Workflow
REMEGEN(688331)
icon
Search documents
荣昌生物: 荣昌生物董事会审核委员会2024年度履职情况报告
Zheng Quan Zhi Xing· 2025-03-27 12:27
Core Viewpoint - The Audit Committee of Rongchang Biopharmaceutical (Yantai) Co., Ltd. has diligently fulfilled its supervisory responsibilities for the year 2024, ensuring compliance with relevant regulations and maintaining effective internal controls [1][4]. Group 1: Audit Committee Overview - The Audit Committee consists of three members, including independent director Ma Lan and director Wang Liqiang, with accounting professional Hao Xianjing serving as the chairperson [1]. - During the reporting period, the Audit Committee held five meetings, with full attendance from all members [1]. Group 2: Key Activities of the Audit Committee - The committee supervised and evaluated the external audit firm, Ernst & Young, ensuring that it adhered to independent and objective auditing standards [1][3]. - The committee guided the internal audit work, reviewing the internal audit plan and confirming its feasibility, while ensuring compliance with the audit plan [2][3]. - The committee reviewed the company's financial reports, concluding that they were true, accurate, and complete, with no significant fraud or misstatements detected [3]. - The committee monitored and assessed the effectiveness of the company's risk management and internal control systems, confirming that there were no major deficiencies [3][4]. - The committee facilitated communication between management, internal audit, and external auditors, enhancing the efficiency of the audit process [4]. Group 3: Overall Evaluation - The Audit Committee has effectively fulfilled its responsibilities in accordance with relevant laws, regulations, and the company's articles of association, promoting sound operations and safeguarding the rights of shareholders [4].
荣昌生物: 荣昌生物2025年度“提质增效重回报”行动方案
Zheng Quan Zhi Xing· 2025-03-27 12:27
Core Viewpoint - Rongchang Biopharmaceutical (Yantai) Co., Ltd. has implemented the "Quality Improvement and Efficiency Enhancement Return Action Plan" for 2024 and 2025, focusing on enhancing core competitiveness and ensuring investor rights [1][7]. Group 1: Business Performance - The company achieved a revenue of 1.717 billion yuan in 2024, representing a year-on-year increase of 58.54%, with a gross margin rising from 77.43% in 2023 to 80.36% in 2024 [1]. - The sales revenue of innovative drugs such as Taitasip and Vidisizumab has seen rapid growth, contributing to the overall increase in revenue [1]. Group 2: Research and Development - The company is advancing its drug development pipeline, with multiple innovative drugs in critical trial phases, including new drug applications for IgA nephropathy and Sjögren's syndrome [1][2]. - Vidisizumab (RC48) is focusing on the development of first-line gastric cancer indications, while RC148 (PD1 VEGF dual antibody) will explore combinations with various ADC drugs [2]. Group 3: Fund Management - The total amount raised is approximately 2.612 billion yuan, with 2.426 billion yuan invested in various projects, achieving a progress rate of 96.80% by the end of 2024 [2][3]. - The company has adhered to fundraising management regulations, ensuring that projects are executed as planned to enhance overall profitability [3]. Group 4: Corporate Governance - The company is continuously improving its governance structure in compliance with relevant laws and regulations, enhancing internal control systems and management practices [3][4]. - The board has conducted multiple meetings to ensure effective decision-making and oversight, thereby improving governance standards [4]. Group 5: Investor Relations - The company emphasizes high-quality information disclosure, ensuring transparency and timely communication with investors [4][5]. - Plans for investor relations activities include hosting performance briefings and engaging in various communication platforms to enhance investor understanding of the company's value [5][6]. Group 6: Incentive Mechanisms - The company has completed the first vesting period of its 2022 A-share restricted stock incentive plan, with ongoing efforts to align management and shareholder interests [6]. - The actual controllers plan to increase their shareholding in the company, demonstrating confidence in its future prospects [6]. Group 7: Future Outlook - The company will continue to monitor the execution of its action plans, regularly assessing the effectiveness of implemented measures and adjusting strategies as necessary [7]. - Ongoing efforts will focus on enhancing core competitiveness, profitability, and risk management capabilities to protect investor interests and contribute to the healthy development of the capital market [7].
荣昌生物: 荣昌生物制药(烟台)股份有限公司关于续聘会计师事务所的公告
Zheng Quan Zhi Xing· 2025-03-27 12:27
Core Viewpoint - The company intends to reappoint Ernst & Young Hua Ming as the A-share audit firm and Ernst & Young as the Hong Kong audit firm for the year 2025, highlighting their compliance with legal and ethical standards in previous audits [1][2][6]. Group 1: A-share Audit Firm Information - Ernst & Young Hua Ming was established in September 1992 and transitioned to a special partnership in August 2012, with its headquarters in Beijing [2]. - The firm reported a total audited business revenue of RMB 5.955 billion for 2023, with audit service revenue of RMB 5.585 billion and securities service revenue of RMB 2.438 billion [2]. - Ernst & Young Hua Ming has audited 137 A-share listed companies in 2023, generating a total fee of RMB 905 million [2]. Group 2: Audit Firm's Compliance and Performance - The firm has a strong investor protection capability, with a cumulative compensation limit exceeding RMB 200 million from its professional risk fund and insurance [3]. - Over the past three years, Ernst & Young Hua Ming has not faced any civil lawsuits or criminal penalties related to its auditing practices [3][5]. - The project partner, Yang Jing, has been a registered accountant since 2015 and has experience in auditing listed companies in the specialized equipment manufacturing and pharmaceutical manufacturing sectors [4]. Group 3: Hong Kong Audit Firm Information - Ernst & Young Hong Kong is a partnership firm providing audit, tax, and consulting services to numerous Hong Kong-listed companies, including financial institutions [5][6]. - The firm has been engaged by the company since 2019 to provide audit services for financial statements submitted to the Hong Kong Stock Exchange [6]. Group 4: Approval Process for Reappointment - The Audit Committee approved the reappointment of the audit firms during its meeting on March 27, 2025, citing their adherence to legal and ethical standards [6][7]. - The Board of Directors also approved the reappointment and agreed to submit the proposal for shareholder approval [7].
荣昌生物: 安永华明会计师事务所(特殊普通合伙)关于荣昌生物制药(烟台)股份有限公司募集资金存放与实际使用情况鉴证报告
Zheng Quan Zhi Xing· 2025-03-27 12:27
荣昌生物制药(烟台)股份有限公司 募集资金存放与实际使用情况鉴证报告 荣昌生物制药(烟台)股份有限公司 目 录 | | | 二、荣昌生物制药(烟台)股份有限公司 募集资金存放与实际使用情况的专项报告 3–8 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70051338_J03 号 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、核对以及我们认为必要的其他程序。我们相信,我们的鉴证工 作 为发表意见提供了合理的基础。 我们认为,荣昌生物制药(烟台)股份有限公司的募集资金专项报告在所有重大 方面按照《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 编制,如实反映了2024年度荣昌生物制药(烟台)股份有限公司募集资金存放与实 际 使用情况。 本报告仅供荣昌生物制药(烟台)股份有限公司披露2024年度报 ...
荣昌生物: 荣昌生物制药(烟台)股份有限公司关于2024年度利润分配方案的公告
Zheng Quan Zhi Xing· 2025-03-27 12:16
证券代码:688331 证券简称:荣昌生物 公告编号:2025-011 港股代码:09995 港股简称:榮昌生物 荣昌生物制药(烟台)股份有限公司 关于 2024 年度利润分配方案的公告 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。 重要内容提示: ? 荣昌生物制药(烟台)股份有限公司(以下简称"公司")2024 年度利 润分配方案为:不派发现金股利,不送红股,不进行资本公积金转增股本。 ? 本次利润分配预案的实施不会触及《上海证券交易所科创板股票上市 规则(2024 年 4 月修订)》第 12.9.1 条第一款第(八)项规定的可能被实施其他 风险警示的情形。 ? 2024 年年度利润分配预案已经公司第二届董事会第二十一次会议和 第二届监事会第十五次会议审议通过,尚需提交公司 2024 年年度股东大会审议。 一、利润分配方案内容 公司于 2025 年 3 月 27 日召开第二届董事会第二十一次会议,审议通过了 《关于公司<2024 年度利润分配预案>的议案》,同意公司 2024 年度不进行利润 分配,也不进行资本公积金 ...
荣昌生物: 荣昌生物第二届董事会第二十一次会议决议公告
Zheng Quan Zhi Xing· 2025-03-27 12:16
Group 1 - The company held its 21st meeting of the second board of directors, with all 8 directors present, ensuring compliance with relevant laws and regulations [1][2] - The board approved the 2024 General Manager's Work Report, emphasizing the importance of scientific decision-making and operational compliance [2][3] - The board also approved the 2024 Board of Directors' Work Report, focusing on maintaining company interests and enhancing governance [2][3] Group 2 - The board approved the 2024 Independent Directors' Work Report, highlighting the independent directors' commitment to their duties and company governance [2][3] - A special opinion on the independence assessment of independent directors was approved, confirming their compliance with relevant regulations [3][4] - The 2024 Financial Settlement Report was approved, with financial statements audited by Ernst & Young, showing no reservations [4][5] Group 3 - The board approved the 2024 Annual Report and its summary, ensuring compliance with stock exchange regulations [4][5] - The 2024 Internal Control Evaluation Report was approved, indicating no significant deficiencies in the internal control system [5][6] - The board decided not to distribute profits for 2024, reporting a net loss of 146.84 million yuan [6][7] Group 4 - The board confirmed the remuneration of senior management for 2024 and proposed adjustments for 2025 based on various factors [6][7] - The board approved the remuneration of directors for 2024, with proposals for 2025 to be based on similar considerations [7][8] - An ESG report for 2024 was approved, reflecting the company's commitment to social responsibility [8][9] Group 5 - The board approved the annual performance report of the Audit Committee, confirming its effective operation [8][9] - A general authorization for share issuance was proposed, allowing the board to issue up to 20% of the total shares [9][10] - The board approved the 2025 "Quality Improvement and Efficiency Enhancement" action plan, aimed at optimizing operations and governance [10][11] Group 6 - The board approved a report on the use of raised funds, ensuring compliance with relevant regulations [11][12] - The board agreed to renew the appointment of Ernst & Young as the auditing firm for 2025 [12][13] - A proposal for a comprehensive credit facility of up to 5.5 billion yuan was approved [13][14] Group 7 - The company plans to use up to 500 million yuan for cash management through safe and liquid financial products [14][15] - The board approved the use of idle raised funds for cash management, with a limit of 140 million yuan [15][16] - The board reviewed the risk management and internal control systems for 2024, confirming their effectiveness [16][17] Group 8 - The board confirmed compliance with the Corporate Governance Code and related rules [17][18] - The board approved the evaluation report on the performance of the auditing firm for 2024, affirming its adherence to auditing standards [18]
荣昌生物(09995) - 2024 - 年度业绩
2025-03-27 12:16
Financial Performance - For the fiscal year ending December 31, 2024, the company's product sales revenue was approximately RMB 1,699.1 million, representing a 61.9% increase from RMB 1,049.2 million in the same period last year[4]. - The total revenue for the fiscal year was RMB 1,710.2 million, with a gross profit of RMB 1,367.4 million[9]. - Revenue increased from RMB 1,076.1 million in 2023 to RMB 1,710.2 million in 2024, driven by strong sales of the autoimmune product TaiTasi and the oncology product VidiSita[38]. - For the year ended December 31, 2024, the company's revenue increased to RMB 1,710,152 thousand, up from RMB 1,076,130 thousand in 2023, representing a growth of approximately 58.8%[63]. - The company reported a net loss of RMB 1,468,362,000 for the year ended December 31, 2024, compared to a net loss of RMB 1,511,229,000 in 2023, indicating a reduction in losses of approximately 2.8%[64]. - Total comprehensive loss for the year was RMB 1,499,240,000, down from RMB 1,570,147,000 in the previous year, reflecting a decrease of about 4.5%[64]. - The net loss for the year decreased to RMB 1,468.36 million in 2024 from RMB 1,511.23 million in 2023, showing a slight improvement in financial performance[48]. Research and Development - Research and development expenses increased by RMB 233.5 million or 17.9% to RMB 1,539.8 million for the fiscal year[9]. - The company has a comprehensive pipeline with over ten candidate drugs, seven of which are in clinical development targeting more than twenty indications[10]. - The company is actively exploring Taisai for other autoimmune diseases, including plans for a Phase III clinical study for membranous nephropathy[20]. - The company is conducting a Phase II clinical trial for RC148 in advanced lung cancer, progressing smoothly as of December 31, 2024[34]. - The company is focused on drug development and has received approval for the comprehensive marketing application of its drug, TaiTasiPu, in November 2023[69]. - The company is committed to adhering to corporate governance codes as outlined in the listing rules[106]. Clinical Trials and Approvals - The company received FDA Fast Track Designation for its product RC18 (Taitai) for the treatment of primary Sjögren's syndrome in March 2024[5]. - RC48 (Widi) showed positive results in a Phase III clinical trial for HER2-positive metastatic breast cancer, achieving the primary endpoint[6]. - Taisai (RC18) received full NMPA approval in China in November 2023 and was successfully included in the national medical insurance drug catalog by the end of 2023[14]. - The company initiated a Phase III clinical trial for Taisai in China for the treatment of IgA nephropathy in the first half of 2023, with patient recruitment completed by May 2024[16]. - The company submitted a Biologics License Application (BLA) for Taisai for rheumatoid arthritis in August 2023, with approval from NMPA expected in July 2024[15]. - The company has completed a Phase II clinical trial for Vidisicimab in HER2-overexpressing urinary tract cancer patients, leading to a multi-center Phase II registration trial[21]. - A Phase III clinical trial comparing Vidisicimab combined with chemotherapy for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC) is ongoing in China, with patient enrollment completed in August 2024[23]. Financial Position and Liabilities - The company's total liabilities to assets ratio increased to 63.9% as of December 31, 2024, compared to 37.8% in 2023, indicating a higher leverage position[51]. - The company's total liabilities increased significantly to RMB 3,512,318,000 in 2024 from RMB 2,091,074,000 in 2023, marking an increase of approximately 68%[66]. - The net asset value decreased to RMB 1,986,201,000 in 2024 from RMB 3,437,269,000 in 2023, a decline of about 42.3%[66]. - The company has cumulative losses of RMB 4,321,871,000 as of December 31, 2024, indicating ongoing financial challenges[69]. - The company maintains that its available funds and unused bank credit are sufficient to support its normal operations, research, and production activities for at least the next 12 months[69]. Market and Strategic Focus - The company aims to become a leading player in the global biopharmaceutical industry, focusing on unmet medical needs in autoimmune, oncology, and ophthalmology diseases[10]. - The company is one of the few Chinese biotech firms that have commercialized two products, RC18 and RC48[10]. - The company is actively pursuing new drug applications and clinical trials to expand its product pipeline[108]. - The core products include RC18 (brand name: 泰愛®), RC48 (brand name: 愛地希®), and RC28-E[107]. - The company is focused on developing antibody-drug conjugates (ADCs) for targeted cancer therapies[106]. Governance and Compliance - The company is subject to regulatory oversight by the National Medical Products Administration (NMPA) in China[108]. - The board of directors includes both executive and non-executive members, ensuring a diverse governance structure[109]. - The group has adopted revised international financial reporting standards, including IFRS 16 and IAS 1, with no impact on its financial position or performance[73]. - The company emphasizes the uncertainty in successfully developing and selling its core products, advising shareholders to act cautiously[105].
荣昌生物(688331) - 荣昌生物2024年度内部控制评价报告
2025-03-27 12:01
公司代码:688331 公司简称:荣昌生物 荣昌生物制药(烟台)股份有限公司 2024 年度内部控制评价报告 □是 √否 2. 财务报告内部控制评价结论 荣昌生物制药(烟台)股份有限公司全体股东: 根据《企业内部控制基本规范》及其配套指引的规定和其他内部控制监管要求(以下简称企业内部 控制规范体系),结合本公司(以下简称公司)内部控制制度和评价办法,在内部控制日常监督和专项 监督的基础上,我们对公司2024年12月31日(内部控制评价报告基准日)的内部控制有效性进行了评价。 一. 重要声明 按照企业内部控制规范体系的规定,建立健全和有效实施内部控制,评价其有效性,并如实披露内 部控制评价报告是公司董事会的责任。监事会对董事会建立和实施内部控制进行监督。经理层负责组织 领导企业内部控制的日常运行。公司董事会、监事会及董事、监事、高级管理人员保证本报告内容不存 在任何虚假记载、误导性陈述或重大遗漏,并对报告内容的真实性、准确性和完整性承担个别及连带法 律责任。 公司内部控制的目标是合理保证经营管理合法合规、资产安全、财务报告及相关信息真实完整,提 高经营效率和效果,促进实现发展战略。由于内部控制存在的固有局限性, ...
荣昌生物(688331) - 荣昌生物制药(烟台)股份有限公司关于续聘会计师事务所的公告
2025-03-27 12:01
证券代码:688331 证券简称:荣昌生物 公告编号:2025-012 港股代码:09995 港股简称:榮昌生物 荣昌生物制药(烟台)股份有限公司 关于续聘会计师事务所的公告 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。 重要内容提示: 拟聘任的会计师事务所名称:荣昌生物制药(烟台)股份有限公司(以 下简称"公司")拟续聘安永华明会计师事务所(特殊普通合伙)(以下简称"安 永华明")为 2025 年度 A 股审计机构及内部控制审计机构,拟续聘安永会计师 事务所(以下简称"安永香港")担任 2025 年度港股审计机构。 一、拟聘任 A 股会计师事务所的基本情况 (一)机构信息 1.基本信息 安永华明会计师事务所(特殊普通合伙)(以下简称"安永华明" )于 1992 年 9 月成立,2012 年 8 月完成本土化转制,从一家中外合作的有限责任制事务 所转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 ...
荣昌生物(688331) - 荣昌生物2024年环境、社会及管治(ESG)报告
2025-03-27 12:01
荣昌生物 2024 年环境、社会及管治(ESG)报告 1 目录 | 日求 | | --- | | 关于本报告 . | | 董事会声明 | | 1. 关于我们 . | | 1. 1 公司简介 | | 1. 2 年度 ESG 亮点绩效 | | 1. 3 年度荣誉奖项 | | 1. 4 ESG 治理 … | | 1.4.1 ESG 管理体系 . | | 1.4.2 利益相关方沟通… | | 1.4.3 双重重要性议题判定……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 10 | | 2. 合规与诚信 . | | 2.1 公司治理 ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 12 | | 2.1.1 公司治理架构 . | | 2.1.2 董事会多元化建设 | | 2. ...