证券代码：688575 证券简称：亚辉龙 公告编号：2025-058 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 人绒毛膜促性腺激素（HCG）是由胎盘滋养层细胞分泌的一种异二聚体糖蛋白，包 含 92 个氨基酸组成的α亚基和 145 个氨基酸组成的β亚基，分子量为 37 kDa。其α亚 基与促甲状腺激素（TSH），促黄体生成素（LH），促卵泡激素（FSH）的α亚基相同， 而β亚基各不相同，赋予激素生物学和免疫学特异性。HCG 在产生、分泌和代谢过程中， 会发生断裂、离解等变化，而以多种不同的形式存在，血液中形式包括完整 HCG、缺口 HCG、完整游离α亚基、大分子游离α亚基、完整游离β亚基、缺口游离β亚基、β亚 基羧基末端丢失的 HCG，在尿中则存在β核心片段。正常妊娠时，完整 HCG 在受精后 7 天左右可在母体检测到，其后呈指数增长，至妊娠 9～11 周达到高峰，妊娠 3 个月后显 著降低，且异位妊娠比宫内孕完整 HCG 明显降低，HCG 检测临床上用于异位妊娠、早孕 的辅助诊断。HCG 的异常升高还常见于妊娠滋养细胞疾病、睾丸癌、膀胱癌等恶性肿瘤。 绒毛膜癌是一种恶性滋养层细胞 ...

Core Insights - The company, Aihuilong (688575.SH), has received a medical device registration certificate from the National Medical Products Administration for its Human Chorionic Gonadotropin (HCG) and β Subunit Assay Kit (Chemiluminescence Method) [1][3] - The product is intended for in vitro quantitative measurement of HCG and its β subunit in human serum and/or plasma, primarily for dynamic monitoring of malignant tumor patients to assist in assessing disease progression or treatment efficacy [1][2] Product Details - HCG is a glycoprotein hormone secreted by trophoblast cells of the placenta, consisting of an α subunit and a β subunit, with a molecular weight of 37 kDa [2] - The hormone exists in various forms in the blood, including intact HCG, free α subunit, and free β subunit, and is used clinically for diagnosing ectopic pregnancy and early pregnancy [2] - Abnormal elevation of HCG is often associated with malignant tumors such as testicular cancer and bladder cancer, with β-HCG being a valuable marker for monitoring trophoblastic diseases [2] Company Developments - The company has obtained a total of 172 domestic medical device registration certificates for chemiluminescence reagents, contributing to a total of 249 registrations [3] - The recent registration enhances the company's automated chemiluminescence product line and expands its testing portfolio in reproductive hormones and tumor markers [3]

Core Viewpoint - The company has received a medical device registration certificate from the National Medical Products Administration for a new product, enhancing its product line in the field of reproductive hormones and tumor markers [1] Product Development - The newly approved product is a human chorionic gonadotropin and β-subunit assay kit (chemiluminescence method) for the quantitative determination of human chorionic gonadotropin and β-subunit levels in human serum and/or plasma [1] - This product enriches the company's fully automated chemiluminescence product line [1] Market Impact - The sales performance of the new product will be influenced by market conditions, making it difficult for the company to predict its impact on future performance [1]

Core Viewpoint - The company, Aihuilong (688575.SH), has received a medical device registration certificate from the National Medical Products Administration for its product, which is a kit for the quantitative determination of human chorionic gonadotropin and its beta subunit in serum or plasma [1] Group 1 - The product is intended for in vitro quantitative measurement of human chorionic gonadotropin and its beta subunit levels in human serum and/or plasma [1] - It is primarily used for dynamic monitoring of malignant tumor patients to assist in assessing disease progression or treatment effectiveness [1] - The product is not intended for early diagnosis or confirmation of malignant tumors and is not used for tumor screening in the general population [1]

Core Viewpoint - The company, Aihuilong (688575.SH), has received a medical device registration certificate from the National Medical Products Administration for its product, which is a kit for the quantitative determination of human chorionic gonadotropin and its beta subunit in human serum and/or plasma [1] Group 1 - The product is primarily used for dynamic monitoring of malignant tumor patients to assist in assessing disease progression or treatment effectiveness [1] - The kit is not intended for early diagnosis or confirmation of malignant tumors and is not used for tumor screening in the general population [1]

Group 1 - Company MengTian Home is planning to acquire control of ChuanTu Microelectronics through a combination of issuing shares and cash payment, which is expected to constitute a major asset restructuring [1] - The actual controller of MengTian Home, Yu Jingyuan, is also planning a transfer of control, which is independent of the aforementioned acquisition [1] - The stock of MengTian Home has been suspended since November 6, 2025, with an expected suspension period of no more than 10 trading days [1] Group 2 - Kweichow Moutai plans to repurchase shares with an investment of between 1.5 billion and 3 billion RMB, with a maximum repurchase price of 1,887.63 RMB per share [2] - The repurchase will be conducted through centralized bidding and will be used for cancellation to reduce the company's registered capital [2] - The company also plans to distribute a cash dividend of 23.957 RMB per share, totaling approximately 30 billion RMB based on the total share capital as of September 30, 2025 [2] Group 3 - JiaYuan Technology has signed a cooperation framework agreement with CATL to deepen their long-term procurement cooperation in the supply, research, and production of materials for new battery anodes [3] - The agreement aims to enhance collaboration in technology research and market expansion, benefiting both companies [3] - JiaYuan Technology will be the preferred supplier for new products developed in cooperation with CATL, which will strengthen its competitive position in the industry [3] Group 4 - KaBeiYi has invested 100 million RMB to establish a wholly-owned subsidiary, Shanghai KaBeiYi Robotics, to accelerate the development of humanoid robot components [4] - The new subsidiary will operate independently and is expected to enhance the company's investment in humanoid robotics [4] Group 5 - Bertley has established a joint venture, Wuhu Bertley Drive Technology Co., Ltd., with a registered capital of 100 million RMB, where Bertley holds a 60% stake [5] - The joint venture will focus on the research, production, and sales of various electric motors, aligning with the company's strategy for technological autonomy and product diversification [5] - This strategic move is aimed at strengthening the company's position in high-growth sectors such as new energy vehicles and humanoid robotics [5] Group 6 - Tongling Nonferrous Metals has successfully acquired exploration rights for the JiGuangShan-HuVillage copper-gold-molybdenum mine for 3.204 billion RMB [6] - Ningbo Port expects to achieve a container throughput of 4.56 million TEUs in October 2025, representing a year-on-year increase of 12.4% [6] - Hongquan Technology will change its stock name to Hongquan Technology starting November 11, 2025, while maintaining its full name and stock code [6] Group 7 - Dongfeng Group has undergone a change in its controlling shareholder and actual controller, leading to a name change to Quzhou Dongfeng New Materials Group Co., Ltd. [7] - Yihong Long has been recognized as a national manufacturing single champion enterprise for its self-immune disease diagnostic products [7] Group 8 - China Shipbuilding Technology's subsidiary plans to publicly transfer 100% equity of a clean energy development company as part of its strategy to enhance operational quality and fund future projects [8] - HeimuDan's subsidiary is selling its developed digital economy industrial park properties for approximately 41.97 million RMB [8] Group 9 - Shenkai Co. has completed the transfer of shares from its original controlling shareholder to Shenzhen Huili Hongsheng Industrial Holdings, changing its controlling shareholder [9] - Luzhou Laojiao is investing approximately 1.478 billion RMB to build a historical and cultural industry park to enhance brand influence [9] Group 10 - Xiling Power has signed a share purchase agreement to acquire 100% of Weipai Automotive Electronics, which specializes in turbocharger production [10] - Mind Electronics plans to divest its 51% stake in a subsidiary for 14.8 million RMB to focus on core business development [10] Group 11 - Triangle Defense has signed development and framework order agreements with Siemens Energy to supply specific items, enhancing its international market presence [11] Group 12 - Hualan Co.'s controlling shareholder plans to increase its stake in the company by investing between 30 million and 60 million RMB [12] - Key executives of Kaili Medical have also increased their stakes in the company through market transactions [12]

Group 1 - Mengtian Home intends to acquire control of ChuanTu Microelectronics through a combination of share issuance and cash payment, leading to a significant asset restructuring. The stock will be suspended from trading starting November 6, 2025, for up to 10 trading days [2] - Guizhou Moutai plans to repurchase shares worth between 1.5 billion and 3 billion RMB, with a maximum repurchase price of 1,887.63 RMB per share. The repurchase will be completed within six months following shareholder approval [3] - Jiayuan Technology has signed a cooperation framework agreement with CATL to deepen their long-term procurement relationship, focusing on the supply and development of materials for new battery anodes [4] Group 2 - Kabeiyi has invested 100 million RMB to establish a wholly-owned subsidiary, Shanghai Kabeiyi Robotics, to accelerate the development of humanoid robot components [5] - Bertley has formed a joint venture with Langfang Jinrun Electric to establish Wuhu Bertley Drive Technology Co., with a registered capital of 100 million RMB, focusing on electric motor systems [7] - Tongling Nonferrous Metals has successfully acquired exploration rights for the Jiguanshan-Hucun copper-gold-molybdenum mine for 3.204 billion RMB [8] Group 3 - Ningbo Port expects to achieve a container throughput of 4.56 million TEUs in October 2025, representing a year-on-year increase of 12.4% [8] - Huayuan Technology has changed its stock name from "Hongquan Technology" to "Hongquan Technology" effective November 11, 2025, while maintaining its full name and stock code [8] - The company plans to invest approximately 1.478 billion RMB in the construction of a historical and cultural industry park to enhance brand influence [12]

Core Points - Company Aihuilong has been recognized as a national-level manufacturing champion enterprise in the ninth batch announced by the Shenzhen Municipal Bureau of Industry and Information Technology [2] - The product that contributed to this recognition is the company's self-immune disease diagnostic products [2]

特此公告。 深圳市亚辉龙生物科技股份有限公司董事会 2025 年 11 月 6 日 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。 根据深圳市工业和信息化局近日发布的《关于第九批制造业单项冠军企业和复核通 过第三批、第六批制造业单项冠军企业名单的公示》，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"）成功入选第九批国家级制造业单项冠军企业， 入选产品为公司的"自身免疫疾病诊断产品"。 制造业单项冠军企业是指长期专注于制造业特定细分领域，生产技术或工艺水平国 际先进，单项产品（生产性服务）市场占有率位居全球或国内前列的企业。单项冠军企 业是制造业创新发展的领头雁、排头兵，代表全球制造业细分领域最高发展水平、最强 市场实力，是制造业竞争力的重要体现。 亚辉龙秉承"专注生命健康事业，努力让科技造福人类"的使命，专注于体外诊断 领域的研发与创新，始终如一、追求卓越，不断为人类生命健康事业提供卓越的产品及 服务。经过十余年的耕耘，公司已成长为国产化学发光领导品牌之一，在自身免疫、生 殖健康、糖尿病、感染性疾病、肝病 ...

Core Viewpoint - The company has been recognized as a national-level manufacturing champion enterprise for its autoimmune disease diagnostic products, which enhances its brand influence and market competitiveness, although it will not significantly impact current performance [1] Group 1 - The company has been selected for the ninth batch of national-level manufacturing champion enterprises by the Shenzhen Municipal Bureau of Industry and Information Technology [1] - The recognized product is the "autoimmune disease diagnostic products," indicating a strong technological and quality standard [1] - This recognition reflects the company's overall strength and is expected to positively influence its operations [1]