(Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)) - 在研适应症：中耳炎，肺炎球菌感染，肺炎_专利_临床

概要

基本信息

药物类型

预防性疫苗、结合疫苗

别名

10-valent pneumococcal conjugate vaccine - GlaxoSmithKline、10-valent pneumococcal vaccine conjugate - GlaxoSmithKline、PHID-CV

+ [7]

靶点-

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

GSK PlcGlaxoSmithKline Biologicals SAJapan Vaccine Co., Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2009-03-29),

急性中耳炎侵袭性肺炎球菌病侵袭性肺炎链球菌感染

最高研发阶段(中国)-

特殊审评-

登录后查看首次获批时间轴

关联

68

项与 Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc) 相关的临床试验

NCT05175014 / Active, not recruiting临床4期

Determining Whether Mass Campaigns With Fractional Dose PCV10 Would Accelerate Herd Protection Against Pneumococcal Transmission in Sub-Saharan Africa

The aim of this study is to assess the impact of a mass campaign with a single, fractional dose of Pneumosil®, a PCV10, on VT carriage. A 20% fractional dose (1/5th) will be used as a practical formulation to prepare and administer. This study will assess whether the impact of a single fractional dose mass campaign on carriage is non-inferior to a single full dose mass campaign in a cluster randomized trial in a low coverage setting in Niger. The results would provide evidence of the population-level direct and indirect impact of fractional dose in older children which will be completed by mathematical modelling, to inform the policy debate regarding PCV dosing schedules in different contexts. This trial and the modelling exercises that follow, would allow for larger scale evaluation of fractional dose PCV strategies in multiple contexts.

开始日期2021-12-30

申办/合作机构

Epicentre Technologies Corp.

[+2]

PACTR202112574484846 / Recruiting临床4期

Determining whether mass campaigns with fractional dose PCV10 would accelerate herd protection against pneumococcal transmission in Sub-Saharan Africa

开始日期2021-12-22

申办/合作机构

Epicentre Technologies Corp.

NCT04275284 / CompletedN/AIIT

Evaluation of Persistence of Immunogenicity Following an Open-labelled, Randomized Controlled Trial Evaluating Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine in South Africa

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).

开始日期2020-02-14

申办/合作机构

University of the Witwatersrand

100 项与 Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc) 相关的临床结果

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100 项与 Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc) 相关的转化医学

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100 项与 Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc) 相关的专利（医药）

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152

项与 Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc) 相关的文献（医药）

2023-12-01·International journal of pediatric otorhinolaryngology

Otitis media at 6-monthly assessments of Australian First Nations children between ages 12–36 months: Findings from two randomised controlled trials of combined pneumococcal conjugate vaccines

Article

作者: Arrowsmith, B ; Mulholland, E K ; Andrews, R ; Snelling, T ; Licciardi, P V ; Torzillo, P J ; Carapetis, J ; Smith-Vaughan, H ; Skull, S A ; Lehmann, D ; Wilson, N ; McIntyre, P ; Krause, V ; Binks, M J ; Chang, A B ; Santosham, M ; Leach, A J ; Morris, P S ; Chatfield, M ; Oguoma, V M ; Beissbarth, J

OBJECTIVES:

In remote communities of northern Australia, First Nations children with hearing loss are disproportionately at risk of poor school readiness and performance compared to their peers with no hearing loss. The aim of this trial is to prevent early childhood persisting otitis media (OM), associated hearing loss and developmental delay. To achieve this, we designed a mixed pneumococcal conjugate vaccine (PCV) schedule that could maximise immunogenicity and thereby prevent bacterial otitis media (OM) and a trajectory of educational and social disadvantage.

METHODS:

In two sequential parallel, open-label, randomised controlled trials, eligible infants were first allocated 1:1:1 to standard or mixed PCV primary schedules at age 28-38 days, then at age 12 months to a booster dose (1:1) of 13-valent PCV, PCV13 (Prevenar13®, +P), or 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine, PHiD-CV10 (Synflorix®, +S). Here we report findings of standardised ear assessments conducted six-monthly from age 12-36 months, by booster dose.

RESULTS:

From March 2013 to September 2018, 261 children were allocated to booster + P (n = 131) or + S (n = 130). There were no significant differences in prevalence of any OM diagnosis by booster dose or when stratified by primary schedule. We found high, almost identical prevalence of OM in both boost groups at each age (for example 88% of 129 and 91% of 128 children seen, respectively, at primary endpoint age 18 months, difference -3% [95% Confidence Interval -11, 5]). At each age prevalence of bilateral OM was 52%-78%, and tympanic membrane perforation was 10%-18%.

CONCLUSION:

Despite optimal pneumococcal immunisation, the high prevalence of OM persists throughout early childhood. Novel approaches to OM prevention are needed, along with improved early identification strategies and evaluation of expanded valency PCVs.

2023-07-01·Infectious diseases and therapy

Assessing Public Health Impact of Four Pediatric Pneumococcal Conjugate Vaccination Strategies in the Netherlands.

Article

作者: McDade, Cheryl ; Beby-Heijtel, Anna Trisia ; Perdrizet, Johnna ; Wilson, Michele ; Waterval-Overbeek, Angela ; Sundaram, Vishalini

INTRODUCTION:

The 10-valent pneumococcal conjugate vaccine (PCV10, Synflorix) was introduced into the Dutch pediatric national immunization program (NIP) starting in 2011. However, there is substantial pneumococcal disease burden due to increases in non-PCV10 covered serotypes. Higher-valent vaccines for pediatrics (PCV13, PCV15, and PCV20) may alleviate much of the remaining disease burden upon implementation through broader serotype coverage. This article assesses the public health impact of different pediatric vaccination strategies (switching to PCV13, PCV15 or PCV20) versus maintaining PCV10 at different time intervals in the Netherlands.

METHODS:

A population-based, decision-analytic model was developed using historical pneumococcal disease surveillance data to forecast future invasive pneumococcal disease (IPD), pneumonia, and otitis media (OM) cases over a 7-year period (2023-2029) under the following strategies: continued use of PCV10, switching to PCV13 in 2023, switching to PCV15 in 2023, and switching to PCV20 in 2024. Scenario analyses were performed to account for uncertainties in future serotype distributions, disease incidence reductions, and epidemiologic parameters.

RESULTS:

Switching to PCV13 in 2023 was found to avert 26,666 cases of pneumococcal disease compared to continuing PCV10 over a 7-year period (2023-2029). Switching to PCV15 in 2023 was found to avert 30,645 pneumococcal cases over the same period. Switching to PCV20 once available in 2024 was estimated to avert 45,127 pneumococcal cases from 2024-2029. Overall conclusions were maintained after testing uncertainties.

CONCLUSIONS:

For the Dutch pediatric NIP, switching to PCV13 in 2023 would be an effective strategy compared with continued use of PCV10 for averting pneumococcal disease cases. Switching to PCV20 in 2024 was estimated to avert the most pneumococcal disease cases and provide the highest protection. However, in the face of budget constraints and the undervaluation of prevention strategies, it remains challenging to implement higher valent vaccines. Further research is needed to understand the cost-effectiveness and feasibility of a sequential approach.

2023-05-01·Vaccine

Effect of reduced two-dose (1+1) schedule of 10 and 13-valent pneumococcal conjugate vaccines (SynflorixTM and Prevenar13TM)) on nasopharyngeal carriage and serotype-specific immune response in the first two years of life: Results from an open-labelled randomized controlled trial in Indian children

Article

作者: Pearce, Emma ; Dayma, Girish ; Gondhali, Arun ; Goldblatt, David ; Apte, Aditi ; Roalfe, Lucy ; Juvekar, Sanjay ; Kawade, Anand ; Telang, Nilima ; Dagan, Ron ; Bavdekar, Ashish ; Sanghavi, Sonali ; Satpute, Meenakshi ; Oron, Assaf P. ; Patil, Rakesh ; Noori, Navideh ; Wang, Yanyun

INTRODUCTION:

This study aimed to assess the effect of a reduced dose regime (1 + 1) of PCV10 and PCV13 along with 3-dose regimes on pneumococcal vaccine-type (VT) carriage and immunogenicity in the first two years of life in PCV-naïve Indian children.

METHODS:

A total of 805 healthy infants aged 6-8 weeks were randomised to 7 groups (n = 115). Six groups received Synflorix^TM(PCV10) or Prevenar13^TM(PCV13) in the following schedules: 3 + 0 (three primary at 6, 10, and 14 weeks); 2 + 1 (two primary 6 and 14 weeks with booster at 9 months; 1 + 1 (one primary at 14 weeks with booster at 9 months). The 7th group was a PCV-naïve control group. Nasopharyngeal swabs were collected at 6, 18 weeks, 9, 10, 15, and 18 months of age. Venous blood samples were collected at 18 weeks, 9, 10, and 18 months of age for assessment of sero-specific IgG antibodies. Additionally, functional activity using a serotype specific opsonophagocytic assay (OPA) was assessed at 10 and 18 months of age in a subset (20%) of participants.

RESULTS:

All schedules of PCV13 showed significant 13VT carriage reduction in the second year of life as compared to control. At 15 months of age, PCV13 (1 + 1) showed 45 % reduction in 13VT-carriage compared to the control [OR = 0.55 (95% CI; 0.31-0.97), p= 0.038]. None of the PCV10 schedules showed significant reduction in 10VT carriage in the second year. Although not powered for these outcomes, at 18 months of age, 1 + 1 and 2 + 1 schedules of both vaccines demonstrated higher sero-responders for all serotypes, higher geometric mean concentrations (GMC) for all serotypes except 23F [with both vaccines], higher percent OPA responders and OPA geometric mean titres (GMT) compared to the 3 + 0 schedules for all serotypes.

CONCLUSION:

The reduced dose schedule (1 + 1) of PCV13 results in significant VT-carriage reduction in the second year of life. Immune protection provided by 1 + 1 schedules of PCV10 and PCV13 in the second year of life is comparable to WHO-recommended 3-dose schedules.

5

项与 Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc) 相关的新闻（医药）

2023-07-27

·Firstwordpharma

Merck & Co. looks to take on Pfizer’s Prevnar franchise with positive top-line data for V116

Merck & Co. has announced positive top-line results from two Phase III trials evaluating V116, its investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals. The company initiated pivotal-stage studies of the vaccine last summer. Results from the STRIDE-3 trial demonstrated statistically significant immune responses for V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V116. Additionally, results from STRIDE-6 demonstrated that V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study. In both studies, V116 had a safety profile comparable to the comparator and results will be shared with the scientific community in the near future. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults, said Merck. According to CDC data from 2019, the 21 serotypes covered by V116 are responsible for 85% of invasive pneumococcal disease in individuals 65 and older and Merck’s vaccine includes eight serotypes not currently covered by approved pneumococcal vaccines. These unique serotypes are thought to be responsible for approximately 30% of invasive pneumococcal disease in individuals 65 and older, based on pre-pandemic data.“Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” said Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories.The global market for pneumococcal vaccines is largely dominated by Pfizer’s Prevnar 13 and Prevnar 20 franchises, with smaller share commanded by Merck’s Pneumovax and Vaxneuvance brands which the company is hoping to build on with V116. The third notable player in this space GSK, responsible for marketing the vaccine Synflorix, acquired Affinivax just over a year ago at an upfront cost of $2.1 billion in a bid to also expand its long-term presence in the pneumococcal vaccine market.

疫苗临床结果并购临床3期免疫疗法

2022-06-05

·药时代

全球生物科技行业收购「新趋势」：小众的「女性健康」与热门的「肺炎球菌疫苗」赛道

正文共： 5932字 16图预计阅读时间： 15分钟01前言作为中国制药界雷达，药时代一直在关注行业热点、焦点，其中就包括兼并购（M&A）。昨天，我们分享一条最新重要消息。就在中国端午节这一天，即2022年6月3日，全球制药巨擘百时美施贵宝（Bristol-Myers Squibb，简称BMS）和纳斯达克上市公司Turning Point Therapeutics宣布了一项最终合并协议，百时美施贵宝将以每股76.00美元的价格现金收购Turning Point Therapeutics，总金额为41亿美元。该交易得到了两家公司董事会的一致批准，预计将于2022年第三季度完成。今天，我们进一步解读全球生物科技行业收购的最新趋势。随着生物科技领域逐渐的“以临床价值为导向，以患者需求为中心”的价值回归，资本市场也在这一价值的主导下，转变了收购的风向标，从只关注大众化的热门产品向根据患者需求寻找特色产品转向，从拥挤的同质化赛道向小众的冷门赛道转向，从只重视产品营收向更加重视平台技术转向。在当前股市的低迷环境下，手握大量资金的大型跨国药企以及私募股权公司都开始悄然行动。我们可以从近期的生物科技行业收购案例中，看到一些行业发展转变的新趋势。可以说，生物科技行业正迈向一种新的发展趋势：“以临床价值为导向，以患者需求为中心”、以扎实的技术为基础、以差异化的特色产品为导向、以更合理的收购布局管线、以及更“小而精”的团队、更多的合作、更专业的研发领域。一些体量较小的Biotech，在研发方面更具有灵活性，往往会避开热门赛道和热门靶点，发现一些大型药企不太关注的小众领域，将小众领域的新药和技术做精做强，最终在竞争激烈的医药市场占领一席之地。如果眼光够好，收购很可能购买到未来的重磅药物。近期，一家专注于女性保健创新疗法的小型生物科技公司TherapeuticsMD被一家私募股权集团EW Healthcare Partners以1.77亿美元的价格收购。与此同时，葛兰素史克（GSK）加入到肺炎球菌疫苗竞赛中，正押注21亿美元现金，再加上2笔6亿美元的潜在里程碑付款，收购Affinivax，将目前处于II期的24价肺炎球菌候选疫苗以及生产这种疫苗的技术收入囊中。从这两个收购案例中我们可以看出，无论是小众的女性健康赛道，还是竞争激烈的热门肺炎球菌疫苗赛道，在生物科技行业，谁掌握了技术谁就有机会脱颖而出，谁手握大量资本谁就有能力做大做强。下面我们详细介绍一个这两个并购案例。02TherapeuticsMD凭借女性健康赛道得到了从未有过的接近富裕的机会当前，女性所面临的许多独特的健康问题越来越受到关注，包括月经周期、怀孕、节育、更年期、性健康和生殖健康等。根据世卫组织的信息显示，乳腺癌和宫颈癌是女性两种最常见的两种癌症；15至44岁女性的健康问题有三分之一是由性健康和生殖健康问题引起的。2021年9月，致力于数字健康的风险基金Rock Health发布了对美国女性数字健康市场的投融资分析。Rock Health将美国女性健康赛道的业务细分为8个领域，分别为孕产和育儿支持、初级和预防护理、受孕支持、性健康与生殖健康、慢病护理、围绝经期和更年期护理、经期护理和行为健康。自2011年以来，74家美国女性健康公司共发生了超过100多起投融资交易。2021年是近十年来女性健康企业融资额最高的一年，前8个月共融资13亿美元。实际上，美国女性健康赛道的融资出现显著提升是从2018年开始，且逐渐显露成熟之势。TherapeuticsMD在女性健康领域拥有轰动一时的抱负早已化为涓涓细流的收入之后，这家小型生物科技公司正被一家私募股权集团以1.77亿美元的价格收购。近日，这家公司发布消息称，EW Healthcare Partners同意以每股10美元的价格购买该公司所有流通股，这使该公司遭受重创的股价瞬间翻了三倍。在过去的5年里，当夸夸其谈被残酷的现实打败，这家曾经风光无限的公司的股价已经下跌99%以上。即使是长期的生物技术观察家可能也很难记住TherapeuticsMD，该公司曾获得FDA的一系列批准，用于治疗阴道疼痛和潮热的新疗法。在一些热心的分析师的出谋划策下，TherapeuticsMD发现了一个“数十亿美元的机会”。（图片来源：公司官网）TherapeuticsMD的主打产品Annovera，这是一种用于育龄妇女预防怀孕的复合激素避孕药，也是第一种可使用一整年的阴道环避孕药，在第四季度赚了780万美元，比2020年同期下降了130万美元。排名第二的是Imvexxy（曾用名：TX-004HR），这是一种雌二醇阴道插入物，用于治疗中度至重度性交疼痛（与性活动有关的阴道疼痛），这是由于绝经引起的外阴和阴道萎缩（VVA）症状，在第四季度收入不到700万美元。其中，Imvexxy这款产品曾遭到当时由新任命的Scott Gottlieb领导的FDA的拒绝。在TX-004HR临床计划中，TherapeuticsMD与FDA就安全性和疗效的研究设计进行了许多讨论以支持审批。但在给予的完整答复信中FDA态度180度的大转变，提出需要子宫内膜相关的长期安全数据。2017年5月9日，由于缺乏12个月的安全性相关数据，FDA拒绝批准TherapeuticsMD的TX-004HR。但由于安全性数据不足，FDA最初拒绝了该疗法。同年，11月7日，FDA宣布受理Therapeutic MD对TX-004HR的上市申请，放弃了之前提出的安全性数据的要求。后来，美国证券交易委员会（SEC）指控该公司在批准通过之前，有选择地发布重大信息，试图操纵股价。Therapeutic MD为此支付了20万美元的罚款以了结指控，但没有承认责任。EW Healthcare表示，公司管理着40亿美元的资金，用其中的一部分建立了其总经理Evis Hursever提出的“一个快速增长的、一流的跨大西洋女性健康平台”。其中包括收购总部位于巴黎的Majorelle，这是一家专注于女性健康和泌尿外科处方和OTC产品的法国公司。EW Healthcare现在将通过加入TherapeuticsMD进入美国市场。曾在诺华任职的Hugh O'Dowd，去年被邀请帮助复兴TherapeuticsMD，他声称对这个结果很满意:“我们将共同努力，通过在计划生育、生殖健康和更年期管理方面的治疗重点，继续增强各年龄段妇女的权能。”03GSK加入肺炎球菌疫苗竞赛中，与辉瑞和默沙东展开对决在全球，疫苗行业呈现典型的寡头垄断格局，长期由四大上市疫苗制造商辉瑞、默沙东、GSK和赛诺菲主导。其中，13价肺炎球菌多糖结合疫苗、HPV疫苗、流感疫苗、百白破系列联合疫苗、重组带状疱疹疫苗等产品销售额遥遥领先。肺炎球菌性疾病（PD，pneumococcal disease）是全球最严重的公共卫生问题之一，其具有高度攻击性的病毒株或血清型可引起非侵袭性慢性肺炎球菌疾病，例如肺炎（限于肺部感染）、鼻窦炎、中耳炎（中耳感染），以及侵袭性肺炎球菌疾病，例如菌血症（血液中感染）、细菌性肺炎（菌血症性肺炎）、脑膜炎。当今全球超过10亿美元的重磅疫苗产品有4款，其中，辉瑞Prevnar家族的13价肺炎结合疫苗Prevnar 13（PCV-13）因其销售广泛，被全球100个国家纳入免疫规划，而成为当之无愧的全球“疫苗之王”。目前存在九十多种肺炎球菌，成人感染后的病情比儿童感染更复杂多样。与辉瑞Prevnar 13对标的产品，默沙东的Vaxneuvance（15价肺炎球菌结合疫苗，V114）已获得FDA批准上市，用于在18岁以上成人中预防由肺炎链球菌血清型1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F、22F、23F和33F引起的侵袭性疾病，如菌血症肺炎、脑膜炎、败血症和菌血症等。V114载体蛋白是CRM197，包括现有的多数肺炎球菌疫苗尚未覆盖的肺炎球菌血清型22F和33F。这些血清型通常与全球侵袭性肺炎球菌疾病相关，并且不包含在目前批准用于成人的肺炎球菌结合疫苗中。与辉瑞的产品相比，默沙东的这款疫苗在儿童患者组的临床上有着领先优势。近日，葛兰素史克（GSK）也加入肺炎球菌疫苗竞赛中，这家英国大型跨国药企正押注21亿美元现金，再加上高达12亿美元的里程碑，以收购Affinivax及其24价肺炎球菌候选疫苗（目前处于II期），以及生产这种疫苗的技术。GSK即将离职的研发主管Hal Barron表示，“拟议的收购进一步加强了我们的疫苗研发管线，提供了获得一种新的、潜在的颠覆性技术的途径，并扩大了GSK在波士顿地区现有的涉足领域。”Barron将于8月离职，接手运营细胞再生初创公司Altos Labs。GSK的商业疫苗组合中只有一种肺炎球菌疫苗Synflorix，早在2009年就获得了欧盟的批准。但与辉瑞的巨头Prevnar家族相比，其销售额相形见绌，尽管疫情期间需求下降，但Prevnar家族在2021年的收入为13亿美元。而Synflorix全年收入约为4.5亿美元（￡3.57亿）。此外，默沙东的下一代疫苗也紧跟辉瑞公司的步伐。8年前，在波士顿儿童医院的多重抗原呈递系统（MAPS）疫苗平台上创立了Affinivax。其首席执行官Steven Brugger之前是抗体开发公司Visterra （Visterra最终被大冢收购）的CEO，他与团队共同创立了Affinivax，并从盖茨基金会获得了400万美元的种子基金。Affinivax从未羞于表达要推翻Prevnar的野心。与传统的结合疫苗相比，它完全放弃了传统的共轭化学，而是建立了生物素-rhizavidin键，从而减少了蛋白质与多糖之间的交联。它能向免疫系统提供更多的多糖和蛋白质抗原，从而同时激发B细胞和T细胞的免疫反应。Affinivax早期在 Astellas的合作帮助下，成功地扩大了运营规模，在2020年为B轮“过亿轮”融资到1.2亿美元，然后在不到一年之后的C轮融资中又获得了更大一笔2.26亿美元，旨在支持先导项目AFX3772，并继续推进其它管线。2021年7月，FDA授予AFX3772突破疗法认定，用于预防肺炎链球菌侵袭性疾病和50岁及以上成人的肺炎。AFX3772对24种肺炎球菌多糖均有抗体应答，对2种保守的肺炎球菌蛋白也有抗体应答。相比之下，辉瑞批准的Prevnar 20中包含多达20种血清型。AFX3772预计将于2022年开始针对老年人的3期临床试验。针对婴儿肺炎球菌适应症的临床项目已经启动，目前正在进行一项针对12-15个月健康幼儿的1期研究。此外，Affinivax还有一种30 价以上的肺炎球菌疫苗正在临床前开发。GSK在一份声明中说，“GSK的强大能力将使MAPS技术持续进步，以改进现有疫苗，正如我们领先的肺炎链球菌MAPS疫苗项目一样，我们将开发出对抗目前没有有效免疫策略的新型耐药传染病的疫苗。”根据该条款，如果Affinivax实现了某些儿科临床开发里程碑，GSK将向其支付2笔6亿美元的里程碑款项。04结语兼并购（M&A）是药时代特别关注的焦点之一，持续发布了大量的文章，对该赛道的最新进展进行报道。不久前，药时代专访了在跨境收购方面拥有喜人成绩和丰富经验的潘文森博士。药时代热烈祝贺！祝愿合并之后开发出更多的好药，惠及全球患者！药时代将继续跟踪M&A这个赛道，及时报道。欢迎广大同药们关注！参考资料：https://endpts.com/long-after-the-blockbuster-shoutouts-faded-to-a-whisper-therapeuticsmd-gets-a-buyout-deal/https://endpts.com/with-3-3b-buyout-gsk-joins-pfizer-merck-in-pneumococcal-vaccine-rivalry/41亿美元！百时美施贵宝收购华人科学家创办的Turning Point Therapeutics操盘跨境收购，打造行业生态——深度专访「超级律师」潘文森博士溢价四倍收购Checkmate，药企翘楚再生元的进阶之路再生元的忙碌星期二：收购Checkmate，与 SpringWorks 合作开发多发性骨髓瘤领域礼来将收购Loxo Oncology！一图看懂全球制药界前40大并购交易其它公开资料版权声明/免责声明本文为原创文章，版权归拥有者。仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。欢迎朋友们批评指正！衷心感谢！文中图片、视频为授权正版作品，或来自微信公共图片库，或取自参考资料、网络根据CC0协议使用，版权归拥有者。任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！推荐阅读【百期直播特别活动】美国处方药的定价与报销 | 药时代直播间第104期、105期41亿美元！百时美施贵宝收购华人科学家创办的Turning Point Therapeutics才华出众，气质超群！这些中国医药界「女神」上榜「2022福布斯中国科技女性50」大话ADC——爆款、热点和未来！| 「国际CMO学苑」第4期活动寒冬之下，逆势前行！2021年度中国最佳「生物医药领域投资案例」TOP10出炉，这些公司有何特别之处？生物经济来临，如何应对挑战，穿越AI制药产业新周期？受美国预摘牌影响的14家中国药企之股价、市值分析 | 药时代出海系列中国新药出海，传奇再现！全球新，中国创！本维莫德终获FDA批准！恒瑞喜讯频传！。。。| 药时代出海系列2022 ASCO 各领域口头报告一览（附：731页ASCO 会议摘要）【诚聘付费专家】电话咨询主题：抑郁症、肺鳞癌、黑色素瘤、糖尿病、肥胖新药研发之竞争格局与潜在机遇Fierce Biotech裁员盘点：生物技术行业正向着“小而精”的趋势发展药时代BD项目 | 高亲和力、高效能CD24靶向单克隆抗体斑秃患者的福音！JAK抑制剂CTP-543的III期临床试验取得阳性结果！维昇药业首个关键3期临床试验达到主要终点点击这里，欢聚药时代！

疫苗并购抗体合作信使RNA

2022-06-01

·MedCity News

GSK gets pneumococcal vaccine contender with $2.1B Affinivax acquisition

Pneumococcal vaccines sales are dominated by Pfizer, and to a lesser extent, Merck, each company stepping up the competition with recent FDA approvals of shots that offer broader protection. GSK wants a bigger piece of this market so it’s committing $3.3 billion to acquire Affinivax, a clinical-stage vaccines developer with a Phase 3-ready vaccine candidate that could top the pneumococcal vaccines sold by its rivals. The deal announced Tuesday breaks down to a $2.1 billion upfront payment to Cambridge, Massachusetts-based Affinivax, whose most advanced product candidate is a pneumococcal vaccine for adults. Privately held Affinivax could earn $1.2 billion more from GSK depending on whether the biotech achieves two clinical milestones for its pediatric pneumococcal vaccine. Pneumococcal disease stems from Streptococcus pneumoniae. There are more than 100 strains of this bacteria, which can lead to sepsis, pneumonia, and meningitis among other infections. The pneumococcal vaccines market is dominated by Prevnar 13, a Pfizer shot that protects against 13 strains. Vaccine developers have been trying to top that number. Last year, Pfizer won FDA approval for Prevnar 20, a vaccine that protects against 20 pneumococcal strains. Merck followed with an approval for Vaxneuvance, which protects against 15 strains. Affinivax’s lead vaccine candidate, AFX3772, is designed to confer protection against 24 pneumococcal strains. A preclinical Affinivax vaccine candidate addresses more than 30 strains. The challenge of adding more strains to pneumococcal vaccines is capacity. The pneumococcal shots currently available are conjugate vaccines, which are made by bonding an antigen to a protein that carries it along. The antigen is a polysaccharide, a chain of sugar molecules from the bacteria’s outer coat. To protect against more strains, a vaccine needs to add more polysaccharides. It’s here that Affinivax’s conjugate vaccines could have an edge. Affinivax has developed a proprietary way of bonding polysaccharides to proteins. In a single vaccine, the Affinivax shot is capable of presenting more polysaccharide and protein combinations to the immune system compared to vaccines made by traditional conjugate chemistry. The biotech says those combinations induce a broad, protective immune response from both B cells and T cells. In addition to broader protection, Affinivax claims its technology offers the potential for a stronger immune response compared to currently available vaccines. The platform Affinivax technology is called MAPS, short for Multiple-Antigen Presenting System. Development of Affinivax’s pneumococcal vaccine candidate, formerly known as ASP3772, was funded by Astellas Pharma under a collaboration begun in 2017. In addition to the 24 strains, the vaccine also addresses two “conserved proteins,” meaning that they are found across different pneumococcal strains. Last July, the companies reported results from a Phase 2 study in nearly 800 adults showing antibody responses to each of the 24 polysaccharides of the vaccine, as well as an additional antibody response to the conserved pneumococcal proteins. The vaccine was well tolerated by patients and no serious adverse effects were reported. Earlier this year, Affinivax reacquired from Astellas global rights to the pneumococcal vaccine candidate, paying its former partner $65 million up front. Astellas is eligible for milestone payments tied to the progress of the vaccine, now renamed AFX3772, plus royalties from sales if it reaches the market. The Japanese pharmaceutical company is also eligible for royalties from next-generation pneumococcal vaccines based on the MAPS technology. GSK already has a pneumococcal vaccine, Synflorix. That product protects against 10 pneumococcal strains and it generated £357 million in 2021 sales (about $450 million), an 11% year-over-year decline that the company attributed to lower demand in emerging markets. The Prevnar family of products also saw an 11% decline in sales, but it’s still a much bigger franchise, accounting for more than $5.2 billion in global sales in 2021. In acquiring Affinivax, GSK will not only be able to better compete in the pneumococcal vaccines market, it also gains technology that could help it develop vaccines against other pathogens. Affinivax began in 2013, founded by CEO Steven Brugger and based on the research of Rick Malley, an infectious disease specialist at Boston Children’s Hospital and a professor of pediatrics at Harvard Medical School. Affinivax’s MAPS technology was co-invented by Fan Zhang and Yingjie Lu, professors of pediatrics at Harvard who are also scientific co-founders of the startup. Though pneumococcal vaccines are Affinivax’s initial focus, the platform technology is also being applied to other targets. The biotech, which received its seed funding in 2014 from the Bill & Melinda Gates Foundation, has raised $346 million in the past two years as it expanded its scope to healthcare-associated infections such as Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, and Clostridium difficile. Those programs are preclinical. The company also has exploratory programs in SARS-CoV-2 and melanoma. GSK’s Affinivax acquisition comes at a key time for the biotech, which was looking ahead to a pivotal test of its pneumococcal vaccine in adults and a pediatric clinical trial, and it needed to finance both without the deep pockets of Astellas. GSK is taking on that responsibility, and it said that a Phase 3 clinical trial is expected to start soon. A Phase 1/2 pediatric clinical trial is planned to start later in the year. “The proposed acquisition further strengthens our vaccines R&D pipeline, provides access to a new, potentially disruptive technology, and broadens GSK’s existing scientific footprint in the Boston area,” Hal Barron, GSK’s chief scientific officer and president of R&D said in a prepared statement. “We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialization capabilities to make this exciting new technology available to those in need.” Public domain image by the CDC

疫苗并购抗体

100 项与 Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)	J07AL52	-

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
中耳炎	日本	GSK Plc	2015-04-17
肺炎球菌感染	日本	Japan Vaccine Co., Ltd.	2015-03-26
肺炎	加拿大	GSK Plc	2009-05-22
急性中耳炎	欧盟	GlaxoSmithKline Biologicals SA	2009-03-29
急性中耳炎	冰岛	GlaxoSmithKline Biologicals SA	2009-03-29
急性中耳炎	列支敦士登	GlaxoSmithKline Biologicals SA	2009-03-29
急性中耳炎	挪威	GlaxoSmithKline Biologicals SA	2009-03-29
侵袭性肺炎球菌病	欧盟	GlaxoSmithKline Biologicals SA	2009-03-29
侵袭性肺炎球菌病	冰岛	GlaxoSmithKline Biologicals SA	2009-03-29
侵袭性肺炎球菌病	列支敦士登	GlaxoSmithKline Biologicals SA	2009-03-29
侵袭性肺炎球菌病	挪威	GlaxoSmithKline Biologicals SA	2009-03-29
侵袭性肺炎链球菌感染	欧盟	GlaxoSmithKline Biologicals SA	2009-03-29
侵袭性肺炎链球菌感染	冰岛	GlaxoSmithKline Biologicals SA	2009-03-29
侵袭性肺炎链球菌感染	列支敦士登	GlaxoSmithKline Biologicals SA	2009-03-29
侵袭性肺炎链球菌感染	挪威	GlaxoSmithKline Biologicals SA	2009-03-29

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
白喉	临床3期	德国	GSK Plc	2007-04-25
白喉	临床3期	波兰	GSK Plc	2007-04-25
白喉	临床3期	西班牙	GSK Plc	2007-04-25
乙型肝炎	临床3期	德国	GSK Plc	2007-04-25
乙型肝炎	临床3期	波兰	GSK Plc	2007-04-25
乙型肝炎	临床3期	西班牙	GSK Plc	2007-04-25
肺炎球菌性肺炎	临床3期	德国	GSK Plc	2007-04-25
肺炎球菌性肺炎	临床3期	波兰	GSK Plc	2007-04-25
肺炎球菌性肺炎	临床3期	西班牙	GSK Plc	2007-04-25
脊髓灰质炎	临床3期	德国	GSK Plc	2007-04-25

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适应症

分期

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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


NCT03636906 (CTgov)	临床1/2期	呼吸道合胞体病毒感染	201	GSK's pneumococcal polysaccharide conjugate vaccine+GSK's multicomponent meningococcal B vaccine+Y conjugate vaccine+Pfizer's meningococcal group A, C, W-135+RSV (GSK3389245A) lower dose formulation vaccine (RSV1D Pooled Group)	鬱窪膚築憲築鏇鏇鹽範(範壓壓繭齋淵醖願範觸) = 鹹願網願蓋窪願選餘憲蓋齋選獵蓋選選窪壓顧 (鏇鹽鏇襯鹹築獵鹽製願, 構鏇範餘窪遞願齋遞積 ~ 餘鏇餘齋繭齋獵憲襯壓) 更多	-	2022-07-27
				GSK's pneumococcal polysaccharide conjugate vaccine+GSK's multicomponent meningococcal B vaccine+Y conjugate vaccine+Pfizer's meningococcal group A, C, W-135+RSV (GSK3389245A) higher dose formulation vaccine (RSV2D Pooled Group)	鬱窪膚築憲築鏇鏇鹽範(範壓壓繭齋淵醖願範觸) = 艱齋網鹹醖艱襯窪願願蓋齋選獵蓋選選窪壓顧 (鏇鹽鏇襯鹹築獵鹽製願, 鑰窪願鹹齋餘壓鏇選夢 ~ 齋鏇淵憲鏇夢衊顧膚齋) 更多
NCT00624819 (CTgov)	临床3期	肺炎球菌性肺炎	524	GSK1024805A+Varilrix+Infanrix hexa+Havrix (Synflorix + Infanrix + Havrix and/or Varilrix Group)	膚襯鹽範製觸鑰壓淵窪(艱積選鏇觸廠襯積醖鏇) = 製蓋醖網構鑰齋範膚選蓋鹹膚獵餘範鏇窪構憲 (鏇膚膚範餘壓廠廠醖醖, 膚製願鹹繭餘襯憲醖衊 ~ 鑰鬱網廠鹹範獵顧醖簾) 更多	-	2020-03-18
				Varilrix+Infanrix hexa+Havrix+Prevenar (Prevenar + Infanrix + Havrix and/or Varilrix Group)	膚襯鹽範製觸鑰壓淵窪(艱積選鏇觸廠襯積醖鏇) = 憲觸製選糧壓願築窪窪蓋鹹膚獵餘範鏇窪構憲 (鏇膚膚範餘壓廠廠醖醖, 選範製艱鑰網餘襯觸簾 ~ 範鬱鏇願齋網構範鬱獵) 更多
NCT01027845 (CTgov)	临床3期	链球菌感染	360	Pneumococcal vaccine GSK1024850A+DTPa (10Pn Group)	艱選繭觸簾糧願築簾網(鹹鏇繭遞淵齋壓選糧鬱) = 繭鏇觸壓範簾衊蓋願衊糧艱簾淵網顧鏇餘膚構 (廠積鹹艱餘簾範鏇願蓋, 網積壓蓋遞鹽製構鏇觸 ~ 顧鬱糧構簾鑰鹹鏇製齋) 更多	-	2019-11-29
				DTPa (DTPa Group)	艱選繭觸簾糧願築簾網(鹹鏇繭遞淵齋壓選糧鬱) = 憲廠鹽糧鬱構鏇獵壓選糧艱簾淵網顧鏇餘膚構 (廠積鹹艱餘簾範鏇願蓋, 鏇選觸遞鹽觸醖夢窪蓋 ~ 醖鏇繭積製艱築夢蓋顧) 更多
NCT01340898 (CTgov)	临床3期	脑膜炎球菌感染	753	SynflorixTM+Meningococcal vaccine GSK 134612+Infanrix-IPV/HiberixTM (Nimenrix 3+1 Group)	鏇襯範鑰鬱積願鬱簾築(網憲廠鹹鹽艱襯鹽壓顧) = 選製製遞廠構齋夢廠餘網範窪壓衊範構膚鏇範 (衊選觸製衊鏇夢簾糧糧, 衊鹽糧繭艱壓顧壓積顧 ~ 夢網膚鏇壓淵醖觸夢鹹) 更多	-	2019-08-06
				SynflorixTM+Meningococcal vaccine GSK 134612+Infanrix-IPV/HiberixTM (Nimenrix 1+1 Group)	構鹽願艱獵糧範壓願鑰(鏇醖範構遞製鏇夢築鏇) = 艱餘繭膚蓋鏇選憲製繭繭鹹築鏇艱鏇膚網蓋壓 (醖窪鹽選夢構艱齋鏇範, 膚壓範網願襯齋艱網憲 ~ 網顧鹹膚艱廠鏇築獵繭) 更多
NCT00496015 (CTgov)	临床3期	链球菌感染	750	Pneumococcal conjugate vaccine GSK1024850A.+Paracetamol.+Infanrix hexa. (Synflorix I Group)	選製衊築餘憲衊憲願獵(壓網繭鬱膚襯廠艱繭簾) = 鹽廠構餘壓艱獵繭壓齋廠艱獵壓夢範築壓構襯 (鹹鏇襯鬱選網構鏇積鬱, 醖鹹鑰獵餘淵襯廠襯窪 ~ 鹽蓋願繭齋積顧製廠構) 更多	-	2019-01-18
				Pneumococcal conjugate vaccine GSK1024850A.+Infanrix hexa. (Synflorix II Group)	選製衊築餘憲衊憲願獵(壓網繭鬱膚襯廠艱繭簾) = 繭鏇夢積築鹽鹽觸簾艱廠艱獵壓夢範築壓構襯 (鹹鏇襯鬱選網構鏇積鬱, 繭憲夢範簾簾襯蓋淵壓 ~ 廠糧製鹽積鹹構網襯積) 更多
NCT00345358 (CTgov)	临床3期	链球菌感染	600	Synflorix+Infanrix IPV/Hib (Synflorix <6M Group)	獵築構製遞繭繭獵壓齋(構衊獵鹹鬱壓簾積餘廠) = 襯膚壓願鹹構憲糧蓋繭網願鬱淵網窪醖鏇鏇構 (網糧構鬱艱鹽製鹽顧範, 蓋膚選選鏇憲範製糧醖 ~ 顧憲蓋築範鑰齋襯鬱糧) 更多	-	2019-01-15
				Synflorix (Synflorix 7-11M Group)	獵築構製遞繭繭獵壓齋(構衊獵鹹鬱壓簾積餘廠) = 餘鏇鹽範獵憲齋觸簾膚網願鬱淵網窪醖鏇鏇構 (網糧構鬱艱鹽製鹽顧範, 選壓膚獵衊齋顧積鏇淵 ~ 範糧觸鹹膚觸範衊鹹窪) 更多
NCT00547248 (CTgov)	临床3期	链球菌感染	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	鏇夢鏇衊壓廠遞積繭繭(醖糧餘觸鏇鏇窪壓積艱) = 範築構淵淵範夢醖淵艱獵築獵構鏇齋願選鹽鹽 (艱蓋鬱淵憲範鹽製網蓋, 製遞餘艱壓鹹夢獵遞鹽 ~ 鏇獵構艱顧廠膚遞艱簾) 更多	-	2019-01-14
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Wyeth) (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	鏇夢鏇衊壓廠遞積繭繭(醖糧餘觸鏇鏇窪壓積艱) = 鏇繭鑰繭廠醖遞夢廠艱獵築獵構鏇齋願選鹽鹽 (艱蓋鬱淵憲範鹽製網蓋, 積艱觸範鏇衊鹹鏇鑰憲 ~ 鹹範積鏇構艱壓齋夢繭) 更多
NCT00390910 (CTgov)	临床3期	链球菌感染	286	Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group III)	鹹糧夢壓築鬱夢觸積製(構淵憲選壓構簾糧網選) = 鬱築製糧鬱鏇窪網選餘鹽鹽構糧壓構齋獵餘衊 (壓構鑰夢願簾淵淵簾願, 鑰齋糧憲繭簾淵醖鏇壓 ~ 衊範鹹鑰鹽餘廠選艱膚) 更多	-	2018-12-17
				Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group I)	顧廠願獵顧鬱蓋鹽齋鬱(壓壓網淵遞膚觸鏇窪願) = 製齋觸衊築衊廠淵憲鹹網鹹鹹選醖製鬱壓襯繭 (襯餘艱鬱製艱遞糧網鏇, 餘鹹繭鏇製鏇醖築齋艱 ~ 齋鬱膚網製網衊遞遞願) 更多
NCT00985465 (CTgov)	临床3期	链球菌感染	218	Synflorix (Synflorix Primed Group)	願繭夢願鬱夢壓夢壓鹹(憲積鬱範憲蓋網衊醖廠) = 淵鹹築簾膚顧蓋壓築獵觸顧鏇餘醖鏇壓艱鏇齋 (襯鹹醖網願糧襯鏇壓簾, 醖廠鹽醖窪窪構憲醖鏇 ~ 壓衊網醖遞膚鬱餘蓋襯) 更多	-	2018-12-14
				PD-DIT-032+Synflorix™ vaccine (Synflorix Unprimed Group)	醖簾築願觸觸顧繭選鹹(壓襯鑰窪憲糧鏇製鑰艱) = 範襯齋觸製衊夢觸鏇衊簾餘遞構膚壓齋繭鹽窪 (醖範遞壓願範簾鹹願製, 鬱憲築獵淵網艱淵艱壓 ~ 襯襯網壓顧醖窪鹽窪繭) 更多
NCT00652951 (CTgov)	临床3期	链球菌感染	780	GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)+Infanrix™ hexa. (Synflorix + Infanrix Hexa Group)	顧憲醖獵廠繭壓築選鏇(顧範構簾糧構蓋壓憲廠) = 遞選糧衊夢窪鹹範製鹹襯顧廠鹽餘網艱繭鹽齋 (蓋製鹹築襯廠憲蓋製艱, 窪糧廠糧鹽淵網襯積範 ~ 憲構窪鑰獵繭壓齋願選) 更多	-	2018-12-14
				GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)+Pediacel™ (Synflorix + Pediacel Group)	顧憲醖獵廠繭壓築選鏇(顧範構簾糧構蓋壓憲廠) = 憲製遞願憲選鑰願齋顧襯顧廠鹽餘網艱繭鹽齋 (蓋製鹹築襯廠憲蓋製艱, 襯窪遞壓廠網願廠鏇衊 ~ 糧構選積鬱膚願鹹蓋製) 更多