登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：300639 证券简称：凯普生物 公告编号：2025-040 一、重要提示 本半年度报告摘要来自半年度报告全文，为全面了解本公司的经营成果、财务状况及未来发展规划，投 资者应当到证监会指定媒体仔细阅读半年度报告全文。 所有董事均已出席了审议本报告的董事会会议。 非标准审计意见提示 □适用 √不适用 董事会审议的报告期利润分配预案或公积金转增股本预案 □适用 √不适用 公司计划不派发现金红利，不送红股，不以公积金转增股本。 董事会决议通过的本报告期优先股利润分配预案 □适用 √不适用 公司是否需追溯调整或重述以前年度会计数据 □是 √否 ■ 3、公司股东数量及持股情况 单位：股 ■ 持股5%以上股东、前10名股东及前10名无限售流通股股东参与转融通业务出借股份情况 □适用 √不适用 前10名股东及前10名无限售流通股股东因转融通出借/归还原因导致较上期发生变化 □适用 √不适用 公司是否具有表决权差异安排 □是 √否 二、公司基本情况 1、公司简介 ■ 2、主要会计数据和财务指标 4、控股股东或实际控制人变更情况 控股股东报告期内变更 □适用 √不适用 ...

中证报中证网讯（王珞）万孚生物（300482）微信公众号8月20日发布消息称，近日，公司自主研发的 分子诊断领域U-CardDx 200全自动核酸扩增分析仪获NMPA第三类医疗器械注册批准上市。此前，该系 统已获批欧盟CE IVDR准入资质，并已在海外多个国家装机应用。 分子诊断作为万孚生物战略布局的前沿技术平台，是精准医疗的核心驱动力。此次获批的U-CardDx 200 全自动核酸扩增分析仪，最快15分钟即可完成全流程核酸检测，不仅为医院和实验室等终端带来了更高 效、更精准的检测工具，更标志着核酸检测已然步入新时代，开启分子诊断新篇章。 据介绍，U-CardDx 200依托经典的磁珠法核酸提取与实时荧光定量PCR技术，通过技术与设计创新，将 全流程核酸检测时间缩短至15分钟。一台仪器就是一个分子诊断实验室，既能满足日常检测所需，又能 应对高峰期的紧急检测需求。 ...

财务费用同比激增387.74%至1669万元，主要因人民币对美元、欧元汇率波动导致汇兑损失增加，叠加 利息收入减少。研发投入2.06亿元，占营收16.5%，重点投向化学发光、分子诊断及AI辅助诊断领域。 分产品看，传染病检测收入3.79亿元（占比30.4%），同比下滑21.14%，主要因国内呼吸道检测需求回 落；慢病管理检测收入5.63亿元（占比45.2%），同比下降26.06%，主要因2024年28省IVD集采（覆盖 肿瘤标志物、甲状腺功能）落地，终端检测单价及销量承压；毒品检测收入1.45亿元（占比11.7%）， 增长4.26%，得益于北美电商渠道放量；优生优育检测收入1.38亿元（占比11.1%），下滑11.67%，出生 率低迷拖累市场表现。毛利率方面，传染病检测毛利率为59.73%（同比微降0.02个百分点），慢病管理 检测毛利率为72.86%（降2.00个百分点），毒品检测毛利率为55.76%（升0.11个百分点），优生优育检 测毛利率为43.95%（升0.67个百分点）。 南方财经8月20日电，万孚生物（300482.SZ）2025年半年度报告显示，公司上半年实现营业收入12.46 亿元，同比下降 ...

Group 1 - The stock price of Zhaoyan New Drug (603127) increased by 16.95% this week, closing at 22.36 yuan, with a weekly high of 22.76 yuan and a low of 18.92 yuan [1] - Zhaoyan New Drug's current total market capitalization is 16.758 billion yuan, ranking 9th in the medical services sector and 950th among all A-shares [1] Group 2 - Zhaoyan New Drug announced its plan to invest up to 20 million yuan in the Huaxia Zhiyuan Venture Capital Fund, which has a target fundraising scale of 35 million yuan [2][4] - The fund will focus on equity investments in unlisted companies related to molecular diagnostics and targeted therapy, with a management fee of 1% per year based on the total capital contributions [2] - As of June 30, 2025, the legal registered capital of Zhaoyan New Drug's H-shares and A-shares remains unchanged at 118,995,206 shares and 630,482,128 shares, respectively [3][4]

Core Viewpoint - Roche Diagnostics is significantly expanding its operations in China through a new investment project in Suzhou, aimed at enhancing local production and R&D capabilities for in vitro diagnostic (IVD) products, thereby addressing the growing healthcare needs in the Asia-Pacific region [1][4][6]. Group 1: Project Details - The new project is located in the Suzhou Industrial Park, covering a total planned area of 108 acres, with an initial investment area of 55 acres and a construction area of approximately 120,000 square meters, including new factories, offices, quality inspection buildings, and warehouses [2][4]. - The initial investment is set at 3 billion RMB (approximately 383 million Swiss Francs), with a total investment expected to reach 10 billion Swiss Francs [2][4]. Group 2: Strategic Importance - This project represents Roche Diagnostics' strategic commitment to the Chinese market, aiming to introduce more internationally leading IVD product lines that cover disease prevention, early diagnosis, and treatment monitoring [4][6]. - The new facility will enhance Roche's production capacity in the Asia-Pacific region, improve supply chain efficiency, and shorten the time for innovative products to enter the market [4][6]. Group 3: Market Trends and Opportunities - The global IVD market is projected to show strong growth, with an estimated valuation of 108 to 116.7 billion USD in 2024, and a compound annual growth rate (CAGR) of 3.61% to 8.4% expected from 2025 to 2030/2035, potentially reaching 1200 to 1900 billion USD [12]. - The Asia-Pacific region, particularly China, is anticipated to be the fastest-growing market, with a CAGR of 6.64% from 2025 to 2034, driven by rising incidences of chronic and infectious diseases, increased healthcare infrastructure investment, and a growing middle-class population [12]. Group 4: Technological Innovations - Roche is positioned as a leader in technological innovations in molecular diagnostics, next-generation sequencing (NGS), artificial intelligence (AI), and point-of-care (POC) testing, with ongoing high R&D investments to continuously launch innovative products [12][13]. - The new project will support the local production of POC products, enhancing Roche's rapid diagnostic product line, particularly in the management of infectious and chronic diseases [13]. Group 5: Historical Context and Future Outlook - Roche Diagnostics has a long-standing presence in China, dating back to 1997, and has progressively expanded its operations, with the Suzhou base established in 2015 as its first production and R&D center in the Asia-Pacific region [9][11]. - The new investment project is expected to be completed by 2027 and operational by 2028, further solidifying Roche's role in the local healthcare landscape [8].

Core Viewpoint - Shanghai Rendu Biotechnology Co., Ltd. received an inquiry letter from the Shanghai Stock Exchange regarding its 2024 annual report, prompting a detailed response about its business performance and financials [1]. Business Overview - The company's main business includes RNA molecular testing reagents, instruments, and testing services, with a revenue growth of 9.94% [1]. - Instrument business revenue reached 8.71 million yuan, a year-on-year increase of 19.88%, while testing services revenue was 6.48 million yuan, a decline of 32.83% [1]. Customer Analysis - The top five customers for reagents generated a total sales revenue of 28.84 million yuan, with significant changes in procurement volumes due to market dynamics [1]. - The top five customers for instruments contributed 6.04 million yuan, with a notable shift towards new clients [3][4]. Revenue Breakdown - Reagent sales accounted for 68.35% of total revenue, with significant growth in blood-related series products due to new product launches [4]. - Instrument sales included 46 units of the AutoSAT system, with a 25.26% increase in revenue [5]. Profit Margin Analysis - The gross margin for reagent business remained stable, while the gross margin for instruments and testing services decreased significantly, attributed to market competition and pricing strategies [5][6]. - The overall gross margin for testing services was 79.49%, reflecting a slight decline from the previous year [6]. Bad Debt Provision - The company reported accounts receivable of 72.64 million yuan, with a significant increase in bad debt provision amounting to 20.73 million yuan, reflecting a cautious approach to credit risk management [7][8]. - The increase in bad debt was primarily due to the nature of clients acquired during the public health crisis, which were deemed to have higher credit risk [10][11]. Expense Management - Sales expenses decreased by 19% year-on-year, with a notable reduction in employee compensation and a strategic focus on cost control [14][15]. - The sales expense ratio remains high compared to industry peers, justified by the company's smaller revenue scale and the need for increased market promotion efforts [16][17]. Fund Utilization - The company raised 652.76 million yuan in its initial public offering, with 36.09% of the funds utilized by the end of 2024, primarily for R&D and marketing network projects [21].

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested Anuo Youda Gene Technology (Beijing) Co., Ltd. to provide supplementary materials regarding the cancellation of certain subsidiaries and the progress of obtaining qualifications for various IVD products and services [1][2]. Group 1: Company Operations - Anuo Youda is required to explain the reasons and progress for the cancellation of Zhejiang Anuo Youda, Anwei Kang Technology, and Yiwu Inspection Institute, and whether this has a significant adverse impact on the company's business [2]. - The company is involved in the development and commercialization of IVD products based on molecular diagnostics, focusing on non-invasive prenatal testing (NIPT) kits, sequencing instruments, and bioinformatics analysis software [6]. - Anuo Youda's NIPT kits, which detect the three most common chromosomal diseases (trisomy 21, 18, and 13), received Class III medical device certification in 2017, establishing the company as one of the early leaders in the prenatal testing market in China [7]. Group 2: Market Position - According to Zhi Shi Consulting, Anuo Youda ranked third in the NIPT market in China by sample testing volume in 2023, with market shares increasing by 9.6%, 11.6%, and 12.1% in 2021, 2022, and 2023, respectively [7]. - The company's clinical sequencing solutions include self-developed IVD testing kits and related services, with clients primarily consisting of hospitals certified for prenatal diagnosis and independent medical laboratories [6]. Group 3: Regulatory Compliance - The CSRC has requested clarification on the company's compliance with foreign investment restrictions and whether its business operations align with the necessary qualifications and regulatory requirements [2][5]. - Anuo Youda must also address any administrative penalties related to violations of the Cybersecurity Law of the People's Republic of China and the progress of any required rectifications [4].

Core Viewpoint - Digital PCR technology is recognized as a revolutionary force in the field of molecular diagnostics, offering absolute quantification capabilities, high sensitivity, and specificity, which are essential for applications such as early cancer screening [1][3]. Group 1: Digital PCR Technology - Digital PCR is referred to as the third generation of PCR technology, showcasing significant advancements in automation and high-throughput detection efficiency [1]. - The technology is expected to provide reliable technical support for clinical applications, particularly in tumor early screening [1]. Group 2: Upcoming Conference - The "9th PCR Technology and Application Online Conference" will be held on May 28, 2025, organized by Instrument Information Network [3]. - The conference will feature various experts and scholars discussing the latest developments and innovative applications of digital PCR technology [1][3]. - A detailed agenda includes presentations on ultra-sensitive detection of low-frequency gene mutations, nucleic acid standard materials, and integrated high-sensitivity nucleic acid rapid detection technologies [3].

Financial Data and Key Metrics Changes - Pharma services revenue for Q1 2025 was $2.1 million, exceeding expectations due to a large order processed quickly, with $1.4 million invoiced in the last few days of the quarter [16][17] - Gross margins for pharma services reached 62%, extending the company's cash runway and deepening customer relationships [16][17] - The company ended Q1 2025 with nearly $33 million in cash, including restricted cash, and reported a free cash flow of negative $6.2 million, aligning with the target average quarterly cash burn of $6 million [20][22] Business Line Data and Key Metrics Changes - The majority of revenue in Q1 came from a single corporate customer, which is now seeking partnership opportunities on one of the oncology assays [17] - The company has 10 sites running its research use only (RUO) assay across various countries, including the US, Germany, UK, Switzerland, Austria, and Southeast Asia [8][12] Market Data and Key Metrics Changes - The company expects to have 20 sites trained on its graft to share workflow by the end of 2025, which is part of a strategy to land hospitals with the RUO product and expand to selling the clinical kitted product post-FDA clearance [8][12] - Interest from several university hospitals in the clinical trial has been noted, with expectations to include at least three of the top 10 transplant centers in the US [6][8] Company Strategy and Development Direction - The company is focused on finalizing its clinical assay and trial design, preparing for an FDA submission by the end of 2025, and spring loading revenue for the second half of 2026 [5][6] - A strategic pivot has been made towards transplant diagnostics, with plans to unveil a new company name that reflects this direction [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made and the future potential of the transplant product, noting increased interest from corporate partners [15] - The company is optimistic about the FDA approval timeline, targeting the first half of 2026 for approval [8][21] Other Important Information - The company is investing in improving and simplifying digital PCR workflows, which are seen as a differentiator compared to NGS platforms [10][11] - The company plans to announce a new Nasdaq ticker alongside the name change, emphasizing a resource-conscious approach to capital allocation [22] Q&A Session Summary Question: Inquiry about the larger revenue-generating pharma customer and oncology interest - Management confirmed that the interest is related to DetermaIO and potential kitted versions, indicating unique advantages in tougher cancers [25] Question: Next milestones for DetermaIO - The focus is on the SWOG study involving 800 patients, with data expected towards the end of the year [28] Question: Feedback from US transplant centers regarding the study - Management reported enthusiasm from transplant centers, indicating a strong desire for in-house technology access [31] Question: Impact of the IOTA model on market growth - Management acknowledged skepticism from partners but noted that increased demand for testing is anticipated [41] Question: Potential friction between transplant centers and physicians regarding test orders - Management indicated that most centers allow physicians to choose tests, emphasizing the importance of demonstrating the technology's performance [45] Question: Final Q-sub meeting expectations - The company is on track for submission and has incorporated FDA feedback into the Q-sub [49]

Financial Performance - The company reported a revenue of 815.53 million CNY in 2024, a decrease of 26.16% year-on-year [8] - The net profit attributable to shareholders was -654.88 million CNY, a decline of 566.20% compared to the previous year [8] - The company recorded a net loss of -659.73 million CNY after excluding non-recurring items, a drop of 682.84% year-on-year [12] Accounts Receivable - As of the end of 2024, the company had accounts receivable totaling 2.02 billion CNY, with a provision for credit impairment of 929.29 million CNY, resulting in a net value of 1.09 billion CNY [7] - The company has been actively managing accounts receivable, with a focus on recovering debts from local governments and healthcare commissions [9][16] Business Strategy and Development - The company is focusing on three main business segments: molecular diagnostic products, medical testing services, and health management [12][23] - The "KaiPu Kang and Medical Testing 5.0 Strategy" aims to integrate precision medicine and health management, leveraging over 30 third-party medical laboratories across the country [3][23] - The company plans to enhance its product offerings in areas such as cervical cancer screening, reproductive health, and personalized medicine [21][25] Challenges and Adjustments - The medical testing services segment faced significant challenges, leading to operational losses due to changes in industry demand and increased competition [4][8] - The company has implemented cost-cutting measures and optimized laboratory operations to improve profitability [4][22] - R&D investment decreased by 37.18% year-on-year, but the company aims to maintain innovation through partnerships and strategic resource allocation [17][18] Market Outlook - The IVD industry is expected to grow due to supportive government policies and increasing health awareness among the population [19] - The company anticipates expanding its market share by enhancing its competitive advantages in technology, cost, and service [20][24]