Zheng Quan Shi Bao Wang·2025-12-15 03:21Core Viewpoint - The company, Innovent Biologics, announced that its novel BTK inhibitor, Orelabrutinib, has met the primary endpoint in a Phase IIb clinical trial for treating systemic lupus erythematosus (SLE) and has received approval from the National Medical Products Administration (NMPA) to initiate Phase III registration trials [1][2]. Group 1: Clinical Trial Results - In the Phase IIb trial, 187 patients were randomized into three groups: two dosage groups of Orelabrutinib (75 mg and 50 mg once daily) and a placebo group [1]. - The primary endpoint, the SLE Response Index-4 (SRI-4) response rate at week 48, showed that the 75 mg group had a significantly higher response rate compared to the placebo group (57.1% vs. 34.4%, p<0.05) [1]. - The 75 mg dosage group also demonstrated a dose-dependent improvement in efficacy compared to the 50 mg group [1]. Group 2: Secondary Endpoints and Subgroup Analysis - At week 48, the SRI-6 response rate and the British Isles Lupus Assessment Group Composite Endpoint (BICLA) response rate for the 75 mg group were significantly higher than those of the placebo group (p<0.05) [2]. - In patients with baseline disease activity BILAG ≥1A or ≥2B, the SRI-4 response rate for the 75 mg group improved by 35% compared to the placebo [2]. - In a subgroup with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg group increased by 43% compared to the placebo [2]. Group 3: Safety and Market Potential - Orelabrutinib exhibited good tolerability and safety, consistent with the mechanism of action of BTK inhibitors and the biology of SLE [2]. - Orelabrutinib is the first BTK inhibitor to demonstrate significant efficacy in a Phase II trial for SLE, with previous Phase IIa data presented at the European League Against Rheumatism (EULAR) conference [2]. - The company aims to accelerate clinical development to provide better treatment options for patients with SLE and other autoimmune diseases, addressing a significant unmet clinical need [3].