2025.10. 20 本文字数：1211，阅读时长大约2分钟 作者 | 第一财经 钱童心 近期，首款国产九价HPV（人乳头瘤病毒）疫苗开放预约渠道，在全国陆续开始接种，2针剂接种范 围扩大至9至17岁。此前，默沙东的九价HPV疫苗和GSK的二价HPV疫苗也都已经扩龄。 截至目前，国内共有6款HPV疫苗获批，进口和国产分别有三款。此前，我国HPV疫苗市场主要由进 口产品主导，默沙东的四价和九价"佳达修"系列以及GSK的二价"希瑞适"占据了90%以上的市场份 额。但近年来，随着万泰生物等公司的多款国产HPV疫苗陆续上市，也推动了价格的进一步下降， 提升了疫苗的可及性。 值得关注的是，上个月的国新办发布会上消息称，今年国家将推出面向适龄女生的HPV疫苗接种服 务，并将HPV疫苗纳入国家免疫规划，保护女性的健康。此举标志着HPV疫苗有望进入普惠时代， 有助于实现"消除宫颈癌"战略目标。 国际经验显示，国家免疫规划是提升疫苗接种率的关键。全球已有149个国家将HPV疫苗纳入规划， 平均接种率约60%：加拿大、澳大利亚、英国2023年接种率分别达86%、71%、68%。 以澳大利亚为例，该国作为全球首个将HPV疫苗纳入 ...

Core Insights - The first domestically produced nine-valent HPV vaccine has opened for appointments and is being administered nationwide, with the vaccination range expanded to ages 9 to 17 [1] - Currently, there are six approved HPV vaccines in China, with three being imported and three domestically produced, previously dominated by imported products [1] - The inclusion of HPV vaccines in the national immunization program is expected to enhance accessibility and contribute to the goal of "eliminating cervical cancer" [1][2] Group 1 - The domestic HPV vaccine market is seeing increased competition, leading to a decrease in prices and improved accessibility for the population [1] - As of now, 149 countries have included HPV vaccines in their national immunization programs, with an average vaccination rate of about 60% [1] - Countries like Canada, Australia, and the UK have achieved high vaccination rates of 86%, 71%, and 68% respectively in 2023 [1] Group 2 - Australia's multi-tiered service system for HPV vaccination includes school-based programs and community clinics, which could serve as a model for China's implementation [2] - Experts predict that the rollout of free HPV vaccines in China will be phased, initially targeting key populations before expanding to a broader audience [2] - The focus on university students as a key demographic for HPV prevention is based on public health strategies, emphasizing the high return on investment for health measures during this stage [2] Group 3 - The concept of "gender-neutral vaccination" is gaining traction, with studies indicating that widespread vaccination can significantly reduce cervical cancer cases by 90% [3] - Vaccination of both males and females can establish strong herd immunity, reducing the transmission of HPV and protecting the entire population [3] - The latest guidelines advocate for the importance of HPV vaccination for both genders, highlighting the broader health benefits of such an approach [3]

Group 1 - Wante Bio reported its first loss since going public, with a net loss of 144 million yuan in the first half of 2025, a year-on-year decline of 155.3% [1][2] - The company's revenue for the first half of 2025 was 844 million yuan, down 38.25% compared to the previous year [1][2] - The decline in performance is attributed to market adjustments in the vaccine sector and the expansion of the age range for the nine-valent HPV vaccine, leading to lower-than-expected sales [1][2] Group 2 - The vaccine segment, which previously contributed significantly to Wante Bio's revenue, has become a major factor in the company's losses [1][2] - In 2022, the approval of Watson Bio's two-valent vaccine "Wozhehui" further intensified market competition, impacting Wante Bio's market share [2][3] - Wante Bio's revenue fell by 59.25% to 2.245 billion yuan in 2024, only one-fifth of its peak revenue in 2022, with net profit declining by 91.49% to 106 million yuan [2][3] Group 3 - Wante Bio's nine-valent HPV vaccine "Xinkening 9" was approved in June 2025, becoming the first in China and the second globally, priced at 499 yuan per dose [3] - The competitive landscape is heating up, with Merck's nine-valent HPV vaccine launching promotional activities, and other domestic competitors also preparing to enter the market [3][4] - The overall HPV vaccine market is experiencing a cooling trend, with a significant drop in demand and prices, contrasting with previous high demand [3][4]

Core Viewpoint - The domestic HPV vaccine market is undergoing a brutal transformation from a blue ocean to a red ocean, as evidenced by the drastic price drop of a leading vaccine product from 329 yuan to 27.5 yuan within three years [1] Financial Performance - Wantai Bio (603392.SH) expects a net profit loss of 130 million to 160 million yuan for the first half of 2025, with a significant decline compared to a net profit of 260 million yuan in the same period last year [1][3] - The company's revenue for 2024 was 2.245 billion yuan, a year-on-year decrease of 59.25%, marking the lowest revenue since 2020 [3] - The net profit attributable to the parent company for 2024 was 106 million yuan, down 91.49% year-on-year, with a non-recurring net profit of -186 million yuan, a decline of 117.29% [3] Market Dynamics - The HPV vaccine market is becoming increasingly competitive, with Wantai Bio's two-valent HPV vaccine facing pressure from imported nine-valent vaccines and other domestic competitors [2][4] - The price of Wantai Bio's two-valent HPV vaccine has dropped significantly due to government procurement policies, with the lowest bid price falling to 63 yuan per dose [5][7] - The introduction of Wantai Bio's nine-valent HPV vaccine, priced at 499 yuan, aims to capture market share but faces strong competition from Merck's Gardasil 9 [8][13] Strategic Response - Wantai Bio is betting on the success of its nine-valent HPV vaccine to offset losses from its two-valent vaccine, which has seen a significant decline in sales [1][2] - The company has invested approximately 1 billion yuan in research and development for the nine-valent vaccine, alongside 590 million yuan for expansion projects [8][15] - The company is also pursuing WHO PQ certification for its nine-valent vaccine to facilitate international market entry [15] Industry Trends - The global HPV vaccine market has seen a compound annual growth rate (CAGR) of 19% since 2019, highlighting the increasing demand for HPV vaccination [4] - The World Health Organization has emphasized the importance of HPV vaccination in its strategy to eliminate cervical cancer globally, which aligns with China's action plan to promote HPV vaccination [9]

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 - 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].

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]

Core Viewpoint - The article discusses the evolution of the HPV vaccine market in China, highlighting the challenges and changes in demand, pricing, and competition among vaccine manufacturers, particularly focusing on Merck's HPV vaccines and the emergence of domestic competitors [1][2][3]. Group 1: HPV Vaccine Market Dynamics - The HPV vaccine market in China has seen significant fluctuations, with Merck's four-valent and nine-valent vaccines initially experiencing high demand but later facing a decline in sales due to market saturation and competition from domestic vaccines [7][8][30]. - The introduction of domestic two-valent HPV vaccines at lower prices has intensified competition, leading to a price war that has drastically reduced the cost of HPV vaccines in China, with prices dropping below 200 yuan per dose [26][29]. - By August 2024, the price of the two-valent HPV vaccine had plummeted to 27.5 yuan per dose, reflecting the aggressive pricing strategies adopted by domestic manufacturers [29]. Group 2: Impact on Merck and Domestic Competitors - Merck's nine-valent HPV vaccine maintained a stable price due to its unique market position, but the increasing affordability of domestic vaccines has eroded its market share, particularly among cost-sensitive consumers [16][30]. - Despite Merck's strong sales growth in the past, with a 136.16% year-on-year increase in the number of nine-valent vaccines sold in 2023, the company faces challenges as the overall market for HPV vaccines in China is experiencing a decline in total issuance [30][33]. - Domestic manufacturers like Wantai and Watson have entered the market, leading to a significant shift in the competitive landscape, with both companies struggling to maintain profitability amid falling prices [29][36]. Group 3: Public Health Implications - The article emphasizes the public health significance of HPV vaccination, noting that cervical cancer remains a leading cause of cancer death among women globally, particularly in developing countries [42][44]. - The disparity in vaccine access and affordability highlights a broader issue of health equity, as lower-income populations are often unable to afford vaccines despite their necessity for cancer prevention [43][49]. - Initiatives for free or subsidized HPV vaccinations in certain regions, such as Inner Mongolia, demonstrate efforts to improve access and reduce the burden of cervical cancer, potentially setting a precedent for broader public health strategies [45][48].