和黃醫藥(00013.HK)向EMA提交索凡替尼(Surufatinib)上市許可申請並獲確認
格隆匯7月16日丨和黃醫藥(00013.HK)發佈公吿,歐洲藥品管理局(“EMA”)已確認並受理索凡替尼用於治療胰腺和胰腺外(非胰腺)神經內分泌瘤(NET)的上市許可申請(MAA)。EMA已確認提交材料的完整性,並且已準備好啟動正式的審評程序。
該申請提交是遵循了EMA人用藥品委員會(“CHMP”)提供的科學建議,其結論為:索凡替尼治療胰腺和非胰腺神經內分泌瘤患者的兩項成功的中國III期研究(SANET-pi及SANET-epii,兩項研究結果均已於《刺針·腫瘤學》期刊上刊登)以及索凡替尼治療美國非胰腺和胰腺神經內分泌瘤患者的現有數據,可以作為支持上市許可申請的依據。和黃醫藥已於2021年7月1日宣佈向美國食品藥品監督管理局(“FDA”)提交新藥上市申請並獲受理。
和黃醫藥(國際)董事總經理兼首席醫學官Marek Kania醫學博士表示:“和黃醫藥的創新腫瘤藥物管線正在全球範圍內取得重要的進展。繼美國FDA受理索凡替尼的美國新藥上市申請後,我們相信此次EMA對該上市許可申請的確認,認可了相關申請材料的科學價值。今年早些時候,索凡替尼於中國上市,為神經內分泌瘤患者提供了重要的治療新選擇,現在我們希望很快能夠將這種重要的治療方法帶向美國和歐洲的患者。”
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