榮昌生物(09995.HK)：泰它西普(商品名：泰愛)獲得國家藥監局完全批准用於治療類風濕關節炎患者
格隆匯7月22日丨榮昌生物(09995.HK)公吿，泰它西普(商品名：泰愛)正式獲得中國國家藥品監督管理局(NMPA)在中國上市的完全批准，用於與甲氨蝶呤聯合治療針對甲氨蝶呤療效不佳的中、重度活動性類風濕關節炎(RA)成人患者。
泰它西普在本適應症獲得批准，是基於一項在RA患者中開展的以甲氨蝶呤為基礎治療的隨機、雙盲、安慰劑對照、多中心的III期臨牀研究，共入組479例患者。該研究旨在評估泰它西普聯合甲氨喋呤治療對甲氨喋呤療效不佳的中重度類風濕關節炎患者的有效性和安全性。最新研究數據顯示，泰它西普顯著提升RA患者ACR20應答率，24周ACR20應答率67.4%，48周ACR20應答率持續提高，達72.2%；顯著延緩RA患者的關節結構損害，92.8%患者24周無影像學進展，89.9%患者48周無影像學進展；顯著改善RA患者的炎症水平和患者身體機能，緩解疼痛；達標(DAS28-ESR≤3.2)患者比例持續增加至48周，且安全可耐受。
泰它西普(RC18，商品名：泰愛)是公司專有用於治療自身免疫性疾病的新型融合蛋白，由人跨膜激活劑及鈣調節劑和親環素配體相互作用因子(TACI)受體的胞外域以及人免疫球蛋白G(IgG)的可結晶片段(Fc)域構成。泰它西普靶向兩類對B淋巴細胞發育至關重要的細胞信號分子：B淋巴細胞刺激因子(BLyS)和增殖誘導配體(APRIL)，得以有效降低B細胞介導的自身免疫應答，自身免疫應答與多種自身免疫性疾病有關。
該產品已於2023年11月正式獲得中國國家藥品監督管理局(NMPA)在中國的完全上市批准，用於治療系統性紅斑狼瘡(SLE)。公司現正就泰它西普用於治療自身免疫性疾病領域的其他多種適應症開展II期或III期臨牀試驗，試圖解決該治療領域大量未滿足或未充分滿足的醫療需求。
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