regulatory
confidence high
sentiment positive
materiality 0.70
RemeGen gets NMPA nods for telitacicept in IgAN and Sjögren’s; Vor Bio holds ex-China rights
Vor Biopharma Inc.
- First BAFF/APRIL-targeting therapy approved for IgA nephropathy; conditional NMPA approval based on Phase 3 TELIGAN trial showing 55% placebo-adjusted UPCR reduction.
- First regulatory approval ever for Sjögren’s disease in China; Phase 3 met primary and secondary endpoints (ESSDAI, ESSPRI).
- Telitacicept now has five approved indications in China; Vor Bio holds exclusive development/commercialization rights outside Greater China.
- Phase 3 IgAN results recently published in NEJM; eGFR stable at 39 weeks vs declines on placebo.
- Vor Bio CEO cites milestone validating dual BAFF/APRIL inhibition as potential foundational therapy for autoimmune diseases.