康寧傑瑞製藥(09966.HK)收到FDA批准在美國進行KN046治療NSCLC II期臨牀試驗可繼續進行函件
格隆匯4月15日丨康寧傑瑞製藥-B(09966.HK)發佈公告,2020年4月15日,公司全資附屬公司江蘇康寧傑瑞收到美國食品藥品監督管理局(“美國FDA”)的批准通知,批准KN046,一種雙特異性抗體,可在美國就針對抗PD-(L)1難治性或複發性非小細胞肺癌(“NSCLC”)進行II 期臨牀試驗。
I I期臨牀試驗已設計為一項開放式標籤、多中心、多隊列的單臂研究,以評估 KN046單一療法或結合化療在局部晚期不可切除或轉移性NSCLC中的療效、安全性及耐受性。美國FDA已完成江蘇康寧傑瑞新藥臨牀申請的安全性審查,並得出結論,江蘇康寧傑瑞可進行II期臨牀試驗。
根據披露,KN046是集團研發的全球創新的程序性死亡配體1(“PD-L1”)╱ 細胞毒性T淋巴細胞相關蛋白4(“CTLA-4”)雙特異性抗體。KN046同時靶向兩個臨牀驗證的免疫檢查點,PD-L1及CTLA-4。KN046的臨牀前研究及臨牀試驗已顯示出良好的安全性,且I期臨牀試驗的初步結果亦表明療效可觀。KN046目前正在進行對 NSCLC、三陰乳腺癌(TNBC)、食管鱗狀細胞癌(ESCC)及胰腺癌的多項II期臨牀試驗。該等臨牀試驗結果將於各種場合(包括醫學會議)發佈。由於KN046藥物機制的優勢,其有望成為第二代免疫腫瘤治療藥物的基石藥物之一。
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