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]

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]

Core Viewpoint - Maiwei Biotech (688062.SH) has received a Study May Proceed Notification from the FDA, allowing the clinical trial application for 9MW1911 to proceed [1] Group 1: Company Information - 9MW1911 is an innovative monoclonal antibody developed based on a high-efficiency B lymphocyte screening platform [1] - The product is classified as a Class 1 therapeutic biological product [1] - 9MW1911 has a high affinity for the ST2 receptor, which blocks the IL33/ST2 signaling pathway [1]

9MW1911为一款基于高效B淋巴细胞筛选平台自主研发的创新单克隆抗体，属于治疗用生物制品1类， 可高亲和力结合ST2受体，从而阻断IL33/ST2 信号通路。 智通财经APP讯，迈威生物(688062.SH)发布公告，近日，公司收到美国食品药品监督管理局(FDA)签发 的《临床研究继续进行通知书》(Study May Proceed Notification)，9MW1911注射液临床试验申请正式获 得FDA许可。 ...

迈威生物公告，近日，公司收到美国食品药品监督管理局（FDA）签发的《临床研究继续进行通知书》 （Study May Proceed Notification），9MW1911注射液临床试验申请正式获得FDA许可。 ...