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荣昌生物制药(烟台)股份有限公司 自愿披露关于泰它西普治疗原发性干燥综合征Ⅲ期临床研究达到 主要研究终点的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-14 08:44
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]
荣昌生物高开近5% 泰它西普治疗原发性干燥综合征III期临床达到主要终点
Zhi Tong Cai Jing· 2025-08-14 01:28
Core Viewpoint - Rongchang Biologics (09995) experienced a nearly 5% increase in opening price, currently up 4.7% at HKD 71.35, with a trading volume of HKD 11.84 million [1] Group 1: Clinical Research Announcement - The company announced that its self-developed BLyS/APRIL dual-target fusion protein innovative drug, Tai'aisip (RC18), has successfully completed Phase III clinical trials for the treatment of primary Sjögren's syndrome (pSS), achieving the primary endpoint as per the study design [1] - The clinical research results indicate that Tai'aisip can sustainably and effectively improve the clinical symptoms of patients with Sjögren's syndrome, demonstrating good efficacy and safety [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) as soon as possible, with detailed data to be presented at major international academic conferences [1]