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更新于：2026-01-14

Recombinant hepatitis B vaccine(Hualan Biological Bacterin Co., Ltd.)

重组乙型肝炎 (华兰生物疫苗)

更新于：2026-01-14

概要

基本信息

药物类型

预防性疫苗、重组亚单位疫苗

别名

Recombinant Hepatitis B Vaccine(Hansenula Polymorpha)、重组乙型肝炎疫苗（汉逊酵母，华兰生物疫苗）

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染消化系统疾病

在研适应症

乙型肝炎

非在研适应症-

原研机构

华兰生物疫苗股份有限公司

在研机构

华兰安康生物股份有限公司

华兰生物疫苗股份有限公司

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

中国 (2010-06-02),

乙型肝炎

最高研发阶段(中国)批准上市

特殊审评-

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关联

项与重组乙型肝炎 (华兰生物疫苗) 相关的临床试验

CTR20132136

/ Active, not recruiting临床3期

20μg重组乙型肝炎疫苗(汉逊酵母)用于16岁及以上健康人群的Ⅲ期临床研究

评价华兰生物20μg重组乙型肝炎疫苗(汉逊酵母)用于16岁及以上健康人群的安全性和免疫原性

开始日期2014-09-30

申办/合作机构

华兰安康生物股份有限公司

[+1]

CTR20132239

/ Active, not recruiting临床3期

随机、双盲、平行对照10μg重组乙型肝炎疫苗(汉逊酵母)用于乙肝母婴阻断的安全性和免疫原性临床试验

评价华兰生物疫苗有限公司研制生产的10μg重组乙型肝炎疫苗（汉逊酵母）接种于HBsAg、HBeAg双阳性母亲所生的新生儿进行乙肝母婴阻断的安全性和阻断效果

开始日期2013-06-18

申办/合作机构

华兰安康生物股份有限公司

[+1]

CTR20132472

/ Active, not recruiting临床3期

随机盲法平行对照10μg重组乙型肝炎疫苗(汉逊酵母)用于健康婴幼儿基础免疫安全性和免疫原性临床试验

评价华兰生物疫苗有限公司生产的10μg重组乙型肝炎疫苗(汉逊酵母)用于未接种过乙肝疫苗的健康婴幼儿基础免疫后的安全性和免疫原性

开始日期2013-05-24

申办/合作机构

华兰安康生物股份有限公司

[+1]

100 项与重组乙型肝炎 (华兰生物疫苗) 相关的临床结果

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100 项与重组乙型肝炎 (华兰生物疫苗) 相关的转化医学

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100 项与重组乙型肝炎 (华兰生物疫苗) 相关的专利（医药）

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项与重组乙型肝炎 (华兰生物疫苗) 相关的文献（医药）

2017-12-01·Liver International

Higher disappearance rate of anti‐HBs in Taiwanese freshers neonatally vaccinated with recombinant yeast hepatitis B vaccine

Article

作者: Jan, Chyi‐Feng ; Lee, Yi‐Chin ; Hsu, Shu‐Hua ; Chih, An‐Hsuan ; Huang, Kuo‐Chin

Abstract:

Background & Aim:

The aim of this study was to compare the long‐term efficacy of infant recombinant yeast hepatitis B vaccine (Recombinant group) and infant plasma‐derived one (Plasma group) in Taiwanese freshers.

Methods:

Recruited were a total of 38 377 freshmen who underwent university entrance health examinations from 2003 to 2015. Subjects were assigned into two groups—plasma type and recombinant type, according to the national neonatal hepatitis B immunization program. The seroprevalences of hepatitis B surface antigen, antibody against hepatitis B surface antigen, and antibody against hepatitis B core antigen in each group and gender were calculated. Multivariate logistic regression analysis was performed to compare the efficacy of two groups.

Results:

The HBsAg‐positive rates in the plasma group and recombinant group were 1.5% and 0.3% respectively. The anti‐HBs positive rates were 43.6% and 30.9%. The hepatitis B viral natural infection rates were 3.6% and 1.3%. Taking those who were born in July 1986‐April 1992 as baseline group after adjustment for gender and age at hepatitis B markers checkup time, the efficacy of recombinant group in decreasing HBsAg positive rate, and decreasing hepatitis B virus natural infection rate was 71.0% (95% C.I.: 59.0‐79.0%, P<.001) and 65.0% (95% C.I. 58.0‐71.0%, P<.001) respectively. On the contrary, the seroprevalence of anti‐HBs positive rate in recombinant group was 39.0% (95% C.I.: 36.0‐42.0%, P<.001) lower than that of plasma group. (P<.001).

Conclusion:

Higher disappearance rate of anti‐HBs was noted in recombinant group than in plasma group when the subjects reached their youth and young adulthood in Taiwan.

2015-05-01·The Indian journal of medical research4区 · 医学

Status of hepatitis B infection - a decade after hepatitis B vaccination of susceptible Nicobarese, an indigenous tribe of Andaman & Nicobar (A&N) islands with high hepatitis B endemicity

4区 · 医学

ArticleOA

作者: Bhattacharya, Debdutta ; Sugunan, A. P. ; Roy, Subarna ; Bhattacharya, Haimanti ; Ghosal, S. R.

Background & objectives::

Andaman and Nicobar Islands of India, home to six primitive tribes, constituting about 10 per cent of the total population of these Islands have been detected with high endemicity of hepatitis B infection. During 2000, a total of 936 individuals ≤ 45 yr, negative for hepatitis B surface antigen (HBsAg) and antibody anti-HBs were vaccinated with three doses of a recombinant DNA hepatitis B vaccine in two villages of Car Nicobar Islands. The present study was undertaken to evaluate the impact of the hepatitis B vaccination with respect to the persistence of antibodies and incidence of new infections, prevalence of surface gene mutations among the Nicobarese community in the two villages ten years after hepatitis B vaccination.

Methods::

Follow up samples were collected from 211 individuals who had received three doses of vaccine ten years back and from a control group of 515 non-vaccinated individuals. The HBsAg, anti-HBs and anti-HBc assay results were compared among vaccinated and non-vaccinated groups. HBV DNA was extracted and sequenced from all the samples for detection of mutation. Genotyping and serotyping of the viruses were performed.

Results::

The results showed that 85.3 per cent of the vaccinated persons retained protective level of antibodies and among the non-vaccinated individuals, 54.2 per cent showed presence of anti-HBs indicating an exposure to the infection. The overall HBsAg positivity among the studies Nicobarese individuals was reduced to 7.4 per cent after 10 years of vaccination. Anti-HBc was positive in 60.6 and 57 per cent among the vaccinated and non-vaccinated individuals, respectively. Overall breakthrough infection of 8.5 per cent was detected among the vaccinated individuals. The predominant genotype and serotype circulating among these tribal populations were D and ayw3, respectively.

Interpretation & conclusions::

The results of this study showed an overall reduction in the pool of HBsAg carriers because of the vaccination which helped in reducing the HBsAg carrier rate among the non-vaccinated also, probably due to an increase in herd immunity and reduction in the source of infection. Further studies need to be done to evaluate long term benefits of hepatitis B vaccination among these tribes.

2013-04-01·Human vaccines & immunotherapeutics3区 · 医学

Preclinical evaluation of a two-dose vaccination schedule of recombinantHansenula Polymorphahepatitis B vaccine in animals

3区 · 医学

Article

作者: Li, Caimei ; Li, Jin ; Zhang, Deyou ; Ma, Rui ; Zhuang, Hui ; Zhao, Kai ; Zhang, Sucai ; Xue, Hesheng ; Yang, Xuqin ; Wang, Xi

AIMS:

The current 3-dose regimen of hepatitis B vaccination for infants requiring over 6 mo period may pose the poor rate of compliance and later protection from hepatitis B virus (HBV) infection. This preclinical study is to investigate the feasibility of reducing the number of doses of hepatitis B (HB) vaccine.

RESULTS:

Eight groups of guinea pigs immunized with two doses of HP-HB vaccines at either 0 and 4 weeks or 0 and 8 weeks elicited geometric titers (GMT) of anti-HBs similar to that of four groups immunized with three doses of controls. The overall GMT of anti-HBs were not significantly different between the E- and C-groups (p>0.05) of monkeys. Specifically, the anti-HBs titers in the C-group reached the peak of 24857 (938.3-104585) mIU/mL one week after the 3rd dose, which were statistically higher than those of the E-group. However, they were reduced to comparable levels of anti-HBs in the E-group during weeks 9-12, suggesting comparable immune response of both vaccination regimens.

METHODS:

Twelve groups of guinea pigs (four animals in each group) were immunized with 2 experimental recombinant yeast Hansenula Polymorpha derived HB vaccines (HP-HB vaccine) and 2 commercial recombinant yeast Saccharomyces Cerevisiae vaccines (Temrevac-HB) as controls at 0, 4 and 8 weeks, 0 and 4 weeks, and 0 and 8 weeks respectively. Each guinea pig received 2 µg vaccine. Twelve Cynomolgus monkeys were randomly divided into two groups (six animals in each group). Animals in the experimental group (E-group) were injected with two doses of pilot produced 20 µg HP-HB vaccine. Animals in the control group (C-Group) were immunized with three doses of 10 µg Temrevac-HB. Both vaccines were administered at an interval of 3 weeks for monkeys.

CONCLUSIONS:

The 2-dose regimen of the HP-HB vaccine has comparable HBV immune responses as the 3-dose regimen of Temrevac-HB vaccine in Cynomolgus monkeys.

115

项与重组乙型肝炎 (华兰生物疫苗) 相关的新闻（医药）

2026-01-13

·新浪看点

华兰疫苗涨0.56%，成交额3.13亿元，近5日主力净流入-177.71万

1月13日，华兰疫苗涨0.56%，成交额3.13亿元，换手率2.58%，总市值119.54亿元。异动分析禽流感+流感+肝炎概念+生物疫苗1、根据2023年2月28日互动易：公司的甲型H7N9流感全病毒灭活疫苗已于先前完成Ⅱ期临床试验，目前作为公司的一项技术储备，若未来有相关疫情发生，公司将继续开展研发工作。2、华兰疫苗已上市的产品主要包括流感病毒裂解疫苗、四价流感病毒裂解疫苗、甲型 H1N1流感病毒裂解疫苗、重组乙型肝炎疫苗(汉逊酵母)以及ACYW135群脑膜炎球菌多糖疫苗、A群C群脑膜炎球菌多糖疫苗等。3、公司拥有多年乙肝疫苗等多种类疫苗的产业化经验，疫苗产品生产工艺领先，可在保证产品质量稳定的同时实现高效生产。4、公司是一家专业从事人用疫苗研发、生产、销售的高新技术企业。公司已上市的产品主要包括流感病毒裂解疫苗、四价流感病毒裂解疫苗、甲型H1N1流感病毒裂解疫苗、重组乙型肝炎疫苗（汉逊酵母）以及ACYW135群脑膜炎球菌多糖疫苗、A群C群脑膜炎球菌多糖疫苗等。(免责声明：分析内容来源于互联网，不构成投资建议，请投资者根据不同行情独立判断)资金分析今日主力净流入712.88万，占比0.02%，行业排名20/55，该股当前无连续增减仓现象，主力趋势不明显；所属行业主力净流入2.87亿，当前无连续增减仓现象，主力趋势不明显。区间今日近3日近5日近10日近20日主力净流入712.88万-901.97万-177.71万-2408.56万-6886.58万主力持仓主力没有控盘，筹码分布非常分散，主力成交额4227.72万，占总成交额的5.85%。技术面：筹码平均交易成本为21.56元该股筹码平均交易成本为21.56元，近期该股获筹码青睐，且集中度渐增；目前股价在压力位20.84和支撑位18.78之间，可以做区间波段。公司简介资料显示，华兰生物疫苗股份有限公司位于河南省新乡市华兰大道甲1号附1号，成立日期2005年11月9日，上市日期2022年2月18日，公司主营业务涉及人用疫苗的研发、生产和销售。主营业务收入构成为：疫苗制品98.11%，其他1.89%。华兰疫苗所属申万行业为：医药生物-生物制品-疫苗。所属概念板块包括：疫苗、抗流感、生物医药、多胎概念、动物疫苗等。截至12月20日，华兰疫苗股东户数2.20万，较上期减少8.33%；人均流通股27302股，较上期增加9.09%。2025年1月-9月，华兰疫苗实现营业收入8.06亿元，同比减少15.81%；归母净利润1.32亿元，同比减少50.51%。分红方面，华兰疫苗A股上市后累计派现10.37亿元。近三年，累计派现9.57亿元。机构持仓方面，截止2025年9月30日，华兰疫苗十大流通股东中，招商国证生物医药指数A（161726）位居第五大流通股东，持股209.51万股，相比上期减少43.99万股。香港中央结算有限公司位居第六大流通股东，持股208.22万股，相比上期增加18.37万股。南方中证1000ETF（512100）位居第七大流通股东，持股165.22万股，相比上期减少8700.00股。华夏中证1000ETF（159845）、天弘国证生物医药ETF（159859）退出十大流通股东之列。风险提示：市场有风险，投资需谨慎。本文为AI大模型自动发布，任何在本文出现的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不构成个人投资建议。

疫苗财报临床2期

2026-01-13

·今日头条

华兰生物、沃森生物、康泰生物、康龙化成、泰格医药，这几家可都是生物医药领域的明星。康龙化成是临床前CRO企业龙二，在临床前研发服务方面实力不俗。泰格医药更是国内临床试验CRO企业龙头，在临床试验这块话语权十足。沃森生物专注肺炎疫苗研发，成果有目共睹。康泰生物是国内最早搞重组乙型肝炎疫苗的，资历

华兰生物、沃森生物、康泰生物、康龙化成、泰格医药，这几家可都是生物医药领域的明星。康龙化成是临床前CRO企业龙二，在临床前研发服务方面实力不俗。泰格医药更是国内临床试验CRO企业龙头，在临床试验这块话语权十足。沃森生物专注肺炎疫苗研发，成果有目共睹。康泰生物是国内最早搞重组乙型肝炎疫苗的，资历深厚。华兰生物在血液制品和疫苗领域也表现出色。在A股市场，股价在50 - 100元的企业不少，它们都有自己的核心竞争力，未来发展值得期待。

疫苗临床研究

2026-01-12

·手机新浪网

华兰疫苗跌0.25%，成交额1.61亿元，今日主力净流入-1817.97万

1月12日，华兰疫苗跌0.25%，成交额1.61亿元，换手率1.36%，总市值118.88亿元。异动分析禽流感+流感+肝炎概念+生物疫苗1、根据2023年2月28日互动易：公司的甲型H7N9流感全病毒灭活疫苗已于先前完成Ⅱ期临床试验，目前作为公司的一项技术储备，若未来有相关疫情发生，公司将继续开展研发工作。2、华兰疫苗已上市的产品主要包括流感病毒裂解疫苗、四价流感病毒裂解疫苗、甲型 H1N1流感病毒裂解疫苗、重组乙型肝炎疫苗(汉逊酵母)以及ACYW135群脑膜炎球菌多糖疫苗、A群C群脑膜炎球菌多糖疫苗等。3、公司拥有多年乙肝疫苗等多种类疫苗的产业化经验，疫苗产品生产工艺领先，可在保证产品质量稳定的同时实现高效生产。4、公司是一家专业从事人用疫苗研发、生产、销售的高新技术企业。公司已上市的产品主要包括流感病毒裂解疫苗、四价流感病毒裂解疫苗、甲型H1N1流感病毒裂解疫苗、重组乙型肝炎疫苗（汉逊酵母）以及ACYW135群脑膜炎球菌多糖疫苗、A群C群脑膜炎球菌多糖疫苗等。(免责声明：分析内容来源于互联网，不构成投资建议，请投资者根据不同行情独立判断)资金分析今日主力净流入-1817.97万，占比0.11%，行业排名44/55，该股当前无连续增减仓现象，主力趋势不明显；所属行业主力净流入-2.46亿，当前无连续增减仓现象，主力趋势不明显。区间今日近3日近5日近10日近20日主力净流入-1817.97万-1471.40万-2287.96万-3449.51万-8120.20万主力持仓主力没有控盘，筹码分布非常分散，主力成交额4710.40万，占总成交额的7.3%。技术面：筹码平均交易成本为21.65元该股筹码平均交易成本为21.65元，近期该股获筹码青睐，且集中度渐增；目前股价在压力位20.84和支撑位18.78之间，可以做区间波段。公司简介资料显示，华兰生物疫苗股份有限公司位于河南省新乡市华兰大道甲1号附1号，成立日期2005年11月9日，上市日期2022年2月18日，公司主营业务涉及人用疫苗的研发、生产和销售。主营业务收入构成为：疫苗制品98.11%，其他1.89%。华兰疫苗所属申万行业为：医药生物-生物制品-疫苗。所属概念板块包括：疫苗、抗流感、生物医药、多胎概念、动物疫苗等。截至12月20日，华兰疫苗股东户数2.20万，较上期减少8.33%；人均流通股27302股，较上期增加9.09%。2025年1月-9月，华兰疫苗实现营业收入8.06亿元，同比减少15.81%；归母净利润1.32亿元，同比减少50.51%。分红方面，华兰疫苗A股上市后累计派现10.37亿元。近三年，累计派现9.57亿元。机构持仓方面，截止2025年9月30日，华兰疫苗十大流通股东中，招商国证生物医药指数A（161726）位居第五大流通股东，持股209.51万股，相比上期减少43.99万股。香港中央结算有限公司位居第六大流通股东，持股208.22万股，相比上期增加18.37万股。南方中证1000ETF（512100）位居第七大流通股东，持股165.22万股，相比上期减少8700.00股。华夏中证1000ETF（159845）、天弘国证生物医药ETF（159859）退出十大流通股东之列。风险提示：市场有风险，投资需谨慎。本文为AI大模型自动发布，任何在本文出现的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不构成个人投资建议。

疫苗财报临床2期

100 项与重组乙型肝炎 (华兰生物疫苗) 相关的药物交易

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