证券代码：600587 证券简称：新华医疗 公告编号：临 2025-039 山东新华医疗器械股份有限公司 关于公司产品获得二类医疗器械注册证的公告 8、适用范围：软式内镜清洗工作站用于软式内镜的清洗和消毒；硬式内镜清 洗工作站用于硬式内镜的清洗。 1、产品名称：内镜清洗工作站 2、注册证编号：鲁械注准 20252110546 3、注册人名称：山东新华医疗器械股份有限公司 4、注册人住所：山东省淄博市高新技术产业开发区新华医疗科技园 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、准确性和完整性承担个别及连带责任。 5、生产地址：山东省淄博市博山区白塔镇九州路 1 号(委托生产) 山东新华医疗器械股份有限公司（以下简称"公司"或"新华医疗"）于近日 收到山东省药品监督管理局颁发的《中华人民共和国医疗器械注册证》，具体情况 如下： 6、结构及组成：软式内镜清洗工作站由超声槽(选配)、清洗槽、漂洗槽、消 毒槽、终末漂洗槽、干燥台组成；硬式内镜清洗工作站由初洗槽、清洗槽、超声槽、 终末漂洗槽、干燥台组成。 一、医疗器械注册证的具体情况 7、型号、规格：详见产品技术 ...

Core Viewpoint - The company has received a medical device registration certificate for its endoscope cleaning workstation, which will enhance its position in the medical infection control sector [1] Group 1: Company Developments - The company announced the receipt of the registration certificate from the Shandong Provincial Drug Administration for its endoscope cleaning workstation [1] - The product is designed for the cleaning and disinfection of flexible endoscopes and the cleaning of rigid endoscopes [1] - Obtaining this registration certificate will further expand the company's technological layout in the field of medical infection control [1] Group 2: Industry Impact - The new product will strengthen the hospital infection prevention and control system [1]

Core Viewpoint - Xinhua Medical (600587.SH) has received the Medical Device Registration Certificate from the Shandong Provincial Drug Administration for its new product, the endoscope cleaning workstation, which enhances its position in the medical infection control sector [1] Group 1: Product Development - The endoscope cleaning workstation is designed for the cleaning and disinfection of both flexible and rigid endoscopes, indicating a comprehensive approach to infection control [1] - The introduction of this next-generation product expands Xinhua Medical's technological layout in the field of medical infection control [1] Group 2: Market Positioning - The intelligent cleaning and disinfection solutions provided by the new workstation strengthen the hospital infection prevention and control system [1] - This product offering provides customers with multiple options, which is beneficial for enhancing the company's medical equipment product matrix [1] - The launch of the endoscope cleaning workstation is expected to continuously consolidate the company's core competitiveness in the disinfection field [1]

Core Viewpoint - Xinhua Medical (600587.SH) has received a medical device registration certificate from the Shandong Provincial Drug Administration for its new product, the endoscope cleaning workstation, which enhances its technology layout in the field of medical infection control [1] Group 1: Product Development - The endoscope cleaning workstation is designed for cleaning and disinfecting both flexible and rigid endoscopes, indicating a comprehensive approach to infection control [1] - The introduction of this next-generation product expands Xinhua Medical's offerings in the medical equipment sector, particularly in the disinfection and cleaning domain [1] Group 2: Market Positioning - The intelligent cleaning and disinfection solutions provided by the new workstation strengthen the hospital infection prevention and control system, offering multiple options for customers [1] - This product launch is expected to enhance the company's product matrix in medical devices, thereby solidifying its core competitiveness in the cleaning and disinfection field [1]

Core Viewpoint - The second "China Dental City" high-quality development conference in Jiamusi, Heilongjiang, aims to promote the development of the dental medical industry and enhance cooperation among industry players and experts [1] Group 1: Industry Development - Jiamusi is actively responding to national strategies to cultivate new productive forces, focusing on building "China Dental City" to drive the development of the entire dental industry chain [1][2] - The city has a solid industrial foundation, housing the earliest tertiary dental hospital in Northeast China, which occupies over one-third of the province's dental medical service market [2] - The dental prosthetics processing cluster has a production capacity exceeding one-quarter of the province's total, attracting leading companies such as Weigao and Xinhua Medical [2] Group 2: Educational and Research Resources - Jiamusi University’s Dental School is the largest and most comprehensive talent training base in the province, having trained over 10,000 graduates [2] - The city has established a support system integrating medical education, research, and production, backed by national clinical key specialties and a dental specialty alliance covering 31 institutions [2] Group 3: Strategic Initiatives and Policies - The city is promoting the "Dental City Industrial Park," covering 15 hectares, which integrates R&D, manufacturing, medical services, and exhibitions [2] - Strong policy support is evident with the introduction of the "China Dental City Development Strategic Plan" and 16 exclusive support policies, along with ten key actions [2] - Since 2022, Jiamusi has partnered with 54 companies, with 17 projects under construction, including significant projects like the Xinhua Disinfection Supply Center [2][3] Group 4: Market Opportunities and Future Prospects - The conference aims to showcase Jiamusi's advantages in dental health, including educational resources, industrial foundation, and market prospects, while exploring cooperation opportunities [3] - The city is focused on enhancing the entire dental industry chain by fostering collaboration with universities and research institutions [3]

Financial Performance - For the first half of 2025, the company's operating revenue was approximately 4.79 billion, a decrease from 5.19 billion in the same period last year, representing a decline of about 7.6% [1] - The total profit for the same period was approximately 454 million, down from 567 million year-on-year, indicating a decrease of about 20% [1] - The net profit attributable to shareholders was approximately 386 million, compared to 484 million in the previous year, reflecting a decline of about 20.2% [1] - The net profit after deducting non-recurring gains and losses was approximately 333 million, down from 474 million, a decrease of about 29.6% [1] - The net cash flow from operating activities was approximately 243 million, showing a significant increase of 76.9% compared to 137 million in the previous year [1] Asset and Liability Changes - As of the end of the first half of 2025, the company's net assets attributable to shareholders were approximately 7.86 billion, an increase from 7.60 billion at the end of the previous year [1] - The company's inventory decreased by 7.78% compared to the end of the previous year, while fixed assets increased by 5.34% [39] - Contract liabilities decreased by 16.32%, while other payables increased by 33.69% [42] Shareholder Structure - The largest shareholder is Shandong Yiyang Health Industry Development Group Co., Ltd., holding approximately 28.91% of the shares [54] - Other notable shareholders include Huabao Zhongzheng Medical ETF and Hong Kong Central Clearing Limited, which have increased their holdings [54] Valuation Metrics - As of August 29, the company's price-to-earnings (P/E) ratio was approximately 16.65, the price-to-book (P/B) ratio was about 1.26, and the price-to-sales (P/S) ratio was around 1.03 [1]

Core Viewpoint - Xinhua Medical (600587) reported disappointing financial results for the first half of 2025, with significant declines in revenue and net profit compared to the previous year [1] Financial Performance - Total revenue for the first half of 2025 was 4.79 billion yuan, a decrease of 7.64% year-on-year [1] - Net profit attributable to shareholders was 386 million yuan, down 20.35% year-on-year [1] - In Q2 2025, total revenue was 2.483 billion yuan, a decline of 6.59% year-on-year, while net profit was 225 million yuan, down 17.55% year-on-year [1] - Gross margin was 25.21%, a decrease of 5.41% year-on-year, and net margin was 8.15%, down 15.14% year-on-year [1] - Total expenses (selling, administrative, and financial) amounted to 580 million yuan, accounting for 12.11% of revenue, an increase of 2.28% year-on-year [1] Balance Sheet and Cash Flow - Cash and cash equivalents were 3.015 billion yuan, an increase of 4.14% year-on-year [1] - Accounts receivable reached 1.991 billion yuan, a slight increase of 2.14% year-on-year, with accounts receivable to net profit ratio at 287.85% [1][2] - Interest-bearing debt was 1.124 billion yuan, up 3.88% year-on-year [1] - Earnings per share (EPS) was 0.64 yuan, a decrease of 35.35% year-on-year, while operating cash flow per share was 0.4 yuan, an increase of 76.86% year-on-year [1] Business Model and Operational Insights - The company's performance is primarily driven by marketing efforts, necessitating a deeper analysis of the underlying factors [2] - The cash flow situation is concerning, with cash and cash equivalents to current liabilities ratio at 68.89% and the average operating cash flow to current liabilities ratio at 14.16% over the past three years [2]

Meeting Overview - The 20th meeting of the 11th Board of Directors of Shandong Xinhua Medical Instruments Co., Ltd. was held on August 27, 2025, with all 11 directors present, complying with legal and regulatory requirements [1]. Financial Reporting - The Board approved the 2025 Half-Year Report, confirming that the report accurately reflects the company's actual situation, with a unanimous vote of 11 in favor [2]. - The Board also approved a special report on the storage and actual use of raised funds for the first half of 2025, stating compliance with relevant regulations and confirming no misuse of funds [2]. ESG Reporting - The Board approved the 2024 Environmental, Social, and Governance (ESG) report, affirming that it meets legal and regulatory standards and accurately reflects the company's situation, with a unanimous vote of 11 in favor [3]. Governance Improvements - The Board approved the establishment and revision of certain governance systems to enhance company quality in line with the latest regulatory requirements, with a unanimous vote of 11 in favor [3].

Meeting Overview - The 20th meeting of the 11th Supervisory Board of Shandong Xinhua Medical Instrument Co., Ltd. was held on August 27, 2025, with all three supervisors present, meeting legal and regulatory requirements [1][2]. Financial Report Review - The Supervisory Board approved the 2025 semi-annual report, affirming that the report accurately reflects the company's operational and financial status, with no false records or omissions [2][3]. - The voting results for the approval were unanimous, with 3 votes in favor and none against or abstaining [2]. Fund Management Report - The Board also approved the special report on the management and use of raised funds for the first half of 2025, confirming compliance with relevant regulations and that funds were stored in dedicated accounts and used appropriately [2][3]. - The voting results for this report were also unanimous, with 3 votes in favor [2]. ESG Report Approval - The Supervisory Board approved the 2024 Environmental, Social, and Governance (ESG) report, stating that the preparation and review processes met legal and regulatory standards, and the report accurately reflects the company's situation [3]. - The voting results for the ESG report were unanimous, with 3 votes in favor [3].

Core Viewpoint - The article outlines the authorization management measures of Shandong Xinhua Medical Equipment Co., Ltd., aimed at improving corporate governance, enhancing operational efficiency, and ensuring compliance with legal regulations [2][3]. Chapter 1: General Principles - The authorization management is defined as the delegation of certain decision-making powers from the board of directors to the management team, within legal and regulatory limits [3]. - The board secretary assists in the authorization management work, with the securities department responsible for implementation and professional support [3]. Chapter 2: Basic Scope of Authorization - The board must consider various factors such as company strategy, operational status, and risk control when determining the scope and limits of authorization [4]. - Certain powers, such as convening shareholder meetings and approving major financial decisions, cannot be delegated to the management [4][5]. Chapter 3: Basic Procedures for Authorization - The authorization decision plan must specify objectives, authorized parties, limits, and operational requirements, and should be approved by the board after discussion [8]. - The management must report progress on long-term authorization matters to the board [10]. Chapter 4: Supervision and Changes - The board retains responsibility for monitoring the execution of authorized powers and must conduct regular evaluations [13]. - The board can adjust or revoke authorizations based on performance, risk management, or changes in circumstances [14][15]. Chapter 5: Responsibilities - The board is responsible for ensuring proper authorization management and must correct any improper actions by authorized parties [17]. - Authorized individuals must act within their limits and protect the interests of shareholders and the company [19]. Chapter 6: Supplementary Provisions - The board is responsible for interpreting the authorization management measures, which take effect upon approval [21][22]. Authorization List for the Management - The management is responsible for daily operations under the board's leadership and can make decisions on specific matters within the authorized limits [11]. - The management can decide on asset write-offs, internal financing, and other operational matters, provided they stay within the defined thresholds [12].