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中國抗體-B(03681.HK)自願撤回舒西利單抗在中國用於治療RA的BLA申請
格隆匯 07-14 18:05

格隆匯7月14日丨中國抗體-B(03681.HK)公吿,舒西利單抗在中國治療類風濕關節炎("RA")的III期臨牀研究中達到主要終點,並已向中華人民共和國("中國")國家藥品監督管理局提交生物製品上市許可申請("BLA")申請。已揭盲的關鍵III期數據顯示舒西利單抗對類風濕關節炎患者有明顯且顯著的療效。主要終點(雙盲階段第24周時的ACR20應答率)達到約50%的應答率,與對照組相比在統計學上展現出顯著差異。長期治療後,ACR20應答率隨時間推移不斷改善,在第52周時超過65%,延長期第104周時超過70%,且未發現新安全性風險。根據III期臨牀研究和延長研究的臨牀數據,舒西利單抗展現了良好的長期療效和安全性。

經近期與國家藥監局藥品審評中心(CDE)溝通後,公司已自願撤回舒西利單抗在中國用於治療RA的BLA申請。該決定乃經內部評估後作出,該評估確定需要補充早期療效的證據(此為CDE明確強調的上市審批的關鍵監管考量因素)以支持BLA的審批。

公司對舒西利單抗獲批准於中國上市仍具信心。公司相信憑藉舒西利單抗的獨特作用機制,通過優先靶向及抑制自身反應性B細胞,在治療包括類風濕關節炎及系統性紅斑狼瘡等自身免疫性疾病適應症中取得長期療效及安全性。公司已開始規劃舒西利單抗用於治療系統性紅斑狼瘡的新臨牀開發計劃。

同時,公司的深厚、廣泛且具差異化的管線包含多項臨牀及臨牀前新型候選藥物,包括但不限於兩個處於臨牀階段的創新藥及四個處於臨牀前階段的創新藥。公司將繼續推進包括SM17的進一步臨牀研究在內的該等管線的研發及臨牀開發。SM171b期臨牀試驗的積極頂線結果已於2025年4月7日發佈。

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