雲頂新耀(01952.HK):耐賦康®獲中國藥監局完全批準用於治療具有疾病進展風險的原發性IgA腎病成人患者
格隆匯5月7日丨雲頂新耀(01952.HK)發佈公告,耐賦康®(NEFECON®)已獲中國國家藥品監督管理局(“中國藥監局”)的完全批準,取消了對蛋白尿水平的限制,用於治療具有疾病進展風險的原發性IgA腎病(“IgA腎病”)成人患者。此次完全批準意味着耐賦康®成爲中國首個且唯一獲得中國藥監局完全批準的IgA腎病對因治療藥物。
此次獲批是基於NefIgArdIII期臨牀研究的完整數據。Nef Ig Ard III期臨牀試驗是一項隨機、雙盲、全球多中心研究,在接受RAS抑制劑優化支持治療的原發性IgA腎病成人患者中評估了耐賦康®(16mg,每日一次)與安慰劑相比的療效和安全性。這項研究爲期2年,包括9個月的耐賦康®或安慰劑治療期,隨後是15個月的停藥隨訪期。全球研究結果顯示:與安慰劑相比,耐賦康®不僅帶來了持久的蛋白尿下降,減少鏡下血尿風險,更重要的是在估算腎小球濾過率(eGFR)上顯示出臨牀意義且統計學差異(p<0.0001),能減少腎功能衰退達50%。在中國人羣中的數據顯示耐賦康®能延緩腎功能衰退達66%,預計將疾病進展至透析或腎移植的時間延緩12.8年。
作爲全球首個獲得美國食品藥品監督管理局和歐洲藥品管理局完全批準的IgA腎病治療藥物,耐賦康®已相繼在公司所有授權區域(包括中國大陸、中國香港、中國澳門、中國臺灣、新加坡及韓國)獲得批準;其於中國大陸、中國香港、中國澳門及新加坡已商業化上市,並預計將於年內於韓國和中國臺灣商業化上市,惠及所有授權區域內的IgA腎病患者。
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