InnoCare Announces First Patient Dosed in Phase III Trial of Orelabrutinib for SLE

BEIJING, April 28, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in the registrational Phase III clinical trial of novel BTK inhibitor orelabrutinib for the treatment of systemic lupus erythematosus (SLE).

This is a randomized, double-blind, placebo-controlled, multicenter Phase III study evaluating the efficacy and safety of orelabrutinib in patients with SLE, with the SRI-4 response rate at Week 52 as the primary endpoint.

The Phase IIb clinical study of orelabrutinib met its primary endpoint, making orelabrutinib the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE. Under stringent steroid-tapering requirements, orelabrutinib 75 mg once daily (QD) achieved a statistically significant improvement in SLE Response Index-4 (SRI-4) rate compared with placebo at Week 48 (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. In a higher disease activity subgroup (BILAG ≥1A or ≥2B; SLEDAI-2K score ≥4), the 75 mg QD group achieved SRI-4 response rate of 68%, representing a 43% absolute improvement over placebo. Notably, 71.1% of patients in the 75 mg group achieved steroid reduction to ≤7.5 mg, compared with 43.6% in the placebo group.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, “There are substantial unmet medical needs for SLE patients. Current treatments require long-term or even lifelong medication that severely impacts patients’ quality of life. We will accelerate the Phase III clinical development to provide better treatment options for patients with SLE.”

SLE is a systemic autoimmune disease that often leads to multi-organ damage, particularly affecting the kidneys, musculoskeletal system, nervous system, skin, blood, and respiratory systems, with nearly all organ systems potentially involved. 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 Pharma

InnoCare (SSE: 688428; HKEX: 9969) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.

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