智通财经网·2025-12-14 10:45Core Viewpoint - The approval of the III phase clinical trial for Obutinib in treating systemic lupus erythematosus (SLE) marks a significant advancement in the company's clinical development efforts, supported by strong data from the IIb phase trial [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 phase trial, 187 SLE patients were randomized into three groups, with the 75 mg dose showing a significant SLE Responder Index-4 (SRI-4) response rate of 57.1% compared to 34.4% in the placebo group (p < 0.05) [1] - The 75 mg dose also demonstrated a dose-dependent efficacy trend, with significant improvements in SRI-6 and 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 group [2] - The study indicates that Obutinib has good tolerability and safety characteristics consistent with the mechanism of action of BTK inhibitors and the underlying biology of SLE [2] Group 3: Future Development Plans - The company is committed to accelerating the clinical development of Obutinib, which is a selective, irreversible oral BTK inhibitor with potential best-in-class advantages [3] - The III phase trial for SLE is expected to enroll the first patient in Q1 2026, while a III phase trial for immune thrombocytopenic purpura (ITP) has completed patient enrollment, with a new drug application planned for submission in H1 2026 [3] - In the multiple sclerosis (MS) field, the III phase trial for primary progressive MS (PPMS) is set to start in Q3 2025, and the trial for secondary progressive MS (SPMS) is expected to begin in Q1 2026 [3] Group 4: Market Recognition - Obutinib has gained significant clinical recognition and market penetration in the hematological malignancies sector since its launch in mainland China [4] - The drug was included in the National Reimbursement Drug List (NRDL) in 2022, covering adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL) patients who have received at least one prior treatment [4] - In 2024, the coverage will expand to include adult marginal zone lymphoma (MZL), making Obutinib the first and only BTK inhibitor approved for relapsed/refractory MZL in China [4]