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基石藥業-B(02616.HK):PD-1抗體nofazinlimab首次人體試驗成果獲發表
阿思達克 09-25 15:37
基石藥業-B(02616.HK)公布,旗下PD-1抗體nofazinlimab用於治療晚期實體瘤的首次人體試驗(CS1003-101),其研究數據近日在國際知名腫瘤學期刊《British Journal of Cancer》發表,表明該產品單藥治療的安全性和耐受性良好,未觀察到劑量限製性毒性(DLT),並在多個瘤種中觀察到初步抗腫瘤活性。 CS1003-101研究是一項I期、開放標簽、劑量遞增和劑量擴展研究,於2018年5月至2021年5月在澳洲和新西蘭開展。 公司透露,nofazinlimab聯合侖伐替尼一線治療晚期肝細胞癌患者的國際多中心III期研究(CS1003-305)已於去年3月成功達成預設患者入組目標,預計將在明年首季公布主要研究結果,預期研究結果將用於支持nofazinlimab在中國、美國、歐洲等國家和地區的註冊上市,nofazinlimab聯合侖伐替尼療法將有望為晚期肝細胞癌患者提供新的治療選擇。
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