Core Viewpoint - The company has initiated the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanlikang for the treatment of active glomerulonephritis in mainland China [1][2]. Group 1: Clinical Study Overview - The study is a double-blind, randomized, controlled, multi-center Phase II trial aimed at evaluating the efficacy, safety, and tolerability of HLX79 combined with Hanlikang compared to a placebo in patients with active glomerulonephritis, including lupus nephritis (LN) and membranous nephropathy (MN) [2]. - The study consists of two phases: the first phase is a dose-escalation period where eligible participants will receive HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) combined with either Hanlikang or a Hanlikang placebo (375 mg/m²) weekly [2]. - The second phase is a preliminary efficacy exploration period, where eligible participants will receive HLX79 (high dose/low dose) combined with Hanlikang (375 mg/m²), HLX79 placebo combined with Hanlikang, or HLX79 placebo combined with Hanlikang placebo weekly, with the primary objective of evaluating clinical efficacy [2]. Group 2: Market Context - As of the date of the announcement, there are no similar combination therapies approved for marketing globally [3].
复宏汉霖(02696)：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