榮昌生物-B(09995.HK)：泰它西普治療組患者的尿蛋白水平與基線相比顯著降低
格隆匯8月10日丨榮昌生物-B(09995.HK)發佈公吿，公司已完成了泰它西普（RC18，商品名：泰愛）在中國治療IgA腎病(IgAN)患者的II期臨牀研究，並獲得了初步數據結果。
II期臨牀研究共招募44名患者。初步分析顯示，泰它西普治療組患者的尿蛋白水平與基線相比顯著降低，相比安慰劑組，其差異具有統計學意義。此外，其他幾個次要終點進一步表明治療組與安慰劑組之間的顯著差異。相關臨牀數據將在有關國際會議或期刊上發表。公司計劃將在中國和美國開展進一步研究。
IgA腎病(IgAN)是一種免疫複合物引起的腎小球腎炎，表現為血尿、蛋白尿及不同比例的進展型腎衰竭。IgA腎病是全球原發性腎臟疾病的最常見原因。根據弗若斯特沙利文的資料，全球IgA腎病患者人數由2015年的880萬人增加至2020年的930萬人（包括中國220萬人）。預計全球IgA腎病患者總數將於2025年達到970萬人（包括中國230萬人），並於2030年達到1,020萬人（包括中國240萬人）。
據悉，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蛋白配體相互作用因子(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2021年3月11日正式獲得中國國家藥品監督管理局(NMPA)在中國的附條件上市的批准，用於治療系統性紅斑狼瘡(SLE)。公司現正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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