恆瑞醫藥(600276.SH)：SHR8008膠囊的相關多中心III期臨牀研究主要研究終點結果達到方案預設的優效標準
格隆匯11月4日丨恆瑞醫藥(600276.SH)公佈，近日，公司開展的評價SHR8008膠囊治療急性外陰陰道假絲酵母菌病的有效性與安全性的隨機、雙盲雙模擬、氟康唑平行對照、多中心III期臨牀研究(SHR8008-302)主要研究終點結果達到方案預設的優效標準。研究結果表明，SHR8008治療急性外陰陰道假絲酵母菌病痊愈率顯著優於氟康唑。公司將於近期向國家藥品監督管理局藥品審評中心遞交新藥上市的溝通交流申請。
SHR8008-302 研究是一項評價 SHR8008 膠囊治療急性外陰陰道假絲酵母菌病的有效性與安全性的隨機、雙盲雙模擬、氟康唑平行對照、多中心III期臨牀研究。由北京清華長庚醫院廖秦平教授擔任主要研究者，全國 25 家中心共同參與，共入組 322 例急性外陰陰道假絲酵母菌病受試者。主要研究終點是第 28 天訪視時急性外陰陰道假絲酵母菌病發作痊癒(定義為急性外陰陰道假絲酵母菌病症狀體徵消失同時真菌培養假絲酵母菌陰性)的受試者比例。
SHR8008是一種新型口服唑類抗真菌藥物，可高度特異性抑制真菌CYP51酶，在美國已經完成針對急性外陰陰道假絲酵母菌病的臨牀II期研究和1項針對復發性外陰陰道念珠菌病的臨牀III期研究。國內外有氟康唑、伊曲康唑、伏立康唑和艾沙康唑等多種同類產品獲批上市。氟康唑由輝瑞公司開發，1990年在美國獲批上市；伊曲康唑由 JANSSEN 公司開發，1992年在美國獲批上市；伏立康唑由輝瑞公司開發，2002年在美國獲批上市；艾沙康唑由 ASTELLAS 公司開發，2015年在美國獲批上市，以上四種藥物均已在國內獲批上市。經查詢，2020年氟康唑、伊曲康唑、伏立康唑和艾沙康唑全球銷售額合計約20.58億美元。
截至目前，SHR8008相關項目累計已投入研發費用約8939萬元。
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