迈威生物:9MW1911注射液临床试验申请获FDA许可

Core Viewpoint - Maiwei Biotech (688062) has received FDA approval for its clinical trial application for 9MW1911 injection, allowing the company to proceed with a Phase IIa clinical study to evaluate the pharmacokinetics, safety, tolerability, and preliminary efficacy of 9MW1911 in participants with moderate to severe chronic obstructive pulmonary disease (COPD) [1] Group 1 - The FDA issued a "Notice of Continuation of Clinical Research" for Maiwei Biotech on December 23 [1] - The clinical study will be randomized, double-blind, and placebo-controlled [1] - The focus of the study is on participants with moderate to severe COPD [1]

Mabwell-迈威生物:9MW1911注射液临床试验申请获FDA许可 - Reportify