Core Viewpoint - The approval and launch of the domestic nine-valent HPV vaccine "Xinkening®9" marks a significant milestone for China's biopharmaceutical industry, breaking the global monopoly of high-priced imported HPV vaccines and establishing China as the second country after the United States capable of independently supplying such vaccines [2][9]. Group 1: Vaccine Development and Approval - The nine-valent HPV vaccine was developed through a collaboration between Xiamen University, Xiang'an Innovation Laboratory, and Wantai Biological Pharmacy, taking 18 years from inception to approval [2]. - The vaccine covers nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, 58) and utilizes an innovative E. coli expression platform, which has reduced production costs and validated safety and efficacy through key clinical trials [2][3]. Group 2: Clinical Trials and Efficacy - Since 2019, five clinical trials have been conducted across China, enrolling over 11,000 healthy volunteers aged 9 to 45, providing robust research data [2]. - The vaccine shows comparable protection rates against HPV16/18-related lesions to imported vaccines and over 98% protection against persistent infections from other high-risk types [3]. Group 3: Market Position and Pricing - The pricing of "Xinkening®9" is set at 499 yuan per dose, approximately 40% of the price of imported vaccines, which were previously monopolized by Merck & Co. at around 1300 yuan per dose [3][9]. - The vaccine has received WHO PQ certification and has gained market access in over 20 countries, being included in immunization programs in four countries, thus positioning it as a "Chinese solution" in global public health [3][9]. Group 4: Industry Context and Future Outlook - The global market for HPV vaccines is projected to grow at an annual rate of 8%, potentially reaching nearly $10 billion by 2027, driven by the increasing inclusion of vaccines in national immunization programs [8]. - The successful launch of "Xinkening®9" exemplifies China's capability in biopharmaceutical innovation and is expected to enhance the competitiveness of Chinese companies in the international market while contributing to global cervical cancer prevention efforts [9].

Core Viewpoint - The introduction of the domestic nine-valent HPV vaccine "Xinkening®9" at a price of 499 yuan per dose intensifies competition in the HPV vaccine market, prompting a potential price war among manufacturers [1][8]. Market Expansion - The global coverage rate for the first dose of the HPV vaccine among girls is projected to reach 27% by 2024, while the coverage rate for women aged 9 to 45 in China is only 10.15%, showing significant room for growth compared to the global average and the 67% coverage in Western countries [5][6]. Market Challenges - Expanding market space is a major challenge for all companies involved in HPV vaccine development. Companies are actively seeking to open up the market, with the approval of new indications for the "Jiadaxiu9" vaccine, which is now the first and only nine-valent HPV vaccine approved for both males and females in China [7][8]. Competitive Landscape - Domestic HPV vaccine manufacturers are shifting focus to price competition after missing the first-mover advantage. However, raising public awareness and vaccination rates is seen as a more effective strategy than price cuts [9][10]. Vaccine Efficacy Evidence - Real-world studies have shown significant reductions in HPV infection rates and cervical cancer cases due to vaccination, with a Scottish study indicating a 90% decrease in HPV infections since the vaccine's introduction in 2008 [11][12]. Conclusion - The competition in the HPV vaccine market is expected to evolve, with data on vaccine efficacy becoming a crucial factor in establishing trust and market presence for new entrants [12].

Core Insights - The first domestically produced nine-valent HPV vaccine "Xinkening 9" by Wantai Biological has been priced at 499 yuan per dose, approximately 40% of the price of imported counterparts [1] - The vaccine was developed in collaboration with Xiamen University and has undergone 18 years of research, with an investment of around 1 billion yuan by 2025 [1] - The approval of "Xinkening 9" marks a significant milestone in the domestic HPV vaccine market, previously dominated by Merck's "Gardasil 9" [1][2] Pricing and Market Impact - The full vaccination cost for the imported vaccine is nearly 4000 yuan, while the domestic vaccine reduces this to about 1500 yuan, and for ages 9-17, the cost is only 998 yuan for two doses [1] - The approval of "Xinkening 9" is expected to enhance HPV vaccination rates in China, which currently stands at 27.43% for the first dose among women aged 9-45, compared to 67% in Western countries [3] Marketing and Distribution Strategy - The company plans to implement a new marketing strategy that combines regional grid management, digital management, and personalized services to cater to different demographics and healthcare resources [3] - Wantai Biological is actively pursuing WHO PQ certification for the nine-valent HPV vaccine and aims to expedite its international market entry based on its previous successes with its bivalent HPV vaccine [3] Financial Performance - Wantai Biological reported a revenue of 2.245 billion yuan for 2024, a decline of 59.25% year-on-year, with a net profit of 106 million yuan, down 91.49%, marking a five-year low [5] - In the first quarter of 2025, the company reported a net loss of 52.78 million yuan, a significant drop from a profit of 126 million yuan in the same period the previous year [5] Competitive Landscape - The nine-valent HPV vaccine market is becoming increasingly competitive, with several domestic companies like Watson Bio, Kangla Weishi, and Ruike Bio also preparing to launch their products [4]

Core Viewpoint - The launch of the domestic nine-valent HPV vaccine "Xinkening 9" by Wantai Biological Pharmacy at a price of 499 yuan per dose, significantly lower than the imported vaccine priced at approximately 1318 yuan, ignites a price war in the HPV vaccine market [1][3][5] Pricing Strategy - Wantai's pricing strategy directly addresses market pain points, offering a two-dose regimen for females aged 9-17 at a total cost of 998 yuan and a three-dose regimen for those aged 18-45 at 1497 yuan, representing a price reduction of about 60% compared to imported options [3][4] - The imported nine-valent HPV vaccine from Merck costs around 1318 yuan per dose, with total costs for two doses for ages 9-14 reaching approximately 2636 yuan and three doses for ages 15-45 amounting to 3954 yuan [3][5] Market Potential - A study from the Chinese Center for Disease Control and Prevention indicates that the HPV vaccine first-dose coverage rate among women aged 9-45 in China is only 27.43%, compared to about 67% in Western countries, suggesting significant room for growth in vaccine penetration [3][4] - Wantai emphasizes that its vaccine is the only one approved for a "two-dose regimen" for ages 9-17, which could enhance vaccination compliance among younger populations [3][4] Competitive Landscape - The HPV vaccine market has shifted from scarcity and high prices to increased supply and competitive pricing, with Wantai's low-cost strategy posing a challenge to both imported products and other domestic competitors like Kanglaisheng, Ruike Biological, and Shanghai Bowei, which are also in the process of launching their nine-valent vaccines [5][6] - Merck's HPV vaccine sales have also seen a decline, with the company announcing a suspension of supply to China starting February 2025 [5][6] Future Growth Opportunities - Domestic vaccine companies, including Wantai, are exploring international markets, particularly in countries with lower HPV vaccination rates, to leverage their cost advantages [6] - The ongoing research into male-targeted HPV vaccines presents another potential growth avenue for the industry [6] - The price competition in the HPV vaccine market is expected to advance cervical cancer prevention efforts, making vaccines more accessible as multiple products enter the market [6]

HPV感染是全球重要的公共卫生问题之一，在"加速消除宫颈癌全球战略"及"健康中国战略"全面推进的 时代背景下，HPV疫苗成为公共健康体系的重要支柱和重要防线。而高价次HPV疫苗可预防更多病毒亚 型，防护更全面，因而备受消费者追捧。 现如今，随着国产九价HPV疫苗进入公众视野，"HPV疫苗怎么选"再次成为热议焦点。相同价次下，如 何选择最优HPV疫苗考验着消费者的决策能力。 在HPV疫苗这个充满期待的领域里，默沙东凭借超高市场占有率，一直稳居HPV疫苗的领导地位。而在 目前上市的九价HPV疫苗中，默沙东的佳达修®9是唯一获批用于预防由7种高危型HPV(16、18、31、 33、45、52、58型)引起的宫颈癌的九价疫苗，且凭借男性适应证在中国的获批成为首个且目前唯一获 批、可适用于男性及女性接种的九价HPV疫苗。这也标志着中国正式进入了"男女共防HPV共创免疫预 防新时代"。 作为全球首个九价HPV疫苗的研发者，默沙东的故事或许能为我们提供另一种视角——一款疫苗的价 值，不仅在于价格标签，更在于其历经时间检验的守护能力。 百年积淀：从实验室到全球的"疫苗基因" 1891年，默沙东的前身在新泽西州成立时，或许未曾 ...

Core Viewpoint - WanTai Biologics has officially launched its nine-valent HPV vaccine "Xinkening®9" at a price of 499 yuan per dose, significantly undercutting the imported vaccine price and marking the end of the "high-price era" for HPV vaccines in China [1][6]. Pricing and Market Impact - The imported nine-valent HPV vaccine "Gardasil 9" is priced at approximately 1318 yuan per dose, with a total cost of nearly 4000 yuan for three doses, while "Xinkening®9" costs about 1497 yuan for three doses [1]. - "Xinkening®9" is the only HPV vaccine approved for a two-dose regimen for ages 9-17, reducing the cost for this age group to 998 yuan, thereby enhancing accessibility and compliance [1]. Historical Context and Market Dynamics - Prior to the launch of "Xinkening®9", the nine-valent HPV vaccine market in China was monopolized by Merck's "Gardasil 9," which faced a dramatic shift from high demand and scarcity to excess inventory [2]. - In 2023, the batch issuance of "Gardasil 9" reached 36.55 million doses, a year-on-year increase of 136.16%, making Merck the highest-grossing multinational pharmaceutical company in China that year [2]. Sales Performance and Challenges - Merck's global sales of the HPV vaccine in 2024 were $8.583 billion, a 3% decline year-on-year, primarily due to weak performance in the Chinese market [3]. - To address high inventory levels, Merck announced a suspension of supply to China starting in early 2025, expected to last until at least mid-2025 [3]. Financial Performance of WanTai Biologics - WanTai Biologics reported a 59.25% year-on-year decline in revenue for 2024, totaling 2.245 billion yuan, with a net profit drop of 91.49% to 106 million yuan [3]. - The company faced significant challenges due to a price collapse in its two-valent vaccine, leading to a drastic reduction in government procurement prices [3]. Market Potential and Future Outlook - The potential market for HPV vaccines in China is substantial, with 70%-80% of the 300 million women aged 9-45 yet to be vaccinated [4]. - National Investment Securities predicts that WanTai's nine-valent HPV vaccine could reach a sales peak of 22.8 billion yuan, with projected revenues of 3.17 billion yuan, 11.4 billion yuan, and 28.63 billion yuan for 2025-2027 [4]. Competitive Landscape - Several domestic pharmaceutical companies are in the late clinical stages of developing their own nine-valent HPV vaccines, creating a competitive environment for WanTai [5]. - WanTai has initiated a Phase III clinical trial for a male indication, but competitors like Kanglaite have already started their trials earlier [5]. International Expansion - WanTai aims to become a leading global vaccine supplier by 2030, with plans to have 3 to 5 WHO pre-qualified products [5]. - Competitors are also pursuing international markets, with Kanglaite planning to submit for approval in Indonesia and Ruike Biologics exploring the Middle East [5]. Industry Trends - The World Health Organization has warned that global HPV vaccine supply may exceed demand from 2025 to 2030, potentially leading to a price war and industry reshuffling [5]. - The WHO's recommendation for a single-dose HPV vaccination regimen could further intensify market competition [5].

曾经需要抢号、黄牛加价才能接种的进口九价HPV疫苗，如今在重庆、西安、广州等多个城市上演价 格"跳水"。原价1320元一针的进口默沙东九价疫苗，正通过"打一针送一针"、"打两针送一针"的优惠活 动变相降价——9-14岁或35-45岁的女性接种者，三针总花费可立省1300多元，实际单针价格被拉低至 700元区间。 "奢侈疫苗"跌落神坛 默沙东的"佳达修"作为国内长期唯一的九价HPV疫苗，自2018年上市以来价格坚挺，三针近4000元的费 用曾让不少女性望而却步。然而市场风向今年急转直下，多个城市接种点纷纷推出大力度的"买赠"活 动。曾经稀缺的疫苗如今变得"随到随打"，市场供应格局已然颠覆。 智飞生物库存承压 进口疫苗光环褪色 市场变化的信号早已在代理商智飞生物的财报中显露端倪。2024年，智飞代理的默沙东九价疫苗批签发 量同比下降14.8%，四价HPV疫苗批签发量更是暴跌95.49%。截至2024年三季度，智飞生物代理产品库 存攀升至惊人的206.93亿元。巨大的库存压力下，默沙东今年2月宣布暂停向中国市场供应HPV疫苗， 至少持续至2025年中。 进口疫苗的撤退与国产力量的崛起紧密交织。6月4日，万泰生物宣布 ...

稍早之前，另一家跨国医药企业默沙东的中国总裁也有变动。5月底，默沙东宣布其全球高级副总裁、 默沙东中国总裁田安娜(Anna Van Acker)将卸任中国总裁一职，后续将出任公司人类健康事业部全球战 略项目的重要管理职位。现任默沙东日本总裁和代表董事Kyle Tattle将担任默沙东中国总裁。 从1994年天津武田药品有限公司成立至今，武田进入中国市场已经超过30年，目前在中国已经建立了覆 盖新药开发、生产、供应保障以及商业化的医药价值链，2024年进博会期间，武田中国宣布将"武田亚 太研发中心"更名为"武田研发中国及亚太中心"，以加强开拓其在中国及亚太区域内的外部创新，发展 区域医药创新能力，助推中国成为推动武田研发创新的重要引擎。 关于单国洪离职之后的去向，有媒体报道称，其将加入另一家生物医药企业百济神州。6月17日，记者 向百济神州求证，截至发稿时，尚未获得回应。 多家外企在华高管有调整 作为全球第二大医药市场，中国市场对跨国医药企业的重要性不言而喻。近年来，随着药品集中带量采 购、医保药品目录谈判等政策的落地，国内医药市场也正经历变革。为应对中国市场的变化，多家外企 也在频繁调整。 6月17日，记者从 ...

6月5日上午，一位上海万泰九价HPV疫苗代理商在见过厂商后，告诉长江商报记者："现在价格还没公 布，他们也没拿到产品说明书。" 此前，万泰生物的王牌产品是二价HPV疫苗，依靠二价HPV疫苗，万泰生物曾实现年度百亿元营收、47 亿元净利。不过，随着竞品相继出现，万泰生物疫苗销量及收入出现滑坡，业绩也断崖式下滑。 随着首个国产九价HPV疫苗获批上市，万泰生物的经营业绩有望修复。目前，其九价HPV疫苗累计已完 成研发投入约10亿元。 首个国产九价HPV疫苗获批上市 6月4日盘后，万泰生物发布公告，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）近日获批上市。同时该子公司通过九价HPV疫苗上市 前的首次药品GMP符合性检查。 万泰生物表示，公司本次获批上市的九价HPV疫苗适用于9—45岁女性，其中9—17岁可采用二剂次接种 程序（0、6月），18—45岁采用三剂次接种程序（0、1和6月）。该疫苗覆盖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。 长江商报消息 全国首个！全球第 ...

九价HPV疫苗已经"飞入寻常百姓家"，默沙东与其国内代理商 智飞生物都在承受销售压力。不再稀缺的九价苗，万泰生物能 卖动吗？ 作者：张英 刘晓诺 封图：图虫创意 6月5日，万泰生物（603392.SH）的股价一字涨停，截至当日收盘，总市值为991亿元，距离千亿 市值仅一步之遥。 6月4日，万泰生物公告其申报的九价人乳头瘤病毒（HPV）疫苗（商品名称：馨可宁9）获批上 市，适用于9—45岁女性。 这是获批上市的首款国产九价HPV疫苗，也是全球第二款九价HPV疫苗。此前，在全球范围内， 九价HPV疫苗仅有默沙东（NYSE:MRK）的佳达修9。 万泰生物是国产HPV疫苗龙头，曾靠其研发的首支国产二价HPV疫苗馨可宁获得超百亿元收入。 如今二价苗营收不佳，业绩已连续下滑两年。有分析师认为，九价疫苗或可成为万泰生物业绩核心 驱动力。 万泰生物尚未公布九价HPV疫苗的价格，不过曾称该疫苗具有生产成本低、价格实惠等优势。默 沙东的佳达修9在中国的定价是每针1300元左右。 不过，九价HPV疫苗已经"飞入寻常百姓家"，默沙东与其国内代理商智飞生物（300122.SZ）都在 承受销售压力。不再稀缺的九价苗，万泰生物还能卖动吗？ ...