德琪醫藥-B(06996.HK)在台灣遞交塞利尼索新藥上市申請用於治療三種血液系統惡性腫瘤適應症
格隆匯7月14日丨德琪醫藥-B(06996.HK)7月14日宣佈，德琪醫藥已向中國台灣食品藥物管理署(TFDA)提交同類首款XPO1抑制劑塞利尼索的新藥上市申請(NDA)，用於治療三個適應症：與硼替佐米、地塞米松聯合或與地塞米松聯合治療復發難治性多發性骨髓瘤(RRMM)患者；單藥治療過往接受過至少二線系統治療的成人復發或難治性瀰漫性大B細胞淋巴瘤(rrDLBCL)患者(包括由濾泡性淋巴瘤轉化的)。
德琪醫藥已在中國、澳大利亞、韓國、新加坡等多個亞太市場為塞利尼索提交了新藥上市申請(NDA)，並獲得了國家藥品監督管理局(NMPA)授予的優先審評資格以及韓國食品和醫藥品安全部(MFDS)授予的孤兒藥認定。此次在中國台灣遞交的新藥上市申請將成為德琪醫藥擴展亞太市場、致力滿足血液系統惡性腫瘤患者臨牀需求的又一個里程碑。
“僅僅9個月，我們已經在6個亞太市場遞交了新藥上市申請，證明了我們致力於滿足亞太地區患者需求的決心。”德琪醫藥創始人、董事長兼首席執行官梅建明博士表示：“我們的團隊在亞太市場具有推動產品註冊及上市的豐富經驗，擁有這樣一支專業的團隊，我相信德琪醫藥一定能達成對患者和亞太市場的承諾，為亞太地區患者帶來前沿的創新療法。”
德琪醫藥首席醫學官Kevin Lynch表示：“塞利尼索是一款全新作用機制的抗腫瘤藥物，在不到2年的時間內獲得美國FDA批准應用在多發性骨髓瘤和瀰漫性大B細胞淋巴瘤兩個瘤種的三個適應症，顯示出其極優越的抗腫瘤作用。塞利尼索聯合地塞米松在5藥難治的多發性骨髓瘤患者中仍有25.3%的總緩解率(ORR)；而對於過往接受過至少一線治療的多發性骨髓瘤患者，在XVd方案中中位無進展生存期(PFS)為13.9個月，明顯高於接受基於硼替佐米標準療法的對照組，在亞組分析中年齡大於65歲，腎功能不全，高危細胞遺傳學的患者仍可顯著獲益。此類患者通常難以治療，但塞利尼索單藥治療就能使部分復發或難治性瀰漫性大B細胞淋巴瘤患者最終獲得深度緩解且持久的療效，其中獲得完全緩解的患者中位緩解持續時間達到23.0個月，為此我們也很期待其在瀰漫性大B細胞淋巴瘤聯合方案中的潛在療效。”
德琪醫藥已與Karyopharm Therapeutics Inc. (NASDAQ: KPTI)達成獨家合作和授權協議，獲得了塞利尼索等三款XPO1抑制劑及一款PAK4/NAMPT抑制劑包括中國大陸在內等17個亞太市場的獨家開發和商業化授權。
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