歌禮制藥-B(01672.HK):河南宣佈已有3例新冠感染患者服用洛匹那韋╱利托那韋等藥品後治癒
格隆匯2月3日丨歌禮制藥-B(01672.HK)公佈,公司已收到相關醫療機構和研究人員申請使用公司研發的ASC09複方片和利托那韋(Ritonavir)開展新型冠狀病毒(2019-nCoV)感染患者臨牀試驗。
目前,公司正在與相關醫療機構和研究人員溝通,積極協助相關醫療機構和研究人員申請由研究人員發起的相關新型冠狀病毒感染患者的臨牀試驗。公司將就該等臨牀試驗的進展及時告知公眾。
河南省衞生健康委員會於2020年1月31日宣佈已有3例確診的新型冠狀病毒感染患者在服用洛匹那韋╱利托那韋等藥品後治癒。
此外,公司醫學團隊在浙江省部分醫院做調查後初步瞭解,截至公告日,浙江省部份醫院已有超過20例確診的新型冠狀病毒感染患者在服用洛匹那韋╱利托那韋后核酸檢測轉陰。
據悉, ASC09複方片(ASC09╱利托那韋)和洛匹那韋╱利托那韋同為HIV蛋白酶抑制劑。在既往國外已完成的IIa期臨牀試驗中,ASC09聯合利托那韋顯示出對艾滋病患者有良好的抗病毒活性及安全性。經14天治療,患者血樣本病毒載量下降高達62倍。研究顯示HIV病毒需有7個基因突變時才有可能對ASC09產生耐藥性,表明ASC09與其它已批准上市的HIV蛋白酶抑制劑包括洛匹那韋相比具有較高的耐藥基因屏障。
公告稱,利托那韋(Ritonavir)及ASC09複方片均為公司尚未獲得上市批文的產品。公司已於2020年1月25日向國家藥品監督管理局及其藥品審評中心申請將利托那韋(Ritonavir)及ASC09複方片納入國家應急通道。相關藥監部門已確認收到公司該等申請。公司正在與相關藥監部門積極溝通,並會就該等申請的任何進展及時告知公眾。
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