麗珠集團(000513.SZ):重組抗人IL-17A/F人源化單克隆抗體注射液Ⅲ期臨牀試驗達到主要研究終點
格隆匯7月21日丨麗珠集團(000513.SZ)公佈,控股附屬公司珠海市麗珠單抗生物技術有限公司(簡稱“麗珠單抗”)與北京鑫康合生物醫藥科技有限公司聯合開發的“重組抗人IL-17A/F人源化單克隆抗體注射液”(簡稱“LZM012”或“本品”)的Ⅲ期臨牀試驗達到主要研究終點。
該Ⅲ期臨牀試驗以第12周時達到銀屑病面積與嚴重程度指數(PASI)100的受試者比例(PASI100應答率)爲主要評價終點。研究結果顯示,該研究的主要療效終點已達到。第12周PASI100應答率,LZM012爲49.5%,對照組司庫奇尤單抗爲40.2%,顯示出LZM012非劣效於司庫奇尤單抗且優效於司庫奇尤單抗。主要的次要療效終點,第4周PASI75應答率,LZM012爲65.7%,對照組司庫奇尤單抗爲50.3%,顯示出LZM012起效速度更快;第52周PASI100應答率,LZM012320mgQ4W和320mgQ8W維持治療組分別爲75.9%和62.6%,顯示銀屑病患者可持續提升獲益。安全性方面,本品整體安全性良好,常見不良事件發生率與對照組各類不良事件發生率相當。
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