Investment Rating - The report maintains an "Overweight" rating for the in vitro diagnostics (IVD) industry [6][54]. Core Viewpoints - The IVD market is expected to benefit from a recent policy initiative aimed at enhancing the adaptability of supply and demand for consumer goods, with a focus on high-end medical devices and efficient IVD equipment [5][53]. - The domestic biochemical diagnostics sector has largely overcome reliance on foreign technologies, indicating a completed process of localization [6][54]. - The report emphasizes the shift towards home health management, moving from a treatment-centered to a prevention-centered approach, which is expected to create a trillion-yuan integrated market [5][53]. Summary by Sections Industry Performance - The pharmaceutical and biological sector rose by 2.67%, with the IVD sector increasing by 2.63% during the week [2][12]. - The IVD sector's current PE ratio is 39.84X, with a PB ratio of 1.85X, reflecting a slight increase from the previous week [4][33]. Company Performance - Notable performers in the medical services sector include Haobio (+14.3%), Shuoshi Biological (+13.6%), and Innotech (+13.3%) [3][29]. - Underperformers include *ST Dongyang (-7.2%) and New Industry (-5.7%) [3][29]. Investment Recommendations - The report suggests focusing on companies in the IVD sector that cater to home consumption scenarios, such as Shengxiang Biological and Sannuo Biological [5][54]. - It highlights the importance of monitoring the growth potential in immunodiagnostics, particularly in chemiluminescence and molecular diagnostics like PCR [6][54].

Policy Developments - The State Council, led by Li Qiang, held a meeting to advance the provincial coordination of basic medical insurance [2] Medical Device Approvals - Yuhanglong received two medical device registration certificates for diagnostic kits related to primary biliary cholangitis and idiopathic membranous nephropathy, enhancing its product line in liver and kidney disease diagnostics [4] - Hengrui Medicine announced the approval of clinical trial notifications for five drugs, including the humanized anti-PD-L1 monoclonal antibody Abedilizumab, with total R&D investments amounting to approximately 1.1 billion yuan [5] Capital Market Activities - Mindray Medical's chairman, Li Xiting, plans to increase his stake in the company by 200 million yuan, having already purchased shares worth approximately 30 million yuan [7] - Huayu Pharmaceutical intends to establish a private equity fund focused on the biomedical sector, with an initial commitment of 150 million yuan from the company [8][9] Industry Milestones - The first brain-computer interface surgery in China was successfully completed, utilizing a device from Wuhan Zhonghua Brain-Machine Fusion Technology Co., with the procedure priced according to government regulations [11] Clinical Trials and Collaborations - Buchang Pharmaceutical's subsidiary signed a contract for clinical trials of a new product, with a total cost of approximately 60 million yuan, aimed at enhancing the company's drug development capabilities [12] - Jincheng Pharmaceutical terminated negotiations with Giskit Pharma B.V. regarding exclusive commercialization rights, with no financial impact expected [14]

Group 1 - Company has received the IVDR CE certification for its HIV reagent, marking the successful certification of its entire series of eight preoperative chemiluminescent detection reagents, including HIV, hepatitis B, hepatitis C, and syphilis [1][2] - A total of 229 products have now obtained IVDR CE certification, which allows them to enter the EU market and regions that recognize CE certification, positively impacting the company's business promotion in these areas [1][2] Group 2 - The company announced the results of the second vesting period of its 2023 restricted stock incentive plan, with 961,500 shares set to be listed on December 3, 2025 [3][4] - The decision-making process for the stock vesting involved multiple board meetings and independent opinions, ensuring compliance with regulations [4][5][6] Group 3 - The company has completed the registration of shares for the second vesting period, with a total of 59 individuals participating in this vesting [8][10] - The total capital after the vesting will be approximately RMB 571,388,300, with the new shares accounting for about 0.17% of the total share capital, which is not expected to significantly impact the company's financial results [11] Group 4 - The company has obtained a medical device registration certificate for the anti-gp210 antibody, which is significant for diagnosing primary biliary cholangitis (PBC) [13][14] - The registration of this medical device is expected to enhance the company's product line in the fields of liver and kidney disease detection [15]

证券代码：688575 证券简称：亚辉龙 公告编号：2025-065 深圳市亚辉龙生物科技股份有限公司 （第一批）归属结果暨股份上市公告 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。 重要内容提示： 本次股票上市类型为股权激励股份；股票认购方式为网下，上市股数为 961,500股。 本次股票上市流通总数为961,500股。 本次股票上市流通日期为2025 年 12 月 3 日。 深圳市亚辉龙生物科技股份有限公司（以下简称"公司"）收到中国证券登记结 算有限责任公司上海分公司于 2025 年 11 月 26 日出具的《证券变更登记证明》， 公司完成了 2023 年限制性股票激励计划（以下简称"本激励计划"）第二个归属期 （第一批）归属的股份登记工作。现将有关情况公告如下： 一、本次限制性股票归属的决策程序及相关信息披露 （一）2023 年 9 月 14 日，公司召开第三届董事会第十六次会议，审议通过了 《关于公司<2023 年限制性股票激励计划（草案）>及其摘要的议案》《关于公司 <2023 年限制性股票激励计划实施考核管 ...

关于自愿披露取得IVDR CE认证的公告 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。 | 1 | iFlash-HIV Combo | IVDR 781232 | 至 | 2030/11/24 | 用于定性检测人血清或血浆中 | | --- | --- | --- | --- | --- | --- | | | 人类免疫缺陷病毒抗 | | | | 的 抗原和 HIV p24 HIV-1/HIV-2 | | | 原和抗体检测试剂盒 | | | | 抗体，辅助诊断 HIV 感染和用于 | | 序号 | 产品名称 （化学发光法） | 证书编号 IVDR 742445 | 至 | 有效期 2026/10/18 | 临床用途 献血筛查。 | 证券代码：688575 证券简称：亚辉龙 公告编号：2025-067 深圳市亚辉龙生物科技股份有限公司 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BSI Group The Netherlands B.V.签发的IVDR CE最高风险等级Class D认 ...

证券代码：688575 证券简称：亚辉龙 公告编号：2025-066 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： 深圳市亚辉龙生物科技股份有限公司董事会 2025 年 11 月 28 日 | 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 | 抗 抗体检测 gp210 IgG 试剂盒（化学发光法） | 粤械注准 20252401549 | 至 2030/11/25 | 二类 | 用于体外定性检测人血清和（或）血 浆中的抗 抗体。临床上用 gp210 IgG 于原发性胆汁性胆管炎的辅助诊断。 | | | | | | | 用于体外定量测定人血清和（或）血 | | | ...

Core Viewpoint - The company has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its iFlash - HIV Combo test kit, marking a significant achievement in its product certification journey [1] Group 1 - The HIV test kit has successfully passed the IVDR CE certification, which is crucial for market entry in the European Union [1] - This certification covers the full range of eight preoperative chemiluminescent test reagents, bringing the total number of certified products to 229 [1] - The certification is expected to positively impact business promotion, although the exact effect on performance remains unpredictable [1]

Core Viewpoint - The company, Aihuilong, has received medical device registration certificates for two products from the Guangdong Provincial Drug Administration, enhancing its product line in the field of liver and kidney disease diagnostics [1] Group 1: Product Registration - The two registered products are the anti-gp210 IgG antibody test kit and the anti-phospholipase A2 receptor IgG antibody assay kit, both utilizing chemiluminescence technology [1] - The registration certificates are valid until November 25, 2030, and both products are classified as Class II medical devices [1] Group 2: Diagnostic Applications - The products are intended for auxiliary diagnosis of primary biliary cholangitis and idiopathic membranous nephropathy [1] Group 3: Market Impact - The company has obtained a total of 176 domestic medical device registration certificates for chemiluminescence reagents [1] - The new certifications will help enrich the fully automated chemiluminescence product line, but the sales performance of these products is subject to market conditions, making the impact on financial performance difficult to predict [1]

Core Viewpoint - The company, 亚辉龙 (688575.SH), currently does not have any certified products for influenza A testing, but it continues to focus on respiratory infection immunity, particularly in the areas of Mycoplasma pneumoniae and Epstein-Barr virus [1] Group 1: Company Overview - 亚辉龙 is the first domestic biotechnology company to apply chemiluminescence technology to serological testing for Mycoplasma pneumoniae [1] - The company is one of the few domestic IVD suppliers that can provide simultaneous testing for Mycoplasma pneumoniae, Chlamydia IgG, and IgM typing [1]

Core Viewpoint - Shenzhen YHLO Biotech Co., Ltd. is set to hold a Q3 2025 earnings presentation on December 3, 2025, to discuss its operational results and financial indicators, inviting investors to submit questions in advance [2][3][4]. Group 1: Earnings Presentation Details - The earnings presentation will take place on December 3, 2025, from 15:00 to 16:00 at the Shanghai Stock Exchange Roadshow Center [2][6]. - Investors can participate online through the Shanghai Stock Exchange Roadshow Center and are encouraged to submit questions from November 26 to December 2, 2025 [5][6]. - Key company personnel, including the Chairman and CFO, will be present to address investor inquiries [4]. Group 2: Medical Device Registration - The company has recently received a medical device registration certificate from the Guangdong Provincial Drug Administration for the ST2 protein test, which is significant for cardiovascular disease detection [7][8]. - The ST2 protein is linked to heart function and can predict outcomes in acute myocardial infarction (AMI) patients, enhancing the company's product offerings in the cardiovascular diagnostics sector [8][9]. - The newly registered iMegaFlow analyzer is a semi-automated device designed for quantitative or semi-quantitative analysis of human samples, featuring a compact design and ease of use [9].