GlobeNewswire·Jun 8, 2026, 8:30 AM ET

Telitacicept Receives NMPA Conditional Approval for the Treatment of IgA Nephropathy in China

China's National Medicinal Products Administration (NMPA) conditionally approved telitacicept for adult patients with IgA nephropathy (IgAN) on June 8, 2026.
This marks the first & only regulatory approval of a BAFF/APRIL-targeting therapy for IgAN.
The approval represents the fourth indication approved for telitacicept in China, following systemic lupus erythematosus, rheumatoid arthritis, & generalized myasthenia gravis.
RemeGen independently developed telitacicept & is responsible for its regulatory approvals & commercialization in China, while Vor Bio holds exclusive rights outside Greater China.
The conditional approval is supported by positive interim Phase 3 TELIGAN trial results & Phase 2 trial data published in The New England Journal of Medicine.
In the Phase 3 TELIGAN primary analysis, patients treated with telitacicept 240 mg achieved a 59% reduction in urinary protein-to-creatinine ratio (UPCR) from baseline at Week 39.
The study demonstrated a 55% placebo-adjusted reduction in UPCR & a favorable safety profile while maintaining stable estimated glomerular filtration rate (eGFR).
Telitacicept is a recombinant fusion protein that inhibits BAFF & APRIL to reduce autoreactive B cells & autoantibody production, addressing the underlying immunopathology of IgAN.
Vor Bio is advancing telitacicept in global Phase 3 trials for generalized myasthenia gravis & Sjogren's syndrome to support potential regulatory approvals in the US, Europe, & Japan.