BEIJING, April 29, 2026
InnoCare Pharma has announced that the first patient has been dosed in the registrational Phase III clinical trial of orelabrutinib, its novel BTK inhibitor, for the treatment of systemic lupus erythematosus (SLE). This major milestone marks the advancement of one of the most promising targeted therapies in autoimmune disease, with orelabrutinib becoming the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE, positioning it as a potential breakthrough treatment for millions of patients worldwide.
Strong Phase IIb Results Drive Phase III Progress
The ongoing Phase III study is a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy and safety of orelabrutinib in patients with SLE, using the SLE Response Index-4 (SRI-4) response rate at Week 52 as the primary endpoint. The trial follows highly encouraging results from the previous Phase IIb clinical study, where orelabrutinib met its primary endpoint under strict steroid-tapering requirements.
Patients receiving 75 mg once daily (QD) achieved a statistically significant SRI-4 response rate of 57.1% compared with 34.4% for placebo at Week 48, demonstrating clear clinical benefit. In patients with higher disease activity, the response rate reached 68%, representing a 43% absolute improvement over placebo. Additionally, 71.1% of patients in the treatment group successfully reduced steroid use to ≤7.5 mg, compared to only 43.6% in the placebo group, highlighting its strong steroid-sparing potential.
Addressing a Major Unmet Need in Autoimmune Disease
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Systemic lupus erythematosus (SLE) is a complex chronic autoimmune disease that can cause severe multi-organ damage, affecting the kidneys, nervous system, musculoskeletal system, skin, blood, and respiratory organs. The disease often requires long-term or lifelong treatment, significantly impacting patient quality of life, particularly among young and middle-aged women, who represent the majority of cases.
According to industry estimates, there are approximately 8 million SLE patients worldwide, including around 1 million patients in China, the highest total patient population globally. Current treatment options often rely heavily on corticosteroids and immunosuppressive therapies, which can create serious long-term side effects. Orelabrutinib’s targeted mechanism offers the potential for a safer and more effective long-term management strategy.
Expanding Leadership in Autoimmune and Oncology Innovation
Orelabrutinib is a highly selective Bruton’s Tyrosine Kinase (BTK) inhibitor developed by InnoCare as part of its broader strategy to address major unmet medical needs across oncology and autoimmune diseases. The company currently has three approved drugs, including orelabrutinib, tafasitamab, and zurletrectinib, alongside more than ten innovative drug candidates in clinical development.
CEO Dr. Jasmine Cui emphasized the company’s commitment to accelerating Phase III development and delivering better treatment options for SLE patients who currently face limited long-term therapeutic choices.
With strong clinical evidence, a robust commercial-stage pipeline, and growing expertise in targeted therapy development, InnoCare is positioning orelabrutinib as a potential new standard of care in systemic lupus erythematosus, offering hope for improved outcomes and reduced treatment burden for patients worldwide.
Source: InnoCare Pharma press release
