華海藥業(600521.SH):HB002.1M獲得藥物臨牀試驗補充申請批准通知書
格隆匯12月1日丨華海藥業(600521.SH)公佈,近日,公司下屬子公司華博生物醫藥技術(上海)有限公司)“華博生物”)收到國家藥監局核准簽發的重組人血管內皮生長因子受體-抗體融合蛋白眼用注射液項目的《藥物臨牀試驗補充申請批准通知書》。
重組人血管內皮生長因子受體-抗體融合蛋白眼用注射液(“HB002.1M”)是一種以血管內皮生長因子(VEGF)為靶點的重組融合蛋白,擬用於治療上述4個適應症。VEGF是公認最快速、有效的血管滲透和新生血管誘導因子,上述4個適應症的病理進程均與VEGF異常表達相關,利用靶向VEGF的重組蛋白或單抗可有效治療上述疾病。國外已上市同靶點、同治療領域藥物包括Lucentis (商品名:諾適得)、Eylea (商品名:艾力雅)和康柏西普(商品名:朗沐),國內上述三個藥物均已經批准上市。除HB002.1M注射液外,據統計國內已經獲批臨牀的同靶點、同治療領域藥物有14個。Novartis International AG (諾華公司)、F. Hoffmann-La Roche Ltd (羅氏公司)和Regeneron Pharmaceuticals Inc (再生元公司)財務年報顯示Lucentis (商品名:諾適得)和Eylea (商品名:艾力雅)2020年全球銷售額分別為33億美元和83.6億美元。成都康弘藥業集團股份有限公司財務年報顯示康柏西普(商品名:朗沐)2020年全國銷售額為13.86億元。與已上市同靶點藥物相比,HB002.1M與VEGF的親和力更高或相當,安全性相似。
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