德琪醫藥-B(06996.HK)：塞利尼索新藥上市申請通過韓國食品醫藥品安全部批准
格隆匯7月30日丨德琪醫藥-B(06996.HK)公吿，2021年7月30日－致力於研發和商業化創新腫瘤療法的領先生物製藥公司－德琪醫藥有限公司今日宣佈，全球首款口服型XPO1抑制劑塞利尼索（美國食品藥品管理局批准的專用英文商品名：XPOVIO，英文通用名：Selinexor）聯合地塞米松的孤兒藥新藥上市申請(NDA)，今日已通過韓國食品醫藥品安全部(MFDS)優先審評程序批准，用於治療已接受至少四種既往治療（包括兩種蛋白酶體抑制劑、兩種免疫調節劑和CD38單克隆抗體在內的四線治療）的復發或難治性多發性骨髓瘤成人患者，以及單藥治療既往接受過至少2線治療的復發難治性瀰漫性大B細胞淋巴瘤(rrDLBCL)的成年患者。
塞利尼索全新且獨特的作用機制—作用於唯一經過臨牀驗證的核輸出蛋白靶點XPO1，和已上市的治療藥物機制均不同，它可與其他多個藥物聯用以提高療效，是真正意義上選擇性核輸出蛋白抑制劑的先驅。截至目前，塞利尼索有5項治療方案被納入美國國家綜合癌症網絡(NCCN)指南。
此外，塞利尼索多個國際多中心臨牀試驗也在北美、歐洲、澳洲以及亞洲等地聯合開展，比如聯合R-GDP治療難治復發瀰漫性大B細胞淋巴瘤的國際多中心臨牀試驗XPORT-DLBCL-030和單藥治療子宮內膜癌的國際多中心臨牀試驗SIENDO。
德琪醫藥韓國區總經理Minyoung Kim表示：“對於韓國MFDS對於塞利尼索的上市批准，我倍感開心。公司相信這一選擇性核輸出蛋白抑制劑口服藥物將發揮其突破性的治療優勢，惠及更多韓國復發或難治性多發性骨髓瘤及復發難治性瀰漫性大B細胞淋巴瘤患者，改善患者的生活質量，創造更多的生命奇跡”。
據悉，塞利尼索是目前首款且唯一一款被美國FDA批准的口服XPO1抑制劑，也是首款可用於治療多發性骨髓瘤和瀰漫性大B細胞淋巴瘤的藥物。通過抑制核輸出蛋白XPO1，促使腫瘤抑制蛋白和其他生長調節蛋白的核內儲留和活化，並下調細胞漿內多種致癌蛋白水平，誘導腫瘤細胞凋亡，而正常細胞不受影響。基於其獨特的作用機制，塞利尼索可與其他多個藥物聯用以提高療效。
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