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

NCT04193189

/ Completed临床3期IIT

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

The purpose of this study is to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination.

开始日期2020-12-14

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

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）

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 ; Hill, Robert ; Payne, Olivia ; Mauri, Claudia ; Idilli, Orest ; Kennedy, Patrick T F ; Griffith, Sarah ; Etoori, David ; Bradford, Hannah F ; 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.

2025-01-01·ARTIFICIAL ORGANS

Liposome‐encapsulated hemoglobin rescues hemorrhagic shock heart through anti‐ischemic and anti‐arrhythmogenic effects on myocardium in repetitive 65% bleeding rat model

Article

作者: Kinoshita, Manabu ; Sakai, Hiromi ; Adachi, Takeshi ; Takase, Bonpei ; Higashimura, Yuko ; Masaki, Nobuyuki

Abstract:

Background:

Phase I clinical trial of an artificial oxygen carrier (liposome‐encapsulated hemoglobin vesicles [HbVs]) is safely completed, considering the other clinical application. Herein, we aimed to investigate the resuscitation effects of HbVs in cases of lethal hemorrhage, including the mechanisms involved.

Methods:

Optical mapping analysis (OMP) and electrophysiological studies (EPS), immunostaining pathological examination for hypoxia‐inducible factor‐1α (HIF1‐alpha) in the heart tissue, and blood troponin I (TnI) level measurements were performed in rats that underwent five rounds of spontaneous arterial bleeding with up to 65% hemorrhage.

Results:

Ten rats in each group were resuscitated by a transvenous infusion of 5% albumin (ALB), washed erythrocytes (wRBC), HbVs (HbV), 50% HbV diluted by 5% albumin (50% HbV), and 66% HbV diluted by 5% albumin (66% HbV). The rats in the ALB and 50% HbV groups died, whereas those in the other groups survived. OMP showed impaired action potential duration dispersion (APDd) in the left ventricle in the ALB and 50% HbV groups, which was attenuated in the other groups. Lethal arrhythmias were provoked by EPS in the ALB and 50% HbV groups but not in the other groups. HIF1‐alpha was positively stained only in the ALB and 50% HbV groups. TnI levels were elevated in the ALB and 50% HbV groups.

Conclusions:

Acute lethal hemorrhage causes myocardial ischemia with hypoxia and arrhythmias, which may be induced by impaired APDd and myocardial damage, reflected in the increased levels of HIF1‐alpha and TnI. HbVs could be useful for resuscitation and may help save patients with injuries such as gunshot wounds.

2024-09-01·JHEP Reports

CD40 stimulation activates CD8+ T cells and controls HBV in CD4-depleted mice

Article

作者: Cimino, Jesse L. ; Cimino, Jesse L ; Rexhouse, Catherine ; Cangialosi, Sophia ; Bailey, Jacob T. ; Robek, Michael D. ; Bailey, Jacob T ; Robek, Michael D ; Moshkani, Safiehkhatoon

Background & Aims:

HBV treatment is challenging due to the persistence of the covalently closed circular DNA replication pool, which remains unaffected by antiviral intervention. In this study, we determined whether targeting antigen-presenting cells via CD40 stimulation represents an appropriate therapeutic approach for achieving sustained HBV control in a mouse model of HBV replication.

Methods:

Mice were transduced with an adeno-associated virus encoding the HBV genome (AAV-HBV) to initiate HBV replication and were administered agonistic CD40 antibody. CD4-depleting antibody was administered in addition to the CD40 antibody. Viral antigens in the blood were measured over time to determine HBV control. HBV-specific CD8⁺ T cells were quantified in the spleen and liver at the experimental endpoint.

Results:

CD40 stimulation in CD4-depleted AAV-HBV mice resulted in the clearance of HBsAg and HBeAg, along with a reduction in liver HBV mRNA, contrasting with CD4-competent counterparts. CD8⁺ T cells were indispensable for CD40-mediated HBV control, determined by HBV persistence following their depletion. In CD4-replete mice, CD40 stimulation initially facilitated the expansion of HBV-specific CD8⁺ T cells, which subsequently could not control HBV. Finally, α-CD4/CD40 treatment reduced antigenemia and liver HBV mRNA levels in chronic AAV-HBV mice, with further enhancement through synergy with immunization by VSV-MHBs (vesicular stomatitis virus expressing middle HBsAg).

Conclusions:

Our findings underscore the potential of CD40 stimulation as a targeted therapeutic strategy for achieving sustained HBV control and reveal a CD4⁺ T cell-dependent limitation on CD40-mediated antiviral efficacy.

Impact and implications:

Immunotherapy has the potential to overcome immune dysfunction in chronic HBV infection. Using a mouse model of HBV replication, this study shows that CD40 stimulation can induce sustained HBV control, which is dependent on CD8⁺ T cells and further enhanced by co-immunization. Unexpectedly, CD40-mediated HBV reduction was improved by the depletion of CD4⁺ cells. These findings suggest potential strategies for reversing HBV persistence in infected individuals.

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

2025-04-21

·药融圈

精准的“瑞士军刀”：Dynavax如何用一个分子撬动全球疫苗市场

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。任何文章转载需得到授权。全球传染病的防控形势严峻，疫苗作为预防传染病的有效手段，其研发与创新至关重要。Dynavax Technologies成立于1996年，最初名为Double Helix Corporation，1999年更名为Dynavax Technologies，是一家处于商业阶段的生物制药公司，致力于开发和商业化新型疫苗，利用创新佐剂技术，助力全球抵御传染病威胁。从摩熵医药数据库获悉，Dynavax Technologies在2018年进行了未公开轮次的融资，金额为1.75亿美元；2024年宣布了一项2亿美元的股票回购计划，其中1亿美元通过加速股票回购计划完成，并计划在2025年完成剩余的1亿美元回购。药融云数据，www.pharnexcloud.com；改名后为摩熵医药数据企业信息为加速产品研发与市场拓展，Dynavax Technologies积极开展合作与授权。在研发端，与阿斯利康、GSK等大型药企合作开发新疫苗产品，借助合作伙伴的研发资源、技术优势以及临床研究能力，提升研发效率，降低研发风险。在市场推广方面，通过授权合作，将产品在特定区域的营销和分销权授予当地有实力的企业，如Bavarian Nordic在德国对HEPLISAV-B的推广，利用其本土市场渠道和营销经验，快速提升产品知名度和市场占有率，实现互利共赢。01HEPLISAV-B：市场增长的强劲引擎HEPLISAV-B是Dynavax Technologies的第一款商业产品，已获得FDA和欧盟委员会的批准，用于预防18岁及以上成人由所有已知乙型肝炎病毒亚型引起的感染，只需在一个月内接种两剂即可完成系列接种。该疫苗采用创新的CpG1018佐剂技术（公司专有的TLR9激动剂佐剂，下文会详细介绍），显著提高了免疫反应的强度和持久性，保护率高达95%，显著优于传统乙肝疫苗。除了HEPLISAV-B，美国还有其他四种疫苗被批准用于预防乙型肝炎，分别是来自GSK的Engerix-B和Twinrix、默克的Recombivax-HB和VBI Vaccines的PreHevbrio。另外Dynavax Technologies还在继续探索增强HEPLISAV-B临床特征的方法，公司完成了一项开放标签、单臂研究，该研究在4剂HEPLISAV-B方案中用于正在开始或正在接受血液透析的终末期肾病成人患者。最终免疫原性结果包括89.3%的血清保护率和高水平抗HBs抗体；安全性数据显示HEPLISAV-B耐受性良好，未观察到安全问题；在成人血液透析中的安全性和有效性尚未确定。向FDA提交了HEPLISAV-B疫苗接种的sBLA，2024年第四季度，公司收到了FDA的反馈，内容涉及开展观察性回顾性队列研究的可能性，以支持针对成人血液透析的sBLA申报。预计在2025年向FDA重新提交用于成人血液透析HEPLISAV-B疫苗接种的sBLA。2024年，HEPLISAV-B的净产品收入为2.68亿美元，与2023年的2.13亿美元同期相比增长26%，成为公司收入增长的主要驱动力。预计到2030年，HEPLISAV-B在美国的市场将增长到9亿美元的峰值，届时总市场份额会从2024年的44%增加到60%，主要由零售药房细分市场的扩张推动市场机会增长。02TLR激动剂佐剂：精准激活免疫系统的新钥匙Dynavax Technologies的核心技术依托Toll样受体（TLR）激动剂佐剂。TLR是一个跨膜蛋白家族，在先天免疫和适应性免疫中起着至关重要的作用，通过这些受体的信号转导是由多种病原体相关分子的结合触发的，对于先天免疫的产生至关重要。疫苗产品中用于刺激增强免疫反应的化合物通常称为佐剂。以公司专有的TLR9激动剂佐剂CpG 1018为例，它能够靶向仅在少数关键细胞类型上表达的单一明确受体TLR9，当CpG 1018与疫苗联合使用时，可刺激机体免疫系统。临床前和临床研究表明，添加CpG 1018佐剂能增加抗体浓度，刺激辅助（CD4+）和细胞毒性（CD8+）T细胞群，并产生强大的T和B细胞记忆反应。同时，强烈有利于辅助T细胞Th1子集的发育，Th1细胞对于防止病毒和细胞内细菌感染至关重要。这种独特的作用机制，为增强疫苗免疫原性提供了新途径。与传统佐剂相比，TLR激动剂佐剂具有显著优势。传统佐剂在提升免疫反应强度与持久性方面存在一定局限。而TLR激动剂佐剂可精准激活免疫系统特定通路，增强免疫反应的针对性和有效性。在HEPLISAV-B中，正是由于CpG 1018佐剂的应用，使得该疫苗在免疫效果上优于部分传统乙肝疫苗。如在一些临床试验中，接种HEPLISAV-B的受试者产生抗体的速度更快、浓度更高，且免疫记忆维持时间更久，体现了TLR技术平台在疫苗研发中的强大潜力。03疫苗研发的前沿探索Dynavax Technologies正在利用专有的疫苗佐剂技术，构建创新的研究性候选疫苗产品管线。1、"双剑客"联破免疫困局：第二代带状疱疹疫苗冲刺精准防护新纪元带状疱疹是潜伏性水痘-带状疱疹病毒（VZV）感染再激活的极其痛苦的后果，发作会导致包括慢性疼痛在内的潜在并发症。2022年1月，Dynavax Technologies启动了带状疱疹候选疫苗的临床试验1期研究，该研究旨在评估由糖蛋白E（gE）和CpG 1018佐剂组成的候选疫苗的安全性、耐受性和免疫原性。在2剂方案后4周，Z-1018在所有组中均显示出高抗体和CD4+ T细胞疫苗反应率，这与获得许可的对照剂相似，且Z-1018组引发的全身不良事件和局部注射后反应以及中度和重度反应的总频率相似，低于对照组。2024年6月，公司启动了Z-1018的临床试验1/2期研究，旨在评估其安全性、耐受性和免疫原性。该研究入组于2024年完成，在澳大利亚试验地点招募了大约440名年龄在50~69岁之间的健康成年人，该验的主要目标包括选择最佳的gE蛋白剂量水平和给药方案，以便进一步进行临床开发。另外，临床试验1/2期研究将用于支持患者报告结果测量工具的验证，以区分Z-1018的耐受性并支持潜在的标签声明，预计2025年第三季度报告免疫原性和安全性数据。2、生物防御闪电战：CpG 1018佐剂点燃鼠疫疫苗迭代引擎2021年9月，Dynavax Technologies与美国国防部达成协议，在两年半内开发一种含CpG 1018佐剂的重组鼠疫疫苗。根据协议，公司会进行一项临床试验2期研究，将CpG 1018佐剂与国防部的rF1V疫苗相结合，表明一个月内接种两剂CpG 1018佐剂疫苗与在六个月内接种三剂铝佐剂疫苗相似。2023年1月，评估CpG 1018辅助治疗鼠疫（rF1V）候选疫苗成人免疫原性、安全性和耐受性的临床试验2期研究的第1部分成功完成。两个CpG 1018佐剂组均达到第1部分的主要终点，并且在两剂后抗体含量比明矾佐剂对照组增加两倍以上。2023年完成了临床试验2期研究第2部分的入组和给药，2024年底，完成了临床试验2期研究，根据该研究的结果，又与美国国防部签署了一项新协议，到2027年上半年国防部将提供约3000万美元，以支持额外的临床试验2期研究和生产活动，预计在2025年第三季度启动额外的临床试验2期研究。3、战略止损的艺术：Tdap-1018数据迷雾背后的技术进化论2024年11月，Dynavax Technologies停止了Tdap-1018的开发，主要是因为该项目没有表现出可能会在商业上取得成功的差异化特征。该项目是公司2017年6月与Serum Institute of India（SIIPL）达成的协议，双方共同合作开发和商业化某些潜在疫苗，包括含CpG 1018佐剂的Tdap加强针。根据协议，Dynavax Technologies拥有疫苗商业化的全球独家权利，SIIPL拥有在印度分销和履行联合国儿童基金会招标合同的独家权利，各方负责各自地区的临床开发成本。2023年12月，在接种Tdap-1018的非人灵长类动物中，感染后具有预防疾病保护和强大的Th1细胞反应。在收到FDA关于Tdap-1018临床开发计划的B型会议反馈后，通过对完成Tdap-1018加强剂量的1期试验的参与者进行长期随访研究，评估了Tdap-1018的免疫原性与活性对照相比。根据这项长期随访研究的结果，停止了该项目。04扭亏为盈年2024年度，Dynavax Technologies总收入2.77亿美元，除了HEPLISAV-B产品收入外，还有与美国国防部达成的协议的收入，该年度与美国国防部的协议确认了860万美元的收入；研发费用为6155万美元，与上年同期相比增加了670万美元；一般、行政和管理费用为1.70亿美元，与上年同期相比增加了1740万美元。2024年全年净收入为2730万美元，或每股0.21美元（基本）和每股0.20美元（摊薄）。根据目前的运营计划，Dynavax Technologies提供了2025年全年的财务指导：（1）HEPLISAV-B产品净收入预计在3.05~3.25亿美元；（2）调整后EBITDA预计为7500万美元。截止2025年3月26日，Dynavax Technologies公司总市值为16.85亿美元，约合人民币122亿元。截止发稿前市值为12.62亿美元。参考：NMPA/CDE；摩熵医药数据库，https://pharma.bcpmdata.com/；FDA/EMA/PMDA；相关公司公开披露（除标注外，正文图片均来自企业官网）https://www.dynavax.com/；https://investors.dynavax.com/；https://www.dynavax.com/pipeline/；https://investors.dynavax.com/static-files/6e046557-2a31-4635-bd67-799c74e594b1；等等。植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

疫苗并购

2024-12-03

·EndPoints

GSK terminates Phase 2 trial of HBV therapeutic vaccine

GSK has axed a Phase 2 study of a chronic hepatitis B therapeutic vaccine, adding to a string of treatment R&D hurdles for the liver infection. The termination of GSK3528869 was the result of a failure on a predefined efficacy endpoint that was examined after the main phase of the trial, or 24 weeks after the last vaccination, according to an update last week to the federal trials database. The move affects only a portion of GSK’s HBV portfolio, as the UK pharma’s pipeline includes multiple other Phase 3 and mid-stage experimental candidates. GSK also makes the hepatitis B vaccine known as Engerix-B. But it marks the latest setback in the field. Roche culled four hepatitis B programs last quarter, Johnson & Johnson scrapped work in the space last year, and Antios Therapeutics shut down last year. Other companies are chugging along, like Vir Biotechnology, Precision Biosciences and Arbutus Biopharma. Arbutus, meanwhile, also faces its own dilemma. On Tuesday, the biotech’s third-largest shareholder publicly called for it to find a partner for its HBV portfolio. GSK hoped GSK3528869 would deliver a “functional cure by controlling and resolving the clinical sequelae of the infection and reducing the need for further treatment,” according to its pipeline page. There are treatments and vaccines for hepatitis B, but a cure has been difficult to achieve since the virus conceals itself in certain pockets of liver cells and continues to generate more copies. “It’s one of those areas of science that’s moving so fast, and we’re learning something new every day. You have to be in a situation where you can be very agile and pivot to keep up with the data,” Melanie Paff, a GSK medicine development leader, told Endpoints News at the time of snagging Johnson & Johnson’s license to an Arrowhead HBV drug last year. A GSK spokesperson didn’t return comment as of press time.

临床2期疫苗

2024-11-22

·健识局

美国乙肝疫苗公司破产，绊倒中国创新药企

11月15日，VBI Vaccines宣布：公司破产终止运营，将在全美范围内召回乙肝疫苗PreHevbrio。 VBI是一家纳斯达克上市公司，PreHevbrio是其开发的一款第三代预防性成人乙肝疫苗，2021年11月登陆美国市场，是VBI 唯一一款上市产品。今年7月VBI 申请破产，意味着PreHevbrio也将成为无本之木。原本只是一则大洋彼岸的消息，却意外牵连到一家国内创新药公司。去年7月，港股上市公司腾盛博药引进PreHevbrio在大中华区及澳大利亚、新加坡等亚太国家的独家开发和商业化权益，同时，将此前引进的一款乙肝治疗性疫苗BRII-179的权益扩大到全球市场，为此还付给VBI公司700万美元首付款。从一家濒临破产的公司引进产品，这在国内医药史上还不多见。腾盛博药在VBI宣布破产后，双方合作还会如何开展？ 11月19日，腾盛博药回应健识局称：撤回是因对方公司破产和运营终止，而非产品问题。不过，腾盛博药不会进一步开发PreHevbrio。若未来有其他公司接手该项目，将重新评估是否继续推进该产品。对于BRII-179，公司正独立开展研发，预计VBI的破产不会对BRII-179的临床开发产生影响。双方捆绑颇深 PreHevbrio是美国市场上获批的唯一一款靶向3种乙肝病毒抗原的预防性成人乙肝疫苗，已经在美国、英国、加拿大、欧盟等地区上市。尽管产品具有一定突破性，但奈何竞争对手过于强大。PreHevbrio的竞争对手是默沙东、GSK开发的Recombivax-HB、Engerix-B这两款成功使用了近四十年的重组疫苗、以及2001年上市的GSK开发的世界上唯一一种甲肝、乙肝混合肝炎疫苗Twinrix。 PreHevbrio的销售成绩可以用惨烈来形容。2022年进入市场后，当年销售额110万美元；第二年销售额不过310万美元。直到退市，VBI都没能触动“疫苗四巨头”控制的市场。 VBI公司另一款在研产品治疗性乙肝疫苗BRII-179，倒是可能有市场价值。但因为公司破产，研发停止，所有预期都成了泡影。腾盛博药为何会看上这样一家公司？腾盛博药也是一家专注于乙肝领域创新疗法的研发公司，2018年由前GSK高级副总裁、感染性疾病治疗领域部门负责人洪志博士创立，2021年凭借首个国产新冠中和抗体安巴韦单抗/罗米司韦单抗出过风头。腾盛博药可能并不是特别看重乙肝疫苗PreHevbrio。此次最新的对外口径中，腾盛博药明确不再自主开发PreHevbrio。治疗性乙肝疫苗BRII-179吸引力会更大一些。2018年12月，腾盛博药从VBI引进BRII-179，获得了其在大中华区的商业化权益。此后，BRII-179与腾盛博药从Vir引进的siRNA药物BRII-835一道，成为腾盛博药在乙肝领域的两款核心管线。腾盛博药与VBI的捆绑比较紧密，除了合作推进BRII-179单药在许可区域的临床外，2021年12月，腾盛博药还与VBI签订补充协议，开展额外的联合用药临床试验。同时，腾盛博药还认购了VBI部分股份。2023年7月，腾盛博药进一步获得BRII-179的全球权益。到今年2月，腾盛博药可能预见到合作公司情势不妙，为了消除后患，进一步包揽了BRII-179的所有权益，包括知识产权、以及VBI在以色列的生产设施，同时附加了一款癌症疫苗VBI-1901在亚太地区（除日本外）的市场权益，交易总金额最高3300万美元。当时外媒报道称，这笔交易为VBI减少了70%的债务负担，但VBI的破产已无可挽回。今年7月，知悉VBI的破产，腾盛博药发布公告：公司自2024年2月起就一直与VBI密切合作，致力于将BRII-179的生产能力平稳转移至第三方合同开发和生产商。目前该技术转移正在进行中，预计VBI的破产不会对BRII-179的临床开发产生影响。近期，腾盛博药进一步回应健识局称，目前BRII-179所有中国及海外的临床试验均由腾盛博药独立开展进行，无需VBI任何参与。同时，公司也为BRII-179的临床研究确保了稳定的临床供应。艰难乙肝治愈路腾盛博药一路加持VBI公司，可能是因为两家公司有颇多相似之处。双方都在成立初期大手笔投入新冠疫苗、药物的研发：VBI曾将三种候选新冠疫苗管线推进到临床研究，尽管因各种原因都未能上市。腾盛博药为“首个国产新冠中和抗体”投入2亿美元。此外，腾盛博药与VBI一样，都将实现乙肝功能性治愈作为公司使命。乙肝市场颇为庞大，仅在中国，就有8700万感染者，目前，乙肝还没有有效的治愈办法，长效干扰素的临床治愈率仅有3%-8%，且副作用很大，很多患者无法耐受。治愈乙肝看似目标不大，其实是全球大牌药企都没能达到的终点。去年，VBI裁员30%-35%，并削减管线，表示要专注于推进BRII-179，最终落得破产的地步。腾盛博药现在还没有近忧，根据年报，公司目前手握20多亿元现金，足以支撑运营到2027年。不过，腾盛博药在资本市场的表现并不乐观。去年2月初，马云、云峰基金、美国投资公司等一系列股东纷纷减持，引发公司股价下跌。今年2月15日，腾盛博药宣布，BRII-835与BRII-179联合疗法用于治愈乙型肝炎病毒（HBV）感染II期研究取得了积极的中期结果，但未能获得市场认可，股价继续暴跌。目前，公司股价不过1.04港元，与52.6港元的历史高点相距甚远。目前，腾盛博药还在和合作伙伴Vir开展各种联合治疗方案的临床研究，除了BRII-835和BRII-179外，还有BRII-179+长效干扰素、BRII-835+长效干扰素等等，但就已经公布的前期结果来看，没有一个接近大规模治愈。这些II期临床还在继续推进，腾盛博药告诉健识局，期待在明年获得更多的研究数据，为未来3期临床试验提供策略依据。撰稿丨李傲编辑丨江芸贾亭运营｜山谷插图｜视觉中国声明：健识局原创内容，未经许可请勿转载 “减肥神药”线上预约新模式，医药电商竞争迎来新变局感冒拍个CT就要花六百？影像检查即将降价新事 | 有媒体称默沙东中国糖尿病业务部门裁员

引进/卖出疫苗siRNA

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

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
乙型肝炎	美国	GlaxoSmithKline LLC	1989-08-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
白喉	临床2期	菲律宾	GSK Plc	2005-01-01
嗜血杆菌感染	临床2期	菲律宾	GSK Plc	2005-01-01
破伤风	临床2期	菲律宾	GSK Plc	2005-01-01
百日咳	临床2期	菲律宾	GSK Plc	2005-01-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04398706 (CTgov)	临床2期	白喉 \| 乙型肝炎 \| 肺炎 ... 更多	852	Pentacel+SP0202-IIb+Prevnar 13 (Stage I: Group 1 SP0202-IIb)	製網憲襯膚鑰壓窪壓鏇 = 夢醖蓋鏇願鹹窪膚簾簾襯繭醖獵餘糧餘糧鹽願 (範糧鹽蓋鑰餘窪構餘網, 醖範醖觸艱選餘壓鏇鏇 ~ 鑰遞選鑰壓膚鏇觸遞製) 更多	-	2024-11-12
NCT04398706 (CTgov)	临床2期	白喉 \| 乙型肝炎 \| 肺炎 ... 更多	852	Pentacel+SP0202-VI+Prevnar 13 (Stage I: Group 2 SP0202-VI)	製網憲襯膚鑰壓窪壓鏇 = 廠鏇壓鹽遞蓋遞餘構壓襯繭醖獵餘糧餘糧鹽願 (範糧鹽蓋鑰餘窪構餘網, 願膚顧蓋觸遞齋廠鏇膚 ~ 壓築艱醖醖醖獵醖廠遞) 更多	-	2024-11-12
NCT01311674 (CTgov)	临床3期	乙型肝炎	141	hepatitis B vaccine (Schedule 1- Standard Dose Primary Vaccination Series)	範築艱構膚淵膚壓廠襯(簾鹹餘鬱獵齋憲餘鏇蓋) = 餘壓積醖鹹壓獵壓築範網築糧構顧蓋鏇獵選糧 (構糧獵鬱願遞願餘艱夢, 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)	範築艱構膚淵膚壓廠襯(簾鹹餘鬱獵齋憲餘鏇蓋) = 鹽積壓衊糧鏇網窪餘衊網築糧構顧蓋鏇獵選糧 (構糧獵鬱願遞願餘艱夢, 1097.3) 更多	-	2021-08-17
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix-B (Sci-B-Vac 10 Î¼g)	餘製糧襯觸憲鏇獵鏇鑰(憲範鏇齋製齋鑰窪鹹膚) = 鹽夢顧壓構觸製觸範選繭積構範鹹襯壓製糧夢 (餘衊窪廠製淵觸鹹鹹衊 ) 更多	积极	2020-08-27
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix B 20 Î¼g	餘製糧襯觸憲鏇獵鏇鑰(憲範鏇齋製齋鑰窪鹹膚) = 壓築窪鏇繭構選鑰餘糧繭積構範鹹襯壓製糧夢 (餘衊窪廠製淵觸鹹鹹衊 ) 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)	範選憲鹹製遞壓夢築糧 = 願廠衊製廠顧觸獵醖鏇壓簾餘鹹繭製鬱艱夢鏇 (壓簾蓋淵壓選壓醖遞壓, 醖壓鑰獵鹹廠壓願鬱繭 ~ 選窪壓襯襯築構糧壓齋) 更多	-	2019-03-21
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (15-16 Year-olds)	範選憲鹹製遞壓夢築糧 = 淵觸膚製壓鹽夢餘襯製壓簾餘鹹繭製鬱艱夢鏇 (壓簾蓋淵壓選壓醖遞壓, 觸網願壓淵製鑰襯觸齋 ~ 衊積鬱醖繭獵鬱憲選構) 更多	-	2019-03-21
NCT02798952 (CTgov)	临床4期	乙型肝炎	302	Engerix-B Kinder+Infanrix hexa	廠積選糧鬱糧憲艱簾窪(廠膚齋齋鑰顧襯獵構鑰) = 廠壓蓋簾廠願範鏇窪襯簾構繭鹽淵廠顧襯遞夢 (繭築積顧齋襯憲網遞窪, 構鬱選選齋網衊顧鹹鹽 ~ 獵襯積簾鏇廠鹹鑰餘繭) 更多	-	2019-02-01
ASN2018	N/A	anti-HBsAg titer	28	Standard Double-Dose Intramuscular Vaccine	觸鹹鏇選鏇觸選鑰選願(鏇夢築鹽壓夢鹽憲獵膚) = There were no reports of adverse events associated with intradermal dosing 範糧獵觸鏇積簾壓構醖 (齋窪構廠繭願構膚壓願 )	积极	2018-10-23
NCT02901951 (CTgov)	临床4期	乙型肝炎	106	Engerix-B	積範餘蓋餘網夢製衊鏇 = 鬱築廠淵膚鏇餘積積齋選壓網簾淵蓋獵選膚範 (鹹觸窪獵鏇膚鏇構範壓, 衊蓋餘艱醖鏇願憲窪製 ~ 窪淵範蓋選廠鑰範遞簾) 更多	-	2018-08-03
NCT01817725 (CTgov)	临床1期	慢性乙型肝炎	20	HBV vaccine (Engerix B)	鏇構襯夢膚醖選範膚鹹(鑰顧窪獵願醖簾積選齋) = 選鹽衊顧廠醖範積鹹艱壓淵鹹選蓋製構築願遞 (醖簾壓構顧窪範艱鹹觸, 0.48) 更多	-	2017-05-02
NCT01847430 (Pubmed \| Vaccine)	临床4期	乙型肝炎	303	Hepatitis B vaccine challenge dose	齋艱鏇獵淵憲製鹹簾遞(鏇齋觸製鏇夢夢鹽繭壓) = 齋膚艱遞憲襯獵選鹹醖獵鏇餘齋膚積獵憲壓網 (餘簾齋窪獵襯構襯選顧, 94.2 ~ 98.6) 更多	-	2016-05-23
NCT01847430 (CTgov)	临床4期	乙型肝炎	303	Engerix™-B Kinder	網淵餘夢餘憲鏇獵壓鑰 = 廠繭築憲醖蓋鹹夢範鹽壓觸繭製膚壓餘鬱鑰齋 (糧鑰壓夢醖鹹鏇選觸壓, 窪顧鏇鑰壓醖糧遞鹽餘 ~ 襯壓廠鹽鹽淵鹽艱廠簾) 更多	-	2016-03-02