智通财经网·2025-08-13 11:00Core Insights - Rongchang Biopharmaceutical (09995) announced that its self-developed dual-target fusion protein innovative drug, Tai'axi (RC18, brand name: Tai'ai®), has achieved the primary endpoint of its Phase III clinical trial for the treatment of primary Sjögren's syndrome (pSS) [1][2] Group 1: Clinical Trial Details - The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Tai'axi in patients with primary Sjögren's syndrome [1] - The trial results indicate that Tai'axi can sustainably and effectively improve the clinical symptoms of patients with Sjögren's syndrome, demonstrating good efficacy and safety [2] Group 2: Disease Background and Market Potential - Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [1] - The prevalence of Sjögren's syndrome in China is between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] Group 3: Mechanism of Action - The overactivation of autoreactive B cells is a key pathological basis for the onset of Sjögren's syndrome [1] - Tai'axi is a recombinant dual-target fusion protein that inhibits the binding of BLyS and APRIL to B cell surface receptors, preventing abnormal differentiation and maturation of B cells, thereby effectively reducing pathological immune responses [1]