Vor Bio announced on August 13, 2025, that its collaborator, RemeGen Co., Ltd, achieved the primary endpoint in a Phase 3 clinical study in China evaluating telitacicept in adults with primary Sjögren's disease. This positive outcome positions telitacicept as a potential best-in-disease therapy for this condition.
The Phase 3 study demonstrated an improvement in disease activity, measured by a reduction in the EULAR Sjögren's syndrome disease activity index (ESSDAI), against placebo. Telitacicept also exhibited a favorable safety profile, which is critical for patient adoption and regulatory approval.
RemeGen plans to submit a Biologics License Application (BLA) to China's National Medical Products Administration (NMPA) for primary Sjögren’s disease, which would mark telitacicept’s fourth approved indication in China. Vor Bio is now evaluating the timing for a global Phase 3 clinical study in primary Sjögren's disease, indicating a significant expansion opportunity beyond its lead indication of myasthenia gravis.
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