Boston, September 29, 2025 Vor Bio has announced that late-breaking Phase 3 clinical data of telitacicept in primary Sjögren’s disease will be presented at ACR Convergence 2025 in Chicago this October. The randomized, double-blind, placebo-controlled study conducted in China is the most advanced clinical investigation of telitacicept for this condition, offering new hope in autoimmune medicine.
Science Significance
The study evaluates telitacicept, a recombinant fusion protein with a dual-target mechanism blocking BLyS (BAFF) and APRIL, two cytokines crucial for B cell and plasma cell survival. By reducing autoreactive B cells and autoantibody production, telitacicept directly targets the underlying drivers of Sjögren’s disease, which currently lacks approved systemic disease-modifying therapies. The Phase 3 findings add critical evidence supporting its role as a potential first-in-class therapy.
Regulatory Significance
Earlier this month, China’s National Medical Products Administration (NMPA) accepted a Biologics License Application (BLA) for telitacicept in primary Sjögren’s disease. If approved, this would represent the drug’s fourth indication in China, following approvals for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). The Phase 3 data to be unveiled at ACR further strengthens the case for global regulatory submissions.
Business Significance
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For Vor Bio, the late-breaking poster at ACR Convergence enhances its clinical and commercial positioning in the autoimmune space. The results could expand telitacicept’s footprint beyond China into major international markets including United States, Europe, South America, and Asia-Pacific, where Phase 3 trials are already underway. Success in Sjögren’s disease would broaden the therapy’s portfolio and highlight its versatility in treating autoantibody-driven conditions.
Patients’ Significance
Sjögren’s disease disproportionately affects women, causing dry eyes, dry mouth, fatigue, and systemic organ complications that significantly impair daily life. With no disease-modifying treatment options available, patients are limited to symptomatic care. Telitacicept, if approved, would represent a transformative therapy that addresses the disease at its immune root, potentially reducing long-term complications and improving quality of life.
Policy Significance
The development of telitacicept underscores the urgent policy need to advance therapies in underserved autoimmune diseases. With nearly half of Sjögren’s cases underdiagnosed and a substantial patient burden, regulators worldwide face pressure to prioritize review pathways and international harmonization to bring innovative biologics to market faster.
The upcoming late-breaking presentation at ACR Convergence 2025 will be a defining moment for Vor Bio and the autoimmune community, signaling progress toward the first systemic disease-modifying therapy for Sjögren’s disease. With advancing regulatory reviews and growing international interest, telitacicept is positioned to reshape the treatment landscape and bring long-awaited relief to patients worldwide.
Source: Vor Bio Press Release
