A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS

BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
This study is seeking healthy pregnant participants:
* aged 49 or younger who can join.
* between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is)
* had a fetal ultrasound examination performed with no major fetal abnormalities observed
* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.
A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.

开始日期2025-08-25

申办/合作机构

Pfizer Inc.

NCT05832502

/ Unknown status临床2期

A Placebo Controlled Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without Human Immunodeficiency Virus (HIV) Infection and Their Infants

A placebo controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants

开始日期2022-10-14

申办/合作机构

St. George's University of London

[+1]

NCT04766086

/ Completed临床2期

A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE

This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.

开始日期2022-08-12

申办/合作机构

Pfizer Inc.

100 项与 Group B streptoccous 6-valent polysaccharide conjugate vaccine(Pfizer Inc.) 相关的临床结果

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100 项与 Group B streptoccous 6-valent polysaccharide conjugate vaccine(Pfizer Inc.) 相关的转化医学

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100 项与 Group B streptoccous 6-valent polysaccharide conjugate vaccine(Pfizer Inc.) 相关的专利（医药）

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项与 Group B streptoccous 6-valent polysaccharide conjugate vaccine(Pfizer Inc.) 相关的文献（医药）

2025-10-01·LANCET INFECTIOUS DISEASES

Safety and immunogenicity of a booster dose of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 2, open-label extension of a phase 1/2 randomised controlled trial

Article

作者: Michelle Gaylord ; Nathan Segall ; Judith Absalon ; Natalie C Silmon de Monerri ; Samantha Munson ; Raphael Simon ; John Perez ; David Radley ; Yasmin Sanchez-Pearson ; Stanley L Block ; William C Gruber ; Lindsay C McLaughlin ; Annaliesa S Anderson ; Kathrin U Jansen ; Daniel A Scott ; Babalwa Jongihlati

BACKGROUND:

A hexavalent group B streptococcus (GBS) polysaccharide conjugate vaccine (GBS6) is being developed to prevent invasive group B streptococcal disease in infants through active maternal immunisation. We previously reported results for GBS6 administered to non-pregnant adults (NCT03170609). Here, we aim to extend these results to determine safety and immunogenicity of a second dose of GBS6 in non-pregnant adults who received a primary dose of GBS6.

METHODS:

This phase 2, open-label extension of a phase 1/2 randomised controlled trial was done at four sites in the USA to assess the safety, tolerability, and immunogenicity of a booster dose (20 μg capsular polysaccharide per serotype per dose) of GBS6 formulated with and without aluminium phosphate (AlPO₄). Healthy adults who were aged 18-49 years during participation in the phase 1/2 study approximately 2 years before and received one of the six GBS6 formulations were enrolled. Participants received a single dose of GBS6 20 μg capsular polysaccharide (CPS) per serotype on study day 1, with or without AlPO₄ based on the formulation received in the phase 1/2 study. Primary endpoints evaluated GBS6 safety (in participants receiving one or more doses) based on solicited local reactions and systemic events within 14 days, adverse events within 1 month, and unsolicited serious adverse events and medically attended adverse events up to 6 months after vaccination. Secondary immunogenicity endpoints (in the evaluable population of participants in compliance with key protocol criteria) included assessments of GBS serotype-specific IgG geometric mean concentrations (GMCs) and geometric mean fold-rises (GMFRs) in serum samples collected at 1 month after versus before booster vaccination. This study is registered with ClinicalTrials.gov (NCT04258995).

FINDINGS:

Of 297 participants who completed the base study, 151 received the GBS6 booster dose (76 participants with and 75 without AlPO₄) and were included in the safety analysis. The median time to booster from primary vaccination was 2·4 years (IQR 2·3-2·5). Most participants were women (114 [75%] of 151) and White (125 [83%] of 151). The mean age was 36·7 years (SD 8·67). Pain at the injection site was the most frequently reported solicited local reaction (52 [68%] of 76 participants who received GBS6 with AlPO₄ and 32 [43%] of 75 without AlPO₄) and was severe in two (3%) of 76 participants who received GBS6 with AlPO₄ and no participant who received the vaccine without adjuvant. Systemic events occurred at similar frequencies in both groups (45 [59%] of 76 with AlPO₄ and 46 [61%] of 75 without AlPO₄), and were mostly mild or moderate in severity. The number of participants reporting any type of unsolicited adverse event was low and similar for GBS6 with AlPO₄ versus GBS6 without AlPO₄ (11 [14%] of 76 vs 12 [16%] of 75). No adverse event was deemed to be related to GBS6. One serious adverse event, assessed as not related to the product being investigated, of thermal burn was reported in a participant who received GBS6 with AlPO₄. Low rates of medically attended adverse events were reported in both groups of participants receiving a booster dose of GBS6 (nine [12%] of 76 with AlPO₄ and seven [9%] of 75 without AlPO₄). For all serotypes, serotype-specific anti-CPS IgG GMCs mostly waned over the 2-year period after the primary vaccination but remained elevated before the booster dose compared with before the primary dose of GBS6. A booster dose of GBS6 elicited robust GBS serotype-specific anti-CPS IgG responses that were two-fold to 18-fold higher 1 month after the booster dose (GMC range 6·025-60·304 μg/mL) than 1 month after the primary dose (0·365-35·173 μg/mL). Anti-CPS IgG GMFRs ranged from approximately ten-fold to 59-fold across the serotypes and formulations from before the booster dose (GMC range 0·130-5·274 μg/mL) to 1 month after the booster dose.

INTERPRETATION:

The results of this study showed that a single 20 μg booster dose of GBS6 given approximately 2 years after a primary dose to healthy, non-pregnant adults was safe and elicited robust immune responses that were consistently higher than those after the primary dose. As there is precedent for repeat doses of vaccines to augment or sustain circulating antibodies available for placental transfer with each pregnancy, results from this study might inform decisions around future dosing strategies for GBS6 for maternal immunisation with subsequent pregnancies should GBS6 be approved for use in pregnancy.

FUNDING:

Pfizer.

2025-07-11·JOURNAL OF INFECTIOUS DISEASES

A Phase 2b Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 6-Valent Group B Streptococcus Vaccine Administered Concomitantly With Tetanus, Diphtheria, and Acellular Pertussis Vaccine in Healthy Nonpregnant Female Individuals

Article

作者: Gaylord, Michelle ; Chawana, Richard ; Smith, William B ; Anderson, Annaliesa S ; Skogeby, Zahra ; Feng, Ye ; Bickham, Kara ; Silmon de Monerri, Natalie C ; Skinner, Julie M ; Beeslaar, Johannes ; Seger, William ; Jongihlati, Babalwa

Abstract:

Background:

Maternal group B Streptococcus (GBS) infection is associated with substantial risk of preterm birth and infant mortality. Preventive approaches to protect infants from GBS infection are needed.

Methods:

In this phase 2b randomized study, healthy nonpregnant 18- to 49-year-old females were randomized 1:1:1 to receive the investigational 6-valent GBS polysaccharide conjugate vaccine (GBS6) and concomitant tetanus, diphtheria, and acellular pertussis vaccine (Tdap) (GBS6 + Tdap), GBS6 and placebo (GBS6 + placebo), or Tdap and placebo (Tdap + placebo). Primary safety endpoints included reactogenicity events within 7 days and adverse events (AEs) through 1 month after vaccination. Primary immunogenicity objectives were to describe immune responses induced by GBS6 + Tdap versus Tdap + placebo and versus GBS6 + placebo for pertussis, tetanus, and diphtheria Tdap antigens and the 6 GBS6 antigens.

Results:

Overall, 304 participants received study vaccination. Most reactogenicity events were mild or moderate in severity and balanced across vaccine groups. Frequency of AEs was ≤8.1% across vaccine groups. One month after vaccination, the proportion of participants achieving antibody concentrations ≥0.1 IU/mL for tetanus and diphtheria antigens was 100% in both the GBS6 + Tdap and Tdap + placebo groups. Immune responses to pertussis antigens were lower in the GBS6 + Tdap group compared to the Tdap + placebo group, with geometric mean ratios <0.6. No consistent effect on immune responses against each of the GBS6 serotypes after concomitant administration with Tdap was observed.

Conclusions:

GBS6 and Tdap administered concomitantly and alone were safe and well tolerated in healthy nonpregnant individuals. Similar immune responses were observed for Tdap when administered with GBS6 or when administered alone. These results will likely inform future studies in pregnant individuals.Clinical Trials Registration. NCT04766086.

2024-07-01·Lancet Microbe

Association between anti-capsular IgG levels at birth and risk of invasive group B streptococcus disease in Finnish newborns: a retrospective case–control study

Article

作者: David Radley ; Riitta Veijola ; Raphael Simon ; Emily Gomme ; Laura Lindholm ; Mikael Knip ; Babalwa Jongihlati ; Maija Toropainen ; Jorma Toppari ; Annika Saukkoriipi ; Arto A Palmu ; Natalie C Silmon de Monerri ; Annaliesa S Anderson

BACKGROUND:

Group B streptococcus is a major cause of neonatal disease. Natural history studies have linked maternally transferred anti-group B streptococcus capsular polysaccharide antibodies with protection against infant group B streptococcus disease. Previous studies of capsular polysaccharide antibody concentration in European populations have used maternal (not infant) sera and a non-standardised assay. This study aimed to evaluate anti-capsular polysaccharide IgG concentrations associated with protection against invasive group B streptococcus disease in Finnish infants.

METHODS:

In this retrospective case-control study, we used cord sera from the Finnish DIPP study repository, which was obtained between Jan 1, 1995, and Dec 31, 2017. We included infants aged 6 months or younger with group B streptococcus infection (cases) and healthy infants (controls). We enrolled infants with invasive neonatal group B streptococcus (55 cases) and matched controls (229 controls) aged 6 months or younger after identification from Finnish health registers. We measured anti-capsular polysaccharide IgG (serotypes Ia-V) concentration using a standardised immunoassay and we estimated its relationship to disease risk using a Bayesian model. We used the derived risk-concentration curve to predict potential efficacy of six-valent group B streptococcus capsular polysaccharide vaccine (GBS6) based on previously reported immunogenicity data.

FINDINGS:

Most (32 [58%] of 55 cases) group B streptococcus cases were due to serotype III and anti-serotype III streptococcus capsular IgG concentrations were higher in serotype III-matched controls than in cases (p<0·001). 0·120-0·266 μg/mL serotype III-specific IgG was estimated to confer 75-90% risk reduction against serotype III disease. A universal risk-concentration curve, aggregating results across all six serotypes, yielded similar results. Application of this curve to GBS6 immunogenicity data predicted maternal immunisation to be more than 80% efficacious for prevention of infant group B streptococcus disease.

INTERPRETATION:

Higher neonatal anti-capsular polysaccharide serum IgG concentration at birth correlated with reduced risk of infant group B streptococcus disease in Finland. Based on these results, a maternal group B streptococcus capsular conjugate vaccine currently in development is predicted to be efficacious.

FUNDING:

Pfizer.

项与 Group B streptoccous 6-valent polysaccharide conjugate vaccine(Pfizer Inc.) 相关的新闻（医药）

2023-08-03

·生物制品圈

辉瑞、默沙东2023Q2财报发布，这4款潜力疫苗产品值得期待！（附报告下载）

8月1日，全球疫苗四大天王中的另外两家——辉瑞和默沙东也相继公布了2023H1业绩：辉瑞今年上半年总营收310亿美元，同比降低42%。其中Q2收入127亿美元，同比降低54%；若不计新冠产品，则同比增长5%。业绩总体下滑的主要原因是新冠口服药Paxlovid和新冠疫苗Comirnaty的患者需求下降。默沙东今年上半年总营收295.22亿美元，同比下降3%。其中Q2收入150.35亿美元，同比增长3%。业绩总体下滑的主要是由于新冠药物Lagevrio的收入大幅减少（-87%）以及两款降糖药销售下滑。下面主要看看这两家企业疫苗板块的情况。（赛诺菲、GSK 2023Q2财报发布，这5款疫苗产品值得关注！附最新管线）PS：在【药时空】公众号后台回复关键词“2023Q2”，即可获取辉瑞、默沙东、GSK、赛诺菲2023Q2业绩报告资料！辉瑞2023年上半年，辉瑞的新冠mRNA疫苗Comirnaty销售额45.52亿美元，肺炎结合疫苗Prevnar销售额29.81亿美元。其中，美国的COVID-19疫苗接种量为1240万剂，虽低于辉瑞此前的预测（1亿剂），但COVID-19疫苗的市场份额超过其之前的预测（60%）。在未来的疫苗业绩贡献方面，辉瑞刚获批的RSV疫苗有望成长为超级重磅炸弹；肺炎结合疫苗20价上市迭代13价，有望巩固其在肺炎球菌疫苗领域的市场地位。辉瑞的RSV二价疫苗 Abrysvo是于今年5月底获FDA批准上市，用于预防60岁及以上人群由RSV引起的急性呼吸道疾病和下呼吸道疾病。其也是全球第2款获批的RSV疫苗。在辉瑞的疫苗在研管线中，可以关注一下五价脑膜炎球菌疫苗MenABCWY和B组链球菌候选疫苗GBS6。MenABCWY辉瑞预计2023年下半年将是新药/新适应症推向市场的密集期，并将带来高于上半年的高增长。在疫苗方面，比较值得关注的待获批新药为五价脑膜炎球菌疫苗MenABCWY。2022年年底，辉瑞的MenABCWY的BLA获美国FDA受理，用于预防10-25岁人群中最常见血清群引起的脑膜炎球菌病。FDA预计将于2023年10月做出决定。MenABCWY是辉瑞2款已上市疫苗Trumenba（B型脑膜炎球菌疫苗）和Nimenrix（脑膜炎球菌A、C、W-135与Y偶联疫苗）的结合，该疫苗涵盖了五种常见的侵袭性脑膜炎球菌血清群（脑膜炎球菌A、B、C、W、Y）。如果该疫苗获批，将会成为首个涵盖所有常见脑膜炎球菌血清群的单一疫苗。GBS6在更长时间段的管线方面，辉瑞有一款六价荚膜多糖（CPS）B组链球菌（GBS）候选疫苗GBS6，该疫苗的2期临床试验结果被发表在了《新英格兰医学杂志》上。GBS6用于给母亲接种，以保护婴儿免受侵袭性GBS疾病的影响。而据这项研究结果显示，母亲接种疫苗后所生婴儿体内的抗CPS IgG浓度>0.184 µg/mL。免疫原性最强的制剂达到57%-97%的血清应答率。GBS6可为新生儿提供有意义的抗侵袭性GBS疾病的保护。另外，辉瑞的其他疫苗在研管线还包括COVID /流感mRNA联合疫苗、莱姆病疫苗（PF405）、mRNA带状疱疹疫苗等。默沙东2023年上半年，默沙东在制药业务领域的主要收入来源是帕博利珠单抗（Keytruda，K药）和HPV疫苗Gardasil/Gardasil 9，二者合计贡献164.95亿美元，占该部分收入63%。其中，Gardasil/Gardasil 9的销售额为44.3亿美元，同比增长41%，主要来自国际市场的增长。另外，Gardasil/Gardasil 9在2023Q2的销售额为24.59亿美元，同比增长47%。2022年8月，Gardasil 9在中国扩龄至9-45岁女性，这促使其销售额实现强劲增长。据默沙东预计，2023年Gardasil/Gardasil 9的销售额将突破2022年的数据（68.97亿美元）。除Gardasil/Gardasil 9外，在疫苗领域，今年上半年默沙东的麻腮风-水痘疫苗/麻腮风疫苗/水痘疫苗ProQuad/M-M-R II/Varivax的销售额为11.09亿美元、五价轮状病毒疫苗RotaTeq的销售额为4.28亿美元、15价肺炎球菌多糖结合疫苗Vaxneuvance的销售额为2.74亿美元、23价肺炎球菌多糖疫苗Pneumovax 23的销售额为1.88亿美元、灭活甲肝疫苗Vaqta的销售额为0.82亿美元。其中，除了Pneumovax 23的销售额同比下降42%外，其他几款疫苗产品均实现了不同程度的增长。在默沙东的疫苗在研管线中，V116和mRNA-4157这2款疫苗产品值得注意，可能成为公司未来贡献销售增长的潜力产品，目前这两款产品均处于III期临床阶段。V1167月底，默沙东宣布其21价肺炎球菌结合疫苗（PCV21）V116的两项3期临床试验（STRIDE-3；STRIDE-6）均获积极顶线结果。V116是一种处于临床3期开发中的21价肺炎球菌结合疫苗，用于预防成年人侵袭性肺炎球菌疾病和肺炎球菌肺炎。V116包括8种独特的血清型——15A、15C、16F、23A、23B、24F、31 和 35B，这些血清型约占成人发病的30%。据默沙东表示，如果V116获批上市，将成为第一个专为成年人设计的肺炎球菌结合疫苗。另外，基于V116的3期临床试验，后续将有潜力扩大血清型覆盖范围，进一步帮助 85% 以上的65岁及以上人群预防侵袭性肺炎球菌疾病。mRNA-4157同样是在7月底，默沙东和Moderna宣布启动肿瘤新抗原mRNA疫苗（mRNA-4157）+Keytruda联合辅助治疗可手术的IIB-IV期高危黑色素瘤的关键性3期临床试验（V940-001）。目前，该试验已经开始了全球患者的招募，且首批患者正在澳大利亚入组。mRNA-4157是针对每个癌症患者的独特肿瘤突变开发的一款个性化肿瘤新抗原疫苗，包含编码最多34种新抗原的单一合成mRNA分子，其设计目标是根据患者肿瘤的突变特征，通过产生T细胞反应来刺激免疫反应。2023年，该疫苗先后获得了FDA的突破性疗法认证和EMA授予的优先药物（PRIME）资格，并成为全球首个获此认证的mRNA肿瘤疫苗。V940-001试验为随机、双盲、安慰剂和活性参比对照设计，计划在超25个国家、超165个中心入组约1089例黑色素瘤患者。试验的主要终点是无复发生存期（RFS），次要终点包括无远处转移生存期、总生存期（OS）和安全性。另外，通过查询clinicaltrials.gov上登记的关于V940-001试验的信息显示，该研究预计将于2029年10月完成。参考资料：[1]辉瑞、默沙东2023Q2业绩报告材料[2]曾经的疫苗之王要被新产品替代了？.新康界.2023-07-29.[3]默沙东21价肺炎球菌结合疫苗3期临床试验达到关键终点，或成为首个成年人用肺炎球菌结合疫苗.RNAScript.2023-07-29.[4]最广泛覆盖率！辉瑞五价脑膜炎球菌疫苗上市申请获FDA受理.药融圈.2023-01-02.[5]速递|预防每年造成超13万新生儿死亡的疾病，辉瑞疫苗2期临床结果积极.药明康德.2023-07-25.相关阅读：赛诺菲、GSK 2023Q2财报发布，这5款疫苗产品值得关注！（附最新管线）

财报疫苗信使RNA上市批准

2023-07-25

·药研发

【药研发0726】歌礼PD-L1单抗艾滋病Ⅱ期临床积极 | 科笛「米诺环素泡沫剂」拟纳入优先审评...

「本文共：15条资讯，阅读时长约：3分钟」今‍日‍头条歌礼PD-L1单抗艾滋病Ⅱ期临床积极。歌礼皮下注射PD-L1抗体恩沃利单抗（ASC22）联合西达本胺用于人类免疫缺陷病毒（HIV）感染的Ⅱ期临床结果积极。第8周和第12周时，ASC22联合治疗显著提高受试者细胞相关HIV RNA较基线变化，平均增幅分别为4.27倍和3.41倍；HIV细胞相关RNA与总DNA的比值也呈现改善趋势。药物总体耐受性良好。详细结果公布于第12届国际艾滋病协会HIV科学会议上。‍‍‍国‍‍‍‍‍‍‍‍‍内‍‍‍‍药‍‍讯‍‍‍‍1.诺和诺德长效凝血素中国报产。诺和诺德长效凝血因子VIII注射用培图罗凝血素α（turoctocog alfa pegol，N8-GP）的上市申请获CDE受理。N8-GP是一款经聚乙二醇（PEG）修饰后半衰期得到显著延长的凝血因子，与非修饰FVIII产品相比，N8-GP在成人/青少年中半衰期延长了1.6倍，在儿童中半衰期延长了1.9倍。在美国，该新药已获批用于成人和儿童血友病A患者的预防性治疗和急性治疗。2.恒瑞PD-1单抗肝癌Ⅲ期临床见刊柳叶刀。恒瑞医药PD-1抑制剂卡瑞利珠单抗联合VEGFR2抑制剂甲磺酸阿帕替尼一线治疗不可切除肝细胞癌的国际Ⅲ期CARES-310（SHR-1210-310）研究发表于《柳叶刀》。与sorafenib相比，卡瑞利珠单抗组合中位无进展生存期（mPFS）显著改善（5.6个月vs3.7个月）；两组中位总生存期（mOS）分别为22.1个月和15.2个月。试验中最常见的3级或4级治疗相关不良事件是高血压、手掌-足底红血病综合征、天冬氨酸转氨酶升高和丙氨酸转氨酶升高。3.科笛「米诺环素泡沫剂」拟纳入优先审评。科笛生物从Foamix公司引进的外用4%米诺环素泡沫剂（CU-10201）获CDE拟纳入优先审评，用于9岁及以上儿童和成人患者的非结节性中重度寻常痤疮炎症性病变的局部治疗。米诺环素是一种用于治疗细菌感染及寻常痤疮的四环素抗生素，它通过阻止胺基酸进入核糖体，从而抑制细菌肽链的形成。科笛生物拥有CU-10201在大中华区的权益。4.信念血友病A基因疗法获批临床。信念医药旗下上海信致的AAV基因治疗药物“BBM-H803注射液”获国家药监局临床许可，拟用于治疗血友病A。BBM-H803旨在通过静脉给药将人凝血因子Ⅷ（Factor Ⅷ，FⅧ）基因导入血友病A患者体内，从而提高并长期维持患者体内凝血因子水平，以期达到“一次治疗、长期有效”的治疗及预防出血效果。在美国，FDA已授予该基因疗法治疗血友病A的孤儿药资格。5.阿斯利康ASO新药中国获批临床。阿斯利康反义寡核苷酸（ASO）疗法eplontersen注射液获国家药监局临床许可，拟用于治疗遗传型和野生型转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）成人患者，以减少心血管死亡和心血管相关住院。它被设计为一月一次，可由患者自己皮下注射，通过抑制TTR蛋白的生产，从而治疗淀粉样变性多发性神经病。目前，eplontersen治疗淀粉样蛋白TTR多发性神经病（ATTR-PN）的新药申请在接受FDA审评。‍‍‍‍国‍‍‍‍‍‍‍‍‍‍际‍‍‍‍药‍讯‍‍1.辉瑞GBS母体疫苗Ⅱ期临床积极。辉瑞开发的由六价荚膜多糖（CPS）与基因解毒白喉毒素交叉反应物质（CRM）偶联产生的B组链球菌（GBS）候选母体疫苗GBS6，在用于给母亲接种以保护婴儿免受侵袭性GBS疾病的Ⅱ期临床获积极结果。数据显示，母亲接种疫苗后所生婴儿体内的抗CPS IgG浓度>0.184 µg/mL。免疫原性最强的制剂达到57%-97%的血清应答率。在母亲和婴儿中，疫苗组和安慰剂组的安全性特征相似。详细结果发表在《新英格兰医学杂志》上。2.创新RNAi疗法高血压早期临床见刊NEJM。Alnylam公司靶向血管紧张素原（AGT）的RNAi（RNA interference）疗法zilebesiran用于治疗轻度至中度高血压患者的Ⅰ期临床积极结果发表在NEJM上。与安慰剂相比，zilebesiran剂量依赖性地降低血清AGT水平，且持续长达6个月；两组不良事件（AE）的发生频率分别为72%和88%。罗氏已以28亿美元与Alnylam达成合作，联合开发zilebesiran用于治疗高血压。3.多特异性NK细胞接合器上临床。Innate Pharma SA公司宣布，由赛诺菲资助的一项验证多特异性NK细胞接合器SAR’514 / IPH6401用于复发/难治性多发性骨髓瘤（R/R MM）的Ⅰ/Ⅱ临床 (NCT05839626)完成首例患者给药。SAR’514/ IPH6401是一种以NKp46/CD16为基础，靶向BCMA的NK细胞接合器，它还能同时结合两种激活受体NKp46和CD16，充分利用NK细胞效应器功能的优势来对抗癌细胞。该项目的推进将激活两家公司于2016年签署的相关合作条款。4.安斯泰来布局新型蛋白降解剂。安斯泰来与日本PeptiDream公司将利用后者专有的PDPS（多肽发现平台系统）技术，为安斯泰来选定的两个靶点，合作开发新型蛋白质降解剂。根据协议，PeptiDream公司将获得30亿日元的预付款，发现、开发和商业销售里程碑后期付款（每个目标最高可达206亿日元），以及产品的销售分成。安斯泰来还有权选择另外三个靶点纳入合作范围。5.Kodiak终止抗VEGF眼科新药开发。Kodiak Sciences公司公布VEGF靶向抗体偶联生物聚合物（ABC）tarcocimab tedromer（KSI-301）用于治疗视网膜血管疾病的3项III期研究（DAYLIGHT、GLEAM和GLIMMER）的顶线结果。在DAYLIGHT研究中，与阿柏西普相比，KSI-301治疗显著改善湿性年龄相关性黄斑变性（AMD）患者的最佳矫正视力（BCVA）评分；且KSI-301总体耐受性良好。在KSI-301对比阿柏西普一线治疗糖尿病性黄斑水肿（DME）患者的GLEAM和GLIMMER研究中，2项研究没有达到主要终点，而且在KSI-301治疗组中观察到白内障发病率增加。Kodiak决定终止该药物的临床开发计划。6.KRAS抑制剂NSCLC适应症未获CHMP支持。欧洲药品管理局（EMA）人用药品委员会（CHMP）不支持Mirati公司口服KRAS G12C抑制剂Krazati（adagrasib）用于治疗KRAS G12C突变晚期非小细胞肺癌 (NSCLC)的有条件上市申请。在注册性KRYSTAL-1研究中，Adagrasib达到43%的客观缓解率（ORR）和80%的疾病控制率（DCR）。基于该结果，FDA已于去年年底加速批准Krazati上市，用于治疗携带KRAS G12C突变的NSCLC患者。‍‍‍‍‍‍‍‍‍医‍‍‍‍‍‍药‍‍‍‍‍‍‍‍‍‍‍‍‍热‍‍‍‍‍‍‍点‍‍‍‍‍‍‍‍‍1.南京大学再添一家附属医院。7月22日，南京大学医学院附属苏州医院签约揭牌。南京大学医学院附属苏州医院由苏州高新区管委会与南京大学医学院附属鼓楼医院合作共建，依托苏州科技城医院良好基础，采用鼓楼医院托管的模式，加快打造高水平医院。此前，南京大学医学院已有5所附属医院：附属鼓楼医院、附属金陵医院（东部战区总医院）、附属口腔医院、附属泰康仙林鼓楼医院和附属盐城第一医院（盐城市第一人民医院）。2.广中医一附院白云医院启动扩建项目。7月21日，广州白云区启动广中医一附院白云医院扩建项目。广中医一附院白云医院扩建项目计划投入14亿元全面升级改造白云医院门急诊医技综合楼、发热门诊楼、应急救治综合楼等，项目预计2026年正式投入使用，建成后床位数将增至1000张以上，占地面积达87亩，成为白云北部最具规模的三级中医医院，进一步实现中医药服务质的提升。3.全球男性美容市场规模高达800亿美元。据德国斯塔蒂斯塔调查公司最新统计，2022年全球男性美容市场规模达到800亿美元，有望在2028年达到1150亿美元。男性美容业风靡全球的背后，是传统观念转变、护肤品牌助推，以及社交媒体影响多重因素作用的结果。相关数据显示，短视频平台TikTok上有关“男性护肤”等关键词的短视频浏览量年增长率为389%，和“男性美容”相关的短视频浏览次数高达19亿。‍‍‍‍‍‍‍评‍‍‍‍‍审‍‍‍‍动‍‍态‍‍‍‍‍‍‍ 1. CDE新药受理情况（07月25日) 2. FDA新药获批情况（北美07月24日）股市资讯上个交易日 A 股医药板块 ++0.42%涨幅前三跌幅前三东亚药业 +3.13% 海特生物 -5.44%康华生物 +2.88% 科源制药 -4.39%景峰医药 +2.83% 东阿阿胶 -4.12%【复兴医药】(1)控股子公司浙江星浩澎博医药有限公司收到国家药品监督管理局关干同意XH-S003胶用干治疗IgA肾病等补体异常激活相关的肾小球疾病的临床试验批准，拟干条件具备后于中国境开展该新药的I期临床试验。(2)根据国家药品监督管理药品审评中心公示信息，控股子公司上海复星医药产业发展有限公司的FCN-159片用于治疗无法手术或术后残留/复发的NF1相关的丛状神经纤维瘤成人患者已被纳入突破性治疗药物程序。【海正药业】全资子公司瀚晖制药有限公司收到国家药品监督管理局核准签发的海博麦布阿托伐他汀钙片(20mg/10mg、10mg/10mg)的《药物临床试验批准通知书》。【欧林生物】收到国家药品监督管理局核准签发的关于冻干b型流感嗜血杆菌结合疫苗的《药物临床试验批准通知书》。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

优先审批孤儿药基因疗法临床3期申请上市

2023-07-24

·药明康德

速递 | 预防每年造成超13万新生儿死亡的疾病，辉瑞疫苗2期临床结果积极

▎药明康德内容团队编辑辉瑞（Pfizer）公司日前宣布，其六价荚膜多糖（CPS）B组链球菌（GBS）候选疫苗GBS6，在一项2期临床试验中获得积极结果。GBS6用于给母亲接种，以保护婴儿免受侵袭性GBS疾病的影响。数据显示，GBS6激发针对疫苗中包含的6种血清型的强大母源抗体应答，这些抗体有效地传递给婴儿。2期研究免疫原性数据表明，GBS6可为新生儿提供有意义的抗侵袭性GBS疾病的保护。这一成果发表在《新英格兰医学杂志》上，并将为计划中的3期临床开发计划提供洞见。GBS是一种常见的细菌，主要在出生后3个月内可引起婴儿的严重疾病，包括败血症、肺炎和脑膜炎。高达四分之一的妊娠个体体内携带GBS细菌，并可能在出生期间或出生前将其传播给婴儿。每年，全球估计有39.4万GBS病例，至少导致13.8万死产和婴儿死亡。侵袭性GBS疾病也可导致痊愈婴幼儿长期神经发育障碍，对患者、家庭及社会影响明显。GBS6是一款由六价荚膜多糖（CPS）与基因解毒白喉毒素交叉反应物质（CRM）偶联产生的在研母体疫苗，以帮助预防新生儿侵袭性B组链球菌疾病。与CRM结合的多糖已被辉瑞成功用于其肺炎球菌疫苗中，其在全球数百万婴儿中具有经证实的安全性和有效性追踪记录。在怀孕期间，抗体会主动从母亲的血液中，穿过胎盘并转移到胎儿体内。这种自然过程被称为经胎盘抗体转移。预期用于预防小婴儿疾病的孕妇疫苗依赖于这种经胎盘抗体转移过程。当孕妇接种疫苗后，她的免疫反应会产生特异性抗体，然后这些抗体可以转移到胎儿身上。这种来自母亲的保护被称为“母体免疫”，帮助婴儿在其免疫系统仍在发育的最脆弱的出生后最初几个月抵抗潜在感染。在《新英格兰医学杂志》发表的研究重点是在南非评估360例18-40岁健康妊娠个体及其婴儿的安全性和免疫原性。受试者被随机分配接受5、10或20 µg/血清型的GBS6单次给药（加或不加佐剂），或安慰剂。研究发现，通常在不加佐剂的GBS6 20 µg剂量下观察到最高抗体应答。这项研究结果显示，母亲接种疫苗后所生婴儿体内的抗CPS IgG浓度>0.184 µg/mL。免疫原性最强的制剂达到57%-97%的血清应答率。同期在《新英格兰医学杂志》上发表的另一项平行自然史研究显示，当抗CPS IgG抗体浓度为0.184-0.827 µg/mL时，对GBS疾病的保护能力为75%-95%。在母亲和婴儿中，疫苗组和安慰剂组的安全性特征相似。局部反应通常为轻度或中度，持续时间较短，最常报告的事件为注射部位疼痛。GBS6组和安慰剂组之间全身性不良事件相似，大多数事件为轻度或中度。总体而言，GBS6组中2%-8%的受试者和安慰剂组中5%的受试者报告了发热。在妊娠个体中，GBS6组中45%-70%的受试者和安慰剂组中61%的受试者发生了不良事件。大家都在看▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] Pfizer Announces New England Journal of Medicine Publication on Group B Streptococcus (GBS) Maternal Vaccine Candidate. Retrieved July 21, 2023, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-new-england-journal-medicine-publication免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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：本文来自药明康德内容团队，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

疫苗临床2期临床结果临床3期

100 项与 Group B streptoccous 6-valent polysaccharide conjugate vaccine(Pfizer Inc.) 相关的药物交易

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研发状态

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
链球菌感染	临床2期	美国	Pfizer Inc.	2019-01-14
链球菌感染	临床2期	南非	Pfizer Inc.	2019-01-14
链球菌感染	临床2期	英国	Pfizer Inc.	2019-01-14

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临床结果

适应症

分期

评价

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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


NCT04258995 (Pubmed \| Lancet Infect Dis)	临床2期	-	297	hexavalent group B streptococcus conjugate vaccine (GBS6 with AlPO4)	憲憲艱鬱齋範艱願鏇壓(廠淵網觸鹹築繭簾繭範) = One serious adverse event, assessed as not related to the product being investigated, of thermal burn was reported in a participant who received GBS6 with AlPO4 鬱襯獵選齋網選鏇憲製 (繭築製積鏇糧壓選範築 )	-	2025-10-01
				hexavalent group B streptococcus conjugate vaccine (GBS6 without AlPO4)
NCT04766086 (CTgov)	临床2期	链球菌感染	306	Tdap+GBS6 (GBS6 + Tdap)	遞鹹淵蓋築醖選鬱膚築 = 衊窪範觸衊蓋積鏇衊繭範網鑰糧齋艱憲鑰獵願 (憲窪醖餘網憲繭餘憲艱, 製鏇簾壓艱選鑰憲鑰鏇 ~ 顧範淵艱壓鬱餘鏇鹹簾) 更多	-	2024-05-24
				GBS6 (GBS6 + Placebo)	遞鹹淵蓋築醖選鬱膚築 = 鹽齋範繭膚選餘衊糧廠範網鑰糧齋艱憲鑰獵願 (憲窪醖餘網憲繭餘憲艱, 網觸衊夢壓廠觸願鏇齋 ~ 襯淵鏇窪憲鹹範艱鑰艱) 更多
NCT03765073 (Corporate Publications) 人工标引	临床2期	格林-巴利综合征	360	GBS6	窪範選鹽廠網窪壓壓醖(餘淵憲憲淵選蓋窪餘獵) = 鹽齋膚窪夢夢廠蓋鑰築襯網鏇簾獵顧簾選簾襯 (簾選選衊餘觸顧構憲選 ) 更多	积极	2023-07-19
				placebo	窪範選鹽廠網窪壓壓醖(餘淵憲憲淵選蓋窪餘獵) = 鹹襯醖憲餘積膚鹽膚膚襯網鏇簾獵顧簾選簾襯 (簾選選衊餘觸顧構憲選 ) 更多
NCT04258995 (CTgov)	临床2期	链球菌感染	151	AlPO4+GBS6 (GBS6 20 μg With AlPO4)	鏇鏇廠鏇鏇廠壓鹹醖淵 = 艱艱襯鹹鹽艱獵窪膚艱遞積願築壓鏇淵構糧鹹 (憲鹹衊築窪繭淵廠範願, 憲構鹽遞憲憲構壓簾製 ~ 鑰範壓鏇構蓋壓廠鹽範) 更多	-	2021-10-13
				GBS6 (GBS6 20 μg Without AlPO4)	鏇鏇廠鏇鏇廠壓鹹醖淵 = 鑰鬱窪餘鏇鑰壓齋選積遞積願築壓鏇淵構糧鹹 (憲鹹衊築窪繭淵廠範願, 範積鏇膚簾壓廠構鬱製 ~ 網積衊鹽範憲繭繭齋艱) 更多
NCT03170609 (CTgov)	临床2期	链球菌感染	365	Placebo	鏇選壓餘繭廠顧衊簾壓 = 壓製醖淵夢壓簾鹹鹹鹹鑰壓餘淵選窪糧廠壓鬱 (繭衊築廠壓繭廠繭鏇鹽, 淵襯鏇顧製願鏇築壓齋 ~ 淵襯顧觸遞蓋繭製膚憲) 更多	-	2019-07-02