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基石藥業(02616.HK)公布旗下產品最終分析結果
阿思達克 07-12 09:38
基石藥業(02616.HK)公布,舒格利單抗用於一線治療IV期非小細胞肺癌(NSCLC)的註冊性臨床研究(GEMSTONE-302)無進展生存期(PFS)最終分析結果。更新的數據顯示,繼去年在PFS期中分析時達到了主要療效終點後,在近期的PFS最終分析中,舒格利單抗聯合化療進一步延長了患者的PFS。同時,這一延長隨訪時間的數據進一步證實了舒格利單抗聯合化療可為患者帶來持久的生存獲益。

公司表示,GEMSTONE-302研究更新數據顯示,在針對主要研究終點的最終分析中,舒格利單抗聯合化療作為轉移性NSCLC一線治療,顯示出比期中分析更長的PFS和持續的生存改善。舒格利單抗治療轉移性NSCLC的新藥上市申請(NDA)已於去年獲中國藥監局(NMPA)受理,目前正在審評中。商業化進程也在加速推進。有效性和安全性數據將用於支援舒格利單抗在多個國家和地區的藥品監督管理部門就該適應證展開溝通。(vi/w)

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