13价肺炎球菌多糖结合疫苗 (辉瑞制药)(Pneumococcal polysaccharide conjugate vaccine) - 在研适应症：细菌性肺炎，中耳炎，急性中耳炎_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

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine、13vPnC、Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

+ [10]

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

Pfizer Europe MA EEIG

辉瑞投资有限公司John Wyeth & Brother Ltd.

+ [5]

非在研机构

赫力昂（苏州）制药有限公司Wyeth AB

GSK Plc

+ [1]

最高研发阶段批准上市

首次获批日期

日本 (2009-10-16),

肺炎球菌感染

最高研发阶段(中国)批准上市

特殊审评-

登录后查看首次获批时间轴

关联

171

项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的临床试验

TCTR20230923001 / Not yet recruiting临床4期

Immunogenicity and Safety of Pneumococcal 13-valent Conjugate Vaccine between Weuphoria and Prevnar 13 in Thai Older People

开始日期2023-11-01

申办/合作机构-

NCT06202703 / RecruitingN/A

Optimisation of Lymph Node Fine Needle Aspiration to Study Pneumococcal Vaccine-induced Immunity

Rationale Causing a wide range of infectious diseases, including pneumonia, otitis media and meningitis, S. pneumoniae represents an important global health problem. Pneumococcal vaccines are clinically effective in preventing invasive pneumococcal disease, but the underlying immune response is likely to differ due to the inclusion of T cell epitopes in the conjugate, but not purified polysaccharide vaccine. However, these differences remain scantly studied. Lymph node fine needle aspiration (FNA) has been recently described to study vaccine-induced germinal centre responses in depth and represents a promising tool to study the underlying immune mechanisms of pneumococcal vaccines. Insight into the underlying immune mechanisms of vaccines could improve future vaccine design, e.g. by refining dosing intervals.
Objective Determine timing of peak germinal centre B cell frequency following pneumococcal vaccination.
Main trial endpoints The main trial endpoint is represented by the frequency of germinal centre B cells (BGC) in lymph node aspirates at various time points after vaccination, as measured by spectral flow cytometry. Both total BGC cells and S. pneumoniae polysaccharide-specific BGC frequencies will be determined.
Trial design Pilot intervention study without a comparator.
Trial population Healthy individuals between the age of 20 - 40
Interventions Subjects will be vaccinated once with Prevenar13. FNA of the draining lymph node will be performed and blood will be drawn at baseline, followed by weekly collection during the first four weeks, every other week between weeks 4 - 8 and a final collection time point after 12 weeks, resulting in a total of 8 sampling time points over the course of three months. Draining lymph node size will be assessed by ultrasound every other day during the first two weeks and then alongside lymph node FNA for the remainder of the study.

开始日期2023-04-15

申办/合作机构

Academisch Ziekenhuis Leiden

NCT05794230 / Recruiting临床3期

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers.
It will be conducted in India and the RSA in 2 cohorts:
Cohort I: Infants and toddlers 6 months to 16 months of age
Cohort II: Infants and toddlers 6 weeks to 15 months of age
In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines.
In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8).
The primary objectives of this study are:
To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA)
To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA
The secondary objectives of this study are:
To describe the antibody titers to the meningococcal serogroups A, C, Y, and W:
before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines.
before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines.
To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine:
in infants and toddlers 6 weeks to 15 months of age in India and the RSA.
in infants and toddlers 6 months to 16 months of age in India and the RSA. The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

开始日期2023-03-27

申办/合作机构

Sanofi Pasteur

100 项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的临床结果

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100 项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的转化医学

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100 项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的专利（医药）

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995

项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的文献（医药）

2024-01-01·Medicina

[Updated recommendations for vaccination in adults with respiratory diseases. Argentine Association of Respiratory Medicine, 2023].

Review

作者: Pulido, Laura ; Gauna, María Laura ; Rizzo, Oscar ; Videla, Alejandro J ; Chirino, Alejandro ; Luna, Carlos M

Adult smokers, those with comorbidities, and the elderly, are at greater risk of contracting infections and their complications. Community acquired respiratory infections due to viruses, pneumococcus and other bacteria, affect both healthy and sick adults. There are vaccines that the pulmonologist must know and prescribe. The target strains of the influenza vaccine are defined by the WHO for the Southern hemisphere considering those involved in the previous influenza season in the Northern hemisphere. Its effectiveness depends on virulence, concordance between circulating and vaccine strains, and population coverage. The anti-pneumococcal polysaccharide vaccine available since 1983 is being replaced by more effective conjugate vaccines to prevent infections related to serotypes present in them. Immunization against SARS-CoV-2 reduced the contagion, severity, and lethality of COVID-19. The acellular vaccine against Bordetella pertussis for adults is present for specific situations in the adult calendar; vaccinating them strengthens the control of childhood contagion. The double (diphtheria + tetanus), and triple (double + pertussis) bacterial vaccines, and the vaccines against measles, chickenpox, rubella, human papillomavirus, Haemophilus influenzae, meningococcus, herpes zoster, Argentine hemorrhagic fever and yellow fever, are of a more limited use. Soon we will have new vaccines such as the one recently approved by the FDA against respiratory syncytial virus. Through a consensus of experts in respiratory infections, we review the new evidence regarding the immunization of adults who consult a pulmonologist, and thus update the recommendations on vaccination made eight years ago.

2023-12-31·Expert review of vaccines

Effectiveness of pneumococcal vaccination on hospitalization and death in the adult and older adult diabetic population: a systematic review

Review

作者: Cosma, Claudia ; Salvati, Cristina ; Bechini, Angela ; Biamonte, Massimiliano Alberto ; Bonito, Benedetta ; Monami, Matteo ; Rigon, Lisa ; Del Riccio, Marco ; Vaccaro, Gabriele ; Zanella, Beatrice ; Giorgetti, Duccio ; Boccalini, Sara ; Bonanni, Paolo

INTRODUCTION:

Diabetic patients are at a higher risk of getting pneumococcal disease and are therefore recommended to get vaccinated. The aim of our systematic review is the retrieval and analysis of all available evidence on the effect of pneumococcal vaccination on the risk of hospitalization and death in adult patients with diabetes.

RESEARCH DESIGN AND METHODS:

MEDLINEand EMBASE were searched from inception until January 2023. We included all studies investigating whether pneumococcal vaccination reduces the risk of dying or being hospitalized in diabetic patients. The Newcastle-Ottawa scale was used to assess risk of bias.

RESULTS:

Only two studies, encompassing a total of 68,246 subjects, were considered eligible for inclusion and of high quality. In both studies polysaccharide pneumococcal vaccination was associated with a reduction of the risk of hospitalization or death in adult diabetic patients (aHR: 0.76 in one study, aOR: 0.97 in the other one). However, in neither of the two included studies the lower risk was statistically significant.

CONCLUSIONS:

Further research is needed due to the potentially major clinical implications for diabetic patients. The results of this systematic review can serve as a foundation for future studies, indicating the importance of continuing research in this area to improve patient outcomes.

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.

110

项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的新闻（医药）

2024-06-19

·CPHI制药在线

肺炎球菌疫苗再迎新成员，玩家不断增多，后续如何卷？

关注并星标CPHI制药在线近日，默沙东的21价肺炎球菌结合疫苗Capvaxive（V116）的生物制品许可申请（BLA）获FDA批准，用于预防18岁及以上成人侵袭性肺炎球菌疾病和肺炎球菌肺炎。这意味着V116成为首个专为成人设计的肺炎球菌结合疫苗。涵盖8种独特血清型，尤其适合50岁及以上患者肺炎球菌疾病是一种由肺炎链球菌引起的感染，包括细菌性肺炎、鼻窦炎和中耳炎等非侵入性疾病、以及脑膜炎等的侵入性疾病。研究显示，肺炎球菌普遍存在于健康人鼻咽部黏膜，其易感人群为2岁以下儿童、65岁以上的成人、以及免疫能力不足或患有慢性疾病的人群。目前人类已经发现90多种血清型的肺炎球菌，其中20-30种血清型的肺炎球菌导致了全球80%以上的致病。此次获批上市的V116专为成年人群设计，涵盖导致50岁及以上成年人中约84%侵袭性肺炎球菌疾病的血清型。包括目前获批的肺炎球菌疫苗未涵盖的8种独特血清型（15A、15C、16F、23A、23B、24F、31和35B），这些血清型是65岁及以上人群中约30%侵袭性肺炎球菌疾病的罪魁祸首。此次获批主要基于STRIDE-3的临床研究数据。这是一项随机、双盲、阳性对照III期研究，旨在评估V116与辉瑞的PCV20（肺炎球菌20价结合疫苗，Prevnar 20）在此前未接种过肺炎球菌疫苗的成人中的安全性、耐受性和免疫原性。通过血清型特异性调理吞噬活性（OPA）几何平均滴度（GMTs）的测量结果发现：在50岁及以上成人中（队列1），V116与PCV20共有的所有10种血清型中，V116引起的免疫应答呈现非劣效性。接种疫苗后的第30天，根据OPA GMT的测定结果以及从第1天至第30天OPA升高≥4倍的患者比例，V116中包含的其中11种血清型中有10种展现良好的免疫应答，PCV20不包含这11种血清型。此外，根据接种后30天血清型特异性OPA GMTs的评估，与50-64岁的成人相比，18-49岁的成人（队列2）中V116引起的免疫应答展现非劣效性。在两个队列中，V116的安全性与PCV20相当。V116的BLA还得到了其他多项3期临床研究结果的支持（包括STRIDE-4、STRIDE-5和STRIDE-6）。两大巨头的肺炎球菌疫苗拉锯战默沙东和辉瑞是肺炎球菌疫苗赛道的主要玩家。两家在肺炎球菌疫苗赛道上很早就开展了一场拉锯战。 1983年，默沙东的23价肺炎球菌疫苗Pseumovax23获批上市，作为全球首款23价肺炎球菌多糖疫苗，一度年销售额超10亿美元。不过2020年，辉瑞的7价肺炎球菌结合疫苗Prevnar 7获FDA批准上市后，打破了默沙东的垄断。 2010年，辉瑞的13价肺炎球菌多糖结合疫苗Prevnar 13获批上市，迅速成为疫苗界的重磅炸弹，多年位列全球药品销售榜前十。至此，辉瑞在肺炎球菌疫苗市场占据主导地位。Pseumovax23与Prevnar 13相比，相形见绌。背后原因与采取的工艺技术相关。 Pseumovax23为多糖疫苗（PPV），适用人群为50岁以上人群及2周岁以上肺炎易感人群。PPV的应答类型为体液免疫。抗原为细菌荚膜多糖，是非T细胞依赖抗原(半抗原)，不能产生免疫记忆，因此免疫持续时间短。对小年龄段儿童尤其是对2岁以下婴幼儿保护效果不好。 Prevnar 13是蛋白结合疫苗（PCV），应答类型为体液/细胞免疫。抗原是将细菌荚膜多糖与蛋白载体结合，结合后成为T细胞依赖抗原(全抗原)，接种后可形成免疫记忆，免疫持续时间长，而且使用不受年龄限制，尤其可对2岁以下婴幼儿具有非常好的保护作用。由于Prevnar 13的制备要将荚膜多糖与蛋白载体相结合，因此工艺流程更为繁复，技术壁垒更高，适用人群更广。除此之外，2021年6月，辉瑞的20价肺炎球菌疫苗PF-06482077（20vPnC）获FDA批准，用于18岁以上成人。PF-06482077包含了PCV13所包含的全部13种血清型肺炎球菌菌株，以及额外7种在全球范围内引起侵袭性肺病和肺炎的常见血清型肺炎球菌菌株。默沙东也不甘落后，2021年7月，默沙东的15价肺炎疫苗V114（PCV15）获FDA批准，用于预防18岁以上成人的肺炎球菌感染以及细菌性肺炎。V114包含了Prevenar 13 的全部13种血清型（1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F），同时增加了2种在老年人侵袭性肺炎球菌疾病中很常见的血清型22F和33F。值得注意的是，V114与Prevnar13采用了相同的工艺，2022年8月，V114将适用人群覆盖至6周龄以上儿童。默沙东对2岁以下人群市场的觊觎之心不言而喻。下一步卷向更高价辉瑞从原先的7价到现在的13价、20价，至今Prevnar（沛儿）这个品牌成为全球肺炎疫苗的代名词，2023年沛儿系列收入64.4亿美元。据悉，辉瑞还在开发下一代肺炎球菌疫苗，出于竞争的原因，价数目前保密。而在已公开消息中，2023年4月，Vaxcyte宣布其迭代的24价肺炎结合疫苗第二项II期临床获得成功，针对65岁以上人群。2023年4月19日，Vaxcyte宣布募资5亿美元，用于24价肺炎结合疫苗的III期临床。公司后续管线还有30价肺炎疫苗、流感疫苗、牙周炎疫苗等。辉瑞凭借Prevnar13在肺炎疫苗领域称霸十余年，但其专利期仅到2026年。另外默沙东的V114有后来居上之势，加上此次V116的获批，使肺炎球菌疫苗市场的未来更加扑朔迷离。此外，其下一代儿童疫苗V117处于I期临床开发中，再加上GSK（24价苗）等巨头的入局，接下来，该赛道的对决将无比精彩。参考来源： 1.https://www.businesswire.com/news/home/20240614126575/en/U.S.-FDA-Approves-CAPVAXIVE%E2%84%A2-Pneumococcal-21-valent-Conjugate-Vaccine-for-Prevention-of-Invasive-Pneumococcal-Disease-and-Pneumococcal-Pneumonia-in-Adults. 2. Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults.By Kevin Dunleavy.Jun 17, 2024 5:03pm. 【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

临床3期上市批准疫苗临床结果

2024-04-09

·E药经理人

罕见！跨国药企牵手本土BigPharma。中国区业务频调，折射了MNC何种现实困境？

退出、合作，看似一进一退的大动作频繁背后，折射出了跨国药企何种现实困境？撰文| Qsher编辑| 润屿彡氜勃林格殷格翰（BI）最近在中国的动作格外频繁。4月8日，BI与中国生物制药展开战略合作，背后直指多个创新肿瘤产品的开发和商业化，成为跨国药企与国内本土BigPharma“牵手”罕见一例。根据协议条款，此次战略合作涵盖BI多个处于临床阶段的资产，包括三个处于临床开发阶段的资产Brigimadlin、Zongertinib和DLL3/CD3双特异性T细胞衔接器，以及若干早期临床资产。格外值得一提的是，在本次双方的合作管线中，多款药物都具备前沿突破性技术。BI中国的意图已经很明晰：看中了中生制药雄厚的商业化等能力。此外，BI与中国生物制药的合作不单局限于“商业化”，直接向前探至研发层面，更进一步扩大了与大型本土药企的合作范围。除了牵手本土BigPharma“共舞”，一个星期前，BI中国还因战略布局调整，决定退出在中国的卒中康复业务，该业务此前为其重点布局方向之一。实际上，做出如此决定的跨国药企并非个例，基于国内医药市场的转变，不少跨国药企选择了简化在华运营，有些明显在华“减少销售投入”，重新配置各事业部、产品的资源，回撤个别业务，“性价比”成为跨国药企而今主要考量因素之一。无论关闭业务还是调整一系列业务单元，背后本质都是为了降低整体业务成本，并提高在中国区域内业务开展的灵活性。站在MNC基于大环境改变在华作调整的角度，能部分理解BI中国为何在近期频繁产生大动作。而从扎根中国后多年的发展脉络来看，BI如今究竟又在下一盘怎样的棋？MNC集体调整背后，又释放了哪些信号？优化与调整背后BI中国动作如此频繁背后，脱离不了跨国药企共同的现实困境，一切优化与调整都是为了更好地适应中国市场。在众所周知的资本、政策等因素叠加下，跨国药企在国内业务增长不似往年容易。纵观过去一年，不少跨国药企调整了部分产品在华打法，尤其是商业化策略，选择和本土企业达成更广泛的合作，积极探寻新商业模式的可能性。如此语境下，BI中国也正试图通过一系列举措进行调整，而此次选择借助国内本土合作伙伴的力量，实属以一种确定性更强的方式借以提振发展。BI卒中康复业务退出中国市场同样也是一种优化调整。4月1日，一纸公告出现在BI旗下品牌“霁达康复”的官网：因公司战略布局调整，现遗憾地决定退出在中国的卒中康复业务。不过，该公司表示还将继续深耕卒中领域，并加速创新疗法的开发，惠及更多中国卒中患者。实际上，BI中国算是卒中疾病领域的领跑者，推出了创新的“卒中整体解决方案”，覆盖预防、疾病教育、检测、急救、诊断、治疗、康复七大模块，设立了卒中康复医疗中心和数字居家康复平台，将德国金标准康复模式全面引入中国。针对此番“临时决定”，霁达康复也提供了同步的“缓冲措施”：一是自2024年4月1日起，霁达云康将停止接收新患者，并会以一支精简团队为现有患者继续提供服务；二是，自同日起，霁达康复官方网站、“勃林格殷格翰霁达”官方微信、“成都霁达康复”官方微信、 “霁达云康服务”微信小程序、“云小康”官方小红书以及其他霁达康复相关账号也将停止服务与运营；三是霁达云康医生端/患者端App将持续运营至2024年6月30日最后一位患者完成服务。不容忽视的是，中国区一直是BI的业务重点区域。自1885年成立以来，BI一直是一家独立家族企业，主要致力于人用药品、动物保健和生物制药合同生产三大业务领域。1994年，BI进入中国，这三大业务同样也被称为该公司在华的“三驾马车”。从业务占比来看，人用药品业务始终是BI中国的重头戏，覆盖了呼吸、心血管代谢、中枢神经、肿瘤、免疫等重要治疗领域，产品包括慢阻肺、高血压、卒中、房颤卒中预防、帕金森病、糖尿病、非小细胞肺癌、抗纤维化、泛发性脓疱型银屑病 (GPP) 等创新治疗药物。前述肿瘤和卒中康复两大调整均归属于人用药品业务板块。为了让这一重头戏板块更好发展，近两年，BI中国内部也进行了人事架构上的更迭，现由聚焦在销售和市场营销领域的陈文汉接任。这也不难理解，在当前大环境不佳的情况下，几乎不少公司都将“赚钱”岗位如销售提至更重要的台前，成为重要“军备”力量。此外，在CDMO业务板块，BI中国对国内CDMO产业发展有不少贡献，它是第一个进入国内CDMO产业的外资企业，也是首个在中国建立国际化生物制药基地的跨国药企，而且还推动了国内首个上市许可持有人采用CDMO模式生产的创新生物药成功获批上市。不过，一切昔日荣光正面临着一场新的市场挑战，该公司CDMO业务或并不太顺利。此前，有受访者对E药经理人直言“龙沙、BI等外资CDMO业务在华表现不佳”。背后原因不难理解，“性价比”始终是外资CDMO融进本土市场的一大“硬伤”。早前，龙沙广州工厂关闭背后的关键便在于——龙沙中国大分子CDMO“难接到订单”。彼时，“没有一家外资品牌CDMO价格卷得过本土企业”的声音甚嚣尘上。在一位业内投资人看来，外资品牌国际化经验和质量毋庸置疑，但当下市场艰难，愿意使用其高质量服务的客户只会相对较少。尤其随着2023年以来，中国的CDMO环境更是变得愈加艰难，情况已不可与往日同日而语。转向也可从前不久与上海莱士的合作中窥见一斑。BI表示启动“商业化供应2.0”战略，致力成为面向亚太地区的生物制药供应中心，利用生物大分子药全球生产和注册的丰富经验，助力本土药企将创新产品推向国外市场。从中国扩大至亚太区，背后也可窥见CDMO业务路径拓展的改变。观察任何一家外资企业在华发展，势必脱离不了全球总部的现状语境而言。可以看见，在全球层面，BI也基于外部环境变化和内部战略规划，正在进行合理的调整。如在近期，由于旗下修美乐生物仿制药Cyltezo销售额不及预期，全球市场份额又仍被修美乐牢牢把持，BI正计划在美国区裁员，转向混合营销模式。MNC在华调整和优化还在持续中。在当下充满不确定性的现实市场环境中，“BI们”如何制定出更为行之有效的市场策略？这一问题将持续扣在MNC的各大业务版图上。推荐阅读 * 辉瑞、GSK、赛诺菲在华选当“甩手掌柜”后，下一个是谁？2024跨国药企在华战略将如何分化？* 接不到订单，连全球巨头都扛不住了！外资CDMO集体“败走”MNC频繁调整中国业务，折射了怎样的现实困境？BI战略和业务布局优化调整不是个例，近一年不少跨国药企都做出了同样选择。最明显的是疫苗领域，辉瑞、GSK都做出了相似选择。辉瑞在中国上市的疫苗仅有13价肺炎疫苗沛儿，但是随着国内情况发生改变，尤其是2019年沃森生物、2021年民海生物13价肺炎疫苗相继上市，辉瑞13价肺炎疫苗沛儿面临地竞争加剧。GSK则因此前疫苗业务发展不及预期，葛兰素史克开始发力，重视与中国本土药企合作，除了将其重磅疫苗产品重组带状疱疹疫苗欣安立适在中国的独家销售权交给了智飞生物，还与厦门万泰共同签署了全球合作协议，联合研发新一代的HPV疫苗。这一现象不仅存在于疫苗领域，同样针对不少跨国药企在华成熟产品线。典型的如赛诺菲中国，对一系列心血管疾病、中枢神经系统疾病和肿瘤等领域的产品转换了商业化思路，与上药控股展开合作，如将核心产品诺维乐和克交由上药推广。同时，这不可避免涉及中国区部分销售团队的优化调整。案例数不胜数，这股调整之火愈演愈烈。可以预想到，今后在部分产品商业化考量上，选择一个强有力的中国合作伙伴或针对中国市场变化进行产品线合并策略等路径，来推进商业化的跨国药企或将增多。不过，硬币的另一面同样表现突出。不少跨国药企仍在续写对中国的“承诺”，选择持续加码中国，并表示将加大投资力度，尤其是选择在有结构性优势的赛道扩大布局。与销售端的“收缩”相反的是，跨国药企相较过往在研发端的布局开始着重发力，加大投资。这同样侧面反映了跨国药企全球对于中国的定位再次发生改变，已从偏销售的医药市场，逐步转向创新研发“蓄水池”。这同样也是几家跨国药企调整在华销售策略的主要原因，在降本增效的语境下，对已有产品的销售力提出了更高要求，同时也促使其将重心更多的前移至研发端，为未来高市场潜力的产品打好筑基战。在创新方面，一场跨国药企浩浩荡荡的多元布局开始铺开，这便要求跨国药企将更多的精力转向新产品研发布局上，并优化资源分配，以寻求未来业绩增长的确定性。更重要的是，按照未来产品的结构及中国市场未来发展趋势，跨国药企需要迅速做出相应战略布局，考虑清楚在中国市场上市的产品组合以及所面对的治疗领域潜力。BI同样也做了如此选择。在今年更早之前，BI还与小核酸Biotech瑞博生物达成超20亿美元的多靶点合作，其交易金额甚至超过了ADC开年的第一笔BD，两者合作是要共同干一件大事：打造NASH siRNA药物。而当下看到的一幕幕，无非是两相权衡之下，跨国药企们选择了一种更高效走向市场的模式。对于此前大举在华扩张的跨国药企来说，更需要重新思考中国业务模式、重新研判风险与机遇。回复“CXO”，了解电子期刊详情精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

2024-03-19

·Pharmaceutical Technology

Microsoft and NVIDIA expand collaboration in healthcare innovation

The partnership will aid in faster drug discovery. Credit: Elnur / Shutterstock.com. Microsoft has announced plans to broaden its partnership with NVIDIA to leverage generative AI, cloud technology and accelerated computing to enhance healthcare and life sciences innovation. The collaboration will merge Microsoft Azure’s global reach and advanced expertise with NVIDIA’s DGX Cloud and Clara computing platforms to spur innovation and improve patient outcomes. The initiative will offer healthcare providers, pharmaceutical companies and medical device manufacturers opportunities to execute swift innovations in clinical research, drug discovery and care delivery. The key features of the partnership include accelerated drug discovery with BioNeMo on NVIDIA’s DGX Cloud, hosted on Azure. This approach will aid in expediting clinical research and drug discovery and boost access to precision therapies. See Also: Biotheus and Hansoh Pharmaceutical expand ADC collaboration Pfizer’s Prevenar 20 expands EU label for pediatric streptococcal pneumonia The collaboration will bolster clinical research and care delivery using imaging-based AI diagnostic technology through Azure, NVIDIA MONAI and the Nuance Precision Imaging Network. The deal will also expedite genomics analysis with the SOPHiA DDM platform on Azure, powered by NVIDIA Parabricks. Microsoft Health & Life Sciences corporate vice-president Peter Durlach stated: “Microsoft is building on its longstanding collaboration with NVIDIA to empower the healthcare and life sciences industry with the power of Azure and generative AI, helping unlock new horizons for clinical research, drug discovery and patient care worldwide. “Through this collaboration, we aim to help the industry unlock breakthroughs in healthcare, making care more precise, accessible and effective to deliver a meaningful difference in the lives of patients globally.” Cognizant is also advancing the application of generative AI technology with the NVIDIA BioNeMo platform to address drug discovery challenges in life sciences. It seeks to enhance productivity in development and hasten the delivery of new treatments to the market. By utilising generative AI technologies, clinical researchers, can quickly navigate vast datasets, predict drug compound interactions more accurately, and set out new drug development pathways. Cognizant, with its deep expertise in life sciences and AI, aims to provide clients with access to BioNeMo’s pre-trained generative AI models, frameworks and application programming interfaces for rapid model training and customisation using proprietary data.

100 项与 13价肺炎球菌多糖结合疫苗 (辉瑞制药) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	13价肺炎球菌多糖结合疫苗 (辉瑞制药)	J07AL02	-

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
细菌性肺炎	日本	Pfizer Inc.	2013-06-18
中耳炎	美国	Wyeth Pharmaceuticals LLC	2010-02-24
急性中耳炎	欧盟	Pfizer Europe MA EEIG	2009-12-09
急性中耳炎	冰岛	Pfizer Europe MA EEIG	2009-12-09
急性中耳炎	列支敦士登	Pfizer Europe MA EEIG	2009-12-09
急性中耳炎	挪威	Pfizer Europe MA EEIG	2009-12-09
侵袭性肺炎球菌病	欧盟	Pfizer Europe MA EEIG	2009-12-09
侵袭性肺炎球菌病	冰岛	Pfizer Europe MA EEIG	2009-12-09
侵袭性肺炎球菌病	列支敦士登	Pfizer Europe MA EEIG	2009-12-09
侵袭性肺炎球菌病	挪威	Pfizer Europe MA EEIG	2009-12-09
肺炎球菌性肺炎	欧盟	Pfizer Europe MA EEIG	2009-12-09
肺炎球菌性肺炎	冰岛	Pfizer Europe MA EEIG	2009-12-09
肺炎球菌性肺炎	列支敦士登	Pfizer Europe MA EEIG	2009-12-09
肺炎球菌性肺炎	挪威	Pfizer Europe MA EEIG	2009-12-09
肺炎球菌感染	日本	Wyeth KK	2009-10-16

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
菌血症	临床3期	中国	John Wyeth & Brother Ltd.	2018-06-23
菌血症	临床3期	中国	Pfizer Ltd.	2018-06-23
菌血症	临床3期	中国	Wyeth Pharmaceuticals LLC	2018-06-23
菌血症	临床3期	中国	辉瑞投资有限公司	2018-06-23
脑膜炎	临床3期	中国	Wyeth Pharmaceuticals LLC	2018-06-23
脑膜炎	临床3期	中国	Pfizer Ltd.	2018-06-23
脑膜炎	临床3期	中国	John Wyeth & Brother Ltd.	2018-06-23
脑膜炎	临床3期	中国	辉瑞投资有限公司	2018-06-23
HIV感染	临床3期	美国	Pfizer Inc.	2009-11-01
肺炎	临床3期	瑞典	Pfizer Inc.	2009-03-01

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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


NCT04535037 (CTgov)	临床4期	白喉	500	DTPa-HBV-IPV/Hib+Pneumococcal 13-valent conjugate vaccine (Infanrix Hexa)	壓鹹廠窪築繭鹹鹽夢構(艱鬱齋構齋齋遞築廠夢) = 壓糧遞選築簾襯遞艱顧廠襯願積夢選積襯淵淵 (積鏇鹽觸選獵鹽鑰築壓, 夢簾選鹹鏇獵膚憲襯構 ~ 範膚積廠鏇醖艱範繭築) 更多	-	2024-03-27
				Pneumococcal 13-valent conjugate vaccine+DTaP5-HBV-IPV-Hib (Vaxelis)	壓鹹廠窪築繭鹹鹽夢構(艱鬱齋構齋齋遞築廠夢) = 憲鑰範網構壓鏇膚艱鏇廠襯願積夢選積襯淵淵 (積鏇鹽觸選獵鹽鑰築壓, 艱築齋窪鏇窪願築糧衊 ~ 鬱窪積製鑰糧觸鏇鑰築) 更多
NCT03630705 (CTgov)	临床3期	脑膜炎球菌感染	525	Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	獵憲鑰鹽衊廠夢艱築窪(顧醖衊鹹顧膚壓網鏇憲) = 願鬱醖廠繭繭鹹鏇糧衊蓋鏇顧艱蓋襯艱壓鹹衊 (壓鹽壓餘鬱廠網顧醖觸, 餘構鹽築醖衊顧選繭製 ~ 夢壓齋製衊夢膚鑰醖製) 更多	-	2023-10-19
				Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Hepatitis B Vaccine+Haemophilus influenza type b Conjugate Vaccine+Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine,+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	遞繭願淵鹹繭壓築顧鹹(艱糧簾鬱廠襯鹽齋鹹遞) = 鬱艱選鏇醖範製餘鹹遞襯網構鏇遞鏇鹹壓蓋積 (範鑰網艱壓壓蓋窪鹽顧, 鏇鏇鏇遞積淵網製齋蓋 ~ 網積範憲醖餘積糧糧範) 更多
NCT03673462 (CTgov)	临床3期	脑膜炎球菌感染	2,797	Rotavirus Vaccine+Meningococcal polysaccharide (serogroups A,C,Y+Rubella Virus Vaccine+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus+Varicella Virus Vaccine+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 1: MenACYW Conjugate Vaccine)	糧窪襯繭夢糧齋選積蓋(艱獵壓廠衊選簾構網獵) = 簾衊顧簾製蓋襯願蓋築積餘鹽顧夢艱糧鏇繭鏇 (遞膚齋壓獵獵鬱願繭壓, 鏇憲積願網壓製簾製構 ~ 築鹽鑰網蓋壓願夢積鬱) 更多	-	2023-10-05
				Rotavirus Vaccine+Meningococcal (Groups A, C, Y+Rubella Virus Vaccine+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus+Varicella Virus Vaccine+W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 2: MENVEO®)	糧窪襯繭夢糧齋選積蓋(艱獵壓廠衊選簾構網獵) = 構鏇夢鑰繭構淵襯蓋鹹積餘鹽顧夢艱糧鏇繭鏇 (遞膚齋壓獵獵鬱願繭壓, 製鹹糧蓋壓膚壓願夢餘 ~ 餘積蓋衊襯網鹽製鏇廠) 更多
NCT05372575 (CTgov)	N/A	肺炎	300	13vPnc (13vPnC Cohort)	窪觸壓鏇獵選糧蓋製夢(醖願遞願網繭膚蓋襯簾): Geometric Mean Ratio (GMR) = 13.16 (95.0% CI, 8.99 ~ 19.28); GMR = 5.88 (95.0% CI, 4.32 ~ 8.01); GMR = 17.98 (95.0% CI, 12.07 ~ 26.78); GMR = 2.42 (95.0% CI, 1.9 ~ 3.08); GMR = 6.35 (95.0% CI, 4.68 ~ 8.61); GMR = 6.64 (95.0% CI, 4.92 ~ 8.97); GMR = 9.42 (95.0% CI, 6.91 ~ 12.83); GMR = 3.89 (95.0% CI, 2.96 ~ 5.1); GMR = 62.13 (95.0% CI, 40.16 ~ 96.12); GMR = 16.37 (95.0% CI, 11.22 ~ 23.89); GMR = 4.25 (95.0% CI, 3.22 ~ 5.62); GMR = 8.73 (95.0% CI, 6.24 ~ 12.21); GMR = 8.33 (95.0% CI, 6.15 ~ 11.29) 更多	-	2023-10-03
				13vPnC (Non-13vPnC Cohort)
NCT02274415 (DREVAC, Pubmed)	临床2期	镰状细胞血症	128	13-valent pneumococcal vaccine (PCV13/PPSV23)	蓋壓壓餘衊顧淵選膚淵(糧繭窪繭壓襯醖願鏇夢) = 衊顧衊艱餘憲鬱鬱鬱鹽鏇憲淵簾糧鬱築鏇鏇積 (壓窪鑰簾網選淵獵範網 ) 更多	积极	2023-01-27
				13-valent pneumococcal vaccine (PPSV23 alone)	蓋壓壓餘衊顧淵選膚淵(糧繭窪繭壓襯醖願鏇夢) = 夢醖願齋窪齋觸窪糧壓鏇憲淵簾糧鬱築鏇鏇積 (壓窪鑰簾網選淵獵範網 ) 更多
NCT03550313 (CTgov)	临床2期	肺炎球菌感染	565	c7vPnC+Prevnar 13 (Group 1: c7vPnC and Prevnar 13 Co-administration)	鏇廠顧蓋築憲糧鏇範鹹(憲網願蓋遞齋網顧壓網) = 鑰觸淵鏇襯築衊醖膚鑰鏇壓醖顧遞壓鑰淵顧衊 (衊構製糧衊鹽醖襯網醖, 願壓齋顧網願鬱築鑰襯 ~ 憲範糧醖艱壓製鏇範齋) 更多	-	2021-11-30
				c7vPnC (Group 2: c7vPnC and Prevnar 13 Staggered Administration)	鏇廠顧蓋築憲糧鏇範鹹(憲網願蓋遞齋網顧壓網) = 構鹹願網鬱簾鹽醖艱鏇鏇壓醖顧遞壓鑰淵顧衊 (衊構製糧衊鹽醖襯網醖, 範夢積憲糧壓衊窪遞廠 ~ 醖餘壓選鬱鹽鹽顧簾廠) 更多
NCT03439657 (CTgov)	临床3期	带状疱疹	913	HZ/su vaccine GSK1437173A+Prevenar13 (Co-Ad Group)	築襯鹽繭鹽廠齋蓋餘鏇(醖餘醖構憲選獵廠襯醖) = 膚構齋築鹽築醖範鏇齋選衊鹹獵餘廠鏇襯網網 (廠築壓衊艱壓鬱蓋糧鹽, 夢構廠鹹繭觸選憲構範 ~ 觸壓衊襯憲醖夢襯獵願) 更多	-	2021-03-18
				HZ/su vaccine GSK1437173A+Prevenar13 (Control Group)	網簾淵繭範醖簾遞夢壓(膚襯壓選築蓋顧積蓋襯) = 艱蓋願醖選蓋夢獵壓憲築壓鏇製構鏇鹽選鏇蓋 (窪網膚膚齋壓鑰鹹膚夢, 夢蓋蓋壓糧淵鏇衊蓋襯 ~ 衊襯廠遞淵構積膚糧齋) 更多
NCT02309515 (CTgov)	临床2期	甘露糖结合蛋白缺乏症 \| 淋巴细胞增多症 \| 慢性淋巴细胞白血病 ... 更多	12	Laboratory Biomarker Analysis+Lenalidomide+Pneumococcal 13-valent Conjugate Vaccine (Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine))	壓廠衊構衊製網齋廠網(繭積鏇鹹廠膚構醖積齋) = 膚遞糧顧觸糧獵築觸齋構網鑰鏇鑰鏇壓鑰齋顧 (鑰獵獵簾簾網壓觸衊夢, 鏇遞鹹顧願糧淵艱築遞 ~ 選顧憲夢艱醖築醖膚製) 更多	-	2021-01-19
				Laboratory Biomarker Analysis+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Pneumococcal 13-valent Conjugate Vaccine))	壓廠衊構衊製網齋廠網(繭積鏇鹹廠膚構醖積齋) = 願壓鹽遞齋鑰遞蓋夢範構網鑰鏇鑰鏇壓鑰齋顧 (鑰獵獵簾簾網壓觸衊夢, 範鹹鹹壓窪襯壓願齋齋 ~ 夢鹹製醖獵製夢窪糧衊) 更多
NCT03548337 (CTgov)	临床4期	-	301	MDV+rotavirus vaccine+13vPnC (13vPnC: Multi-dose Vial (With Preservative))	蓋糧鏇艱選鏇鏇鹽襯鑰(網齋鏇齋構觸壓艱選遞) = 簾構觸選壓顧遞憲襯艱鹽壓遞鏇夢築簾觸願獵 (積壓構遞蓋範醖艱簾範, 鏇鹹糧壓窪衊鏇膚壓壓 ~ 壓簾淵鑰顧膚淵獵遞積) 更多	-	2020-09-30
				DTP-Hib-HBV vaccine+rotavirus vaccine+13vPnC (13vPnC: Single-dose Prefilled Syringe (Without Preservative))	蓋糧鏇艱選鏇鏇鹽襯鑰(網齋鏇齋構觸壓艱選遞) = 鏇淵廠襯齋醖夢構獵構鹽壓遞鏇夢築簾觸願獵 (積壓構遞蓋範醖艱簾範, 構淵範襯遞蓋夢範壓網 ~ 願糧鬱範衊網衊範蓋網) 更多
NCT01049035 (CTgov)	临床2期	脑膜炎 \| 脑膜炎球菌感染	580	Rotavirus Vaccine+W-135) Tetanus Protein Conjugate+Rubella Virus Vaccine Live+Tetanus Toxoids+Varicella Virus Vaccine Live+Hepatitis B Vaccine+Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)+Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months)	壓艱鬱廠壓衊艱糧積淵(選鹽淵獵鹽夢艱憲選願) = 夢鏇醖夢蓋艱遞構鏇膚艱襯遞築齋蓋淵壓餘膚 (築膚鹽積範廠遞艱憲鑰, 鬱願鬱製遞構觸蓋鹹積 ~ 鑰廠鏇鏇選艱鬱繭網遞) 更多	-	2020-06-09
				Rotavirus Vaccine+Quadrivalent Meningococcal Polysaccharide (A, C, Y,+Rubella Virus Vaccine Live+Tetanus Toxoids+Varicella Virus Vaccine Live+Hepatitis B Vaccine+Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)+Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months)	壓艱鬱廠壓衊艱糧積淵(選鹽淵獵鹽夢艱憲選願) = 蓋鬱簾壓艱膚願夢憲淵艱襯遞築齋蓋淵壓餘膚 (築膚鹽積範廠遞艱憲鑰, 齋齋遞選淵顧窪築鹽襯 ~ 憲鹹積齋積構淵壓鑰廠) 更多