Core Insights - Guangdong Hengrui Medicine Co., Ltd. has initiated a Phase II clinical trial for SHR-2173 injection in patients with primary membranous nephropathy (PMN) [1] - The trial aims to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of SHR-2173 [1] Group 1: Clinical Trial Details - The clinical trial is a randomized, open-label, multi-center study with registration number CTR20254655, first publicly disclosed on November 24, 2025 [1] - The primary objective is to assess the safety and tolerability of SHR-2173 in PMN patients, while secondary objectives include evaluating efficacy, PK, and PD characteristics [1] - The drug is a biological product with a dosage form of injection, specified at 0.15 g per bottle, to be used as per the study protocol [1] Group 2: Disease Background and Trial Metrics - Primary membranous nephropathy is an autoimmune glomerular disease characterized by significant proteinuria and hypoalbuminemia, with diagnosis relying on kidney biopsy [1] - Key endpoints of the trial include safety evaluations over 52 weeks, assessing adverse events, vital signs, physical examinations, laboratory tests, and 12-lead ECG [1] - Secondary endpoints involve the proportion of subjects achieving overall remission, complete remission, partial remission, and complete immunological remission at 12, 24, 36, and 52 weeks [1] - The trial is currently ongoing with a target enrollment of 75 participants [1]
广东恒瑞SHR - 2173注射液启动II期临床 适应症为原发性膜性肾病
Xin Lang Cai Jing·2025-11-24 05:17