Core Viewpoint - The company, Capbio, announced that its wholly-owned subsidiary, Guangzhou Capbio Medical Technology Co., Ltd., has obtained the Medical Device Registration Certificate for in vitro diagnostic reagents from the National Medical Products Administration of China for its six-pathogen respiratory nucleic acid detection kit (PCR-fluorescent probe method) [2] Group 1 - Capbio's subsidiary has received regulatory approval for a new diagnostic product [2] - The approved product is designed for the detection of multiple respiratory pathogens [2]

Group 1 - The core point of the article is that Capstone Bio (300639.SZ) has received a medical device registration certificate from the National Medical Products Administration for its in vitro diagnostic reagent kit [1] - The product is named "Six Pathogen Nucleic Acid Detection Kit for Respiratory Tract" and is designed for qualitative detection of nucleic acids from various respiratory pathogens [1] - The kit can detect nucleic acids of respiratory syncytial virus, influenza A virus, influenza B virus, adenovirus, parainfluenza virus, and Mycoplasma pneumoniae from nasopharyngeal swab samples [1]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Guangzhou Capbio Medical Technology Co., Ltd., has received the Medical Device Registration Certificate from the National Medical Products Administration for six respiratory pathogen nucleic acid detection kits [1] Group 1 - The detection kits utilize PCR-fluorescent probe method for in vitro qualitative detection of nucleic acids in throat swab samples [1] - The kits are designed to detect respiratory syncytial virus, influenza A virus, influenza B virus, adenovirus, parainfluenza virus, and Mycoplasma pneumoniae [1]

Group 1 - The core point of the article is that Capbio has received a medical device registration certificate for its "Six Pathogen Nucleic Acid Detection Kit" from the National Medical Products Administration of China [1] - Capbio's revenue composition for the first half of 2025 is as follows: molecular diagnostic products account for 67.65%, medical testing services account for 29.07%, and medical service income accounts for 3.27% [1] - As of the report date, Capbio's market capitalization is 3.7 billion yuan [1] Group 2 - The article also mentions a competitive situation in the beverage industry, where Nongfu Spring's new green bottle has led to a significant decline in market share for Yibao, dropping nearly 5 percentage points [1]

本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误 导性陈述或者重大遗漏。 广东凯普生物科技股份有限公司（以下简称"公司"）的全资子公司广州凯 普医药科技有限公司近日取得国家药品监督管理局颁发的《中华人民共和国医疗 器械注册证（体外诊断试剂）》。具体情况如下： | 产品名称 | 注册 | 注册证编号 | 注册证有 效期 | | 预期用途 | | --- | --- | --- | --- | --- | --- | | | 分类 | | | | | | 六项呼吸道病 | 类 III | | 2025 | 年 9 | 本试剂盒用于体外定性检测人口咽 | | 原体核酸检测 | | 国 械 注 准 | 月 29 | 日至 | 拭子样本中呼吸道合胞病毒、甲型 | | 试剂盒（PCR- | | 20253401988 | 2030 | 年 9 | 流感病毒、乙型流感病毒、腺病毒、 | | 荧光探针法） | | | 月 28 | 日 | 副流感病毒和肺炎支原体的核酸。 | 一、医疗器械注册证的具体情况 证券代码：300639 证券简称：凯普生物 公告编号：2025-056 广东凯普生物科技股份有限 ...

Core Viewpoint - The company, once thriving due to its nucleic acid testing business, is now facing significant challenges in the post-pandemic era, including declining revenues, increased losses, and strategic, financial, and innovation hurdles [1][6]. Revenue and Profitability - In the first half of 2025, the company's revenue decreased by 23% year-on-year, with a net loss expanding to 89.59 million yuan, marking two consecutive years of losses [1]. - The company reported a total net loss of 650 million yuan for the entire year of 2024, indicating a severe downturn in financial performance [2]. Cost Management Efforts - To mitigate financial pressure, the company has implemented workforce reductions and salary cuts, decreasing its employee count from 3,339 in 2022 to 2,205 in 2024, and reducing average employee compensation from 266,500 yuan to 150,000 yuan [2]. - Despite these cost-cutting measures, losses in the first half of 2025 still increased by 16% year-on-year, suggesting that mere cost reduction is insufficient to reverse the downward trend [2]. Market Challenges - The company's HPV testing business, which previously accounted for over 80% of its revenue, is now facing pricing pressures due to collective procurement policies, leading to a 28% year-on-year decline in revenue from its molecular diagnostics segment in the first half of 2025 [3]. - The increase in VAT from 3% to 13% has further impacted the profitability of core products, highlighting the company's vulnerability in a competitive pricing environment [3]. Investment and Cash Flow Issues - The company is investing heavily in new growth areas, including the establishment of 31 medical laboratories and a 1.512 billion yuan investment in the KaiPu Medical Science Park, which is only 16.35% complete, with a funding gap of nearly 400 million yuan [4]. - The company is also planning to develop the Guangdong Kanghe Hospital, but the healthcare sector typically requires 5-10 years to achieve a return on investment, exacerbating cash flow pressures amid declining core business revenues [4]. Accounts Receivable and Financial Stability - As of June 2025, the company's accounts receivable stood at 1.93 billion yuan, with 990 million yuan already provisioned for bad debts, indicating a significant amount of capital tied up in long-recovery receivables from pandemic-related testing services [5]. - The company has applied for a 900 million yuan syndicated loan to support the construction of the science park, but the dual investment in the science park and hospital has strained its financial resources, raising concerns about potential refinancing pressures if receivables are not collected as expected [5]. Conclusion - The company's challenges reflect broader issues within the in vitro diagnostics industry, including policy, market, and innovation pressures. The ability to manage accounts receivable, control investment pace, and overcome technological barriers will be crucial for the company's sustainable transformation [6].

Group 1 - The company, Capstone Bio, reported that as of September 19, 2025, the total number of shareholders is 28,146 [2]

Group 1 - The company emphasizes the importance of research and development (R&D) innovation and is committed to building a professional and efficient R&D talent team [1] - The company implements a scientific and reasonable management system to stimulate the innovative capabilities of R&D personnel [1] - The product center adopts the M-IPD system management and leverages its postdoctoral research workstation, enterprise technology center, and engineering center to enhance R&D effectiveness [1] Group 2 - The company strengthens collaboration with external research institutions and focuses on the transformation of innovative achievements [1]

Group 1: Company Overview and Financial Performance - The company reported a loss due to industry demand adjustments and credit impairment of accounts receivable, with accounts receivable balance at ¥1,926.20 million and bad debt provision at ¥985.59 million as of the reporting period [15] - The company has implemented measures to improve cash flow management and is focused on enhancing operational efficiency to achieve better financial results [4][6] Group 2: Product Development and Market Strategy - The company is a leading provider of molecular diagnostic products and services, focusing on three main business segments: molecular diagnostics, medical testing services, and healthcare management [5][21] - The company has developed new products, including HPV E6/E7 mRNA detection and cervical cancer methylation detection, to enhance its market competitiveness [19][25] - The company aims to expand its product offerings in maternal and child health, early cancer screening, and precision medicine, aligning with national health policies [22] Group 3: Research and Development - The company emphasizes R&D efficiency by fostering a professional and innovative research team and collaborating with external research institutions [3][12] - The company has established a digital learning platform to enhance employee training and development, conducting over 100 training sessions in the first half of 2025 [12][18] Group 4: Market Challenges and Responses - The company faces challenges from price reductions due to centralized procurement affecting its HPV-DNA product sales, although sales volume remains stable [13][19] - The company is actively working to optimize its medical laboratory operations, consolidating facilities to improve service efficiency and reduce costs [11][23] Group 5: Future Outlook and Growth Plans - The company plans to leverage its new hospital, Kaipu Kanghe Hospital, to enhance service offerings and expects to achieve significant revenue growth as operations stabilize [26][27] - The company is committed to maintaining investor confidence through share buybacks and dividend distributions, having repurchased shares worth over ¥390 million [20]

暨辖区上市公司中报业绩说明会活动的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 证券代码：300639 证券简称：凯普生物 公告编号：2025-055 广东凯普生物科技股份有限公司 关于参加 2025 年广东辖区投资者集体接待日 特此公告。 广东凯普生物科技股份有限公司董事会 二〇二五年九月十七日 — 1 — 为进一步加强与投资者的互动交流，广东凯普生物科技股份有限公司（以下简称 "公司"）将参加由广东证监局、广东上市公司协会联合举办的"向新提质 价值领 航--2025 年广东辖区投资者集体接待日暨辖区上市公司中报业绩说明会"活动，现 将相关事项公告如下： 本次活动将采用网络远程的方式举行，投资者可登录"全景路演"网站 （http://rs.p5w.net），或关注微信公众号：全景财经，或下载全景路演 APP,参与 本次互动交流，活动时间为 2025 年 9 月 19 日（周五）15:30-17:00。 届时公司管理层将在线就公司 2025 年半年度业绩、公司治理、发展战略、经营 状况和可持续发展等投资者关心的问题，与投资者进行沟通与交流，欢迎广大投资 ...