中國生物製藥(01177.HK):羅伐昔替尼片“JAK/ROCK抑制劑”納入突破性治療藥物程序
格隆匯8月6日丨中國生物製藥(01177.HK)發佈公告,集團自主研發的羅伐昔替尼片「TQ05105 (JAK/ROCK抑制劑)」已被中國國家藥品監督管理局藥品審評中心(CDE)納入突破性治療藥物程序(BTD),用於慢性移植物抗宿主病(cGVHD)的治療。
羅伐昔替尼是全球研發進度最快的JAK/ROCK雙重小分子抑制劑。集團已於2024年7月向CDE遞交羅伐昔替尼的上市申請並獲受理,用於治療中高危骨髓纖維化(MF)。目前,羅伐昔替尼正在中國開展cGVHD的III期臨牀試驗,並已在美國獲批開展II期臨牀試驗。
目前,羅伐昔替尼用於治療中重度cGVHD的Ⅲ期臨牀試驗正在受試者招募環節。集團將加速羅伐昔替尼的全球臨牀開發,儘早爲全球患者帶來更優的治療方案。
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