RemeGen to Seek China Approval for Telitacicept in IgA Nephropathy After Phase III Success

RemeGen, in partnership with Vor Bio, will file for Chinese regulatory approval of telitacicept in immunoglobulin-A nephropathy (IgAN) after the drug achieved its primary endpoint in a Phase III trial (NCT05799287). Administered subcutaneously once weekly, the B-cell-targeting fusion protein led to a 55% reduction in proteinuria at 39 weeks, as measured by the 24-hour urine protein-to-creatinine ratio, compared with placebo. The trial enrolled Chinese IgAN patients at risk of kidney failure despite prior treatment with renin-angiotensin system blockers.

Telitacicept demonstrated a favourable safety profile, though full safety and secondary endpoint data remain undisclosed. RemeGen plans to present results at an upcoming medical conference. Already approved in China for SLE, gMG, and rheumatoid arthritis, the drug is also under review for Sjögren’s disease. With two new biologics licence applications imminent, RemeGen is expanding its autoimmune portfolio while pursuing global trials, though competition remains strong in both IgAN and gMG markets.

28-08-2025