Core Viewpoint - Wantai Biological's nine-valent HPV vaccine has been approved for market release, which may provide a turnaround for the company's pressured performance [1][10]. Group 1: Product Approval and Development - Wantai Biological's subsidiary, Xiamen Wantai Canghai Biotechnology Co., Ltd., has received approval for its nine-valent HPV vaccine, named Xinkening 9 [1]. - The nine-valent HPV vaccine covers seven high-risk types (HPV 16/18/31/33/45/52/58) and two low-risk types (HPV 6/11), effectively preventing related diseases [1]. - The company is the second globally and the first in China to apply for clinical trials for a domestic nine-valent cervical cancer vaccine, with the application process taking approximately 10 years [4][6]. Group 2: Financial Implications and Market Potential - As of May 2025, the cumulative R&D investment in the nine-valent HPV vaccine is approximately 1 billion yuan (unaudited) [5]. - Analysts predict that the nine-valent HPV vaccine could generate sales of up to 22.8 billion yuan, potentially becoming a core driver for the company's performance [10]. - The company has faced declining profits, with net profit dropping from 4.736 billion yuan in 2022 to 1.248 billion yuan in 2023, and projected to fall further to 106 million yuan in 2024 [11]. Group 3: Market Position and Competitive Landscape - The nine-valent HPV vaccine is expected to compete with the existing imported product, Merck's Gardasil 9, which was the only nine-valent HPV vaccine available until now [6]. - The vaccine is suitable for women aged 9-45, with different dosing schedules based on age [6]. - The pricing strategy for Wantai's vaccine remains undisclosed, but the imported version is priced at approximately 4,380 yuan for three doses [7][8]. Group 4: Shareholder Information - As of the first quarter of 2025, Zhong Shanshan directly holds 224 million shares of Wantai Biological, and his wholly-owned company, Yangshengtang, is the largest shareholder with 706 million shares, collectively holding about 73.5% of the total shares [12]. Group 5: Current Market Valuation - As of the latest closing, Wantai Biological's stock price is 71.24 yuan per share, with a total market capitalization of approximately 90.127 billion yuan [13].

万泰生物（603392）于盘后发布公告称，全资子公司厦门万泰沧海生物技术有限公司申报的九价人乳头 瘤病毒疫苗(大肠埃希菌)(商品名称：馨可宁9)获批上市。疫苗预约平台"约苗"显示，广州地区【9-45 岁】九价HPV疫苗三针(进口)价格为4390元，九价HPV疫苗(进口)为1331元。记者致电万泰生物询问其 九价HPV的价格，工作人员表示，没办法透露价格，也不清楚定价策略。(21财经) ...

Core Viewpoint - HPV infection is a significant public health issue globally, and vaccination is the best preventive measure against it. The market for HPV vaccines in China is facing challenges, particularly for bivalent vaccines, due to increased competition and the expansion of the age range for the nine-valent vaccine, impacting sales and revenue for companies like Wantai Biological Pharmacy [1][2][3]. Company Performance - Wantai Biological reported a 2024 revenue of 2.245 billion yuan, a year-on-year decline of 59.25%, and a net profit of 106 million yuan, down 91.49%, which fell short of analyst expectations [1]. - The decline in revenue and profit is attributed to market fluctuations, government procurement policies, and the competitive landscape with the nine-valent vaccine [1]. Market Dynamics - The HPV vaccine market in China is projected to grow from 135 billion yuan in 2020 to 690 billion yuan by 2030, with a compound annual growth rate of 17.7% [4]. - The nine-valent vaccine is expected to capture a significant market share due to its higher efficacy in preventing cervical cancer compared to bivalent and quadrivalent vaccines [4][5]. Competitive Landscape - Merck holds over 80% market share in the HPV vaccine sector, with its nine-valent vaccine being the only one that meets clinical trial efficacy standards [7][8]. - Domestic companies, including Wantai Biological, are developing their own nine-valent vaccines, with expectations for market entry around 2025 [7][11]. Regulatory and Clinical Developments - Wantai Biological's nine-valent HPV vaccine has been approved for use in women aged 9-45, with different dosing schedules based on age [3]. - The approval and market entry of domestic nine-valent vaccines are anticipated to intensify competition and potentially lead to price wars [11]. Public Health Impact - The World Health Organization reports an increase in HPV vaccination coverage among girls globally, indicating a growing acceptance and demand for HPV vaccines [4][5]. - There is significant room for improvement in vaccination rates in China, suggesting potential for market expansion [5][10]. Future Outlook - The HPV vaccine market in China is expected to experience rapid growth due to supportive government policies and increasing public health awareness [10][12]. - Companies are encouraged to invest in research and development for higher-valent vaccines and improve their market strategies to enhance their competitive positions [12][13].

证券代码：603392 证券简称：万泰生物 公告编号：2025-032 北京万泰生物药业股份有限公司 关于全资子公司通过 GMP 符合性检查的公告 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、准确性和完整性承担法律责任。 检查地址：厦门市海沧区山边洪东路 52 号、厦门市海沧区山边洪东路 60 号 检查范围：九价人乳头瘤病毒疫苗（大肠埃希菌）（注射剂）[疫苗生产车 间（C）原液生产线（C01）、制剂生产线（C02）、制剂生产线（C03），疫苗 生产车间（B）制剂生产线（B02）] 检查时间：2024 年 11 月 5 日-2024 年 11 月 8 日 检查结论：符合 二、本次检查所涉生产线及产品情况 生产车间生产线：疫苗生产车间（C）原液生产线（C01）、制剂生产线（C02）、 制剂生产线（C03），疫苗生产车间（B）制剂生产线（B02） 生产品种：九价人乳头瘤病毒疫苗（大肠埃希菌）（以下简称"九价 HPV 疫苗"） 2025 年 6 月 4 日，福建省药品监督管理局网站公示，北京万泰生物药业股 份有限公司(以下简称"公司")全资子公司厦门万泰沧海生 ...

证券代码：603392 证券简称：万泰生物 公告编号：2025-031 北京万泰生物药业股份有限公司 关于公司九价 HPV 疫苗上市许可申请 获得批准的公告 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、准确性和完整性承担法律责任。 上市许可持有人：厦门万泰沧海生物技术有限公司 生产企业：厦门万泰沧海生物技术有限公司 近日，北京万泰生物药业股份有限公司(以下简称"公司")全资子公司厦门 万泰沧海生物技术有限公司申报的九价人乳头瘤病毒疫苗（大肠埃希菌）（商品 名称：馨可宁 9）获批上市。现将有关情况公告如下： 一、《药品注册证书》的主要信息 药品名称：九价人乳头瘤病毒疫苗（大肠埃希菌） 商品名称：馨可宁 9 剂型：注射剂 申请事项：药品注册（境内生产） 1、公司九价 HPV 疫苗取得药品注册证书后尚需取得产品批签发证明并完成 各地准入等程序，上市销售时间具有一定的不确定性。 2、公司九价 HPV 疫苗上市后的销售情况受到市场竞争环境及销售渠道等诸 多因素影响，后续市场销售情况存在不确定性。 敬请广大投资者谨慎决策，注意防范投资风险。 审批结论：根据《中华人 ...

Core Points - WanTai BioPharma's subsidiary, Xiamen WanTai Canghai Biotechnology Co., Ltd., passed the compliance inspection for Good Manufacturing Practice (GMP) [1] - The inspection covered the production workshop and production line for the nine-valent human papillomavirus (HPV) vaccine, conducted from November 5 to November 8, 2024, with a conclusion of compliance [1] - The nine-valent HPV vaccine is a self-developed biological product by the company, targeting seven high-risk types (HPV 16/18/31/33/45/52/58) and two low-risk types (HPV 6/11), aimed at preventing diseases related to HPV infections [1]

Group 1: Regulatory Oversight - The National Healthcare Security Administration (NHSA) is investigating potential violations related to pharmacists' credentials in retail pharmacies, with findings indicating that some pharmacists' names appear in multiple pharmacies, suggesting possible credential fraud or "hanging certificates" [1] - The investigation involves 24 provinces, 23,997 retail pharmacies, and 9,563 pharmacists, highlighting the widespread nature of the issue [1] - The NHSA has mandated self-inspections by pharmacists and comprehensive checks by pharmacies to ensure compliance and proper role fulfillment [1] Group 2: Drug Approvals - Heng Rui Medicine's new drug, injection of Rui Kang Qu Mo Zhu San, has received approval for treating adults with HER2-positive non-small cell lung cancer who have undergone at least one prior systemic therapy [3] - Te Bao Bio's long-acting growth hormone injection has been approved for treating growth hormone deficiency in children aged three and above [4] - Fosun Pharma's new small molecule cancer drug, Lu Wo Mei Ti Ni, has been approved for treating Langerhans cell histiocytosis and symptomatic neurofibromatosis type I in children and adolescents [11] Group 3: Financing Activities - Field Medical has completed a $40 million Series A financing round, aimed at advancing research and commercialization of its PFA system for treating ventricular tachycardia and atrial fibrillation [6] - Ausper Biopharma has announced a $50 million B+ financing round to support the clinical development of its innovative antisense oligonucleotide drug AHB-137 for chronic hepatitis B [7] - Ji Min Health's subsidiary has signed a strategic cooperation framework agreement with Da Bo Bio to accelerate new drug development and clinical transformation [8]

Core Viewpoint - Wantaibio is experiencing a significant decline in performance, attributed mainly to a sharp drop in its vaccine business, marking the most severe downturn in its history since going public [2][3][4]. Financial Performance - In 2024, Wantaibio's revenue was 2.245 billion yuan, a year-on-year decrease of 59.25%, following a revenue of 5.511 billion yuan in 2023, which was down 50.73% [3]. - The net profit attributable to shareholders in 2024 was 106 million yuan, down 91.49%, the lowest since the company was listed; the net profit after excluding non-recurring gains and losses was -186 million yuan, a decline of 117.29% [3]. - For Q1 2025, the company reported approximately 400 million yuan in revenue, a year-on-year decrease of 46.76%, with a net profit of -52.78 million yuan, a significant drop of 141.98% compared to a profit of 126 million yuan in the same period last year [4]. Vaccine Business Decline - The vaccine segment's revenue plummeted over 80%, with 2024 vaccine revenue at 606 million yuan, down 84.69% from 4.111 billion yuan the previous year [5]. - The production volume of vaccines in 2024 was 10.59 million doses, a decrease of 64.66%, while sales volume was 9.0492 million doses, down 42.4% [5]. - The market for HPV vaccines is facing intense competition, particularly from Watson Biotech and Merck's nine-valent HPV vaccine, which has further pressured Wantaibio's market share [6][9]. Future Prospects - Wantaibio is heavily investing in the development of its nine-valent HPV vaccine, with total R&D expenditures reaching 283 million yuan in 2024, accounting for 12.65% of its revenue [7]. - The company has committed 590 million yuan to the second-phase expansion of the nine-valent HPV vaccine project, which is 47% of the total project cost [7]. - Despite the challenges, Wantaibio aims to leverage the nine-valent HPV vaccine as a flagship product while expanding its portfolio of high-value vaccines to meet market demands [7][8].

证券代码：603392 证券简称：万泰生物 公告编号：2025-030 北京万泰生物药业股份有限公司 高级管理人员集中竞价减持股份结果公告 本公司董事会、全体董事及相关股东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、准确性和完整性承担法律责任。 重要内容提示： 高级管理人员持股的基本情况 截至减持计划披露日（2025 年 2 月 12 日），北京万泰生物药业股份有限公 司（以下简称"公司"）副总经理叶祥忠先生持有公司股份 462,079 股，占公司 总股本的 0.0365%，该部分股份为无限售流通股，来源为公司首次公开发行股票 并上市前取得的股份及上市后公司实施2020年度至2022年度股利分配方案后取 得的股份。 减持计划的实施结果情况 公司于 2025 年 5 月 28 日收到叶祥忠先生发来的《股份减持结果告知函》， 因本次减持股份计划实施完毕。截至本公告披露日，叶祥忠先生已通过集中竞价 交易方式累计减持公司股份 99,300 股，叶祥忠先生当前持股数量为 362，779 股， 占公司总股本的 0.0287%。 | 股东名称 | 叶祥忠 | | | | --- | -- ...

Group 1 - The National Vaccine and Biotechnology Index (980015) has seen a strong increase of 2.39% as of May 29, 2025, with notable gains in constituent stocks such as Zhaoyan New Drug (603127) up 9.99%, Yifan Pharmaceutical (002019) up 9.17%, and Dizhe Pharmaceutical (688192) up 8.73% [1] - The Biovaccine ETF (159657) rose by 2.28%, with the latest price reported at 0.63 yuan [2] - The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting will take place from May 30 to June 3, 2025, in Chicago, showcasing the development of oncology research in China, with over 70 studies from Chinese scholars selected for presentation [2] Group 2 - The top ten weighted stocks in the National Vaccine and Biotechnology Index (980015) as of April 30, 2025, include Fosun Pharma (600196), Changchun High-tech (000661), and others, collectively accounting for 63.18% of the index [3] - The Biovaccine ETF closely tracks the National Vaccine and Biotechnology Index, which consists of 50 companies involved in the biotechnology industry, reflecting the overall performance of quality listed companies in the sector [2]