雲頂新耀-B(01952.HK)：耐賦康®在中國台灣獲批，擴大IgA腎病治療範圍
格隆匯10月24日丨雲頂新耀-B(01952.HK)宣佈有關耐賦康®的兩項振奮人心的最新進展，耐賦康®為全球首個且是唯一獲得美國食品藥品監督管理局完全批准的免疫球蛋白A腎病(“IgA腎病”)對因治療藥物。
中國台灣地區藥政部門已批准耐賦康®用於治療“罹患原發性免疫球蛋白A腎病變且病情有進展風險的成人病人，用以延緩腎功能下降”，且無基線蛋白線水平限制。這標誌着擴大耐賦康®的治療範圍可治療更多IgA腎病患者。在IgA腎病患者中，亞洲人羣進展為終末期腎病的風險相較於其他人羣高56%，且疾病進展更快，因此存在巨大未被滿足的臨牀需求。
此外，《腎臟360》雜誌以“耐賦康對中國大陸IgA腎病患者中的療效及安全性：兩年NefIgArd試驗結果”為題，刊登了耐賦康®在NefIgArd III期研究中完整2年數據的中國亞組資料。文章表示，在2年的治療和觀察期間，中國亞組數據顯示，耐賦康®在腎臟保護作用，蛋白尿下降和鏡下血尿改善等方面取得了比全球研究中數值上更好的療效。與安慰劑相比，耐賦康®治療9個月後，2年內患者腎小球濾過率(eGFR)的保留效果好。經過9個月的耐賦康®治療，停藥隨訪15個月，在2年內實現了臨牀上顯著的腎功能保護，2年期間減少約66%的腎功能衰退，並觀察到持續的蛋白尿下降，9個月時尿蛋白與肌酐比較基線顯著下降37.6%。中國患者中觀察到的治療獲益數值更大，同時耐受性良好，沒有觀察到新的安全性信號。此前，中國亞組數據已於2023年11月舉行的美國腎臟病學會腎臟週上公佈。
目前，耐賦康®已於今年5月在中國大陸開出首張處方，並相繼在中國澳門、中國香港、新加坡與中國台灣獲批。今年7月，中國國家藥品監督管理局正式受理耐賦康®最終臨牀試驗階段完整資料的補充申請，耐賦康®有望成為國內首個且唯一獲得完全批准的IgA腎病對因治療藥物。此外，近期耐賦康®還被納入《2024版KDIGO IgA腎病和IgA血管炎臨牀管理實踐指南(公開審查草案)》，並被指南草案證實是迄今為止唯一被證明可以降低致病性IgA和IgA免疫複合物水準的治療方法。
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