上海盟科药业股份有限公司 审计报告及财务报表 二〇二四年度 上海盟科药业股份有限公司 审计报告及财务报表 （2024 年 01 月 01 日至 2024 年 12 月 31 日止） | | 目录 | 页次 | | --- | --- | --- | | 一、 | 审计报告 | 1-5 | | 二、 | 财务报表 | | | | 合并资产负债表和母公司资产负债表 | 1-4 | | | 合并利润表和母公司利润表 | 5-6 | | | 合并现金流量表和母公司现金流量表 | 7-8 | | | 合并所有者权益变动表和母公司所有者权益变动表 | 9-13 | | | 财务报表附注 | 1-93 | 审计报告 信会师报字[2025]第 ZA10177 号 上海盟科药业股份有限公司全体股东： 一、审计意见 我们审计了上海盟科药业股份有限公司（以下简称盟科药业）财 务报表，包括 2024 年 12 月 31 日的合并及母公司资产负债表，2024 年度的合并及母公司利润表、合并及母公司现金流量表、合并及母公 司股东权益变动表以及相关财务报表附注。 | 关键审计事项 | 该事项在审计中是如何应对的 | | --- | --- ...

上海盟科药业股份有限公司 董事会审计委员会对会计师事务所 2024 年度履行监督职责情况报告 根据《中华人民共和国公司法》《中华人民共和国证券法》《上市公司治理准则》 《国有企业、上市公司选聘会计师事务所管理办法》等规定和要求，上海盟科药业股份 有限公司（以下简称"公司"）董事会审计委员会本着勤勉尽责的原则，恪尽职守，认 真履职，对立信会计师事务所（特殊普通合伙）（以下简称"立信"）2024 年度审计工 作履行了监督职责，现将具体情况汇报如下： 一、变更会计师事务所的情况说明及履行的程序 立信由我国会计泰斗潘序伦博士于 1927 年在上海创建，1986 年复办，2010 年成为 全国首家完成改制的特殊普通合伙制会计师事务所，注册地址为上海市，首席合伙人为 朱建弟先生。立信是国际会计网络 BDO 的成员所，长期从事证券服务业务，新证券法实 施前具有证券、期货业务许可证，具有 H 股审计资格，并已向美国公众公司会计监督委 员会（PCAOB）注册登记。 截至 2024 年末，立信拥有合伙人 296 名、注册会计师 2,498 名、从业人员总数 10,021 名，签署过证券服务业务审计报告的注册会计师 743 名。 ...

一、审计委员会构成 公司第二届董事会审计委员会成员为独立董事黄寒梅女士、独立董事周伟 澄先生、董事吉冬梅女士，主任委员由会计专业人士黄寒梅女士担任。审计委 员会人员构成符合相关监管要求和公司规定。 二、审计委员会 2024 年度会议召开情况 2024 年度，董事会审计委员会共召开 6 次会议，全体委员均亲自出席了所 有会议。具体情况如下： | 会议届次 | 召开时间 | 议案内容 | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1、《关于<公司 | 年年度报告及其摘要>的议 | 2023 | | | | | | | 案》； | | | | | | | | | 2、《关于<公司 | 年度财务报表>的议案》； | 2023 | | | | | | | 第二届董事会审 | 3、《关于<公司2023年度财务决算报告>的议案》； | | | | | | | | 计委员会第二次 | 年 | 月 | 日 | 4、《关于<公司2024年度财务预算报告>的议案》； | 2024 | 3 | 26 | | 会议 | 5、《关于<公司 | 年度内部控制 ...

公司代码：688373 公司简称：盟科药业 上海盟科药业股份有限公司 2024 年度内部控制评价报告 上海盟科药业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，故仅能为实现上述目标提供 合理保证。此外，由于情况的变化可能 ...

二、2024 年年审会计师事务所基本情况 （一）会计师事务所基本情况 上海盟科药业股份有限公司 关于会计师事务所 2024 年度履职情况评估报告 根据《中华人民共和国公司法》《中华人民共和国证券法》《上市公司治理准则》 《国有企业、上市公司选聘会计师事务所管理办法》等规定和要求，上海盟科药业股份 有限公司（以下简称"公司"）对立信会计师事务所（特殊普通合伙）（以下简称"立 信"）在 2024 年度的审计工作的履职情况进行了评估。经评估，公司认为，立信资质 等方面合规有效，履职能够保持独立性，勤勉尽责，公允表达其意见。具体情况如下： 一、变更会计师事务所的情况说明及履行的程序 公司前任会计师事务所为普华永道中天会计师事务所（特殊普通合伙）（以下简称 "普华永道中天"），对公司 2023 年度财务报告的审计意见类型为标准无保留意见。 2024 年，因普华永道中天已经连续多年为公司提供审计服务，为更好地保证审计工 作的独立性、客观性及公允性，并综合考虑公司业务发展和未来审计服务需求，变更立 信为公司 2024 年度财务审计机构及内部控制审计机构。 公司已就变更会计师事务所的相关事宜与前、后任会计师事务所进行了沟通， ...

证券代码：688373 证券简称：盟科药业 公告编号：2025-011 上海盟科药业股份有限公司 第二届监事会第十次会议决议公告 本公司监事会及全体监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。 一、 监事会会议召开情况 上海盟科药业股份有限公司（以下简称"公司"）第二届监事会第十次会 议（以下简称"本次会议"）于2025年3月17日在公司会议室，通过现场表决与 通讯表决相结合的方式召开。本次会议通知及相关资料已于2025年3月6日通过 邮件送达全体监事。本次会议应出席监事3人，实际出席监事3人。本次会议由 监事会主席卢亮先生召集并主持。本次会议的召集和召开符合《中华人民共和 国公司法》等相关法律、行政法规、规范性文件和《上海盟科药业股份有限公 司章程》（以下简称"《公司章程》"）的规定，会议形成的决议合法、有效。 二、 监事会会议审议情况 (一)审议通过《关于<公司2024年年度报告及其摘要>的议案》 经审议，监事会认为：公司2024年年度报告编制和审议程序符合法律法规、 《公司章程》和公司内部管理制度的各项规定；报告内容真实、准确、完整 ...

Financial Performance - The company reported a net profit attributable to the parent company of negative value, indicating it has not yet achieved profitability[5]. - The company plans not to distribute cash dividends, issue bonus shares, or increase capital reserves for the 2024 fiscal year[9]. - In 2024, the company's operating revenue reached CNY 130.27 million, a year-on-year increase of 43.51%, primarily driven by the sales growth of its self-developed product, Contizole Tablets[30]. - The net loss attributable to shareholders increased by CNY 19.60 million, while the net loss after deducting non-recurring gains and losses increased by CNY 5.17 million compared to the previous year[30]. - Basic earnings per share for 2024 were -CNY 0.67, and the diluted earnings per share were also -CNY 0.67[29]. - The company reported a significant increase in revenue, achieving a total of 2.19 billion in sales for the year[85]. - The company has received a standard unqualified audit report from its accounting firm, ensuring the accuracy of its financial statements[7]. - The company has increased its sales expenses due to expanded academic promotion and distribution network efforts since the commercialization of Contizolam tablets[188]. Research and Development - The company has incurred significant research and development expenses, leading to cumulative losses that continue to increase[6]. - The company is focused on developing innovative drugs for infectious diseases, which typically require long development cycles and substantial investment[5]. - The company continues to enhance its core competitiveness by enriching its new drug pipeline, with multiple innovative drugs in critical clinical trial stages[30]. - The company maintains a high level of overall R&D investment to support ongoing projects[30]. - The R&D expenditure as a percentage of operating revenue was 282.92%, a decrease of 96.98 percentage points compared to the previous year[29]. - The company has established a comprehensive antibacterial new drug R&D system, covering the entire process from early design to clinical development and production management[184]. - The total R&D investment for the year was approximately ¥368.56 million, representing a 6.87% increase from the previous year[178]. - The company has filed 33 new patent applications this year, bringing the total number of applications to 82[175]. Product Development and Pipeline - The core product, Kangtaizuoan tablets, has been launched, with multiple other products in clinical trials both domestically and internationally[5]. - The company has one marketed drug, four drugs in clinical stages, and multiple drugs in preclinical research, indicating a robust R&D pipeline[186]. - The company is actively advancing the development of MRX-8 for resistant Gram-negative bacterial infections, with the Phase I clinical trial in China successfully completed[46]. - The company has initiated a Phase II clinical trial for oral Contizolam tablets in treating complex skin and soft tissue infections in children aged 6 to 17, with 12 centers obtaining ethical approval[45]. - The international multi-center Phase III clinical trial for injectable MRX-4 has been approved in nearly 20 countries, with 324 patients enrolled[46]. - The company is exploring a full oral treatment strategy including MRX-5 for patients with NTM infections, aiming for safer and more effective treatment options[48]. - The company is focused on expanding its market presence and enhancing its product offerings through innovative research and development initiatives[54]. Market and Competitive Landscape - The overall business performance is maintaining a good growth trend, supported by continuous innovation and market demand[41]. - The company is committed to developing core competencies in drug discovery and targeting unmet clinical needs, with a focus on both domestic and international markets[41]. - The company is focusing on expanding its product line with new antibiotics targeting resistant strains, which is expected to enhance market competitiveness[85]. - The company aims to expand potential indications for MRX-4 by initiating a Phase III clinical trial for treating resistant Gram-positive bacterial infections[63]. - The company is leveraging its existing products to deepen its engagement in the antibiotic market, particularly for multi-drug resistant infections[160]. Risks and Challenges - The company emphasizes the risks associated with its ongoing research and development activities, which may affect future profitability[6]. - The company faces risks related to clinical trial progress, potential failures, and regulatory approvals for its pipeline products[192]. - The company has no independent production capability and relies on a single supplier, which poses a risk of supply shortages[194]. - The company is currently unprofitable, which may impact its ability to sustain R&D investments and operational stability[189]. Antimicrobial Resistance - The focus on antimicrobial resistance highlights the importance of developing new antibiotics to combat resistant strains, a key area of research for the company[74]. - The company is focused on developing new antimicrobial drugs and diagnostic tools to combat the global resistance issue, as highlighted by the World Health Organization's global action plan[77]. - The company recognizes the urgent need for investment in new drugs, vaccines, and diagnostic tools to optimize the use of existing antimicrobials and combat resistance[77]. - The company is committed to addressing the challenges posed by bacterial infections, which can spread through various transmission routes, including contact and airborne methods[78]. Clinical Trials and Approvals - The company is advancing its MRX-1 and MRX-4 candidates into Phase III clinical trials for the treatment of multi-drug resistant Gram-positive infections[132]. - The FDA has declined approval for Solithromycin and Iclaprim, while Levonadifloxacin is in Phase III trials and expected to be the first approved treatment for Gram-positive multi-drug infections[132]. - The company has received approval from the National Medical Products Administration to conduct clinical trials for MRX-5 tablets in China[67]. Strategic Initiatives - The company is exploring potential mergers and acquisitions to bolster its research and development capabilities and expand its product portfolio[85]. - The company is actively participating in national medical insurance negotiations to improve product accessibility for patients[73]. - A new strategic partnership has been established to enhance distribution channels, aiming to improve product availability in key markets[85].

证券代码：688373 证券简称：盟科药业 公告编号：2025-008 上海盟科药业股份有限公司 关于自愿披露美国子公司提起诉讼的公告 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： 一、 本次诉讼事项受理的基本情况 公司全资子公司盟科美国于北京时间2025年2月24日收到美国俄亥俄州南区 联邦地区法院西部分院起诉立案确认通知，盟科美国诉Medpace, Inc.（以下简称 "Medpace"）合同纠纷一案已完成起诉立案。 截至本公告披露日，上述案件尚未开庭审理。 二、 本次诉讼的基本情况 1、原告：盟科美国 1、案件所处的诉讼阶段：法院已立案，尚未开庭审理。 2、上市公司所处的当事人地位：上海盟科药业股份有限公司（以下简称" 公司"）的全资子公司MicuRx Pharmaceuticals, Inc.（以下简称"盟科美 国"）为原告 3、涉案的金额：盟科美国提起的诉讼申请暂未提及具体金额，需以法院判 决或执行结果为准 4、是否会对上市公司损益产生负面影响：截至本公告披露日，本次诉讼尚 未开庭审理，最终实际 ...

Financial Performance - In 2024, the company achieved total operating revenue of RMB 130.27 million, a year-on-year increase of 43.51%[4] - The net profit attributable to the parent company was a loss of RMB 440.72 million, an increase in loss of RMB 19.60 million compared to the previous year[7] - Total assets at the end of 2024 were RMB 849.13 million, a decrease of 27.34% year-on-year[8] - The equity attributable to the parent company decreased by 47.37% year-on-year, amounting to RMB 438.96 million[5] - The basic earnings per share were -0.67 RMB, compared to -0.64 RMB in the previous year[4] - The net asset per share attributable to the parent company was 0.67 RMB, down 47.24% year-on-year[5] Research and Development - The company increased its investment in R&D, leading to higher R&D expenses during the reporting period[9] - The company continues to promote key R&D projects and actively market its core product, resulting in sustained high levels of loss[12] Business Growth - The increase in hospital coverage and prescription volume contributed to steady growth in main business revenue[12] Reporting Accuracy - There are no significant uncertainties affecting the accuracy of the performance report[13]