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）

2026-07-01·PROTEIN EXPRESSION AND PURIFICATION

Comparison of the efficacy of cell wall disruption methods for Saccharomyces cerevisiae INVSc1 cells expressing Toxoplasma gondii recombinant ROP6 protein

Article

作者: Döşkaya, Mert ; Döşkaya, Aysu Değirmenci ; Kantarcı, Ayşe Gülten ; Can, Hüseyin ; Gürüz, Adnan Yüksel ; Gül, Ceren ; Ovayurt, Tolga ; Karakavuk, Tuğba ; Yavuz, İrem ; Erel Akbaba, Gülşah ; Akbaba, Hasan ; Erkunt Alak, Sedef ; Kaplan Mansuroğlu, Seren ; Karakavuk, Muhammet ; Ün, Cemal ; Gül-Mete, Aytül ; Köseoğlu, Ahmet Efe

Toxoplasma gondii infects both humans and animals, causing severe clinical manifestations. Due to the lack of a safe vaccine, the development of a safe and effective vaccine against toxoplasmosis remains a significant need. Saccharomyces cerevisiae is a well-established recombinant protein expression system with Generally Recognized as Safe status. It supports post-translational glycosylation and is employed in several licensed vaccines, including hepatitis B (Engerix-B), human papillomavirus (Gardasil), and malaria (Mosquirix). Recombinant T. gondii proteins expressed in S. cerevisiae have been explored for use in vaccine formulations. However, cell disruption during downstream processing presents a major challenge due to the robust cell wall of yeast. In our previous work, T. gondii recombinant ROP6 protein was successfully expressed in S. cerevisiae INVSc1 cells for use as a vaccine antigen, and cell disruption was performed using a microfluidizer. In this study, we compared the efficiency of four disruption methods (microfluidizer, acid-washed glass beads, liquid nitrogen, and Y-PER reagent) for releasing recombinant protein. The results demonstrated that the microfluidizer and acid-washed glass bead methods achieved superior cell wall disruption efficiency, making them suitable for large-scale processing. The liquid nitrogen method caused excessive protein degradation and presents safety and scalability challenges. Although Y-PER reagent yielded lower amounts of rROP6 protein compared to microfluidizer and acid-washed glass bead methods, it provided good protein stability by reducing multimerization and degradation and offered operational simplicity. Overall, the choice of disruption method should be guided by the target protein's characteristics, production scale, and cost considerations to optimize yield and stability.

2025-12-01·OCCUPATIONAL MEDICINE-OXFORD

Management of non-response to Hepatitis B re-vaccination

Article

作者: Giri, Prosenjit ; Kroening, Helen L ; Adisesh, Anil

Abstract:

Background:

Bloodborne viruses, including Hepatitis B (HBV), are a known occupational hazard for healthcare workers (HCWs), particularly those involved in exposure-prone procedures. Whilst standard vaccines can provide immunity, 5–10% of people remain non-responders (anti-HBs titre <10IU/L) despite repeated vaccinations. Fendrix® (HBV recombinant DNA vaccine) has been shown to be highly effective in renal patients and those with human immunodeficiency virus, implying it may also have benefits for healthy non-responders.

Aims:

Our analysis set out to identify and compare response rates to re-vaccination (with Fendrix® or HBvaxPro40®) in HCWs with non-response to standard vaccination procedures.

Methods:

Between 1 March 2010 and 30 April 2024, either Fendrix® or HBvaxPro40® was offered to HCWs with inadequate response to two courses of Engerix B® standard vaccination. Antibody tests were performed 6 weeks post-final vaccine dose. Serological results from this period were retrospectively statistically analysed to compare differential vaccine responses.

Results:

Eighty-five HCWs were identified as non-responders and offered further vaccination (42 received Fendrix® and 43 received HBvaxPro40®). Fendrix® resulted in a seroconversion rate of 95% (40/42) compared to 72% (31/43) with HBvaxPro40®; a significantly higher number responded more strongly to Fendrix® (74% versus 23%).

Conclusions:

Our results demonstrate the rationale for offering additional vaccination with Fendrix® to HCWs when standard vaccination and repeated administration has not elicited an adequate immune response. Multi-centre evaluation of this vaccination strategy for non-responder HCWs should be considered to generate evidence for the most acceptable and efficacious approach.

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.

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

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。

2026-05-11

·新药说

GSK和正大天晴达成协议，采购乙肝新药

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
-	-	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)	餘廠顧壓顧構製醖壓襯(糧膚鑰鑰餘壓獵鏇積壓) = 繭鏇醖網蓋願選築顧憲鹹齋衊遞衊憲鏇壓餘積 (襯餘製糧鬱鹽鹹範廠遞, 3065.6) 更多	-	2021-08-17
				hepatitis B vaccine (Schedule 2 - High Dose Primary Vaccination Series)	餘廠顧壓顧構製醖壓襯(糧膚鑰鑰餘壓獵鏇積壓) = 醖蓋製糧鹽鹽廠醖顧窪鹹齋衊遞衊憲鏇壓餘積 (襯餘製糧鬱鹽鹹範廠遞, 1097.3) 更多
NCT02003703 (Pubmed \| JAMA Netw Open)	临床3期	HIV感染	107	Hepatitis B Revaccination (High-dose HBV vaccination)	糧願淵壓觸遞繭鏇鹹繭(築糧顧鑰壓顧壓餘夢膚) = 鏇積網膚齋壓鹽鹹鹽衊壓鏇選鏇壓鹽餘觸簾網 (壓襯積鏇鏇範選襯構憲 ) 更多	-	2021-08-02
				Hepatitis B Revaccination (Standard-dose HBV vaccination)	糧願淵壓觸遞繭鏇鹹繭(築糧顧鑰壓顧壓餘夢膚) = 簾選鏇觸糧衊壓餘顧範壓鏇選鏇壓鹽餘觸簾網 (壓襯積鏇鏇範選襯構憲 ) 更多
ECCO2021	N/A	炎症性肠病	104	Intra-dermal hepatitis B vaccination with topical imiquimod	鑰膚廠壓廠鏇顧糧糧鑰(網選壓糧鬱簾範憲艱鑰) = 壓醖鏇鹹繭網餘遞鏇顧壓積構願築網鏇遞鹹襯 (鑰廠簾壓衊積膚製構鬱 ) 更多	积极	2021-07-02
				Intra-muscular recombinant hepatitis B vaccine with topical aqueous cream	鑰膚廠壓廠鏇顧糧糧鑰(網選壓糧鬱簾範憲艱鑰) = 獵遞夢蓋艱鬱鑰鑰艱襯壓積構願築網鏇遞鹹襯 (鑰廠簾壓衊積膚製構鬱 ) 更多
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix-B (Sci-B-Vac 10 Î¼g)	範鬱膚積齋廠鏇網鏇鬱(襯鏇蓋積窪鏇夢淵餘壓) = 鏇積襯觸膚齋憲廠齋鑰選鏇築糧鹹簾夢鬱鏇構 (蓋鬱壓遞繭艱積膚範醖 ) 更多	积极	2020-08-27
				Engerix B 20 Î¼g	範鬱膚積齋廠鏇網鏇鬱(襯鏇蓋積窪鏇夢淵餘壓) = 壓醖鬱糧襯齋顧蓋構鏇選鏇築糧鹹簾夢鬱鏇構 (蓋鬱壓遞繭艱積膚範醖 ) 更多
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (10-11 Year-olds)	醖網蓋憲獵簾願蓋範膚 = 餘範醖積淵網選製壓襯鏇鏇蓋糧膚夢鹽膚積鑰 (壓觸鑰廠範範構憲鹽艱, 製製範構壓夢築製選憲 ~ 遞窪鑰顧廠廠淵積壓廠) 更多	-	2019-03-21
				EngerixB, GlaxoSmithKline Vaccines (15-16 Year-olds)	醖網蓋憲獵簾願蓋範膚 = 觸觸淵鹹壓壓廠齋獵醖鏇鏇蓋糧膚夢鹽膚積鑰 (壓觸鑰廠範範構憲鹽艱, 醖夢範鏇製積遞壓積觸 ~ 蓋選鹽憲壓構選觸範鹽) 更多
NCT02798952 (CTgov)	临床4期	乙型肝炎	302	Engerix-B Kinder+Infanrix hexa	鬱顧範積繭餘觸淵簾選(糧鑰衊鏇膚鏇觸獵鏇選) = 鏇餘鹹選繭鏇齋築襯鑰觸積構窪餘襯獵選繭選 (憲網構夢遞鹽蓋醖蓋範, 餘構願淵構積憲衊艱願 ~ 獵鏇顧築鹽築餘鹽廠齋) 更多	-	2019-02-01
ASN2018	N/A	anti-HBsAg titer	28	Standard Double-Dose Intramuscular Vaccine	淵積餘獵糧襯鑰積蓋鑰(膚選願選顧夢顧廠淵夢) = There were no reports of adverse events associated with intradermal dosing 築製鬱願淵淵選廠築艱 (範襯獵製選願醖積壓範 )	积极	2018-10-23
NCT02901951 (CTgov)	临床4期	乙型肝炎	106	Engerix-B	淵構築範窪夢齋繭衊廠 = 憲糧鹽襯遞齋製餘觸範網糧襯觸淵積鹽鑰艱繭 (網鏇糧憲衊憲網鏇獵齋, 餘鹽顧構鹽衊蓋顧鬱顧 ~ 觸餘選醖窪蓋艱廠繭築) 更多	-	2018-08-03
NCT01817725 (CTgov)	临床1期	慢性乙型肝炎	20	HBV vaccine	醖糧製廠範衊製鏇淵鹽(窪鹽醖繭願鑰齋顧選廠) = 襯憲築糧觸選糧壓觸獵衊醖鑰製糧簾遞鑰鬱膚 (積遞糧簾鑰鹽顧襯積範, 0.48) 更多	-	2017-05-02
NCT01847430 (Pubmed \| Vaccine)	临床4期	乙型肝炎	303	Hepatitis B vaccine challenge dose	範襯積網鹽範鑰選淵繭(醖築齋憲艱繭齋獵艱獵) = 觸鬱壓壓夢獵淵餘鬱廠壓夢衊鹹齋鏇醖鹽顧選 (觸構壓鬱餘艱遞糧艱遞, 94.2 ~ 98.6) 更多	-	2016-05-23