智通财经网·2025-08-14 12:29Core Viewpoint - Rongchang Biopharmaceutical (09995) announced that its innovative BLyS/APRIL dual-target fusion protein drug, Tai'aisip (泰爱), has successfully completed the primary endpoint of a Phase III clinical trial for the treatment of primary Sjögren's syndrome (pSS) in China, and the company plans to submit a marketing application to the National Medical Products Administration (NMPA) soon [1][2] Group 1 - Tai'aisip is the first BLyS/APRIL dual-target fusion protein drug globally to complete Phase III research for the treatment of Sjögren's syndrome [1] - The Phase III clinical study is a multi-center, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Tai'aisip in pSS patients, with the primary endpoint being the change in ESSDAI score at week 24 [1] - The results indicate that Tai'aisip can sustainably and effectively improve clinical symptoms in pSS patients, demonstrating good efficacy and safety [1] Group 2 - Primary Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocyte 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 estimated to be between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] - The overactivation of autoreactive B cells is a key pathological basis for the onset of Sjögren's syndrome, and Tai'aisip effectively inhibits the overexpression of BLyS and APRIL, preventing abnormal differentiation and maturation of B cells [2] Group 3 - Tai'aisip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for the Use of Super Drugs in Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Tai'aisip has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its indication in Sjögren's syndrome and has been approved to conduct global multi-center Phase III clinical trials [2]