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雲頂新耀-B(01952.HK):治療IgA腎病創新藥物Nefecon為擬突破性治療品種
格隆匯 12-02 07:35

格隆匯 12 月 2日丨雲頂新耀-B(01952.HK)發佈公告,國家藥品監督管理局藥品審評中心在其官網上公示Nefecon為擬突破性治療品種,Nefecon是公司引進開發用於治療IgA腎病(“IgAN”)的創新藥物。

根據披露,Nefecon是布地奈德的口服靶向釋放製劑,有潛力成為首個治療IgA腎病的新藥,目前正在開展一項全球3期臨牀研究NefIgArd,評估其對原發性IgA腎病患者的療效和安全性。公司目前正在招募中國IgA腎病患者加入NefIgArd臨牀研究,以支持Nefecon在中國的註冊審批。

公司的合作伙伴Calliditas Therapeutics AB(“Calliditas”,納斯達克股票代碼:CALT)於2020年11月8日公佈了全球NefIgArd臨牀試驗A部分獲得良好結果,結果顯示該試驗Nefecon達到了其主要終點,在治療9個月後,患者的尿蛋白肌酐比率(或蛋白尿)在統計學上顯著降低,在治療12個月後,指標有了顯著的持續性改善。此外,Nefecon已被美國食品藥品管理局(FDA)和歐洲藥品管理局(EMA)認定為治療IgA腎病的孤兒藥物。

最新修訂的《藥品註冊管理辦法》將突破性治療藥物納入優先審評審批的適用範圍及條件,這有助於加快中國針對嚴重疾病開發新藥,尤其是針對那些尚無現有療法,或者有初步證據顯示比現有療法更具優勢的新藥解決方案。 

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