Core Viewpoint - InnoCare Pharma announced that the phase IIb clinical study of its BTK inhibitor orelabrutinib has successfully met its primary endpoint in treating systemic lupus erythematosus (SLE) and has received approval for a phase III trial [1][8]. Clinical Study Results - Orelabrutinib showed significant efficacy and a well-tolerated safety profile in SLE patients after 48 weeks of treatment, with 187 patients enrolled in the study [2][6]. - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was achieved with the 75 mg QD group showing a response rate of 57.1% compared to 34.4% in the placebo group (p < 0.05) [3]. - The 75 mg QD group also demonstrated better efficacy than the 50 mg QD group, indicating a dose-dependent improvement [3]. Secondary Endpoint and Subgroup Analysis - At week 48, the 75 mg QD group met secondary endpoints with significantly higher SRI-6 and BICLA response rates compared to placebo (p < 0.05) [4]. - In patients with baseline BILAG ≥1A or ≥2B, the placebo-adjusted difference in SRI-4 response rate for the 75 mg QD group was 35%, and for those with a clinical SLEDAI-2K score ≥4, it was 43% [5]. Safety Profile - Orelabrutinib was well tolerated among SLE patients, with a safety profile consistent with BTK inhibition and the disease's biology [6]. Market Potential and Company Overview - Orelabrutinib is the first BTK inhibitor to show significant efficacy in a phase II clinical trial for SLE, with expectations to become a first-in-class oral treatment [7]. - SLE affects approximately 8 million people globally, with around 1 million patients in China, highlighting a significant unmet medical need [8]. - InnoCare is focused on developing first-in-class and best-in-class drugs for cancer and autoimmune diseases, with operations in multiple locations including China and the United States [9].