InnoCare Announces Phase IIb Success for Orelabrutinib in SLE and Clears Path for Phase III
BEIJING, December 14, 2025 — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focused on oncology and autoimmune diseases, today disclosed that the phase IIb trial of the novel BTK inhibitor orelabrutinib achieved its primary endpoint in patients with systemic lupus erythematosus (SLE). The company has also secured approval from the Center for Drug Evaluation (CDE) to advance a phase III registrational study.
In the phase IIb trial, orelabrutinib demonstrated strong efficacy and a favorable safety profile over 48 weeks in SLE patients. A total of 187 participants were randomized evenly into three arms: orelabrutinib 75 mg once daily (QD), orelabrutinib 50 mg QD, and placebo.
The primary endpoint was the SLE Responder Index-4 (SRI-4) response rate at week 48. At this time point, the 75 mg QD dose achieved a statistically significant improvement in SRI-4 response versus placebo (57.1% vs 34.4%, p < 0.05), thereby meeting the primary endpoint. Moreover, the 75 mg QD group outperformed the 50 mg QD group, indicating a dose-related trend in efficacy.
Secondary endpoints were also met: at week 48, the 75 mg QD group showed significantly higher SRI-6 and British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) response rates compared with placebo (p < 0.05).
In predefined subgroups, patients with baseline BILAG ≥1A or ≥2B exhibited a placebo-adjusted SRI-4 improvement of 35% for the 75 mg QD dose. Among those with baseline BILAG ≥1A or ≥2B and a clinical SLEDAI-2K score ≥4, the placebo-adjusted SRI-4 improvement reached 43%.
Safety outcomes indicated that orelabrutinib was well tolerated in the SLE cohort, with a safety profile consistent with BTK inhibition and the underlying disease biology of SLE.
Orelabrutinib represents the first BTK inhibitor to show meaningful efficacy in a phase II trial for SLE. Earlier phase IIa data for orelabrutinib in SLE were presented as a late-breaking oral presentation at the European Congress of Rheumatology (EULAR). The drug is poised to be a first-in-class oral BTK inhibitor for SLE.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, commented, “SLE patients face significant unmet medical needs and often endure long-term or lifelong therapy that can severely impact quality of life. We’re pleased that the phase IIb study met its primary endpoint with robust efficacy and that the phase III registrational trial has now been approved. We will continue to accelerate development to broaden treatment options for SLE and other autoimmune diseases.”
SLE is a systemic autoimmune disorder that can damage multiple organs, including the kidneys, musculoskeletal system, nervous system, skin, blood components, and lungs, among others. Frost & Sullivan estimates about 8 million people live with SLE worldwide. The 2020 China SLE Development Report notes roughly 1 million SLE patients in China, the highest total globally and second in incidence rate. The majority of patients are young to middle-aged women, necessitating long-term management and creating substantial 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 therapies for cancer and autoimmune diseases with unmet needs in China and worldwide. The company maintains operations in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
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