Core Viewpoint - Maiwei Biotech has received approval from the National Medical Products Administration for the clinical trial application of 9MW3811 injection for the treatment of pathological scars, marking a significant step in its drug development process [2][4]. Drug Basic Information - Drug Name: 9MW3811 Injection - Application: Clinical trial for domestic drug registration - Applicant: Maiwei Biotech - Clinical Trial Notification Number: 2025LP02967 - Approval Conclusion: The application meets the requirements for drug registration and is approved to proceed with clinical trials [2]. Drug Mechanism and Potential - IL-11 is a cytokine involved in chronic inflammation and fibrosis-related diseases, playing a crucial role in the fibrotic processes of various organs [3]. - Pathological scars include hypertrophic scars, keloids, and contracture scars, with IL-11 being particularly significant in their formation [3]. - 9MW3811 is a humanized monoclonal antibody targeting IL-11, designed to inhibit the abnormal activation of the IL-11/IL-11Rα signaling pathway, thus intervening in the pathological progression of fibrosis-related diseases [4]. Clinical Development and Market Potential - 9MW3811 has shown significant efficacy in preclinical studies for pulmonary fibrosis and other fibrosis-related diseases, with a global patient population of approximately 25 million for pathological scars, including about 7.4 million in China [4]. - The company plans to initiate Phase II clinical trials for 9MW3811 targeting pathological scars by the end of 2025, positioning it as the first IL-11 targeted drug to enter clinical stages for this indication [5]. - Maiwei Biotech has entered into an exclusive licensing agreement with CALICO LIFE SCIENCES LLC, which includes an upfront payment of $25 million and potential milestone payments totaling up to $571 million, indicating strong commercial prospects for 9MW3811 [5].

Group 1 - Digital Zhengtong's subsidiary Baoding Jindi won a bid for a smart water project in Jinan, with a total contract value of 109 million yuan, of which Baoding Jindi's share is approximately 77 million yuan [1] - Lingzhi Software plans to acquire 100% equity of Kaimiride through a combination of cash and stock issuance, with the final transaction price yet to be determined [1] - Tianjin Port's subsidiary plans to transfer 60% equity of China Railway Storage and Transportation, with an estimated value of 37.54 million yuan for the entire equity [2] Group 2 - New Wufeng reported a 56.97% year-on-year increase in pig sales in October, selling 610,000 pigs [3] - New Peng Co. announced a joint investment of approximately 15 million USD with Jabil to build a battery storage box project in Thailand [4] - Maiwei Bio received approval for a clinical trial of its 9MW3811 injection for pathological scars [6] Group 3 - Jiangsu Sopo completed maintenance and resumed production of its methanol and acetic acid facilities [8] - Luoniushan reported a 24.65% year-on-year increase in pig sales revenue in October, totaling 116 million yuan [9][10] - Zhongbei Communication signed a 1 billion yuan comprehensive computing service framework agreement with Xiamen Hongxin Electronics [11] Group 4 - Huayang New Materials announced the resignation of its general manager, Wu Yuehua [12] - Zhongxin Co. used 50 million yuan of idle funds to purchase structured deposits with expected annual returns between 0.55% and 2.05% [14] - Huajian Group's subsidiary signed a construction engineering design contract worth 96.54 million yuan [16] Group 5 - Jianyou Co. received FDA approval for a new production site for its injectable drug [17] - Beilu Pharmaceutical obtained a drug registration certificate for its iodine mepivacaine injection, which is included in the national medical insurance catalog [19] - *ST Yuancheng's stock will be suspended due to falling below the market cap threshold for delisting [20] Group 6 - Xiantan Co. reported a 9.3% year-on-year increase in chicken product sales revenue in October, totaling 503 million yuan [21] - Huanxu Electronics reported an 8.93% year-on-year decrease in consolidated revenue for October, amounting to 5.598 billion yuan [23] - Yisheng Co. reported a 22.97% year-on-year decrease in white feather chicken seed sales revenue in October [25] Group 7 - Yuandong Bio initiated a Phase I/II clinical trial for its ADC drug YLSH003 targeting advanced solid tumors [25] - Xiaoming Co. reported a 34.89% year-on-year decrease in chicken product sales revenue in October [26] - Nanjiao Food reported a 5.27% year-on-year decrease in consolidated revenue for October, totaling 235 million yuan [28] Group 8 - Chuangye Huikang announced a potential change in control, leading to a temporary stock suspension [30] - Tangrenshen reported a 17.91% year-on-year decrease in pig sales revenue in October, totaling 828 million yuan [32][33] - Wancheng Group plans to distribute a cash dividend of 1.5 yuan per 10 shares to shareholders [34] Group 9 - Kangguan Technology plans to distribute a cash dividend of 3.6 yuan per 10 shares to shareholders [36] - Shoudu Online's executive plans to reduce holdings of up to 19,400 shares [38] - Maolai Optical received approval for the issuance of convertible bonds [40] Group 10 - Jinkai New Energy plans to distribute a cash dividend of 0.1 yuan per share to shareholders [41] - Tianchen Medical raised the upper limit for share repurchase to 70 yuan per share [42] - Tianmu Lake used 38 million yuan of idle funds to purchase structured deposits [43]

Core Viewpoint - Maiwei Biotech (688062) 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] Company Summary - 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 and holds independent intellectual property rights [1]

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]

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]