榮昌生物-B(09995.HK)：泰它西普獲批准在中國有條件上市
格隆匯3月11日丨榮昌生物-B(09995.HK)公吿，公司自主研發的雙靶向融合蛋白藥物泰它西普（RC18，商品名：泰愛）正式獲得中國國家藥品監督管理局(NMPA)在中國的有條件上市的批准，用於治療系統性紅斑狼瘡(SLE)。
泰它西普（RC18，商品名：泰愛）獲准上市銷售是集團的一項重大里程碑，體現了集團在自身免疫疾病治療領域的成就，也彰顯了集團在生物藥物開發領域的能力，並顯示出集團強大的自主研發能力。
系統性紅斑狼瘡(SLE)是自身免疫性風濕疾病中死亡率及致殘率最高的疾病之一。根據弗若斯特沙利文的資料，2019年全球SLE患病人口約為7.7百萬人，估計到2030年將達到860萬人。在中國，2019年SLE患者約為100萬人，估計到2030年將增至約110萬人。根據弗若斯特沙利文的資料，估計全球SLE生物療法的市場規模將按複合年增長率26.8%由2019年的8億美元增至2030年的108億美元。泰它西普是近60年內在中國獲批的第二個可用於SLE的全新生物製劑。
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。公司現正於多種適應症開展II期或III期臨牀試驗，評估泰它西普，以探索其治療各種自身免疫性疾病的潛力，旨在解決該治療領域中大量未滿足或未充分滿足的醫療需求。公司現正於後期臨牀試驗評估泰它西普，以探索其解決七大自身免疫性疾病的潛力，旨在解決該治療領域中大量未滿足或未充分滿足的醫療需求。
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