Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 10 hours ago
- 2 min read
08/06/2026
Telitacicept received NMPA conditional approval for the treatment of IgA Nephropathy in China (Ref)
Vor Bio and RemeGen Co. announced that China’s National Medicinal Products Administration (NMPA) had conditionally approved telitacicept (BAFF/APRIL dual inhibitor) for the treatment of adult patients with IgA nephropathy (IgAN).
The conditional approval was supported by positive results from Phase 3, TELIGAN trial in IgAN.
RemeGen independently developed telitacicept and was responsible for its development, regulatory approvals, and commercialization in China.
Vor Bio held exclusive rights to develop and commercialize telitacicept outside of Greater China.
Telitacicept received NMPA approval for the treatment of Sjögren’s disease in China (Ref)
Vor Bio and RemeGen Co. announced that China’s National Medicinal Products Administration (NMPA) had approved telitacicept (BAFF/APRIL dual inhibitor) for the treatment of adult patients with Sjögren’s disease (SjD).
The approval was based on positive results from RemeGen's Phase 3 trial that demonstrated statistically significant and clinically meaningful improvements in both ESSDAI and ESSPRI in patients with Sjögren's disease.
RemeGen independently developed telitacicept and was responsible for its development, regulatory approvals, and commercialization in China.
Vor Bio helds exclusive rights to develop and commercialize telitacicept outside of Greater China.
Alvotech announced FDA acceptance of a BLA for AVT16, a proposed interchangeable biosimilar to Entyvio® (Ref)
Alvotech announced that the US FDA had accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.
The BLA submission was supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT16 and the reference product.
Under a partnership with Teva Pharmaceutical, Alvotech was responsible for development and manufacturing of AVT16, while Teva was responsible for commercialization.
Entyvio was approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.
