RemeGen’s Telitacicept Delivers Positive Phase III Results in Sjögren’s Syndrome

RemeGen has announced that its fusion protein telitacicept (Taiai) achieved its primary endpoints in a Phase III trial (NCT05673993) for Sjögren’s syndrome in China. The study showed a significant reduction in ESSDAI scores over 24 weeks, alongside a favorable safety profile. The company plans to present detailed findings at upcoming international conferences and will submit the data to China’s Center for Drug Evaluation for regulatory approval.

Telitacicept is already approved in China for myasthenia gravis, rheumatoid arthritis, and systemic lupus erythematosus. Beyond China, a US-based Phase III trial is underway, with results expected in 2027. The therapy received FDA Fast Track designation in 2024.

Earlier this year, Vor Bio licensed global rights (ex-China) for $125m upfront and up to $4bn in milestones, highlighting telitacicept’s commercial potential. With Novartis’ ianalumab also advancing, analysts forecast competitive market growth, projecting telitacicept sales of $582m by 2031.

14-08-2025