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]

Group 1 - The core point of the news is that Maiwei Biotech's stock price has dropped by 5.01%, currently trading at 42.24 CNY per share, with a total market capitalization of 16.879 billion CNY [1] - Maiwei Biotech, established on May 12, 2017, and listed on January 18, 2022, focuses on the research, production, and sales of therapeutic biological products, with 99.91% of its revenue coming from product sales [1] - The trading volume for Maiwei Biotech reached 256 million CNY, with a turnover rate of 2.90% [1] Group 2 - Southern Fund's Southern CSI 1000 ETF (512100) has entered the top ten circulating shareholders of Maiwei Biotech, holding 2.1906 million shares, which is 1.07% of the circulating shares [2] - The estimated floating loss for the Southern CSI 1000 ETF today is approximately 4.885 million CNY [2] - The Southern CSI 1000 ETF was established on September 29, 2016, with a current scale of 76.63 billion CNY and has achieved a year-to-date return of 28.25% [2] Group 3 - The fund manager of Southern CSI 1000 ETF is Cui Lei, who has been in the position for 7 years and 2 days, managing a total asset scale of 122.76 billion CNY [3] - During Cui Lei's tenure, the best fund return was 176.39%, while the worst return was -15.93% [3]

Group 1 - The core viewpoint of the news is that Maiwei Biotech has shown significant financial activity, with a notable increase in revenue and changes in shareholder structure [1][2]. Group 2 - As of November 6, 2023, Maiwei Biotech's stock price increased by 0.50%, with a trading volume of 304 million yuan. The financing buy-in amount was 22.19 million yuan, while the financing repayment was 30.38 million yuan, resulting in a net financing buy of -8.19 million yuan [1]. - The total margin balance for Maiwei Biotech reached 613 million yuan, with the financing balance accounting for 6.74% of the circulating market value, indicating a high level compared to the past year [1]. - The company has not engaged in any short selling on November 6, 2023, with a short selling balance of 93.38 million yuan, also reflecting a high level compared to the past year [1]. Group 3 - For the period from January to September 2025, Maiwei Biotech reported a revenue of 566 million yuan, representing a year-on-year growth of 301.03%. However, the net profit attributable to the parent company was -598 million yuan, showing a year-on-year increase of 13.89% [2]. - As of September 30, 2025, the number of shareholders for Maiwei Biotech reached 19,600, an increase of 9.15% from the previous period. The average circulating shares per person decreased by 8.38% to 10,425 shares [2]. - Among the top ten circulating shareholders, E Fund Medical Healthcare Industry Mixed A ranked as the fourth largest shareholder with 3.17 million shares, while Hong Kong Central Clearing Limited ranked sixth with 2.87 million shares, showing a decrease of 1.87 million shares from the previous period [2].