基石藥業-B(02616.HK):舒格利單抗治療復發或難治性結外NK/T細胞淋巴瘤的新適應症在中國獲批,成為首個獲批此適應症的PD-1或PD-L1單克隆抗體
格隆匯10月31日丨基石藥業-B(02616.HK)發佈公吿,中國國家藥品監督管理局(NMPA)已批准PD-L1抗體舒格利單抗(擇捷美®)用於治療復發或難治性結外NK/T細胞淋巴瘤(R/R ENKTL)患者。由此,舒格利單抗成為全球首個針對R/R ENKTL適應症獲批的腫瘤免疫治療藥物。
基石藥業首席執行官兼執行董事楊建新博士表示:“非常高興舒格利單抗再次獲得NMPA的認可。R/R ENKTL適應症的成功獲批,不僅是繼III期和IV期NSCLC之後舒格利單抗達成的又一重要里程碑,背後更是凝聚了基石團隊針對該在罕見疾病領域經年累月的探索和創新。我們始終堅信,癌症患者未被滿足的臨牀需求不應因其羣體微小或病種罕見而被忽視。除肺癌以外,舒格利單抗還將覆蓋一線胃癌和食管癌這樣的大適應症,目前新藥上市申請正在NMPA審評中 。此外,我們也將持續與FDA保持緊密溝通,進一步加速舒格利單抗在美國的註冊上市進程。”
舒格利單抗GEMSTONE-201主要研究者、中山大學附屬腫瘤醫院黃慧強教授表示:“感謝 NMPA和相關部門對NK/T細胞淋巴瘤這類罕見疾病的關注。一直以來,R/R ENKTL患者面臨着治療困境,缺乏標準治療,導致患者生存期短,存在高度未被滿足的臨牀需求。GEMSTONE-201研究數據表明,舒格利單抗單藥在R/R ENKTL患者中能展現出優異的抗腫瘤活性、持久的腫瘤緩解和良好的安全性。隨着該項適應症的獲批,我們期待更多R/R ENKTL患者能早日用上舒格利單抗。”
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