InnoCare Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical Trial

BEIJING, Dec. 14, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the phase IIb clinical study of novel BTK inhibitor orelabrutinib has met the primary endpoint in patients with systemic lupus erythematosus (SLE). InnoCare has also received approval from the Center for Drug Evaluation (CDE) to conduct a phase III registrational clinical trial.

Orelabrutinib demonstrated outstanding efficacy and well-tolerated safety profile in patients with SLE who had 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. At week 48, the orelabrutinib 75 mg QD group achieved a statistically significant improvement in SRI-4 response rate compared with placebo (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. Additionally, the efficacy of the orelabrutinib 75 mg QD group was better than that of the 50 mg QD group, indicating a dose-dependent improvement trend in efficacy.

At week 48, the orelabrutinib 75 mg QD group demonstrated 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), meeting the secondary endpoint.

In the subgroup of patients with baseline BILAG ≥1A or ≥2B, the placebo-adjusted difference in 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 SRI-4 response rate for orelabrutinib 75 mg QD was 43%.

The study showed that orelabrutinib was well tolerated in SLE patients. The safety profile was consistent 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 expected to become a first-in-class oral BTK inhibitor for the treatment of SLE.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, “SLE patients have huge unmet clinical needs, requiring long-term or even lifelong medication that severely impact their quality of life. We are happy to see that the phase IIb study of orelabrutinib for SLE has met its primary endpoint with outstanding efficacy and has received approval to conduct phase III registrational trial. We will continuously accelerate clinical development to provide better treatment options for patients with SLE and other autoimmune diseases.”

SLE is a systemic autoimmune disease that often leads to damage to multiple organs, particularly the kidneys and musculoskeletal system, nervous system, skin, blood system, and respiratory system; almost all systems can be affected. According to Frost & Sullivan, there are approximately 8 million people with SLE worldwide. According to the “China SLE Development Report 2020”, there are approximately 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 for years or even decades, resulting in huge unmet medical needs.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

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