Core Viewpoint - Maiwei Biotech has received approval from the National Medical Products Administration for the clinical trial of its drug 9MW3811, aimed at treating pathological scars in a Phase II study [1] Group 1: Company Overview - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, developed independently by Maiwei Biotech [1] - The drug is classified as a Class 1 therapeutic biological product [1] Group 2: Product Details - 9MW3811 works by binding with high affinity to IL-11, effectively inhibiting the abnormal activation of the IL-11/IL-11Rα signaling pathway [1] - The mechanism of action is aimed at intervening in the pathological progression of fibrotic diseases [1]

国务院办公厅印发《关于进一步促进民间投资发展的若干措施》，政策利好的重点板块与个股参考: ——清洁能源与高端制造， 民间资本可参与核电项目，并投身清洁能源、智能制造等重大工程。 如太 阳电缆 (002300)融资余额显著增长，市场关注度高，海陆重工(002255)融资余额环比增长25.40%。 ——"专精特新"与科技小盘股，政策注重激发民营创新活力，与私募机构青睐调研小盘科技股的趋势相 符。 如迈威生物 (688062)、海光信息(688041)、京北方*(002987)均获私募密集调研，股价表现强势。 ——电子、医药与机械设备，这些行业是私募调研热点，也符合政策支持的"新质生产力"方向。 如天 孚通信*(300394)融资余额环比增长32.61%，东岳硅材*(300821)融资余额环比增长31.02%。 综合来看， 政策核心在于"拓空间、破壁垒、强保障"。投资布局时可重点关注以下主线：主线一：把握政策强制推 动的领域。重点关注铁路、核电、油气管道等以往门槛较高的行业，政策设定了民间投资参股比例的最 低要求，这将为相关领域的民营企业带来直接的业务机会。主线二：布局符合经济转型方向的赛道。电 子、半导体、生物医 ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-066 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW3811 注射液临床试验申请 获得国家药品监督管理局批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 8 月 29 日受理的 9MW3811 注射液临床试验申请符合药品注册的有关要求， 同意本品开展临床试验。 二、药品的其他相关情况 白介素-11（IL-11）是一种在慢性炎症和纤维化相关疾病中发挥关键作用的 细胞因子，广泛参与肺、皮肤、肾脏和肝脏等多个器官的纤维化进程，并与衰老 相关疾病的发生密切相关（Nature，2024）。病理性瘢痕主要包括增生性瘢痕、 瘢痕疙瘩、挛缩瘢痕等，在其形成过程中，IL-11 的作用尤为突出。2022 年发表 重要内容提示： 近日，迈威（上海）生物科技股份有限公司（以下简称"迈威生物"或"公 司"）收到国家药品监督管理局核准签发的《药物临床试验批准通知书》， 9MW3811 注射液用 ...

Core Insights - Maiwei Biotech has received approval from the National Medical Products Administration for the Phase II clinical trial application of 9MW3811 injection for pathological scars, potentially becoming the first IL-11 targeted drug to enter clinical stages for this indication [1] Group 1: Clinical Development - The Phase II clinical trial for 9MW3811 is planned to start by the end of 2025, marking a significant milestone in the treatment of pathological scars [1] - 9MW3811 has already been approved for clinical research in advanced malignant tumors and idiopathic pulmonary fibrosis globally, having completed Phase I trials in Australia and China [1] Group 2: Licensing Agreement - The company has entered into an exclusive licensing agreement with CALICO Life Sciences LLC, granting CALICO global rights outside of Greater China [1] - CALICO has made an upfront payment of $25 million to the company, with potential milestone payments reaching up to $571 million related to near-term, development, registration, and commercialization [1]

Core Insights - The company, Maiwei Biotech, has received approval from the National Medical Products Administration for a Phase II clinical trial of its drug 9MW3811 injection for the indication of pathological scars [1] - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, which has already been approved for clinical research in advanced malignancies and idiopathic pulmonary fibrosis globally [1] - The company plans to initiate the Phase II clinical trial for pathological scars by the end of 2025 [1] - Maiwei Biotech has entered into an exclusive licensing agreement with CALICO, receiving an upfront payment of $25 million, with potential milestone payments totaling up to $571 million and royalties [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received approval from the National Medical Products Administration for the clinical trial of 9MW3811 injection for pathological scars, marking a significant advancement in its clinical research pipeline [1] Group 1: Clinical Trial Approval - The company announced that it has obtained the Clinical Trial Approval Notice for 9MW3811 injection for the indication of pathological scars, allowing it to proceed with Phase II clinical trials [1] - The Phase II clinical trial is planned to start by the end of 2025, making it the first IL-11 targeted drug to enter clinical stages for this indication [1] Group 2: Global Research Progress - 9MW3811 has already been approved for clinical research in advanced malignant tumors and idiopathic pulmonary fibrosis globally, having completed Phase I trials in Australia and China [1] - The development progress of 9MW3811 is currently leading among global peers targeting similar pathways [1] Group 3: Licensing Agreement - The company has entered into an exclusive licensing agreement with CALICO Life Sciences LLC, granting CALICO global rights outside of Greater China [1] - CALICO has made an upfront payment of $25 million to the company, with potential milestone payments reaching up to $571 million for near-term, development, registration, and commercialization milestones [1]

Core Viewpoint - Maiwei Biotech (688062) has received approval from the National Medical Products Administration for its clinical trial application for 9MW3811 injection, aimed at treating pathological scars in a Phase II clinical trial [1] Group 1 - The company announced the approval of its clinical trial for 9MW3811 injection [1] - The indication for the clinical trial is pathological scars [1] - The approval is specifically for a Phase II clinical trial [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received approval from the National Medical Products Administration for the clinical trial of 9MW3811 injection for pathological scar indications, marking a significant advancement in its research and development pipeline [1] Group 1: Clinical Trial Approval - The company announced that it has obtained the Clinical Trial Approval Notice for 9MW3811 injection, which is intended for use in pathological scar indications [1] - The II phase clinical trial for 9MW3811 is planned to start by the end of 2025, making it the first IL-11 targeted drug to enter clinical stages in this indication area [1] Group 2: Global Research and Development Progress - 9MW3811 has already been approved for clinical research in advanced malignant tumors and idiopathic pulmonary fibrosis globally, having completed Phase I trials in Australia and China [1] - The development progress of 9MW3811 is currently leading among global peers targeting similar pathways [1] Group 3: Licensing Agreement - The company has entered into an exclusive licensing agreement with CALICO Life Sciences LLC, granting CALICO global rights outside Greater China [1] - CALICO has made an upfront payment of $25 million to the company, with potential milestone payments reaching up to $571 million for near-term, development, registration, and commercialization milestones [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received approval from the National Medical Products Administration for the Phase II clinical trial of its drug 9MW3811, aimed at treating pathological scars [1] Company Summary - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The drug effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, which is crucial in the progression of fibrotic diseases [1] - Key advantages of 9MW3811 include higher target affinity and signaling blockade capability, as well as a long half-life of over one month, making it suitable for chronic disease treatment requiring long-term administration [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received approval from the National Medical Products Administration for the clinical trial of its drug 9MW3811, targeting pathological scars in a Phase II study [1] Company Summary - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The drug effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, which is crucial in the progression of fibrotic diseases [1] - Key advantages of 9MW3811 include higher target affinity and signaling blockade capability, along with a long half-life of over one month, making it suitable for chronic disease treatment requiring long-term administration [1]