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復宏漢霖(02696.HK):HLX20用於晚期實體瘤治療的1期臨牀研究結果顯示其安全性及耐受性良好
格隆匯 04-19 17:52

格隆匯4月19日丨復宏漢霖(02696.HK)宣佈,近日,公司自主開發的HLX20(重組抗PD-L1全人單克隆抗體注射液)("HLX20")於澳大利亞完成1期臨牀研究,其在一項於晚期實體瘤患者中開展的1期臨牀研究中展現了良好的安全性及耐受性。

本研究是一項HLX20在經標準治療失敗的轉移或復發的實體瘤患者中開展的開放、劑量遞增、首次人體1期試驗。研究的主要終點為不良事件的發生率和HLX20的最大耐受劑量(MTD)。次要終點包括藥代動力學特徵、免疫原性和初步療效。本研究遵循BOIN設計,26名合格的患者分別被納入到1、3、10和20mg/kg四個劑量組。研究結果表明HLX20在晚期實體瘤患者中具有良好的安全性和耐受性。

截至公吿日,於全球範圍內上市的靶向PD-L1的單克隆抗體藥品包括羅氏製藥的泰聖奇®、阿斯利康製藥有限公司的英飛凡®、默克製藥的BAVENCIO®等。根據IQVIAMIDASTM提供的資料(IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商),2021年度,靶向PD-L1的單克隆抗體藥品於全球範圍內的銷售金額約為66.42億美元。

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