
格隆匯 04-19 17:25

格隆匯 4 月 19日丨中國同輻(01763.HK)發佈公吿,近日,原子高科(股份代號:430005,以下簡稱“公司”)取得了國家食品藥品監督管理局頒發的“治療用碘[131I]化鈉膠囊”藥品註冊證書。

根據披露,該品種為自2005年以來首個在國內獲批的仿製國外已上市藥品的放射性藥物新制劑(首仿)品種,是公司在新藥品註冊法規頒佈後申報成功的首個產品,也是作為口服固體制劑視同為通過一致性評價的首個品種。此次,該品種的獲批將為國內臨牀甲癌及甲亢的治療提供一種新選擇,隨着其在臨牀應用上的不斷推廣,將有利於提高甲癌及甲亢患者的生活質量。

公司表示,“治療用碘[131I]化鈉膠囊”的獲批將對公司放射性藥品研發、註冊、生產及銷售起到推動作用,有望帶動公司銷售收入及利潤增加;對國內放射性藥物產業及核醫學的發展具有特殊重要意義。

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