中國生物製藥(01177.HK):羅伐昔替尼臨牀前及臨牀數據在EHA 2025公佈
格隆匯6月18日丨中國生物製藥(01177.HK)發佈公告,集團已在2025年歐洲血液學年會(EHA)以口頭報告的形式公佈了羅伐昔替尼(Rovadicitinib)用於治療急性移植物抗宿主病(aGVHD)的臨牀前及Ib期臨牀研究結果:28天總體緩解率(ORR)達84.6%,中位應答時間爲4天,12個月總生存率爲92.3%。
aGVHD是異基因造血幹細胞移植(allo-HSCT)後的主要併發症之一,或可危及患者生命。糖皮質激素是目前aGVHD的標準一線治療方案,但超過半數患者對糖皮質激素無反應或初始應答後出現疾病進展,因此死亡率極高。羅伐昔替尼作爲一種口服、選擇性JAK1/2和ROCK1/2抑制劑,靶向調控aGVHD的多個通路,有望爲糖皮質激素耐藥(SR)aGVHD患者提供更佳治療選擇。
快速起效、持久緩解:臨牀數據顯示,28天ORR達84.6%,腸道緩解率達80%,中位總體應答時間僅4天,12個月生存率高達92.3%。
激素減停:56天內,38.5%的患者完全停用激素,極大地減少了長期免疫抑制的副作用。
羅伐昔替尼是全球首款JAK/ROCK雙通路抑制劑,該研究結果標誌着公司在移植物抗宿主病(GVHD)治療領域的又一突破。此外,羅伐昔替尼用於治療慢性移植物抗宿主病(cGVHD)已啓動三期臨牀試驗,目前正在受試者入組環節。集團將持續關注移植物抗宿主病領域,旨在爲患者提供更優的治療方案。
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