BEIJING, Dec. 14, 2025 — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical enterprise focused on cancer and autoimmune disease treatments, announced today that the phase IIb clinical study of the novel BTK inhibitor orelabrutinib has met its primary endpoint in patients with systemic lupus erythematosus (SLE). InnoCare has also secured approval from the Center for Drug Evaluation (CDE) to conduct a phase III registrational clinical trial.
Orelabrutinib displayed notable efficacy and a well-tolerated safety profile in SLE patients who received 48 weeks of treatment in the phase IIb study. 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. By week 48, the orelabrutinib 75 mg QD group achieved a statistically significant improvement in the SRI-4 response rate compared to the placebo group (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. Additionally, the efficacy of the orelabrutinib 75 mg QD group outperformed that of the 50 mg QD group, indicating a dose-dependent trend in efficacy improvement.
At week 48, the orelabrutinib 75 mg QD group showed significantly higher SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates compared to the placebo group (p < 0.05), fulfilling the secondary endpoint.
Among the subgroup of patients with baseline BILAG ≥1A or ≥2B, the placebo-adjusted difference in the SRI-4 response rate for orelabrutinib 75 mg QD was 35%. In the subgroup of patients with baseline BILAG ≥1A or ≥2B and a clinical SLEDAI-2K score ≥4, the placebo-adjusted difference in the SRI-4 response rate for orelabrutinib 75 mg QD was 43%.
The study indicated that orelabrutinib was well tolerated in SLE patients. The safety profile aligned with the mechanism of action of BTK inhibition and the underlying disease biology of SLE.
Orelabrutinib is the first BTK inhibitor to demonstrate significant efficacy in a phase II clinical trial for SLE. Phase IIa clinical data on orelabrutinib for SLE was previously presented as a late-breaking oral presentation at the European Union Congress of Rheumatology (EULAR). Orelabrutinib is anticipated to become a first-in-class oral BTK inhibitor for SLE treatment.
Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, stated, “SLE patients have substantial unmet clinical needs, requiring long-term or even lifelong medication that severely impacts their quality of life. We are pleased to see that the phase IIb study of orelabrutinib for SLE has met its primary endpoint with remarkable efficacy and has received approval to conduct a phase III registrational trial. We will continue to accelerate clinical development to provide better treatment options for patients with SLE and other autoimmune diseases.”
SLE is a systemic autoimmune disease that often causes damage to multiple organs, particularly the kidneys, musculoskeletal system, nervous system, skin, blood system, and respiratory system; nearly all bodily systems can be affected. According to Frost & Sullivan, there are approximately 8 million people with SLE worldwide. As per the “China SLE Development Report 2020,” there are around 1 million SLE patients in China, ranking first globally in total number and second in incidence rate. Most SLE patients are young and middle-aged women, requiring long-term management over years or even decades, leading to significant unmet medical needs.
About InnoCare
InnoCare is a commercial-stage biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for treating cancers and autoimmune diseases with unmet medical needs in China and globally. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
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