Ge Long Hui·2025-08-14 13:00Core Insights - Rongchang Biopharmaceutical (09995.HK) announced that its dual-target fusion protein drug, Taitasip (brand name: Tai'ai®), has successfully completed Phase III clinical trials for the treatment of primary Sjögren's syndrome (pSS) in China, achieving the primary endpoint of the study [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [1] - Taitasip is the first dual-target fusion protein drug to complete Phase III trials in the field of Sjögren's syndrome treatment [1] Clinical Study Details - The Phase III clinical study was a multicenter, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Taitasip in patients with primary Sjögren's syndrome [2] - 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 Taitasip significantly and sustainably improved clinical symptoms in patients, demonstrating good efficacy and safety [1] 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 dryness of the mouth and eyes, and potentially affecting 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] Mechanism of Action - Research indicates that the overactivation of autoreactive B cells is a key pathological basis for the onset of Sjögren's syndrome [2] - Taitasip is a novel dual-target fusion protein developed by the company that simultaneously inhibits the overexpression of B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), effectively preventing abnormal differentiation and maturation of B cells [2] - Taitasip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2]