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澤璟製藥(688266.SH):甲苯磺酸多納非尼片新適應症上市申請獲得受理
格隆匯 10-18 14:27

格隆匯10月18日丨澤璟製藥(688266.SH)公佈,20211015日,公司收到國家藥品監督管理局(NMPA)下發國家1類新藥甲苯磺酸多納非尼片(多納非)用於治療局部晚期/轉移性放射性碘難治性分化型甲狀腺癌(RAIR-DTC)適應症的新藥上市申請(NDA)的《受理通知書》。

甲苯磺酸多納非尼片是公司開發的口服多靶點、多激酶抑制劑類小分子抗腫瘤藥物,屬於1類新藥,公司擁有獨立的自主知識產權。多納非尼一線治療晚期肝細胞癌適應症已於2021 6 月獲批上市。多納非尼已經被證明是一個療效確切、安全性良好、患者可及和風險獲益平衡良好的晚期肝癌一線治療靶向新藥。多納非尼聯合柔紅黴素和阿糖胞苷治療複發性急性髓系白血病(AML)的I試驗正在進行中;多納非尼與腫瘤免疫治療藥物聯合治療晚期腫瘤的多項臨牀試驗正在進行中

此次用於治療局部晚期/ 轉移性放射性碘難治性分化型甲狀腺癌(RAIR-DTC)適應症上市申請主要是基於多納非尼治療局部晚期/轉移性放射性碘難治性分化型甲狀腺癌(RAIR-DTC)的多中心、隨機、雙盲、安慰劑對照的 III 期臨牀試驗(代號:ZGDD3)的結果相關信息詳見公司於2021817日披露的《關於自願披露甲苯磺酸多納非尼片治療碘難治性分化型甲狀腺III期臨牀試驗期中分析提前達到試驗終點的公吿》(公吿編號:2021-033)詳細數據將適時發表在國際學術期刊上。

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