China-based RemeGen has received National Medical Products Administration (NMPA) approval in its China homeland for telitacicept for two new indications: primary Sjögren's syndrome (pSS) and primary IgA nephropathy (IgAN). Telitacicept is a first‑in‑class fusion protein that simultaneously blocks BLyS (BAFF) and APRIL, key survival factors for B-cells, thereby suppressing the differentiation and maturation of autoreactive B-cells. This marks the first biologic therapy approved globally for Sjögren's syndrome, addressing a significant unmet need in a condition affecting an estimated 0.3%–0.7% of China's population.

In the Phase III pSS trial, telitacicept significantly reduced disease activity scores versus placebo (−4.4 vs −0.6, p<0.0001). The IgAN study showed a 55% reduction in 24‑hour urine protein‑to‑creatinine ratio at 39 weeks. Telitacicept is already approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and myasthenia gravis.

RemeGen previously out‑licensed ex‑Greater China rights to Vor Biopharma in a deal worth up to USD 4.23 billion. With five approved indications, telitacicept is establishing itself as a cornerstone therapy across B‑cell‑mediated autoimmune diseases.

According to PharmCube's NextBiopharm® database, telitacicept is the furthest developed TACI receptor fusion protein globally. Click here to request a free trial for NextBiopharm®.