Preservation and Transfer of Hepatitis B Virus Immunity After Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation in Adult Sickle Cell Disease Patients (Protect Study)

Sickle cell disease (SCD) patients ending with mixed mononuclear chimerism after non-myeloablative HSCT with alemtuzumab/TBI conditioning will probably preserve their immune response to vaccinations administered prior to the transplantation and will therefore not need to be revaccinated. Furthermore, SCD patients after haploidentical HSCT might benefit from adoptive transfer of immunity from their donors.
To test the first hypothesis, patients undergoing alemtuzumab/TBI HSCT will be vaccinated with a hepatitis B virus (HBV) vaccine before the transplant. To test the second hypothesis, haploidentical and matched related donors will be vaccinated prior to stem cell donation against HBV. Neither the patient nor the donor may previously have been immunized against HBV in all cohorts. Post-transplantation, the investigators will be able to evaluate whether SCD patients preserve their pre-transplant immune response in the post-transplantation period. Furthermore, the investigators will determine whether donors transfer their immunity to HSCT recipients with SCD disease.

开始日期2021-06-08

申办/合作机构

Academic Medical Center University of Amsterdam

NCT04326803

/ Unknown status临床4期IIT

Hepatitis B Virus (HBV) Infection in Haitian Immigrants in Chile: Determination of HBV Genotypes, Viral Escape Mutants and Host Factors Influencing Response to Vaccination

International migration to Chile has sharply increased since 2010. Particularly, Haitian migration now totals approximately 200.000 people. Preliminary results show a high prevalence of hepatitis B infection in this population. Approximately 35% of adult Haitian migrants in Chile have been exposed to hepatitis B infection. In this study the investigators aim to study the clinical and molecular characteristics of this infection and also to assess the serological response to an accelerated schedule of hepatitis B vaccination (0, 1 and 2 months).

开始日期2020-06-01

申办/合作机构

Pontificia Universidad Católica de Chile

NCT04398706

/ Completed临床2期

Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

Primary objectives:
* To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection).
* To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4)
* To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8)
* To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8)
Secondary objectives:
* To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4)
* To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8)
* To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8)
* In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel
* In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX])

开始日期2020-05-22

申办/合作机构

Sanofi Pasteur SA

100 项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的临床结果

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100 项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的转化医学

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项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的文献（医药）

2025-09-01·INTERNATIONAL JOURNAL OF DRUG POLICY

A decentralized point of service triple prevention and treatment model for hepatitis B, C and HIV in people who inject drugs in South Africa

Article

作者: Sishwili, Nozipho S ; Hechter, Vanessa B ; Sonderup, Mark W ; Saayman, Elaine

BACKGROUND:

The burden of viral hepatitis and HIV in sub-Saharan Africa is substantial with an estimated 64.7 million living with hepatitis B virus (HBV), 8 million with hepatitis C virus (HCV) and 20.8 million people living with HIV infection. HBV is endemic in South Africa. People who inject drugs (PWID) are disproportionately burdened with HIV and HCV infection. In Pretoria, South Africa, an HCV infection epicenter for PWID, co-infection with HIV is steadily increasing. Given this growing burden, we established and evaluated a decentralized triple prevention and management intervention for PWID.

METHODS:

A point of service model recruited PWID who reside in Pretoria through convenience sampling and were screened utilizing point-of-care testing for HBsAg (Determine™), anti-HCV and anti-HIV (OraQuick®). The presence of HCV-viraemia was confirmed using an onsite GeneXpert-IV® (Cepheid) PCR system. In those eligible, tenofovir/emtricitabine combination was offered as HIV PrEP and initiated in those who were HBsAg positive and HIV negative. If HIV positive or HIV-HBV co-infected, tenofovir/lamivudine/dolutegravir combination as ART was commenced. In those with confirmed HCV-viraemia, 12-weeks of sofosbuvir and daclatasvir as HCV DAA therapy were initiated in those with HCV mono-infection, or with HIV and/or HBV co-infection, if stable on treatment.

RESULTS:

A total of n = 213 participants, 86 % (n = 184) male with median age of 34 [IQR 31-37] years, were recruited. Of these, 82 % (n = 174) were anti-HCV positive, of which 62 % (n = 131) were HIV-HCV co-infected. Most results were available within 2 [1-3] hours of initial screening with 90 % (n = 138) viraemic. Of these, 73 % (n = 100) met eligibility criteria, with 95 % (n = 95) initiating DAA therapy. Of these 84 % (n = 80) completed 12 weeks of therapy and 86 % (n = 48) achieved a sustained virological response (SVR). All 7 %, (n = 14) HBsAg positive participants were initiated on appropriate therapy. HBV-vaccine were administered to 86 % (n = 172) of HBsAg screen negative participants. HIV was diagnosed in 70 % (n = 150) and 92 % (n = 138) were initiated on ART, 75 % (n = 67) were retained for 6-months, and of those, at 12-months 81 % (n = 21) were virally suppressed. A higher PrEP uptake and 12-week retention was observed for those on DAA therapy. Our approach simplified treatment algorithms, employed task sharing, and use of point-of-care technology to enable single-visit interventions and reduce input costs.

CONCLUSION:

A comprehensive, simplified and decentralized point of service triple disease prevention and management intervention model demonstrates a feasible approach to improve access for PWID in South Africa to viral hepatitis and HIV care.

ETHICS APPROVAL:

The authors declare that they have obtained ethics approval University of Cape Town HREC R0145/2014; R793/2022 from an appropriately constituted ethics committee/institutional review board where the research entailed animal or human participation.

2025-07-01·Annals of Hepatology

A global comparison of hepatitis B & C drug pricing

Article

作者: Yao, Leah ; Tsai, Catherine ; Congly, Stephen E ; Malik, Getan ; Jesudian, Arun B ; Brown, Robert S ; Ying, Xiaohan

INTRODUCTION AND OBJECTIVES:

Drug pricing is a major driver of healthcare spending in the United States (US) and the cost of medications in the US is up to three times higher than other countries. This cross-sectional study aims to investigate the current price differences between hepatitis B (HBV) and hepatitis C (HCV) antiviral therapies in the US as compared to peer high-income countries.

MATERIALS AND METHODS:

Publicly available drug formularies for Canada, UK, Japan, France, Germany, Italy, and Australia were used to collect 2024 prices for seven HBV medications (lamivudine, adefovir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate, entecavir, peginterferon alfa-2a, emtricitabine/TDF) and seven HCV medications (sofosbuvir/velpatasvir, sofosbuvir/ledipasvir, sofosbuvir, ribavirin, elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir/voxilaprevir). US prices were obtained from UpToDate®'s listed representative average wholesale price and Medicare Part D 2022 drug prices.

RESULTS:

US prices for HBV originator medications were on average 4.71x (range 1.99-6.17x) the prices in the peer countries. US generic HBV drug prices for TDF, entecavir, and emtricitabine/TDF were on average 45% cheaper or 0.55x less than the average generic prices in peer countries (range 0.48-0.66x). US originator prices for HCV medications were on average 1.83x the prices in peer countries (range 0.63-2.66x).

CONCLUSIONS:

HBV and HCV originator medications cost significantly more in the US compared to seven other major industrial countries. However, the introduction of HBV generic medications has lowered the cost of treatment for patients in the US. Future adoption of international reference pricing may help bridge remaining pricing disparities.

2025-05-01·JHEP Reports

Auto-antibodies against interferons are common in people living with chronic hepatitis B virus infection and associate with PegIFNα non-response

Article

作者: Maini, Mala K ; Payne, Olivia ; Hill, Robert ; Mauri, Claudia ; Idilli, Orest ; Kennedy, Patrick T F ; Griffith, Sarah ; Bradford, Hannah F ; Etoori, David ; Fink, Douglas L ; Gill, Upkar S ; Kartikapallil, Nikita ; McCoy, Laura E

Background & Aims:

Type one (T1) and three interferons (T3IFNs) are implicated in chronic hepatitis B (CHB) immunopathogenesis. IFN remains the only licenced immune modulating therapy for CHB. We measured the prevalence of auto-antibodies (auto-Abs) against T1 and T3IFNs to examine the hypothesis that they impact HBV control and treatment response, as highlighted by COVID-19.

Methods:

Our multi-centre retrospective longitudinal study accessed two CHB cohorts; auto-Ab levels and neutralisation status were measured against T1IFN and T3IFN. Associations were tested against HBV clinical parameters.

Results:

Overall, 16.7% (46/276) of patients with CHB had any detectable anti-IFN auto-Abs at any time and 6.5% (18/276) anti-T3IFN auto-Abs, with a high incidence of PegIFNα-induced de novo auto-Abs (31.4%, 11/35). However, only a minority of auto-Ab-positive sera demonstrated neutralisation in vitro (4/46, 8.7%). Auto-Ab positivity correlated with higher median HBsAg levels (p = 0.0110). All individuals with detectable anti-T1IFN auto-Abs were PegIFNα non-responders.

Conclusions:

Non-neutralising anti-IFN auto-Abs are common in CHB and associate with higher median HBsAg levels. Further prospective study of anti-cytokine auto-Abs in CHB are required to characterise the association with long-term outcomes.

Impact and implications:

HBV and PegIFNα individually may induce broad autoreactivity associated with dysregulated antiviral immune responses. Auto-Ab screening prior to PegIFNα treatment or other immunotherapies may play a critical role in predicting treatment responses.

项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的新闻（医药）

2025-12-06

·ETPharma

Vaccine makers raise concerns over US panel's shift away from hepatitis B shots for newborns

Bengaluru: Vaccine makers expressed concern on Friday's decision by a U.S. advisory panel to scrap its long-standing recommendation that all infants receive a hepatitis B vaccine at birth, a shift that public health experts fear will undermine decades of public health advances. Merck, whose Recombivax HB has been a staple of the U.S. childhood immunization program, said it was "deeply concerned" by the decision of the CDC's Advisory Committee on Immunization Practices (ACIP), warning it "puts infants at unnecessary risk of chronic infection, liver cancer and even death." The company said the universal birth dose, which was instituted in 1991, has driven a 99% drop in acute hepatitis B cases in children and young adults and argued there is no evidence that delaying it provides any benefit. Infectious disease experts, as well as organizations representing pediatricians, pharmacists and public health professionals decried the move. Hepatitis B, which can spread from mother to child during birth, can cause severe liver disease and early death, and has no cure. According to the National Foundation for Infectious Diseases, the universal hepatitis B birth dose has prevented more than 500,000 childhood infections, cut infant cases by 95% and averted an estimated 90,100 deaths. Many of the committee members, which were appointed by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, criticized the vaccine safety data and said that the U.S. vaccine schedule was out of step with other countries, particularly Denmark, that have low hepatitis B rates. GSK said it stands behind the science supporting its vaccine and is awaiting the CDC's formal adoption of the recommendation to assess its impact. Its vaccine, Engerix-B, has been approved since 1989, with 1.4 billion doses administered worldwide. Merck and GSK shares fell about 1% each following the vote. U.S.-listed shares of Sanofi, another maker of hepatitis B shots, rose about 0.7%. The panel now recommends only infants born to mothers who test positive for hepatitis B should receive the birth dose. Parents of infants whose mothers test negative are advised to decide, in consultation with a healthcare provider, when or whether to begin the vaccine series. Merck urged the committee to return liaison organizations and frontline clinicians to its work groups, calling discussions led by medical and scientific experts "essential to informing sound, evidence-based recommendations that safeguard public health." (Reporting by Mrinalika Roy in Bengaluru; Editing by Alan Barona)>

疫苗上市批准

2025-11-23

·生物制品圈

类病毒样颗粒（VLP）：一种多功能且高效的疫苗平台

摘要：传统减毒或灭活疫苗存在复制失控、免疫原性不足、生产复杂等问题，而病毒样颗粒（VLPs）作为新型疫苗平台，凭借 “模仿病毒却无感染性” 的特性脱颖而出。本文通俗解读 VLPs 的结构优势、生产方式，以及已获批的乙肝、HPV、疟疾等 VLPs 疫苗的效果，还有正在研发的 RSV、诺如病毒等 VLPs 疫苗进展，让你看懂这款 “万能疫苗平台” 的潜力。一、疫苗界的 “高仿选手”：VLPs 到底是什么？我们先搞懂核心：病毒样颗粒（VLPs）是由病毒结构蛋白自组装形成的 “高仿病毒”—— 它长得和真实病毒几乎一模一样，大小、表面结构、电荷特性都高度相似，却少了最关键的 “核心”：病毒基因组。这就意味着，VLPs 既保留了病毒能被免疫系统识别的 “特征”，又完全没法复制、不会致病，对比传统减毒活疫苗（有突变返毒风险）、灭活疫苗（免疫原性弱），安全性直接拉满。更妙的是，VLPs 的尺寸大多在 20-200 纳米，和天然病毒一致，能快速进入淋巴系统，还能和巨噬细胞、树突状细胞等抗原呈递细胞高效结合，激活 T 细胞和 B 细胞，触发强免疫反应。而且 VLPs 表面有规律排列的抗原表位（间隔 5-10 纳米），刚好是激活 B 细胞的 “黄金间距”；内部还能包裹佐剂（比如 Toll 样受体配体），进一步增强免疫效果。甚至可以做成 “嵌合 VLPs”—— 把不同病毒的蛋白嵌进去，一针防多种病，灵活性拉满。图1 病毒样颗粒（VLPs）及嵌合病毒样颗粒生成流程（注：原图展示了普通 VLPs 的构建过程 —— 从克隆病毒衣壳蛋白基因、转入表达系统，到蛋白自组装形成 VLPs；同时呈现了嵌合 VLPs 的构建 —— 在衣壳蛋白基因中插入外源肽基因，最终生成携带外源抗原的嵌合颗粒，如疟疾 VLPs 疫苗中疟原虫蛋白与乙肝表面抗原的融合设计）二、VLPs 是怎么 “造” 出来的？不同生产线各有千秋想让 VLPs 大规模量产，得选对 “生产车间”，目前主流的表达系统有 5 种，各有优劣：细菌系统：成本低、产量高、易放大，适合做简单的 VLPs（比如仅含 1-2 种结构蛋白），但没法给蛋白做糖基化修饰，可能影响免疫原性，还得控制内毒素含量。酵母/昆虫细胞系统：产量和细菌差不多，能做简单糖基化修饰，HPV 疫苗 Gardasil 9（酵母）、Cervarix（昆虫细胞）都是这么做的；但酵母需要裂解细胞提取 VLPs，昆虫细胞易被杆状病毒污染。哺乳动物细胞系统：能做最复杂的蛋白修饰，适合生产结构复杂的 VLPs（比如乙肝疫苗 PreHevbrio、基孔肯雅热疫苗 Vimkunya），但成本高、产量低。植物细胞系统：低成本、易放大，新冠 VLPs 疫苗 Covifenz 就是用烟草属植物生产的，不过同样没法做复杂糖基化。下表清晰总结了各表达系统的优缺点：表1 病毒样颗粒生产常用表达系统的优劣势三、已落地的 VLPs 疫苗：从乙肝到 HPV，保护力又稳又久目前已有多款 VLPs 疫苗通过审批并广泛应用，下表汇总了这些疫苗的适用疾病、生产系统、获批时间、保护效果等关键信息，能让大家快速 get 各款疫苗的核心优势：表 2 已获批病毒样颗粒疫苗关键信息汇总乙肝 VLPs 疫苗：最早的 VLPs 疫苗之一，Recombivax HB、Engerix-B 三针接种后，婴幼儿保护率接近 100%，抗体能持续 30 年；新一代 Heplisav-B 只需两针，40-55 岁人群保护率达 96.9%，PreHevbrio 则针对老年人优化，65 岁以上人群保护率 83.6%，远超传统疫苗。 HPV VLPs 疫苗：堪称 VLPs 的 “代表作”。二价 Cervarix 防 HPV16/18（致 70% 宫颈癌），保护率 90.4%；四价 Gardasil 额外防 HPV6/11（致 90% 生殖器疣），保护率 100%；九价 Gardasil 9 覆盖 9 种 HPV，防 90% 宫颈癌，抗体能持续 10 年以上，部分国家已简化为 1-2 针接种。疟疾 VLPs 疫苗：Mosquirix 把疟原虫蛋白嵌在乙肝 VLPs 上，解决了单一抗原免疫原性差的问题，儿童接种后保护率 36.3%；新一代 R21/Matrix-M 优化了抗原密度，保护率提升到 68%-75%。基孔肯雅热 VLPs 疫苗：2025 年刚获批的 Vimkunya，单针接种后 12-65 岁人群保护率达 98%，65 岁以上也有 76%，不良反应仅为注射部位疼痛、乏力等轻微症状。下图是已获批 VLPs 疫苗的时间线，能直观看到这款技术的发展速度：图2 病毒样颗粒疫苗获批时间线（注：原图展示了 1981-2025 年获批的 VLPs 疫苗，包括乙肝 Recombivax HB（1986）、HPV Gardasil（2006）、疟疾 Mosquirix（2015）、新冠 Covifenz（2022）、基孔肯雅热 Vimkunya（2025）等）四、未来可期：正在研发的 VLPs 疫苗，瞄准更多 “难缠” 疾病 VLPs 的潜力远不止于此，多款候选疫苗已进入临床后期： RSV/人偏肺病毒（hMPV）疫苗：IVX-A12 把 RSV 和 hMPV 的融合蛋白嵌进人工设计的 VLPs，给 60 岁以上老人接种后，RSV 中和抗体提升 6 倍，hMPV 提升 4 倍，有望解决老年人呼吸道感染难题。诺如病毒疫苗：二价 VLPs 疫苗 rNV-2 v 能诱导交叉免疫，覆盖更多诺如毒株，有望应对每年 20 万诺如相关死亡。脊髓灰质炎疫苗：VLPs 脊髓灰质炎疫苗能避免减毒活疫苗的 “疫苗衍生病毒” 风险，助力彻底消灭脊灰。五、VLPs vs mRNA 疫苗：各有优势，未来互补新冠疫情让 mRNA 疫苗火遍全球，但 VLPs 也有不可替代的优势： mRNA 疫苗研发快，但生产成本高、需超低温储存，在低收入国家推广难；VLPs 生产成本低、常温稳定，运输和储存更友好。 VLPs 免疫原性强，低剂量就能触发强保护，还能诱导持久的 IgG1 抗体；而反复接种 mRNA 疫苗可能导致 IgG4 抗体占比升高，影响长期保护力。当然，两者不是竞争关系 —— 未来结合 AI 设计 VLPs 抗原、优化生产工艺，VLPs 有望和 mRNA 疫苗互补，成为全球免疫计划的核心力量。结语从乙肝到基孔肯雅热，从已获批到研发中的 RSV、诺如疫苗，病毒样颗粒（VLPs）用 “模仿病毒却不致病” 的特性，解决了传统疫苗的诸多痛点。它的灵活性、安全性和持久保护力，让这款平台成为疫苗研发的 “万能选手”。随着生产工艺优化、多价疫苗研发推进，VLPs 不仅能应对已知传染病，还可能拓展到癌症免疫治疗等领域，真正成为守护人类健康的 “硬核武器”。

2025-05-22

·摩熵医药

带状疱疹疫苗 “战国时代”：GSK 霸主地位不保？六家本土药企强势突围！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。本文以摩熵咨询《中国带状疱疹疫苗行业分析报告》为依据，解读行业竞争格局。全球疫苗巨头葛兰素史克，以深厚研发与市场积累，左右行业发展；百克生物作为本土代表，凭创新与本土化优势抢占市场。绿竹生物、迈科康生物等企业，凭借技术、研发及市场策略各显神通，共同勾勒出行业未来发展图景。 01GSK：全球领先生物制药巨头，疫苗业务领跑行业葛兰素史克（GSK）成立于2000年，总部位于英国伦敦，作为全球领先的制药和医疗保健公司，业务广泛覆盖抗感染、中枢神经系统等领域，在150多个国家开展业务。它专注创新药物、疫苗与健康产品研发，是世卫组织认定唯一研发艾滋病、疟疾和结核病疫苗的公司。在疫苗业务方面，2024年营收占比达29.0%，依托12个生产基地，2022年具备生产交付5亿剂疫苗的能力，当年药物和疫苗交付量达23亿，全球每年40%的儿童接种其疫苗，超20种疫苗抵御脑膜炎等疾病。财务上，2024年营业额134亿英镑，同比增长8%，核心经营利润91亿英镑，同比增长13% ，核心每股收益159.3便士，同比增长12% ，经营活动现金流79亿英镑。在带状疱疹疫苗领域，2022-2024年销售额分别为29亿、35亿、34亿英镑，其上市疫苗还有Cervarix希瑞适双价人乳头瘤病毒吸附疫苗、Engerix B安在时重组乙型肝炎疫苗（酿酒酵母）等。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于GSK官网等公开资料葛兰素史克（GSK）秉持创新多元战略，聚焦核心领域，借国际化合作促增长。其研发管线丰富，众多产品处于关键阶段。疫苗领域，虽未直接提及带状疱疹疫苗，但呼吸道合胞病毒、脑膜炎、水痘等疫苗研发亮眼；药物研发覆盖多疾病领域，通过广泛研发为健康事业及产品创新筑牢根基。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、GSK官网等公开资料02百克生物：专注传染病防治，水痘疫苗市占率高，带状疱疹疫苗填补国内空白百克生物成立于2004年，作为专注传染病防治的创新药企，通过完善体系、多元技术平台，历经水痘疫苗等产品上市，2023年带状疱疹疫苗上市填补国内空白，凭借丰富产品矩阵在国内疫苗市场尤其是带状疱疹疫苗领域发挥重要防控作用。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于百克生物官网等公开资料截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、百克生物官网等公开资料03绿竹生物：创新疫苗与抗体领域的新锐力量绿竹生物自2001年创立，专注创新型人用疫苗及治疗性生物制剂研发，致力于疾病预防。截至2023年末，三款产品处于临床阶段，核心产品LZ901进入Ⅲ期临床并获美国FDA批准开展美国Ⅰ期临床，有望成国内首款创新重组带状疱疹疫苗，且具全球首创四聚体分子结构。资本运作上，2019-2023年多轮融资助力发展。技术上有五大核心平台保障药物全周期研发。生产布局含北京研发中试中心，一期拿证、二期在建。专利布局广泛，与伙伴推进商业化。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于绿竹生物官网等公开资料绿竹生物聚焦创新疫苗与抗体领域，在研管线丰富。核心产品重组带状疱疹疫苗（LZ901）优势突出，具全球首创四聚体分子结构，临床前及I期试验显示高免疫原性、安全性好，适用人群广（III期扩至40岁及以上），液体制剂便于储运。已完成中国III期临床，计划2024年二季度在美国完成I期临床，有望提供创新预防方案，其研发模式和申报策略彰显领先地位。此外，在研管线还含治疗自身免疫病、癌症抗体及预防水痘等疫苗，研发实力强、产品储备丰富。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、百克生物官网等公开资料04成都迈科康：创新疫苗佐剂领军者，技术平台国际领先成都迈科康2016年由陈德祥博士创立，专注人用和兽用创新疫苗研产销。公司有国际领先平台，布局十余项管线，4项临床，预计1年内2-3项获批。发展中获多轮融资，在成都、上海有基地，设多家子公司。核心团队资深，陈德祥从业超30年。技术平台先进，基因工程识别抗原，佐剂自主设计生产，mRNA技术独特。其积淀与创新有望为带状疱疹等疫苗研发突破，推动产业发展。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于迈科康生物官网等公开资料成都迈科康践行国际化，重预防治疗，在研管线进展快。重组带状疱疹疫苗（CHO细胞）受关注，用MA105复合佐剂防带状疱疹，2021-2024年研发稳步推进。其管线还有多种人用疫苗及治疗产品，在多领域发力，研发实力强，前景广，有望为疫苗防控献创新成果。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、迈科康生物官网等公开资料05中慧元通：人用新型疫苗和多联多价创新疫苗实践者江苏中慧元通2015年成立，践行人用新型及多联多价创新疫苗，成果丰硕。产品涵盖多种重磅疫苗，在研管线多元。研发有专业团队，与知名机构合作，技术平台多元。专利方面，重组带状疱疹疫苗专利获批，佐剂专利审查中。生产基地一、二期完善，上海设研发中心。其在带状疱疹等疫苗领域全方位布局，实力潜力兼具，助力中国疫苗事业。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于中慧元通官网等公开资料江苏中慧元通在疫苗研发领域布局多元、创新力强。其重组带状疱疹疫苗（CHO细胞）受关注，用于防带状疱疹及并发症，注册1.2类，2020 - 2025年研发按序推进。在研管线含多种疫苗，覆盖多疾病预防领域，已上市四价流感疫苗适3岁+人群防流感。公司靠研发投入与创新，在带状疱疹等疫苗研发发力，有望提供优质创新产品提升疾病防控水平。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、中慧元通官网等公开资料瑞科生物专注疫苗研产销，有新型佐剂等三大平台，开发10余款疫苗覆盖多重大疾病领域。带状疱疹疫苗方面，REC610免疫原性好已临床。核心产品REC603处III期，ReCOV为强竞争力二代新冠疫苗。2017-2022年多轮融资并IPO。生产基地布局优，HPV疫苗基地年产2000万剂达WHO标准，创新疫苗基地获证且通过欧盟审计，用于REC610临床样品生产，凭优势有望为疾病防控献更多成果。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于瑞科生物官网等公开资料瑞科生物以HPV疫苗为核心，深耕带状疱疹疫苗并布局mRNA技术。其重组带状疱疹疫苗（CHO细胞）受关注，注册3.3类，防带状疱疹（非原发性水痘），用BFA01佐剂，2023-2024年研发按序推进。在研管线还有多种疫苗，覆盖多疾病预防领域。公司借技术平台优势推进研发，有望提供优质疫苗，尤其在带状疱疹疫苗研发助力疾病防控。截图来源：摩熵咨询《中国带状疱疹疫苗行业分析报告》，数据来自于摩熵医药中国药品审评库、瑞科生物官网等公开资料小结漫漫征途未有期，科技浩浩终可追。群雄逐鹿成新局，行业浪潮正奔涌，全球制药巨头GSK凭借深厚底蕴，带状疱疹疫苗销售额稳居高位；百克生物作为本土先锋，填补国内带状疱疹疫苗市场空白。绿竹生物、迈科康等新锐企业也各展锋芒——绿竹生物核心产品有望成国内首款创新重组疫苗；迈科康凭借复合佐剂技术突破；中慧元通、瑞科生物在研管线布局多元。众企角逐，谁将引领行业未来？END本文为原创文章，转载请留言获取授权中国带状疱疹疫苗行业分析报告完整报告领取方式近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

疫苗财报

100 项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BC01	DBSALT001978

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
乙型肝炎	美国	GlaxoSmithKline LLC	1989-08-28

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临床结果

适应症

分期

评价

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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


NCT01311674 (CTgov)	临床3期	乙型肝炎	141	hepatitis B vaccine (Schedule 1- Standard Dose Primary Vaccination Series)	顧窪觸餘範鏇憲願襯遞(醖衊衊網鹹醖簾網鏇築) = 觸選醖觸糧構簾築製襯鏇憲鹽選觸餘衊醖膚鏇 (憲壓糧廠構夢鬱遞鹹範, 3065.6) 更多	-	2021-08-17
NCT01311674 (CTgov)	临床3期	乙型肝炎	141	hepatitis B vaccine (Schedule 2 - High Dose Primary Vaccination Series)	顧窪觸餘範鏇憲願襯遞(醖衊衊網鹹醖簾網鏇築) = 範鹽遞範觸繭構廠鹹觸鏇憲鹽選觸餘衊醖膚鏇 (憲壓糧廠構夢鬱遞鹹範, 1097.3) 更多	-	2021-08-17
NCT02003703 (Pubmed \| JAMA Netw Open)	临床3期	HIV感染	107	Hepatitis B Revaccination (High-dose HBV vaccination)	衊鬱構範鹽構憲積鹹築(窪構鏇襯獵壓糧鹹顧糧) = 範獵衊網築窪餘衊膚壓願選鏇鬱簾鹹艱獵構遞 (鬱糧鹹齋製醖鑰觸積艱 ) 更多	-	2021-08-02
NCT02003703 (Pubmed \| JAMA Netw Open)	临床3期	HIV感染	107	Hepatitis B Revaccination (Standard-dose HBV vaccination)	衊鬱構範鹽構憲積鹹築(窪構鏇襯獵壓糧鹹顧糧) = 淵壓齋襯艱選網夢鑰積願選鏇鬱簾鹹艱獵構遞 (鬱糧鹹齋製醖鑰觸積艱 ) 更多	-	2021-08-02
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix-B (Sci-B-Vac 10 Î¼g)	鹹艱廠鑰觸築鹽顧蓋醖(繭衊繭繭遞齋顧膚網網) = 簾餘淵餘獵窪簾衊網醖餘鏇製網鏇憲蓋築鬱艱 (獵鑰糧鏇艱壓築鹽衊膚 ) 更多	积极	2020-08-27
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix B 20 Î¼g	鹹艱廠鑰觸築鹽顧蓋醖(繭衊繭繭遞齋顧膚網網) = 鏇範鏇鹹壓廠鏇鬱繭餘餘鏇製網鏇憲蓋築鬱艱 (獵鑰糧鏇艱壓築鹽衊膚 ) 更多	积极	2020-08-27
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (10-11 Year-olds)	襯廠築餘糧積襯簾憲淵 = 齋醖衊糧鏇網遞襯餘範築齋鬱選觸願獵鹽夢衊 (齋鬱壓壓獵膚築憲糧鹽, 鬱鏇餘顧製鹹鏇鹹鬱淵 ~ 膚憲鑰選夢鬱遞觸積鹽) 更多	-	2019-03-21
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (15-16 Year-olds)	襯廠築餘糧積襯簾憲淵 = 醖糧繭艱選衊夢簾憲網築齋鬱選觸願獵鹽夢衊 (齋鬱壓壓獵膚築憲糧鹽, 積鏇築鹹襯餘醖遞願網 ~ 齋構遞壓膚廠顧餘獵齋) 更多	-	2019-03-21
NCT02798952 (CTgov)	临床4期	乙型肝炎	302	Engerix-B Kinder+Infanrix hexa	構醖獵鹹顧齋膚鬱觸艱(窪鏇鬱糧願築糧鏇壓構) = 齋衊構衊築遞鹽鑰襯鹹獵醖糧艱積願醖夢餘網 (醖廠壓遞艱憲鹹餘繭醖, 鬱積鬱廠遞憲蓋齋膚製 ~ 簾選壓簾鏇遞獵積範構) 更多	-	2019-02-01
ASN2018	N/A	anti-HBsAg titer	28	Standard Double-Dose Intramuscular Vaccine	衊艱鏇壓糧選夢觸遞繭(構夢構鑰鹽繭憲鹽糧繭) = There were no reports of adverse events associated with intradermal dosing 夢艱鹽憲願襯廠襯鑰構 (鬱鹽簾鬱積襯襯淵淵艱 )	积极	2018-10-23
NCT02901951 (CTgov)	临床4期	乙型肝炎	106	Engerix-B	築築觸鹹網顧簾憲顧繭 = 蓋夢壓獵糧觸遞鹹簾獵簾襯鹽糧願夢蓋選襯艱 (膚鹹遞構淵齋鏇膚遞繭, 淵醖範廠鹽廠鑰醖廠憲 ~ 淵積簾製願積觸壓齋壓) 更多	-	2018-08-03
NCT01817725 (CTgov)	临床1期	慢性乙型肝炎	20	HBV vaccine+Engerix B	憲製鑰簾艱醖選構醖顧(糧繭簾願膚醖鹽範齋齋) = 鹽顧壓衊簾網鏇糧餘憲夢餘糧築鹹簾鹹鬱膚憲 (糧鹹築網獵遞餘艱憲繭, 0.48) 更多	-	2017-05-02
NCT01847430 (Pubmed \| Vaccine)	临床4期	乙型肝炎	303	Hepatitis B vaccine challenge dose	膚壓鹽製齋積醖範觸網(鑰夢繭鬱壓遞願簾糧積) = 衊獵築襯夢膚顧製鬱糧艱簾憲襯艱膚積範憲積 (顧鑰壓鬱淵襯範獵鏇鹽, 94.2 ~ 98.6) 更多	-	2016-05-23
NCT01847430 (CTgov)	临床4期	乙型肝炎	303	Engerix™-B Kinder	顧憲繭遞鹽衊遞製壓窪 = 鹹蓋願齋鬱網鑰鬱窪製廠選簾網鑰積範蓋繭鬱 (遞壓糧窪淵廠鑰網鑰鏇, 築製繭構憲衊艱夢網醖 ~ 襯遞醖繭選選鑰憲築範) 更多	-	2016-03-02