榮昌生物(09995.HK)：泰它西普(商品名：泰愛®)治療原發性乾燥綜合徵中國III期臨牀研究達到主要終點
格隆匯8月14日丨榮昌生物(09995.HK)公佈，全球首創BLyS/APRIL雙靶點融合蛋白藥物泰它西普（商品名：泰愛®)用於治療原發性乾燥綜合徵(pSS)的中國III期臨牀研究，達到方案設計的臨牀試驗主要研究終點，將盡快向國家藥品監督管理局藥品審評中心(CDE)遞交上市申請，並擇機在國際重大學術會議上公佈具體數據。泰它西普成爲治療乾燥綜合徵領域全球首個完成III期研究的BLyS/APRIL雙靶點融合蛋白藥物。
這是一項多中心、隨機、雙盲、安慰劑對照的III期臨牀研究，旨在評價泰它西普用於治療原發性乾燥綜合徵患者的有效性和安全性。主要終點是治療第24周ESSDAI評分（衡量乾燥綜合徵疾病活動的金標準）較基線的變化。臨牀研究結果顯示，泰它西普可持續有效改善乾燥綜合徵患者的臨牀症狀，顯示出良好的療效和安全性。
乾燥綜合徵是一種慢性炎症性自身免疫性疾病，以淋巴細胞浸潤和外分泌腺體損傷爲主要特徵。除唾液腺和淚腺功能障礙導致的持續口乾、眼乾外，還可累及多系統器官。中國乾燥綜合徵的患病率爲0.3%-0.7%，且呈上升趨勢，存在巨大尚未被滿足的臨牀需求。
研究表明，自身反應性的B細胞過度活化是乾燥綜合徵發病的重要病理基礎。泰它西普是由公司自主研發的新型雙靶融合蛋白，可同時靶向抑制B淋巴細胞刺激因子(BLyS)及增殖誘導配體(APRIL)的過度表達，有效阻止B細胞異常分化與成熟，在臨牀和真實世界研究中展現出良好的療效和安全性。
在中國，泰它西普獲得《乾燥綜合徵超藥品說明書用藥中國臨牀實踐指南》《B細胞靶向藥物治療風溼免疫病中國專家共識》《原發性乾燥綜合徵多學科診療專家共識》等多項權威指南推薦。在國際上，泰它西普的乾燥綜合徵適應症已獲美國食品藥物監督管理局授予的快速通道資格並獲準開展全球多中心III期臨牀試驗。
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