基石藥業-B(02616.HK)：舒格利單抗治療復發難治性結外NK/T細胞淋巴瘤的新適應症上市申請獲國家藥監局受理並納入優先審評
格隆匯9月13日丨基石藥業-B(02616.HK)發佈公吿，舒格利單抗治療復發或難治性結外NK/T細胞淋巴瘤(“R/R ENKTL”)的新適應症上市申請獲中國國家藥品監督管理局(“NMPA”)受理並納入優先審評。
根據披露，這是繼III期和IV期非小細胞肺癌適應症後，舒格利單抗在國內申報的第三項新適應症上市申請，舒格利單抗有望成為全球首個獲批用於R/R ENKTL的腫瘤免疫治療藥物。GEMSTONE-201為目前已知樣本量最大的PD-(L)1抗體針對R/R ENKTL的註冊性臨牀研究。2022年1月，基石藥業宣佈該研究經獨立影像評估委員會(“IRRC”)評估達到了預設的客觀緩解率(“ORR”)主要研究終點。舒格利單抗先後被美國食品藥品監督管理局(“FDA”)和NMPA授予突破性療法認定和納入突破性治療藥物用於治療成人R/R ENKTL。
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：“一直以來，R/R ENKTL患者缺乏標準治療，目前NCCN和CSCO指南仍首推臨牀試驗。該疾病治癒率低，患者生存期短，存在迫切的高度未滿足的臨牀需求。此前的研究結果證實了舒格利單抗在 R/R ENKTL患者中具有較好的療效，我們期待舒格利單抗該項適應症早日獲批上市，為R/R ENKTL患者帶來新的治療選擇。”
基石藥業首席執行官兼執行董事楊建新博士表示：“我們很高興地宣佈舒格利單抗用於治療 R/R ENKTL的新適應症上市申請已獲得NMPA的受理，舒格利單抗在R/R ENKTL患者中取得了優異的抗腫瘤活性、持久的腫瘤緩解和良好的安全性。目前全球範圍內尚無PD-1或PD-L1抗體針對R/R ENKTL適應症獲批。我們會與NMPA密切協作，期待舒格利單抗能夠造福更多患者。”
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