Core Insights - A strategic cooperation agreement has been established among InSilico Medicine, Maiwei Biotech, and Haoyuan Pharmaceutical to develop a new library of ADC compounds targeting hundreds of antigens, aiming to accelerate the industrialization of innovative ADC drugs [1][2] Group 1: Company Contributions - Maiwei Biotech possesses an internationally leading ADC drug development platform that has been clinically validated, showcasing strong R&D capabilities and commercialization potential [1] - InSilico Medicine will utilize its Pharma.AI platform to design innovative payload-linkers based on disease mechanisms and target characteristics, demonstrating the advantages of AI in drug development [2] - Haoyuan Pharmaceutical will provide a rich resource library of molecular building blocks and tool compounds to support the synthesis of ADC payload-linkers, facilitating a full-process collaboration from screening to clinical development [2] Group 2: Industry Impact - This collaboration represents an innovative breakthrough in China's biopharmaceutical industry within the ADC drug sector, integrating AI technology with traditional drug development to create a new model for ADC drug development [2] - The partnership aims to significantly shorten the molecular optimization process, which traditionally takes years, thereby enhancing R&D efficiency [2] - The collaboration establishes a complete value chain for ADC drug development, maximizing the strengths of each party to efficiently advance innovation and provide more treatment options for global patients [2][3]

Group 1 - The strategic cooperation agreement was signed between Insilico Medicine, Maiwei Biotech, and Haoyuan Pharmaceutical to develop a new ADC compound library covering hundreds of targets, aiming to accelerate the industrialization of innovative ADC drugs [1][2] - Maiwei Biotech possesses an internationally leading ADC drug development platform with clinical validation, providing a strong R&D capability and commercial potential for the collaboration [1][2] - Insilico Medicine will utilize its Pharma.AI platform to design innovative payload-linkers based on disease mechanisms and target characteristics, showcasing the advantages of AI in drug development [2][3] Group 2 - The collaboration represents an innovative breakthrough in China's biopharmaceutical industry within the ADC drug field, integrating AI technology with traditional drug development processes [2] - The partnership aims to create a complete value chain for ADC drug development, enhancing efficiency and quality in the research and development process [2][3] - The CEOs of the involved companies emphasized the importance of this collaboration in accelerating the development of ADC drugs and providing better treatment options for cancer patients globally [3]

Summary of the Conference Call on Maiwei Biotech and the Tracer Project Company and Industry Overview - **Company**: Maiwei Biotech - **Industry**: Neurodegenerative Diseases, specifically focusing on Parkinson's Disease (PD) and Multiple System Atrophy (MSA) through the Tracer project [2][4] Key Points and Arguments 1. **Tracer Project Overview**: - Tracer is a novel radiolabeled small molecule drug targeting PD and MSA, with significant application potential and a clear clinical development path [2][4] - It is the only team globally developing such a tracer for PD, aiming to be the first approved tracer for this condition [2][4] 2. **Funding and Support**: - The project has received unconditional funding from the MicroG Fox Foundation, indicating strong scientific and commercial backing [2][5] - Collaboration with top research institutions, including the Chinese Academy of Sciences, enhances the project's credibility and potential [2][6] 3. **Clinical Development Timeline**: - FDA IND approval is expected in 2025, with the first patient enrollment planned for Q4 2025 [5][6] - The Chinese IND is anticipated to be approved in early 2026, with over 100 patient imaging studies already conducted at Huashan Hospital [5][6] 4. **Market Potential**: - The Tracer project targets a large unmet market for PD, with no similar products currently approved, positioning Maiwei Biotech to set new treatment standards [6][10] - The project is expected to solidify Maiwei's position in the chronic disease sector, particularly in age-related diseases [6][10] 5. **Operational Model**: - Maiwei is the largest external investor in the project, which operates independently but leverages Maiwei's core operational capabilities [3][8] - The company plans to explore overseas licensing and transfer opportunities as the project matures [9][20] 6. **Clinical Trial Design**: - Phase I trials will focus on safety, radiation dosimetry, and pharmacokinetics, with a target enrollment of 20 to 30 patients [15][22] - The project faces challenges in obtaining post-mortem data for validation, which may require international collaboration [15][22] 7. **Challenges in Commercialization**: - High costs and lack of insurance coverage for PD diagnostics may hinder market acceptance [15][18] - The company plans to integrate diagnostic tools with therapeutic drugs to enhance market uptake [15][18] 8. **AI Integration**: - AI technology is being explored to improve imaging analysis and diagnostic accuracy, potentially increasing market penetration [16][18] 9. **Future Development Plans**: - Maiwei is committed to expanding its pipeline in neurodegenerative diseases, including Alzheimer's, while adopting differentiated strategies to enhance drug development efficiency [14][24] 10. **Shareholding Structure**: - Maiwei holds a 35% stake in the Tracer project, with plans to potentially increase investment to meet clinical needs and achieve commercialization [23][24] Additional Important Insights - The Tracer project is positioned as a first-in-class solution in the PD space, with significant implications for future investment returns compared to the Alzheimer's market, which has multiple approved tracers [10][12] - The collaboration with international partners and the establishment of a robust BD network are crucial for the project's success and future opportunities [11][19]

Core Viewpoint - The strategic collaboration among Maiwei Biotech, Yingshi Intelligent, and Haoyuan Pharmaceutical aims to develop a novel ADC compound library targeting hundreds of sites, accelerating the industrialization of innovative ADC drugs [1] Group 1: Company Collaboration - Maiwei Biotech, Yingshi Intelligent, and Haoyuan Pharmaceutical have officially announced a strategic cooperation agreement [1] - The partnership focuses on screening and advancing next-generation ADC candidate molecules [1] - The collaboration is expected to enhance the innovation and commercialization of ADC drugs [1]

Group 1 - Huadian Co., Ltd. plans to issue H-shares and list on the Hong Kong Stock Exchange [2] - Cisco Ray's 2022 annual report was found to have inflated revenue by 9.96 million and profit by 7.0054 million, leading to penalties and a change in stock name to ST Cisco Ray [3] - Tianpu Co., Ltd. experienced a 245.20% increase in stock price over 13 consecutive trading days, indicating a risk of rapid decline [4] - ST New Power is under investigation by the China Securities Regulatory Commission for suspected violations of information disclosure laws [6] - Baoli International intends to invest in semiconductor testing equipment company Hongtai Technology, acquiring 1%-3% equity [7] - Ankai Micro plans to invest 20 million yuan to acquire 4% equity in Shiqi Future, focusing on smart vision technology [8] Group 2 - SF Holding reported a revenue of 24.787 billion yuan in August, a year-on-year increase of 7.86% [9] - Various companies are involved in share transfers, including Guangli Micro and *ST Tianlong, with plans for significant asset restructuring [11] - Xinwangda's subsidiary aims to establish a storage industry fund with professional investment institutions [12] - Several companies are planning share repurchases, including Shunhao Co. and Lingyun Optics, with adjustments to repurchase plans [18]

Market Overview - The global financial market exhibited a "divided" trend, with the Dow Jones Industrial Average slightly up by 0.57%, while the Nasdaq and S&P 500 fell by 0.33% and 0.10% respectively, highlighting a significant disparity in performance among major tech stocks [1][3] - Chinese assets, in contrast, saw a strong performance, with the Nasdaq Golden Dragon China Index surging by 2.8%, and Baidu experiencing a gain of over 11% [1][3] Federal Reserve Actions - The Federal Reserve's recent decision to lower the benchmark interest rate by 25 basis points to a range of 4.00%-4.25% has had a profound impact on global markets [3] - The Fed's acknowledgment of rising risks in the employment sector marks a shift from its previous stance on a strong job market, indicating a cautious outlook on the economic future [3] Economic Data - Recent U.S. economic data revealed a decline in new housing starts to an annualized rate of 1.3 million units, a 3.7% drop from July, and building permits fell from 1.362 million to 1.312 million, the lowest since May 2020 [4][3] - The weak housing data has raised concerns among investors about a potential economic slowdown, overshadowing the positive effects of the Fed's rate cut [4][3] Policy Developments - The Chinese government is set to introduce a series of policy measures aimed at boosting the service sector, including high-quality development in the accommodation industry and integration of rail and tourism [5] - The Ministry of Industry and Information Technology is seeking public input on mandatory national standards for intelligent connected vehicles, which could enhance safety in the automotive sector [6] Industry News - CATL announced that it will begin mass supply of sodium-ion batteries for passenger vehicles next year, which offer a range of over 500 kilometers and are expected to meet over 40% of domestic passenger vehicle market demand [6][14] - Major tech events, such as Huawei's Connect 2025 and Meta Connect 2025, are anticipated to unveil significant advancements in AI, cloud computing, and smart vehicles, potentially influencing the tech industry [9][11] Investment Insights - Analysts suggest that the current economic stability and the Fed's rate cut cycle could provide a favorable environment for market sentiment and capital inflow, with expectations of a potential upward trend in A-shares and economic performance [11] - There are indications of a shift in market focus, with low-positioned sectors like semiconductor manufacturing and smart driving showing signs of recovery, while high-positioned sectors may face profit-taking pressures [11]

Group 1 - Honghe Technology plans to increase capital by 300 million yuan to its wholly-owned subsidiary Huangshi Honghe through debt-to-equity conversion, raising its registered capital from 700 million yuan to 1 billion yuan [1] - Huaxia Happiness has completed debt restructuring amounting to approximately 192.67 billion yuan, with a total of 24 billion yuan in overdue debts as of August 31 [1] - Chengyi Pharmaceutical's controlling shareholder plans to reduce its stake by up to 1.18%, amounting to 387,560 shares [1][2] Group 2 - Yuanwang Valley received a warning letter from the Shenzhen Securities Regulatory Bureau for failing to halt trading when its controlling shareholder's stake changed to a multiple of 5% [2] - Gongjin Co. received government subsidies of 8.9 million yuan, accounting for 11.13% of its latest audited net profit [3] - Maiwei Biotech's application for the listing of 9MW0813 injection has been accepted by the National Medical Products Administration [4] Group 3 - Jianfeng Group plans to repurchase shares worth between 20 million and 40 million yuan at a maximum price of 12.42 yuan per share [6] - Ankai Micro plans to invest 20 million yuan to acquire a 4% stake in Shiqi Future [7] - Pinming Technology's stock will continue to be suspended as it is actively pursuing a significant matter that may lead to a change in control [8] Group 4 - China Communications has signed new contracts worth 256.34 billion yuan from January to August, with domestic contracts totaling 206.05 billion yuan [18] - Round Express reported a revenue of 5.39 billion yuan in August, a year-on-year increase of 9.82% [38] - China Pacific Insurance's original insurance premium income reached 217.05 billion yuan from January to August, up 13.2% year-on-year [39] Group 5 - *ST Chuangxing's chairman is under investigation, and the general manager will act as the chairman during this period [40] - Fengshan Group signed a technical development contract with Tsinghua University for a project related to sodium-ion battery electrolytes [40] - Yongxin Optical stated that its optical components related to lithography machines account for less than 1% of its revenue [41] Group 6 - Tianyuan Dike's subsidiary received a government subsidy of 3.77 million yuan, representing 16.27% of its latest audited net profit [42] - Huaxiang Co. plans to issue convertible bonds to raise no more than 1.308 billion yuan for various projects [43] - Wolong Electric Drive reported that its robot-related products accounted for only 2.71% of total revenue in the first half of the year [44]

公告显示，9MW0813注射液是阿柏西普（艾力雅®）的生物类似药，为VEGFR—1和VEGFR—2胞外区 结合域与人免疫球蛋白Fc段重组形成的融合蛋白，可与VEGF—A和PlGF结合。 北京商报讯（记者 王寅浩 实习记者 宋雨盈）9月19日，迈威生物发布公告称，公司近日收到国家药品 监督管理局核准签发的《受理通知书》，9MW0813注射液的上市许可申请获得受理，用于糖尿病性黄 斑水肿（DME）和新生血管（湿性）年龄相关性黄斑变性（nAMD）。 ...

证券之星消息，9月19日化学制药板块较上一交易日下跌1.84%，迈威生物领跌。当日上证指数报收于 3820.09，下跌0.3%。深证成指报收于13070.86，下跌0.04%。化学制药板块个股涨跌见下表： | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | --- | --- | --- | --- | --- | --- | | 300233 | 金城医药 | 20.18 | 4.67% | 26.91万 | 5.29亿 | | 002742 | *ST三圣 | 4.76 | 3.93% | 6.20万 | 2902.55万 | | 688197 | 首药控股 | 45.90 | 2.41% | 3.07万 | 1.43亿 | | 301263 | 泰恩康 | 36.82 | 1.63% | 6.19万 | 2.28亿 | | 000908 | ST景峰 | 5.94 | 1.37% | 12.52万 | 7421.20万 | | 301065 | 本立科技 | 23.38 | 0.95% | 2.17万 | 5015.95万 | | 603669 | 灵康药业 | 5. ...

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。 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《受理通知书》，9MW0813 注射液的 上市许可申请获得受理，用于糖尿病性黄斑水肿（DME）和新生血管（湿性） 年龄相关性黄斑变性（nAMD）。由于药品的研发周期长、审批环节多，容易受 到一些不确定性因素的影响，本次上市许可申请能否获得批准存在不确定性，敬 请广大投资者谨慎决策，注意防范投资风险。现将相关情况公告如下： 证券代码：688062 证券简称：迈威生物 公告编号：2025-055 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW0813 注射液上市许可申请 获得受理的公告 1 一、药品基本情况 药品名称：阿柏西普眼内注射溶液 申请事项：境内生产药品注册上市许可 受理号：CXSS2500098 申请人：迈威（上海）生物科技股份有限公司 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 9MW0813 根据 ...