InnoCare's orelabrutinib advances to phase III for lupus after positive results

InnoCare Pharma Limited's orelabrutinib has demonstrated positive phase IIb clinical trial results for systemic lupus erythematosus (SLE), leading to the Center for Drug Evaluation's (CDE) approval to initiate a phase III clinical trial. The phase III study will evaluate a 75 mg once-daily dosing regimen, targeting the first patient for the first quarter of 2026.

The phase IIb study, involving 187 patients, showed the orelabrutinib 75 mg QD group achieved a statistically significant improvement in the SLE Response Index-4 (SRI-4) response rate compared to placebo at week 48 (57.1% vs. 34.4%, p < 0.05). Orelabrutinib was also well-tolerated in SLE patients, with a safety profile consistent with its mechanism as a BTK inhibitor.

InnoCare retains rights for SLE and other autoimmune indications in Greater China and Southeast Asia, while international rights have been licensed to Zenas. Orelabrutinib has already achieved significant clinical recognition in hemato-oncology in mainland China and was included in the National Reimbursement Drug List (NRDL) for various lymphoma indications.