復宏漢霖(02696.HK)：ACE2-Fc受體融合蛋白HLX71(用於治療新型冠狀病毒肺炎)1期臨牀研究結果顯示其安全性及耐受性良好
格隆匯3月14日丨復宏漢霖(02696.HK)發佈公吿，公司自主研發的ACE2-Fc受體融合蛋白HLX71（HLX71）於近日完成1期臨牀研究，其在一項於健康成年受試者中開展的1期臨牀研究中展現了良好的安全性及耐受性。
本研究是一項隨機、雙盲、安慰劑對照、劑量遞增的1期臨牀試驗。試驗共有1mg/kg、3mg/kg、10mg/kg及15mg/kg四個劑量組，每組各入組8名健康成年受試者，按3:1的比例，6名給予HLX71，2名給予安慰劑。該研究的主要目的為評估HLX71的劑量限制性毒性(DLT)，安全性及耐受性。次要目的包括評估HLX71的免疫原性、藥效動力學及藥代動力學特性。
試驗中未見受試者出現劑量限制性毒性(DLT)，且研究中無新增安全性信號。試驗結果表明HLX71在健康成年受試者中展現了良好的安全性和耐受性。
據悉，HLX71是公司自主研發的、C末端帶有IgG1 Fc的重組人血管緊張素轉換酶2（human Angiotensin converting enzyme 2，hACE2）融合蛋白，擬用於治療新型冠狀病毒肺炎(COVID-19)。其作用機理為HLX71可以競爭性地與SARS-CoV-2表面的Spike蛋白結合，從而抑制病毒與宿主細胞表面的血管緊張素轉換酶2（Angiotensin converting enzyme 2，ACE2）結合，最終達到抑制病毒感染的效果。臨牀前藥理學研究、藥代動力學研究及安全性評價證明，HLX71能夠顯著抑制SARS-CoV-2病毒感染，具有良好的安全性，可以用於開展後續的人體臨牀試驗。2020年11月，HLX71用於治療新型冠狀病毒肺炎(COVID-19)的臨牀試驗申請(IND)獲美國食品藥品管理局(FDA)批准。
截至本公吿日，於全球範圍內尚無針對新型冠狀病毒肺炎(COVID-19)的ACE2-Fc受體融合蛋白藥物獲批上市。
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