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君實生物(01877.HK):VV116片正處於國際多中心III期臨牀研究階段

格隆匯4月28日丨君實生物(01877.HK)公吿,近日,由公司控股子公司上海君拓生物醫藥科技有限公司與蘇州旺山旺水生物醫藥有限公司(以下簡稱“旺山旺水”)合作開發的口服核苷類抗SARS-CoV2藥物VV116片正處於國際多中心的III期臨牀研究階段,多項針對輕中度和中重度新型冠狀病毒肺炎患者的註冊臨牀研究正在進行中。

2022年4月,香港中文大學(中大)臨牀研究中心宣佈與中大醫院合作進行臨牀研究,以評估VV116用於早期治療輕度至中度COVID-19患者的有效性。由於藥品的研發週期長、審批環節多,容易受到一些不確定性因素的影響,VV116的臨牀研究進程、研究結果及審批結果均具有一定的不確定性。

據悉,VV116是一款新型口服核苷類抗SARS-CoV-2藥物,可抑制SARS-CoV-2複製。臨牀前研究顯示,VV116在體內外都表現出顯着的抗SARS-CoV-2作用,對SARS-CoV-2原始株和已知重要變異株(Alpha、Beta、Delta和Omicron)均表現出抗病毒活性,同時具有很高的口服生物利用度和良好的化學穩定性。VV116由中國科學院上海藥物研究所、中國科學院武漢病毒研究所、中國科學院新疆理化技術研究所、中國科學院中亞藥物研發中心/中烏醫藥科技城(科技部“一帶一路”聯合實驗室)、旺山旺水和公司共同研發。

2021年9月,君拓生物與旺山旺水訂立合作開發合同,共同承擔VV116在合作區域內的臨牀開發和產業化工作,合作區域為除中亞五國1、俄羅斯、北非2、中東3四個區域外的全球範圍。

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