Study Results of Orelabrutinib in Patients with SLE Published in the Journal of Autoimmunity

Beijing, July 10, 2026 – InnoCare Pharma today announced that the Journal of Autoimmunity has published results from a clinical study evaluating orelabrutinib, a BTK (Bruton’s tyrosine kinase) inhibitor, in patients with systemic lupus erythematosus (SLE).

The study confirmed for the first time that orelabrutinib is well-tolerated and efficacious in patients with SLE, marking orelabrutinib as the first BTK inhibitor to show clinical efficacy in treating SLE. Professor Ru Li and Associate Chief Physician Xue Li from the Department of Rheumatology and Immunology/Institute of Peking University People's Hospital are the co-first authors of the publication, with Professor Zhanguo Li serving as the corresponding author.

The multicenter, double-blind, randomized, placebo-controlled, parallel-group, phase Ib/IIa study was conducted at 11 sites in China. Patients with SLE were randomized 1:1:1:1 to receive oral orelabrutinib at 50 mg, 80 mg, 100 mg, or placebo once daily for 12 weeks, respectively.

Among all evaluable patients, the SLE Responder Index (SRI)-4 response rates at week 12 were 50%, 62%, and 64% for orelabrutinib at 50 mg, 80 mg, and 100 mg, respectively, compared with 36% for placebo, demonstrating a dose-dependent improvement in disease activity. Among patients with higher baseline disease activity (SLEDAI-2K > 8), significantly higher SRI-4 response rates were observed with orelabrutinib at 50 mg (80%), 80 mg (83%), and 100 mg (100%) compared with placebo (0%). Orelabrutinib treatment was also associated with reductions in proteinuria, anti-dsDNA, IgG, and IgM, as well as increased C4 levels.

In terms of safety, most treatment-related adverse events (TRAEs) were Grade 1-2.

Notably, the large-sample Phase IIb clinical study of orelabrutinib in treating SLE met its primary and secondary endpoints, making orelabrutinib the first BTK inhibitor globally to demonstrate efficacy in a Phase II clinical trial for SLE. These data were presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Annual Congress.

Patient enrollment is ongoing in the registrational Phase III clinical study of orelabrutinib for SLE.

The Journal of Autoimmunity is an international, peer-reviewed journal in the field of immunology, published by Academic Press, an imprint of Elsevier. Founded in 1988, it publishes research across diverse aspects of autoimmunity, including the mechanisms of self-recognition, regulation of autoimmune responses, and experimental autoimmune diseases.

Note: The content of this press release is derived from this published article. Full text can be found in https://www.sciencedirect.com/science/article/pii/S0896841126000569?via%3Dihub .