VOR•VOR•China’s NMPA fully approved telitacicept as the first therapy for adult Sjögren’s disease, based on Phase 3 data demonstrating significant ESSDAI and ESSPRI improvements. The agency also granted conditional approval for IgA nephropathy after TELIGAN Phase 3 showed a 59% reduction in urinary protein-to-creatinine ratio at Week 39.
The NMPA approved telitacicept for treating adult Sjögren’s disease, marking the first and only therapy for this indication in China. Approval was based on a Phase 3 trial demonstrating statistically significant and clinically meaningful reductions in disease activity index (ESSDAI) and patient-reported symptoms (ESSPRI) sustained through Week 48, representing the fifth approved indication for the drug.
Telitacicept received conditional approval for adult IgA nephropathy following positive Phase 2 and Phase 3 TELIGAN results showing a 59% decline in urinary protein-to-creatinine ratio at Week 39 and stable eGFR compared with placebo. This marks the fourth indication approval, underpinned by favorable safety data and immunological effects consistent with dual BAFF/APRIL inhibition.
RemeGen holds development and commercialization rights in Greater China while Vor Bio retains exclusive ex-China rights and is positioned to earn royalties on Chinese sales. Vor Bio is advancing global Phase 3 trials in Sjögren’s disease and generalized myasthenia gravis in the US, Europe and Japan, targeting additional regulatory approvals and revenue milestones.
