Core Points - Shenzhen Yahui Long Biotechnology Co., Ltd. has received a medical device registration certificate from the Guangdong Provincial Drug Administration, marking a significant milestone for the company [1][2]. Group 1: Medical Device Registration - The registered product is an automatic fluorescence immunoassay analyzer, capable of quantitative or qualitative detection of analytes in human serum and plasma samples [1]. - The analyzer has a maximum processing capacity of 72 samples per hour and can simultaneously test multiple different biomolecules, allowing for multiplex testing [1]. Group 2: Market Impact - The acquisition of the registration certificate represents a breakthrough for the company in the field of multiplex detection, enhancing its core competitiveness and market expansion capabilities [2]. - The liquid phase multiplex detection platform, which is being applied in the field of autoantibody detection, reflects the company's innovative spirit and commitment to advancing autoantibody testing in China [2].

Key Points - 合富中国's stock will resume trading on November 20 after completing an investigation into unusual trading fluctuations, confirming normal business operations and no undisclosed significant matters [1] - 中金公司 plans to merge with 东兴证券 and 信达证券, leading to a suspension of its A-shares starting November 20 due to uncertainties surrounding the merger [1] - 大为股份 is progressing with the transition from exploration to mining rights for its lithium battery project in Hunan, having received necessary approvals [1] - 燕东微's major shareholders plan to reduce their stakes by up to 2.5% through block trades or centralized bidding from December 11, 2025, to March 11, 2026 [2] - 中水渔业's major shareholder reduced its stake to 5% after selling 258.88 million shares [3] - 韵达股份 reported a slight decline in express service revenue for October 2025, totaling 4.495 billion yuan, a year-on-year decrease of 0.88% [4] - 倍杰特 intends to acquire a 55% stake in 大豪矿业 for 224.8 million yuan [4] - 辰奕智能 plans to acquire a 55% stake in 华泽电子 through cash [4] - 赣粤高速's actual controller will change from the provincial transportation department to the provincial state-owned assets supervision and administration commission [5] - 东软集团 received a notification for a 4.2 billion yuan contract for intelligent cockpit controllers from a major domestic automotive manufacturer [5] - 海正药业's subsidiary plans to invest in a pet prescription food project [5] - 龙利得's controlling shareholder plans to increase its stake by at least 56 million yuan [6] - 新兴装备's shareholders plan to reduce their stakes by up to 3.13% [6] - 普洛药业 plans to repurchase shares worth between 180 million and 360 million yuan [6]

证券代码：688575 证券简称：亚辉龙 公告编号：2025-062 深圳市亚辉龙生物科技股份有限公司 关于自愿披露取得医疗器械注册证的公告 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。 深圳市亚辉龙生物科技股份有限公司（以下简称"公司"或"亚辉龙"）于近日收 到了由广东省药品监督管理局签发的医疗器械注册证，具体信息如下： | 序 | 产品名称 | 注册编号 | 注册证有效期 | 注册 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 号 | | | | 分类 | | | 1 | 全自动荧光免疫分析仪 | 粤械注准 | 至 2030/11/17 | 二类 | 采用基于藻红蛋白的磁条码免疫荧光发光 法，与亚辉龙生产的检测试剂共同使用，在 | | | | 20252221513 | | | 临床上用于对来源于人体的血清、血浆样本 | | | | | | | 中的被分物进行定性或定量检测。 | 一、医疗器械注册证的基本情况 二、对公司的影响 亚辉龙全自动荧光免疫分析仪是一款全自动 ...

Core Viewpoint - The company has received a medical device registration certificate for its fully automated fluorescent immunoassay analyzer, which is expected to enhance its competitiveness and market expansion capabilities, although the impact on performance remains uncertain due to various influencing factors [1] Group 1: Product Registration - The company received the medical device registration certificate from the Guangdong Provincial Drug Administration [1] - The registration number is 粤械注准20252221513, and it is valid until November 17, 2030 [1] - The analyzer is classified as a Class II medical device [1] Group 2: Product Capabilities - The analyzer can test human serum and plasma samples [1] - It has a maximum processing capacity of 72 samples per hour [1] Group 3: Market Implications - The certification represents a breakthrough for the company in the field of multi-detection [1] - The sales performance of the product will be influenced by various factors, making the impact on financial performance unpredictable [1]

证券代码：688575 证券简称：亚辉龙 公告编号：2025-060 深圳市亚辉龙生物科技股份有限公司 关于控股股东、实际控制人兼董事长及其一致行动人 权益变动触及 1%整数倍的提示性公告 控股股东、实际控制人兼董事长及其一致行动人保证向本公司提供的信息真实、 准确、完整，没有虚假记载、误导性陈述或重大遗漏。 本公司董事会及全体董事保证公告内容与信息披露义务人提供的信息一致。 重要内容提示： | 权益变动方向 | 比例增加□ | | 比例减少√ | | --- | --- | --- | --- | | 权益变动前合计比例 | 47.06% | | | | 权益变动后合计比例 | 46.96% | | | | 本次变动是否违反已作出的承 | 是□ | 否√ | | | 诺、意向、计划 | | | | | 是否触发强制要约收购义务 | 是□ | 否√ | | 一、 信息披露义务人及其一致行动人的基本信息 1.身份类别 | | √控股股东/实际控制人及其一致行动人 □其他 5%以上大股东及其一致行动人 | | --- | --- | | 投资者及其一致行动人的身份 | □合并口径第一大股东及其一致行动人（仅适用 ...

证券代码：688575 证券简称：亚辉龙 公告编号：2025-061 深圳市亚辉龙生物科技股份有限公司 关于向银行申请抵押贷款的进展公告 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。 一、公司向银行申请抵押贷款基本情况 深圳市亚辉龙生物科技股份有限公司（以下简称"公司"）于 2021 年 8 月 26 日召 开第二届董事会第十九次会议，审议通过了《关于向银行申请抵押贷款的议案》。为满 足公司宝龙二期产业园项目（现名：启德大厦项目）建设需要，改善公司现金流状况、 降低经营风险、促进公司经营发展，公司拟以部分自有资产作为抵押，向商业银行申请 不超过人民币 6 亿元贷款，最终贷款金额、贷款期限、贷款利率等以银行审批为准，并 授权公司董事长及/或其授权代表在上述贷款金额及贷款期限内与相关银行签署贷款协 议、担保协议及其他相关文件（包括该等文件的修正及补充）并办理相关手续，授权期 限至前述事项办理完毕为止。 根据上述授权，公司向招商银行股份有限公司深圳分行（以下简称"招商银行深圳 分行"）申请不超过人民币 59,200 万元的固定 ...

Core Viewpoint - The company, Aihuilong (688575.SH), announced that its controlling shareholder and chairman, Hu Kunhui, reduced his shareholding through a block trade, impacting the overall ownership structure of the company [1] Group 1 - Hu Kunhui reduced his shareholding by selling a total of 600,000 shares on November 17-18, 2025 [1] - After the reduction, Hu Kunhui and his concerted parties hold a total of 267,851,515 shares, decreasing their combined ownership percentage from 47.06% to 46.96% [1] - The change in equity ownership triggered a 1% integer change in the shareholding structure [1]

Core Insights - Shenzhen Yahui Long Biotechnology Co., Ltd. has received approval for its self-developed soluble CD146 detection kit (chemiluminescence method) from the Guangdong Provincial Drug Administration, marking a significant breakthrough in the detection of central nervous system diseases [1][2] - The company is the first globally to offer a soluble CD146 detection kit for cerebrospinal fluid, bringing its total number of domestic chemiluminescent reagent products to 173 [1] Group 1: Product Development and Innovation - The soluble CD146 detection kit demonstrates a notable increase in sCD146 concentration in cerebrospinal fluid among patients with multiple sclerosis (MS) and neuromyelitis optica, addressing the challenge of early and accurate diagnosis in these conditions [1][2] - Traditional laboratory testing methods have limitations, including complex procedures and long detection cycles, which the new chemiluminescence method overcomes by simplifying operations and enhancing sensitivity and specificity [1] Group 2: Clinical Implications and Market Position - The introduction of the soluble CD146 detection kit is expected to transition the field of central nervous system immune inflammatory demyelinating diseases from "diagnosable" to "precise and early diagnosis," laying a crucial foundation for disease intervention and prognosis improvement [2] - The collaboration with Academician Yan Xiyun, a prominent figure in nanobiology and tumor immunology, highlights the innovative nature of this project and strengthens China's international position in the diagnostic field for these diseases [2]

Core Insights - Aihuilong (688575.SH) has received approval from the Guangdong Provincial Drug Administration for its self-developed soluble CD146 detection kit (chemiluminescence method), marking a significant breakthrough in the detection of central nervous system diseases [1] - Aihuilong is the first company globally to possess a soluble CD146 detection kit for cerebrospinal fluid, bringing its total number of domestic chemiluminescent reagent products to 173 [1] Group 1: Clinical Significance - Research indicates that the concentration of soluble CD146 (sCD146) in cerebrospinal fluid is significantly elevated in patients with central nervous system autoimmune inflammatory demyelinating diseases, such as multiple sclerosis (MS) and neuromyelitis optica [2] - Traditional laboratory testing methods for these diseases have limitations, including complex procedures and long detection cycles, which Aihuilong's innovative chemiluminescence method aims to overcome by simplifying operations and enhancing sensitivity and specificity [2][3] - The sCD146 level in cerebrospinal fluid has shown a strong correlation with various inflammatory factors, making it a crucial auxiliary diagnostic marker for early and precise diagnosis of these diseases [2] Group 2: Technological Innovation - The soluble CD146 detection kit represents a groundbreaking technological achievement developed in collaboration with Professor Yan Xiyun, a renowned academician and expert in nanobiology [4] - This innovation not only transforms the diagnostic approach for central nervous system autoimmune inflammatory demyelinating diseases but also strengthens China's international leadership in this diagnostic field [4] - Aihuilong is conducting multi-center studies with Xuanwu Hospital to establish new diagnostic technologies and solutions based on sCD146, with plans to expand its application in various medical fields, including obstetrics, autoimmune diseases, cardiovascular diseases, and oncology [4]

关于自愿披露取得医疗器械注册证的公告 证券代码：688575 证券简称：亚辉龙 公告编号：2025-059 深圳市亚辉龙生物科技股份有限公司 sCD146 是中国科学院生物物理研究所阎锡蕴院士发现的创新型指标，亚辉龙与阎 院士团队携手，持续探索以该指标为靶点的诊疗方案。目前，亚辉龙分别与北京大学第 一医院、北京宣武医院、北京大学第三医院等国内顶尖医疗机构，围绕 sCD146 的潜在 应用领域开展深入课题研究。本次获批的诊断试剂产品，是亚辉龙与阎院士团队历时多 年攻关达成的产学研转化成果，也是 sCD146 这一创新标志物在全球范围内实现转化的 首个检测试剂。 截至目前，公司已先后取得 173 项化学发光试剂国内《医疗器械注册证》（共 250 个发光试剂国内注册证）。本次《医疗器械注册证》的取得，有利于进一步丰富公司的 全自动化学发光产品线，增加了亚辉龙的神经系统疾病领域检测套餐。 三、风险提示 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。 深圳市亚辉龙生物科技股份有限公司（以下简称"公司"或"亚辉龙"）于近日收 到了由广 ...