肾小球肾炎治疗

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复宏汉霖:HLX79注射液联合汉利康 治疗活动期肾小球肾炎的2期临床研究于中国境内完成首例患者给药
Zhi Tong Cai Jing· 2025-08-06 09:29
Core Viewpoint - The company Fuhong Hanlin (02696) has announced the completion of the first patient dosing in a Phase II clinical trial for HLX79 injection combined with Hanlikang (Rituximab injection) for the treatment of active glomerulonephritis in China, excluding Hong Kong, Macau, and Taiwan [1] Group 1 - The study is a double-blind, randomized, controlled, multi-center Phase II clinical trial aimed at evaluating the efficacy, safety, and tolerability of HLX79 combined with Hanlikang compared to placebo in patients with active glomerulonephritis, specifically lupus nephritis (LN) and membranous nephropathy (MN) [2] - The trial consists of two phases: the first phase is a dose-escalation period where eligible participants will receive weekly doses of HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) combined with Hanlikang or Hanlikang placebo (375 mg/m²) [2] - The primary objective of the first phase is to assess the safety and tolerability of HLX79 combined with Hanlikang compared to placebo combined with Hanlikang in treating active glomerulonephritis [2] Group 2 - The second phase is an exploratory efficacy phase where eligible participants will receive weekly doses of HLX79 (high dose/low dose) combined with Hanlikang (375 mg/m²), HLX79 placebo combined with Hanlikang, or HLX79 placebo combined with Hanlikang placebo in a 2:2:1:1 ratio [2] - The primary objective of the second phase is to evaluate the clinical efficacy of HLX79 combined with Hanlikang, placebo combined with Hanlikang, and placebo treatment for active glomerulonephritis on top of standard treatment [2] - Secondary objectives include assessing other clinical efficacy, safety, tolerability, pharmacokinetic characteristics, and immunogenicity, while exploratory objectives aim to evaluate the dynamic changes of potential biomarkers [2] - As of the date of the announcement, there are no similar combination therapies approved for marketing globally [2]