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翰森製藥(03692.HK):IBREXAFUNGERP片獲臨牀試驗批准通知書
格隆匯 12-15 21:51

格隆匯12月15日丨翰森製藥(03692.HK)公吿,Ibrexafungerp片獲得中國國家藥品監督管理局核准簽發的臨牀試驗批准通知書。集團將於中國境內開展針對外陰陰道念珠菌病(VVC)的3期臨牀試驗。

截至本公吿日期,該產品已獲得美國食品藥品監督管理局批准用於治療外陰陰道念珠菌病,成為二十多年來首個新抗真菌類,也是首個及唯一的陰道酵母菌感染非唑類療法。

Ibrexafungerp是首個全新三萜類結構的糖原合成酶抑制劑,是一種全新作用機制的抗真菌類藥物。該藥物已被驗證可以高效抑制糖原合成酶活性,並具有口服和注射兩種劑型方便使用。Ibrexafungerp多項適應症已處於後期臨牀開發階段,包括主要由念珠菌(包括耳念珠菌)和麴黴屬等真菌引起的院內感染。體內和體外實驗已顯示出Ibrexafungerp具有廣譜的抗真菌活性,可以用於唑類和棘白菌素類等多種藥物耐藥菌株引起的感染。

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