綠葉製藥(02186.HK):新冠中和抗體已在中國完成I期臨牀試驗
格隆匯 5 月 6日丨綠葉製藥(02186.HK)發佈公吿,集團附屬公司山東博安生物技術股份有限公司所開發的治療新型冠狀病毒肺炎(“COVID-19”)的在研新藥LY-Cov Mab已在中國完成I期臨牀試驗。
此次在中國完成的臨牀研究是一項評價LY-Cov Mab注射液單次給藥的安全性、耐受性、藥代動力學特徵及免疫原性的Ⅰ期臨牀研究,共納入42例中國健康受試者。結果顯示,LY-Cov Mab具有良好的安全性和耐受性,為後期臨牀試驗提供了明確的參考依據。
嚴重急性呼吸系統綜合徵冠狀病毒2(SARS-CoV-2)造成COVID-19大流行,對全球人民健康以及經濟帶來巨大威脅。LY-Cov Mab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(RBD),並能有效阻斷病毒與宿主細胞表面受體血管緊張素轉換酶2(ACE2)的結合。其臨牀前藥效學研究結果顯示,LY-Cov Mab在治療及預防SARS-CoV-2感染方面均具有良好療效。LY-Cov Mab是具有高效力的中和抗體,同時能有效應對病毒突變。此外,引入LY-Cov Mab的FALA突變消除了與Fc受體或補體受體的結合,以避免抗病毒抗體常伴隨的ADE效應(抗體依賴的增強作用)的發生。
LY-Cov Mab由博安生物的全人抗體轉基因小鼠和噬菌體展示技術平台開發。利用博安生物自有的全人抗體轉基因小鼠BA-huMab™篩選出的抗體,無需經過傳統的抗體人源化過程,中和抗體獲得僅用了不到50天,大大提高了抗體開發速度。COVID-19在全球肆虐,LY-Cov Mab顯示出高潛力的治療效果,其相關研究已在國際權威期刊《Nature》雜誌子刊《Communications Biology》發表。LY-Cov Mab預計將於近期在中國、美國和歐洲同步開展II期臨牀試驗。集團將推進其全球上市進程,為廣大患者提供有效的治療方案。LY-Cov Mab已被納入科技部《新型冠狀病毒中和抗體產品研發應急項目》,這將加速其在中國的研發上市進程。
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