（股份代號：9995） 自願公告 泰它西普（商品名：泰愛®）治療IgA腎病 中國III期臨床研究A階段達到主要終點 本公告由榮昌生物製藥（煙台）股份有限公司（「本公司」）自願作出。 本公司董事會（「董事會」）欣然宣佈，本公司自主研發的全球首創BLyS/APRIL雙 靶點融合蛋白創新藥泰它西普（商品名：泰愛®）用於治療IgA腎病(IgAN)的中國III 期臨床研究，達到A階段的主要研究終點。我們將盡快向中國國家藥品監督管理 局(NMPA)藥品審評中心(CDE)遞交上市申請(BLA)。 這是一項多中心、隨機、雙盲、安慰劑對照臨床試驗，納入了318例接受過標準 治療的IgAN成人患者，泰它西普的使用劑量為240mg，皮下注射，每週1次。A 階段分析結果顯示：與對照組相比，泰它西普組患者在治療39周時的24小時尿蛋 白肌酐比值(UPCR)降低了55%(P<0.0001)，且表現出良好的耐受性和安全性。詳 細數據將在國際重大學術會議上公佈。 IgAN是一種常見的原發性腎小球疾病，該病臨床表現多樣，如反覆發作的鏡下血 尿或肉眼血尿，伴有不同程度蛋白尿，部分患者可以出現嚴重高血壓或者腎功能 異常。IgA腎病也是中國慢性腎臟 ...

Core Insights - The company has successfully completed a Phase III clinical trial for its innovative drug, Tai'ai (RC18), targeting primary Sjögren's syndrome, achieving the primary endpoints as per the study design [1][3] Group 1: Drug Development and Clinical Research - Tai'ai is a dual-target fusion protein developed by the company, designed to inhibit the overactivation of autoreactive B cells, which is a significant pathological basis for the onset of Sjögren's syndrome [2] - The Phase III clinical trial was a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Tai'ai in patients with primary Sjögren's syndrome [1][3] - Results from the clinical study indicate that Tai'ai can sustainably and effectively improve clinical symptoms in patients, demonstrating good efficacy and safety [3] Group 2: Market and Clinical Need - Primary Sjögren's syndrome is a chronic inflammatory autoimmune disease with a prevalence rate in China ranging from 0.3% to 0.7%, indicating a growing unmet clinical need [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) in China, with detailed data expected to be presented at major international academic conferences [3]