头孢比罗酯钠(Ceftobiprole Medocaril Sodium) - 药物靶点：PBPs_在研适应症：社区获得性肺炎，医院获得性肺炎，新生儿败血症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

ceftobiprole、ceftobiprole medocaril、Ceftobiprole medocaril free acid

+ [12]

靶点

PBPs

作用机制

PBPs抑制剂(细菌青霉素结合蛋白家族抑制剂)

治疗领域

感染呼吸系统疾病遗传病与畸形+ [1]

在研适应症

社区获得性肺炎医院获得性肺炎新生儿败血症

非在研适应症

细菌感染社区获得性细菌性肺炎发热+ [14]

原研机构

Basilea Pharmaceutica AG

在研机构

Basilea Pharmaceutica AGBasilea Pharmaceuticals Deutschland GmbH

Avir Pharma, Inc.初创企业

非在研机构

Janssen Pharmaceutical Unlimited Co.Johnson & Johnson Pharmaceutical Research & Development LLCBasilea Pharmaceutica International Ltd.

最高研发阶段批准上市

首次获批日期

加拿大 (2018-03-20),

社区获得性肺炎医院获得性肺炎

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、快速通道 (美国)、合格传染病产品 (美国)

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结构/序列

分子式C26H26N8NaO11S2

InChIKeyBYUIXTXYXHAECA-LCJFHXTKSA-N

CAS号252188-71-9

关联

36

项与头孢比罗酯钠相关的临床试验

NCT06808646

/ Recruiting临床1期

A Phase 1, Single-center, Open-label, Non-randomized, Fixed-sequence, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Intravenous Ceftobiprole on the Pharmacokinetics of Oral Pitavastatin (OATP1B Substrate) and on Plasma Levels of Coproporphyrin I (OATP1B Biomarker) in Healthy Subjects

The goal of this clinical study is to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of increased levels of cholesterol in blood) from the body. This interaction will be investigated by pharmacokinetic (PK) assessments.
The PK of pitavastatin will be assessed when administered alone and when administered together with ceftobiprole in a study design including two treatment periods.
The clinical study will also investigate the safety of ceftobiprole and how well ceftobiprole is tolerated by healthy subjects when it is administered in combination with pitavastatin. In addition, the effect of ceftobiprole on a specific marker, called coproporphyrin I, will be assessed in the blood.
The duration of the study will be a maximum of 38 days.

开始日期2025-01-17

申办/合作机构

Basilea Pharmaceutica AG

[+1]

ChiCTR2500096047

/ Recruiting早期临床1期IIT

Pharmacokinetic Characteristics and Blood-Brain Barrier Penetration of Ceftobiprole in Patients with Proposed or Confirmed Central Nervous System Infection

开始日期2024-10-28

申办/合作机构-

NCT05856227

/ Completed临床3期

A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis

This study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

开始日期2023-08-06

申办/合作机构

Basilea Pharmaceutica AG

100 项与头孢比罗酯钠相关的临床结果

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100 项与头孢比罗酯钠相关的转化医学

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100 项与头孢比罗酯钠相关的专利（医药）

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443

项与头孢比罗酯钠相关的文献（医药）

2025-02-01·CLINICAL MICROBIOLOGY AND INFECTION

Therapeutic drug monitoring of antibiotics for methicillin-resistant Staphylococcus aureus infections: an updated narrative review for clinicians

Review

作者: Riccardi, Niccolò ; Falcone, Marco ; Galfo, Valentina ; Tiseo, Giusy

BACKGROUND:

Infections caused by methicillin-resistant Staphylococcus aureus (MRSA) are associated with high mortality rates. Optimal antibiotic dosage plays a crucial role in reducing MRSA burden; thus, the use of therapeutic drug monitoring (TDM) in the clinical practice, especially of new drugs such as ceftobiprole, ceftaroline, dalbavancin, and oritavancin, should be implemented.

OBJECTIVES:

We aim to examine and summarize the available evidence about TDM of anti-MRSA molecules, with a focus on pneumonia, endocarditis and vascular infections, and bone and joint infections.

SOURCES:

We applied 'therapeutic drug monitoring' and 'Staphylococcus aureus' as search terms in PubMed, considering a time frame of 24 years (2001-2024). Articles in English language, non-duplicated, evaluating antibiotic therapeutic target, and role of TDM were included in the study.

CONTENT:

In this review, available data for therapeutic target and TDM were critically analysed and summarized and suggestions about the use of old and new anti-MRSA antibiotics were provided, focusing on optimal dosages, tissue penetration according to infection types, and toxicity. Limitations to the widespread use of TDM in clinical practice were discussed.

IMPLICATIONS:

The use of TDM may play an important role for the optimal management of patients with MRSA infections and may impact on patient outcomes by increasing efficacy and reducing the risk of adverse events. TDM may be implemented in clinical practice; however, several limitations such as the wide variability in the methodology and the need for skilled personnel need to be considered.

2025-02-01·NURSE PRACTITIONER

The Drug Update

Article

作者: Theroux, Jenna D. ; Marino, Adriane B. ; Self, Destiny S. ; Anderson, James Layton ; Drake, Evan S.

ABSTRACT:

In the first half of 2024, the US FDA approved several new drugs that have relevance for those practicing in primary care. This article, the winter 2025 edition of the journal's biannual Drug Update, highlights the following new medications: sotatercept-csrk (Winrevair), aprocitentan (Tryvio), resmetirom (Rezdiffra), berdazimer (Zelsuvmi), ceftobiprole medocaril sodium (Zevtera), sofpironium (Sofdra), and ensifentrine (Ohtuvayre).

2025-01-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Safety of ceftobiprole in patients with impaired renal, hepatic or immune function: a multinational retrospective hospital chart review (RETRACE study)

Article

作者: Tiseo, Giusy ; Gentile, Ivan ; Corne, Philippe ; Gniadek, Claudine ; Venturini, Sergio ; Marrazzo, Tommaso ; Pascale, Renato ; Karruli, Arta ; Francisci, Daniela ; Ettahar, Nicolas ; de Novales, Francisco Javier Membrillo ; Jimenez, Luisa ; Menendez, Rosario ; Tazza, Beatrice ; Moriello, Nicola Schiano ; Sequera, Sergio ; Hidalgo-Tenorio, Carmen ; Fernández-Hidalgo, Nuria ; Romero, Lidia ; Corcione, Silvia ; Durante-Mangoni, Emanuele ; Gallo, Raffaella ; Gamboni, Giulia ; Soriano, Alex ; Jemmely, Noëlle ; Callegari, Astrid ; Genga, Giovanni ; Crapis, Massimo ; Bravo, Olga ; Cedar, Eve ; Scirocco, Maria Michela ; Galgo, Valentina ; Quevedo, Juan ; Legrand, Stephany ; Méndez, Raul ; Shbaklo, Nour ; Falcone, Marco ; Moreno, Antonio ; Gonzalez, Paula ; Sellarés-Nadal, Júlia ; Vidovic, Paola ; Mata, Tatiana ; Estébanez, Miriam ; De Rosa, Francesco Giuseppe

Ceftobiprole, an advanced-generation cephalosporin with broad bactericidal activity, is approved for community-acquired and hospital-acquired pneumonia (excluding ventilator-associated pneumonia). We aimed to evaluate, in a real-world setting, the safety profile of ceftobiprole in patients with risk conditions (severe renal impairment, hepatic impairment, and immunocompromised status), groups excluded from clinical trials. In this retrospective study (NCT04170309), 396 consecutive charts of patients treated with ceftobiprole during 2016-2022 in 15 centers in France, Italy, and Spain were analyzed: 62 had severe renal impairment, 51 had hepatic impairment, 120 were immunocompromised, and 203 had no predefined risk condition (controls). Ceftobiprole was used for off-label indications in 110/396 (27.8%) patients; 46/396 (11.6%) patients received a higher-than-recommended dose. Treatment-emergent adverse events (TEAEs) considered as ceftobiprole-related occurred in 44 patients, more frequently in the risk groups compared to controls (severe renal impairment: 8/62 [12.9%]; hepatic impairment: 7/51 [13.7%]; immunocompromised: 19/120 [15.8%]; controls: 15/203, [7.4%]); in 7/44 patients, these events were serious. Compared to controls, liver-related AEs occurred more frequently in the impaired hepatic function (17/51 [33.3%] vs 22/203 [10.8%], odds ratio [OR:]: 4.11; 95% confidence interval [CI]: 1.98-8.55) and immunocompromised (30/120 [25.0%] vs 22/203 [10.8%], OR: 2.74; 95%CI: 1.50-5.02) groups. Hyponatremia was also more frequent in immunocompromised patients than controls (14/120 [11.7%] vs 9/203 [4.4%], OR: 2.85; 95%CI: 1.19-6.80). Underlying disease, concomitant medications and the poor health status of the patients likely affected these imbalances. Overall, no new safety concerns related to ceftobiprole use in real-world patients with severe renal impairment, hepatic impairment or immunocompromised status were identified.

120

项与头孢比罗酯钠相关的新闻（医药）

2025-02-08

·GlobeNewswire-Health Care

Strong launch for Cresemba in Japan triggers first sales milestone payment from AKP to Basilea

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today that the sales of the antifungal Cresemba® (isavuconazole) in Japan exceeded the threshold triggering the first sales milestone payment from its partner Asahi Kasei Pharma (AKP), amounting to approximately CHF 1.2 million. David Veitch, Chief Executive Officer of Basilea, said: “Japan is a key market with significant growth potential for Cresemba. The achievement of the first sales milestone already in the second year of commercialization is a testament of the commercial capability of our partner AKP in this important market. The strong sales ramp-up in the early stage of its life cycle in Japan underscores that Cresemba is meeting critical medical needs of patients with life-threatening fungal infections.” By year-end 2024, Cresemba was marketed in more than 70 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. In Japan, the oral and intravenous formulations are approved for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis.2 Isavuconazole is also approved in the United States (US),3 China, the EU4 and several additional countries in Europe and beyond.5 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. References IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar. PMDA List of Approved Drugs April 2022 to March 2023: https://www.pmda.go.jp/files/000267877.pdf [Accessed: February 04, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: February 04, 2025] European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: February 04, 2025] The content above comes from the network. if any infringement, please contact us to modify.

上市批准

2025-02-04

·赛柏蓝

国谈集采后，2025年抗菌注射剂市场分析

编者按：本文来自药智网，作者头孢英雄；赛柏蓝授权转载，编辑yuki 集采国谈后，国内仿制药何去何从？本文将从临床使用占比较大的抗感染类注射剂药物切入，以京津冀2024年抗菌药物临床管理目录为主线结合感染临床分类，全景分析2025年国谈集采后时代的抗菌注射剂药物市场。 01 非限制使用级药物非限制使用级药物经长期临床应用证明安全、有效，是对病原菌耐药性影响较小，价格相对较低的抗菌药物。主要为社区型获得感染（CAI）、手术预防感染的药物。 CAI在临床上以社区获得性肺炎(CAP)最常见，上呼吸道感染、腹泻、泌尿道感染、胆囊胆道感染、腹腔感染、皮肤软组织感染等为常见。非限制使用级抗感染药物基本已经纳入了国家集采。手术预防感染，一般手术分为：Ⅰ类切口（清洁手术）、Ⅱ类切口（清洁－污染手术）、Ⅲ类切口（污染手术）、Ⅳ切口（污秽－感染手术），大部分临床手术为Ⅰ类切口、Ⅱ类切口。在2015版《抗菌药物临床应用指导原则》中，手术预防感染抗菌药物推荐的选用有循证医学证据的头孢一代二代药物，在备注里说明：有循证医学证据的第一代头孢菌素主要为头孢唑啉，第二代头孢菌素主要为头孢呋辛。目前未被国家集采的只剩苯唑西林钠，目前已经超过5家过评，2024年12月河北地方集采，过评企业0.5g已经报出6.6的价格。表1 非限制使用级抗感染药物国家集采情况 02 限制级抗感染药物限制级抗感染药物经长期临床应用证明安全、有效，对病原菌耐药性影响较大。一般用于经验治疗非限制级药物已经耐药的社区获得性感染，医院获得性感染等方面。医院内感染又称医院获得性感染，是指患者、探视者和医院职工在医院内受到感染并出现症状。分为外源性感染（交叉感染）和内源性感染（自身感染）。此类抗菌药物一般在分类管理为限制级。表2 限制使用级抗感染药物国家集采情况注：★为集采价格有调整的产品。限制级未集采热点产品：甲苯磺酸奥马环素医保国谈产品，是在米诺环素基础上通过化学基团修饰后得到的半合成化合物，属于四环素家族的一员。2019年2月7日，《新英格兰医学杂志》（NEJM）以莫西沙星为阳性对照药，意向性分析集共纳入了774例肺炎严重指数（PSI）为II~IV级的成人细菌性社区获得性肺炎（CABP）。其结果证明了奥马环素治疗组的临床疗效非劣于莫西沙星组。吗啉硝唑 2014年中国化药1.1，第三代硝基咪唑类衍生物，主要用于治疗厌氧菌和寄生虫感染，专利期已过。2014年12月初集中出了四家过评批文，适逢河北地方集采，有厂家报价不足17元。厄他培南作为碳青霉烯类唯一限制级的药物，对非发酵菌无效，很遗憾的是在临床上并没有实现经验性普遍应用，远远低于美罗培南的市场认知和销量，目前已经过评4家。 03 特殊级抗感染药物特殊级抗感染药物一般抗菌作用较强、抗菌谱广，经常或过度使用会使病原菌过快产生耐药的；疗效、安全性方面的临床资料较少，不优于现用药物。一般应用于耐药菌感染，多重耐药的复杂性感染等。多重耐药菌是指具有多重耐药性的细菌，较为明确地定义为对三类或三类以上抗菌药物同时耐药的细菌，广义的多重耐药菌也包括广泛耐药细菌和全耐药细菌。其中包括耐碳青霉烯类鲍曼不动杆菌、铜绿假单胞菌、肠杆菌、耐三代头孢菌素肠杆菌等阴性菌；耐万古霉素屎肠杆菌、耐万古霉素/甲氧西林金黄色葡萄球菌等阳性菌等。此类抗菌药物一般在分类管理为特殊级。表3 特殊使用级抗感染药物国家集采情况特殊级未集采热点产品：多重耐药菌“三剑客” 近几年碳青霉烯耐药的阴性菌CRO发展迅猛，在临床应用中衍生出“三剑客”的概念：头孢他啶阿维巴坦钠，黏菌素类，替加环素&盐酸依拉环素。头孢他啶阿维巴坦钠，一经上市，在医院获得性肺炎和呼吸机相关性肺炎（HAP/VAP）领域获得极大的关注和应用。在2024年初通过国谈竞价进入医保目录，340元/支，有厂家在医院准入已经报出了270元的低价，现在一致性评价已经超过10家，离下一步集采不远了。四环素类药物中对常见致病菌和多重耐药菌均具有良好的抗菌活性，广泛覆盖革兰阳性菌和阴性菌，尤其是对产超广谱β-内酰胺酶（extended Spectrum Beta-Lactamases，ESBLs）的肠杆菌属细菌，使得替加环素在过去几年成为对抗CRO的三剑客之一。但由于替加环素在肺组织中分布不足，全因死亡率高，说明书加了警示语“当没有合适的替代疗法时，替加环素应该继续用于临床治疗”。 2023年5月，新一代氟环素类盐酸依拉环素在中国上市，其组织浓度高，抗菌活性是替加环素的2-8倍，抗菌谱覆盖除铜绿的阴性菌和所有阳性菌，无肝肾毒性，尤其针对CRAB、CRKP，真实世界数据显示30天存活率可达94.7%。由于种种优势，在迅速替代替加环素，和头孢他啶阿维巴坦钠，黏菌素类成为对抗CRO新的“三剑客”。黏菌素在上世纪50年代就已上市，当时其主要的应用价值是针对铜绿假单胞菌，后来因其副作用严重且又有新药诞生，逐渐在临床上淡出。进入21世纪后由于碳青霉烯耐药的阴性菌CRO在世界范围内流行，其具有破坏革兰阴性杆菌外膜完整性的独特机制，又被赋予了目前尚难以替代的新的使命。可静脉应用的黏菌素目前共有3种：多黏菌素B（Polymyxin B）、甲磺酸黏菌素E（CMS）与硫酸黏菌素E（只在中国上市）。耐药阳性菌药物列入世界卫生组织（WHO）全球重点微生物清单的革兰氏阳性菌为耐甲氧西林和耐万古霉素金黄色葡萄球菌（分别为MRSA和VRSA），耐万古霉素屎肠球菌（VRE），青霉素不敏感肺炎链球菌（PNSP）。万古霉素和去甲万古霉素作为针对甲氧西林耐药葡萄球菌、肠球菌属等耐药革兰阳性球菌所致血流感染、心内膜炎、脑膜炎、肺炎、骨髓炎等感染的一线用药。万古霉素已经形成了6+1的局面，离集采不远了。作为中国独创的去甲万古霉素，在去掉甲基后，药效增加10%，如果再有丰富的真实世界数据，展现出去甲基后的耐药机制，安全性，PK/PD等等数据，会是一个很有含金量的产品。 04 其它热点产品粉液双室袋既配型注射剂粉液双室袋既配型批准文号大都集中在头孢、青霉素类为主的β-内酰胺类抗感染药物，自从2022年底进入了国谈目录，给予了对应普通注射剂加15元的剂型差，在第十批国家集采中，给予了加10元的剂型差。粉液双室袋产品临床和社会优势比较明显，减少二次污染、提高药物的利用度、提高了配药效率。粉液双室袋的治疗费用，远远低于粉针剂+大输液+配药费的总治疗费用，明显降低了医保资金的使用。尤其集采后的头、青类产品，逐渐进入普药化价格，此类抗感染药物的粉液双室袋剂型，相信会迎来销售快速增长期。中国首发上市β-内酰胺酶抑制剂+头孢（青）类产品在国家局查询，此类产品还是很多，头孢曲松钠舒巴坦钠、头孢噻肟钠舒巴坦钠、头孢噻肟钠他唑巴坦钠、头孢哌酮钠他唑巴坦钠、哌拉西林钠舒巴坦钠。目前，只有头孢噻肟钠他唑巴坦钠在2024年国谈目录，2025年2家上市进入常规目录。此类产品由于历史原因，适应症都是承袭了药物中单方抗感染药物的感染部位适应症，且规定应用于药物中单方药物耐药者，因此在临床使用中比较受局限。舒巴坦钠-度洛巴坦钠 5.1类新药，2024年5月20日中国大陆获批上市，规格为注射用舒巴坦钠（1.0g，意大利Mitim S.r.l生产）1瓶与注射用度洛巴坦钠（0.5g，美国Lyophilization Services of New England,Inc.(LSNE)生产）2瓶。用于治疗18岁及以上患者由鲍曼-醋酸钙不动杆菌复合体敏感分离株所致医院获得性细菌性肺炎（HABP）、呼吸机相关性细菌性肺炎（VABP）。本品不适用于治疗由鲍曼不动杆菌复合物易感分离株以外的病原体引起的HABP/VABP。这个产品的神奇之处在于组合包装文号的准予注册，而且组合的两个药还不是一个药厂生产的。头孢比罗酯 2024年底进入新一版医保国谈目录，限成人以下感染方予支付：1.医院获得性肺炎(HAP)，但呼吸机相关性肺炎(VAP)除外；2.社区获得性肺炎(CAP)。在耐药感染又添加了一个选择。此药物2010年在欧洲上市，由此推算，专利期应该快过了，目前国内已经有两家企业在联合申报。注射用亚胺西瑞新型碳青霉烯/酶抑制剂复合制剂，该药品适用于治疗18岁及以上患者由敏感革兰阴性菌引起的下列感染：医院获得性细菌性肺炎(HABP)，呼吸机相关性细菌性肺炎(VABP)，治疗药物选择有限或无替代治疗的复杂性尿路感染(cUTI)(包括肾盂肾炎)、复杂性腹腔内感染(CIAI)。亚胺培南、西司他丁和瑞来巴坦三种成分组合，能否再度复制亚胺培南/西司他丁过去的辉煌，拭目以待。 05结语抗感染药物已经进入集采后时代。在临床上耐药性严重、细菌变异不断的情况下，业内也更期待有循证依据的新型抗感染药物早日上市，从而给患者和临床更多选择。 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

2025-02-01

·GlobeNewswire-Health Care

Strong sales growth for Cresemba and Zevtera trigger further milestone payments to Basilea

January 28, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today that the sales in 2024 of the antifungal Cresemba® (isavuconazole) and the antibiotic Zevtera® (ceftobiprole) exceeded thresholds triggering sales milestone payments from distribution partners to Basilea, in the total amount of approximately CHF 2.2 million. For Cresemba, this comprises a milestone payment for sales in Canada, by AVIR Pharma Inc, as well as the first sales milestone payment for the Middle East and North Africa (MENA) region, by Hikma Pharmaceuticals LLC. For Zevtera, this reflects a milestone payment in Europe, by Advanz Pharma. David Veitch, Chief Executive Officer, said: “We are very pleased with the commercial progress of our two commercialized brands in Canada, the MENA region and Europe. Their continued growth confirms that Cresemba and Zevtera are serving significant medical needs around the world.” Basilea’s commercial partnerships cover well over 100 countries worldwide. By year-end 2024, Cresemba was marketed in more than 70 countries while Zevtera was marketed in 20 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba®. In Canada, Cresemba is approved for use in adults and pediatrics from 1 year up to 18 years for the treatment of invasive aspergillosis and invasive mucormycosis.2 In countries of the MENA region, it is indicated in adults for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate. Isavuconazole is also approved in the United States (US),3 the EU4 and several additional countries in Europe and beyond, including Japan and China.5 Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.6 In several countries in Europe, the brand is approved as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP).6 Zevtera is also approved in the United States7, 8, China and several other countries.5 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. References IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar. Health Canada, Cresemba® (isavuconazole) Product Monograph: https://pdf.hres.ca/dpd_pm/00077745.PDF [Accessed: January 27, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: January 27, 2025] European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: January 27, 2025] The registration status and approved indications may vary from country to country. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: January 27, 2025] The content above comes from the network. if any infringement, please contact us to modify.

上市批准

100 项与头孢比罗酯钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	头孢比罗酯钠	J01DI01	DB14733

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
社区获得性细菌性肺炎	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
右侧感染性心内膜炎	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
皮肤和皮肤结构感染	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
金黄色葡萄球菌菌血症	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
社区获得性肺炎	加拿大	Avir Pharma, Inc.初创企业	2018-03-20
医院获得性肺炎	加拿大	Avir Pharma, Inc.初创企业	2018-03-20

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
传染性皮肤病	申请上市	欧盟	Janssen Pharmaceutical Unlimited Co.	-
软组织感染	申请上市	欧盟	Janssen Pharmaceutical Unlimited Co.	-
新生儿败血症	临床3期	美国	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	保加利亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	爱沙尼亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	德国	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	拉脱维亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	立陶宛	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	波兰	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	斯洛伐克	Basilea Pharmaceutica AG	2023-08-06

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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


NCT03138733 (FDA_CDER) 人工标引	临床3期	金黄色葡萄球菌菌血症	387	ZEVTERA	衊襯鏇艱憲繭鹽齋淵鹽(觸窪網簾構餘鑰鑰鏇廠) = 憲壓廠醖選齋壓餘衊窪築襯鹽衊蓋壓築襯餘壓 (憲衊觸淵醖壓構壓夢淵 ) 更多	积极	2024-04-03
				Daptomycin	衊襯鏇艱憲繭鹽齋淵鹽(觸窪網簾構餘鑰鑰鏇廠) = 醖簾遞網簾艱願夢艱餘築襯鹽衊蓋壓築襯餘壓 (憲衊觸淵醖壓構壓夢淵 ) 更多
NCT00326287 \| NCT03439124 (FDA_CDER) 人工标引	临床3期	社区获得性细菌性肺炎	-	Ceftobiprole medocaril (Adult Patients)	鏇壓遞膚範選繭顧簾襯(積鹽獵膚壓鹽窪鏇餘網) = 膚獵壓遞窪構網築廠繭壓積膚願衊願範顧積窪 (襯觸積醖醖襯網壓獵觸 ) 更多	积极	2024-04-03
				Ceftriaxone with or without Linezolid (Adult Patients)	鏇壓遞膚範選繭顧簾襯(積鹽獵膚壓鹽窪鏇餘網) = 窪齋鹽壓繭壓壓鑰範鬱壓積膚願衊願範顧積窪 (襯觸積醖醖襯網壓獵觸 ) 更多
NCT03137173 (FDA_CDER) 人工标引	临床3期	皮肤和皮肤结构感染	679	ZEVTERA 667 mg	築膚醖衊齋鬱獵獵範鹹(醖鏇願憲壓簾繭鹹鏇繭) = 夢範膚繭鏇糧範願範憲蓋構廠構願範膚築鹽遞 (膚積餘廠網膚襯襯願鬱 ) 更多	积极	2024-04-03
				Vancomycin plus aztreonam	築膚醖衊齋鬱獵獵範鹹(醖鏇願憲壓簾繭鹹鏇繭) = 獵夢鹹糧製範鬱醖窪糧蓋構廠構願範膚築鹽遞 (膚積餘廠網膚襯襯願鬱 ) 更多
NCT03138733 (ERADICATE, Pubmed)	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole 500 mg IV every 6 hours for 8 days and every 8 hours thereafter	獵餘鑰壓廠艱網積壓網(繭鹽糧壓網憲糧艱鹹膚) = 憲鏇鏇窪製顧構憲窪願網夢壓鹹夢糧糧築夢襯 (餘網繭餘願築選蓋獵鹹 ) 更多	积极	2023-10-12
				Daptomycin 6 to 10 mg/kg IV every 24 hours plus optional aztreonam	獵餘鑰壓廠艱網積壓網(繭鹽糧壓網憲糧艱鹹膚) = 遞製網餘窪顧鑰鑰築鑰網夢壓鹹夢糧糧築夢襯 (餘網繭餘願築選蓋獵鹹 ) 更多
NCT03138733 (Trial 1 \| ERADICATE, CTgov)	临床3期	金黄色葡萄球菌菌血症	390	Daptomycin	衊網鹹鑰膚壓鏇齋網構(蓋築餘糧繭築願壓鹽廠) = 觸製淵製餘糧窪繭鏇憲遞憲積艱壓窪齋鹽積顧 (壓壓築構齋窪艱網製獵, 願鏇壓壓鬱範簾艱淵蓋 ~ 壓鬱壓鬱範襯壓壓範範) 更多	-	2023-05-06
NCT03138733 (ERADICATE, Corporate Publications) 人工标引	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole Medocaril Sodium	窪繭窪築鹽壓觸襯淵衊(鑰鏇衊淵膚築選網艱顧) = 廠鏇壓壓鹹憲襯蓋淵憲願壓鬱憲蓋繭鏇觸範築 (醖襯構廠廠醖窪觸積遞 ) 更多	非劣	2022-10-24
				Aztreonam+Daptomycin	窪繭窪築鹽壓觸襯淵衊(鑰鏇衊淵膚築選網艱顧) = 餘網獵襯鏇廠鹽繭糧糧願壓鬱憲蓋繭鏇觸範築 (醖襯構廠廠醖窪觸積遞 ) 更多
NCT02527681 \| NCT03439124 (Pubmed \| Pediatr Infect Dis J)	N/A	-	-	Ceftobiprole (Neonates and infants up to 3 months of age)	艱築鑰選壓壓製築憲鏇(壓糧廠選獵壓製鏇鹹襯) = 簾餘夢壓醖範窪廠艱願淵醖獵築選襯鹽築淵衊 (壓膚蓋網鬱廠願襯製鹽 ) 更多	-	2021-11-01
				Ceftobiprole (Patients 3 months to 17 years of age)	艱築鑰選壓壓製築憲鏇(壓糧廠選獵壓製鏇鹹襯) = 壓鑰壓憲壓鏇鬱築願膚淵醖獵築選襯鹽築淵衊 (壓膚蓋網鬱廠願襯製鹽 ) 更多
NCT03137173 (TARGET, Pubmed \| Clin Infect Dis) 人工标引	临床3期	皮肤和皮肤结构感染	679	Ceftobiprole Medocaril Sodium	襯廠憲淵繭艱淵膚餘鹹(襯製顧醖憲廠艱襯蓋襯) = 鑰繭淵醖願壓遞鑰膚積糧獵鹽鏇積夢網餘鹹範 (窪積淵壓簾齋願選觸廠 ) 更多	非劣	2021-10-05
				Vancomycin Hydrochloride+Aztreonam	襯廠憲淵繭艱淵膚餘鹹(襯製顧醖憲廠艱襯蓋襯) = 鹹壓艱鑰鹹壓夢醖網選糧獵鹽鏇積夢網餘鹹範 (窪積淵壓簾齋願選觸廠 ) 更多
NCT03439124 (Pubmed \| Pediatr Infect Dis J)	临床3期	儿童肺炎	138	Ceftobiprole	憲鏇製膚選糧壓網膚蓋(範鏇艱齋鹹憲願觸鹹齋) = 鬱衊獵蓋積淵衊獵艱衊醖廠膚鹽蓋範憲顧網膚 (襯構顧選遞壓醖壓簾壓 ) 更多	积极	2021-01-21
				Standard-of-care IV cephalosporin treatments (ceftazidime or ceftriaxone)	憲鏇製膚選糧壓網膚蓋(範鏇艱齋鹹憲願觸鹹齋) = 繭築顧積鏇淵窪積築膚醖廠膚鹽蓋範憲顧網膚 (襯構顧選遞壓醖壓簾壓 ) 更多
NCT02527681 (CTgov)	临床1期	细菌感染	15	Ceftobiprole (Ceftobiprole PK Population)	憲糧窪顧鑰膚遞觸夢築(壓夢膚蓋夢範鏇鹹製顧) = 鏇壓餘鑰繭鹹獵壓餘襯範蓋願鏇繭艱鑰鹹顧蓋 (積蓋艱築簾網觸獵壓簾, 憲齋衊壓製顧鏇淵構鏇 ~ 鏇鑰繭願繭製繭顧簾積) 更多	-	2021-01-06
				Ceftobiprole (Ceftobiprole ITT/Safety Population)	簾齋製製鏇蓋壓壓廠襯(膚選齋觸淵齋選簾鹹鬱) = 壓憲鹹鏇積鹹積築壓觸繭憲鏇顧築鏇顧淵選壓 (網鏇襯繭淵獵網廠繭壓, 願構鹽獵簾淵壓艱遞鬱 ~ 夢製餘艱鏇遞鑰觸壓膚) 更多