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恆瑞醫藥(600276.SH):子公司收到貝伐珠單抗注射液的藥品補充申請批准通知書
格隆匯 09-27 16:40

格隆匯9月27日丨恆瑞醫藥(600276.SH)公佈,近日,公司子公司蘇州盛迪亞生物醫藥有限公司收到國家藥品監督管理局核准簽發關於貝伐珠單抗注射液的《藥品補充申請批准通知書》。

貝伐珠單抗是一種人源化抗VEGF單克隆抗體,由中外製藥和羅氏的子公司基因泰克合作開發,最早於2004年由美國食品藥品監督管理局批准上市,商品名為Avastin(安維汀),目前已在中國和全球多個國家上市銷售。

公司貝伐珠單抗注射液(商品名:艾瑞妥)已於2021年6月獲批上市,適應症為轉移性結直腸癌和晚期、轉移性或複發性非小細胞肺癌。除安維汀及艾瑞妥外,國內目前有3個貝伐珠單抗注射液獲批上市,分別為2019年12月獲批的安可達(齊魯製藥)、2020年6月獲批的達攸同(信達生物)和2021年4月獲批的博優諾(山東博安生物)。同時,國內多家企業的同類產品已向國家藥品監督管理局遞交上市申請,目前狀態為“在審評審批中”,包括綠葉製藥、貝達藥業、百奧泰、東曜藥業、復宏漢霖、正大天晴等。

經查詢 EvaluatePharma數據庫,安維汀2020年全球銷售額約53.24億美元。截至目前,貝伐珠單抗相關項目累計已投入研發費用約為2.63億元。

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