公告显示，两产品针对呼吸道传染病症表现4天内的前鼻腔样本，定性检测和区分甲乙型流感病毒，提 供家庭自测（OTC）与专业医疗场景使用两种版本。其中，OTC版是美国市场第一个获得许可的同类产 品。 北京商报讯（记者 王寅浩 实习记者 宋雨盈）8月21日，万孚生物发布公告称，公司美国全资子公司 Wondfo USA Co.,Ltd近日收到美国食品药品监督管理局（FDA）通知，其甲型流感病毒及乙型流感病毒 双联家庭检测试剂盒（OTC版）WELLlife Flu A&B Home Test和甲型流感病毒及乙型流感病毒双联检测 试剂盒（Professional use版）WELLlife Influenza A&B Test两项产品获得美国FDA510(k)许可。 ...

Core Viewpoint - Wondfo USA Co., Ltd, a wholly-owned subsidiary of Wondfo Biotech, has received FDA 510(k) clearance for two influenza test kits, marking a significant milestone in the company's product offerings in the U.S. market [1] Company Summary - Wondfo Biotech's influenza test kits include the WELLlife Flu A&B Home Test for OTC use and the WELLlife Influenza A&B Test for professional use, both designed to qualitatively detect and differentiate between influenza A and B viruses from nasal samples within four days of symptom onset [1] - The OTC version is noted as the first of its kind to receive FDA approval in the U.S. market, highlighting the company's innovative position in the healthcare sector [1]

Core Viewpoint - The report from Kaiyuan Securities indicates that Wanfu Biology's performance in H1 2025 is under pressure, but international business shows steady progress, maintaining a "Buy" rating [1] Group 1: Financial Performance - In H1 2025, the company's infectious disease business revenue was 379 million yuan, a year-over-year decrease of 21.14%, primarily due to lower intensity of respiratory disease outbreaks and reduced medical burden compared to the same period last year [1] - The company is enhancing product hospital admissions and R&D iterations, with the immunochromatography analyzer FG-3000 completing development [1] Group 2: Product Development and Market Expansion - The respiratory triple test is expected to receive certification in H2 2025, while blood and digestive infectious disease businesses continue to gain momentum [1] - The company has made strategic breakthroughs in key countries across Europe, Asia, and Latin America, continuously promoting localization efforts, with subsidiaries established in Russia and the Philippines in H1 2025 [1] Group 3: Market Position and Growth Potential - The introduction of chemiluminescence business is advancing into the mid-to-high-end market, with overseas installed capacity growing rapidly year-over-year [1] - In the U.S. market, the COVID-19, influenza A and B triple test POC/OTC version received FDA 510(k) approval in January 2025, rapidly advancing sales channel coverage, which is expected to provide sustained revenue growth momentum [1] - The drug testing market is improving, and the integrated research, production, and sales layout is helping to stabilize market share [1]

Core Viewpoint - The company reported a significant decline in revenue and net profit for the first half of 2025, with a year-over-year revenue decrease of 20.9% and a net profit drop of 46.8% [1] Group 1: Financial Performance - In the first half of 2025, the company achieved revenue of 1.246 billion yuan and a net profit of 189 million yuan, with a significant decline in operating cash flow to -56 million yuan [1] - For Q2 2025, the company reported revenue of 445 million yuan, down 37.64% year-over-year, and a net profit of 6 million yuan, reflecting a 99.95% decrease [1] Group 2: Business Segment Analysis - The drug testing business showed recovery with a revenue of 145 million yuan, up 4.3% year-over-year, benefiting from a strong position on Amazon in the U.S. [2] - Infectious disease testing revenue was 379 million yuan, down 21.1% year-over-year, attributed to lower respiratory disease prevalence compared to the previous year [2] - Chronic disease management testing generated 563 million yuan, down 26.1% year-over-year, impacted by medical procurement policies, but future growth is expected with platform upgrades [2] Group 3: Profitability and Innovation - The company's gross margin for H1 2025 was 62.87%, a decrease of 1.47 percentage points year-over-year, primarily due to a higher proportion of lower-margin drug testing [3] - The company is pursuing a dual-track R&D strategy focusing on expanding existing product lines and developing new technology platforms, which is expected to enhance its market position in POCT [3] Group 4: Revenue Forecast - Projected revenues for 2025-2027 are 2.668 billion, 3.081 billion, and 3.520 billion yuan, with year-over-year growth rates of -12.9%, 15.5%, and 14.2% respectively [4] - Expected net profits for the same period are 403 million, 500 million, and 615 million yuan, with respective growth rates of -28.2%, 24.1%, and 23.0% [4]

Core Viewpoint - Wondfo USA Co., Ltd, a wholly-owned subsidiary of Wondfo Biotech, has received FDA 510(k) clearance for its dual influenza A and B home test kits, indicating a significant advancement in the company's product offerings in the U.S. market [1] Group 1: Product Approval - The FDA has granted clearance for two products: WELLlife Flu A&B Home Test (OTC version) and WELLlife Influenza A&B Test (Professional use version) [1] - The dual influenza test kits have successfully completed performance and clinical validation in the U.S., demonstrating a sensitivity exceeding 90% and a specificity of 100% [1] Group 2: Product Features - The test kits are designed for qualitative detection and differentiation of influenza A and B viruses from nasal samples within four days of respiratory symptom onset [1] - The products cater to different application needs by providing both home self-testing (OTC) and professional medical use versions, offering reliable and rapid diagnostic support [1]

Financial Performance - In the first half of 2025, the company achieved revenue of 1.246 billion CNY and a net profit of 189 million CNY, impacted by intensified competition and demand pressure in the in vitro diagnostics industry [2] - As of the end of the first half of 2025, accounts receivable amounted to 1.19 billion CNY, showing a decrease of 12.5% from the previous quarter [3] Strategic Initiatives - The company is focusing on IPD transformation to enhance core competitiveness and is committed to continuous innovation in the immunology field [2] - The company aims to strengthen its market position in infectious disease testing by increasing the coverage of flu detection products and launching new respiratory detection products [2][6] International Expansion - The international department sells products to over 150 countries and regions, with a focus on local operations and partnerships in key markets [5] - The company has established subsidiaries in Russia and the Philippines, and a controlling subsidiary in Malaysia to enhance operational efficiency [5] Product Development - The company is advancing its product lines in various sectors, including immunofluorescence, chemiluminescence, and electrochemical platforms, with a focus on cardiovascular, metabolic, and infectious diseases [4][8] - New products such as the Ucare-6000 blood gas analyzer and the FG-3000 immunochromatographic analyzer are being introduced to improve diagnostic capabilities [3][6] Market Challenges and Responses - The company is adapting to external pressures by emphasizing long-term strategies and maintaining investment in R&D despite a challenging environment [4] - The domestic market for respiratory infectious disease testing has seen a decline compared to the previous year, prompting the company to reinforce its market presence and product offerings [6] Future Outlook - The company anticipates significant growth in international markets, particularly in the "Belt and Road" regions and the U.S., with a clear focus on internationalization as a core strategy [10] - The overall performance for the year is expected to meet targets, supported by a solid foundation in the U.S. toxicology market and the introduction of new respiratory products [9]

Group 1 - Core viewpoint: Cinda Securities issued a report on August 21, giving Wanfu Biology (300482.SZ, latest price: 23.01 yuan) a buy rating [2] - Reason for rating: The toxicology testing business is recovering growth, while testing for infectious and chronic diseases is under pressure [2] - Short-term profitability is under pressure, but innovation is expected to drive long-term growth [2]

【万孚生物：美国子公司呼吸道双联检产品获美国FDA510(k)许可】智通财经8月21日电，万孚生物 (300482.SZ)公告称，公司美国全资子公司WondfoUSACo.,Ltd近日收到美国FDA通知，其甲型流感病毒 及乙型流感病毒双联家庭检测试剂盒（OTC版）和专业使用版试剂盒获得美国FDA510(k)许可。两项产 品针对呼吸道传染病症表现4天内的前鼻腔样本，定性检测和区分甲乙型流感病毒。OTC版为美国市场 第一个获得许可的同类产品，后续可通过美国的专业场景及电商、药店、商超等渠道销售，为不同应用 需求提供可靠、快速的诊断支持。该产品将进一步丰富公司在美国市场呼吸道检测领域的产品布局，对 公司美国市场的发展具有正面影响。 转自：智通财经 ...

| 证券代码：300482 | 证券简称：万孚生物 | 公告编号：2025-046 | | --- | --- | --- | | 债券代码：123064 | 债券简称：万孚转债 | | 广州万孚生物技术股份有限公司 关于美国子公司呼吸道双联检产品获得美国 FDA 510(k)许可的公告 特此公告。 广州万孚生物技术股份有限公司董事会 | 名称 | | | 510(K)编号 | 获批日期 | 预期用途 | | --- | --- | --- | --- | --- | --- | | WELLlife | | Flu A&B | | 2025/08/20 | 针对呼吸道传染病症表现 天内的前鼻腔样本， 4 定性检测和区分甲乙型流感病毒。该产品属于非 处方家庭使用 产品。 OTC | | Home | Test | | K251563 | | | | WELLlife | | Influenza | | | 针对呼吸道传染病症表现 天内的前鼻腔样本， 4 | | A&B | Test | | | 2025/08/20 | 定性检测和区分甲乙型流感病毒。该产品用于专 | | | | | | | 业使用场景。 | ...

Investment Rating - The investment rating for the company is "Buy" [1] Core Views - The company reported a revenue of 1.246 billion yuan in the first half of 2025, a year-on-year decrease of 20.9%, and a net profit attributable to shareholders of 189 million yuan, down 46.8% year-on-year [1][3] - The report highlights that the toxicology testing business is recovering, while infectious disease and chronic disease testing are under pressure. The toxicology testing revenue reached 145 million yuan, an increase of 4.3% year-on-year, with strong sales on platforms like Amazon in the U.S. [3] - The company is expected to see a recovery in revenue from respiratory disease testing as new products gain certification in both domestic and U.S. markets [3] - The report anticipates that the company's revenue will be 2.668 billion yuan in 2025, with a year-on-year growth rate of -12.9%, followed by 3.081 billion yuan in 2026 and 3.520 billion yuan in 2027, with respective growth rates of 15.5% and 14.2% [4] Financial Summary - For the first half of 2025, the company's gross profit margin was 62.87%, a decrease of 1.47 percentage points year-on-year, attributed to a higher proportion of lower-margin toxicology tests and domestic medical reform policies [3] - The company’s operating cash flow was -56 million yuan, a year-on-year decline of 128.1% [1] - The projected earnings per share (EPS) for 2025 is 0.84 yuan, with a price-to-earnings (P/E) ratio of 27.66 times based on the closing price on August 20, 2025 [4]