China’s NMPA has approved telitacicept for the treatment of adult patients with Sjögren’s disease — marking the first regulatory approval of any therapy specifically indicated for this condition anywhere in the world. The approval, granted to RemeGen Co., Ltd. (HKEX: 9995), represents the fifth NMPA-approved indication for telitacicept and positions the dual cytokine inhibitor as the only approved systemic disease-modifying option for a condition where multiple candidates have failed in late-stage development over the past decade, leaving physicians limited largely to symptomatic treatments.
Telitacicept is a recombinant fusion protein that simultaneously neutralizes BLyS (BAFF) and APRIL, two cytokines critical to the survival and activation of B cells and plasma cells. By blocking both ligands, the molecule suppresses autoreactive B cell populations and reduces autoantibody production — pathological processes central to Sjögren’s disease. The approved dosing and administration schedule were not specified in the announcement, though the Phase III program evaluated 80 mg and 160 mg dose groups.
The NMPA approval was supported by a nationwide, multicenter, randomized, double-blind, placebo-controlled Phase III trial evaluating telitacicept in patients with Sjögren’s disease. The primary endpoint was change from baseline in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at Week 24. Both the 80 mg and 160 mg groups demonstrated statistically significant reductions in ESSDAI versus placebo, with efficacy sustained through Week 48. Telitacicept also demonstrated improvements in the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), capturing patient-reported symptom burden alongside objective disease activity measures.
The dual BAFF/APRIL inhibition mechanism places telitacicept in a broader class of agents targeting B cell survival pathways in autoimmunity. Vertex Pharmaceuticals is advancing povetacicept, another TACI-Fc fusion protein with the same dual BAFF/APRIL inhibition mechanism, in multiple autoimmune indications — representing a direct mechanistic parallel, though in earlier global development for Sjögren’s disease specifically.