Mabwell(688062)
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迈威生物: 海通证券股份有限公司关于迈威(上海)生物科技股份有限公司2024年持续督导年度跟踪报告
Zheng Quan Zhi Xing· 2025-03-30 10:27
Core Viewpoint - The company, Maiwei Biotech, is facing significant financial challenges, including a net loss of approximately 106.96 million yuan, primarily due to high R&D expenditures and the short market presence of its products [2][10][11]. Financial Performance - The company's net profit attributable to shareholders was -104.39 million yuan, with a net loss excluding non-recurring items of -106.96 million yuan, indicating a slight increase in losses compared to the previous year [10][18]. - Revenue for the year reached 199.78 million yuan, a 56.28% increase from the previous year, driven by a significant rise in drug sales [18][26]. - R&D expenses for the year were approximately 78.29 million yuan, reflecting a decrease of 6.33% compared to the previous year [10][18]. Product Development and Market Position - The company has three products on the market: Junmaikang®, Mailishu®, and Maiweijian®, with ongoing clinical trials for several innovative drugs [10][11][26]. - The company has a pipeline of 16 products at various stages, including 12 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases [10][11]. - The sales revenue from the drug Deshu Single Antibody reached approximately 138.97 million yuan, marking a 230.17% increase year-on-year [26][27]. Regulatory and Compliance - The company is subject to stringent regulatory oversight, with compliance to various national and local drug management regulations impacting its operations [14][15]. - The company has established internal systems to ensure compliance with legal and regulatory requirements, including information disclosure obligations [4][5]. R&D and Innovation - The company emphasizes innovation, with a focus on developing differentiated products and maintaining a robust R&D pipeline [20][21]. - The company has established multiple technology platforms to enhance its drug discovery and development processes, contributing to its competitive edge in the market [20][21]. Market Strategy - The company is expanding its commercial sales efforts, with a focus on building a professional sales and marketing team to enhance product promotion and market penetration [25][28]. - The marketing strategy is centered around a patient-centric approach, leveraging clinical data to educate healthcare providers and patients about its products [28].
迈威生物: 迈威生物关于变更经营范围、修订《公司章程》并办理工商变更登记的公告
Zheng Quan Zhi Xing· 2025-03-30 10:17
Core Viewpoint - The company plans to expand its business scope to include medical research, drug production, and related activities, requiring amendments to its articles of association and subsequent registration with the industrial and commercial authorities [1][2]. Summary by Relevant Sections Business Scope Changes - The company intends to add medical research and experimental development, drug production, and other related activities to its existing business scope [1]. - The revised business scope includes general projects such as technical services, technology development, medical research, gene diagnosis and treatment technology development, and various medical device rentals [1][2]. Articles of Association Amendments - The amendments to the articles of association will reflect the new business scope and will require approval from the company's shareholders [1]. - Other contents of the articles of association will remain unchanged, and the final approved content will be based on the registration authority's confirmation [2]. Shareholder Meeting - The board of directors will seek authorization from the shareholder meeting to allow management and authorized representatives to handle the necessary registration and filing related to the business scope changes [2].
迈威生物: 迈威生物第二届监事会第十六次会议决议公告
Zheng Quan Zhi Xing· 2025-03-30 10:17
Meeting Overview - The second session of the Supervisory Board of Maiwei (Shanghai) Biotechnology Co., Ltd. was held on March 30, 2025, with all three supervisors present, confirming the legality and validity of the meeting [1]. Resolutions Passed - The Supervisory Board approved the 2024 Annual Report and its summary, affirming that the report accurately reflects the company's financial status and operational results without any misleading statements or omissions [2]. - The 2025 Financial Budget Report was also approved, pending review at the 2024 Annual General Meeting [2]. - The 2024 Financial Settlement Report received approval, also subject to the upcoming shareholder meeting [2]. - A special report on the storage and actual use of funds raised in 2024 was approved, confirming compliance with relevant regulations and proper use of funds [2][3]. - The 2024 Internal Control Evaluation Report was approved, indicating effective internal control execution without significant defects [3]. - The profit distribution plan for 2024 was approved, pending shareholder review [4]. - The reappointment of Ernst & Young Hua Ming as the auditing firm for 2025 was approved, ensuring compliance with legal and regulatory requirements [4]. - The 2025 Employee Compensation Plan was approved, aimed at enhancing management levels and motivating employees [5]. - The proposal for the company and its subsidiaries to apply for credit limits from financial institutions was approved, aligning with business needs [5][6]. - The proposal for the use of surplus funds from completed fundraising projects to supplement working capital was approved, enhancing fund utilization efficiency [6][7].
迈威生物: 迈威生物关于召开2024年年度股东大会的通知
Zheng Quan Zhi Xing· 2025-03-30 10:17
Group 1 - The company, Mabwell (Shanghai) Biotechnology Co., Ltd., is convening its 2024 Annual General Meeting on April 21, 2025, at 15:00 in Shanghai [1][3] - Voting will be conducted through a combination of on-site and online methods, utilizing the Shanghai Stock Exchange's network voting system [1][4] - The registration date for shareholders to attend the meeting is April 14, 2025, and shareholders must complete registration by April 15, 2025, at 17:00 [5][6] Group 2 - The agenda includes several non-cumulative voting proposals, such as the application for credit limits from financial institutions and the approval of the 2024 annual report [2][9] - The meeting will also hear reports from independent directors regarding their performance for the year 2024 [2][3] - Shareholders can delegate their voting rights to representatives, who do not need to be shareholders themselves [5][8]
迈威生物: 迈威生物2025年度”提质增效重回报”行动方案
Zheng Quan Zhi Xing· 2025-03-30 10:17
Core Viewpoint - The company aims to enhance operational efficiency and shareholder returns through its "Quality Improvement and Efficiency Enhancement Action Plan" for 2025, focusing on innovative drug development and global market expansion [1][18]. Group 1: Drug Development and Pipeline - The company is concentrating on the research and development of innovative drugs, with a pipeline of 16 core products, including 12 innovative drugs and 4 biosimilars, primarily targeting oncology and age-related diseases [1]. - The key pipeline product 9MW2821 is an innovative antibody-drug conjugate (ADC) targeting Nectin-4, with clinical trials ongoing for multiple cancers, including bladder, cervical, esophageal, and triple-negative breast cancer [2]. - The company has received several FDA designations for 9MW2821, including Fast Track Designation (FTD) and Orphan Drug Designation (ODD) for various cancer treatments [3]. Group 2: Clinical Trials and Research - The company has reported significant clinical trial progress, with over 800 participants enrolled in various studies for 9MW2821, demonstrating promising efficacy and safety data [2][4]. - The company is also advancing other innovative pipelines, such as 9MW1911 for chronic obstructive pulmonary disease (COPD), which has shown good safety and tolerability in early trials [5][6]. Group 3: Commercialization and Revenue Growth - The company has achieved a 56.28% year-on-year increase in revenue for 2024, primarily driven by a 243.53% increase in drug sales, amounting to 144.59 million yuan [7]. - The company has successfully launched three products, with significant sales and hospital access achieved for its innovative drugs [7][8]. Group 4: Global Market Expansion - The company is actively pursuing international collaborations and market expansion, having established agreements for the commercialization of its products in multiple countries, including India, Brazil, and Peru [9][10]. - The company aims to leverage its innovative drug pipeline and international partnerships to enhance its global market presence [10]. Group 5: Production and Supply Chain - The company has established production facilities compliant with international standards, enabling the manufacturing of antibodies and recombinant proteins for clinical and commercial use [11][12]. - Ongoing projects aim to expand production capacity and improve efficiency, supporting the company's growth and commercialization efforts [13][14]. Group 6: Corporate Governance and Investor Relations - The company is enhancing its corporate governance structure to align with international standards, ensuring compliance and transparency for investors [15][18]. - The company is committed to improving information disclosure and investor communication, establishing multiple channels for engagement [16][18]. Group 7: Management and Incentives - The company has implemented a performance-based incentive system for management, promoting alignment between management and shareholder interests [17]. - The company is focused on talent development and retention, fostering a culture of innovation and growth [17].
迈威生物: 迈威生物董事会关于独立董事独立性自查情况的专项报告
Zheng Quan Zhi Xing· 2025-03-30 10:17
Group 1 - The company has three independent directors: Qin Zhengyu, Xu Qing, and Zhao Qian, who have conducted a self-assessment of their independence [1] - The self-assessment results indicate that all independent directors meet the independence requirements as per the relevant regulations, with no direct or indirect interests that could affect their objective judgment [1] - The board confirmed that the independent directors have not held any positions other than their role as independent directors and have no conflicts of interest with the company or its major shareholders [1] Group 2 - The independent directors have maintained a high level of independence throughout the reporting period, fulfilling their duties in accordance with the strict regulations and requirements of the relevant governance guidelines [1] - The independent directors have provided fair and independent professional opinions to support the company's decision-making processes [1]
迈威生物: 迈威生物关于部分募集资金投资项目结项并将节余募集资金永久补充流动资金的公告
Zheng Quan Zhi Xing· 2025-03-30 10:17
证券代码:688062 证券简称:迈威生物 公告编号:2025-013 迈威(上海)生物科技股份有限公司 关于部分募集资金投资项目结项 并将节余募集资金永久补充流动资金的公告 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。 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") 于 2025 年 3 月 30 日分别召开第二届董事会第十七次会议、第二届监事会第十六 次会议及第二届董事会独立董事专门会议第三次会议,审议通过了《关于部分募 集资金投资项目结项并将节余募集资金永久补充流动资金的议案》,同意公司将 首次公开发行股票募集资金投资项目(以下简称"募投项目")"年产 1,000kg 抗体产业化建设项目"予以结项,并将节余募集资金中的 18,944.20 万元用于永 久补充流动资金。公司监事会发表了明确同意的意见,保荐机构海通证券股份有 限公司亦对上述事项出具了明确同意的核查意见,该事项尚需提交公司股东大会 审议。现将相关情况公告如下: 一、募集资金基本情况 根据中国证券监督管理委员会于 2021 年 12 月 ...
迈威生物: 迈威生物2024年度环境、社会及公司治理报告
Zheng Quan Zhi Xing· 2025-03-30 10:17
Company Overview - Mabwell Biotech (688062.SH) is an innovative biopharmaceutical company with a full industry chain layout, committed to transforming innovation from dreams into reality and exploring life to benefit health [1] - Since its establishment in 2017, the company has built an innovative system covering the entire drug development cycle, from antibody drug target validation and molecular discovery to commercialization [1] - The company has a competitive pipeline with 16 products in various stages, including 12 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases [1] Production and Compliance - Mabwell has established a production base in Taizhou, Jiangsu, compliant with NMPA, FDA, and EMA GMP standards, and is constructing large-scale commercial production bases in Shanghai and Taizhou [2] - The company aims to become a leading international innovative biopharmaceutical company with a full industry chain layout [2] Key Performance Indicators - As of the end of the reporting period, the company has three marketed products: Junmai Kang®, Mai Li Shu®, and Mai Wei Jian® [4] - Mai Li Shu® was approved for marketing in March 2023, with 245,341 units shipped and 1,137 new hospitals added during the reporting period [4] - Mai Wei Jian® was approved in March 2024, with 12,530 units shipped and 75 hospitals added [4] Financial Data - The report includes financial data in RMB, with discrepancies noted against the annual financial report [3] - The company has achieved significant milestones in product commercialization and pipeline development, including the approval of biosimilars and innovative drugs [5][6] Research and Development - Mabwell focuses on unmet clinical needs, developing biosimilars and innovative drugs targeting mature targets, with a complete industrial chain from preclinical research to commercialization [22] - The company has made progress in various clinical trials, including the development of 9MW2821, a targeted Nectin-4 ADC for esophageal cancer, and 9MW0813, a biosimilar for diabetic macular edema [24][25] Governance and ESG - The company has established a governance structure in compliance with relevant laws and regulations, including a board of directors and various committees [8] - Mabwell actively promotes ESG principles, integrating them into its governance framework to ensure sustainable development and compliance [10][11] Intellectual Property and Information Security - The company has filed 79 new patent applications and received 8 new patent grants during the reporting period, with a total of 466 patent applications filed [20] - Mabwell emphasizes information security and data protection, adhering to relevant laws and establishing comprehensive management systems [21][22]
迈威生物: 关于迈威(上海)生物科技股份有限公司非经营性资金占用及其他关联资金往来情况汇总表的专项审计报告
Zheng Quan Zhi Xing· 2025-03-30 10:17
关于迈威(上海)生物科技股份有限公司 非经营性资金占用及其他关联资金往来情况 汇总表的专项审计报告 目 录 委托单位:迈威(上海)生物科技股份有限公司 审计单位:安永华明会计师事务所(特殊普通合伙) 联系电话:021-22284403 非经营性资金占用及其他关联资金往来情况的专项说明 安永华明(2024)专字第70036563_B04号 迈威(上海)生物科技股份有限公司 迈威(上海)生物科技股份有限公司董事会: 我们审计了迈威(上海)生物科技股份有限公司的2023年度财务报表,包括2023 年12月31日的合并及公司资产负债表,2023年度的合并及公司利润表、股东权益变动 表和现金流量表以及相关财务报表附注,并于2024年4月8日出具了编号为安永华明 (2024)审字第70036563_B01号的无保留意见审计报告。 按照《上市公司监管指引第8号——上市公司资金往来、对外担保的监管要求》的 要求,迈威(上海)生物科技股份有限公司编制了后附的2023年度非经营性资金占用 及其他关联资金往来情况汇总表(以下简称"汇总表")。 如实编制和对外披露汇总表,并确保其真实性、合法性、完整性是迈威(上海) 生物科技股份有限 ...
迈威生物: 迈威生物《公司章程修正案》(2025年3月修订)
Zheng Quan Zhi Xing· 2025-03-30 10:17
迈威(上海)生物科技股份有限公司 修订前内容 修订后内容 第二章 公司的经营宗旨和经营范围 《公司章程修正案》 (2025 年 3 月修订) 根据《中华人民共和国公司法》《中华人民共和国证券法》《上市公司章程 指引》,为更好满足公司业务发展需求,结合公司实际情况,公司计划在原有经 营范围的基础上,增加医学研究和试验发展、药品生产等经营范围,并拟对《公 司章程》相关条款进行修订,具体情况如下: 第十四条 经依法登记,公司的经营范 第十四条 经依法登记,公司的经营范 围是:从事生物科技领域内的技术开 围是:一般项目:技术服务、技术开发、 发、技术咨询、技术服务、技术转让, 技术咨询、技术交流、技术转让、技术 技术推广服务,自有设备租赁,从事货 推广;医学研究和试验发展;人体基因 物及技术的进出口业务。【依法须经批 诊断与治疗技术开发;细胞技术研发和 准的项目,经相关部门批准后方可开展 应用;租赁服务(不含许可类租赁服 经营活动】 务);第一类医疗设备租赁;第二类医 疗设备租赁;技术进出口;货物进出口; 食品进出口;第一类医疗器械销售;第 二类医疗器械销售;特殊医学用途配方 食品销售;食品销售(仅销售预包装食 品) ...