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恆瑞醫藥(600276.SH):釓布醇注射液獲得美國FDA批准文號
格隆匯 11-21 16:25

格隆匯11月21日丨恆瑞醫藥(600276.SH)公佈,近日,江蘇恆瑞醫藥股份有限公司收到美國食品藥品監督管理局(“FDA”)通知,公司向美國FDA申報的釓布醇注射液簡略新藥申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。

釓布醇注射液是一種用於磁共振成像(MRI)的順磁性對比劑,是臨牀應用最廣泛的第二代釓造影劑,適用於成人及全年齡段兒童(包括足月新生兒)的磁共振成像(MRI)。因其高濃度、高弛豫率的優勢,在中樞神經系統原發性及轉移性腫瘤、多發性硬化等MRI檢測方面,可以明顯提升病灶細節的顯示,提高診斷水平。

釓布醇注射液最早由 Bayer Schering公司開發,商品名為Gadovist,1999年在瑞士獲批上市,後在包括中國在內的多個國家陸續獲批上市。美國市場除原研產品外,公司產品為該品種首仿藥。國內市場,公司釓布醇注射液於2022年3月獲批上市,視同通過仿製藥質量和療效一致性評價,是國內首家通過仿製藥質量和療效一致性評價的產品。經查詢,2021年釓布醇相關劑型全球銷售額約為4.95億美元。截至目前,釓布醇注射液相關項目累計已投入研發費用約2908萬元。

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