（文章来源：北京商报） 北京商报讯（记者王寅浩实习记者宋雨盈）8月15日，达安基因发布公告称，公司近日取得国家药品监 督管理局颁发的医疗器械注册证一个，医疗器械名称为人类MTHFR基因分型检测试剂盒（PCR—荧光 探针法），有效期自批准之日起至2030年8月13日。该试剂盒适用于体外定性检测人全血样本基因组 DNA中5,10—亚甲基四氢叶酸还原酶（MTHFR）基因C677T位点的多态性。 ...

证券代码：002030 证券简称：达安基因 公告编号：2025-041 广州达安基因股份有限公司 关于取得一个医疗器械注册证的提示性公告 特此公告。 广州达安基因股份有限公司 董 事 会 2025 年 8 月 15 日 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。 近日，广州达安基因股份有限公司（以下简称"公司"）取得国家药品监督管 理局颁发的医疗器械注册证一个，具体为： 医疗器械名称：人类 MTHFR 基因分型检测试剂盒（PCR-荧光探针法），注 册证编号：国械注准 20253401571。有效期自批准之日起至 2030 年 8 月 13 日。 预期用途：本试剂盒适用于体外定性检测人全血样本基因组 DNA 中 5,10-亚甲基 四氢叶酸还原酶（MTHFR）基因 C677T 位点的多态性。 上述医疗器械注册证的取得丰富了公司的产品组合，拓宽了公司产品的应用 领域。目前，上述产品尚处于市场开发阶段，市场需求存在不确定性，请广大投 资者注意投资风险。 ...

证券日报网讯达安基因（002030）8月1日在互动平台回答投资者提问时表示，截至2025年7月31日，公 司股东总户数约为15万8千户。 ...

Core Viewpoint - The article discusses the outbreak of Chikungunya fever in China and globally, highlighting the urgent need for effective detection and prevention measures due to the lack of specific treatments and vaccines [2][3]. Group 1: Current Situation - As of July 23, 2025, Foshan reported a total of 3,645 confirmed cases of Chikungunya fever, with the Shunde District accounting for 3,317 cases, an increase of 383 cases from the previous day [2]. - The World Health Organization (WHO) has warned that 119 countries and regions are experiencing virus transmission, with approximately 5.5 million people at risk of infection, potentially straining healthcare systems [2]. Group 2: Prevention and Control - There are currently no specific drugs or vaccines for Chikungunya fever; the primary prevention strategy is mosquito control, including eliminating breeding sites and using personal protective measures [3]. - The clinical features of Chikungunya fever include acute fever, severe joint pain, and rash, with higher risks for children, the elderly, and immunocompromised individuals [3]. Group 3: Diagnostic Methods - Common diagnostic methods for Chikungunya fever include serological testing, nucleic acid testing, and virus isolation, with specific timelines for sample collection to ensure accurate results [4]. - Currently, there are no approved test kits for Chikungunya fever in China, which poses a challenge for timely diagnosis [4]. Group 4: Market Opportunities - Several domestic companies, including DaAn Gene, Wanfu Biology, and Shengxiang Biology, are developing Chikungunya fever detection solutions based on PCR methodologies, with others exploring high-throughput sequencing and antigen-antibody detection methods [5]. - The ongoing outbreak is expected to accelerate the accumulation of clinical data for these detection products, potentially speeding up their approval and market entry [5].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [4]. Core Insights - The number of confirmed cases of Chikungunya fever is rapidly increasing, with 3,645 cases reported in Foshan as of July 23, 2025, including a daily increase of 383 cases in Shunde District [1]. - The World Health Organization (WHO) has warned that 119 countries and regions are at risk of virus transmission, with approximately 5.5 million people facing infection risk [1]. - There are currently no specific drugs or vaccines available for Chikungunya fever, making mosquito control the primary prevention strategy [2]. - Multiple companies have launched testing solutions for Chikungunya fever, and the approval of these products is expected to accelerate [3]. Summary by Sections Industry Overview - Chikungunya fever is caused by the Chikungunya virus (CHIKV) and primarily transmitted by Aedes mosquitoes, with symptoms including acute fever and severe joint pain [2]. - The absence of effective treatment and vaccines necessitates supportive care and preventive measures such as mosquito control [2]. Testing Solutions - Common testing methods for Chikungunya fever include serological testing, nucleic acid testing, and virus isolation, but no test kits have been approved for sale in China [2]. - Companies like DaAn Gene, Wanfu Biology, and others have developed PCR-based testing solutions, while others are exploring high-throughput sequencing methods [3]. Investment Opportunities - The report suggests focusing on companies that have developed Chikungunya testing solutions, including DaAn Gene, Wanfu Biology, and others [3].

Core Viewpoint - The epidemic of Chikungunya fever in Guangdong Province remains at a high plateau, indicating a severe situation that requires attention [1]. Summary by Sections Epidemic Situation - As of July 22, 2025, Shunde District in Foshan City reported a total of 2,934 confirmed cases of Chikungunya fever, with a significant increase of 463 cases in just one day [4][5]. - The first report of the epidemic in Shunde was on July 15, 2025, with 478 confirmed cases, showing an increase of over 2,000 cases in just over a week [4]. - The World Health Organization (WHO) reported that 119 countries and regions have identified Chikungunya virus transmission, with approximately 5.5 million people at risk globally, potentially leading to widespread outbreaks [4][5]. Companies Involved in Prevention and Detection - **Runben Co., Ltd. (润本股份)**: A leading domestic company in mosquito repellent products, with a revenue of 440 million yuan in 2024, showing a year-on-year growth of 35.4% and a gross margin of 54.2% [7]. - **Rainbow Group (彩虹集团)**: A well-known pest control company in China, offering a full range of mosquito repellent products that play a crucial role in controlling Chikungunya fever [8]. - **Shanghai Jahwa (上海家化)**: The "Liushen" brand is the top brand in China for mosquito repellent flower water, holding significant brand influence in mosquito prevention and personal care [9]. - **Longyun Group (朗云集团)**: A Hong Kong-listed company that has maintained the number one market share in pest control products for ten consecutive years, with notable products performing well during the epidemic [10]. - **Kangzhi Pharmaceutical (康芝药业)**: Offers a full range of baby and child health protection products, including disinfectants and mosquito repellents, demonstrating expertise in child health protection [11]. - **Shuoshi Gene (硕世纪录物)**: Utilizes gene sequencing technology for Chikungunya fever testing, providing precise diagnostic support for epidemic prevention [12]. - **Da'an Gene (达安基因)**: Provides nucleic acid testing kits for Chikungunya virus, leveraging extensive experience in molecular diagnostics [13]. - **Huiyu Medical (会域医学)**: A leading medical testing institution in China, employing advanced technology for accurate diagnosis of Chikungunya fever [14]. - **Wansheng Biology (万学生物)**: Offers rapid testing solutions for Chikungunya virus, focusing on point-of-care testing [16]. - **Nuo Weisha (诺唯莎)**: Combines molecular design with various heat-start technologies to enhance detection efficiency for mosquito-borne viruses [17].

Group 1 - The number of confirmed cases of Chikungunya fever in Shunde, Guangdong has reached 2,934, primarily affecting Lecong, Beijiao, and Chen Village, all of which are mild cases [1][2] - The World Health Organization has issued a warning regarding the potential for widespread outbreaks of Chikungunya fever, with 119 countries and regions reporting cases, putting approximately 5.5 million people at risk [2][3] - Local governments in Guangdong are actively promoting mosquito control measures, including public announcements urging citizens to eliminate mosquito breeding sites and participate in coordinated mosquito eradication efforts [2][3] Group 2 - The "mosquito repellent concept" has gained traction in the capital markets, with stocks related to mosquito control and testing reagents seeing significant increases [5][6] - Companies such as Rainbow Group and Kangzhi Pharmaceutical have experienced stock price surges, while others like Runben Co., Shanghai Jahwa, and Qingsong Co. have also seen gains [6] - Several companies, including Rendu Biotech and Mindray, have highlighted their mosquito-borne virus testing products, indicating a growing market interest in diagnostic tools for diseases like Chikungunya [6]

Group 1 - The core viewpoint of the news highlights a significant rise in virus prevention stocks, particularly in response to the reported cases of Chikungunya fever in Foshan, Guangdong Province [1][2][3] - Notable stock performances include Zhifei Biological, which increased by 16.86%, and Watson Bio, which rose by 13.39%, among others [2] - The total market capitalization of Zhifei Biological is reported at 57.7 billion, while Watson Bio stands at 21 billion [2] Group 2 - As of July 22, Foshan has reported a total of 3,195 confirmed cases of Chikungunya fever, primarily concentrated in the Shunde District [2] - The World Health Organization has issued a warning regarding mosquito-borne diseases, urging countries to prepare for potential outbreaks [3]

Core Insights - The in vitro diagnostics (IVD) industry is a crucial component of modern healthcare, providing essential data for disease prevention, diagnosis, and treatment through various testing methods [1][5][10] - China's IVD market has surpassed 120 billion yuan in 2024, with a projected growth to 165 billion yuan by 2029, reflecting a compound annual growth rate of 5-8% [1][10][19] - The industry is experiencing significant domestic substitution, with over 80% of Class III diagnostic products being domestically produced, while the share of imported products has decreased from 29.3% to 19.5% from 2021 to 2024 [1][14] Industry Overview - IVD encompasses several testing methods, including biochemical, immunological, molecular, microbiological, blood diagnostics, and point-of-care testing (POCT) [2][5] - The industry is transitioning from scale expansion to high-quality development, driven by government policies and technological innovations [5][21] Policy and Regulatory Environment - Recent government policies, such as the "14th Five-Year Plan for Bioeconomic Development" and the "Comprehensive Action Plan for Improving Medical Quality (2023-2025)," provide a strong impetus for the IVD industry [5][7] - The introduction of the "List of In Vitro Diagnostic Reagents Exempt from Clinical Trials (2025)" has expanded the range of products available in the market [7] Market Dynamics - The IVD industry is characterized by a multi-tiered market structure, with foreign giants dominating the high-end market and domestic leaders gradually increasing their market share [15][19] - The competitive landscape is evolving, with leading companies like Mindray Medical and New Industry Bio showing strong performance, while former leaders in COVID-19 testing, such as Da An Gene and BGI, are seeking business transformation [19][20] Growth Trends - The IVD industry is witnessing a shift towards precision and intelligent diagnostics, with advancements in molecular diagnostics, chemiluminescence, and POCT technologies [21][22] - The integration of AI and big data is enhancing diagnostic efficiency, while the demand for home health management and early cancer screening is rising due to an aging population [21][24] Competitive Landscape - The first tier of the market is dominated by international giants like Roche and Abbott, while domestic leaders such as Mindray and New Industry Bio are gaining traction in immunological and molecular diagnostics [15][19] - The market is seeing increased consolidation, with leading companies acquiring smaller firms to enhance their technological capabilities [23] Registration and Product Development - The registration of IVD products has been robust, with a compound annual growth rate of 25.3% from 2021 to 2024, indicating a vibrant development in the sector [14] - In 2024, the registration of domestic Class III diagnostic products reached 533, accounting for 80.5% of total IVD product registrations [14]

Policy Developments - The National Healthcare Security Administration reported that the basic medical insurance coverage rate in China remains stable at over 95%, with 1.32662 billion people insured by the end of 2024 [2] - The total income of the national basic medical insurance fund for 2024 is projected to be CNY 34,913.37 billion, while total expenditures are expected to be CNY 29,764.03 billion, resulting in a current balance of CNY 4,639.17 billion [2] - Since the establishment of the National Healthcare Security Administration in 2018, 835 new drugs have been added to the medical insurance drug list, with over 5,400 million CNY in sales from newly negotiated drugs between 2018 and 2024 [2] Drug and Device Approvals - Bayer's non-hormonal drug elinzanetant has been approved by the UK Medicines and Healthcare products Regulatory Agency for treating moderate to severe vasomotor symptoms related to menopause [5] - Innovent Biologics' new BCL2 inhibitor mesutoclax has received FDA approval to commence clinical trials for treating myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndromes [6] - Tianyu Co., Ltd.'s subsidiary has passed the review for ezetimibe raw materials by the National Medical Products Administration, pending GMP compliance inspection results for market launch [7] Capital Market Activities - Innostellar Biotherapeutics has signed a ten-year exclusive promotion agreement with Golden Age Health for the commercialization of its gene therapy candidate LX101 in mainland China [9] Earnings Disclosures - Da'an Gene anticipates a net loss of CNY 140 million to 200 million for the first half of 2025 [11] - Huahai Pharmaceutical expects a net profit decline of 40% to 50% year-on-year, projecting a profit range of CNY 374 million to 449 million [12] - KingMed Diagnostics forecasts a net loss of CNY 95 million to 65 million for the first half of 2025, representing a significant year-on-year decline [13] - Xinmai Medical projects a net profit of CNY 304 million to 361 million for the first half of 2025, a decrease of 10.52% to 24.78% compared to the previous year [14] - Wantai Biological Pharmacy anticipates a net loss of CNY 130 million to 160 million for the first half of 2025 due to market pressures and policy adjustments [15] Industry Events - *ST Suwu has received a notice of administrative penalty from the China Securities Regulatory Commission for falsifying financial reports, which may lead to forced delisting [17] - This incident serves as a warning for the pharmaceutical industry to focus on genuine innovation and establish effective internal controls to mitigate risks associated with management [17] Shareholder Movements - Qihe Venture, a shareholder holding over 5% of Xuantai Pharmaceutical, plans to reduce its stake by up to 7 million shares, representing no more than 1.5441% of the company's total shares [19]