Vor Bio (VOR) today announced that Telitacicept (developed by RemeGen) has received approval from China's NMPA for the treatment of adult patients with Sjögren's disease.
Sjögren's disease (SjD), a chronic autoimmune condition that affects moisture-producing glands and can cause dry eyes, dry mouth, fatigue, and systemic complications. This marks the first and only approved therapy for SjD in China.
Telitacicept is a novel fusion protein that simultaneously targets B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), two pathways implicated in autoimmune disease progression. By modulating abnormal B-cell activity, the therapy aims to reduce systemic inflammation and improve patient symptoms across multiple autoimmune indications.
The approval was supported by results from a nationwide Phase 3 trial, randomized, double-blind, placebo-controlled study. Telitacicept met its primary endpoint, showing statistically significant reductions in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scores at Week 24, with efficacy sustained through Week 48. Patients also reported meaningful improvements in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), reflecting benefits across systemic disease activity and patient-reported symptoms.
Telitacicept demonstrated a favorable safety profile, reinforcing its potential as a foundational therapy in autoimmune diseases. This approval represents the fifth indication for Telitacicept in China. Outside Greater China, Vor Biopharma holds exclusive rights to develop and commercialize the therapy.
Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio, described the approval as a landmark moment, noting that patients with Sjögren's disease have long lacked approved treatment options. He emphasized that Telitacicept is the only therapy to show statistically significant and clinically meaningful improvements in both systemic disease activity and patient-reported outcomes.
The company implemented a 1-for-20 reverse stock split on September 15, 2025.
VOR is currently trading at $13.05, down 0.84%.
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