A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

开始日期2021-12-29

申办/合作机构

GSK Plc

NCT05082285

/ Active, not recruiting临床2期

A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

开始日期2021-11-29

申办/合作机构

GSK Plc

NCT04886154

/ Completed临床1/2期

A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)

The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study was conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and served as a safety lead-in to the Phase II study. The Phase II part of the study was conducted in 2 parts: The 'formulation and schedule-finding' part followed in healthy adolescents and young adults and was designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part was conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.

开始日期2021-06-14

申办/合作机构

GSK Plc

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项与 5合1脑膜炎疫苗(GlaxoSmithKline) 相关的文献（医药）

2025-05-01·LANCET INFECTIOUS DISEASES

Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial

Article

作者: Langley, Joanne ; Carter, Robert ; Simon, William ; Jeanfreau, Robert ; Ackerman, Ronald ; Pelayo, Enrique ; Ukkonen, Benita ; Willemsen, Arnold ; Trapani, Mauro ; Freeman, George ; Staben, Jonathan ; Chakerian, Maia ; Vale, Noah ; Rämet, Mika ; de Looze, Ferdinandus ; Lattanzi, Maria ; Dionne, Marc ; Cetin, Benhur Sirvan ; Zemanek, Josef ; Paavola, Pauliina ; Vachon, Marie-Louise ; Athan, Eugene ; Dzongowski, Peter ; Surber, Joseph ; Beran, Jiří ; Cetin, Benhur ; Osowa, Alexander ; Farjo, Rand ; Dinleyici, Ener Cagri ; Silas, Peter ; Ayesu, Kwabena ; Byars, William ; Spaziererova, Martina ; Koski, Susanna ; Tipton, Mary ; Dalebout, Marije ; Meisalu, Sandra ; Lechevin, Isabelle ; Adamovska, Renata ; Bhusal, Chiranjiwi ; Ince, Tolga ; Rouhbakhsh, Rambod ; Tapiero, Bruce ; Raulier, Stefanie ; Laajalahti, Outi ; Finn, Daniel ; Grubb, Paul ; Bernard, David ; Gottfredson, Ryan ; Morelle, Danielle ; Pavlasek, Miroslav ; Kokko, Satu ; Jones, Jake ; Richmond, Peter ; Kiiroja, Kaia ; Toneatto, Daniela ; Dražan, Daniel ; Patel, Minesh ; Bloch, Mark ; Rok, Walter ; Seppä, Ilkka ; Sanchez, Yamirka ; Schear, Martin ; Tiong, Florence ; Gupta, Anil ; Sadarangani, Manish ; Mehta, Hemalini ; Scott, John ; Nolan, Terry ; Richmond, Peter C ; Kellner, James ; Wauters, Dominique ; Ulukol, Betul ; Langley, Joanne M

BACKGROUND:

A multicomponent meningococcal serogroups ABCWY vaccine (MenABCWY) could provide broad protection against disease-causing meningococcal strains and simplify the immunisation schedule. The aim of this trial was to confirm the effect of the licensed meningococcal serogroup B (MenB) vaccine, 4CMenB, against diverse MenB strains, and to assess the breadth of immune response against a panel of 110 MenB strains for MenABCWY containing the antigenic components of 4CMenB and licensed serogroups ACWY vaccine, MenACWY-CRM, the non-inferiority of the immune response with MenABCWY versus 4CMenB and MenACWY-CRM, safety, and MenABCWY lot-to-lot consistency.

METHODS:

We conducted a phase 3 randomised, controlled, observer-blinded trial of healthy adolescents and young adults (age 10-25 years) across 114 centres in Australia, Canada, Czechia, Estonia, Finland, Türkiye, and the USA. Exclusion criteria included previous vaccination with a MenB vaccine or (within the last 4 years) MenACWY vaccine. Participants were randomly allocated (5:5:3:3:3:1 ratio) via a central randomisation system using a minimisation procedure to receive 4CMenB at months 0, 2, and 6 (referred to as 4CMenB 0-2-6 hereafter); or 4CMenB at months 0 and 6 (referred to as 4CMenB 0-6 hereafter); or MenABCWY (three groups, each receiving one production lot of the MenACWY-CRM component) at months 0 and 6; or MenACWY-CRM at month 0. Demonstration in the per-protocol set of the consistency of three MenACWY-CRM component lots of the MenABCWY vaccine was a primary objective (demonstrated with two-sided 95% CIs for the ratio of human serum bactericidal antibody [hSBA] geometric mean titres against each serogroup within predefined criteria [0·5-2·0]). The primary endpoints (breadth of immune response) for the MenB component of MenABCWY and 4CMenB were measured using the endogenous complement hSBA (enc-hSBA) assay against a panel of 110 diverse MenB invasive disease strains. For each serum sample, 35 strains from the 110 MenB strain panel were randomly selected for testing. The 4CMenB breadth of immune response data have been published separately. For MenABCWY, breadth of immune response was assessed in two analyses: a test-based analysis of the percentage of samples (tests) without bactericidal serum activity against MenB strains 1 month after two MenABCWY doses versus the percentage after one MenACWY-CRM dose in the per-protocol set, and a responder-based analysis of the percentage of participants (responders) whose sera killed 70% or more strains at 1 month after two MenABCWY doses in the full analysis set. A lower limit of two-sided 95% CI above 65% would demonstrate breadth of immune response. Other primary outcomes included non-inferiority (5% margin) of two MenABCWY doses versus two 4CMenB doses by enc-hSBA assay in the per-protocol set, non-inferiority (10% margin) of two MenABCWY doses versus one MenACWY-CRM dose in MenACWY vaccine-naive participants by traditional hSBA assay in the per-protocol set, and safety in all vaccinated participants. This trial is registered with ClinicalTrials.gov, NCT04502693, and is complete.

FINDINGS:

Between Aug 14, 2020, and Sept 3, 2021, 3651 participants were enrolled and randomly allocated (900 in the 4CMenB 0-2-6 group and 908 in the 4CMenB 0-6 group, 1666 in the three MenABCWY groups combined, and 177 in the MenACWY-CRM group). All primary objectives for MenABCWY were met. Consistency of immune responses against the three production lots of the MenACWY component of MenABCWY was demonstrated since two-sided 95% CIs for the ratios of hSBA geometric mean titres against serogroups A, C, W, and Y for each pair of lots were within the predefined equivalence criteria. The lot data were pooled for the remainder of MenABCWY endpoints. By enc-hSBA assay, breadth of immune response against the MenB strain panel was 77·9% (95% CI 76·6 to 79·2) in the test-based analysis and 84·1% (81·4 to 86·5; 687 of 817 participants) in the responder-based analysis. Non-inferiority of MenABCWY to 4CMenB was demonstrated by enc-hSBA assay: the difference in percentage of samples with bactericidal serum activity between the MenABCWY group (82·5% [95% CI 82·1 to 83·0]; 21 222 of 25 715) and 4CMenB 0-2 group (83·1% [82·7 to 83·6]; 22 921 of 27 569) was -0·61% (-1·25 to 0·03). Non-inferiority of two-dose MenABCWY to one-dose MenACWY-CRM was demonstrated by traditional hSBA assay, with differences between the MenABCWY group and MenACWY group in percentages of participants with a four-fold rise in hSBA titres of 11·3% (5·9 to 19·0) for serogroup A, 47·2% (38·1 to 56·3) for serogroup C, 35·3% (26·9 to 44·5) for serogroup W, and 27·0% (19·4 to 35·8) for serogroup Y. MenABCWY reactogenicity was mostly of mild or moderate severity and transient, with similar frequencies of adverse events in the MenABCWY and 4CMenB groups and no safety concerns were identified.

INTERPRETATION:

This study demonstrates breadth of immune response against a panel of 110 MenB strains for the MenB component of the investigational MenABCWY vaccine, when administered as a 0-6 months schedule to the target population of adolescents and young adults, with predefined criteria for success met for both breadth of immune response endpoints and for non-inferiority versus 4CMenB. This investigational vaccine could provide broad meningococcal serogroup coverage in a simplified immunisation schedule, thus aiding the public health attempt in preventing invasive meningococcal disease due to five Neisseria meningitidis serogroups in adolescents and young adults.

FUNDING:

GSK.

2025-04-30·CLINICAL INFECTIOUS DISEASES

Immunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults Who Had Previously Received a Meningococcal ACWY Vaccine: A Phase 3, Randomized Controlled Clinical Study

Article

作者: Surber, Joseph ; Hong, Matthew ; Teijeiro, Ricardo Augusto ; Silas, Peter ; Ceballos, Ana ; Yut, Clifford ; de Looze, Ferdinandus ; Rok, Walter ; Richmond, Peter ; Wadia, Ushma ; Gupta, Anil K ; Akinsola, Adebayo ; Bartlett, Andrew ; Richmond, Peter C ; Matherne, Paul G ; Mzolo, Thembile ; Toneatto, Daniela ; Bordon, Jose ; Fink, Ezekiel ; Carr, Jeremy Peter James ; Voloshyna, Olga ; Obed, Mora Nair ; Sullivan, Katherine ; Bloch, Mark Theo ; Farjo, Rand ; Byars, William ; Batra, Divya ; OħMahony, John ; Soto, Adriana Elvira ; Tiong, Florence ; Bhusal, Chiranjiwi ; Mann, Darvy ; Llapur, Conrado Juan ; Domachowske, Joseph ; Kasarjian, Julie ; Riera, Fernando Oscar ; Gunner, Elizabeth Anne ; Arya, Mark ; Hoberman, Alejandro ; Lattanzi, Maria ; Ampajwala, Madhavi ; Gilsoul, Jennifer ; Nolan, Terry ; Gentile, Angela ; Marc, Gonzalo Perez ; Wallace, Garry ; Mitchell, Gretchen ; Saravolatz, Louis ; Llapur, Conrado J ; Deluca, Mercedes ; Domachowske, Joseph B

Abstract:

Background:

A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the 5 meningococcal serogroups that cause most invasive disease cases.

Methods:

In this phase 3 study, healthy participants aged 15–25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive 2 MenABCWY doses 6 months apart or 1 MenACWY-CRM dose. Primary objectives were to demonstrate the noninferiority of MenABCWY 1 month postvaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above −10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety. Secondary endpoints included percentages of participants with hSBA titers greater than or equal to the lower limit of quantitation (≥LLOQ) against serogroups ACWY and vaccine antigen-specific serogroup B (MenB) indicator strains.

Results:

Noninferiority of MenABCWY versus MenACWY-CRM was demonstrated following each MenABCWY dose. Percentages of participants with hSBA titers ≥LLOQ for serogroups ACWY were 97.9%–98.9% and 99.5%–100% following 1 and 2 MenABCWY doses, respectively, and 96.8%–99.0% following 1 MenACWY-CRM dose. After 2 MenABCWY doses, 75.6%–96.3% of participants had hSBA titers ≥LLOQ against MenB indicator strains. The MenABCWY vaccine was well tolerated in MenACWY-primed individuals, with a favorable safety profile.

Conclusions:

Immune responses against serogroups ACWY following 1 and 2 doses of investigational MenABCWY vaccine are noninferior to those following MenACWY-CRM in MenACWY-primed adolescents and young adults. Robust immune responses were observed against MenB indicator strains after 2 MenABCWY doses administered 6 months apart.Clinical Trials Registration. NCT04707391.

2025-03-01·PHARMACOECONOMICS

Public Health Impact of Introducing a Pentavalent Vaccine Against Invasive Meningococcal Disease in the United States

Article

作者: Carrico, Justin ; Shah, Hiral Anil ; Hicks, Katherine A ; Grace, Mei ; Jutlla, Ginita ; Graham, Jonathan ; Kocaata, Zeki ; Herrera-Restrepo, Oscar ; Clements, Diana E ; Begum, Shahina ; Kuylen, Elise ; Burman, Cindy ; Sohn, Woo-Yun

BACKGROUND:

Invasive meningococcal disease (IMD) is primarily associated with five Neisseria meningitidis serogroups: A, B, C, W, or Y. In the United States (US), available vaccines protect against serogroups B (MenB), A, C, W, and Y (MenACWY), and A, B, C, W, and Y (MenABCWY). The Advisory Committee on Immunization Practices is re-evaluating the adolescent meningococcal vaccination schedule with varying recommendation formats. This analysis aimed to predict which schedule could avert the most IMD cases and have the most positive public health impact (PHI).

METHODS:

An epidemiological model compared the 15-year PHI of vaccination schedules using MenB, MenACWY, and/or MenABCWY vaccines versus current US standard of care (SoC). Varying coverage rates reflected routine, shared clinical decision making, and risk-based recommendations. Sensitivity analyses assessed robustness of the results to different inputs/assumptions.

RESULTS:

The most positive PHI compared with SoC was observed with one dose of MenACWY at 11 years of age and two doses of MenABCWY (6 months apart) at 16 years of age, assuming routine recommendation and coverage reflecting real-world uptake of MenACWY. This strategy resulted in 123 IMD cases averted (MenB: 59, MenACWY: 64), 17 deaths prevented, 574 life-years saved, and 757 quality-adjusted life-years gained versus SoC. Eliminating MenACWY vaccination at 11 years was found to result in an additional IMD burden.

CONCLUSION:

A routinely recommended two-dose pentavalent vaccine, with doses administered 6 months apart at 16 years of age, alongside the routinely recommended MenACWY vaccine at 11 years of age, would improve the PHI and benefits of IMD vaccination to society.

项与 5合1脑膜炎疫苗(GlaxoSmithKline) 相关的新闻（医药）

2025-05-05

·药明康德

5款已获FDA批准！今年有望上市的10款潜在重磅疗法最新进展一览

编者按：今年初，行业媒体Evaluate发布报告，梳理了预计于2025年上市的关键创新疗法。随着2025年进程已过三分之一，我们也对这些潜在重磅疗法的最新进展进行回顾。在报告列出的十项疗法中，有五款为小分子药物，充分体现了小分子药物在2025年生物医药创新格局中所占据的重要地位。在这五款小分子潜力疗法中，药明康德化学业务平台很高兴为其中两款提供了赋能服务，助力合作伙伴加速创新成果转化。面向未来，药明康德将持续发挥平台优势，携手全球客户，推动更多创新疗法早日惠及全球患者。图片来源：123RF在这份报告中所提到的10款潜在重磅疗法当中，已有5款率先获得美国FDA批准，包含由Vertex Pharmaceuticals所开发，在去年底获批用以治疗囊性纤维化（CF）患者的Alyftrek；由阿斯利康（AstraZeneca）与第一三共（Daiichi Sankyo）联合开发用以治疗乳腺癌的Trop2靶向抗体偶联药物（ADC）Datroway（datopotamab deruxtecan），以及同样由Vertex Pharmaceuticals所开发、用于治疗急性疼痛的Journavx（suzetrigine）则在今年1月分别接连获得FDA批准；而由GSK所开发的脑膜炎球菌疫苗Penmenvy（MenABCWY）则在2月获批；强生开发的抗体疗法Imaavy（nipocalimab）在4月底获批治疗全身性重症肌无力（gMG）。值得注意的是，在这些潜在重磅疗法当中，有不少具有显著的创新性。例如，由GSK所开发的depemokimab是在3期试验中进行评估的首个白细胞介素5（IL-5）靶向超长效生物制品。根据新闻稿，该疗法可能成为仅须每6个月给药一次、用于治疗严重哮喘的首个获批超长效生物制品。而Vertex Pharmaceuticals的新闻稿则指出，其NaV1.8抑制剂suzetrigine为二十多年来首个用于治疗急性疼痛的新机制药物。此外，强生（Johnson & Johnson）旗下新生儿Fc受体（FcRn）靶向单抗nipocalimab具有治疗多种免疫疾病的潜力，获批治疗gMG之外，它还是在干燥综合征（Sjögren’s disease，SjD）领域获得突破性疗法认定（BTD）的首款疗法。▲2025年10款潜在重磅疗法一览（图表来源：根据参考资料[1]整理制表）在列出的10款潜在重磅疗法中，小分子药物占据一半（5款，占比50%）；单克隆抗体疗法占据2款（占比20%）；而抗体偶联药物（ADC）、多肽药物及疫苗各自占据1款（各占比10%）。这一分布进一步印证了小分子药物在2025年生物医药创新版图中举足轻重的地位。2025年的十款潜在重磅疗法疗法：Alyftrek（vanzacaftor/tezacaftor/deutivacaftor）公司：Vertex Pharmaceuticals研发状态：2024年12月20日获美国FDA批准Alyftrek是一款下一代囊性纤维化跨膜电导调节因子（CFTR）调节剂三联疗法，该疗法在去年12月获FDA批准用于治疗6岁及以上、携带至少一个F508del突变或其他对Alyftrek有应答的CFTR基因突变的囊性纤维化患者。在两项随机双盲3期临床试验中，接受治疗24周后，基于一秒用力呼气量百分比（ppFEV1）数值的评估，Alyftrek的疗效与获批CF疗法Trikafta相当，达到试验的主要终点。此外，Alyftrek在降低汗液氯化物（SwCl）水平方面与活性对照药物相比表现出优效性，这是两项3期试验的关键次要终点之一。▲Alyftrek在SKYLINE 102和SKYLINE 103试验中达到主要终点（图片来源：Vertex公司官网）疗法：Datroway（datopotamab deruxtecan，Dato-DXd）公司：阿斯利康、第一三共研发状态：2025年1月17日获美国FDA批准Datroway是一款由人源化、靶向Trop2的单克隆抗体与创新DNA拓扑异构酶I抑制剂（DXd），通过可裂解的四肽连接子偶联生成的ADC。该疗法在今年1月获FDA批准上市，用于治疗无法切除或转移性HR阳性、HER2阴性的成年乳腺癌患者，这些患者曾接受过内分泌疗法和化疗。美国FDA的批准主要基于TROPION-Breast01临床3期试验的结果。分析显示，Datroway治疗组的中位无进展生存期（PFS）为6.9个月（95% CI：5.7，7.4），化疗组为4.9个月（95% CI：4.2，5.5），即Datroway相较于化疗，可将患者的疾病进展或死亡风险降低37%（HR=0.63，95% CI：0.52，0.76，p<0.0001）。Datroway与化疗组患者的确认客观缓解率（ORR）分别为36%（95% CI：31，42）和23%（95% CI：19，28）。今年1月，美国FDA授予Datroway优先审评资格用于治疗局部晚期或转移性表皮生长因子受体突变（EGFRm）的非小细胞肺癌（NSCLC）成人患者，预计将在2025年第三季度完成审评。疗法：Journavx（suzetrigine）公司：Vertex Pharmaceuticals研发状态：2025年1月30日获美国FDA批准Suzetrigine是一种口服选择性NaV1.8抑制剂，与其它NaV离子通道相比，它对NaV1.8具有高度选择性。根据关键性3期临床试验的积极结果，suzetrigine在急性疼痛治疗中表现出显著效果。具体来说，在接受腹部整形手术（abdominoplasty）患者中进行的3期临床试验结果显示，suzetrigine达到了试验的主要终点，与安慰剂相比，药物组患者48小时内疼痛强度差异的时间加权总和评分（SPID48）显著降低，SPID48的平均差异为48.4（95% CI：33.6，63.1；P<0.0001）。此外，患者在手术48小时后的数值疼痛评分量表（NPRS）评分与基线相比也显著降低。而在接受拇囊炎切除手术（bunionectomy）的患者中，该疗法亦达成主要终点，SPID48的平均差异为29.3（95% CI：14.0，44.6；P=0.0002）。▲Suzetrigine达成试验主要终点（图片来源：Vertex官网）疗法：Aficamten公司：Cytokinetics研发状态：PDUFA日期为2025年12月26日Aficamten是一种下一代心肌球蛋白抑制剂，用于治疗梗阻性肥厚型心肌病（HCM）。该药物的上市申请主要基于关键性3期临床试验SEQUOIA-HCM结果。分析显示，与安慰剂相比，aficamten治疗24周显著提高了患者的运动能力。通过心肺运动试验（CPET）测得的峰值氧气摄取量（pVO2）与基线相比，在aficamten治疗组增加了1.8 ml/kg/min，而安慰剂组为0.0 ml/kg/min。此外，接受aficamten治疗的患者在10个预先设定的次要终点中，均观察到了统计学上显著的改善。FDA曾于2021年12月授予aficamten治疗梗阻性HCM的突破性疗法认定。▲Aficamten达到SEQUOIA-HCM试验的主要终点（图片来源：Cytokinetics官网）疗法：Brensocatib公司：Insmed研发状态：PDUFA日期为2025年8月12日Brensocatib是一种口服、可逆性DPP1小分子抑制剂。DPP1是一种酶，负责激活中性粒细胞中的中性粒细胞丝氨酸蛋白酶（NSPs）。Brensocatib可通过抑制DPP1降低NSPs的活化，从而降低炎症性疾病（如支气管扩张）的组织损伤。这款疗法已经获得美国FDA授予的突破性疗法认定，用于治疗非囊性纤维化支气管扩张。一项包含1680名成人和41名青少年非囊性纤维化支气管扩张症患者的临床试验结果显示，试验达到主要终点，10 mg和25 mg剂量的brensocatib分别将患者的年化肺部症状恶化（PE）率降低21.1%和19.4%，统计学显著并具有临床意义。▲Brensocatib的3期临床试验疗效数据（图片来源：参考资料[4]）疗法：Tolebrutinib公司：赛诺菲（Sanofi）研发状态：PDUFA日期为2025年9月28日Tolebrutinib是一款在研口服、能穿越血脑屏障且具有生物活性的布鲁顿氏酪氨酸激酶（BTK）抑制剂，它能够达到足以调节B淋巴细胞和疾病相关小胶质细胞的脑脊液浓度。临床3期试验结果表明，tolebrutinib与安慰剂相比，可将非复发性继发进展型多发性硬化（nrSPMS）出现6个月确认残疾进展（CDP）的时间延缓31%（HR=0.69；95% CI，0.55-0.88；p=0.0026）。进一步的次要终点分析显示，接受tolebrutinib治疗的参与者中，确认残疾获得改善的患者比例（10%）是安慰剂组（5%）的两倍（HR=1.88；95% CI，1.10-3.21）。Tolebrutinib目前正在多个3期临床试验中评估其治疗多种类型多发性硬化的潜力。该疗法在2024年12月获得FDA授予突破性疗法认定，用于治疗nrSPMS成年患者。▲Tolebrutinib分子结构（图片来源：PubChem）疗法：玛仕度肽（Mazdutide，IBI362）公司：信达生物（Innovent）、礼来（Eli Lilly and Company）研发状态：在中国用于治疗肥胖与2型糖尿病治疗的监管申请结果预定分别在2025年上半年与下半年公布玛仕度肽是信达生物与礼来共同推进的一款胰高血糖素样肽-1受体（GLP-1R）和胰高血糖素受体（GCGR）双重激动剂。之前发布于eClinicalMedicine期刊上的一篇研究结果显示，接受每周一次9 mg玛仕度肽皮下注射治疗的受试者从基线至第12周体重的平均百分比变化为-11.7%，接受安慰剂治疗的受试者为-1.8%（估计治疗差异：-9.8%；95% CI：-14.4，-5.3；P=0.0002）。安全性方面，玛仕度肽的耐受性良好，并具有良好的安全性。未报告严重不良事件。所有治疗相关不良事件均为轻度或中度。疗法：Depemokimab公司：GSK研发状态：PDUFA日期为2025年12月16日Depemokimab是在3期试验中进行评估的首个白细胞介素5（IL-5）靶向超长效生物制品。SWIFT-1和SWIFT-2临床3期试验结果显示，试验达主要终点，depemokimab可显著降低严重哮喘患者的哮喘发作率达54%（HR=0.46，95% CI：0.36–0.59，p<0.001），这些患者具有2型炎症特征（以血液嗜酸性粒细胞计数为标志）。此外，试验亦达成次要终点。与安慰剂相比，患者需要住院或急诊救治的临床显著恶化减少达72%（HR=0.28，95% CI：0.13–0.61，p=0.002）。GSK预计在2025年启动该疗法用于治疗慢性阻塞性肺病（COPD）患者的3期临床试验。根据新闻稿，depemokimab可能成为仅须每6个月给药一次、用于治疗严重哮喘的首个获批超长效生物制品。疗法：Penmenvy（MenABCWY）公司：GSK研发状态：2025年2月14日获美国FDA批准五种脑膜炎球菌血清群（A，B，C，W和Y）占全球大部分地区的几乎所有侵袭性脑膜炎球菌病病例。GSK的五合一MenABCWY疫苗结合已获批的脑膜炎疫苗Bexsero和Menveo的抗原成分，可针对这五种血清群的脑膜炎球菌保护接种者。将两种有效疫苗合并为一种的目的是帮助简化免疫接种计划，进而增加疫苗覆盖率，帮助减少疾病的总负担。在3期试验中，MenABCWY疫苗成功达到所有主要终点，包括在免疫原性方面不劣于一剂GSK的A、C、Y和W群脑膜炎球菌疫苗，以及在对110种不同的B群脑膜炎球菌侵袭性菌株产生的免疫反应上，不劣于两剂GSK的B群脑膜炎球菌疫苗。此外，该疫苗显示出良好的耐受性，其安全性与上述两种疫苗一致。疗法：Nipocalimab公司：强生研发状态：2025年4月29日获美国FDA批准Nipocalimab是一款潜在“best-in-class”，靶向新生儿Fc受体的抗体疗法。它通过与FcRn结合，让被单核细胞和内皮细胞摄入的自身抗体不会重新释放到血液中，而是在细胞内被降解。已有研究显示，它可以将血液循环中包括致病自身抗体在内的IgG水平降低超过75%。它在4月29日获FDA批准，治疗抗AChR、抗MuSK抗体阳性的全身性重症肌无力（gMG）成人与12岁以上儿童患者。强生公司还在罕见自身抗体疾病、母体同种抗体介导的母胎疾病和风湿病领域探索nipocalimab的潜力。它在去年11月获得FDA授予突破性疗法认定，用于治疗中度至重度SjD成人患者。根据新闻稿，nipocalimab是在SjD领域获得突破性疗法认定的首个疗法。DAHLIAS临床2期试验结果显示，nipocalimab达到主要终点，从第4周开始，15 mg/kg nipocalimab组患者就开始获得缓解，并在整个24周的治疗期间持续增加。在第24周，与安慰剂相较，15 mg/kg组受试者在主要终点上，显示出平均系统性疾病活动程度相对于安慰剂超过70%的改善。▲DAHLIAS研究疗效结果摘要（图片来源：参考资料[5]）参考资料：[1] Top 10 most anticipated drug launches of 2025. Retrieved April 27, 2025 from https://www.fiercepharma.com/marketing/top-10-most-anticipated-drug-launches-2025[2] Insmed Provides Business Update at 43rd Annual J.P. Morgan Healthcare Conference. Retrieved January 21, 2025 from https://filecache.investorroom.com/mr5ir_insmed/371/2025-01-10-Insmed-Provides-Business-Update-at-43rd-Annual-J-P-Morgan-Healthcare-Conference.pdf[3] Delivering strong and sustained momentum. Retrieved January 21, 2025 from https://www.gsk.com/media/11750/gsk-2025-jpm-conf-presentation-14-january-2025.pdf[4] Insmed Announces Positive Topline Results from Landmark ASPEN Study of Brensocatib in Patients with Bronchiectasis. Retrieved May 28, 2024, from https://www.prnewswire.com/news-releases/insmed-announces-positive-topline-results-from-landmark-aspen-study-of-brensocatib-in-patients-with-bronchiectasis-302156279.html[5] LBA0010 EFFICACY AND SAFETY OF NIPOCALIMAB, AN ANTI-FcRn MONOCLONAL ANTIBODY, IN PRIMARY SJOGREN’S DISEASE: RESULTS FROM A PHASE 2, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY (DAHLIAS). Retrieved November 12, 2024 from https://ard-bmj-com.libproxy1.nus.edu.sg/content/83/Suppl_1/240.2免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

上市批准疫苗抗体药物偶联物临床3期突破性疗法

2025-04-30

·药时空

GSK Q1：全年营收超 95 亿美元，肿瘤收入大涨 53%

4 月 30 日，葛兰素史克（GSK）发布 2025 年 Q1 财报，全年营收 75.16 亿英镑（95.04 亿美元），同比增长 4%（按固定汇率计算，下同）。研发投入 14.62 亿英镑（18.49 亿美元），同比增长 3%。来源：GSK 官网（下同）GSK 的业务主要分为特药（Specialty Medicines）、疫苗（Vaccines）以及普药（General Medicines）三个版块，2025 年 Q1 分别贡献了 29.33 亿英镑（37.10 亿美元，+17%）、20.95 亿英镑（26.48 亿美元，-6%）、24.88 亿英镑（31.46 亿美元，稳定）的业绩收入。具体来说，特药方面，GSK 在HIV、呼吸/免疫和肿瘤疾病领域分别斩获了 17 亿英镑（+7%）、8 亿英镑（+28%）、4 亿英镑（+53%），增长迅猛，尤其是肿瘤产品，已经成为 GSK 业绩新的增长点。GSK 肿瘤板块增长主要得益于骨髓纤维化贫血患者药物 Ojjaara/Omjjara（莫洛昔尼，2023 年 9 月上市）的推出，以及 PD-1 单抗 Jemperli（Dostarlimab，2021 年 4 月上市）新适应症的拓展和市场渗透程度的增加，两款产品 2025 年 Q1 销售额分别为 1.12 亿英镑和 1.74 亿英镑，2 款产品的同比增长率均大于 100%。呼吸/免疫领域，Nucala （美泊利珠单抗）和 Benlysta（贝利尤单抗）分别为 GSK 贡献了 4.44 亿英镑（+21%）和 3.59 亿英镑（+39%）的销售额。HIV 领域，GSK 手握长效产品，市场表现不俗，销售额持续增长。其中 Cabenuva（卡替拉韦+利匹韦林）、Apretude （卡替拉韦）和 Dovato （多替拉韦+拉米夫定）分别获得了 2.94 亿英镑（+38%）、0.89 亿英镑（+63%）和 5.7 亿英镑（+19%）的收入。疫苗方面，GSK 产品销售陷入疲软期，收入 20.95 亿英镑，仅脑膜炎疫苗实现了两位数增长，被寄予厚望的 RSV 疫苗 Arexvy 遭受腰斩。Arexvy 在 2023 年 5 月首次获 FDA 批准，随后又相继在欧盟、日本获批上市。作为全球首款 RSV 疫苗，Arexvy 在上市第一年便成功斩获了 15.43 亿美元的销售额。但 2024 年，由于需求下降，该产品全球销售额下滑 51%，仅有 5.90 亿英镑的收入。2025 年 Q1 销售额达 0.78 亿英镑，同比下滑 57%。Shingrix 是一款重组带状疱疹疫苗，2024 年以 33.64 亿英镑（+1%）的收入继续稳坐全球疫苗大品种的宝座。2025 Q1 该产品的销售额为 8.67 亿英镑，同比下滑 7%。脑膜炎疫苗 Meningitis（包括 Bexsero 和 Menveo ）增长强劲，为 GSK 疫苗板块注入了新的动力，2025 年 Q1 斩获了 3.5 亿英镑的销售额，同比增长 20%。GSK 在财报中披露，预计 2025 年 FDA 将批准 5 项主要新产品：2025 年第一季度批准：Penmenvy，脑膜炎疫苗；Blujepa，用于治疗尿路感染的首创抗生素预计进一步获批的药物包括：Nucala（慢性阻塞性肺病）；Blenrep（多发性骨髓瘤）；以及 Depemokimab（严重哮喘和鼻息肉）识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

财报疫苗上市批准

2025-04-17

·PMLiVE

GSK’s five-in-one meningococcal vaccine recommended by CDC advisory committee

GSK’s five-in-one meningococcal vaccine has been recommended by the US Centers for Disease Control and Prevention’s (CDC) immunisation panel as part of the adolescent meningococcal vaccination schedule. Penmenvy combines the antigenic components of GSK’s approved Bexsero and Menveo meningococcal vaccines to target five common invasive meningococcal disease (IMD)-causing serotypes (A, B, C, W and Y). The Advisory Committee on Immunization Practices (ACIP) has recommended that individuals aged over ten years be given a single dose of Penmenvy as an alternative to the separate administration of MenACWY and MenB vaccinations when both vaccines would be given in the same visit, typically at age 16. It is hoped that this will simplify meningococcal vaccine delivery and lead to higher uptake. The CDC will now review ACIP’s recommendation as it makes a final decision on Penmenvy. IMD is an uncommon but serious illness caused by the bacterium Neisseria meningitidis. It is a major cause of meningitis and septicaemia, and can result in long-term consequences such as neurological damage, amputations and hearing loss. Babies, young children and those who are in their late teens and early adulthood are among those at the highest risk. GSK’s chief scientific officer, Tony Wood, said: “We welcome this positive recommendation that can help strengthen disease prevention efforts in the US. “Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunisation rates among adolescents and young adults in the US, who are at an age with increased risk.” The recommendation comes just two months after the US Food and Drug Administration (FDA) approved Penmenvy for use in individuals aged from ten to 25 years. The regulator’s decision was supported by positive results from two late-stage trials, which evaluated Penmenvy’s safety, tolerability and immune response in over 4,800 people in this age population. Judy Klein, president and founder of Unity Consortium, a non-profit organisation focused on adolescent health and immunisation in the US, welcomed the FDA’s decision: “The consequences of IMD can be devastating for those who contract it, for their families and friends… Pentavalent menABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.”

疫苗上市批准信使RNA临床研究

100 项与 5合1脑膜炎疫苗(GlaxoSmithKline) 相关的药物交易

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适应症	国家/地区	公司	日期
脑膜炎球菌感染	美国	GlaxoSmithKline Biologicals SA	2025-02-14

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适应症	最高研发状态	国家/地区	公司	日期
流行性脑脊髓膜炎	临床3期	美国	GSK Plc	2021-01-25
流行性脑脊髓膜炎	临床3期	阿根廷	GSK Plc	2021-01-25
流行性脑脊髓膜炎	临床3期	澳大利亚	GSK Plc	2021-01-25
流行性脑脊髓膜炎	临床3期	加拿大	GSK Plc	2021-01-25

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临床结果

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


NCT04707391 (FDA_CBER) 人工标引	临床3期	脑膜炎球菌感染	-	PENMENVY	觸鹽壓積窪遞餘壓醖襯(繭糧選願顧糧鏇繭網膚) = 齋壓糧鬱鑰願鹽繭餘鏇製齋衊糧糧襯獵廠鏇鏇 (醖選網壓壓衊鬱齋獵蓋, 91.6 ~ 98.3) 更多	积极	2025-02-14
				MENVEO	觸鹽壓積窪遞餘壓醖襯(繭糧選願顧糧鏇繭網膚) = 醖繭窪觸獵糧膚鬱獵遞製齋衊糧糧襯獵廠鏇鏇 (醖選網壓壓衊鬱齋獵蓋, 93.0 ~ 96.9) 更多
NCT04502693 (FDA_CBER) 人工标引	临床3期	脑膜炎球菌感染	-	PENMENVY	淵構窪構壓餘獵襯窪醖(選壓製鑰繭築鏇製鹹網) = 憲齋糧糧艱鬱鑰淵窪顧鑰糧願蓋築餘膚遞鬱艱 (觸願壓積願積繭範繭艱, 69.7 ~ 76.5) 更多	积极	2025-02-14
				BEXSERO	淵構窪構壓餘獵襯窪醖(選壓製鑰繭築鏇製鹹網) = 齋鏇獵簾糧網齋夢餘鹹鑰糧願蓋築餘膚遞鬱艱 (觸願壓積願積繭範繭艱, 74.8 ~ 81.2) 更多
NCT04502693 (FDA_CBER) 人工标引	临床3期	脑膜炎球菌感染	-	PENMENVY	鬱糧繭鹹網鏇艱膚淵簾(壓艱醖鹽構鑰膚獵艱築) = 鬱網糧蓋艱鹹觸醖積築製繭餘簾衊憲膚築製築 (繭鬱簾襯顧製廠獵獵獵, 95.7 ~ 97.8) 更多	积极	2025-02-14
				MENVEO	鬱糧繭鹹網鏇艱膚淵簾(壓艱醖鹽構鑰膚獵艱築) = 醖鏇鬱艱鏇鏇製鹽獵構製繭餘簾衊憲膚築製築 (繭鬱簾襯顧製廠獵獵獵, 77.6 ~ 91.5) 更多
NCT04707391 (CTgov)	临床3期	流行性脑脊髓膜炎	1,250	Placebo+MenABCWY vaccine (ABCWY Group)	範餘齋醖選選鏇糧鏇齋 = 構獵廠構淵鑰顧窪顧構觸製遞齋艱網淵鑰鹽繭 (夢窪遞壓膚觸築鬱餘醖, 鹽選遞觸壓蓋選鹽膚選 ~ 構膚鏇積淵鹽艱願窪願) 更多	-	2024-07-03
				MenB vaccine+MenACWY vaccine (ACWY Group)	範餘齋醖選選鏇糧鏇齋 = 襯選簾遞衊選簾醖憲醖觸製遞齋艱網淵鑰鹽繭 (夢窪遞壓膚觸築鬱餘醖, 網製積獵積鑰襯顧鑰繭 ~ 選齋製簾遞壓選鹹廠憲) 更多
NCT04502693 (CTgov)	临床3期	脑膜炎球菌感染	3,657	rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY)+Meningococcal Groups A, C, W and Y Conjugate Vaccine ( (MenB_0_2_6 Group)	夢鹹齋鑰窪簾觸糧壓顧 = 網鹽觸憲鏇積網鏇鹽繭襯築廠築獵糧醖顧積選 (網糧鏇餘糧積願積構淵, 築構鏇鑰憲獵鹽憲艱網 ~ 襯窪觸鹽壓鬱夢鬱鑰壓) 更多	-	2024-03-05
				Placebo+rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY)+Meningococcal Groups A, C, W and Y Conjugate Vaccine ( (MenB_0_6 Group)	夢鹹齋鑰窪簾觸糧壓顧 = 窪觸積壓築憲網鬱艱鹹襯築廠築獵糧醖顧積選 (網糧鏇餘糧積願積構淵, 窪膚築鬱齋觸艱壓簾齋 ~ 淵顧鹽窪願顧顧範範鏇) 更多
NCT02451514 (CTgov)	临床2期	脑膜炎球菌感染	129	MenABCWY+OMV vaccine (MenABCWY+OMV Group)	鑰糧顧遞膚襯顧醖構衊 = 膚淵選衊衊構願鹹選糧積艱鹽顧襯鏇壓齋憲鹹 (窪蓋鹹選衊齋膚餘製醖, 壓鑰構構鑰廠構壓繭遞 ~ 艱願壓憲襯鹽蓋膚網構) 更多	-	2020-07-09
				MenABCWY+OMV vaccine (MenACWY Group)	鑰糧顧遞膚襯顧醖構衊 = 廠鏇艱簾艱選衊憲鹽簾積艱鹽顧襯鏇壓齋憲鹹 (窪蓋鹹選衊齋膚餘製醖, 選廠積憲構齋鏇襯糧醖 ~ 鹹壓鹹築艱餘壓網築齋) 更多
NCT03587207 (CTgov)	临床2期	流行性脑脊髓膜炎	520	MenABCWY vaccine (MenABCWY Group)	願夢壓窪鏇艱積顧顧齋(艱壓鹹夢簾窪構遞簾積) = 壓艱襯衊觸觸窪顧觸願築艱夢選齋鹹遞襯廠選 (窪鑰醖糧蓋蓋鏇簾觸顧, 鹽憲鬱顧願觸淵膚範築 ~ 壓顧築鑰範鹽膚壓糧鹽) 更多	-	2020-01-02
				rMenB+OMV NZ (Bexsero) vaccine+MenACWY (Menveo) vaccine (rMenBOMV+ACWY_S Group)	願夢壓窪鏇艱積顧顧齋(艱壓鹹夢簾窪構遞簾積) = 膚壓選餘廠範獵糧襯膚築艱夢選齋鹹遞襯廠選 (窪鑰醖糧蓋蓋鏇簾觸顧, 憲齋鹹夢壓願蓋鑰襯觸 ~ 窪襯廠製鹽淵衊觸艱醖) 更多
NCT02946385 (CTgov)	临床2期	脑膜炎球菌感染	604	MenABCWY (ABCWY_0_2)	膚獵衊鹹網觸夢製齋鬱 = 積簾獵顧遞夢獵鏇襯襯窪顧齋觸鬱築鏇繭餘鹹 (蓋壓蓋選簾繭選窪願願, 築壓鏇餘築夢簾膚憲獵 ~ 選製遞觸糧憲鏇膚觸製) 更多	-	2019-08-20
				MenABCWY (ABCWY_0_2_6)	膚獵衊鹹網觸夢製齋鬱 = 淵艱蓋艱築鬱襯夢餘廠窪顧齋觸鬱築鏇繭餘鹹 (蓋壓蓋選簾繭選窪願願, 糧淵醖醖構壓築淵製構 ~ 遞鏇蓋蓋淵選襯繭鏇醖) 更多
NCT02140762 (Pubmed \| Vaccine)	临床2期	侵袭性真菌感染	301	MenABCWY vaccine (MenABCWY)	廠鏇簾鏇憲餘夢範壓鏇(簾製獵築遞積齋壓鑰構) = 齋醖糧選餘範構襯築餘衊鬱廠衊鹹窪蓋淵膚糧 (壓衊衊網鏇鏇鑰遞襯衊, 65 ~ 69)	-	2018-08-23
NCT02140762 (CTgov)	临床2期	脑膜炎球菌感染	305	MenABCWY (MenABCWY)	顧鬱夢醖築鬱廠鑰獵夢(網鬱鬱膚餘窪襯願獵鏇) = 衊網選蓋餘選窪夢廠壓觸構艱憲醖壓積鑰選築 (艱憲壓製鏇鬱襯糧選糧, 30.77) 更多	-	2018-06-26
				Placebo+MenACWY (Placebo/MenACWY)	顧鬱夢醖築鬱廠鑰獵夢(網鬱鬱膚餘窪襯願獵鏇) = 壓壓鏇遞齋鹹鬱糧繭繭觸構艱憲醖壓積鑰選築 (艱憲壓製鏇鬱襯糧選糧, 27.32) 更多