REMEGEN (09995) announced that telitacicept (brand name: Tai'ai®), the company's independently developed world-first BLyS/APRIL dual-target fusion protein innovative drug for treating IgA nephropathy (IgAN), has achieved the primary endpoint in Phase A of its China Phase III clinical study. The group will submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) as soon as possible.

This was a multicenter, randomized, double-blind, placebo-controlled clinical trial that enrolled 318 adult IgAN patients who had received standard treatment. Telitacicept was administered at a dose of 240mg via subcutaneous injection once weekly. Phase A analysis results showed that compared to the control group, patients in the telitacicept group demonstrated a 55% reduction in 24-hour urine protein creatinine ratio (UPCR) at 39 weeks of treatment (P<0.0001), with good tolerability and safety profile. Detailed data will be published at major international academic conferences.

IgAN is a common primary glomerular disease with diverse clinical manifestations, including recurrent microscopic hematuria or gross hematuria, accompanied by varying degrees of proteinuria. Some patients may present with severe hypertension or abnormal kidney function. IgA nephropathy is also one of the main causes of chronic kidney disease and end-stage renal disease in China, with up to 40% of IgA nephropathy patients reaching end-stage renal disease within 20 years of diagnosis, creating an urgent unmet medical need for novel therapies.

Currently, the academic community believes that excessive secretion of galactose-deficient IgA1 (Gd-IgA1) is the core and initiating factor in IgA nephropathy pathogenesis. Research shows that B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) are important cytokines that promote the production of Gd-IgA1 and its antibodies.

Telitacicept is a recombinant BLyS/APRIL dual-target fusion protein independently developed by the company. By simultaneously inhibiting BLyS and APRIL binding to B-cell surface receptors, it prevents abnormal B-cell differentiation and maturation, effectively reducing pathological immune responses in the body. It has currently been approved in China for treating myasthenia gravis (MG), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA) indications.