智通财经网·2025-12-14 10:48Core Viewpoint - The approval of the III phase clinical trial for Obutinib in treating systemic lupus erythematosus (SLE) marks a significant advancement for the company, supported by strong data from the IIb phase trial demonstrating efficacy and safety [1][2][3] Group 1: Clinical Trial Results - The III phase trial will evaluate a daily dose of 75 mg of Obutinib, building on solid data from the IIb phase trial [1] - In the IIb trial, 187 SLE patients were randomized into three groups, with the 75 mg dose showing a significant SLE response index-4 (SRI-4) response rate of 57.1% compared to 34.4% in the placebo group at 48 weeks (p < 0.05) [1] - The 75 mg dose also demonstrated a dose-dependent efficacy trend, with significant improvements in SRI-6 and British Isles Lupus Assessment Group (BILAG) response rates compared to the placebo group (p < 0.05) [1] Group 2: Subgroup Analysis - In patients with baseline BILAG ≥ 1A or ≥ 2B, the SRI-4 response rate for the 75 mg dose improved by 35% compared to the placebo group [2] - Among patients with baseline BILAG ≥ 1A or ≥ 2B and clinical SLEDAI-2K scores ≥ 4, the SRI-4 response rate increased by 43% for the 75 mg dose compared to the placebo [2] Group 3: Future Development Plans - The company aims to accelerate the clinical development of Obutinib, which is a selective, irreversible oral BTK inhibitor with potential best-in-class advantages [3] - The III phase trial is expected to enroll the first patient in Q1 2026, with ongoing trials for immune thrombocytopenic purpura (ITP) and multiple sclerosis (MS) also in progress [3] - Obutinib has already gained significant clinical recognition and market penetration in the hematological malignancies sector, having been included in China's National Reimbursement Drug List (NRDL) [4]