Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers Among Women of Childbearing Age, and Young Adults in Zimbabwe in the Context of Mental Health: a Multimodal, Multifaceted Approach.

Aim: The main goal of this observational study is to determine the prevalence of Human Papilloma Virus(HPV) infection, and Hepatitis B (Hep B) immunity amongst women of childbearing age 13 to 45 years) attending clinics at Mtshabezi Mission and Matobo clinic respectively; and assess behavioral risk factors of high school students at these catchment areas that can put them at risk for developing cancer of the cervix and liver.
Question: Can screening for cancer, and vaccination against Hep B and HPV, and cognitive behavior intervention help in preventing related cancers amongst these groups of participants.

开始日期2026-01-01

申办/合作机构

National University of Sciences & Technology

NCT06793410

/ Recruiting临床2期IIT

Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation

Patients who undergo allogeneic stem cell transplantation lose previously acquired immunity and are routinely revaccinated against many infectious diseases. For several reasons, these patients have a long-term immune deficiency due to the transplant itself (lack of immune reconstitution) and due to possible complications, primarily GvHD and its treatment. The risk of secondary malignancy in the long-term following an allogeneic bone marrow transplant is greatly increased, and secondary cancer cases account for a significant proportion of late deaths in both women and men after transplantation. Some of these secondary cancers are associated with HPV. The risk of cervical cancer has been reported to be 13 times increased compared to a healthy population.
Therefore in this trial, the aim is to study immune response (antigen-specific antibody response) after vaccination with 9-valent HPV vaccine (Gardasil 9®) in adult women and men (up to and including 45 years of age) who have undergone allogeneic stem cell transplantation. In this trial, the sponsor will compare "early" (start 9 months after tx) with "late" (start 15 months after tx) vaccination.

开始日期2025-05-12

申办/合作机构

Region Västra Götaland

NCT06799494

/ Not yet recruiting临床4期IIT

Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults

This study aims to answer the question: does 1-dose HPV vaccination generate the same immune responses compared to 2- or 3-dose HPV vaccination? This will be done by studying the immune response in blood, lymph nodes, and bone marrow.
Human papillomaviruses (HPV) cause cancers (cervical, anal, oropharyngeal, vulvar, vaginal, and penile), and the current HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases. While this vaccine generates high levels of antibodies that last for > 10 years, understanding of how this occurs is limited, and studying this immune response will help design new and better vaccines.
The study population consists of healthy adult (age 18-45) participants who have not previously received an HPV vaccine, do not have antibodies against certain types of HPV, do not have a history of HPV infection or disease (such as genital warts, abnormal pap test, or HPV DNA test), and do not have contraindications to study procedures. Populations of increased concern are not being enrolled.

开始日期2025-05-01

申办/合作机构

Emory University

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100 项与九价人乳头瘤病毒疫苗(酿酒酵母) (默沙东) 相关的临床结果

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100 项与九价人乳头瘤病毒疫苗(酿酒酵母) (默沙东) 相关的转化医学

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100 项与九价人乳头瘤病毒疫苗(酿酒酵母) (默沙东) 相关的专利（医药）

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607

项与九价人乳头瘤病毒疫苗(酿酒酵母) (默沙东) 相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

Willingness to pay for vaccines in China: A systematic review and single-arm Bayesian meta-analysis

Review

作者: Zhou, Liangru ; Li, Yi ; Liu, Ziwei ; Li, Ruifeng

The effective implementation of vaccination heavily depends on the society's willingness to pay (WTP). There is currently a dearth of comprehensive evidence about WTP for vaccines in China. This systematic review aims to review studies on the WTP for vaccines, to summarize factors affect WTP in China. Base-case analysis and Sensitivity analysis of WTP for every vaccine were estimated via single-arm Bayesian meta-analysis. A total of 28 studies were included for systematic review. The point estimates and 95% Credible Interval of pooled WTP for influenza and HPV (9-valent) vaccine were $27.409 (23.230, 31.486), $464.707 (441.355, 489.456). Influencing factors to WTP were age, income, peer influence, health condition and etc. Future research should give focus to improving sample representativeness and survey tool, conducting intervention trials, identifying effective methods to promote WTP.

2025-12-31·Human Vaccines & Immunotherapeutics

Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies

Article

作者: Giuliano, Anna R. ; Palefsky, Joel M. ; Lin, Jianxin ; Goldstone, Stephen E. ; Guevara, Ana María ; Kaplan, Susan ; Schilling, Andrea ; Luxembourg, Alain ; Van Damme, Pierre ; Vandermeulen, Corinne ; Mogensen, Ole ; Bornstein, Jacob ; De Coster, Ilse ; Bonawitz, Rachael ; Ellison, Misoo C.

Post hoc analyses of 9-valent human papillomavirus (9vHPV) vaccine immunogenicity were conducted in five Phase 3 studies that enrolled males. Month 7 antibody geometric mean titers (GMTs) after three 9vHPV vaccine doses were analyzed in 10,024 males/females aged 16-26 years from studies 001 (NCT00543543), 002 (NCT00943722), 003 (NCT01651949), and 020 (NCT02114385). Covariates considered were age, gender, sexual orientation, region of residence, and race. GMTs among 2599 males/females aged 9-15 years (studies 002 and 010 [NCT01984697]) were assessed 6 months after one, two, and three 9vHPV vaccine doses. 9vHPV vaccine immunogenicity was robust across populations. Month 7 GMTs were generally higher in participants aged 16-21 versus 22-26 years. Region and race minimally impacted immunogenicity. Adjusted integrated analysis showed lower immunogenicity in men who have sex with men (MSM) versus heterosexual men (HM) for nine HPV types, and higher immunogenicity in HM versus females for seven HPV types. Among 9-15-year-olds, trends toward higher GMTs in males versus females post-Dose 3, similar GMTs post-Dose 2, and lower post-Dose 1 were observed. In conclusion, 9vHPV vaccine immunogenicity was robust in males aged 16-26 years across a range of baseline characteristics. GMT ratios for males versus females aged 9-15 years tended to increase with more doses.

2025-12-31·Human Vaccines & Immunotherapeutics

Assessing the influence of male vaccination on cervical cancer elimination in China under different vaccination coverage scenarios: A modeling study

Review

作者: Chen, Ya-Ting ; Wu, Hai Bin ; Wang, Wei (Vivian) ; Bian, Rui ; Wang, Yin ; Zhang, Xingxing ; Daniels, Vincent ; Diakite, Ibrahim ; Wang, Xu Sheng ; Kyle, Jeffrey ; Situ, Sujian

Cervical cancer caused by human papillomavirus (HPV) infection remains a significant public health challenge in China, where screening and HPV vaccination uptake fall well below World Health Organization's (WHO) targets. This study aimed to assess the impact of gender-neutral vaccination (GNV) on cervical cancer elimination in China at a range of vaccination coverage rates (VCRs) and screening uptake rates. Using a model to project cervical cancer incidence and cases in China over 100 years, we evaluated different vaccination strategies using either a bivalent (2vHPV) or nonavalent (9vHPV) vaccine and estimated the time taken to reach the WHO's elimination threshold of 4 cases per 100,000 women. Results showed that all GNV strategies were more effective than the corresponding girls-only strategy at preventing cervical cancer, and all 9vHPV-based strategies were more effective than the corresponding 2vHPV-based strategies, especially at lower female VCRs. At a 70% screening uptake and a female VCR of 60%, the fastest predicted disease elimination time (65 years) was achieved using GNV-9vHPV; this timeline was accelerated to 56 years at a female VCR of 90%. The time to elimination using GNV-9vHPV could be accelerated by up to 6 years by adding a catch-up vaccination program or 7 years by increasing the screening rate. These results suggest that updating the current Chinese HPV vaccination program by including males and using a nonavalent vaccine, in conjunction with efforts to increase cervical cancer screening uptake, offers the fastest route to cervical cancer elimination in China, especially while VCRs remain low.

190

项与九价人乳头瘤病毒疫苗(酿酒酵母) (默沙东) 相关的新闻（医药）

2025-07-14

·医药健闻

跨国药企在中国 | 强生、GE医疗、诺和诺德、赢创、西门子医疗、费森尤斯卡比、索诺瓦、辉瑞、罗氏、默沙东、诺华、卫材等新动态

跨国药企在中国重点资讯文 | 苏丁企业动态诺和诺德7月8日，跨国生物制药企业诺和诺德与天津经开区管委会签署合作谅解备忘录，约定投资约8亿元建设天津生产厂质量检测实验室扩建项目。项目启动活动同日举行。诺和诺德天津生产厂质量检测实验室扩建项目总建筑面积约1.8万平方米，包括化学实验室、微生物实验室和生物实验室等，计划于2026年底建设完成。2024年，投资40亿元的无菌制剂扩建项目启动，时隔一年，又启动了实验室扩建项目，目前，诺和诺德在天津经开区的累计投资已经超过百亿元。GE医疗位于成都天府国际生物城的GE医疗中国精准医疗产业化基地一期项目日前竣工并通过验收，标志着GE医疗西部首个精准医疗高端装备产业化基地正式建成投用。该基地项目首期核心任务聚焦核医学一体化精准诊疗体系的核心装备——回旋加速器的稳定国产化生产，这一突破将显著提升GE医疗在核素治疗领域的布局能力和本土化产业生态构建能力。未来，GE医疗中国还将推进二期计划。赢创赢创全球最大的医疗器械技术中心7月9日在上海举行开业仪式。该中心专注于生物可吸收医疗器械半成品部件的研发和加工，将服务整个亚洲市场。赢创医疗器械方案上海技术中心提供从概念讨论、材料选择与定制、原型设计、分析测试、质量法规支持到万级洁净室生产的一站式解决方案。强生强生医疗科技宣布启动苏州产业园外科工厂产能升级项目。该项目计划将原位于园区兴浦路的吻合器产线整体迁入长阳街强生医疗科技苏州产业园内，并升级集吻合器、缝线、超声刀等外科手术器材生产于一体的智造集群和供应链基地。西门子医疗西门子医疗表示，预计中国对欧盟医疗设备的采购限制不会影响其业务。这家德国医疗技术公司证实，获得中国国家药品监督管理局许可的产品不会受到影响。费森尤斯卡比国药器械与费森尤斯卡比华瑞制药有限公司近日在北京举行战略合作签约仪式。此次合作国药器械将依托覆盖全国的智慧供应链体系和“国械在线”数字化平台，与费森尤斯卡比在肠内营养领域展开深度合作。费森尤斯则将依托其先进的医疗技术和丰富的临床经验，为国药器械带来前沿的医疗解决方案和创新产品，助力其提升在医疗领域的专业服务能力。赫力昂7月8日，赫力昂中国正式对外宣布，赫力昂（Haleon）已于近日完成对其非处方药合资企业中美天津史克制药有限公司（TSKF）的收购。赫力昂以总计16.23亿元人民币（约合2亿英镑）的价格，收购了TSKF剩余的12%股权。至此，中美史克正式成为赫力昂的全资子公司。索诺瓦7月9日，瑞士索诺瓦集团，总部直设的子公司“索诺瓦听力技术（海南）有限公司，在海南博鳌乐城国际医疗旅游先行区迎正式运营。索诺瓦听力技术（海南）有限公司与乐城先行区内博鳌超级医院、树兰（博鳌）医院签署了战略合作协议，整合优势资源，共同探索和打造听力健康服务新模式。辉瑞辉瑞中国选择亚马逊云科技，构建现代化数据基座，确保安全合规与数据本地化的同时，挖掘数据价值，驱动企业的数字化转型。基于亚马逊云科技存储、数据库和分析在内的云计算服务，辉瑞中国打造湖仓一体化的数据基座，打破数据孤岛，实现基于数据的业务洞察。此外，亚马逊云科技基于安全合规理念和安全技术能力，为辉瑞中国提供一站式全方位的合规服务，有效保障数据的隐私与安全。罗氏7月6日，由“淋巴瘤之家”主办，罗氏制药中国公益支持的“人生A/B面”弥漫性大B细胞淋巴瘤（DLBCL）患者公益活动举办，这是国内首个聚焦DLBCL患者的专项公益活动。项目旨在构建全新的医患互动平台，提高DLBCL患者对于疾病规范化诊疗的认知，呼吁社会关注淋巴瘤治疗药物的可及性与可支付性。默沙东7月12日，由中国癌症基金会发起、默沙东支持的中国低卫生资源地区宫颈癌综合防控项目在山西省长治市襄垣县妇幼保健院举行了项目县执行启动会，会上中国癌症基金会与该项目覆盖的项目县代表签署了项目县请捐HPV疫苗协议。2024年11月，默沙东与中国癌症基金会签署了HPV疫苗捐赠协议，聚焦加速消除宫颈癌这一目标，由默沙东向中国癌症基金会捐赠共计8.1万支HPV疫苗，为山西省长治市襄垣县、山西省长治市沁县、云南省德宏州芒市、四川省阿坝州松潘县、四川省雅安市石棉县等多个项目县的适龄初中女生进行免费接种。产业动态维泰瑞隆宣布与诺华达成一项战略协议，授予诺华一项独家选择权，以收购其专有的“脑部递送模组（Brain Delivery Module, BDM）”平台。该平台是一种差异化的血脑屏障穿透技术，旨在提高多种形式药物的脑部递送效率。同时，维泰瑞隆保留使用该平台继续开发选定项目的权利。诺华将在选择权期限内对BDM平台进行评估。若行使选择权，诺华将获得该平台的全球独家权利。维泰瑞隆有资格获得总计高达1.75亿美元的预付款及近期付款。强生医疗科技在亚太地区正式推出VARIPULSE消融平台。该平台已在中国（包括香港和台湾地区）、日本、澳大利亚和韩国获得批准，将改变亚太地区房颤患者们的治疗格局。VARIPULSE消融平台用于治疗房颤（AFib），是首个将消融与标测整合至CARTO 3单一工作流的脉冲电场消融（PFA）技术。国家药品监督管理局药品审评中心（NMPA）批准星汉德生物（SCG）乙肝病毒（HBV）特异性T细胞受体（TCR）工程化T细胞治疗——SCG101V新药1/2期临床试验（IND）申请，用于治疗慢性乙型肝炎。星汉德生物利用其自主研发的GianTCR技术平台，成功筛选出特异性靶向乙肝表面抗原的高亲力、高活性天然TCR，并通过T细胞工程改造重塑患者免疫系统。依托此核心专利，星汉德开发了其针对慢性乙肝的创新细胞治疗管线SCG101V。他泽司他（tazemetostat）发货仪式于和黄医药上海创新药生产基地正式举行，标志着这一全球首个EZH2抑制剂在全国范围内投入临床使用。他泽司他是由益普生（Ipsen）旗下公司Epizyme开发的全球同类首创的EZH2甲基转移酶抑制剂。截至2025年5月，默沙东九价HPV疫苗在全球累计接种已超4亿剂次，覆盖112个国家和地区。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。卫材（中国）药业有限公司宣布，创新药多替诺雷片（商品名：优乐思）首批商业化产品正式从卫材中国苏州工厂放行。多替诺雷是我国首个高选择性URAT1抑制剂。苏州工厂内，智能化生产线高效运转，经过严格质量检验的首批多替诺雷产品被有序装箱。联系美通社+86-10-5953 9500info@prnasia.com

并购

2025-07-11

·BiG生物创新社

百亿收购拿下全球首创，默沙东发力再造“K药”神话？

作者｜与安7月9日，默沙东宣布与Verona Pharma（下称“Verona”）达成协议，将通过子公司以每股107美元的价格收购Verona的美国存托股票（ADS），较其在纳斯达克前一交易日收盘价溢价23%，较60日成交量加权平均价溢价39%，交易预计今年第四季度完成，总价值约达100亿美元。金额之高，一举成为今年生物医药领域第二大并购案，仅次于此前强生146亿美元收购Intra-Cellular。通过此次收购，默沙东将获得Verona的重磅呼吸病新药Ohtuvayre（ensifentrine，恩司芬群）。这是一款针对磷酸二酯酶3和4（PDE3和PDE4）的first-in-class选择性双重抑制剂，可作为单药或与现有类固醇疗法联用，用于治疗慢性阻塞性肺病（COPD，俗称“烟肺”），也是二十多年来首款新药，自上市以来市场表现十分强劲，目前预计年销售峰值已达数十亿美元，其独特的双重机制和强大的市场潜力为本次重磅交易提供了强力支撑。图1 默沙东宣布收购Verona 01 百亿买局默沙东瞄准“神药第二”默沙东近年的重大交易基本以隔年一次的节奏推进。2021年以115亿美元收购Acceleron及其肺动脉高压（PAH）治疗药物Winrevair，2023年则以108亿美元纳入Prometheus及其晚期肠道疾病候选药物PRA023，而本次收购同样延续了这种步调，以百亿美金的成交金额创下了自2023年以来最大手笔。如此连番豪掷，远不仅是以优势标的对自家管线做强力扩充，更是默沙东面对已然逼近的专利悬崖和增长停摆，为摆脱对王牌产品的过度依赖所做出的关键抉择和战略举措。短期来看，本次交易将为默沙东带来直接有力的营收增长。未来5年，生物医药领域将迎来新一波专利悬崖到期潮，其中不乏多款常年销冠和主力选手，如此形势下，各大药企争相瞄准拥有商业化产品的biotech，以更低风险和即时收益填补专利到期造成的营收鸿沟。现有增长主力中，占据默沙东营收近半壁江山的全球药王Keytruda（pembrolizumab，帕博利珠单抗）即将于2028年迎来专利到期，美国政府预计将在2026年根据IRA对该产品实施谈判，一旦仿制药上市，K药销售额预计暴跌30%-50%，默沙东或将面临近150亿美元的收入缺口。与此同时，第二大畅销产品HPV疫苗Gardasil则直面来自中国国产疫苗的激烈竞争，万泰生物的首款国产疫苗定价499元，相较Gardasil9的1331元直接打了6折。至今年一季度，Gardasil中国市场销售额暴跌约11亿元，其余市场虽整体实现了14％的增长，该药总销售额仍然下降了41％。随着支柱性产品相继面临不确定性，挖掘新的增长主力迫在眉睫。此时这款加速商业化的新药的加入，就显得格外关键。Ohtuvayre自2024年6月底获批上市，市场表现一路走高，至年底便已实现4230万美元销售额，截至今年一季度，更是成倍飙升至7100万美元，环比增长95%，开出处方量已达25000张，新患者启动量环比增长超过25%，且其中60%的处方为续方，表明患者依从性和满意度较高。而自去年8月至今，其商业化甚至还未满一年，市场渗透力可谓惊人。根据SeekingAlpha预测，Ensifentrine的年峰值销售额已达21~36亿美元。如此强劲的市场表现，对默沙东的后续业绩可以说是一针尤为适时的强心剂，有望成为其新的核心增长引擎。图2 PDE3/PDE4双重抑制剂Ohtuvayre而长期考量，Ohtuvayre则将显著丰富默沙东的呼吸系统疾病管线，凭借出色的临床价值和应用前景，与PAH药物Winrevair、呼吸道合胞病毒（RSV）预防药物Enflonsia形成有效协同，推动构建一个多元化、多机制的产品矩阵，推动呼吸管线向第三战略支柱发展，打造更为坚固的竞争壁垒。关于未来交易，默沙东首席执行官Robert Davis此前公开表示，“将会持续寻求10-150亿美元的交易”，这位积极布局管线并购重构的CEO明确表示，“对并购交易持开放态度”，只要目标合适，更大规模的交易仍有可能。 02 全球首创单独给药实现双重疗效根据权威指南《慢性阻塞性肺疾病全球倡议》（GOLD 2025）介绍，COPD是一种异质性、持续性肺部疾病，其特征是由气道和/或肺泡异常导致的慢性呼吸道症状以及持续性、渐进性的气流受限，居全球死因前列，致病机理复杂，主要与吸烟和长期暴露于空气污染有关，俗称“烟肺”。当前治疗手段以3种吸入制剂为主，主要是扩张支气管的长效毒蕈碱拮抗剂（LAMA）和长效β2受体激动剂支气管扩张剂（LABA），以及吸入性糖皮质激素。作为首个用于COPD治疗的新型吸入式机制药物，Ohtuvayre是一款PDE3/PDE4小分子抑制剂，可同时作用于气道平滑肌、炎症细胞、支气管上皮细胞，由此形成其兼具支气管扩张和非甾体抗炎的独特双重机制：•支气管扩张：通过选择性抑制在平滑肌上表达较多的PDE3，舒张气道平滑肌，使呼吸更加顺畅•非甾体抗炎：通过抑制和炎症反应高度相关的PDE4，减轻呼吸道慢性炎症这就直接弥补了当前COPD治疗模式的一大缺陷，即通常绕不开的双联、三联用药，患者需要同时服用不同药物类别的、具有多种作用机制的药物（如支气管扩张剂和吸入性皮质类固醇），才能达到类似效果。通过在单一分子中融合双重疗效，Ohtuvayre由此形成了显著的差异化优势，其通过标准喷射雾化器直接递送至肺部的给药方式，基于相对简化的给药操作，最大化药物在肺部的暴露量、最小化与口服PDE抑制剂相关的全身性副作用，在疗效和安全性之间取得了更好平衡。图3 Ohtuvayre作用机制具体到临床数据上，Ohtuvayre在肺功能方面的出色疗效主要体现于两项关键Ⅲ期临床试验ENHANCE-1和ENHANCE-2。这两项随机、双盲、安慰剂对照多中心试验分别评估了该药作为单一疗法或作为LAMA或LABA的附加药物在40 岁至 80 岁的中重度 COPD 患者中的疗效和安全性。图4 Ohtuvayre两项Ⅲ期试验核心数据结果显示，两项试验中Ohtuvayre均达到主要终点，受试者的肺功能得到显著改善。与安慰剂相比，Ohtuvayre在24周内将COPD急性加重率降低36％-43％，恶化风险降低38%-42%，症状控制情况更加良好，在整个试验过程中表现出良好的耐受性。此外，体外研究表明，Ohtuvayre还能刺激囊性纤维化跨膜电导调节因子（CFTR），或将有助于改善黏液纤毛清除功能并降低黏液粘度。对于伴有慢性支气管炎的患者而言，这一特性可能带来额外的临床获益。目前，Verona Pharma还在探索Ohtuvayre用于治疗非囊性纤维化支气管扩张、囊性纤维化和哮喘等适应症，并开发了Ensifentrine+LAMA（Nebulizer）固定剂量组合疗法，以及ensifentrine吸入粉雾剂（DPI）和定量吸入气雾剂（MDI），进一步加强其临床应用布局的拓展与深化。 03 百亿市场拥抱COPD的广阔前景与挑战由于吸烟率攀高，加之人口老龄化增加患病率，据Research Nester预测，2025年COPD市场预计达到235.4亿美元，2024年全球市场规模超227亿美元，年复合增长率约为4.6％，到2037年将超过407.3亿美元。市场虽然广阔，前路却不好走。过往数十年，其治疗鲜少实现作用机制上的真正突破性，大多数“新药”只是将现有药物类别进行组合，上演一场新瓶装旧酒。但广泛需求却早已明确形成。在使用最大剂量的LAMA/LABA/ICS三联疗法后，仍有相当一部分患者的症状依然持续。以我国情况为例，现有方案治疗下，COPD患者得到有效控制的比例甚至不足5%。重点还是在于研发难度大。对默沙东来说，这也不是其在COPD领域的第一次尝试了，早年放弃开发的Setileuton、MK0873、SCH 351591等都是该适应症药物，最终未能破局。如今引入Ohtuvayre，也意味着该司在COPD领域正式落下一子。如今，各家药企也已先后实现突破，新晋入场的竞争对手包括赛诺菲2024年9月获批的IL-4R单抗度普利尤单抗和GSK今年5月获批的IL-5单抗美泊利珠单抗，蓄力抢占蓝海份额。而国内在研的PDE3/4抑制剂中，则有三款已进入临床阶段，分别是正大天晴的TQC3721、海思科的HSK39004和恒瑞医药的HRS-9821。其中，正大天晴的吸入混悬液剂型TQC3721是国内研发进度最快的国产PDE3/4抑制剂，用于治疗中重度慢性阻塞性肺病，目前位于全球进度第二。其IIa期临床数据显示其有同类最优的潜力，预计2025年启动治疗慢阻肺病（COPD）的Ⅲ期临床。其吸入粉雾剂剂型也已处于治疗COPD的1期临床阶段。海思科的HSK39004同样开发了吸入混悬液和吸入粉雾剂两种剂型，目前已登记Ⅱ期临床研究。恒瑞医药的HRS-9821吸入混悬液则已在去年获批临床试验默示，用于COPD维持治疗。值得一提的是，优锐医药（Nuance Pharma）于2021年获得了Ensifentrine在大中华区临床开发与商业化的独家权利，目前在中国开展的COPDⅢ期临床试验（ENHANCE-CHINA）也已达成主要终点，实现了肺功能显著改善，预计将在今年下半年向NMPA提交新药申请。结语一年不到，已达数十亿美元估值。默沙东大手一挥，再入重磅管线。面对将遇蚕食的市场份额，多方押注的默沙东能否突破重围？背靠巨头的研发和商业化能力，这枚机制独特的商业新星又能否续写K药神话？我们期待后续表现。但无论如何，可以肯定的是，各家药企争相加速推进的临床进展正在打破COPD治疗僵局，为患者带来更为有效的新选择。主要参考文献 1. https://www.merck.com/news/merck-to-acquire-verona-pharma-expanding-its-portfolio-to-include-ohtuvayre-ensifentrine-a-first-in-class-copd-maintenance-treatment-for-adults-and-expected-to-drive-growth-into-the-next-dec/2.Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2025 Report.3.https://www.researchnester.com/cn/reports/chronic-obstructive-pulmonary-disease-market/70514.https://www.fiercepharma.com/pharma/merck-sweetens-its-portfolio-10b-acquisition-verona-and-potential-copd-blockbuster-ohtuvayre5.https://www.fiercepharma.com/pharma/pressuring-mercks-gardasil-china-home-made-9-valent-hpv-vaccine-priced-60-discount6.Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2025 Report.7.Anzueto, A., Barjaktarevic, I. Z., Siler, T. M., Rheault, T., Bengtsson, T., Rickard, K., & Sciurba, F. (2023). Ensifentrine, a Novel Phosphodiesterase 3 and 4 Inhibitor for the Treatment of Chronic Obstructive Pulmonary Disease: Randomized, Double-Blind, Placebo-controlled, Multicenter Phase Ill Trials (the ENHANCE Trials). Americannjournal of respiratory and critical care medicine, 208(4), 406-416. https://doi.org/10.1164/rccm.202306-0944OC8. 企业官网介绍等公开资料共建Biomedical创新生态圈！如何加入BiG会员？

并购专利到期

2025-07-10

·FiercePharma

Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount

Merck has reportedly been offering three-dose courses of its HPV vaccine Gardasil 9 at the price of two doses in some areas of China. China’s first domestically made nine-valent HPV vaccine, a direct competitor to Merck’s Gardasil 9, is being priced at 499 yuan ($70) per dose, the state-owned Xinhua News Agency reports.The shot’s developer, Wantai BioPharm’s Xiamen Innovax Biotech, has set the sticker at an approximately 60% discount compared with the roughly 1,300 yuan-per-dose price for Gardasil 9 in China.A lower price from a local competitor, while expected, marks another blow to Merck’s under-pressure Gardasil franchise. Thanks to its performance in China, Gardasil had been a top growth driver for the New Jersey pharma giant up until the second quarter of 2024. At that time, declining China sales slowed Gardasil’s year-over-year quarterly growth to merely 1%, compared with 14% during the three months before. As Gardasil represents Merck’s second-largest product behind cancer blockbuster Keytruda, news of the slowdown triggered a rare 9% share price drop for the company.The situation has not improved since then. In the first quarter of 2025, Gardasil sales declined 41% to $1.3 billion, as its sales in China plummeted by about $1.1 billion. Excluding China, the shot’s sales grew 14%.Merck has a multifold explanation for Gardasil’s dramatic downturn in China. Besides a chilling effect from the Chinese government’s anti-corruption drive targeting the entire healthcare field, Merck CEO Rob Davis has cited a slowdown in “discretionary consumer spending” as one reason for a cooling across China’s vaccine space.Because HPV vaccines are not included in China’s national immunization program, people must pay out of pocket to get vaccinated. Then entered Wantai and its vaccine. In June, the company’s nine-valent HPV shot Cecolin 9 became China’s first domestically produced jab to win an approval. The approval is for girls and women ages 9 to 45 years old. The shot is given in two doses for those 9 to 17 years of age and as a three-dose regimen for adults.By comparison, Gardasil 9 covers the same age range, but its two-dose course is for those aged 9 to 14 years. Thanks to an expansion in April, Gardasil 9 boasts a unique authorization in men ages 16 to 26 years old.In a head-to-head study conducted in women ages 18 to 26 years in China, Cecolin 9 showed noninferior immune responses and similar adverse reaction rates compared with Gardasil 9, with some slight differences in each HPV type.Merck apparently has been trying to offset its price disadvantage. Media reports suggest that the company, through its local partner Chongqing Zhifei Biological Products, has been offering three-dose courses of Gardasil 9 at the price of two doses in some areas. The U.S. drugmaker has also ramped up its marketing push for Gardasil in the country. Despite the headwinds, the Chinese HPV market still has great potential. Only 27% of Chinese women who were eligible had received at least one dose of an HPV vaccine, Wantai noted in an investor communication Tuesday, citing Chinese CDC data. Compared with the roughly 67% penetration rate in Western countries, HPV vaccines still have much room to grow in China, the Chinese company said.Wantai said it’s currently working to get Cecolin 9 onto the World Health Organization prequalification list to pave the way for its introduction outside China. The company is also testing the nine-valent shot in men in a phase 3 study and is developing a 21-valent version, as well.

上市批准疫苗临床3期

100 项与九价人乳头瘤病毒疫苗(酿酒酵母) (默沙东) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BM03	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
头颈部肿瘤	加拿大	Merck GmbH	2022-04-11
口咽肿瘤	加拿大	Merck GmbH	2022-04-11
外阴上皮内瘤变	日本	MSD KK (Tokyo)	2021-11-01
腺癌	日本	MSD KK (Tokyo)	2020-07-21
鳞状细胞癌	日本	MSD KK (Tokyo)	2020-07-21
肛门肿瘤	中国	Merck & Co., Inc.	2018-04-29
宫颈癌	中国	Merck & Co., Inc.	2018-04-29
阴道肿瘤	中国	Merck & Co., Inc.	2018-04-29
尖锐湿疣	欧盟	Merck Sharp & Dohme BV	2015-06-10
尖锐湿疣	冰岛	Merck Sharp & Dohme BV	2015-06-10
尖锐湿疣	列支敦士登	Merck Sharp & Dohme BV	2015-06-10
尖锐湿疣	挪威	Merck Sharp & Dohme BV	2015-06-10
HPV相关癌症	欧盟	Merck Sharp & Dohme BV	2015-06-10
HPV相关癌症	冰岛	Merck Sharp & Dohme BV	2015-06-10
HPV相关癌症	列支敦士登	Merck Sharp & Dohme BV	2015-06-10
HPV相关癌症	挪威	Merck Sharp & Dohme BV	2015-06-10
乳头状瘤病毒感染	美国	Merck Sharp & Dohme LLC	2014-12-10

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
疣	临床3期	美国	Merck Sharp & Dohme Corp.	2024-03-25
新型冠状病毒感染	临床3期	美国	Merck Sharp & Dohme Corp.	2022-03-28
严重急性呼吸综合征	临床3期	美国	Merck Sharp & Dohme Corp.	2022-03-28
阴茎肿瘤	临床3期	中国	Merck Sharp & Dohme Corp.	2022-02-18
阴茎肿瘤	临床3期	中国	默沙东研发（中国）有限公司	2022-02-18
HPV阳性的口咽鳞状细胞癌	临床3期	美国	Merck Sharp & Dohme Corp.	2021-02-23
HPV阳性的口咽鳞状细胞癌	临床3期	巴西	Merck Sharp & Dohme Corp.	2021-02-23
HPV阳性的口咽鳞状细胞癌	临床3期	墨西哥	Merck Sharp & Dohme Corp.	2021-02-23
持续感染	临床3期	美国	Merck Sharp & Dohme Corp.	2020-02-27
持续感染	临床3期	日本	Merck Sharp & Dohme Corp.	2020-02-27

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05119855 (V503-076, CTgov)	临床3期	新型冠状病毒感染 \| 乳头状瘤病毒感染 \| 严重急性呼吸综合征	165	mRNA-1273 Vaccine+9vHPV Vaccine (Concomitant Group)	鏇鹹糧遞夢壓簾構製願(鏇衊鏇憲壓繭鹽廠齋選) = 艱餘範壓蓋觸願網繭餘鬱構艱範選願網網鹹製 (鹹鏇構簾繭範憲製襯鏇, 壓築壓簾積糧鬱壓艱衊 ~ 選鑰鹽顧餘齋觸觸蓋糧) 更多	-	2025-07-17
				mRNA-1273 Vaccine+9vHPV Vaccine (Non-concomitant Group)	鏇鹹糧遞夢壓簾構製願(鏇衊鏇憲壓繭鹽廠齋選) = 鹽簾夢鏇襯遞襯廠顧窪鬱構艱範選願網網鹹製 (鹹鏇構簾繭範憲製襯鏇, 鏇觸顧製鏇衊顧觸壓艱 ~ 襯範餘鬱網襯願繭簾構) 更多
NCT04772534 (V503-066, CTgov)	临床3期	乳头状瘤病毒感染	314	9vHPV vaccine (2-dose in 9 to 14 Year Old Boys)	蓋遞艱構遞廠範範獵願 = 窪獵壓夢遞顧築醖蓋窪選襯積構襯衊蓋網範糧 (廠製淵膚膚選遞觸鏇獵, 繭鹽蓋膚鹹衊淵鹽選顧 ~ 簾糧顧醖窪繭淵餘艱選) 更多	-	2025-05-30
				9vHPV vaccine (2-dose in 9 to 14 Year Old Girls)	蓋遞艱構遞廠範範獵願 = 醖構淵構壓獵憲憲鹽衊選襯積構襯衊蓋網範糧 (廠製淵膚膚選遞觸鏇獵, 簾獵網蓋願觸鹹衊鬱壓 ~ 餘鹽鏇壓顧顧膚築鹹構) 更多
NCT01824537 (TRAP-HPV, CTgov)	临床4期	乳头状瘤病毒感染	372	Gardasil 9+HPV vaccine (HPV Vaccine, Gardasil 9)	鑰鹹窪鑰構鹽遞簾積顧(築餘窪顧衊願鏇顧餘廠) = 願淵遞鬱築鹹蓋淵鬱蓋構網願淵築蓋鹹選醖鹽 (觸襯鹽衊選顧窪醖獵醖, 觸憲壓夢廠餘壓繭襯簾 ~ 構簾艱鏇簾艱鹽遞願獵) 更多	-	2025-03-19
				Hepatitis A vaccine (Hepatitis A Vaccine)	鑰鹹窪鑰構鹽遞簾積顧(築餘窪顧衊願鏇顧餘廠) = 壓願觸顧衊顧構願遞網構網願淵築蓋鹹選醖鹽 (觸襯鹽衊選顧窪醖獵醖, 網網蓋積鬱壓壓鹽襯鑰 ~ 鏇鬱糧蓋鹹餘醖遞憲築) 更多
NCT04635423 (V503-064, CTgov)	临床3期	尖锐湿疣 \| 肛门肿瘤	1,059	V503 (V503)	糧膚簾遞糧製齋顧鹹築 = 願築餘襯糧夢選淵獵襯鏇衊齋蓋餘願構齋衊範 (襯醖艱願範築獵壓衊構, 簾顧淵築鑰膚簾獵醖鏇 ~ 糧淵鑰糧壓艱繭築構窪) 更多	-	2025-01-13
				Placebo (Placebo)	糧膚簾遞糧製齋顧鹹築 = 築構築願憲鏇遞餘繭膚鏇衊齋蓋餘願構齋衊範 (襯醖艱願範築獵壓衊構, 範蓋製衊糧築繭鹽衊襯 ~ 窪遞築壓選淵積襯製鏇) 更多
NCT04635423 (V503-064, BusinessWire) 人工标引	临床3期	尖锐湿疣	-	GARDASIL 9	淵獵積艱糧製鑰襯鏇鹹(願鏇簾簾鑰製醖齋鹽鑰) = a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared with a placebo. 範餘糧範範選網觸願醖 (糧簾積淵鑰廠壓齋遞鑰 ) 达到	积极	2024-09-11
				Placebo
NCT03051516 (CTgov)	临床4期	肛门上皮内瘤变 \| 鳞状上皮内病变	188	Questionnaire Administration+Recombinant Human Papillomavirus Nonavalent Vaccine (Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine))	餘築觸築鏇艱構憲觸餘: P-Value = 0.89; P-Value = 0.65; P-Value = 0.056; P-Value = 0.38; P-Value = 0.33 更多	-	2024-02-28
				Questionnaire Administration (Arm II (Placebo))
NCT04274153 (Pubmed \| JAMA Netw Open) 人工标引	临床4期	乳头状瘤病毒感染	129	2-dose Gardasil9ne regimen	膚鹽顧齋製窪窪艱夢壓(遞觸觸窪願鬱蓋糧襯顧): Ratio = 2.29 (90% CI, 2.03 ~ 2.58) 更多	积极	2024-01-02
				3-dose Gardasil9ne regimen
NCT04274153 (PPV, CTgov)	临床4期	乳头状瘤病毒感染	225	Gardasil9	憲糧醖簾遞醖夢襯網願(網顧積遞鏇齋選構鹽襯) = 鏇獵願網鑰遞選齋鹹製積蓋積醖鑰鹽構齋餘積 (繭鹽繭網淵齋觸鹽遞簾, 顧憲醖衊範築廠夢簾繭 ~ 憲襯齋鹹艱築膚衊窪衊) 更多	-	2023-08-29
NCT02568566 (CTgov)	临床2期	乳头状瘤病毒感染 \| HPV相关癌症	201	Laboratory Biomarker Analysis+Recombinant Human Papillomavirus Nonavalent Vaccine	夢窪構顧夢獵餘鏇願蓋(襯遞獵遞範鹹構築製廠) = 鏇範鏇艱製壓構選積繭鏇網廠觸窪艱憲齋齋壓 (蓋構淵顧衊蓋衊繭膚顧, 0.54) 更多	-	2022-04-05
NCT03451071 (CTgov)	临床4期	HPV相关癌症	195	Gardasil9	膚網鏇鏇憲獵繭顧齋齋 = 鏇蓋衊憲憲範鑰獵鏇網鹹願廠餘構繭顧積窪艱 (憲糧鑰製餘餘簾襯獵艱, 遞壓襯築膚範夢壓網齋 ~ 糧淵憲構積鬱鬱艱醖衊) 更多	-	2021-10-04