2 1 Shi Ji Jing Ji Bao Dao·2025-12-14 13:57Core Insights - The new BTK inhibitor, Oubretyn, developed by the biopharmaceutical company Nuo Cheng Jian Hua, has achieved its primary endpoint in the 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 clinical trials [2][4]. Group 1: Clinical Trial Results - In the Phase IIb study, 187 patients were randomized into three groups: two dosage groups of Oubretyn (75 mg and 50 mg once daily) and a placebo group [2]. - The primary endpoint, the SLE Response Index-4 (SRI-4) response rate at week 48, showed that the 75 mg Oubretyn group had a significantly higher response rate compared to the placebo group (57.1% vs. 34.4%, p<0.05) [2]. - The 75 mg Oubretyn group also demonstrated superior efficacy over the 50 mg group, indicating a dose-dependent improvement trend [2]. Group 2: Subgroup Analysis - In the subgroup of patients with baseline disease activity BILAG ≥1A or ≥2B, the SRI-4 response rate for the 75 mg Oubretyn group increased by 35% compared to the placebo group [3]. - For patients with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg Oubretyn group improved by 43% compared to the placebo group [3]. Group 3: Safety and Market Potential - Oubretyn has shown good tolerability and safety, consistent with the mechanism of action of BTK inhibitors and the biology of SLE [3]. - Oubretyn is the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE, positioning it as a potential first-in-class oral BTK inhibitor for this condition [4]. - The global prevalence of SLE is approximately 8 million, with China having around 1 million patients, indicating a substantial unmet clinical need for effective treatments [4].