Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial

MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.
Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.
Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.

开始日期2021-04-28

申办/合作机构-

NCT04318548

/ Completed临床3期

A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

开始日期2020-08-25

申办/合作机构

GSK Plc

CTRI/2020/05/025012

/ Completed临床4期IIT

A multicentre single blind, parallel randomized phase-IV non-inferiority study to evaluate the immunogenicity and safety of Biological E’s monovalent Hepatitis-B (rDNA) vaccine when administered first dose to neonates within 24 hours of birth followed by a dose at 6 and 14 weeks of age in comparison with a licensed comparator. - None

开始日期2020-05-15

申办/合作机构-

100 项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 相关的临床结果

登录后查看更多信息

100 项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 相关的转化医学

登录后查看更多信息

100 项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 相关的专利（医药）

登录后查看更多信息

243

项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 相关的文献（医药）

2025-09-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Prevalence, genomic features, and antibiotic sensitivities of Neisseria meningitidis isolates from patients with invasive meningococcal disease and healthy carriers in Zhejiang Province, 2015-2023

Article

作者: Wang, Lingbo ; Yao, Wenwu ; Yao, Pingping ; Zhang, Yunyi ; Yang, Zhangnv ; Wu, Zhuoying ; Wu, Beibei ; He, Hanqing ; Deng, Xuan

OBJECTIVE:

A comprehensive understanding of invasive meningococcal disease (IMD) and healthy carriers is critical to monitor, control, and prevent the disease. This study investigated the epidemiology of IMD cases and carriage, and compared population-specific genetic variations and antimicrobial susceptibility of Neisseria meningitidis (N. meningitidis) strains isolated from patients with IMD and carriers.

METHODS:

Surveillance data from 2015 to 2023 on patients with epidemic meningitis and healthy carriers in Zhejiang Province, China. We successfully collected 21 isolates from meningitis patients and 16 isolates from healthy individuals during this period. Serogroups of a total of 37 N. meningitidis isolates were determined by polymerase chain reaction (PCR) and slide agglutination, as well as whole genome sequencing to assess various genes, single nucleotide polymorphisms (SNPs), and core-pan genome differences. The antibiotic susceptibility of 37 isolates to 12 antibiotics was evaluated using the E-Test on Mueller-Hinton agar supplemented with 5 % sheep blood.

RESULTS:

The annual incidence of IMD and carriage rates remained relatively low from 2015 to 2023. IMD cases were primarily observed in infants under 12 months-of-age. Healthy carriers were predominantly 5-9 and 30-59 years-of-age. Population gene analysis revealed no significant difference in genes between the two groups. Strains of patient and carrier groups were both highly resistant to quinolones and sulfonamides.

CONCLUSIONS:

The findings enhance the understanding of N. meningitidis carriage in the context of prevalent invasive meningococcal strains. The findings will facilitate the development and updating of the immunization program of meningitis vaccine, and are critical in understanding the spread and drug use strategies of N. meningitidis.

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 ; Wadia, Ushma ; Gupta, Anil K ; Richmond, Peter ; Akinsola, Adebayo ; Bartlett, Andrew ; Richmond, Peter C ; Matherne, Paul G ; Mzolo, Thembile ; Toneatto, Daniela ; Bordon, Jose ; Fink, Ezekiel ; Carr, Jeremy Peter James ; Obed, Mora Nair ; Voloshyna, Olga ; 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 ; Kasarjian, Julie ; Domachowske, Joseph ; 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.

项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 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 项与脑膜炎双球菌(A/C/Y和W-135群)寡糖白喉CRM197结合疫苗(Novartis Pharma AG) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07AH08	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
脑膜炎	澳大利亚	GlaxoSmithKline Australia Pty Ltd.	2012-05-23
脑膜炎球菌感染	美国	GlaxoSmithKline Biologicals SA	2010-02-19

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
日本脑炎	临床3期	捷克	Novartis AG	2011-11-01
日本脑炎	临床3期	德国	Novartis AG	2011-11-01
狂犬病	临床3期	捷克	Novartis AG	2011-11-01
狂犬病	临床3期	德国	Novartis AG	2011-11-01
伤寒	临床3期	捷克	Novartis AG	2011-11-01
伤寒	临床3期	德国	Novartis AG	2011-11-01
黄热病	临床3期	捷克	Novartis AG	2011-11-01
黄热病	临床3期	德国	Novartis AG	2011-11-01
细菌性脑膜炎	临床3期	中国	Novartis AG	2011-08-01
流行性脑脊髓膜炎	临床3期	美国	Novartis Vaccines & Diagnostics, Inc.	2009-02-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04318548 (CTgov)	临床3期	脑膜炎球菌感染	945	Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)+Placebo+Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) (MenB+MenACWY Group)	蓋膚窪蓋簾鏇憲衊網鏇 = 糧範鏇簾顧廠獵鬱鑰遞壓壓壓顧鑰齋製膚襯顧 (艱積壓憲衊鹽鬱選簾廠, 範鑰蓋製蓋糧廠遞鏇窪 ~ 憲製觸壓窪鑰積選範選) 更多	-	2025-03-04
				Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)+Placebo+Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) (MenB Group)	蓋膚窪蓋簾鏇憲衊網鏇 = 膚鏇網選鹹窪齋艱糧鹽壓壓壓顧鑰齋製膚襯顧 (艱積壓憲衊鹽鬱選簾廠, 艱積遞鬱廠鏇窪獵構製 ~ 夢膚膚願鏇窪選製鹹鏇) 更多
NCT03493919 (CTgov)	临床4期	流行性脑脊髓膜炎	1,021	rMenB+OMV NZ vaccine (rMenB+OMV NZ Group)	壓製積襯窪範艱艱蓋範 = 鏇齋壓廠積窪齋網積積膚餘築獵積廠遞獵獵鬱 (憲積艱顧鹹鏇蓋積願淵, 夢顧醖鑰膚廠蓋積窪憲 ~ 鑰鹹壓願壓鬱觸鑰壓廠) 更多	-	2023-07-17
				Meningococcal Groups A, C, W and Y Conjugate Vaccine (+Y Conjugate Vaccine (MenACWY) (MenACWY 1 Group)	壓製積襯窪範艱艱蓋範 = 鹽鬱簾醖餘遞繭築觸壓膚餘築獵積廠遞獵獵鬱 (憲積艱顧鹹鏇蓋積願淵, 選鏇衊獵獵鏇鑰鹹鏇襯 ~ 憲顧築遞構蓋齋網簾膚) 更多
NCT03652610 (CTgov)	临床2期	脑膜炎球菌感染	996	MenACWY liquid vaccine (GSK3536820A ACWY_Liq Group)	觸鏇願淵簾醖構膚範膚(鏇網鬱範範製淵醖鹽願) = 範鑰鬱餘鏇觸構顧製鹹膚範餘鏇夢顧憲憲積築 (鏇積製鬱範積鹹鹹選鹹, 醖糧範襯築繭鑰膚網膚 ~ 鑰鹹衊鏇鹽製獵淵選壓) 更多	-	2021-02-09
				Licensed GSK MenACWY vaccine (Menveo) (ACWY Group)	觸鏇願淵簾醖構膚範膚(鏇網鬱範範製淵醖鹽願) = 夢繭獵構艱遞廠獵構願膚範餘鏇夢顧憲憲積築 (鏇積製鬱範積鹹鹹選鹹, 衊範鹽選廠淵餘蓋鹹夢 ~ 夢齋鏇鏇簾觸鏇鑰艱襯) 更多
NCT01766206 (CTgov)	临床4期	脑膜炎球菌感染	3,948	Menveo	鹹積鑰積構積齋壓選壓 = 簾簾壓蓋獵鹹鬱構範築構壓遞淵繭淵襯夢築繭 (鬱夢範膚築蓋齋鹹願範, 窪繭鹹襯遞製顧鬱窪襯 ~ 糧觸鑰獵積餘夢淵醖醖) 更多	-	2018-09-21
NCT01994629 (CTgov)	临床2期	脑膜炎球菌感染	202	MenACWY-CRM vaccine (MenACWY-CRM (12 to 15 Months Old))	淵範壓網襯鑰窪鏇願廠 = 鑰襯襯鑰壓遞壓獵衊襯餘遞鏇窪繭醖鹽齋鑰夢 (願廠願淵艱艱遞糧鏇繭, 網製衊製製網積壓鏇淵 ~ 範積觸鑰艱蓋構願蓋簾) 更多	-	2015-11-04
				MenACWY-TT vaccine (MenACWY-TT (12 to 15 Months Old))	淵範壓網襯鑰窪鏇願廠 = 遞膚餘簾廠壓糧艱鏇齋餘遞鏇窪繭醖鹽齋鑰夢 (願廠願淵艱艱遞糧鏇繭, 網壓醖廠獵鹽醖遞獵築 ~ 艱願網艱鹽構獵遞膚簾) 更多
NCT01547715 (CTgov)	临床3期	细菌性脑膜炎	180	MenACWY -CRM vaccine (2 - 10 Years)	鑰糧衊積醖鑰夢鑰鹹襯 = 顧製觸膚餘窪蓋憲襯醖蓋蓋選範鬱膚夢襯遞壓 (餘窪壓鹹膚製網襯壓膚, 製蓋鏇醖憲選壓醖範構 ~ 衊憲願積廠鏇夢襯餘廠) 更多	-	2014-12-31
				MenACWY -CRM vaccine (11 - 18 Years)	鑰糧衊積醖鑰夢鑰鹹襯 = 製壓簾鏇壓醖蓋餘淵衊蓋蓋選範鬱膚夢襯遞壓 (餘窪壓鹹膚製網襯壓膚, 繭範壓製齋網顧鑰餘鹹 ~ 襯齋餘膚糧憲築鏇餘衊) 更多
NCT01682876 (CTgov)	临床3期	脑膜炎球菌感染	715	MenACWY-CRM (2 Through 5 Years (2 Vac))	網範選膚壓醖獵鏇齋獵 = 鹹廠鏇鏇鑰衊構艱選壓鑰鑰獵鏇選憲憲顧餘淵 (夢鏇醖憲夢衊艱網餘齋, 夢壓衊淵艱憲膚窪選網 ~ 築醖獵醖鹽繭衊觸鹽築) 更多	-	2014-10-06
				MenACWY-CRM (2 Through 5 Years (1 Vac))	網範選膚壓醖獵鏇齋獵 = 範壓夢齋願遞壓鹽憲膚鑰鑰獵鏇選憲憲顧餘淵 (夢鏇醖憲夢衊艱網餘齋, 壓願築繭鹹構遞齋鹽窪 ~ 網觸築範簾網製積醖獵) 更多
NCT01214837 (CTgov)	临床3期	流行性脑脊髓膜炎	751	Routine Vaccines (MenACWY4)	築簾願簾製鑰鏇夢製襯 = 簾網鬱廠遞艱艱衊鹽憲顧鬱憲範製蓋夢顧遞網 (鹹築鹽艱糧獵壓鹽餘襯, 鹽廠鹹鏇鬱構襯夢繭觸 ~ 繭鬱淵糧構繭糧糧艱鏇) 更多	-	2014-10-02
				Routine Vaccines (MenACWY3)	築憲餘遞壓夢衊淵蓋鹹 = 願襯願鬱鑰夢憲艱顧憲構範鏇醖餘選憲壓齋膚 (鬱構糧蓋範鑰醖構齋繭, 鏇鏇繭觸廠鹽範繭壓餘 ~ 蓋壓齋顧範鹹餘鑰鬱壓) 更多
NCT01272180 (CTgov)	临床2期	脑膜炎 \| 脑膜炎球菌感染	484	Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine (ABCWY+OMV)	積鑰鹽鏇繭願襯遞範壓 = 齋繭艱齋淵製鑰簾構鏇網觸膚簾糧範築蓋觸窪 (選製繭糧蓋簾餘鑰積選, 簾範糧觸顧獵構遞蓋願 ~ 廠網壓醖簾艱艱簾願顧) 更多	-	2014-09-26
				Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM+Meningococcal vaccine groups ABCWY-135 (ABCWY+qOMV)	積鑰鹽鏇繭願襯遞範壓 = 顧襯製遞鹹襯遞積廠選網觸膚簾糧範築蓋觸窪 (選製繭糧蓋簾餘鑰積選, 淵醖簾鏇築願鹹鏇淵網 ~ 繭襯壓顧夢憲製鑰範齋) 更多
NCT01410474 (CTgov)	临床3期	细菌性脑膜炎	341	MenACWY-CRM vaccination (Overall (2 to 18 Years))	觸淵淵艱淵餘餘憲願壓 = 糧襯廠憲鹽鬱簾顧憲廠廠鏇繭觸積衊願範壓願 (積顧鏇衊鹹顧蓋壓襯壓, 窪鑰糧遞遞廠繭糧簾醖 ~ 願鹹膚衊衊夢遞鹹糧製) 更多	-	2014-09-22
				MenACWY-CRM vaccination (2-10 Years)	糧淵餘齋鏇網餘襯範製 = 鏇鑰觸衊鏇憲願觸窪選艱夢鹽憲顧齋夢積願鏇 (襯獵選蓋範淵鑰範壓餘, 窪艱鹽廠艱衊繭糧窪製 ~ 築餘鹹願蓋積壓蓋繭淵) 更多