A Randomized, Double-blind Phase III Clinical Trial to Evaluate the Lot-to-lot Consistency of Three Consecutive Batches of Recombinant Herpes Zoster Vaccine (CHO Cell) Produced At a Commercial Scale in Subjects Aged 40 Years and Older.

To evaluate the lot-to lot consistency of three batches of recombinant herpes zoster vaccine (CHO cell) produced on a commercial scale in subjects aged 40 years and older after receiving 2 doses on a 0, 2 month schedule.

开始日期2024-11-01

申办/合作机构

成都迈科康生物科技有限公司初创企业

CTR20241986 / Recruiting临床3期

多中心、随机、双盲、安慰剂对照设计评价重组带状疱疹疫苗（CHO 细胞）在 40 周岁及以上人群中接种的保护效力、免疫原性和安全性的Ⅲ期临床试验

主要目的：评价重组带状疱疹疫苗（CHO细胞）（以下简称“试验疫苗”）以0，2月免疫程序在40周岁及以上人群中全程免疫30天后预防带状疱疹的保护效力。次要目的：1)评价试验疫苗以0，2月免疫程序在40-49周岁、50-59周岁、60-69周岁、≥70周岁人群中全程免疫30天后预防带状疱疹的保护效力；2)评价试验疫苗以0，2月免疫程序在40周岁及以上人群，40-49周岁、50-59周岁、60-69周岁、≥70周岁人群有效终点病例中预防任何程度〔带状疱疹简明疼痛评估量表（Zoster Brief Pain Inventory，ZBPI）评分＞0〕及预防重度（ZBPI评分≥3）带状疱疹后神经痛（Postherpetic Neuralgia，PHN）的保护效力；3)评价试验疫苗的安全性；4)评价试验疫苗的免疫原性和免疫持久性。

开始日期2024-07-13

申办/合作机构

上海迈科康生物科技有限公司

[+1]

NCT06447779 / Active, not recruiting临床3期

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of Recombinant Zoster Vaccine (CHO Cell) in Adults Aged 40 Years and Above

The purpose of the sutdy is to evaluate efficacy, safety and immunogenicity of Recombinant Zoster Vaccine (CHO Cell) with 2 doses at 2-month interval in adults aged 40 years and older.

开始日期2024-07-13

申办/合作机构

成都迈科康生物科技有限公司初创企业

100 项与重组带状疱疹疫苗(CHO细胞)(成都迈科康生物) 相关的临床结果

登录后查看更多信息

100 项与重组带状疱疹疫苗(CHO细胞)(成都迈科康生物) 相关的转化医学

登录后查看更多信息

100 项与重组带状疱疹疫苗(CHO细胞)(成都迈科康生物) 相关的专利（医药）

登录后查看更多信息

173

项与重组带状疱疹疫苗(CHO细胞)(成都迈科康生物) 相关的文献（医药）

2024-03-11·Human vaccines & immunotherapeutics3区 · 医学

Long-term efficacy data for the recombinant zoster vaccine: impact on public health and cost effectiveness in Germany

3区 · 医学

Article

作者: Curran, Desmond ; Van Oorschot, Desirée ; Salem, Ahmed Ehab ; Schwarz, Magdalena ; Matthews, Sean ; Hain, Johannes

The aim of the study was to update previously published public health impact and cost-effectiveness analyses of the recombinant zoster vaccine (RZV), in the German population aged ≥50 years of age (YOA), with the latest vaccine efficacy (VE) estimates against herpes zoster (HZ). The updated estimates are derived from a long-term follow-up study. A previously published multi-cohort Markov model following age cohorts over their lifetime was used. Demographic, epidemiological, cost, and utility data were based on German specific sources. Vaccine coverage was assumed to be 40%, with a second dose compliance of 70%. The estimated VE at time 0 was 98.9% (95% C.I.: 94.0-100%) with an annual waning of 1.5% (95% CI: 0.0-3.4%) for the age group 50-69 YOA. Corresponding values were 95.4% (95% C.I.: 89.7-100%) and 2.3% (95% CI: 0.3-4.4%) for the age group ≥70 YOA. It was estimated that, over the remaining lifetime since vaccination, RZV would prevent approximately 884 thousand (K), 603 K, and 538 K HZ cases in three age cohorts 50-59, 60-69, and ≥70 YOA, respectively. The number needed to vaccinate to prevent one HZ and one postherpetic neuralgia case was 6 and 36 (50-59 YOA cohort), 6 and 34 (60-69 YOA cohort), 10 and 48 (≥70 YOA cohort). The incremental cost-effectiveness ratio of vaccination ranged from €26 K/quality-adjusted life year (QALY) in 60 YOA to €35 K/QALY in 70 YOA. Due to the higher, sustained, RZV VE, improved public health and cost-effectiveness results were observed compared to previous analyses.

2024-03-01·JAMA ophthalmology

Risk of Herpes Zoster Ophthalmicus Recurrence After Recombinant Zoster Vaccination

Article

作者: Sun, Yuwei ; Walia, Anushka ; Acharya, Nisha R

Importance:

The recombinant zoster vaccine (RZV) is currently recommended for immunocompetent adults aged 50 years or older and immunocompromised adults aged 19 years or older and is effective in preventing herpes zoster ophthalmicus (HZO). However, questions about the safety of RZV in patients with a history of HZO remain.

Objective:

To evaluate whether there is an increased risk of HZO recurrence after RZV in patients with a history of HZO.

Design, Setting, and Participants:

This retrospective cohort study used medical and outpatient pharmacy claims data for commercial and Medicare Advantage enrollees from the Optum Labs Data Warehouse. Patients with incident HZO from January 1, 2010, to December 31, 2021, were identified; the study period ended on March 31, 2022. The vaccinated group consisted of patients with at least 1 dose of RZV more than 90 days following the initial HZO diagnosis. The unvaccinated group consisted of patients without any record of RZV in the study period. Vaccinated and unvaccinated patients were matched using exact k:1 matching without replacement.

Exposure:

Recombinant zoster vaccination.

Main Outcomes and Measures:

The main outcome was the number of HZO recurrences with and without RZV exposure.

Results:

A total of 16 408 patients were included in the matched analysis, of whom 12 762 were unvaccinated (7806 [61.2%] female; mean [SD] age at diagnosis, 68.8 [10.3] years) and 3646 were vaccinated (2268 [62.2%] female; mean [SD] age at diagnosis, 67.4 [9.8] years). Within the primary risk period of 56 days after the index date (ie, the start of follow-up for the outcome), the incidence of HZO recurrence after any RZV exposure was 37.7 per 1000 person-years compared with 26.2 per 1000 person-years in the unexposed group. After controlling for race and ethnicity, inpatient stays, emergency department visits, concomitant vaccines, and eye care practitioner visits, the association between vaccination status and HZO exacerbation in the primary risk period had an adjusted hazard ratio for any RZV exposure of 1.64 (95% CI, 1.01-2.67; P = .04).

Conclusions and Relevance:

In this study, RZV exposure was associated with a higher likelihood of HZO recurrence in patients with a history of HZO compared with no RZV exposure. These findings support consideration that patients with a history of HZO may benefit from monitoring after receiving RZV in case of HZO recurrence.

2024-03-01·Journal of Crohn's & colitis

Mitigating the Risk of Tofacitinib-induced Adverse Events in the Elderly Population with Ulcerative Colitis

Article

作者: Fries, Walter ; Viola, Anna ; Bivacqua, Chiara ; Costantino, Giuseppe ; Li Voti, Raffaele ; Muscianisi, Marco ; De Francesco, Clara

Abstract:

Background and Aims:

Older patients with ulcerative colitis treated with tofacitinib are at risk for major cardiovascular events, thromboembolism, herpes zoster, and malignancies and, accordingly, its use is limited by the regulatory authorities. The aim of the present study was to evaluate the occurrence of adverse events and potential preventive measures.

Methods:

We retrospectively evaluated patients treated with tofacitinib, divided into two groups according to comorbidities and age. Patient- and disease-related variables were recorded [primary non-response, loss of response, and persistence], together with deviations from the recommended induction regimen, ie, dose reduction, and concomitant treatments with anti-thrombotic therapy.

Results:

The age-adjusted Charlson comorbidity index of Group 1 [n = 30] was ≥2 and that of Group 2 [n = 37] was ≤ 1. No differences were observed for primary or secondary treatment failures. Both groups achieved comparable steroid-free remission rates at 12 months [53% and 46%, respectively]. Herpes zoster occurred in two patients per group, and no more cases occurred after strict recombinant zoster vaccination. No major cardiovascular event or thromboembolism was registered. Half of patients in Group 1 were treated with a reduced induction dose of 5 mg twice daily and 47% were on concomitant anti-thrombotic therapy. Malignancies were registered in two patients from Group 1 and one patient from Group 2.

Conclusions:

Modulation of induction dose and anti-thrombotic therapy may have contributed to prevent cardiological events and thromboembolism. The introduction of zoster vaccine virtually eliminated zoster risk after the first cases. Potential malignancies deserve a careful work-up of older patients before treatment start.

项与重组带状疱疹疫苗(CHO细胞)(成都迈科康生物) 相关的新闻（医药）

2022-07-19

·蒲公英Ouryao

【出海新进展】四检测试剂获CE认证、1原料药获韩国注册证书

来源：企业公告整理：wangxinglai2004同和药业API获韩国注册证书一、药品基本情况生产商名称：江西同和药业股份有限公司生产商地址：江西省奉新高新技术产业园区认证范围：利伐沙班原料药证书编号：2022-A1-1255签发日期：2022.07.05利伐沙班是一种新型的抗凝药，临床广泛用于静脉血栓栓塞性疾病的预防和治疗，以及非瓣膜性房颤的卒中预防。公司利伐沙班产品获得韩国药品注册证书，标志着公司利伐沙班原料药获得了韩国市场的准入资格，将对公司进一步扩大国际市场业务起到积极作用。上海之江生物4产品获欧盟认证一、药品基本情况 1、相关认证情况2、涉及的相关产品情况二、业绩影响公司以上产品获得欧盟CE认证后，可在欧盟国家和认可欧盟CE认证的国家进行销售。其中 Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 2 Genes)新型冠状病毒 2019-nCoV 核酸检测试剂盒（荧光 PCR 法）是一款反应液采用冻干工艺的试剂盒，核酸直接加样到冻干粉中溶解冻干粉，无需额外溶解，操作简便。该试剂盒常温保存，可常温运输，进一步提升了公司的国际化竞争力，对于公司扩充海外销售产品品类及国际业务拓展具有积极作用。往期新闻赛升药业获FDA临床许可一、药品基本情况 1、药品名称：重组带状疱疹疫苗（CHO细胞） 2、IND:28183 3、持有人：北京绿竹生物技术股份有限公司二、药品的其他相关情况重组带状疱疹疫苗是指通过DNA重组技术在工程细胞中转染带状疱疹病毒糖蛋白E序列，利用工程细胞表达特异性带状疱疹病毒糖蛋白E(gE)抗原，可刺激人体产生水痘-带状疱疹病毒抗体，预防和控制带状疱疹疾病。本产品的主要用途为成人预防带状疱疹。带状疱疹（herpes zoster）是由长期潜伏在脊髓后根神经节或颅神经节内的水痘-带状疱疹病毒（varicella-zoster virus）经再激活引起的感染性皮肤病，长期影响患者日常生活。绿竹生物的核心产品重组带状疱疹疫苗LZ901，是中国首款也是唯一一款寻求全球申报的带状疱疹疫苗。在分子设计上，LZ901采用了独特的四聚体设计。 LZ901在临床前研究中表现出优异的免疫原性、有效性和安全性。LZ901的分子设计模拟了带状疱疹病毒入侵人体时，与抗体形成免疫复合物。抗原递呈细胞表面的Fc受体与LZ901的Fc部分结合，通过巨噬细胞、树突细胞的吞噬作用和B细胞的内吞作用被内化，降解为肽段后递呈到细胞表面。进而诱导Th2和Th1型免疫反应，启动CD8T细胞杀死感染带状疱疹病毒的细胞，与此同时B细胞响应产生抗体，中和带状疱疹病毒，并通过记忆B细胞提供长期保护。华海药业制剂获FDA批准文号一、药品基本情况 1、药物名称：马来酸依那普利片 2、ANDA 号：2132733、剂型：片剂 4、规格：2.5mg、5mg、10mg、20mg5、申请事项：ANDA（美国新药简略申请） 6、申请人：普霖斯通制药有限公司（Prinston Pharmaceutical, Inc.）二、药品的其他相关情况马来酸依那普利片主要用于治疗高血压。马来酸依那普利片由Merck 研发，最早于1986年在美国上市。当前，美国境内生产厂商主要有Wockhardt、Taro、Northstar。 2021年该药品美国市场销售额约50,237,965美元（数据来源于IMS数据库）。截至目前，公司在马来酸依那普利片项目上已投入研发费用约825万元人民币。亚宝药业获得澳大利亚一期临床许可一、药品注册的基本情况英文名：YBSW015 Injection剂型：注射液规格：90mg/3mL/瓶 CTN 号：CT-2022-CTN-01714-1 v1二、药品的其他相关情况 YBSW015注射液为一种抗新冠病毒双特异性中和抗体药物，拟用于SARS-CoV-2病毒感染的治疗。YBSW015是针对SARS-CoV-2 的S蛋白受体结合域（receptor binding domain，RBD）的双特异性抗体，可以通过抗体中和作用封闭新冠病毒入侵细胞的S蛋白RBD的不同表位，阻断病毒入侵途径。目前国内外暂无同类产品上市。截至目前，公司在该产品研发项目上已投入研发费用约为5355万元人民币。根据澳大利亚药品注册相关的法律法规要求，药物在获得临床试验伦理许可并向澳大利亚药品管理局临床试验备案后，尚需开展临床试验并经其审评、审批通过后方可生产上市。长春金赛药业获得FDA药物临床试验公告主要内容 2022年6月14日，长春高新技术产业(集团)股份有限公司(以下简称“公司”)控股子公司——长春金赛药业有限责任公司(以下简称“金赛药业”)收到了美国FDA(美国食品药品监督管理局)关于注射用金纳单抗用于成人斯蒂尔病的临床许可的函，相关内容如下：关于金赛药业根据《联邦食品、药品和化妆品法案》(FDCA)第 505(i)规定递交的注射用金纳单抗新药临床研究申请(IND)的事宜，我们已经完成了对该申请的安全性审查并认为金赛药业可开展针对成人斯蒂尔病(AOSD)的临床研究。你的每一次“在看”，我都看得见！

抗体疫苗

2022-06-21

·药创客

绿竹生物计划第三季度赴港上市：国内第一家向美国申请疫苗临床研究的企业

北京绿竹生物技术股份有限公司（以下简称“绿竹生物”）计划第三季度正式向港交所递交招股说明书，拟主板挂牌上市。成立于2001年11月的绿竹生物由前北京生物制品研究所研究员孔健、副研究员蒋先敏和张琰平三人联合创办。针对当时国内外无可用于2岁以内儿童预防流行性脑脊髓膜炎感染的疫苗的现实，结合已掌握的多糖蛋白质偶联技术，绿竹生物成功开发出了多种细菌多糖蛋白结合疫苗和高纯度低热原的多糖疫苗（均已转让给上市公司智飞生物，股票代码：300122.SZ），同时也是全球首家开发出A群C群脑膜炎球菌多糖结合疫苗的企业。2021年8月3日，国家药品监督管理局正式批准绿竹生物技自主研发的1.2类创新药重组带状疱疹疫苗（CHO细胞）开展新药临床试验（IND）。绿竹生物成立于2001年11月，以人用疫苗、治疗性单抗药物为主要研究方向，公司自2009年开始进行人用单克隆抗体、双特异性抗体药物、重组病毒疫苗的研究，2017年获得单克隆抗体生物类似药临床批件2个，2019年获得治疗B细胞白血病及淋巴瘤的双特异抗体K193抗体注射液临床批件1个，2021年8月重组带状疱疹疫苗获准进入临床研究，同时申报美国Pre-IND，目前正处于FDA审评阶段。绿竹生物充分利用已经建立的双功能抗体平台技术（已申请中国专利、PCT专利、美国专利；注册商标Fabite，Fabsca ），开发出了多种用于人类白血病治疗用的双功能抗体药物，将陆续进入临床前安全性评价。 End 声明：本文旨在传递更多信息，版权归原作者所有。原创文章转载均需经过授权并注明来源，如涉及内容、版权或其他问题请时联系小编删除！文章仅代表作者个人观点，并不代表公众号立场。本公众号拥有对此声明的最终解释权！投稿邮箱：yck19876@163.com

疫苗抗体生物类似药

100 项与重组带状疱疹疫苗(CHO细胞)(成都迈科康生物) 相关的药物交易

登录后查看更多信息