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迈威生物: 迈威生物2025年度”提质增效重回报”行动方案
证券之星· 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
证券之星· 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2024年度环境、社会及公司治理报告
证券之星· 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: 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
证券之星· 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: 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
证券之星· 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)
证券之星· 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) ...
迈威生物: 迈威生物2024年度营业收入扣除情况专项说明
证券之星· 2025-03-30 10:17
迈威(上海)生物科技股份有限公 迈威(上海)生物科技股份有限公司 营业收入扣除情况专项说明 关于迈威(上海)生物科技股份有限公司 安永华明(2025)专字第 迈威(上海)生物科技股份有限公司董事会: 我们接受委托,审计了迈威(上海)生物科技股份有限公司的财务报表,包括 益变动表和现金流量表以及相关财务报表附注,并于2025年3月30日出具了编号为安 永华明(2025)审字第70036563_B01的无保留意见审计报告。 根据《上海证券交易所科创板上市公司自律监管指南第9号——财务类退市指标: 营业收入扣除》的规定,迈威(上海)生物科技股份有限公司编制了后附的2024年 度 营业收入扣除情况表(以下简称"情况表")。如实编制和对外披露情况表并确保其 真实性、合法性、完整性是迈威(上海)生物科技股份有限公司管理层的责任。 基于我们为对迈威(上海)生物科技股份有限公司财务报表整体发表审计意见而 实施的审计工作,我们未发现后附情况表所载相关信息与我们审计迈威(上海)生 物 科技股份有限公司2024年度财务报表时所审核的会计资料及2024年度财务报表中所 70036563_B03号 公司 (本页无正文) 安永华明会计师 ...
迈威生物: 迈威生物2024年度募集资金存放与实际使用情况鉴证报告
证券之星· 2025-03-30 10:17
迈威(上海)生物科技股份有限公司 募集资金存放与实际使用情况 鉴证报告 页码 募集资金存放与实际使用情况鉴证报告 安永华明(2025)专字第 70036563_B02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: 我们接受委托,对后附的迈威(上海)生物科技股份有限公司2024年度的募集资 金存放与实际使用情况的专项报告("募集资金专项报告")进行了鉴证。按照《上 市公司监管指引第2号——上市公司募集资金管理和使用的监管要求》、《上海证券 交 易所科创板上市公司自律监管指引第1号——规范运作》及相关格式指南编制募集资 金 专项报告,并保证其内容真实、准确、完整,不存在虚假记载、误导性陈述或重大 遗 漏是迈威(上海)生物科技股份有限公司董事会的责任。我们的责任是在执行鉴证 工 作的基础上对募集资金专项报告独立发表鉴证意见。 我们按照《中国注册会计师其他鉴证业务准则第3101号——历史财务信息审计或 审阅以外的鉴证业务》的规定执行了鉴证业务。该准则要求我们计划和执行鉴证工 作,以对募集资金专项报告是否不存在重大错报获取合理保证。在鉴证过程中,我 们 实施了包括了解、抽查、核对以及我 ...
迈威生物: 迈威生物2024年度会计师事务所履职情况评估报告
证券之星· 2025-03-30 10:17
迈威(上海)生物科技股份有限公司 一、2024 年度会计师事务所基本情况 安永华明会计师事务所( (以下简称"安永华明")于 1992 年 (特殊普通合伙) 制为特殊普通合伙制事务所。安永华明总部设在北京,注册地址为北京市东城区 东长安街 1 号东方广场安永大楼 17 层 01-12 室。截至 2024 年末拥有合伙人 251 人,首席合伙人为毛鞍宁先生。安永华明一直以来注重人才培养,截至 2024 年 末拥有执业注册会计师逾 1700 人,其中拥有证券相关业务服务经验的执业注册 会计师超过 1500 人,注册会计师中签署过证券服务业务审计报告的注册会计师 逾 500 人。安永华明 2023 年度业务总收入人民币 59.55 亿元,其中,审计业务 收入人民币 55.85 亿元,证券业务收入人民币 24.38 亿元。2023 年度 A 股上市公 司年报审计客户共计 137 家,收费总额人民币 9.05 亿元。这些上市公司主要行 业涉及制造业、金融业、批发和零售业、采矿业、信息传输、软件和信息技术服 务业、租赁和商务服务业等。本公司同行业上市公司审计客户 13 家。 二、2024 年度会计师事务所履职情况 迈威( ...
迈威生物: 迈威生物关于2025年度向金融机构申请授信额度的公告
证券之星· 2025-03-30 10:17
本次申请授信额度事宜尚需提交公司2024年年度股东大会审议。为提高工作 效率,董事会授权公司管理层在上述额度内办理金融机构授信及融资所需的相关 具体事项。 特此公告。 董事会 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。 或"迈威生物")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, 审议通过了《关于2025年度向金融机构申请授信额度的议案》,本事项尚需提交 公司2024年年度股东大会审议,现将具体情况公告如下: 为保障公司生产经营和项目建设快速发展需要,公司及/或其子公司拟向金 融机构申请合计不超过62亿元的授信/融资额度,此授信/融资额度不涉及对外担 保事项,有效期自公司股东大会审议通过之日起12个月内有效。授信/融资期限 内,授信/融资额度可循环使用,实际使用的授信/融资额度最终以相关金融机构 实际审批的金额为准,具体借款金额将视公司经营的实际资金需求确定。具体授 信/融资方式包括但不限于非流动资金贷款、流动资金贷款、银行承兑汇票、中 长期贷款、信用证、保函、内保外贷、外保内贷、融资租赁、信托贷款等。本次 ...