基石藥業-B(02616.HK)：舒格利單抗再獲突破性治療藥物認定 復發難治性淋巴瘤迎來新希望
格隆匯 2 月 8日丨基石藥業-B(02616.HK)發佈公吿，舒格利單抗(抗PD-L1單抗)被國家藥品監督管理局藥品審評中心納入突破性治療藥物認定，擬定適應症為復發或難治性(“R/R”)結外自然殺傷細胞/T細胞淋巴瘤(“ENKTL”)。這是繼2020年10月美國食品藥品監督管理局分別授予舒格利單抗孤兒藥資格用於治療T細胞淋巴瘤和突破性療法認定用於治療成人R/R ENKTL後，舒格利單抗取得的又一個重要進展。
近年來，為鼓勵創新和滿足臨牀急需，中國設立了藥品快速審評上市通道。其中，突破性治療藥物針對的是臨牀試驗期間，具有明顯臨牀優勢的創新藥或改良型新藥。舒格利單抗獲得國家藥品監督管理局突破性療法的認定，將極大加快其在中國的開發及商業化速度。
此次突破性治療藥物認定是基於CS1001-201研究，即一項評價舒格利單抗單藥治療成人R/R ENKTL的單臂、多中心、II期、註冊性研究。2020年CSCO會議上公佈的研究資料顯示，在38例療效可評估患者中，客觀緩解率(“ORR”)為44.7%，完全緩解(“CR”)率為31.6%，中位緩解持續時間為16.8個月。在接受舒格利單抗治療的43例患者中，中位總生存期為19.7個月，1年總生存率為55.5%，且安全性和耐受性良好。
CS1001-201牽頭研究者、中山大學附屬腫瘤醫院黃慧強教授表示：“復發或難治性結外自然殺傷細胞/T細胞淋巴瘤惡性程度高、侵襲性強，加上臨牀缺乏有效治療藥物，導致該疾病治癒率低、預後差，患者存在非常迫切的臨牀治療需求。研究資料顯示，舒格利單抗有望成為R/R ENKTL患者新的治療選擇。”
基石藥業首席醫學官楊建新博士表示：“我們非常高興地看到舒格利單抗被國家藥品監督管理局納入突破性治療藥物。中美兩國的藥物監管部門對同一款藥物均授予突破性治療藥物認定，這在國內創新藥領域實屬罕見，也充分證明了這款藥物的巨大臨牀價值。我們期待與中國國家藥品監督管理局等監管機構繼續密切協作，力爭早日將舒格利單抗帶給中國R/R ENKTL患者。”
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