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重磅消息!中国生物四价HPV疫苗获批上市,终结国产二价低危HPV防护空白【附HPV疫苗行业市场现状分析】
Qian Zhan Wang· 2025-09-29 08:40
Core Insights - China National Pharmaceutical Group's subsidiary, China Biological Products, has received approval for its quadrivalent HPV vaccine "Aiweijia," marking a significant milestone as China becomes one of the few countries capable of independently developing such vaccines [2] - The vaccine offers protection against low-risk HPV types 6 and 11, addressing the limitations of existing domestic bivalent vaccines that only cover high-risk types 16 and 18 [2] - Phase III clinical trials show that "Aiweijia" has a 100% efficacy rate in preventing cervical CIN2 and above lesions, with safety and effectiveness validated [2] Industry Overview - Cervical cancer is the second deadliest female reproductive cancer, with nearly 600,000 new cases and approximately 300,000 deaths globally each year, primarily linked to HPV infections [3] - The global HPV vaccine market was valued at $6 billion in 2021, with Merck leading the market with $5.673 billion in revenue [7] - The HPV vaccine market is projected to grow at an annual rate of 8%, potentially reaching nearly $10 billion by 2027 [8] Competitive Landscape - Domestic HPV vaccines from companies like Wantai Biological Pharmacy and Watson Biotech have broken the import monopoly, offering lower prices and sufficient supply [9] - The first domestic nine-valent HPV vaccine is expected to be approved by 2025, positioning China as the second country to supply this vaccine independently [9] - The National Health Commission's inclusion of HPV vaccines in the national immunization program is anticipated to increase vaccination rates significantly [11]
9至17岁女性只需接种两针! 首款国产九价HPV疫苗正式落地浙江
Mei Ri Shang Bao· 2025-09-26 22:19
Core Viewpoint - The launch of China's first domestically developed nine-valent HPV vaccine in Zhejiang marks a significant advancement in cervical cancer prevention, providing a more affordable option for women aged 9 to 45 [2][4]. Group 1: Vaccine Details - The vaccine is priced at 499 yuan per dose, which is only 40% of the cost of imported counterparts, significantly lowering the barrier for vaccination [2]. - The vaccine utilizes an advanced E. coli expression system, breaking international monopolies and making China the second country capable of independently supplying high-priced HPV vaccines [2]. - Clinical studies published in The Lancet Infectious Diseases confirm that the vaccine's immune response and safety are comparable to imported vaccines, with a 100% protection rate against persistent infections caused by HPV types 52 and 58, which are prevalent among Asian women [2]. Group 2: Vaccination Program - The vaccination schedule has been optimized: a two-dose regimen for females aged 9-17 and a three-dose regimen for those aged 18-45 [3]. - Experts emphasize that while vaccination is crucial, regular HPV testing and TCT screenings are necessary for comprehensive prevention, highlighting the importance of a "vaccine + screening" approach [3]. Group 3: Community Support and Initiatives - Wantai Biological Pharmacy announced a donation of 6,000 doses of bivalent HPV vaccines to the Zhejiang Cancer Foundation to support public welfare activities, particularly for sanitation workers and migrant workers [3]. - The Zhejiang Cancer Foundation has been active for ten years in providing medical assistance and promoting early detection and treatment of cancer, aiming to spread cancer prevention knowledge throughout the province [3]. Group 4: Future Plans - Starting in October, Zhejiang Province will fully implement the vaccination program for the nine-valent HPV vaccine, aiming to increase vaccination coverage and contribute to the World Health Organization's goal of cervical cancer elimination [4].
首款国产九价HPV疫苗河南开打
He Nan Ri Bao· 2025-09-16 10:00
Core Viewpoint - The launch of the first domestically produced nine-valent HPV vaccine "Xinkening 9" in Zhengzhou marks a significant step in increasing HPV vaccination rates in China, particularly among women aged 9 to 45 [2][3]. Group 1: Vaccine Launch and Reception - The first day of vaccination saw nearly 200 appointments, primarily from women in their twenties and thirties, indicating strong demand for the domestic HPV vaccine [3]. - The introduction of the domestic nine-valent HPV vaccine is expected to address the low vaccination coverage in China, which was only 10.15% for the first dose in 2022 [3]. Group 2: Comparison of Domestic and Imported Vaccines - The main differences between domestic and imported nine-valent HPV vaccines lie in the manufacturers, pricing, target populations, and some production details, but both have been validated for safety and efficacy [4]. - The domestic vaccine utilizes a novel E. coli virus-like particle expression technology, which is designed to induce a high immune response [4]. Group 3: Pricing and Accessibility - The price of the domestic nine-valent HPV vaccine is set at 499 yuan per dose, which is less than half the price of imported alternatives, making it more accessible [5]. - The vaccination schedule for women aged 9 to 17 requires two doses at a total cost of approximately 1000 yuan, while women aged 18 to 45 need three doses at around 1500 yuan [5]. Group 4: Future Developments - The first batch of the vaccine is expected to be distributed to community health service centers across Henan province by mid to late September [6]. - There are discussions about including the HPV vaccine in the national immunization program, which could potentially make it available for free in the future, although it currently remains a self-paid option [7].
北京:初一女生开学免费接种HPV疫苗
Bei Jing Wan Bao· 2025-08-29 12:24
Group 1 - Beijing will launch free HPV vaccination for first-year female students starting in September to enhance health protection for young women [1] - The HPV vaccine is currently the most economical and effective method for preventing cervical cancer, with high protective efficacy against pre-cancerous lesions and cancers caused by HPV types 16 and 18 [1] - Eligible first-year female students, aged 9 and above, can receive the domestically procured bivalent HPV vaccine for free, following a two-dose immunization schedule [1] Group 2 - District CDCs will coordinate with local education departments to designate vaccination clinics for each school, with vaccinations primarily conducted at the school’s designated clinic [2] - Parents or guardians must accompany students to the vaccination site, and a 30-minute observation period is required post-vaccination [2] - Students wishing to self-pay for the quadrivalent or nonavalent HPV vaccines can make appointments through various platforms, provided they meet the vaccination criteria [2]
这种威胁女性健康的癌症,真的可以预防!
Ren Min Wang· 2025-06-30 08:21
Core Viewpoint - Cervical cancer is a common malignant tumor among women, with significant global and national incidence and mortality rates in 2022 [1] Group 1: Incidence and Mortality - In 2022, there were 661,000 new cases of cervical cancer globally, with 348,000 deaths [1] - In China, the new cases and deaths were 151,000 and 56,000 respectively [1] Group 2: Causes of Cervical Cancer - Human Papillomavirus (HPV) infection is the primary cause of cervical cancer, with over 200 types identified, categorized into high-risk and low-risk types [2] - High-risk HPV types, particularly HPV16 and HPV18, are the most carcinogenic [2] - Risk factors include early sexual activity, multiple sexual partners, multiple pregnancies, smoking, and long-term use of oral contraceptives [2] Group 3: Prevention Measures - Health education is crucial for cervical cancer prevention, promoting awareness and healthy lifestyle choices [3] - There is a rising trend of early sexual behavior and high-risk sexual activities among young women in China [3] Group 4: HPV Vaccination - HPV vaccination is an effective preventive measure against cervical cancer, with five types of vaccines available in China [4] - It is recommended for high-risk women to receive the vaccine early [5] - Women with a history of HPV infection or cervical abnormalities can still receive the vaccine [6] - Pregnant or breastfeeding women should avoid vaccination [7] - The optimal age for vaccination is 9-26 years, especially for girls aged 9-14 [8] Group 5: Screening and Early Detection - Regular cervical cancer screening is essential for early detection and intervention [12] - The main screening methods are Liquid-based Cytology (TCT) and HPV DNA testing [12] - Women aged 21-65 should undergo regular screenings, with specific recommendations based on age [13] Group 6: Treatment Protocols - Standardized treatment is key for improving cure rates and survival for diagnosed precancerous lesions and cervical cancer [14] - Treatment options vary based on the severity of the condition, with a focus on surgical and chemoradiation therapies for advanced cases [14] - Regular follow-ups are necessary post-treatment to monitor health [14]
国产九价HPV疫苗,重大突破!钟睒睒或成最大赢家
21世纪经济报道· 2025-06-04 09:59
Core Viewpoint - The first domestically produced nine-valent HPV vaccine in China has been approved for market release, which is expected to enhance the company's product line and core competitiveness, providing a solid foundation for sustainable development [2][8]. Group 1: Product Approval and Market Position - Wantai Biological's nine-valent HPV vaccine, named "Xinkening 9," has received approval for market release after approximately 10 years of development, including clinical trials [4][5]. - The vaccine is designed to prevent cervical cancer, which is the most common malignant tumor among women, and is the only cancer that can be effectively prevented through vaccination [2][4]. - Wantai is the second company globally and the first in China to apply for clinical trials of a nine-valent cervical cancer vaccine, with the only other competitor being Merck's Gardasil 9 [5][15]. Group 2: Pricing and Market Potential - The expected peak sales for Wantai's nine-valent HPV vaccine could reach 22.8 billion yuan, with projections for revenue growth from 3.5 billion yuan in 2025 to 60.1 billion yuan by 2027 [7][10]. - The pricing for the imported nine-valent HPV vaccine is approximately 4,380 yuan for three doses, with a single dose costing around 1,331 yuan [6]. Group 3: Competitive Landscape - Currently, Merck holds over 80% market share in the HPV vaccine sector in China, dominating both the four-valent and nine-valent vaccine markets [15]. - The nine-valent vaccine is expected to capture a larger market share due to its ability to prevent approximately 90% of cervical cancer cases, compared to the 70% prevention rate of two-valent and four-valent vaccines [16]. Group 4: Financial Impact and Future Outlook - Wantai Biological's net profit has significantly declined from 47.36 billion yuan in 2022 to an estimated 1.06 billion yuan in 2024, indicating financial pressure prior to the vaccine's approval [9]. - Analysts predict that the nine-valent HPV vaccine will become a core driver of the company's performance, potentially leading to a market valuation of 865 billion yuan based on projected sales [10][11].