上海誼眾(688091.SH):核心產品紫杉醇膠束新藥上市註冊申請的技術審評工作及藥品商品名稱“紫晟”的補充申請技術審評工作均已結束
格隆匯10月18日丨上海誼眾(688091.SH)公佈,公司10月15日從國家藥品監督管理局藥品審評中心(“國家藥審中心”)網站查詢獲悉,公司核心產品注射用紫杉醇聚合物膠束(“紫杉醇膠束”)新藥上市註冊申請的技術審評工作以及藥品商品名稱“紫晟”的補充申請技術審評工作均已結束,並於10月15日報送國家藥品監督管理局進行審批。
截至公吿發布日,紫杉醇膠束的新藥上市註冊程序尚未完成,尚需國家藥品監督管理局的審批,具有不確定性。
紫杉醇膠束為廣譜抗癌化療藥紫杉醇的創新劑型,屬於國家重大新藥創制項目。相較於已上市的其它紫杉醇劑型:紫杉醇膠束臨牀使用劑量大幅提升,用藥前無需任何抗過敏預處理,無需使用特殊輸液裝置,臨牀使用便捷;臨牀研究結果顯示,紫杉醇膠束在晚期非小細胞肺癌(NSCLC)一線治療上無論療效及安全性均顯示了其獨特的優勢和先進性,將成為非小細胞肺癌化療藥物的新選擇。
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