君實生物(688180.SH):抗SARSCoV-2藥物VV116在健康受試者中表現出令人滿意的安全性和耐受性
格隆匯3月16日丨君實生物(688180.SH)公佈,近日,由上海君實生物醫藥科技股份有限公司控股子公司上海君拓生物醫藥科技有限公司(簡稱“君拓生物”)與蘇州旺山旺水生物醫藥有限公司(簡稱“旺山旺水”)合作開發的口服核苷類抗SARSCoV-2藥物VV116片(簡稱“VV116”)的3項I期臨牀研究結果在藥學領域知名期刊Acta Pharmaceutica Sinica發表,復旦大學附屬華山醫院張文宏教授、中國科學院上海藥物研究所王震研究員、上海市徐彙區中心醫院劉罡一主任為共同通訊作者。
研究結果顯示,VV116在健康受試者中表現出令人滿意的安全性和耐受性,且口服吸收迅速,可在空腹或普通飲食條件下口服用藥,建議在後續臨牀研究中探索每日兩次200毫克至600毫克給藥劑量。這是國產口服小分子抗SARS-CoV-2藥物首次公佈I期臨牀數據。
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著的抗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。
截至公吿披露日,VV116已在烏茲別克斯坦獲得批准用於中重度新型冠狀病毒肺炎患者的治療。
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