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]

开源证券8月21日发布研报称，给予万孚生物（300482.SZ，最新价：23.14元）买入评级。评级理由主 要包括：1）常规业务短期承压，毒品检测逆势增长；2）国际市场持续发力，产品矩阵不断丰富，本地 化进程持续深化。风险提示：公司产品研发、注册不及预期，汇率波动风险。 （文章来源：每日经济新闻） ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company's revenue for H1 2025 was 1.246 billion yuan, a year-over-year decrease of 20.92%, with a net profit attributable to shareholders of 189 million yuan, down 46.82% year-over-year. In Q2 2025, revenue was 445 million yuan, a decline of 37.64%, and net profit was 6,350 yuan, down 99.95% year-over-year [4][5] - The increase in expense ratios is attributed to a decline in revenue base, with sales expense ratio at 25.6% (+5.38 percentage points), management expense ratio at 7.34% (+0.52 percentage points), and R&D expense ratio at 13.99% (+1.46 percentage points). The gross margin was 62.87% (-1.47 percentage points) and net margin was 15.27% (-7.48 percentage points) due to industry policy adjustments affecting terminal testing volume and pricing [4][5] - The company has adjusted its profit forecasts for 2025-2027, expecting net profits of 428 million, 499 million, and 600 million yuan respectively, with corresponding EPS of 0.89, 1.04, and 1.25 yuan. The current stock price corresponds to P/E ratios of 26.1, 22.3, and 18.6 times for the respective years [4][5] Summary by Sections Financial Performance - In H1 2025, the infectious disease business generated 379 million yuan (down 21.14% year-over-year), primarily due to lower respiratory disease prevalence and medical load. Chronic disease management testing revenue was 563 million yuan (down 26.06% year-over-year) due to policy adjustments affecting terminal demand [5] - Drug testing revenue increased to 145 million yuan (up 4.26% year-over-year), supported by localized operations and channel expansion, with the U.S. Amazon platform ranking first in sales [5] - The company continues to enhance its product offerings and expand into international markets, with significant growth in overseas revenue, particularly in Europe, Asia, and Latin America [6] Market Strategy - The company is focusing on developing markets, establishing subsidiaries in Russia and the Philippines in H1 2025. The introduction of chemiluminescence products is aimed at penetrating the mid-to-high-end market, with rapid growth in overseas installations [6] - In the U.S. market, the company received FDA 510(k) approval for a COVID-19 and flu testing product in January 2025, which is expected to drive revenue growth through comprehensive sales channel coverage [6]

Core Viewpoint - Wanfu Bio's U-CardDx 200 fully automatic nucleic acid amplification analyzer has received NMPA Class III medical device registration approval for market launch, marking a significant advancement in molecular diagnostics [1] Company Summary - The U-CardDx 200 system has also obtained EU CE IVDR certification and is already in operation in multiple countries overseas [1] - This device utilizes classic magnetic bead nucleic acid extraction and real-time fluorescence quantitative PCR technology, innovatively reducing the total nucleic acid testing time to 15 minutes [1] - The U-CardDx 200 serves as a complete molecular diagnostic laboratory in a single instrument, capable of meeting routine testing needs and addressing urgent testing demands during peak periods [1] Industry Summary - Molecular diagnostics is a key strategic platform for Wanfu Bio, driving precision medicine [1] - The approval of the U-CardDx 200 signifies a new era in nucleic acid testing and opens a new chapter in molecular diagnostics, providing hospitals and laboratories with more efficient and precise testing tools [1]

证券日报网讯8月20日晚间，万孚生物（300482）发布公告称，公司近日收到国家药品监督管理局颁发 的医疗器械注册证，产品名称为全自动核酸扩增分析仪。 ...

（文章来源：证券日报） 证券日报网讯 8月20日晚间，万孚生物发布公告称，选举王芳女士担任公司第五届监事会职工代表监 事。 ...

| | 2020-12-31 | 2021-12-31 | 2022-12-31 | 2023-12-31 | 2024-1 | | --- | --- | --- | --- | --- | --- | | ■ 王继华 | 101.2万 | 112.6万 | 164.6万 | 149.0万 | 171.0万 | | ■ 行业平均 | 186.9万 | 223.6万 | 222.5万 | 188.6万 | 189.0万 | | | 本报告期 | 上年同期 | 本报告期比上年同期增减 | | --- | --- | --- | --- | | 营业收入(元) | 1, 245, 654, 367. 05 | 1. 575. 250, 376. 82 | -20. 92% | | 归属于上市公司股东的净利 润(元) | 189, 198, 935, 53 | 355, 800, 226, 55 | -46. 82% | | 归属于上市公可股东的扣除 非经常性损益的净利润 | 153, 547, 946, 09 | 324, 816, 812. 36 | -52.73% | | (71) | | | | | 经营活 ...