Telitacicept shows promise in treating primary Sjögren's disease, favorable safety profile.

Vor Bio's collaborator, RemeGen, achieved the primary endpoint in a Phase 3 clinical study evaluating telitacicept for primary Sjögren's disease in China. The treatment demonstrated a favorable safety profile and is positioned as a potential best-in-disease profile for this condition. Data from the study will be presented at an upcoming medical conference.

YANTAI, China, Aug. 13, 2025 /PRNewswire/ -- Remegen (688331.SH/09995.HK) announced today that its global first-in-class BLyS (BAFF)/APRIL dual-target fusion protein drug, Telitacicept, met the primary endpoint in its Phase III clinical trial for the treatment of primary Sjögren's syndrome (pSS) in China. The company plans to promptly submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences in due course.

The multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluated the efficacy and safety of Telitacicept in patients with primary Sjögren's syndrome. The primary endpoint was the change from baseline in the ESSDAI score (the gold standard for measuring Sjögren's syndrome disease activity) at Week 24. The clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sjögren's syndrome patients while showing a favorable safety profile.

Primary Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocyte infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, as well as potential systemic complications. The prevalence rate in China is estimated to be between 0.3% to 0.7%, or 4-10 million potential patients. The lack of effective treatment methods rigorously validated by evidence-based medicine has been a significant challenge in managing this condition.

Telitacicept, developed independently by Remegen, simultaneously inhibits the overexpression of B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL). It effectively blocks the abnormal differentiation and maturation of B cells and has demonstrated favorable efficacy and safety in both clinical and real-world studies. The drug has been recommended by multiple authoritative guidelines in China, including the Chinese Clinical Practice Guideline for Off-Label Use of Drugs in Sjögren's Syndrome, the Chinese Expert Consensus on B-Cell Targeted Therapy for Rheumatic Immune Diseases, and the Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Primary Sjögren's Syndrome.

Internationally, Telitacicept's Sjögren's syndrome indication has been granted Fast Track designation by the US FDA and approval to initiate a global multicenter Phase III clinical trial. This development positions Telitacicept as a potential best-in-disease profile for Sjögren's syndrome treatment.

References:
[1] https://finance.yahoo.com/news/telitacicept-meets-primary-endpoint-phase-095700267.html
[2] https://www.stocktitan.net/news/NVS/novartis-announces-both-ianalumab-phase-iii-clinical-trials-met-2vtnewbeiien.html