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復宏漢霖-B(02696.HK)研制之藥物試驗結果反映安全性和耐受性良好
阿思達克 03-31 21:25
復宏漢霖-B(02696.HK)公布,公司研制的重組抗EGFR人源化單克隆抗體注射液HLX07,在一項評估其治療標準治療耐藥的轉移性或復發性上皮瘤的前瞻性、開放性、劑量爬坡1期臨床試驗中顯示了良好的安全性及耐受性,並已於近日完成相關臨床研究報告。

該試驗結果論證了HLX07安全性和耐受性良好,至試驗第28天患者耐受達800mg,且未檢測到劑量限制性毒性和最大耐受劑量(Maximum Tolerated Dose, MTD)。

藥代動力學結果顯示,單次及多次給藥HLX07的暴露呈劑量依賴性,且在高劑量組中出現累積。晚期實體瘤患者中觀察到腫瘤應答。這項研究確立了表皮生長因子受體(EGFR)抗體HLX07的安全性和初步療效。

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