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君實生物(01877.HK):新冠病毒中和抗體JS016完成首例受試者給藥
格隆匯 06-07 18:34

格隆匯6月7日丨君實生物-B(01877.HK)發佈公告,重組全人源抗SARS-CoV-2單克隆抗體注射液(項目代號:JS016)已於近日獲得國家藥品監督管理局批准開展I期臨牀研究並已完成首例受試者給藥。該研究設計是一項隨機、雙盲、安慰劑對照研究,目的是評價JS016在中國人羣中的耐受性、安全性和藥代動力學特徵及免疫原性,為JS016後續臨牀研究提供依據。

據悉,JS016是一款重組全人源單克隆中和抗體,特異性結合SARS-CoV-2表面刺突蛋白受體結構域,並能有效阻斷病毒與宿主細胞表面受體ACE2的結合。該項目由公司與中國科學院微生物研究所(“中科院微生物所”)共同開發。

在新冠肺炎疫情爆發之初,公司迅速啟動了中和抗體的研發工作以抗擊疫情。在兩個月的時間內,公司利用自身的工藝平台完成了IND所需的臨牀前研究,用於GLP毒理研究的抗體工藝開發和生產,以及臨牀批次的抗體GMP生產。 JS016是中國最早進入臨牀階段的新冠病毒中和抗體,其開發速度處於國際領先地位。

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