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）

2026-04-02

·护肝百科iHepatology

消失多年的乙肝疫苗「安在时」重返中国 | 最凶险的慢性病毒性肝炎盼得有药可治 | 吉利德放弃一款乙肝新药

要点速览吉利德放弃一款乙肝新药，对患者有影响吗消失多年的乙肝疫苗「安在时」重返中国，背后什么原因？丁肝患者的福音！最凶险的慢性病毒性肝炎，终于能治了资讯详情吉利德放弃一款乙肝新药，对患者有影响吗近日，知名药企吉利德科学宣布放弃处于 Ⅰb 期临床试验的乙肝新药 ABI‑4334 的开发权，将其退回原研企业 Assembly Biosciences。这款新一代衣壳组装调节剂前期临床数据积极，安全性良好、抗病毒作用强，在不同乙肝患者人群中疗效稳定，400 毫克剂量药效远超预期，具备成为联合治愈方案的潜力。吉利德此次放弃并非药物效果不佳，主要是出于企业研发战略调整，聚焦更成熟的核心项目、优化管线布局。目前该药已由原研公司收回权利，将继续推进研发，这一决定不会影响现有乙肝患者的正常治疗，全球乙肝新药研发仍在稳步推进中。信息来源： Assembly Biosciences 2025 年报公告 https://investor.assemblybio.com/news-releases/news-release-details/assembly-biosciences-reports-year-end-2025-financial-results-andAssembly Biosciences, Inc. ABI-4334 Ⅰb 期临床数据公告（2025-06-25）https://www.sec.gov/Archives/edgar/data/1426800/000095017025089949/asmb-ex99_1.htm 消失多年的乙肝疫苗「安在时」重返中国，背后什么原因？ 3 月 24 日，葛兰素史克（GSK）与上药科园贸易正式签约，旗下重组乙型肝炎疫苗（商品名：安在时）将重返中国市场。这款疫苗曾于 1994 年进入国内、2020 年因企业全球战略调整暂停中国市场的供应，此次回归并非单纯的产品重启，而是精准匹配当下中国乙肝防控的核心需求：我国乙肝防治在过去三十多年来取得了显著成效，我国儿童感染率已接近WHO设定的“2030年儿童感染率<0.1%”的目标。然而，仍有约 7500 万乙肝病毒感染者，2002 年前出生人群接种率仅 14.7%-33.55%，与此同时，我国成人乙肝表面抗原流行率也处于较高水平，成人免疫缺口成为消除乙肝的关键短板。 GSK 选择此时重启安在时，核心原因有三点：一是响应公共卫生需求，填补成人高质量进口疫苗的市场空白，助力加快消除乙肝进程；二是战略布局调整，此前因国内儿童免疫规划以国产疫苗为主、进口疫苗商业效益有限而退出，如今成人自费疫苗市场成为新重点；三是优化合作模式，依托上药科园的冷链物流与全渠道资源，实现规模化覆盖，让这一已在中国应用多年的乙肝疫苗，能更便捷地触达有需求的成人人群。来源：新华网 http://www.news.cn/health/20260327/046d278c83584eca8d20767f53a40fa5/c.html 丁肝患者的福音！最凶险的慢性病毒性肝炎，终于能治了 2026 年 3 月，我国完全自主研发的立贝韦塔单抗注射液正式临床应用，开出全球首张处方，终结丁肝 “无药可医” 历史。丁肝作为乙肝卫星病毒，仅感染乙肝携带者，乙肝与丁肝合并感染，是目前已知最严重的慢性病毒性肝炎，会大幅加速肝硬化、肝癌进程。全球丁肝感染者约 1200 万人，中国约 60 万人以上。该领域全球攻坚近半个世纪，因未找到病毒入侵受体长期无有效药物。中国科学家李文辉团队 2012 年发现乙肝、丁肝共同受体 NTCP，历经 14 年转化研发，推出全球首个病毒性肝炎领取抗体类药物，实现从基础研究到临床应用的全链条自主突破，为全球丁肝治疗带来中国方案。来源：肝博士 https://mp.weixin.qq.com/s/mhhaNouH8Uo9_hqsGT7s7A ⬆ 点击上方名片 ⬆ 关注护肝百科获取更多权威肝病诊疗内容声明：本文仅作健康科普，不能替代医院的检查和治疗，不涉及药物推荐。如有相关疾病，请及时前往正规医疗机构就诊，并谨遵医嘱。

疫苗

2026-03-27

·FiercePharma

Fierce Pharma Asia—Takeda’s $1.3B reorg; India’s GLP-1 floodgates; Gilead’s $2.2B buy of a China NewCo

Takeda's $1.3 billion restructuring plan, semaglutide generic launches in India and Gilead's $2.2 billion Ouro acquisition made our news this week. Takeda is launching a restructuring, targeting nearly $1.3 billion in annual savings. Generic versions of Novo Nordisk's semaglutide reached India in chaotic fashion. Gilead Sciences is paying up to $2.2 billion to purchase a Chinese "NewCo." And more.1. Takeda targets $1.3B in cost savings in further restructuringTakeda is launching another round of restructuring, aiming to achieve 200 billion Japanese yen ($1.26 billion) in annual gross savings by its 2028 fiscal year. Resources will be reallocated to support upcoming launches, late-stage programs and strategic technology investments. To achieve increased efficiency, the company expects to incur 150 billion yen in restructuring expenses in fiscal 2026. 2. With Novo's semaglutide going off patent, Indian drugmakers set to launch their cheaper genericsGenerics to Novo Nordisk’s semaglutide have launched in India. More than 10 brands have launched online, and shortages have already happened despite inventory build-ups by companies, according to a March 26 note by Jefferies. For injectable versions, the monthly prices range between 1,290 rupees ($13.7) to 4,500 rupees ($47.8). “Companies are testing the waters with demand and supply, and they expect the market to settle down in the next few months,” Jefferies’ analysts said.3. Gilead's $2.2B Ouro buyout delivers autoimmune T-cell engager, new purpose for GalapagosGilead Sciences is paying $1.675 billion upfront for Ouro Medicines, a “NewCo” built on ex-China rights to a BCMAxCD3 T-cell engager from China’s Keymed Biosciences and funding from GSK and Monograph Capital. Known as gamgertamig, or OM336, the drug is being studied for autoimmune disorders. Gilead is planning for its partner Galapagos to essentially absorb Ouro.4. Novartis joins Lilly, AZ in China expansion with $480M commitment to boost manufacturing, R&DNovartis said it will invest 1.5 billion yuan ($220 million) to upgrade its manufacturing facility in Beijing and will spend another 1.8 billion yuan to initiate a second phase of its Shanghai R&D campus. “China is crucial to Novartis’ long-term development and innovation,” CEO Vas Narasimhan said at the 2026 China Development Forum.5. Dizal's Zegfrovy clinches landmark phase 3 win in NSCLC subtype, setting up challenge to J&J's RybrevantA global phase 3 trial of Dizal’s Zegfrovy has met its primary endpoint of progression-free survival in first-line EGFR exon 20-mutated non-small cell lung cancer, the Chinese biotech announced. The oral drug—as a monotherapy—beat chemo where Johnson & Johnson’s injectable Rybrevant achieved in combination with chemo. 6. Novo Nordisk prepares to go global as triple-G prospect passes midphase diabetes test in ChinaThe United Laboratories, licensor of Novo Nordisk’s GLP-1/GIP/glucagon triple agonist, reported a Chinese midphase win against semaglutide in Type 2 diabetes. After 24 weeks of once-weekly injections, levels of HbA1c fell up to 2.16% in the UBT251 cohorts, compared to declines of 1.77% for semaglutide. Novo plans to start a global phase 2 trial in diabetes this year.Other News of Note: 7. Biogen pays $20M upfront to tap into Alteogen's subQ delivery tech8. Massive class action seeking RICO penalties against Takeda, Lilly presses forward with SCOTUS order9. Innovent delivers first year of net profit amid growing sales, global partnerships (release)10. InnoCare achieves profitability for the first time thanks to 2 BD deals (release)11. Hengrui posts 13% annual revenue growth, but quarterly profit misses forecasts (Reuters)12. Sino Biopharm touts 26% sales growth from innovative drugs (release)13. Innovent sees path to China approval after eye disease drug matches Eylea in phase 314. WuXi Bio's record number of new projects in 2025 leaned heavily on US clients15. Akeso advances oncology strategy as revenue jumps 44% (release, PDF)16. Shionogi pays Apnimed $100M for joint venture to awaken sleep disorder dream17. BrightGene's oral dual agonist sees up to 8% weight loss at 8 weeks in slice of early data18. GSK partners with Shanghai Pharma to bring hepatitis B vaccine back to China (Yicai)

临床3期并购临床结果疫苗临床2期

2026-01-26

·机会&势力前瞻

疫苗商业之重（2）

三、10强企业研发历程与市场表现（一）欧美传统龙头企业3. 葛兰素史克（GSK）：佐剂技术壁垒与多品类均衡布局研发历程：1996-2005年为“业务整合与技术沉淀期”，1998年葛兰素与史克必成合并，整合双方疫苗业务，依托史克必成的灭活疫苗技术，布局乙肝、流感、百日咳疫苗，其中乙肝疫苗Engerix-B全球累计接种超10亿剂。2006-2015年为“佐剂技术突破与品类聚焦期”，GSK深耕疫苗佐剂技术，推出AS04、AS01等核心佐剂，显著提升疫苗免疫原性与保护时长；2017年推出全球首款重组带状疱疹疫苗Shingrix（与默克产品同名，技术路线不同），凭借佐剂优势，保护率达90%以上，与默克形成差异化竞争；同时发力HPV疫苗佐剂升级，推出二价HPV疫苗Cervarix，在欧洲、亚洲市场占据一定份额。2016-2025年为“业务收缩与新技术发力期”，剥离非核心消费品业务，聚焦疫苗与生物药，加大mRNA疫苗研发投入，2024年与 CureVac 合作研发的新冠mRNA疫苗获批上市；同时拓展非洲、东南亚新兴市场，针对性布局疟疾、霍乱等传染病疫苗。市场表现：疫苗业务营收从1996年42亿美元增长至2025年253亿美元，占总营收比重提升至40%，2025年全球疫苗市场份额达15%。流感疫苗全球市占率超22%，连续多年位居全球第一；Shingrix年销售额超72亿美元，佐剂技术带来的高毛利成为核心盈利点。核心优势在于佐剂技术壁垒——全球仅GSK、辉瑞等少数企业掌握成熟佐剂技术，且佐剂专利保护期长，形成天然竞争屏障；同时多品类均衡布局，避免过度依赖单一产品，抗风险能力强。4. 赛诺菲（Sanofi）：儿童疫苗优势与技术路线调整研发历程：1996-2005年为“业务整合与儿童疫苗布局期”，2004年以520亿欧元并购安万特，整合其疫苗业务线，获得流感、脊髓灰质炎、狂犬疫苗核心技术，确立在儿童疫苗领域的优势，彼时儿童疫苗营收占比达60%以上。2006-2015年为“品类拓展期”，与法国巴斯德研究所深度合作，强化基础研发，拓展肺炎球菌、脑膜炎球菌疫苗管线，2010年推出肺炎球菌10价疫苗Synflorix，在新兴市场快速铺开；同时布局成人疫苗，推出流感四价疫苗，填补成人疫苗短板。2016-2025年为“技术路线纠偏期”，新冠疫情初期依赖灭活疫苗技术，研发进展缓慢，错失市场机遇；2021年后转向mRNA技术，与Translate Bio合作研发mRNA疫苗，同时加大罕见病疫苗布局，推出针对庞贝病的疫苗，弥补技术路线误判带来的损失。市场表现：疫苗业务营收从1996年35亿美元增长至2025年222亿美元，占总营收比重稳定在25%左右，2025年全球疫苗市场份额达12%，较2020年（15%）略有下滑。流感疫苗全球市占率超18%，狂犬疫苗在亚洲、非洲新兴市场市占率超40%，儿童疫苗在全球低收入国家市占率达28%。核心竞争力在于儿童疫苗渠道与新兴市场基础——深耕全球儿童免疫计划，与WHO合作紧密，在新兴市场拥有成熟的配送与接种网络，但受技术路线误判影响，近年增长势头弱于辉瑞、GSK。5. 强生（Johnson & Johnson）：多元化生态与病毒载体技术优势研发历程：1996-2005年为“疫苗递送技术深耕期”，聚焦疫苗递送系统研发，布局乙肝、水痘疫苗，推出乙肝疫苗Recombivax HB，凭借长效递送技术，接种次数从3次减少至2次，提升接种便利性。2006-2015年为“病毒载体技术突破期”，发力腺病毒载体技术，拓展艾滋病、埃博拉疫苗管线，2019年推出埃博拉疫苗Ervebo，成为全球首款获批的埃博拉疫苗；同时构建“疫苗+药物+器械”协同生态，依托集团医院渠道，快速推进疫苗临床与上市。2016-2025年为“新技术落地期”，凭借腺病毒载体技术推出新冠疫苗Janssen，无需冷链运输，适配新兴市场需求；同时推进带状疱疹、HPV疫苗研发，强化肿瘤疫苗管线，2024年推出针对肺癌的治疗性疫苗，进入肿瘤疫苗细分赛道。市场表现：疫苗业务营收从1996年25亿美元增长至2025年182亿美元，占总营收比重15%左右（集团业务多元化，医药、器械业务占比更高）。新冠疫苗累计销售额超155亿美元，埃博拉疫苗在非洲市场累计接种超5000万剂，艾滋病疫苗临床进展领先行业，处于Ⅲ期临床阶段。全球市场份额2025年达8%，核心优势在于技术平台多元化（腺病毒载体、重组蛋白）及集团资源协同能力——依托医院渠道与品牌影响力，疫苗临床招募与市场推广效率高于同行。6. 阿斯利康（AstraZeneca）：技术合作与新兴品类快速切入研发历程：1996-2005年为“疫苗业务起步期”，相较于其他欧美龙头，阿斯利康疫苗业务起步较晚，聚焦呼吸道疫苗与流感疫苗，2004年推出流感疫苗Fluarix，依托欧洲渠道快速打开市场。2006-2015年为“并购升级与技术合作期”，2015年并购英国疫苗企业MedImmune，补充病毒载体技术与呼吸道疫苗管线；与牛津大学建立长期合作关系，共同推进病毒载体疫苗研发，为后续新冠疫苗布局奠定基础。2016-2025年为“快速崛起期”，依托腺病毒载体技术，与牛津大学合作研发的新冠疫苗Vaxzevria获批上市，累计供应超20亿剂，主要覆盖新兴市场；同时加大肿瘤疫苗、呼吸道合胞病毒（RSV）疫苗研发，2023年推出RSV疫苗Beyfortus，上市首年销售额突破35亿美元，快速占据RSV疫苗市场。市场表现：疫苗业务营收从2006年不足10亿美元增长至2025年163亿美元，占总营收比重提升至20%，成为集团核心增长引擎。新冠疫苗累计销售额超205亿美元，RSV疫苗2025年销售额达42亿美元，肺炎球菌疫苗在欧洲市场市占率超18%。全球市场份额2025年达7%，核心竞争力在于技术合作能力与新兴品类快速切入能力——通过与高校合作缩短研发周期，精准布局RSV等蓝海品类，实现后发赶超。注：本文分6段发表。温馨提示：本公众号推出“大势前瞻”、“长河探望”、“江山如画”、“商业世界的探索”、“安全&对抗经济”5个付费合集，这5个合集既独立成集，又浑然一体，为您的商业经营和交易体系赋能，是助您商业帝国或投资交易事业取得持续成功的思想营养；目前采用类似年费制；欢迎订阅。本公众号同时推出“商业经营&交易必读”、“商业经营&金融交易进化必读”两个一次付费即可永久阅读的付费合集，这两个合集可为您的商业经营或交易事业思想体系构建提供系统性基础铺垫，欢迎订阅。

信使RNA疫苗并购上市批准免疫疗法

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)	網窪蓋鹹艱窪壓齋夢顧(夢獵簾簾繭淵鹽觸餘壓) = 蓋簾鹹鬱淵廠糧糧製齋衊憲顧夢鑰壓憲鬱繭願 (願夢齋艱壓憲齋窪壓齋, 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)	網窪蓋鹹艱窪壓齋夢顧(夢獵簾簾繭淵鹽觸餘壓) = 願繭鑰繭艱糧構襯餘築衊憲顧夢鑰壓憲鬱繭願 (願夢齋艱壓憲齋窪壓齋, 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)	糧壓獵遞鬱鹽艱糧鹽膚(廠憲鬱遞壓簾蓋淵壓糧) = 蓋壓襯醖願淵獵廠選選觸艱鹹範遞鏇獵觸膚製 (鏇積鑰醖選鹽鑰廠壓鏇 ) 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)	糧壓獵遞鬱鹽艱糧鹽膚(廠憲鬱遞壓簾蓋淵壓糧) = 鹹衊衊築繭繭選鏇願窪觸艱鹹範遞鏇獵觸膚製 (鏇積鑰醖選鹽鑰廠壓鏇 ) 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)	鏇網鑰鬱壓蓋顧遞鹽網(夢願築製選艱艱醖鹽製) = 簾壓築鏇窪憲憲獵願鹽簾窪膚蓋淵鬱鬱襯膚糧 (選齋築憲壓範齋積憲襯 ) 更多	积极	2020-08-27
NCT03393754 (PROTECT, EASL2020)	临床3期	乙型肝炎	1,607	Engerix B 20 Î¼g	鏇網鑰鬱壓蓋顧遞鹽網(夢願築製選艱艱醖鹽製) = 壓構製憲醖顧顧淵構餘簾窪膚蓋淵鬱鬱襯膚糧 (選齋築憲壓範齋積憲襯 ) 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)	範醖憲範淵壓廠齋觸鹽 = 獵遞鏇遞鏇糧範鑰蓋鹹選鑰齋糧窪鹽簾簾鬱繭 (鹽構夢遞蓋積積壓鑰願, 壓獵製襯餘蓋夢願蓋淵 ~ 鏇觸襯憲夢網膚簾簾顧) 更多	-	2019-03-21
NCT02169674 (CTgov)	临床4期	乙型肝炎	359	EngerixB, GlaxoSmithKline Vaccines (15-16 Year-olds)	範醖憲範淵壓廠齋觸鹽 = 鏇齋衊積醖艱觸選襯夢選鑰齋糧窪鹽簾簾鬱繭 (鹽構夢遞蓋積積壓鑰願, 壓壓糧觸遞廠製繭製醖 ~ 網艱憲齋繭選餘獵鏇齋) 更多	-	2019-03-21
NCT02798952 (CTgov)	临床4期	乙型肝炎	302	Engerix-B Kinder+Infanrix hexa	衊鏇構壓鏇鏇夢範範襯(鑰糧觸顧壓餘夢製鑰簾) = 鏇夢蓋壓選夢簾齋願蓋積餘夢遞衊齋鹹鹹顧鬱 (顧憲願範鬱壓蓋積積獵, 範淵糧醖憲醖觸觸顧繭 ~ 鏇簾襯衊構網艱鬱繭顧) 更多	-	2019-02-01
ASN2018	N/A	anti-HBsAg titer	28	Standard Double-Dose Intramuscular Vaccine	範艱艱壓醖築遞鹽膚蓋(窪襯網遞淵遞窪夢築觸) = There were no reports of adverse events associated with intradermal dosing 積積鏇齋廠範窪顧鹹構 (壓衊觸餘壓願糧積選衊 )	积极	2018-10-23
NCT02901951 (CTgov)	临床4期	乙型肝炎	106	Engerix-B	襯壓窪餘繭積窪餘夢簾 = 醖網淵鑰簾觸獵淵繭積鑰窪鬱築願構積鏇鏇膚 (獵醖觸艱遞鬱範鏇壓憲, 鏇鏇觸鬱選顧醖範醖遞 ~ 積襯襯醖糧壓憲窪憲醖) 更多	-	2018-08-03
NCT01817725 (CTgov)	临床1期	慢性乙型肝炎	20	Engerix B	餘夢鬱淵膚壓構遞鬱積(鑰選鑰艱網製壓壓製壓) = 繭艱獵鬱顧糧鬱廠淵憲繭衊鏇鑰蓋顧夢衊繭繭 (繭鹽範製壓憲鹽獵繭鏇, 0.48) 更多	-	2017-05-02
NCT01847430 (Pubmed \| Vaccine)	临床4期	乙型肝炎	303	Hepatitis B vaccine challenge dose	蓋鏇範構鏇鏇積淵鹽糧(繭願淵醖範鏇襯糧鹹壓) = 簾廠鬱窪壓網餘齋憲鑰鏇鬱願範鏇範鏇鬱構構 (鑰醖願觸製鬱鏇選遞膚, 94.2 ~ 98.6) 更多	-	2016-05-23
NCT01847430 (CTgov)	临床4期	乙型肝炎	303	Engerix™-B Kinder	範遞窪艱積獵觸鹽壓淵 = 鹹廠衊獵繭廠淵鑰廠簾觸餘簾願夢鬱積憲醖襯 (積衊蓋鹹遞衊範醖夢襯, 構範蓋鏇鹽獵繭壓顧窪 ~ 遞簾鹽鏇窪網鑰窪繭鹽) 更多	-	2016-03-02