InnoCare Makes Significant Progress with Orelabrutinib for SLE, Achieves Key Study Goals and Secures Phase III Trial Approval
BEIJING, Dec. 14, 2025 (GLOBE NEWSWIRE) -- In a groundbreaking announcement today, InnoCare Pharma (HKEX: 09969; SSE: 688428), a prominent player in the biopharmaceutical sector focusing on innovative treatments for cancer and autoimmune diseases, revealed that its Phase IIb clinical trial of orelabrutinib, a novel BTK inhibitor, has successfully met its primary endpoint in patients suffering from systemic lupus erythematosus (SLE). Moreover, the Center for Drug Evaluation (CDE) has granted approval for the subsequent Phase III registrational clinical trial.
Orelabrutinib has shown remarkable effectiveness and a well-tolerated safety profile among SLE patients who underwent 48 weeks of treatment during the Phase IIb study. This trial involved 187 participants who were equally divided into three groups: one receiving orelabrutinib at a dosage of 75 mg once daily (QD), another at 50 mg QD, and a control group taking a placebo.
The primary endpoint was assessed using the SLE Response Index-4 (SRI-4) response rate at week 48. At this time point, the group treated with orelabrutinib at 75 mg QD showed a statistically significant improvement in the SRI-4 response rate when compared to the placebo group (57.1% versus 34.4%, p < 0.05), thereby achieving the primary goal of the study. Furthermore, the 75 mg QD cohort outperformed the 50 mg QD group, indicating a clear dose-dependent trend in efficacy.
Additionally, by week 48, the 75 mg QD group exhibited significantly higher response rates on both the SRI-6 and the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) when contrasted with the placebo group (p < 0.05), thus fulfilling the secondary endpoints as well.
In a deeper analysis focusing on specific subgroups of patients with baseline BILAG scores of ≥1A or ≥2B, orelabrutinib at 75 mg QD demonstrated a substantial placebo-adjusted difference of 35% in the SRI-4 response rate. In those with more severe symptoms, indicated by a clinical SLEDAI-2K score of ≥4, this difference increased to 43%.
Importantly, the safety profile of orelabrutinib remained consistent with the expected effects of BTK inhibition and the underlying biology associated with SLE, reinforcing its potential as a viable therapeutic option.
This milestone marks orelabrutinib as the first BTK inhibitor to exhibit significant efficacy in a Phase II clinical trial dedicated to SLE treatment. Prior Phase IIa findings regarding orelabrutinib for SLE were highlighted via a late-breaking oral presentation at the European Union Congress of Rheumatology (EULAR). There is optimism that orelabrutinib could emerge as a pioneering oral BTK inhibitor specifically designed for SLE therapy.
Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare expressed her enthusiasm, stating, "Patients with SLE face considerable unmet clinical needs, often requiring lifelong medication that can severely diminish their quality of life. We are thrilled that our Phase IIb study of orelabrutinib has not only achieved its primary endpoint but also received approval to advance to Phase III trials. Our commitment to accelerating clinical development aims to provide enhanced treatment alternatives for individuals battling SLE and other autoimmune disorders."
SLE is a complex systemic autoimmune condition that can inflict damage on multiple organs, particularly affecting the kidneys, musculoskeletal system, nervous system, skin, blood, and respiratory systems; virtually every bodily system may be impacted. According to Frost & Sullivan, approximately 8 million individuals worldwide are affected by SLE. The "China SLE Development Report 2020" indicates that China alone accounts for around 1 million SLE patients, leading globally in total case numbers and ranking second in incidence rates. Notably, most SLE patients are young to middle-aged women, necessitating long-term management spanning years or even decades, which contributes to significant unmet medical demands.
About InnoCare
InnoCare is a biopharmaceutical company currently in the commercial stage, dedicated to the discovery, development, and commercialization of first-in-class and/or best-in-class medications aimed at addressing cancers and autoimmune diseases that are inadequately treated in China and around the globe. With operational branches located in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States, InnoCare is positioned to make a meaningful impact in the healthcare landscape.
InnoCare Forward-Looking Statements
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