迈威生物9MW1911注射液临床试验申请获得美国FDA许可

Core Viewpoint - Maiwei Biotech announced that it received a Clinical Study Continuation Notification from the FDA, allowing the clinical research of 9MW1911 to proceed as planned, focusing on its pharmacokinetics, safety, tolerability, and preliminary efficacy in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) participants [1] Group 1 - The FDA has approved the continuation of the clinical study for 9MW1911, which is a randomized, double-blind, placebo-controlled Phase IIa clinical trial [1] - 9MW1911 is an innovative monoclonal antibody developed based on a high-efficiency B lymphocyte screening platform, classified as a Class I therapeutic biological product [1] - The drug targets the ST2 receptor to block the IL33/ST2 signaling pathway and is currently advancing rapidly in Phase II clinical research in China, having completed the Phase IIa clinical study in COPD patients [1]