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復宏漢霖-B(02696.HK):ACE2-Fc受體融合蛋白HLX71用於治療新冠病毒1期臨牀研究於美國完成首例受試者給藥
格隆匯 04-14 19:53

格隆匯4月14日丨復宏漢霖-B(02696.HK)公吿,近日,公司自主開發的ACE2-Fc受體融合蛋白HLX71用於治療新型冠狀病毒肺炎(COVID-19)的1期臨牀研究於美國完成首例受試者給藥。

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名受試者。該研究的主要目的為評估HLX71在健康成年受試者中的劑量限制性毒性、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。

HLX71是公司自主研發的、C末端帶有IgG1Fc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。此外,HLX71已獲國家重點研發計劃“公共安全風險防控與應急技術裝備”重點專項新冠肺炎應急項目立項。

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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