Group 1: Core Insights - Rongchang Biologics (09995.HK) announced that its innovative drug Taitasip (brand name: Tai Ai®) for treating primary Sjögren's syndrome has met the primary endpoint in a Phase III clinical trial in China [1] - Taitasip is the first BLyS/APRIL dual-target fusion protein drug to complete Phase III research in the field of Sjögren's syndrome globally [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Taitasip, with the primary endpoint being the change in ESSDAI score at week 24 compared to baseline [1] Group 2: Disease Background and Drug Mechanism - 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 [2] - 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 [2] - Taitasip is a novel dual-target fusion protein developed by the company that simultaneously inhibits the overexpression of BLyS and APRIL, effectively preventing abnormal differentiation and maturation of B cells [2] Group 3: Regulatory and Clinical Recognition - 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] - Internationally, Taitasip has been granted Fast Track designation by the U.S. FDA for its indication in Sjögren's syndrome and has been approved to conduct global multi-center Phase III clinical trials [2]