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].

中国国际金融股份有限公司 关于上海仁度生物科技股份有限公司 2024 年年度报告信息披露监管问询函回复的核 查意见 上海证券交易所： 根据贵所于 2025 年 5 月 23 日出具的《关于上海仁度生物科技股份有限公 司 2024 年年度报告的信息披露监管问询函》（上证科创公函【2025】0156 号）， 以下简称"年报问询函"）的要求，中国国际金融股份有限公司（以下简称"持 续督导机构"）会同公司及年审会计师立信会计师事务所（特殊普通合伙）（以 下简称"会计师"），就年报问询函提及的事项逐项进行了认真讨论、核查与落 实，并出具了明确的核查意见如下： （在本回复中，若合计数与各分项数值相加之和在尾数上存在差异，均为 四舍五入所致。） 1 问题一 关于主营业务。公司主营业务为 RNA 分子检测试剂、仪器和检测服务等。 2024 年，公司营业收入为 17,735.15 万元，同比增长 7.87%；归母净利润为- 781.22 万元，较上年由盈转亏。其中，试剂业务营业收入为 16,216.45 万元，同 比增长 9.94%；仪器业务实现营收 870.73 万元，同比增长 19.88%；检测服务实 现营业收入为 647 ...

工信会计师事务所(特殊普通合 CHINA SHU LUN PAN CERTIFIED PUBLIC ACCOUNTANTS I 立信会计师事务所(特殊普通合伙) 关于上海仁度生物科技股份有限公司 2024年年报问询函回复的核查意见 信会师函字[2025]第 ZA244 号 上海证券交易所科创板公司管理部: 由上海仁度生物科技股份有限公司(以下简称"仁度生物"或"公司") 转来贵所于 2025年 5 月 23 日下发的《关于上海仁度生物科技股份有限公司 2024 年年度报告的信息披露监管问询函》(上证科创公函《2025》0156 号,以 下简称《问询函》）业已收悉,立信会计师事务所(特殊普通合伙)（以下简 称"本所"或"年审会计师")作为仁度生物 2024年度的年审会计师,对年报 问询函中提出的问题进行了认真研究和核查,相关事项说明如下: 说明:本核查意见中若出现总计数尾数与所列数值总和尾数不符的情况, 均为四舍五入所致。 问题一 关于主营业务。公司主营业务为 RNA 分子检测试剂、仪器和检测服务等。 2024 年,公司营业收入为 17,735.15 万元,同比增长 7.87%;归母净利润为- 781.22 万 ...

证券代码：688193 证券简称：仁度生物 公告编号：2025-030 上海仁度生物科技股份有限公司（以下简称"公司"或"仁度生物"）于 近日收到由上海证券交易所下发的《关于上海仁度生物科技股份有限公司 2024 年年度报告的信息披露监管问询函》（上证科创公函【2025】0156 号）（以下 简称《问询函》），根据《问询函》的要求，公司与中国国际金融股份有限公 司（以下简称"持续督导机构"）和立信会计师事务所（特殊普通合伙）（以 下简称"年审会计师"），对问询函所列问题进行了认真核查并作出如下回复。 说明：本回复报告中若出现总计数尾数与所列数值总和尾数不符的情况， 均为四舍五入所致。 问题一 关于主营业务。公司主营业务为 RNA 分子检测试剂、仪器和检测服务等。 2024 年，公司营业收入为 17,735.15 万元，同比增长 7.87%；归母净利润为- 781.22 万元，较上年由盈转亏。其中，试剂业务营业收入为 16,216.45 万元，同 比增长 9.94%；仪器业务实现营收 870.73 万元，同比增长 19.88%；检测服务实 现营业收入为 647.96 万元，同比下降 32.83%；试剂业务毛利率 ...

Group 1 - Huapei Power received a project intention letter from a domestic new energy vehicle company for a thermal management system PTC water heater, with an estimated sales amount of approximately 9 million yuan over a 5-year lifecycle starting from 2026 [1] - Antu Biotech obtained medical device registration certificates for products including "Cytomegalovirus IgM Antibody Test Kit" [1][2] - Yihong Technology adjusted the upper limit of its share repurchase price to 65.04 yuan per share, with a total repurchase amount of 6.9583 million yuan for 198,000 shares [2] Group 2 - Aihui Long received a medical device registration certificate for the Hepatitis B virus core antibody detection kit, valid until May 28, 2030 [2][3] - Quanxin Co. plans to engage in commodity futures hedging to mitigate raw material price fluctuations, with a maximum guarantee amount of 8 million yuan [3] - Jiahua Intelligent plans to lease idle assets in Dongguan for a total rental amount of approximately 6.3193 million yuan over 6 years [3] Group 3 - Qianjiang Biochemical announced the resignation of its chairman and a director, with a new chairman to be elected [4][5] - Aerospace Morning Light was suspended from participating in military procurement activities due to violations, with internal investigations underway [6] - Guang'an Aizhong intends to establish a fund with a total scale of 70.7 million yuan, focusing on distributed wind and solar power generation [7] Group 4 - Zhejiang Medicine plans to use up to 1 billion yuan of idle funds for entrusted wealth management, with a maximum investment period of 12 months [10] - Hengrui Medicine's subsidiary received approval for clinical trials of HRS9531 injection, aimed at treating type 2 diabetes patients [11] - Taiji Co. announced the purchase of 10 million yuan in wealth management products, with a minimum holding period of 6 months [12] Group 5 - Hong Kong-listed company Huichuang Pharmaceutical received approval for the clinical trial of a spray for treating primary premature ejaculation [26][27] - Haichuang Pharmaceutical's new drug application for a prostate cancer treatment was approved by the National Medical Products Administration [28] - Zhuhai Guanyu was selected as a designated supplier for low-voltage lithium batteries by SAIC Volkswagen [29] Group 6 - Huayi Technology opened a tax refund service for overseas travelers, enhancing its retail offerings [32] - Baobian Electric plans to transfer 90% of its subsidiary's shares for 137 million yuan [33] - Yiwei Communication intends to invest 100 million yuan to establish a wholly-owned subsidiary to enhance its strategic layout [34]

证券代码：688193 证券简称：仁度生物 公告编号：2025-029 上海仁度生物科技股份有限公司 关于自愿披露公司相关产品 取得医疗器械注册证的公告 特此公告。 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。 上海仁度生物科技股份有限公司 一、产品注册证具体情况 | 产品名称 | 注册证书编号 | 注册类别 | | 注册证有效期 | | --- | --- | --- | --- | --- | | 乙型肝炎病毒核酸测定试 | 国械注准 | 三类 | 2025年5月29日至2030 | | | 剂盒（DNA 捕获探针法） | 20253401041 | | 年 | 月 日 5 28 | 二、对公司的影响 上述产品系公司血源传染病系列的新产品，通过对乙型肝炎患者血中 HBV DNA 基线水平和变化情况的监测，评估抗病毒治疗的应答和治疗效果，与公司 已有的 HBV RNA 检测形成"双维"检测，实现了"乙丙艾"三大传染病全自动高 敏检测产品线全覆盖。 三、风险提示 上述注册证书涉及的产品实际销售情况取决于未来市场推广效果， ...

Core Viewpoint - The company has received regulatory approval for its hepatitis B virus nucleic acid testing kit, which is expected to enhance its product line and market presence in the infectious disease testing sector [1] Group 1: Product Approval - The hepatitis B virus nucleic acid testing kit (DNA capture probe method) has been granted a Class III registration certificate with a registration number of 202.53 billion [1] - The registration certificate is valid from May 29, 2025, to May 28, 2030 [1] Group 2: Product Features and Market Impact - This new product is part of a series for blood-borne infectious diseases, allowing for the monitoring of HBV DNA baseline levels and changes in patients, which aids in evaluating antiviral treatment responses and effectiveness [1] - The product complements the existing HBV RNA testing, creating a comprehensive "dual-dimension" testing approach and covering the full automated high-sensitivity testing product line for hepatitis B, C, and E [1] - The actual sales performance of this product will depend on future marketing efforts, and its impact on the company's future performance remains uncertain [1]

Group 1: Hologene (HOLX) - Hologene is a major player in the medical device sector, recently rejecting a $16 billion acquisition offer from TPG and Blackstone, which would have been one of the largest leveraged buyouts in the global medical field by 2025 [1] - The acquisition offer was priced at $70 to $72 per share, significantly above Hologene's closing price of $54.28 on May 24, indicating a strong market interest in the company [1] - Hologene remains committed to its long-term development strategy, believing that its technological and market advantages will lead to a future value exceeding $100 billion [1] Group 2: Rendu Biotech (仁度生物) - Rendu Biotech, listed on the STAR Market, is emerging as a potential leader in the RNA testing field, with its founder having extensive experience at Hologene [2] - The company has developed RNA testing technology over the past decade, supported by a strong R&D team with nearly 50% of members holding master's or doctoral degrees [2] - Rendu has established a robust patent portfolio with 62 patents, including 40 invention patents, showcasing its commitment to innovation in RNA diagnostics [2] Group 3: Market Position and Challenges - Rendu's CT and NG testing products hold a significant market share domestically, with a reported revenue of 177 million yuan in 2024, reflecting a year-on-year growth of 7.87% [3] - The company is actively developing various projects, including an anticipated HPV testing product that aims to challenge foreign market dominance [3] - Despite its technological strengths, Rendu faces challenges in market recognition, as RNA testing is still a nascent field in China, with many institutions and patients favoring traditional methods [3]

Core Viewpoint - The recent revision of the Infectious Disease Prevention Law in China emphasizes the need for standardized isolation treatment for infectious tuberculosis (TB) patients, marking a significant shift towards a modernized prevention and control system in TB management starting from September 1, 2025 [1][2][3]. Group 1: Policy Changes - The new law mandates standardized isolation treatment for infectious TB patients and screening of close contacts, providing a legal basis for medical institutions to implement these measures [2][3]. - The National TB Prevention and Control Plan (2024-2030) and the Guangxi TB Prevention and Control Plan (2025-2030) highlight the importance of reducing transmission in community and hospital settings through effective isolation [2][3]. Group 2: Technological Advancements - The TB-RNA nucleic acid testing system launched by Rendu Biotech is the only rapid live bacteria detection product in China, enhancing the scientific and efficient isolation treatment of infectious TB patients [1][4]. - TB-RNA technology offers unique advantages in accurately identifying live bacteria, which is crucial for controlling transmission and adjusting treatment plans, overcoming limitations of traditional methods [4][5]. Group 3: Efficiency and Economic Benefits - TB-RNA testing significantly reduces the time required for diagnosis, with results available in hours compared to weeks for traditional culture methods, thus shortening patient isolation periods and improving resource utilization [5][6]. - The integration of TB-RNA technology into diagnostic protocols is expected to yield positive health economic benefits by reducing hospitalization days and minimizing unnecessary isolation due to false positives from DNA testing [7].

Core Viewpoint - The report outlines the continuous supervision work conducted by China International Capital Corporation for Shanghai Rendu Biotechnology Co., Ltd. during the 2024 fiscal year, emphasizing compliance with regulations and the company's operational integrity [1][2][3]. Continuous Supervision Work - The sponsor has established and effectively implemented a continuous supervision system, along with a corresponding work plan [1]. - A sponsorship agreement has been signed with Rendu Biotechnology, clarifying the rights and obligations of both parties during the supervision period [2]. - Continuous supervision is conducted through daily communication, regular visits, on-site inspections, and due diligence [3]. Compliance and Governance - Rendu Biotechnology has adhered to legal and regulatory requirements, ensuring that its directors and senior management comply with relevant laws and regulations [4][5]. - The company has established effective internal control systems, including financial management and internal audit procedures, which have been verified by the sponsor [7]. - The sponsor has reviewed the company's information disclosure documents to ensure there are no false records or misleading statements [6]. Financial Performance - For the fiscal year 2024, Rendu Biotechnology reported a revenue of 177.35 million, a 7.87% increase from 164.41 million in 2023 [18]. - The net profit attributable to shareholders was -7.81 million, a significant decline from 23.33 million in 2023 [18]. - The company has faced challenges in maintaining profitability, with a notable decrease in net assets and total assets compared to the previous year [19]. Industry Context - The in vitro diagnostic industry, particularly the molecular diagnostics sector, is experiencing rapid growth, driven by government support and increasing market demand [11][13]. - Rendu Biotechnology focuses on RNA molecular diagnostics, which offers higher specificity and sensitivity compared to DNA diagnostics, positioning the company favorably in the market [22]. - The company has established a strong market presence, particularly in the reproductive health sector, with a market share of 30.4% in the sexually transmitted infection diagnostics segment [24]. Risks and Challenges - The company faces risks related to significant declines in performance due to macroeconomic factors and changes in market demand for molecular diagnostics [9]. - Rendu Biotechnology must continuously innovate and develop new products to maintain its competitive edge in a technology-driven industry [10]. - The company is also challenged by the need to comply with evolving regulatory standards and the potential impact of international market dynamics [12][15]. Research and Development - Rendu Biotechnology has increased its R&D investment, focusing on the development of new products and technologies, including a digital micro-droplet RNA amplification detection system [26]. - The company has received multiple patents and regulatory approvals for its innovative products, enhancing its competitive position in the market [27][28]. - Ongoing projects cover a wide range of diagnostic areas, including reproductive health, blood-borne pathogens, and cancer diagnostics [27].