麗珠醫藥(01513.HK):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日丨麗珠醫藥(01513.HK)公告,近日,公司控股附屬公司珠海市麗珠單抗生物技術有限公司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”(LZM012)的Ⅲ期臨牀試驗達到主要研究終點。
該Ⅲ期臨牀研究是一項在中重度斑塊型銀屑病患者中開展的多中心、隨機、雙盲、陽性對照(司庫奇尤單抗)的臨牀試驗。臨牀試驗組長單位爲復旦大學附屬華山醫院。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(PASI 100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PASI 100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PASI 75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PASI 100應答率,LZM012 320mg Q4W和320mg Q8W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。
公司近期已就LZM012治療成人中重度斑塊狀銀屑病適應症,向國家藥品監督管理局藥品審評中心(CDE)遞交上市許可申請前的溝通交流申請,推進LZM012的上市進程。
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