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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100 项与重组乙型肝炎疫苗(酿酒酵母)(GlaxoSmithKline Plc) 相关的专利（医药）

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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）

2026-10-01·JAMA Internal Medicine

Serologic Immunity to Hepatitis A and B in US Adults and High-Risk Populations

Article

作者: Roldan, Giovanni A. ; Davie, Timothy ; Lake, John R. ; Udompap, Prowpanga ; Fletcher, Jesse ; Leventhal, Thomas M.

Importance:

Serologic immunity to hepatitis A virus (HAV) and hepatitis B virus (HBV) protects against acute infection and severe outcomes among high-risk groups; however, contemporary data on population-level immunity remain limited, especially in high-risk populations.

Objective:

To estimate the prevalence and factors associated with serologic immunity in the overall population and across high-risk subgroups, including those with chronic liver disease (CLD), chronic kidney disease, diabetes, and immunosuppression and pregnant people.

Design, Setting, and Participants:

This cross-sectional study used data from the National Health and Nutrition Examination Survey from January 2017 to August 2023 and included adults aged 20 years or older with available HAV and HBV serologic test results. Data were analyzed from January 3 to May 10, 2026.

Main Outcomes and Measures:

The primary outcomes were the prevalence of serologic immunity to HAV, defined by hepatitis A antibody positivity, and HBV, defined by hepatitis B surface antibody positivity, with vaccine-derived immunity specifically identified by surface antibody positivity in the absence of hepatitis B core antibodies. Data were weighted to generate nationally representative estimates of the US adult population. Multivariable survey-weighted logistic regression models were used to identify independent factors associated with viral hepatitis immunity.

Results:

Among 13 514 individuals, representing an estimated 226.1 million US adults (mean [SE] age, 48.65 [0.40] years; 51.76% female), 39.5% (95% CI, 37.7%-41.3%) demonstrated serologic immunity to hepatitis A, corresponding to approximately 89.4 million individuals. For HBV, 27.1% (95% CI, 25.8%-28.4%) demonstrated serologic immunity, corresponding to approximately 61.3 million individuals, while vaccine-derived immunity was present in 25.2% (95% CI, 23.9%-26.5%). In adjusted models, HAV immunity was associated with younger age (eg, 20-29 vs ≥65 years: adjusted odds ratio [AOR], 0.51; 95% CI, 0.44-0.60); lower educational attainment (eg, &lt;grade 9 vs college graduate or above: AOR, 0.32; 95% CI, 0.24-0.42); non-Hispanic Black (AOR, 1.67; 95% CI, 1.34-2.09), Mexican American (AOR, 4.22; 95% CI, 3.42-5.21), other Hispanic (AOR, 2.01; 95% CI, 1.60-2.54), non-Hispanic Asian (AOR, 3.03; 95% CI, 2.45-3.76), and multiracial or other (AOR, 1.36; 95% CI, 1.04-1.79) race and ethnicity; being born outside the US (AOR, 4.54; 95% CI, 3.74-5.52); and liver disease awareness (OR, 1.65; 95% CI, 1.29-2.09). Obesity was associated with lower odds of HAV immunity (AOR, 0.83; 95% CI, 0.72-0.96). Vaccine-derived HBV immunity was associated with younger age (eg, 20-29 vs ≥65 years: AOR, 0.18; 95% CI, 0.15-0.23), female sex (AOR, 1.36; 95% CI, 1.18-1.56), non-Hispanic Asian (AOR, 1.47; 95% CI, 1.17-1.86) and non-Hispanic Black (AOR, 1.15; 95% CI, 1.00-1.32) race and ethnicity, and higher educational attainment (eg, &lt;grade 9 vs college graduate or above: AOR, 3.29; 95% CI, 2.35-4.61). In high-risk subgroups, HAV immunity ranged from 26.7% (95% CI, 18.9%-34.4%) for metabolic dysfunction–associated alcohol-related liver disease to 63.7% (95% CI, 50.0%-77.4%) for chronic HBV infection, while HBV vaccine-derived immunity ranged from 14.0% (95% CI, 11.3%-16.6%) for chronic kidney disease to 38.6% (95% CI, 28.0%-49.1%) for pregnancy.

Conclusions and Relevance:

This cross-sectional study found that population-level serologic immunity to HAV and HBV was suboptimal and substantial susceptibility persisted across high-risk clinical subgroups. These findings highlight persistent gaps in viral hepatitis protection and support targeted, systematic vaccination strategies for HAV and HBV, especially among high-risk populations.

2026-09-01·International Health

Coverage and determinants of hepatitis B virus vaccine uptake among children aged 12–36 months in Ethiopia: an analysis of the 2016 Ethiopian Demographic and Health Survey

Article

作者: Lim, Aaron G ; Alamneh, Tesfa Sewunet ; Walker, Josephine G ; White, Kathleen Kenyatta

Abstract:

Background:

In Ethiopia, chronic hepatitis B virus (HBV) prevalence is high (∼6%) and infant vaccination targets are unmet. We assessed HBV vaccination uptake and associations with parental sociodemographic and obstetric factors among children (aged 12–36 months) in Ethiopia.

Methods:

We utilised the 2016 Ethiopian Demographic and Health Survey. We included a weighted sample of 3,855 children (aged 12–36 month) to assess HBV vaccination coverage level (none, incomplete, and complete) and its spatial distribution. Additionally, we identified associated factors of HBV vaccination coverage level using ordinal logistic regression.

Results:

Overall, 51.2% of children received complete HBV vaccination, with wide regional variation. Older maternal age (adjusted odds ratio (AOR)=1.05, 95% confidence interval (CI): 1.02–1.07), better maternal education level (mean AOR=1.66–2.08), higher household wealth quantile (mean AOR=1.51–2.32), distance to a healthcare facility not a big problem (AOR=1.54, 95% CI: 1.25–1.89), and complete maternal continuum care utilisation (AOR=2.59, 95% CI: 1.25–5.30) were positively associated with HBV vaccination coverage, while higher number of children in the household (AOR=0.86, 95% CI: 0.79–0.92) was negatively associated.

Conclusions:

HBV vaccination coverage falls below World Health Organization (WHO) targets in Ethiopia and has substantial regional variation. Targeted vaccination campaigns for mothers in lower socioeconomic groups and larger families may improve vaccination coverage.

2026-09-01·JHEP Reports

Predictors of seronegativity to HBV vaccine in infants of HBsAg-positive mothers in a national prevention program

Article

作者: Ki, Moran ; Kim, Jong-Hyun ; Kim, Byung-Woo ; Baduge, Naradi

BACKGROUND & AIMS:

Seronegativity following perinatal hepatitis B prophylaxis increases the risk of horizontal infection. This study analyzed 20 years of data from the Korean Perinatal Hepatitis B Prevention Program (PHBPP) to identify factors associated with hepatitis B vaccine seronegativity after immunoprophylaxis in infants born to HBsAg-positive mothers.

METHODS:

The study population comprised 233,455 mother-infant pairs from 2002 to 2021, identified by linking the PHBPP database with National Health Insurance Service data. Among the 154,351 pairs with initial post-vaccination serologic testing (PVST) results, 150,709 pairs were analyzed, excluding 3,642 cases of mother-to-child transmission (immunoprophylaxis failure). Multivariable logistic regression was used to analyze factors associated with seronegativity.

RESULTS:

Overall, 11.3% of infants were seronegative at the initial PVST, with the proportion decreasing from 15.1% in 2002 to 4.2% in 2021. Higher seronegativity was associated with delayed PVST (7.8% at <10 months, 15.6% at 10-19 months, and 31.3% at ≥20 months post-vaccination), preterm birth, cesarean section, and maternal HBeAg-negative status without antiviral prophylaxis. Seronegativity varied by birth weight: 10.6% (≥3,000 g), 12.7% (2,500-2,999 g), 15.7% (2,000-2,499 g), and 14.5% (<2,000 g with four doses).

CONCLUSIONS:

Timely PVST, full-term gestation, appropriate birth weight, vaginal delivery and maternal antiviral prophylaxis are associated with robust vaccine immunogenicity. To enhance program effectiveness, strict adherence to the recommended PVST timing is crucial, and extending the four-dose schedule to infants weighing 2,000-2,499 g warrants consideration.

IMPACT AND IMPLICATIONS:

By analyzing a 20-year nationwide cohort of over 150,000 mother-infant pairs, this study establishes a robust scientific basis for the 9-15 month post-vaccination serologic testing window, demonstrating it as an optimal balance between clinical accuracy and practical healthcare access. Furthermore, we identified a specific immune vulnerability in infants weighing 2,000-2,499 g, suggesting that extending the four-dose vaccination schedule to this group is warranted to ensure optimal protection. These insights can directly inform global public health policies and optimize strategies toward achieving the WHO 2030 HBV elimination goals.

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

2026-10-05

·听大象呼吸的人

看清乙肝的治疗天花板：病毒指标已堆满，免疫干预尚遥远

【前置说明】本人非临床医务人员，系与慢性乙型肝炎相伴四十年的长期病程观察者。本文为个人对乙肝治疗天花板与免疫学现状的思考，仅作圈层交流参考，不构成任何疾病诊断、用药调整、治疗方案选择的医疗建议。文中提及的检测手段、药物研发进展均来自公开文献，解读仅为个人观点，欢迎专业从业者指正。所有诊疗决策务必遵从正规医院专科医嘱。一、临床监测指标的天花板：病毒学堆满，免疫学荒漠我们都知道评估乙肝感染状态，基础依靠乙肝两对半。在追求功能性治愈的目标下，乙肝表面抗原与表面抗体是最核心的观察指标；在长期抗病毒阶段，除两对半之外，临床会叠加高敏HBV DNA监测；当表面抗原实现转阴后，为预判病毒复阳风险，前沿研究又引入HBV RNA、pgRNA、HBcrAg等新型标志物。综合来看，除两对半中的表面抗体、e抗体、核心抗体之外，其余上述标志物全部属于病毒学指标范畴，临床医生也长期依托这一套病毒学指标，制定、调整治疗方案。但矛盾之处在于：乙肝病毒本身的复制生命周期，科研层面的底层机制已经研究得相对透彻，病毒学相关检测手段仿佛摸到了发展天花板；反观免疫学领域，能直接指导临床决策的免疫指标却极度匮乏。不少科普文章会提及HBV特异性T细胞免疫，但在临床能常规开展的，目前仅有T淋巴细胞亚群检测，这项检测只能统计免疫细胞总数与比例，无法区分细胞是针对乙肝病毒的特异性免疫，还是人体广谱的非特异性免疫。部分可以直接反映乙肝特异性免疫状态的检测——如四聚体染色、胞内细胞因子染色、ELISPOT等——目前仍局限于实验室研究阶段，部分机制甚至还停留在假说推演层面。至于特异性B细胞，临床上仅能依靠表面抗体水平，粗略窥见B细胞应答的冰山一角，缺少可常规开展的检测手段去评估B细胞活化、分化、记忆细胞储备等细节，也就很难基于免疫状态预判患者长期预后走向。二、新药研发的悖论：全力靶向病毒，寄希望于免疫自行恢复当前新药研发的主流思路，大多围绕病毒本身展开。核心策略是压低甚至清除表面抗原，继而寄希望于患者自身免疫功能随之恢复，多款在研药物的目标就是把表面抗原降至极低水平乃至实现转阴，但这些干预都属于直接针对病毒及其抗原产物的手段。同时受制于现有检测平台的检出下限，所谓“转阴”不等于肝细胞内病毒模板被清除或永久沉默。检测结果阴性不代表肝细胞内不存在低水平的病毒转录渗漏。而直接靶向免疫系统的候选药物，目前除治疗性疫苗具备一定潜力外，整体进展有限。治疗性疫苗的核心难点在于：如何打破长期感染形成的免疫耐受，同时避免过度激活引发肝脏炎症风暴，这一平衡极难把握，目前尚无成熟方案。部分临床试验观察到，少数受试者的B细胞可被激活，诱导产生表面抗体；但即便如此，体内仍能检出低水平表面抗原，即使表面抗原阴性，在停药后，表面抗体依然会迅速下降，这些现象或许提示：B细胞虽出现活化信号，但细胞功能缺陷并未完全修复，免疫应答远达不到健康人群的完备状态。简单来说，行业普遍认同“免疫重建才是最终出路”，但研发资金投入的重心，几乎都集中在抗原抑制方向，本质上是把免疫系统当成一个被动跟随的变量，而非可以主动调控、定向重编程的干预靶点。三、三个尚无标准答案的问题基于上面的现状，我想抛出三个问题。就现阶段而言，没有答案可以给到病友足够确定的预期：第一，病毒学常规检测还有没有深入的潜力？高敏HBV DNA之外还有超敏检测，HBV RNA、HBcrAg也正在尝试推向临床常规。但标准化平台建设、统一判定阈值、卫生经济学成本这三道门槛如果无法跨越，再精细的病毒学检测，只会停留在大型三甲专科的科研工具，难以普及到普通病友的常规化验单中。第二，能够评估乙肝特异性免疫的检测，成本能否下降从而走向常规？可以直接检测HBV特异性T细胞的四聚体、胞内细胞因子染色，评估B细胞耗竭状态与抗体亲和力的功能学试验，技术原理已经存在，但卡在检测标准化、大样本参考阈值建立两大难点。免疫功能检测虽有降本空间，但距离“抽取一管血即可出标准化临床报告”的常规化应用，仍有巨大差距。第三，是否存在理想递送载体，可以进入肝细胞核，且不在体液环境中快速降解？ GalNAc偶联技术能够把药物递送到肝细胞胞质；LNP包裹mRNA可进入胞质，少量实现入核；AAV载体天然具备入核能力，但免疫原性、一次性高剂量带来的安全隐患是难以回避的硬伤。外泌体、仿生纳米载体尚处在临床前研究阶段，至今没有任何一种载体，可以同时满足：体液环境稳定不降解、覆盖绝大多数肝细胞、高效入核、支持重复给药、成本低廉可常规使用这五项要求。这三个问题，共同框定了乙肝治疗的天花板。病毒学维度能挖掘的潜力已经接近上限，免疫学评估与干预还徘徊在门外，免疫检测无法落地，临床决策就只能更多依靠经验推断。新药如果无法同时突破递送技术瓶颈与免疫重编程难题，功能性治愈就只会是少数受试者的幸运结果，而不是多数病友可预期的确定性方案。四、结语对于病友而言能做的或许只有一件事：保持逻辑上的清醒，不被“转阴率提升数倍”这类博眼球标题裹挟，也不要因为“治愈近在眼前”的宣传画饼，过早放弃当前成熟稳妥的长期抗病毒方案。借用短剧流行梗:看清天花板在哪里，远比假装天花板不存在，更加踏实，才不会烧心。【后置重要声明】本文所有内容仅为作者个人对乙肝治疗现状与免疫学瓶颈的批判性思考与逻辑推演，不构成任何疾病诊断、用药调整、治疗方案选择的医疗建议。文中提及的检测手段、临床试验数据均来自公开文献，解读仅为个人观点，欢迎专业从业者指正。所有诊疗决策务必遵从正规医院专科医嘱。作者拒绝私信解读个人化验数据、拒绝提供个体诊疗咨询，请所有读者理性阅读、科学就医。

疫苗核酸药物

2026-05-19

·Biotech前瞻

乙肝“功能性治愈”要来了？GSK重磅新药在华加速，正大天晴负责落地

乙肝清除为何如此艰难很多乙肝患者最关心的问题，不是“病毒能不能压下去”，而是：我有没有机会停药？乙肝表面抗原能不能转阴？以后肝硬化、肝癌风险能不能真正降下来？最近，正大天晴与GSK围绕慢乙肝创新药 Bepirovirsen 达成独家战略合作，将推动这款药物在中国内地上市和可及。根据GSK公告，Bepirovirsen目前已在中国进入优先审评，GSK仍作为上市许可持有人，负责注册、质量和药物警戒等工作，正大天晴将承担中国内地的进口、分销、医院准入及相关推广工作。这意味着，慢乙肝治疗正在从“长期压制病毒”，向“追求功能性治愈”迈出重要一步。但对患者来说，更重要的是把话说清楚：这不是乙肝已经被彻底攻克，也不是所有患者马上都能停药，而是乙肝治疗目标正在发生变化。乙肝难治的核心原因，在于HBV进入肝细胞后，会形成类似“病毒种子库”的cccDNA。很多药物可以把血液中的HBV DNA压得很低，甚至检测不到，但并不等于肝细胞里的病毒模板被完全清除。这也是为什么很多患者长期服用恩替卡韦、替诺福韦等核苷（酸）类似物后，病毒复制控制得很好，却仍然难以实现乙肝表面抗原，也就是HBsAg转阴。换句话说，现有治疗更像是把病毒“按住”，而不是把病毒“连根拔起”。只要乙肝表面抗原长期存在，人体免疫系统就可能持续处于被病毒干扰的状态，肝脏慢性炎症、纤维化、肝硬化和肝癌风险仍需长期管理。所以，乙肝治疗真正困难的地方，不只是把HBV DNA降下来，而是让身体重新建立对病毒的免疫控制。目前慢乙肝治疗的主力，仍然是核苷（酸）类似物和干扰素。核苷（酸）类似物的优势是口服方便、抗病毒效果明确，能够显著降低病毒复制，减少肝炎活动和疾病进展风险。但它的局限也很清楚：多数患者需要长期服药，一旦不规范停药，可能出现病毒反弹，甚至肝功能波动。干扰素则更强调激活免疫清除，有些患者可以获得更持久的应答，但它对人群选择要求高，不良反应相对更多，并不适合所有患者。因此，临床上越来越重视一个概念：功能性治愈。它通常指在治疗结束后，患者仍能保持乙肝表面抗原阴性，并维持病毒学控制。它不等于把体内所有病毒遗留痕迹完全清零，但对患者来说，已经是比单纯长期抑制病毒更高一级的治疗目标。 Bepirovirsen带来的新信号 Bepirovirsen是一种反义寡核苷酸药物，也就是小核酸疗法的一类。它的设计思路不是单纯抑制HBV DNA复制，而是希望降低乙肝表面抗原水平，并帮助免疫系统重新识别和控制乙肝病毒。 GSK披露，Bepirovirsen的上市申请基于III期B-Well 1和B-Well 2研究结果；在既往接受标准治疗的慢乙肝患者中，Bepirovirsen联合标准治疗相比单用标准治疗，显示出具有统计学意义和临床意义的功能性治愈率提升，且在基线HBsAg较低的人群中效果更突出。这对患者的启发是：未来乙肝治疗可能不再只看“HBV DNA有没有转阴”，还会越来越重视HBsAg水平、肝功能状态、肝纤维化程度、既往治疗情况以及患者是否属于更可能获益的人群。但也要特别提醒：Bepirovirsen仍处在监管审评和上市推进阶段，并不代表已经在中国临床常规可用。根据GSK公告，该药在中国处于优先审评；Reuters报道也提到，中国监管批准预计可能在2027年。正大天晴与GSK合作这次合作的重点，不只是“一个新药来了”，而是如果未来获批，药物如何更快进入医院、如何覆盖更多患者、如何完成准入和规范使用。 GSK公告中提到，慢乙肝在中国影响约7500万人，是重要公共卫生问题；此次合作将借助正大天晴在肝病领域的商业化和准入网络，覆盖中国超过5000家医疗中心。对患者来说，这可能带来三个现实变化。第一，乙肝治疗目标会被重新讨论。过去很多患者只知道“病毒量低就可以”，未来医生可能会更频繁地评估HBsAg水平，判断患者是否有机会进入更积极的治疗策略。第二，患者分层会更重要。不是所有慢乙肝患者都适合同一种新疗法。基线HBsAg较低、正在接受标准抗病毒治疗、肝功能和肝纤维化状态稳定的人群，可能更值得和医生讨论未来治疗机会。第三，规范随访仍然是底线。即使未来出现功能性治愈疗法，乙肝患者也不能自行停药、换药或中断复查。肝功能、HBV DNA、HBsAg、肝纤维化评估以及肝癌筛查，仍然是长期管理的重要组成部分。 Bepirovirsen的进展值得期待，因为它让“乙肝功能性治愈”从一个遥远目标，变成了更接近临床应用的现实方向。但期待不等于盲目乐观。对于乙肝患者来说，现在最重要的不是等待某一个“神药”，而是做好三件事：规范抗病毒治疗、定期复查肝脏风险、和医生讨论自己是否属于未来新疗法可能获益的人群。乙肝治疗正在进步，但真正保护患者的，永远不是单一药物，而是早筛查、早治疗、长期随访和科学决策。医学科普提示本文仅用于医学科普和疾病认知，不构成诊断、治疗或用药建议。慢性乙肝患者是否需要治疗、能否停药、是否适合新疗法，应由肝病专科或感染科医生结合HBV DNA、HBsAg、肝功能、肝纤维化、肝硬化及肝癌风险等因素综合判断。 💡 关注Biotech视野了解自己，关爱家人，健康并非遥不可及~

寡核苷酸核酸药物优先审批

2026-05-11

·腾讯网

功能性治愈乙肝新药，引入中国

2026年5月11日，葛兰素史克（GSK）正式与中国生物制药（SBP Group）及其子公司正大天晴药业集团（CTTQ）达成独家战略合作，以加速其潜在的“首创”慢性乙肝治疗药物bepirovirsen在中国大陆的上市步伐。根据协议条款，在最初的5.5年内，正大天晴将向GSK采购bepirovirsen，并全面负责该药物在中国大陆的进口、分销、医院准入以及各项推广活动。在此期间，GSK将保留药物的上市许可持有人身份，继续负责监管、质量、药物警戒和全球医学战略，并将合作供应的销售额计入自身财务报表。除了共同推进这款乙肝新药，这项协议还赋予了GSK一项特权——能够评估中国生物制药集团的部分早期管线资产，从而探索在中国以外地区展开进一步合作的潜力。全球范围内，慢性乙肝（CHB）影响着超过2.5亿人，每年导致约110万人死亡。而在中国，慢性乙肝无疑是一项国家级的健康优先事项，该疾病影响着约7500万人，中国高达84.4%的肝癌患者与慢性乙肝感染相关。正如GSK国际部总裁Mike Crichton所言：“通过将GSK的创新实力与正大天晴广泛的本地规模和执行力相结合，我们希望能触及更多患者，产生更大的影响力，并直接应对中国最紧迫的医疗优先事项之一”。正大天晴在中国建立的庞大商业版图覆盖了超过5000家医疗中心，拥有极度完善的肝病产品组合，这种本土网络正是GSK确保该药物成功惠及广大患者的核心所在。这款新药bepirovirsen，是GSK从Ionis制药公司授权引进的一种处于研究阶段的反义寡核苷酸（ASO）药物，它具备极具创新性的“三重作用”机制。这种药物旨在抑制体内病毒DNA的复制、降低血液中乙肝表面抗原（HBsAg）的水平，还能刺激免疫系统，从而增加患者获得持久且持续缓解的几率。在今年1月份，GSK就已宣布了其两项关键的III期临床试验（B-Well 1和B-Well 2）达到了主要终点。这两项试验招募了1800多名基线HBsAg≤3000 IU/ml的慢性乙肝患者，结果显示，与单独使用标准疗法相比，bepirovirsen展现出了具有统计学意义和临床意义的“功能性治愈”率。所谓功能性治愈，指的是在完成有限的疗程后，至少在24周内患者体内的HBsAg消失且HBV DNA检测不到。数据显示，在所有排名的终点中，尤其是基线HBsAg≤1000 IU/ml的患者群体中，bepirovirsen的疗效更为显著，且该药物展现出了与既往研究一致的可接受的安全性和耐受性。基于这些极为积极的临床数据，bepirovirsen目前正处于中国国家药品监督管理局（NMPA）的优先审评阶段，并已于此前获得中国的突破性疗法认定，同时在国际上也斩获了美国FDA的优先审评和快速通道资格，以及日本的SENKU认定。bepirovirsen的商业前景和临床价值无疑是革命性的。业内对其寄予厚望，瑞银（UBS）分析师Colin White预测，鉴于全球庞大的病患基数，bepirovirsen最高年销售额有望达到20亿美元，具备典型的“重磅炸弹”药物潜力。如果最终获批，bepirovirsen有望成为全球首个针对慢性乙肝的“有限、为期六个月”的治疗方案。在当前的医学界，实现功能性治愈（即停药后至少6个月内血液中的病毒DNA和表面抗原无法被检测到）已成为中国最新《国家病毒性肝炎防治行动计划（2025-2030年）》的重要治疗目标，因为它能够切实降低包括肝癌在内的长期并发症风险。虽然一年多前，GSK曾因未达到预定疗效终点而被迫终止了一项名为GSK3528869的CHB治疗性疫苗I/II期试验，但其在抗击乙肝的道路上拥有充足的技术储备。除了市面上现有的Engerix-B和Twinrix/Ambirix等重组疫苗产品外，GSK的研发管线中还包括了siRNA序贯组合GSK5637608（daplusiran/tomligisiran）、PAPD5/PAPD7抑制剂GSK3965193以及TLR8激动剂GSK5251738等多种潜力候选药物。可以说，此次GSK与正大天晴的强强联手，有望将创新药物以最快速度送达患者手中。

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
D04432	-	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)	憲淵齋鏇選築蓋範餘製(願餘範製遞醖繭製範鹹) = 製顧觸網憲夢構築鏇壓淵鹽築淵繭醖築夢積鑰 (壓鑰窪繭糧膚壓醖鏇獵, 3065.6) 更多	-	2021-08-17
				hepatitis B vaccine (Schedule 2 - High Dose Primary Vaccination Series)	憲淵齋鏇選築蓋範餘製(願餘範製遞醖繭製範鹹) = 觸鑰簾醖醖簾衊蓋鬱遞淵鹽築淵繭醖築夢積鑰 (壓鑰窪繭糧膚壓醖鏇獵, 1097.3) 更多
NCT02003703 (Pubmed \| JAMA Netw Open)	临床3期	HIV感染	107	Hepatitis B Revaccination (High-dose HBV vaccination)	鹽廠觸遞製製願願窪蓋(艱窪襯衊製鏇範壓醖壓) = 廠夢製築繭壓鹹蓋艱醖糧襯範艱鏇艱顧艱襯鬱 (繭製鬱構齋膚夢鏇鑰簾 ) 更多	-	2021-08-02
				Hepatitis B Revaccination (Standard-dose HBV vaccination)	鹽廠觸遞製製願願窪蓋(艱窪襯衊製鏇範壓醖壓) = 餘壓鑰繭鹹淵艱鑰願鹽糧襯範艱鏇艱顧艱襯鬱 (繭製鬱構齋膚夢鏇鑰簾 ) 更多
ECCO2021	N/A	炎症性肠病	104	Intra-dermal hepatitis B vaccination with topical imiquimod	齋蓋顧製艱淵積選鬱淵(夢壓選鬱顧鹹壓簾獵夢) = 衊憲積鬱顧積淵衊餘範鑰窪蓋獵鏇淵選蓋艱膚 (築淵遞憲範糧餘醖選繭 ) 更多	积极	2021-07-02
				Intra-muscular recombinant hepatitis B vaccine with topical aqueous cream	齋蓋顧製艱淵積選鬱淵(夢壓選鬱顧鹹壓簾獵夢) = 餘餘網廠鏇顧遞鹹範獵鑰窪蓋獵鏇淵選蓋艱膚 (築淵遞憲範糧餘醖選繭 ) 更多
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix-B (Sci-B-Vac 10 Î¼g)	鏇齋膚醖獵積鹽繭憲積(窪顧衊鹽壓選鑰衊顧糧) = 繭製壓艱淵選襯願糧鬱醖窪糧齋觸壓鹽構糧醖 (積製襯淵醖製顧夢顧窪 ) 更多	积极	2020-08-27
				Engerix B 20 Î¼g	鏇齋膚醖獵積鹽繭憲積(窪顧衊鹽壓選鑰衊顧糧) = 範願獵簾簾構鹹鏇製衊醖窪糧齋觸壓鹽構糧醖 (積製襯淵醖製顧夢顧窪 ) 更多
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (10-11 Year-olds)	廠窪夢淵遞壓鹽願選窪 = 窪衊齋繭簾廠網膚願餘觸夢艱網廠衊醖艱齋鹹 (憲簾艱夢壓膚糧築選醖, 憲憲範鏇膚遞鏇築積淵 ~ 網夢願範淵窪築鹹醖廠) 更多	-	2019-03-21
				EngerixB, GlaxoSmithKline Vaccines (15-16 Year-olds)	廠窪夢淵遞壓鹽願選窪 = 鏇鏇鑰顧蓋鬱鏇網淵觸觸夢艱網廠衊醖艱齋鹹 (憲簾艱夢壓膚糧築選醖, 遞繭廠鏇襯範醖簾膚鑰 ~ 壓窪鏇願糧築衊淵壓夢) 更多
NCT02798952 (CTgov)	临床4期	乙型肝炎	302	Engerix-B Kinder+Infanrix hexa	鬱襯糧廠膚壓窪齋鬱製(衊願膚鏇顧壓壓淵顧憲) = 鬱製夢觸網糧鏇選簾簾築衊獵鹽願蓋築遞醖獵 (艱鏇齋衊築衊遞顧鑰顧, 築積遞夢窪鹽願範遞願 ~ 選鑰齋夢鏇積廠廠鹹淵) 更多	-	2019-02-01
ASN2018	N/A	anti-HBsAg titer	28	Standard Double-Dose Intramuscular Vaccine	鑰顧選築襯獵襯窪鏇獵(鏇簾獵鑰築鏇鹹鏇憲蓋) = There were no reports of adverse events associated with intradermal dosing 顧膚選遞膚夢獵獵鏇選 (願構繭範範糧積獵廠觸 )	积极	2018-10-23
NCT02901951 (CTgov)	临床4期	乙型肝炎	106	Engerix-B	鏇鏇鹹鹽鑰鹹鏇廠廠壓 = 獵範鹽鏇淵襯壓繭蓋醖廠衊夢壓獵齋範鏇繭構 (醖糧淵積鹽糧壓構鹹窪, 鏇遞壓鹹構繭積繭製襯 ~ 簾廠鬱網醖鹹夢製壓鏇) 更多	-	2018-08-03
NCT01817725 (CTgov)	临床1期	慢性乙型肝炎	20	HBV vaccine	壓艱糧憲簾簾窪衊觸遞(積膚積範獵鬱齋壓構艱) = 構遞餘觸簾艱鏇積範廠網繭膚鏇夢憲鏇壓簾鏇 (選淵構選獵積襯選憲鏇, 0.48) 更多	-	2017-05-02
NCT01847430 (Pubmed \| Vaccine)	临床4期	乙型肝炎	303	Hepatitis B vaccine challenge dose	淵壓衊鑰膚夢鏇網廠窪(衊膚醖衊壓簾壓獵淵壓) = 膚網範襯簾艱願蓋憲鏇顧鏇選選製築夢鏇夢鬱 (選廠窪簾網積鹽夢積蓋, 94.2 ~ 98.6) 更多	-	2016-05-23