綠葉製藥(02186.HK):新冠中和抗體已在中國完成I期臨牀試驗全部受試者入組
格隆匯1月18日丨綠葉製藥(02186.HK)公吿,集團子公司山東博安生物技術有限公司的創新抗體產品LY-CovMab已在中國完成I期臨牀試驗中的全部受試者入組。
嚴重急性呼吸系統綜合徵冠狀病毒2(SARS-CoV-2)是造成新型冠狀病毒肺炎(COVID-19)的病毒。LY-CovMab是一款重組全人源單克隆中和抗體,以高親和力特異性結合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。其臨牀前藥效學研究結果顯示,LY-CovMab在治療及預防SARS-CoV-2感染方面均具有良好療效。LY-CovMab具有高效力的中和抗體,同時能有效應對病毒突變。此外,其能有效避免ADE效應(抗體依賴的增強作用)發生。
此前,LY-CovMab還被納入科技部《新型冠狀病毒中和抗體產品研發應急項目》。這將加速其研發上市進程,為廣大患者提供有效的治療方案。
COVID-19在全球肆虐,LY-CovMab顯示出高潛力的治療效果。因此集團也將在美國直接開展患者的臨牀研究,推進其全球上市進程。
據悉,LY-CovMab乃是山東博安憑藉其全人抗體轉基因小鼠和噬菌體展示技術平台開發。山東博安共擁有四個抗體發現平台,即全人抗體轉基因小鼠及噬菌體展示技術、雙特異性T細胞銜接系統技術、抗體偶聯技術及納米抗體平台。基於這四個抗體發現平台,山東博安已開發出10餘個擁有國際知識產權保護的創新抗體,其中1個在I期臨牀階段,4個預期即將進入臨牀階段。
除創新抗體外,山東博安還擁有8個生物類似藥,其中LY 01008(Avastin的生物類似藥)已申報中國上市申請;LY 06006(Prolia的生物類似藥)處於中國III期臨牀及歐美I期臨牀;LY 01011(Xgeva的生物類似藥)處於中國III期臨牀;LY 09004(Eylea的生物類似藥)處於中國III期臨牀。
公司表示,集團將持續加大對於生物製藥領域的研發投入,以加快推進創新型生物製品的開發,為全球患者提供更好的治療方案和藥品可及性。
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