Zhi Tong Cai Jing·2025-08-14 12:29Core Viewpoint - Rongchang Biologics (09995) has announced that its innovative BLyS/APRIL dual-target fusion protein drug, Taisip, has successfully met the primary endpoint of its Phase III clinical trial for treating primary Sjögren's syndrome (pSS) in China, marking it as the first of its kind globally to complete such a study [1][2] Group 1: Clinical Trial Details - The Phase III clinical trial was a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Taisip in patients with primary Sjögren's syndrome [1] - The primary endpoint was the change in ESSDAI score at week 24, which is the gold standard for measuring disease activity in Sjögren's syndrome [1] - Results indicated that Taisip can sustainably and effectively improve clinical symptoms in patients, demonstrating good efficacy and safety [1] Group 2: Disease Background and Market Potential - Primary 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 estimated to be between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] Group 3: Drug Development and Recognition - Taisip is a novel dual-target fusion protein developed by the company, designed to simultaneously inhibit the overexpression of B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), effectively preventing abnormal differentiation and maturation of B cells [2] - In China, Taisip has received recommendations from several authoritative guidelines, including the "Chinese Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Taisip has been granted Fast Track designation by the U.S. Food and Drug Administration and has been approved to conduct global multicenter Phase III clinical trials for its indication in Sjögren's syndrome [2]