Key Takeaways:
China's NMPA approved telitacicept for Sjögren's disease, the first regulatory approval for the autoimmune condition globally.
"The approval represents a landmark moment for patients who have long lacked approved treatment options," Jean-Paul Kress, Chief Executive Officer and Chairman of Vor Bio, said.
The approval was supported by a Phase 3 study in which telitacicept achieved statistically significant reductions in ESSDAI score at Week 24 compared with placebo, with efficacy sustained through Week 48. The drug also showed clinically meaningful improvements in ESSPRI, a patient-reported measure of symptoms including dryness, fatigue, and pain. Both the 160 mg and 80 mg doses met the primary endpoint with a favorable safety profile.
Sjögren's disease is a chronic autoimmune condition driven by overactive B cells that damage moisture-producing glands and other organs. Hallmark symptoms include dry eyes, dry mouth, fatigue, and pain, with about one-third of patients developing systemic complications affecting the skin, lungs, kidneys, and nervous system. Despite being one of the most common rheumatic autoimmune diseases, no systemic disease-modifying therapies existed before this approval.
Telitacicept is a recombinant fusion protein that inhibits BLyS (BAFF) and APRIL, two cytokines essential to B-cell and plasma cell survival. By reducing autoreactive B cells and autoantibody production, the drug targets the underlying immunopathology of autoantibody-driven diseases. The therapy is already approved in China for systemic lupus erythematosus, rheumatoid arthritis, generalized myasthenia gravis, and IgA nephropathy.
RemeGen independently developed telitacicept and is responsible for its development, regulatory approvals, and commercialization in China. Vor Bio holds exclusive rights to develop and commercialize the drug outside Greater China.
"We congratulate RemeGen on this achievement and believe this fifth approved indication for telitacicept further reinforces its potential to become a foundational therapy across autoimmune diseases," Kress said.
The approval opens a new commercial market for RemeGen in China and strengthens the clinical evidence supporting telitacicept's mechanism across multiple autoimmune conditions. Vor Bio is advancing global Phase 3 trials in Sjögren's disease and generalized myasthenia gravis to support potential regulatory filings in the US, Europe, and Japan.
This article is for informational purposes only and does not constitute investment advice.
