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]

Core Viewpoint - The biopharmaceutical and vaccine sector is experiencing growth driven by new drug approvals and increasing demand for vaccines, particularly in the context of an aging population and rising health awareness in China [2][3]. Group 1: Market Performance - As of May 30, 2025, the National Vaccine and Biotechnology Index (980015) increased by 0.44%, with notable gains from companies such as Jinbo Biotechnology (5.61%), Fosun Pharma (5.23%), and Zhaoyan New Drug (5.12%) [1]. - The Biopharmaceutical ETF (159657) rose by 0.64%, with the latest price at 0.63 yuan [2]. Group 2: New Drug Approvals - On May 29, the National Medical Products Administration released approvals for 11 new drugs, covering areas such as oncology and metabolic diseases, involving several domestic pharmaceutical companies [2]. - The approval of new drugs is expected to contribute positively to the performance of related companies [3]. Group 3: Industry Growth Potential - The demand for shingles vaccines is projected to grow significantly, with the Chinese market expanding from 0 in 2015 to 600 million yuan in 2021, and expected to reach 10.8 billion yuan by 2025 [2]. - Globally, the market for shingles vaccines is also expanding, with low vaccination rates in many countries indicating substantial future growth potential [2]. - Domestic vaccines are emerging, with two out of four globally approved shingles vaccines already available in China, suggesting increased market options and further industry development [2]. Group 4: Index Composition - The National Vaccine and Biotechnology Index (980015) consists of 50 companies involved in the biotechnology sector, reflecting the overall performance of quality listed companies in the industry [3]. - As of April 30, 2025, the top ten weighted stocks in the index include Fosun Pharma, Changchun High-tech, and Wantai Biological Pharmacy, collectively accounting for 63.18% of the index [3].

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]

Group 1 - The liquidity of the biotechnology vaccine ETF showed a turnover of 1.21% with a transaction volume of 3.1203 million yuan, and the average daily transaction volume over the past week was 11.3875 million yuan as of May 28 [2] - The biotechnology vaccine ETF closely tracks the CSI Vaccine and Biotechnology Index, which selects no more than 50 companies involved in vaccine research, production, and related biotechnology sectors, reflecting the overall performance of listed companies in this theme [2] - As of April 30, 2025, the top ten weighted stocks in the CSI Vaccine and Biotechnology Index include Wantai Biological Pharmacy, Zhifei Biological Products, and others, accounting for a total of 48.51% of the index [2] Group 2 - The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting will take place from May 30 to June 3 in Chicago, showcasing cutting-edge clinical oncology research and treatment technologies [2] - Guotai Junan Securities recently indicated that the vaccine industry is expected to see a significant increase in inventory levels in both halves of 2024, continuing into the first quarter of 2025, influenced by demand fluctuations and channel inventory adjustments [2] - The overall sentiment in the vaccine sector is under pressure due to factors such as centralized procurement policies and regional political issues [2] Group 3 - Guoxin Securities reported that in April 2025, domestic innovative drug NDA/IND applications remained active, with progress in approvals for vaccine products like the Kangle Guardian trivalent HPV vaccine potentially supporting industry sentiment [3]

Group 1: HPV Infection and Public Awareness - HPV infection is a significant public health issue affecting both men and women, with a notable lack of awareness regarding male HPV infection risks [2][4] - In China, cervical cancer cases reached approximately 110,000 in 2020, with around 59,000 deaths, making it the second highest burden of cervical cancer globally [2] - Misconceptions persist about male HPV infection, leading to underestimation of risks and a lack of urgency in vaccination [4][5] Group 2: HPV Vaccination Developments - The nine-valent HPV vaccine has received approval for use in males aged 16-26 in China, marking a significant step towards gender-inclusive HPV prevention [3] - Currently, there are two HPV vaccines available for males: a four-valent vaccine for ages 9-26 and a nine-valent vaccine for ages 16-26, with the latter providing broader protection [6] Group 3: Market Demand and Future Projections - The HPV vaccine market in China is projected to grow from 13.5 billion yuan in 2020 to 69 billion yuan by 2030, with the nine-valent vaccine expected to capture the largest market share [8] - Despite the potential for growth, the current vaccination rate remains low, with only about 21% of women vaccinated since the introduction of the HPV vaccine in China [9][10] - There is a significant unmet demand for HPV prevention among men, which presents a substantial market opportunity as health awareness increases [10]

Group 1 - The Shanghai Composite Index turned positive on May 27, with the Biopharmaceutical ETF (159859) rising by 0.28% at the time of reporting [1] - Notable gainers within the Biopharmaceutical ETF included Dizhe Pharmaceutical-U, which increased by over 3%, along with Teva Biopharmaceuticals, Kailaiying, and Wantai Biological Pharmacy [1] - The Innovative Drug ETF Tianhong (517380) saw a decline of 0.33%, with Zhejiang Pharmaceutical rising by over 3%, while Ruizhi Pharmaceutical dropped by 3% [1] Group 2 - On May 26, the Biopharmaceutical ETF (159859) experienced a net inflow of 35.36 million yuan despite a drop of 0.57%, while the Innovative Drug ETF Tianhong (517380) had a net inflow of 3.6 million yuan despite a decline of 1.64% [1] - The Biopharmaceutical ETF closely tracks the National Biopharmaceutical Index (399441.SZ), which includes the top 30 securities in the biopharmaceutical sector based on market capitalization and liquidity [1] - The Innovative Drug ETF Tianhong, launched in 2021, has a scale of 389 million yuan as of May 26, and is the only product covering the entire market for the "Hengsheng Huasheng Hong Kong Innovative Drug Selected 50" index [2] Group 3 - Minsheng Securities remains optimistic about the pharmaceutical sector, particularly in the innovative drug and new consumption areas, highlighting ongoing catalysts in the innovative drug sector [2] - Key focus areas for the innovative drug sector include anti-tumor, autoimmune, GLP-1, stem cell, and gene therapy directions, along with an emphasis on domestic production and medical consumption, especially in the beauty sector [2]