WANTAI BIOLOGICAL(603392)

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HPV疫苗市场争夺战升级:二价失宠,国产九价获批,千亿蛋糕如何切割?
2 1 Shi Ji Jing Ji Bao Dao· 2025-06-04 08:18
21世纪经济报道记者季媛媛闫硕上海北京报道 HPV感染是全球重要的公共卫生问题之一,男性和女性都面临着感染风险。而接种疫苗是预防HPV感染 的最佳方法。 根据21世纪经济报道记者的梳理,目前我国市场上销售的HPV疫苗包括默沙东的四价HPV疫苗(佳达修 ®)和九价HPV疫苗(佳达修®9)、GSK的二价HPV疫苗(希瑞适®)、万泰生物的二价HPV疫苗(馨 可宁®),以及上海泽润的二价HPV疫苗(沃泽惠®)。但眼下,二价HPV疫苗的销售情况受到九价 HPV疫苗扩龄和市场竞争加剧的影响,导致销售量未达预期,进而影响了公司的营收。 财报数据显示,万泰生物2024年营业收入为22.45亿元,同比下降59.25%;归母净利润为1.06亿元,同 比下降91.49%。该数据低于大多数分析师的预期。 面对利润的急剧下滑,万泰生物此前直言:其疫苗业务因市场波动、政府集中采购政策以及九价HPV疫 苗适用年龄段的扩展等多重因素,导致销售未达预期,进而引发疫苗板块的收入与利润显著下降,最终 陷入了净亏损的境地。 2019年底,二价宫颈癌疫苗(馨可宁 Cecolin)获批并于2020年5月上市销售。此前,万泰生物借此在4 年内完成"三级跳 ...
万泰生物(603392) - 万泰生物关于全资子公司通过GMP符合性检查的公告
2025-06-04 08:15
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 ...
万泰生物(603392) - 万泰生物关于公司九价HPV疫苗上市许可申请获得批准的公告
2025-06-04 08:15
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 ...
万泰生物:子公司通过GMP符合性检查
news flash· 2025-06-04 07:35
万泰生物(603392)公告,全资子公司厦门万泰沧海生物技术有限公司通过《药品生产质量管理规范》 符合性检查。检查范围包括九价人乳头瘤病毒疫苗(大肠埃希菌)的生产车间和生产线,检查时间为2024 年11月5日至11月8日,结论为符合。九价HPV疫苗是公司自主研发的预防用生物制品,覆盖 HPV16/18/31/33/45/52/58七种高危型和HPV6/11两种低危型,可预防上述型别人乳头瘤病毒感染引起的 相关疾病。 ...
健讯Daily|对定点零售药店药师“挂证”等情况开展核查;恒瑞医药、复星医药、特宝生物新药上市
2 1 Shi Ji Jing Ji Bao Dao· 2025-05-29 23:53
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]
二价HPV受重创!万泰生物疫苗量价齐跌,押注九价或成最后底牌
Hua Xia Shi Bao· 2025-05-29 09:43
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].
万泰生物(603392) - 万泰生物高级管理人员集中竞价减持股份结果公告
2025-05-29 08:32
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 | | | | --- | -- ...
生物疫苗ETF(159657)涨超2%,ASCO大会召开在即
Xin Lang Cai Jing· 2025-05-29 06:51
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]
HPV疫苗企业一季度业绩集体失速
Zhong Guo Jing Ying Bao· 2025-05-18 23:22
Core Viewpoint - The performance of major Chinese vaccine companies, including Wantai Biological Pharmacy (万泰生物), Zhifei Biological Products (智飞生物), and Watson Bio (沃森生物), has significantly declined in Q1 2025, primarily due to a shrinking self-paid market for HPV vaccines amid economic pressures [1] Group 1: Company Performance - Wantai Biological reported a revenue of 401 million yuan in Q1 2025, a year-on-year decrease of 46.76%, with a net loss of 52.78 million yuan [1] - Zhifei Biological's revenue fell to 2.374 billion yuan, down 79.16% year-on-year, resulting in a net loss of 305 million yuan [1] - Watson Bio achieved a revenue of 462 million yuan, a decline of 22.93%, with a net profit of 2.65 million yuan, down 81.27% [1] Group 2: Market Dynamics - The HPV vaccine market is experiencing a significant contraction, with a 61.57% year-on-year drop in the total number of HPV vaccine batches approved for sale in 2024 [3] - The two-valent HPV vaccine's sales revenue for Wantai Biological plummeted by 84.69% to 606 million yuan in 2024, influenced by price reductions and increased competition from the nine-valent HPV vaccine [3][4] - The price of HPV vaccines has drastically decreased, with the two-valent vaccine's procurement price dropping from over 300 yuan to 27.5 yuan in Shandong province, reflecting a nearly 90% decline [7] Group 3: Competitive Landscape - The introduction of the nine-valent HPV vaccine has intensified competition, with consumers favoring higher-priced vaccines, leading to a sharp decline in demand for the two-valent vaccine [4] - Zhifei Biological, as the exclusive agent for Merck's HPV vaccines, faced a 95.49% drop in the issuance of four-valent HPV vaccines in 2024, exacerbated by Merck's suspension of supplies to China [4][5] - The price war in the HPV vaccine market has severely compressed profit margins, with Wantai Biological's vaccine segment gross margin falling from 91.6% in 2022 to 70.4% in 2024 [7] Group 4: Future Outlook - The development of domestic nine-valent HPV vaccines is accelerating, with several companies, including Wantai Biological, advancing their clinical trials [8] - The potential introduction of male-targeted HPV vaccines may open new growth avenues, as Merck's four-valent HPV vaccine has been approved for male use [9]
研判2025!中国疾病防控行业政策汇总、产业链、发展现状、竞争格局及发展趋势分析:政策赋能“体卫融合”,为疾病防控带来新的发展机遇[图]
Chan Ye Xin Xi Wang· 2025-05-17 02:17
Core Viewpoint - The disease prevention and control industry in China is experiencing growth due to increased public awareness, government funding, and advancements in biotechnology and data analysis, leading to improved efficiency in disease management [1][13]. Summary by Sections Industry Overview - Disease prevention and control is a crucial part of public health, focusing on reducing the occurrence and spread of diseases through scientific methods [3]. - Effective disease control can lower healthcare costs, enhance quality of life, and support economic stability [3]. Industry Development - The scale of China's disease prevention and control industry has been on the rise, with central government funding for disease control projects increasing from 17.526 billion to 20.38 billion from 2020 to 2022, followed by a projected recovery to 20.881 billion in 2024, marking an 18.06% year-on-year increase [1][13]. - The number of disease control centers in China has grown from 3,376 in 2021 to 3,429 in 2024, enhancing public health emergency management capabilities [11]. Policy Initiatives - Recent policies emphasize strengthening disease control institutions, enhancing core functions, and promoting scientific research and public health cooperation [5][7]. - The 2024-2025 National Disease Prevention and Control Action Plan encourages local institutions to engage in applied research and technology transfer [5][7]. Competitive Landscape - The disease prevention market in China is competitive, with key players including Fosun Pharma, Kangtai Biological, and Zhifei Biological, which are focusing on innovation and service quality to capture market share [15][19]. Industry Trends - The chronic disease management market is expected to grow significantly due to the aging population and increasing prevalence of chronic diseases, which currently account for 88% of total deaths in China [21]. - Technological innovations such as big data, AI, and IoT are set to transform disease prevention and control, enhancing monitoring and decision-making processes [22]. - The integration of sports and health ("body-health integration") is emerging as a new trend, promoting physical activity as a preventive measure against chronic diseases [23].