REMEGEN (09995) announced that its globally pioneering BLyS/APRIL dual-target fusion protein drug Telitacicept (brand name: Taiai) has achieved the primary endpoint in a China Phase III clinical trial for treating primary Sjögren's syndrome (pSS). The company will submit a marketing application to China's National Medical Products Administration Center for Drug Evaluation (CDE) as soon as possible and will present detailed data at major international academic conferences at an appropriate time. Telitacicept becomes the world's first BLyS/APRIL dual-target fusion protein drug to complete Phase III studies in the field of Sjögren's syndrome treatment.

This was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Telitacicept in treating patients with primary Sjögren's syndrome. The primary endpoint was the change in ESSDAI score (the gold standard for measuring Sjögren's syndrome disease activity) from baseline at week 24 of treatment. Clinical trial results showed that Telitacicept can sustainably and effectively improve clinical symptoms in Sjögren's syndrome patients, demonstrating good efficacy and safety.

Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized primarily by lymphocyte infiltration and exocrine gland damage. Beyond salivary and lacrimal gland dysfunction causing persistent dry mouth and dry eyes, it can also affect multiple organ systems. The prevalence of Sjögren's syndrome in China ranges from 0.3% to 0.7% and shows an upward trend, representing a significant unmet clinical need.

Research indicates that excessive activation of autoreactive B cells is an important pathological basis for Sjögren's syndrome development. Telitacicept is a novel dual-target fusion protein independently developed by the company that can simultaneously target and inhibit the overexpression of B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), effectively preventing abnormal B cell differentiation and maturation, and has demonstrated good efficacy and safety in clinical and real-world studies.

In China, Telitacicept has received recommendations from multiple authoritative guidelines including the "Chinese Clinical Practice Guidelines for Off-label Use of Drugs in Sjögren's Syndrome," "Chinese Expert Consensus on B-cell Targeted Drug Therapy for Rheumatic and Immune Diseases," and "Multidisciplinary Expert Consensus on Primary Sjögren's Syndrome Diagnosis and Treatment." Internationally, Telitacicept's Sjögren's syndrome indication 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.