RemeGen has secured priority review designation from the Centre for Drug Evaluation (CDE) in its China homeland for BLyS/APRIL dual-target fusion protein telitacicept in primary immunoglobulin A nephropathy following Phase III trial showing 55% reduction in urinary protein creatinine ratio versus placebo at 39 weeks. The subcutaneous biologic demonstrated significant proteinuria improvement with favourable tolerability in 318 patients receiving weekly 240mg dosing alongside standard care. Telitacicept displays a first-in-class mechanism simultaneously inhibiting BlyS and APRIL addressing key pathogenic drivers in IgA nephropathy where abnormal immunoglobulin A deposition causes progressive kidney damage.

The global IgA nephropathy patient population is projected to reach 10.16 million by 2030, including 2.37 million cases in China where the disease accounts for 54.3% of renal biopsy specimens. Current treatment relies on nonspecific immunosuppressants with 30% to 40% patients progressing to end-stage renal disease, creating urgent need for targeted therapies. RemeGen plans a new drug application (NDA) submission leveraging the accelerated review pathway.

According to PharmCube's NextBiopharm® database, telitacicept has so far entered 145 studies across 23 different indications. Click here to request a free trial for NextBiopharm®.