日前，《细胞》旗下临床医学期刊《Med》发表我国学者中国工程院院士、北京协和医院妇产科名誉主 任郎景和、北京协和医院妇产科学系主任朱兰教授团队开展的光动力疗法用于宫颈高级别鳞状上皮内病 变的临床研究结果。该研究首次在全球范围内，通过严谨的多中心、随机、双盲对照设计，证实了新型 光动力疗法APL-1702的有效性和安全性。 论文作者之一、中国医学科学院北京协和医学院群医学及公共卫生学院教授乔友林介绍，光动力疗法通 过让感染HPV的细胞吸收光敏剂，然后进行LED光照杀灭。以前的光敏剂是静脉注射，导致患者在治疗 时全身无法见光，限制了光动力疗法的应用。此次进行临床试验的APL-1702创新了诊疗方式，通过装 置的设置，使得光敏剂可以被患病部位吸收，且内设冷光源，大大提升了使用的便利性。 据介绍，该项临床试验研究是一项在国际61家中心开展的高质量临床试验，共纳入402例经中心病理专 家组确认的高级别鳞状上皮内病变患者（含CIN2、CIN3），以2∶1的比例随机分配至APL-1702治疗组或 安慰剂对照组，以5%氨酮戊酸己酯局部用药，结合特定波长光源进行照射，随着病变细胞选择性摄取 并转化光敏剂后，在内置的冷光源照射下 ...

Group 1 - The core message is the inclusion of the HPV vaccine in China's national immunization program, which is expected to significantly reduce cervical cancer cases among young women in the country [1][2][5] - The announcement was made unexpectedly during a press conference on September 11, 2023, catching many stakeholders by surprise despite prior rumors [2][3] - The decision is seen as a culmination of nearly two decades of advocacy and research efforts by experts in the field, particularly highlighting the contributions of key figures like Qiao Youlin [3][4][5] Group 2 - The HPV vaccine's journey to approval in China has been lengthy, with the first vaccine being approved globally in 2006 and entering China in 2014, leading to a nearly 20-year wait for its inclusion in the national program [5][6][12] - The initial high cost of the vaccine, approximately $360 (around 4300 RMB today), posed significant barriers to access, particularly for lower-income populations [6][12] - The vaccine distribution faced bureaucratic hurdles, with a significant delay caused by regulatory approvals, which resulted in donated vaccines being redirected to other countries [6][8][9] Group 3 - Clinical trials for the HPV vaccine in China faced challenges, requiring extensive local data to satisfy regulatory requirements, which prolonged the approval process [10][11][12] - The approval of the 9-valent HPV vaccine in 2018 marked a significant milestone, with the process taking only eight days compared to previous lengthy approvals, indicating a shift in regulatory efficiency [13][15] - The global health community, including the WHO, emphasizes the importance of equitable access to the HPV vaccine, particularly for vulnerable populations, to effectively combat cervical cancer [16][17]

Core Points - China will provide free HPV vaccinations to girls born on or after November 10, 2011, starting from November 10, 2025, marking a significant step in cervical cancer prevention and women's health promotion [1] - The World Health Organization (WHO) has praised this decision as a milestone that will protect millions of women and girls from cervical cancer [1] - The HPV vaccine will be included in the national immunization program, with a focus on girls aged 13, as this age offers optimal protection and cost-effectiveness [2] Group 1 - The HPV vaccination program aims to prevent high-risk HPV infections, significantly reducing cervical cancer incidence, with existing vaccines shown to prevent over 70% of cervical cancer cases [1][2] - The decision to target 13-year-old girls is based on research indicating that vaccination before sexual activity provides stronger protection, with antibody levels in this age group being more than double those in older populations [2] - The vaccination schedule consists of two doses administered six months apart, with a recommendation that the interval should not exceed one year [3] Group 2 - In 2022, China reported approximately 151,000 new cervical cancer cases and 56,000 deaths, accounting for nearly one-fifth of the global total, highlighting the significant burden of cervical cancer in the country [3] - The program is expected to contribute to global efforts to eliminate cervical cancer, with WHO representatives emphasizing its importance [3] - Various departments will collaborate to ensure vaccine supply and safety, including monitoring production and providing necessary medical support during vaccinations [4][5]

Core Viewpoint - The inclusion of the HPV vaccine in the national immunization program is set to significantly reduce disease burden and enhance public health, while intensifying market competition and accelerating industry restructuring [2][6]. Group 1: National Immunization Program - The National Health Commission and seven other departments announced that the HPV vaccine will be included in the national immunization program starting November 10, 2025, providing free vaccinations for girls born after November 10, 2011, who are at least 13 years old [1][7]. - Approximately 60% of eligible girls in China have already benefited from local government initiatives providing free HPV vaccinations [1][6]. - The program aims to address the rising incidence and mortality rates of cervical cancer in China, particularly among younger women [6][7]. Group 2: Market Dynamics - The government procurement project for the HPV vaccine has a budget of approximately 425 million yuan, with a total of 15.4465 million doses planned, and a maximum price of 27.5 yuan per dose [10][12]. - Currently, three bivalent HPV vaccines are approved in China, with increasing competition as domestic products enter the market, challenging the previous foreign monopolies [10][12]. - The HPV vaccine market is experiencing intensified competition, leading to structural adjustments within the industry [11][12]. Group 3: Financial Performance - Major companies in the HPV vaccine market, such as Wantai Biological Pharmacy and Watson Bio, are facing significant revenue declines, with Wantai's revenue dropping by 23.09% in the first three quarters of 2023 [12][13]. - Watson Bio's revenue also decreased by 19.73% in the same period, indicating a challenging financial environment for leading firms [12][13]. - Despite short-term pressures, the long-term growth potential of the HPV vaccine market remains strong, with projections estimating the market size to reach 69 billion yuan by 2030 [13].

Core Viewpoint - The inclusion of the HPV vaccine in the national immunization program is expected to significantly reduce the disease burden and improve public health, while also intensifying market competition and accelerating industry restructuring [2][4]. Group 1: National Immunization Program - The National Health Commission and other departments have announced that starting from November 10, 2025, the HPV vaccine will be included in the national immunization program, providing free vaccinations for girls born after November 10, 2011, who are at least 13 years old [1][5]. - Currently, three types of bivalent HPV vaccines are approved in China, including those from WanTai Bio and Watson Bio, as well as GSK's Cervarix [1][8]. Group 2: Market Dynamics - The government procurement project for the bivalent HPV vaccine has a budget of approximately 425 million yuan, with a total of 15.4465 million doses planned, indicating a competitive landscape with only two manufacturers involved [8]. - The HPV vaccine market in China is experiencing increased competition, with prices for bivalent vaccines dropping significantly; for instance, the price fell from 329 yuan at launch to as low as 27.5 yuan in recent government procurement projects [9][10]. Group 3: Industry Challenges and Opportunities - Major companies like WanTai Bio and Watson Bio are facing significant revenue declines, with WanTai's revenue dropping by 23.09% in the first three quarters of 2023, marking its first loss since going public [10]. - Despite short-term challenges, the long-term growth potential of the HPV vaccine market remains strong, with projections indicating the market could grow from 13.5 billion yuan in 2020 to 69 billion yuan by 2030 [10].

Core Viewpoint - The inclusion of the HPV vaccine in the national immunization program is set to significantly reduce disease burden and enhance public health, while intensifying market competition and accelerating industry restructuring [2][3]. Group 1: National Immunization Program - The National Health Commission and other departments have announced that starting from November 10, 2025, the HPV vaccine will be included in the national immunization program, providing free vaccinations for girls born after November 10, 2011, who are at least 13 years old [1][4]. - Approximately 60% of eligible girls in China have already benefited from local government initiatives providing free HPV vaccinations [1][3]. - The program aims to address the rising incidence and mortality rates of cervical cancer in China, particularly among younger women [3][4]. Group 2: Market Dynamics - The government procurement project for the HPV vaccine has a budget of approximately 425 million yuan, covering 15.4465 million doses, with a maximum price of 27.5 yuan per dose [7]. - Currently, there are three approved bivalent HPV vaccines in China, with increasing competition as domestic companies enter the market [7][9]. - The price of bivalent HPV vaccines has been decreasing, with recent procurement prices dropping to 27.5 yuan per dose, significantly lower than initial market prices [8][9]. Group 3: Industry Challenges and Opportunities - Major companies like Wantai Biological Pharmacy and Watson Bio are experiencing significant revenue declines, with Wantai's revenue dropping by 23.09% in the first three quarters of 2023 [9]. - Despite short-term challenges, the long-term growth potential of the HPV vaccine market remains strong, with projections indicating a market size increase from 13.5 billion yuan in 2020 to 69 billion yuan by 2030 [9]. - Industry experts suggest that companies should increase R&D investments and accelerate the development of higher-valent vaccines to meet diverse market needs [9].

Core Viewpoint - The inclusion of the HPV vaccine in the national immunization program is a significant step towards reducing cervical cancer incidence in China, particularly by targeting girls aged 13 and above for vaccination [3][4]. Summary by Sections Vaccination Plan - The HPV vaccine will be provided free of charge to girls born after November 10, 2011, who are 13 years old, with a schedule of two doses administered six months apart starting from November 10, 2025 [3][4]. - The initiative aims to reduce the social costs associated with cervical cancer prevention by ensuring that more eligible females receive the vaccine before potential sexual exposure [3]. Target Population - The decision to target girls aged 13 aligns with research indicating that vaccination between the ages of 9-14 generates a stronger immune response, providing better protection against HPV [6][7]. - The high-risk age groups for HPV infection in China are identified as 17-24 years and 40-44 years, emphasizing the need for early vaccination [7]. Implementation Challenges - Despite previous efforts in 18 provinces to include HPV vaccination in public health projects, actual vaccination rates remain low, with school-based vaccination being a critical bottleneck [3][4][14]. - The transition from local to central funding for vaccination programs poses challenges in policy implementation and coverage [3][12]. Catch-Up Vaccination - The plan includes provisions for catch-up vaccinations for girls who missed the initial vaccination opportunity, allowing them to receive the vaccine before turning 18 [11][12]. - Concerns exist regarding the execution of catch-up programs, particularly for mobile populations and areas with lower vaccination rates [12][13]. School-Based Vaccination - The article discusses the potential for school-based vaccination programs to improve accessibility and increase vaccination rates among eligible girls [14][15]. - Collaboration between health and education departments is essential for the successful implementation of school-based vaccination strategies [15]. Economic Impact - The inclusion of the HPV vaccine in the national immunization program is expected to stabilize vaccine prices, as the government procurement price has already reached a low of 27 yuan per dose [19][20]. - Experts suggest that the focus should shift from price competition to ensuring vaccine quality and maintaining supply [20][21]. Future Considerations - The integration of HPV vaccination with cervical cancer screening programs could enhance overall cancer prevention strategies, potentially reducing healthcare costs associated with treatment [17][18]. - The long-term effectiveness of the vaccination program will take 15-20 years to manifest, necessitating sustained efforts in vaccination and public health education [4][13].

Core Viewpoint - The inclusion of the HPV vaccine in the national immunization program is a significant step towards reducing cervical cancer incidence in China, but challenges remain in achieving effective vaccination rates and addressing existing immunity gaps among older populations [1][2]. Group 1: HPV Vaccine Implementation - The HPV vaccine will be provided for free to girls aged 13 and above, starting from November 10, 2025, as part of the national immunization program [1]. - The vaccination plan aims to ensure that girls receive two doses of the bivalent HPV vaccine, spaced six months apart, to establish immunity before potential sexual exposure [1][3]. - Previous initiatives in 18 provinces have shown that actual vaccination rates are not ideal, with school-based vaccination being a critical bottleneck [1][2]. Group 2: Target Population and Age Considerations - The decision to target girls aged 13 aligns with research indicating that vaccination between the ages of 9-14 generates a stronger immune response [3][4]. - There is a significant immunity gap among older populations who may not yet be eligible for cancer screenings, highlighting the need for ongoing vaccination efforts [2][10]. Group 3: Challenges in Implementation - The feasibility of mobilizing parents for vaccination in higher grades of elementary school is questioned, suggesting that early middle school is a more suitable time for vaccination [4][5]. - The notification includes provisions for catch-up vaccinations for girls who miss the initial opportunity, allowing for one additional dose before the age of 18 [8][10]. Group 4: Vaccine Market Dynamics - The government procurement price for the bivalent HPV vaccine is set at approximately 27.5 yuan per dose, with a total budget of about 425 million yuan for 2025 [14]. - The market for the HPV vaccine is expected to stabilize in terms of pricing, as the focus shifts from price competition to ensuring vaccine quality [15][17]. Group 5: Integration of Preventive Measures - The integration of HPV vaccination with cervical cancer screening is seen as a cost-effective strategy to reduce overall healthcare expenditures related to cervical cancer treatment [13]. - The potential for optimizing screening strategies in the "post-vaccine era" is highlighted, with suggestions for extending screening intervals as vaccination rates increase [13].

Core Insights - The Chinese government has officially included the HPV vaccine in the national immunization program, providing free vaccinations for eligible girls, which raises awareness for cervical cancer prevention but presents new challenges due to limited vaccine coverage and the need for screening in older high-risk populations [1][3] Group 1: HPV Vaccine and Screening Importance - Cervical cancer is a leading cause of cancer death among women in low- and middle-income countries, with over 70% of high-grade cervical lesions linked to HPV types 16 and 18 [1] - The HPV infection rate among Chinese women is 12.1%, with peaks in the 17-24 and 40-44 age groups, indicating a need for effective screening strategies [1] - Screening remains crucial for women aged 35-64, as the vaccine's impact on reducing cervical cancer incidence may take 10 to 20 years to manifest [1][3] Group 2: Screening Strategies and Challenges - Self-sampling techniques, such as urine testing, have been recognized globally for over 20 years as effective methods to increase screening participation rates [2] - Current screening rates for women aged 35-64 in China are 51.5%, and 36.8% for women aged 20 and above, falling short of the WHO's target of 70% [4] - Traditional screening methods often involve invasive procedures, leading to discomfort and reluctance among women, which self-sampling could alleviate [4][5] Group 3: Market Trends and Future Prospects - The cervical cancer early screening market in China grew from 5.674 billion to 8.497 billion yuan from 2018 to 2023, with a compound annual growth rate of 8.41% [7] - The market is expected to continue growing, reaching 11.756 billion yuan by 2028, with a compound annual growth rate of 6.86% [7] - The cost of HPV nucleic acid testing typically ranges from 100 to 500 yuan, with urine testing being slightly more expensive but expected to decrease as automation improves efficiency [7]

Core Viewpoint - The article discusses the significant expansion of the national immunization program in China, with the inclusion of the HPV vaccine aimed at protecting women's health, particularly targeting school-aged girls [3][4]. Group 1: HPV Vaccine Inclusion - The HPV vaccine will be added to the national immunization program, focusing on the bivalent vaccine for school-aged girls [3]. - This marks a shift from a child-centric vaccination approach to a "lifecycle vaccination" strategy [3]. - The bivalent vaccine primarily targets HPV types 16 and 18, which account for 70%-80% of cervical cancer cases [3][4]. Group 2: Cervical Cancer Statistics - Cervical cancer is the second most common malignancy among women globally, with China accounting for 23% of cases and 16% of deaths worldwide [4]. - Nearly all cervical cancer cases (99.7%) are linked to HPV infection, which can lead to cervical cancer if persistent [4]. Group 3: Government Initiatives - The Chinese government has been promoting free HPV vaccination for eligible girls, with 18 provinces and several cities already implementing this initiative [5][6]. - Approximately 60% of eligible girls in China are now covered by the free vaccination policy [5]. Group 4: Vaccine Accessibility and Cost - The production and research capabilities for HPV vaccines in China have significantly improved since 2021, with two domestic bivalent vaccines approved for use [7]. - The price of the HPV vaccine has dropped dramatically, with the lowest bid now at 27.5 yuan per dose, less than one-tenth of the initial price [7]. Group 5: Comprehensive Prevention Strategy - The successful inclusion of the HPV vaccine in the national immunization program is expected to enhance the integration of primary and secondary prevention strategies for cervical cancer [8]. - A comprehensive prevention strategy may include vaccination, screening, and early diagnosis and treatment [8]. Group 6: Future Directions - The national health authorities are preparing a five-year plan to narrow the gap between domestic and international immunization programs, considering the addition of new vaccines and optimizing existing vaccination schedules [9]. - The exploration of vaccine exit strategies for those not suitable for universal vaccination is also on the agenda [9].