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InnoCare Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical Trial
Orelabrutinib 75 mg daily improved SLE Response Index-4 response rate to 57.1% versus 34.4% for placebo at week 48, leading to phase III trial approval by China's CDE.
- On Dec. 14, 2025 in Beijing, InnoCare Pharma announced its phase IIb study of orelabrutinib met its primary endpoint in SLE, and the Center for Drug Evaluation approved a phase III registrational trial.
- The randomized trial enrolled 187 patients into orelabrutinib 75 mg once-daily , 50 mg QD, and placebo with SLE Response Index-4 at week 48 as the endpoint, showing dose-dependent improvement favoring 75 mg QD.
- Subgroup analyses revealed placebo-adjusted SRI-4 differences of 43% and secondary endpoints favored 75 mg with a safety profile.
- InnoCare plans to accelerate clinical development, with Dr. Jasmine Cui stating `SLE patients have huge unmet clinical needs.`
- SLE affects roughly 8 million people worldwide and 1 million in China, and orelabrutinib, after prior phase IIa data at EULAR, is expected to become a first-in-class oral BTK therapy if phase III confirms.
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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…
·New York, United States
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Total News Sources16
Leaning Left10Leaning Right1Center2Last UpdatedBias Distribution77% Left
Bias Distribution
- 77% of the sources lean Left
77% Left
L 77%
15%
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