Phase IIb Study Results of InnoCare’s Orelabrutinib in Patients with SLE Presented at 2026 EULAR

BEIJING, June 05, 2026 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that study results of its novel BTK inhibitor orelabrutinib in Phase IIb Study for systemic lupus erythematosus (SLE) were presented at the EULAR 2026 European Congress of Rheumatology in London.

The Phase IIb clinical study of orelabrutinib for SLE met its primary and secondary endpoints, making orelabrutinib the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE. The study also showed that orelabrutinib can significantly reduce disease activity and Glucocorticoid (GC) dosage, and exhibited a favorable trend toward SLE relapse delay and biomarkers improvement. Orelabrutinib was safe and well tolerated in participants with SLE.

Poster Presentation

Orelabrutinib, a highly selective inhibitor of Bruton’s tyrosine kinase (BTK), for the treatment of systemic lupus erythematosus (SLE): results of a randomized, double-blind, placebo-controlled, phase IIb study

Abstract Number: 2253

The study aimed to evaluate the efficacy and safety of orelabrutinib in patients with moderate to severe SLE. A total of 187 patients were enrolled and randomized (1:1:1) into three groups: orelabrutinib 75 mg once-daily (QD), orelabrutinib 50 mg QD, and placebo. The primary endpoint of this study was the SLE Response Index-4 (SRI-4) response rate at week 48. The secondary endpoints were the SLE Response Index-6 (SRI-6) and the British Isles Lupus Assessment Group (BILAG 2004)-based Composite Lupus Assessment (BICLA) Response at week 48. SRI-4 and BICLA are the most common primary endpoints in SLE randomized controlled trials.

Under stringent steroid-tapering requirements, orelabrutinib 75 mg once daily (QD) achieved a statistically significant improvement in SLE Response Index-4 (SRI-4) rate compared with placebo at Week 48 (57.1% vs. 34.4%, p = 0.01 vs placebo), meeting the primary endpoint. At week 48, the orelabrutinib 75 mg QD group demonstrated higher SRI-6 and BICLA response rates compared to the placebo group (p < 0.05), meeting the secondary endpoints.

Notably, 71.1% of patients in the 75 mg group achieved steroid reduction to ≤7.5 mg, compared with 43.6% in the placebo group. Mean cumulative corticosteroid exposure through 48 weeks was reduced by 301.0 mg in the 75 mg QD group versus placebo.

Orelabrutinib was safe and well tolerated. The overall safety profile of TEAEs was consistent with previous studies, and no new safety signals were identified.

Currently, the Company has been accelerating the patient enrollment of the registrational Phase III clinical trial of orelabrutinib for the treatment of SLE.

About InnoCare Pharma

InnoCare (SSE: 688428; HKEX: 09969) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.

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