By Fineline Cube 
China-based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995), a China-based pharmaceutical firm, announced on August 14, 2025, that its Phase III clinical study for telitacicept (RC18), a self-developed innovative drug, has achieved its primary endpoint for the treatment of primary Sjögren’s syndrome (pSS). This milestone highlights the potential of telitacicept to address a significant unmet clinical need in the treatment of this chronic autoimmune disease.
About Sjögren’s Syndrome
Sjögren’s syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands. It often manifests as persistent dry mouth and dry eyes due to salivary and lacrimal gland dysfunction and can affect multiple organ systems. In China, the prevalence of Sjögren’s syndrome ranges from 0.3% to 0.7% and is increasing, underscoring the urgent need for effective therapies.
Telitacicept Mechanism
Telitacicept is a recombinant B-lymphocyte stimulator (BLyS)/proliferation-inducing ligand (APRIL) dual-target fusion protein developed by RemeGen. It works by simultaneously inhibiting the binding of BLyS and APRIL to B-cell surface receptors. This action prevents the abnormal differentiation and maturation of B cells, thereby reducing pathological immune responses.
Clinical Approval History
Since its initial approval in China in March 2021 for the treatment of systemic lupus erythematosus (SLE), telitacicept has also received approvals for rheumatoid arthritis and myasthenia gravis. The positive results from the Phase III clinical trial for pSS further reinforce its potential as a versatile treatment option for autoimmune diseases.-Fineline Info & Tech