证券代码： 301097 证券简称：天益医疗 公告编号：2023-052 宁波天益医疗器械股份有限公司 关于拟变更会计师事务所的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 特别提示： 1、拟聘任会计师事务所名称：天健会计师事务所（特殊普通合伙）（以下 简称"天健"）；原聘任会计师事务所名称：立信会计师事务所（特殊普通合伙） （以下简称"立信"）。 2、变更会计师事务所的原因：根据《国有企业、上市公司选聘会计师事务 所管理办法》（财会〔2023〕4 号）及《关于做好上市公司选聘会计师事务所工 作的通知》（甬证监发〔2023〕54 号）有关规定及要求，同时结合公司业务发 展需要及未来审计需要等实际情况，为了更好地推进审计工作开展，经公司内部 综合评估及审慎研究，公司通过邀请选聘方式，拟聘任天健为公司 2023 年度审 计机构，聘期一年。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 所进行了充分沟通，前后任会计师事务所均已明确知悉本次变更事项并确认无异 议。 公司于 2023 年 12月 6 日召开第三届董事会第七次会议和第三届监事会第七 次会议， ...

宁波天益医疗器械股份有限公司 会计师事务所选聘制度 第二条 公司选聘（含续聘、改聘）对公司进行会计报表审计等业务的会计师事务 所（下称会计师事务所），需遵照本制度的规定。 第三条 公司选聘会计师事务所时，应经董事会和股东大会审议。提交董事会审议 前，应经审计委员会全体成员过半数同意。 第二章 会计师事务所执业质量要求 第四条 公司选聘的会计师事务所应当具有证券期货相关业务资格，具有良好的执 业质量记录，并满足下列条件： （一）具有独立的主体资格； （二）具有固定的工作场所、健全的组织机构和完善的内部管理和控制制度； （三）熟悉国家有关财务会计方面的法律、法规、规章和政策； （四）具有完成审计任务和确保审计质量的注册会计师； （五）认真执行有关财务审计的法律、法规、规章和政策规定，具有良好的社会声 誉和执业质量记录； 第一章 总则 第一条 为规范宁波天益医疗器械股份有限公司（以下简称公司）选聘（含续聘、 改聘）对公司进行审计的会计师事务所的行为，切实维护股东利益，提高财务信息质量， 根据《中华人民共和国公司法》（以下简称《公司法》）、《中华人民共和国证券法》 （以下简称《证券法》）等有关法律法规和规范性文件，以 ...

关于公司新产品取得产品注册证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 宁波天益医疗器械股份有限公司（以下简称"公司"）于近日收到国家药品 监督管理局颁发的《医疗器械注册证》，具体情况如下： 一、产品注册证具体情况 | 1 | 一次性使用补 | 国械注准 | Ⅲ | 2023 | 年 | 10月 | 23 | 日至 | 用于血液透析滤过、 血液滤过时作为补充 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 液管路 | 20233101528 | | 2028 | 年 | 月 10 | 22 | 日 | | | 序号 | 产品名称 | 注册证编号 | 注册 类别 | | | 注册证有效期 | | | 预期用途 置换液的管路 | 二、对公司的影响 证券代码： 301097 证券简称：天益医疗 公告编号：2023-049 宁波天益医疗器械股份有限公司 新产品注册证的取得丰富了公司产品线，可满足不同客户对血液净化产品差 异化、多样化的需求，巩固在血液净化耗材领域内的竞 ...

Financial Performance - The company's revenue for Q3 2023 was ¥96,054,181.96, a decrease of 9.52% compared to the same period last year[5]. - Net profit attributable to shareholders for Q3 2023 was ¥8,890,964.06, down 79.42% year-on-year[5]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥1,155,817.49, a decline of 95.76% compared to the previous year[5]. - Basic earnings per share for Q3 2023 were ¥0.15, a decrease of 79.65% from the same quarter last year[5]. - The weighted average return on equity was 0.72%, down 79.49% year-on-year[5]. - The company reported a cash flow from operating activities of ¥35,285,273.22, which is a decrease of 9.38% year-to-date[5]. - The total revenue for the period was CNY 275,269,865.85, a decrease of 1.8% compared to CNY 278,832,107.10 in the previous period[24]. - The net profit for Q3 2023 was CNY 60,972,271.70, a decrease of 30.0% compared to CNY 87,104,476.44 in Q3 2022[25]. - The total comprehensive income for the period was CNY 61,103,707.65, compared to CNY 87,104,476.44 in Q3 2022[26]. - The total profit before tax was CNY 71,639,315.26, down from CNY 100,985,007.61 in the previous year[25]. Assets and Liabilities - Total assets at the end of Q3 2023 amounted to ¥1,710,767,713.56, reflecting a 5.14% increase from the end of the previous year[5]. - As of September 30, 2023, the total assets of Ningbo Tianyi Medical Equipment Co., Ltd. amounted to CNY 1,710,767,713.56, an increase from CNY 1,627,081,762.90 at the beginning of the year, reflecting a growth of approximately 5.1%[22]. - The company's total liabilities increased to CNY 432,812,719.05 from CNY 392,008,168.91, representing an increase of about 10.4%[23]. - The company's cash and cash equivalents decreased to CNY 380,403,459.47 from CNY 448,969,393.50, a decline of approximately 16.2%[21]. - The company's cash and cash equivalents at the end of the period stood at CNY 380,403,459.47, a decrease from CNY 470,407,387.02 at the end of Q3 2022[28]. Expenses and Costs - The total operating costs rose to CNY 237,117,489.86, up from CNY 209,151,373.23, indicating an increase of approximately 13.4%[24]. - Research and development expenses for the period were CNY 20,725,295.40, compared to CNY 18,817,200.85 in the previous period, marking an increase of about 9.6%[24]. - The company experienced increased sales expenses and R&D investments, contributing to the decline in net profit[9]. Shareholder Information - The total number of common shareholders at the end of the reporting period is 4,774[11]. - Wu Zhimin holds 47.50% of shares, totaling 28,000,000 shares, while Wu Bin holds 20.36%, totaling 12,000,000 shares[11]. - The total number of restricted shares held by Wu Zhimin and Wu Bin remains at 28,000,000 and 12,000,000 respectively, with no changes during the reporting period[13]. Strategic Initiatives - The company plans to invest approximately RMB 450 million in the construction of a new manufacturing base for dialysis consumables and ICU equipment in Ningxiang[14]. - The project is expected to enhance the company's overall production capacity and market competitiveness[15]. - The company has approved the use of RMB 60 million of excess raised funds to permanently supplement working capital[16]. - The company established special accounts for raised funds at Ping An Bank and China Construction Bank in September 2023[16]. - The company has signed tripartite supervision agreements for the management of raised funds with its subsidiaries and sponsoring institutions[16]. - The company has adjusted the use of raised funds as approved in the board and shareholder meetings held in July 2023[15]. - The company’s strategic planning aligns with the interests of all shareholders, focusing on expanding product and service reach[15]. Product Development and Regulatory Compliance - In Q3 2023, the company received a Class III medical device registration certificate for a disposable infusion tube, valid for 5 years until October 22, 2028[18]. - The company has a total of 31 medical device registration certificates, with various classifications including Class II and Class III, indicating a diverse product portfolio[18]. - The company has ongoing applications for additional medical device registration certificates, indicating a commitment to expanding its product offerings[18]. - The company’s blood purification device received its registration certificate on December 27, 2022, valid until June 26, 2028, showcasing its focus on critical healthcare solutions[18]. - The company has a strong pipeline of medical devices, with several products set to expire in 2024, indicating potential for renewal and innovation[18]. - The company’s product registrations include a variety of surgical and diagnostic tools, reflecting its strategic focus on the medical device market[18]. - The company’s medical device registrations are primarily approved by national and provincial regulatory bodies, ensuring compliance with industry standards[18]. - The company is actively pursuing market expansion through new product registrations and internal restructuring to better position itself in the healthcare sector[17]. Management Changes - The company appointed Shao Kejie as the new CFO and Zhang Zhongliang as the head of the internal audit department, effective July 12, 2023[17]. - The company’s internal management changes aim to enhance operational efficiency and financial oversight[17].

证券代码： 301097 证券简称：天益医疗 公告编号：2023-047 宁波天益医疗器械股份有限公司 本公司及监事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 一、监事会会议召开情况 2023 年 10 月 24 日，宁波天益医疗器械股份有限公司（"公司"）第三届监 事会第六次会议在公司会议室召开。本次会议由陈云俊主持。应出席监事 3 名， 亲自出席监事 3 名。符合《公司章程》规定的法定人数，本次监事会会议决议合 法有效。 二、监事会会议审议情况 经与会监事审议表决，一致通过如下议案： 1、审议通过了《关于<2023 年第三季度报告>的议案》 监事会认为：公司 2023 年第三季度报告的内容真实、准确、完整地反映了 公司 2023 年第三季度经营的实际情况，不存在虚假记载、误导性陈述或者重大 遗漏；报告的编制和审核程序符合法律、行政法规的要求，符合中国证监会及深 圳证券交易所的相关规定。 第三届监事会第六次会议决议公告 具体内容详见同日在中国证监会指定创业板信息披露网站巨潮资讯网上发 布的相关公告。 宁波天益医疗器械股份有限公司监事会 2023 年 10 月 24 ...

证券代码： 301097 证券简称：天益医疗 公告编号：2023-046 宁波天益医疗器械股份有限公司 第三届董事会第六次会议决议公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 一、董事会会议召开情况 本议案无需提交公司股东大会审议。 三、备查文件 1、第三届董事会第六次会议决议； 1 宁波天益医疗器械股份有限公司(以下简称"公司")第三届董事会第六次会 议通知于 2023 年 10 月 21 日以电话、短信、电子邮件等方式向公司全体董事发 出。会议于 2023 年 10 月 24 日上午 9:00 在公司会议室召开。 本次会议应参会董事 7 名，实际参会董事 7 名。会议由董事长吴志敏先生召 集和主持，部分高管列席了会议。本次会议的召集、召开及表决程序符合有关法 律、行政法规、部门规章、规范性文件及《公司章程》的规定。 二、董事会会议审议情况 经与会董事审议表决，一致通过如下议案： 1、审议通过了《关于<2023 年第三季度报告>的议案》 公司董事会在全面审核公司 2023 年第三季度报告后，一致认为：公司 2023 年第三季度报告的内容真实、准确、完 ...

证券代码： 301097 证券简称：天益医疗 公告编号：2023-045 宁波天益医疗器械股份有限公司 关于签署募集资金三方监管协议的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 宁波天益医疗器械股份有限公司（以下简称"公司"）于 2023 年 7 月 12 日 召开的第三届董事会第四次会议、第三届监事会第四次会议审议通过了《关于变 更募集资金用途的议案》，同意变更募集资金用途，同意向全资子公司泰瑞斯科 技及湖南天益医疗科技进行增资，同意在本次募集资金投资项目的调整事项经公 司股东大会审议通过之后，授权公司在有相应资质的银行开设募集资金监管专户， 同时授权公司董事长与开户银行、保荐机构国泰君安股份有限公司签订募集资金 监管协议，上述议案已经公司 2023 年 7 月 28 日召开的 2023 年第一次临时股东 大会审议通过。具体情况如下： 一、募集资金基本情况 经中国证券监督管理委员会《关于同意宁波天益医疗器械股份有限公司首次 公开发行股票注册的批复》(证监许可[2021]3939 号)同意注册，公司首次公开发 行人民币普通股（A 股）1,473.68 ...

二、项目进度情况说明 证券代码： 301097 证券简称：天益医疗 公告编号：2023-044 宁波天益医疗器械股份有限公司 关于湖南宁乡研发制造基地项目开工奠基的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 一、对外投资概述 为了合理优化公司生产管理布局，提升公司整体产能，扩大公司产品和服务 辐射范围，同时也能一定程度上降低公司的人力及运输成本，宁波天益医疗器械 股份有限公司（以下简称"公司"）拟通过子公司湖南天益医疗科技有限公司在 宁乡高新区投资建设血液透析耗材及设备、ICU 连续性血液净化机(CRRT)耗材 及设备、外科急危重症耗材研发制造基地（简称"（宁乡）建设项目"），2022 年 5 月，公司与宁乡高新技术产业园区管理委员会签订《项目合作合同》，该合 同为意向性质的框架协议，具体内容详见公司于 2022 年 5 月 13 日在巨潮资讯网 披露的《关于公司与宁乡高新技术产业园区管理委员会签订项目合作框架协议的 公告》（公告编号：2022-015）。 公司于 2023 年 7 月 12 日召开第三届董事会第四次会议，审议通过了《关于 对外投资的 ...

Financial Performance - The company's operating revenue for the first half of 2023 was ¥179,215,683.89, representing a 3.79% increase compared to ¥172,665,706.54 in the same period last year[26]. - Net profit attributable to shareholders was ¥52,136,985.04, an increase of 18.99% from ¥43,816,347.55 year-on-year[26]. - The net cash flow from operating activities improved significantly to ¥22,843,414.53, a 2,589.73% increase from a negative cash flow of ¥917,506.62 in the previous year[26]. - Basic and diluted earnings per share increased to ¥0.89, up 4.71% from ¥0.85 in the same period last year[26]. - Total assets at the end of the reporting period reached ¥1,739,362,602.88, a 6.90% increase from ¥1,627,081,762.90 at the end of the previous year[26]. - The net assets attributable to shareholders were ¥1,257,746,383.01, reflecting a 1.85% increase from ¥1,234,855,860.26 at the end of the previous year[26]. - The company reported a decrease of 5.90% in net profit after deducting non-recurring gains and losses, totaling ¥30,035,207.91 compared to ¥31,920,075.96 in the previous year[26]. - The weighted average return on equity decreased to 4.17%, down 1.07% from 5.24% in the same period last year[26]. - Operating costs decreased by 7.23% to ¥107,947,896.40 from ¥116,361,592.76, contributing to improved profitability[82]. - The gross profit margin for the medical device segment is 39.55%, with a year-on-year increase of 7.87%[84]. Market Overview - The global medical device market was approximately $533.5 billion in 2021 and is projected to grow to $916.7 billion by 2030, reflecting a significant growth trend[34]. - The Chinese medical device market reached approximately ¥843.8 billion in 2021, with a year-on-year growth of 15.62%, and is expected to grow to ¥1,660.6 billion by 2023[37]. - The global dialysis market was estimated at €82 billion in 2022, with dialysis products accounting for about €15 billion and dialysis care approximately €67 billion[36]. - As of the end of 2021, the number of dialysis patients in China was approximately 749,600, representing a year-on-year increase of 8.21%[40]. - The upstream market for blood dialysis in China is expected to grow from ¥14.6 billion in 2016 to nearly ¥30 billion by 2025[41]. Company Strategy and Operations - The company employs a "production based on sales" model, ensuring efficient production and inventory management aligned with market demand[62]. - The procurement strategy is based on a "production-driven" approach, allowing for efficient inventory management and timely material acquisition[60]. - The company has established a high degree of automation in its production lines, enhancing flexibility to respond quickly to market demands[62]. - The external processing model is used for non-core products, which helps alleviate current production capacity constraints and improves overall operational efficiency[63]. - The company focuses on the research, production, and sales of medical polymer consumables in the fields of blood purification and ward care, with a strong brand influence and recognition as a national-level "little giant" enterprise[47]. - The company has established partnerships with leading international firms, such as Fresenius Medical and Baxter, to strengthen its market position[68]. - The company aims to further enhance its market share in blood purification and ward care products, aspiring to become a leading international medical device manufacturer[69]. Research and Development - The company invested CNY 13.48 million in R&D during the reporting period, with R&D expenses accounting for 7.52% of its operating revenue[72]. - The company employs a dedicated R&D team of 127 members, representing 10.55% of its total workforce, with expertise across multiple disciplines[72]. - The company has developed high-value-added products in the blood purification field, gradually upgrading its product structure to enhance overall competitiveness[73]. - The company is investing 50 million yuan in R&D for advanced medical technologies over the next two years[99]. - The company’s R&D investment has increased over the past three years, with amounts of 28.06 million, 20.26 million, and 15.97 million yuan respectively, indicating a commitment to innovation[118]. Regulatory Compliance and Quality Control - The company has passed the EN ISO 13485:2016 quality management system certification and has obtained EU MDR certification in January 2023, indicating compliance with international standards[76]. - The company has established a comprehensive product quality control system, ensuring that no quality-related medical accidents occurred during the reporting period[76]. - The company adheres to strict quality control measures, ensuring compliance with all relevant medical device regulations throughout the production process[138]. - The company has been awarded the ISO 14001:2015 environmental management system certification, emphasizing its commitment to environmental protection[139]. Financial Management and Investments - The total amount of raised funds is 71,542.93 million yuan, with 4,701.41 million yuan invested during the reporting period[105]. - Cumulative investment of raised funds reached 22,250.64 million yuan as of June 30, 2023[105]. - The company has not changed the purpose of the raised funds, with a cumulative change ratio of 0.00%[105]. - The company plans to achieve an annual production capacity of 4 million sets of blood purification materials by 2025[107]. - The company has incurred intermediary fees of 25,314,319.32 yuan related to the issuance of raised funds[105]. Shareholder Information - The total share capital of Ningbo Tianyi Medical Devices Co., Ltd. is 58,947,368 shares, with 44,971,152 shares subject to trading restrictions, accounting for 76.29% of the total[176]. - The largest shareholder, Wu Zhimin, holds 47.50% of shares, totaling 28,000,000 shares[182]. - The company has not reported any share buyback or repurchase activities during this period[178]. - The report indicates a 1.73% stake held by E Fund Management Co., Ltd., totaling 1,017,298 shares, with a decrease of 50,700 shares during the reporting period[183]. Risks and Challenges - The company faces risks related to gross margin fluctuations due to market demand and competition, and it is implementing measures to mitigate these risks[117]. - The implementation of volume-based procurement policies may negatively impact the company's revenue and profit margins if it fails to win bids or if bid prices drop significantly[120]. - The company faces high customer concentration risk, primarily relying on Avanos Medical for sales of feeding devices and tubes, which could lead to significant adverse impacts on performance if this key customer is lost[119]. - The company is committed to enhancing product quality and customer loyalty to navigate potential risks from regulatory changes and market competition[120].

宁波天益医疗器械股份有限公司 第三届监事会第五次会议决议公告 本公司及监事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 一、监事会会议召开情况 2023 年 8 月 25 日，宁波天益医疗器械股份有限公司（"公司"）第三届监 事会第五次会议在公司会议室召开。本次会议由陈云俊主持。应出席监事 3 名， 亲自出席监事 3 名。符合《公司章程》规定的法定人数，本次监事会会议决议合 法有效。 证券代码： 301097 证券简称：天益医疗 公告编号：2023-040 二、监事会会议审议情况 2、审议通过了《关于公司<2023 年半年度募集资金存放与使用情况专项报 告>的议案》 监事会认为：公司 2023 年半年度募集资金的存放与使用符合相关监管要求， 不存在重大风险，《专项报告》如实反映了募投项目及募集资金的实际情况，不 存在违规存放与使用募集资金的情况，也不存在改变或变相改变募集资金投向和 损害股东利益的情况。 1 具体内容详见同日在中国证监会指定创业板信息披露网站巨潮资讯网上发 布的相关公告。 表决结果：3 票同意、0 票反对、0 票弃权，0 票回避表决。 经与会监事审议表决 ...