Telitacicept wins NMPA approval for Sjögren's disease in China
Vor Bio and RemeGen have announced that China's National Medicinal Products Administration (NMPA) has approved telitacicept for the treatment of adult patients with Sjögren's disease (SjD) — marking the first regulatory approval for this indication anywhere in the world, and the fifth approved indication for the molecule overall.
RemeGen, which independently developed telitacicept and retains full development, regulatory, and commercial rights within Greater China, supported the filing with data from a nationwide, randomised, double-blind, placebo-controlled Phase 3 study. The primary endpoint — change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 24 — was met with statistical significance in both the 160 mg and 80 mg dosing cohorts, with the effect sustained through Week 48. The candidate also produced clinically meaningful improvements on the patient-reported ESSPRI index, capturing symptom burden alongside systemic disease activity.
The drug and the deal
Telitacicept is a recombinant fusion protein that inhibits two cytokines — BLyS (BAFF) and APRIL — that are critical to B-cell and plasma-cell survival. By suppressing both targets simultaneously, the molecule reduces autoreactive B cells and autoantibody production, the key pathological drivers of Sjögren's and several related autoimmune conditions. The drug is already approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis, and generalised myasthenia gravis (gMG).
Vor Bio (Nasdaq: VOR) holds exclusive rights to develop and commercialise telitacicept outside Greater China. The Boston-listed company is currently running global Phase 3 trials in both gMG and SjD with the aim of seeking regulatory approval in the United States, Europe, and Japan. Jean-Paul Kress, chief executive and chairman of Vor Bio, described the NMPA decision as "a landmark moment for patients who have long lacked approved treatment options," adding that telitacicept is the only therapy to have demonstrated significant, clinically meaningful improvements across both ESSDAI and ESSPRI in the indication.
Market context and competitive landscape
Sjögren's disease affects an estimated three to four million people in the United States alone, with women comprising the large majority of cases. Despite its prevalence and the significant burden of its systemic complications — including elevated lymphoma risk — no disease-modifying systemic therapy has previously been approved in any market. Current standard of care relies on symptomatic relief with artificial tears, saliva substitutes, and off-label immunosuppressants, none of which address underlying disease activity.
The unmet need has attracted a number of late-stage development programmes. Iqirvo (elafibranor), approved in a different autoimmune context, and a range of pipeline candidates targeting CD20, type I interferons, and JAK pathways are in various stages of clinical evaluation for SjD. Telitacicept's dual BLyS/APRIL mechanism differentiates it mechanistically from anti-CD20 approaches such as rituximab, which has been studied off-label in the condition without generating sufficient evidence for approval. The NMPA decision establishes a precedent that could support regulatory conversations in Western markets, though the FDA and EMA will require independent global-trial datasets rather than accepting the Chinese Phase 3 data on its own.
Vor Bio's ex-China Phase 3 programme in SjD is therefore the critical near-term value driver for the company. Investors will focus on enrolment progress, interim safety readouts, and the timing of any primary data read. A positive global trial outcome would position telitacicept as the first approved disease-modifying therapy in SjD across major markets — a commercially significant milestone in a large and historically neglected indication.