The conditional approval is supported by positive efficacy and safety data from RemeGen's completed Phase 2 trial (18C014) and Phase 3 TELIGAN trial (18C021 Part A) in IgAN. RemeGen independently developed telitacicept and is responsible for its development, regulatory approvals, and commercialization in China. Vor Bio holds exclusive rights to develop and commercialize telitacicept outside of Greater China.
"We are delighted to see telitacicept receive NMPA conditional approval in IgA nephropathy, representing an important achievement for the field and the first regulatory approval of a BAFF/APRIL-targeting therapy for IgAN," said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. "We congratulate our collaborator RemeGen on the successful development, regulatory submission, and approval of telitacicept in China. Together with the positive Phase 3 TELIGAN results recently published in The New England Journal of Medicine, this milestone further validates the potential of dual BAFF/APRIL inhibition to address the underlying immunopathology of IgAN and supports our belief that telitacicept has the potential to become a foundational therapy across multiple autoimmune diseases globally."
The NMPA approval was supported by positive results from the Phase 3 TELIGAN trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating telitacicept in adults with IgAN. The primary endpoint was change from baseline in urinary protein-to-creatinine ratio (UPCR) at Week 39.
In the primary analysis, patients treated with telitacicept 240 mg achieved a 59% reduction in UPCR from baseline at Week 39, corresponding to a 55% placebo-adjusted reduction. The study met its primary efficacy endpoint and demonstrated a favorable safety profile.
As previously reported in The New England Journal of Medicine, telitacicept treatment was also associated with encouraging preservation of kidney function. Estimated glomerular filtration rate (eGFR) remained largely stable through 39 weeks of treatment, while greater declines were observed in the placebo arm. Additional findings included reductions in circulating CD19+ B cells and serum immunoglobulin levels, including IgA, consistent with telitacicept's mechanism of action.