Comparative Study of the Efficacy and Safety of Tigecycline Based Regimen Versus Colistimethate Sodium-based Regimen in Patients with Central Nervous System Bacterial Infections

This observational study compares the efficacy and safety of tigecycline, an alternative antibiotic with broad-spectrum activity, versus the standard colistimethate sodium-based regimen in managing these infections in pediatric patients.
Inclusion Criteria:
Pediatric patients aged 1 month to 18 years. Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.
EVD placement for managing CNS infections.
Exclusion Criteria:
Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
Neonates (less than 1 month old), pregnant, or breastfeeding patients.
Outcome Measures:
Primary Outcomes: Clinical cure (resolution of infection symptoms) and microbiological cure (sterilization of CSF cultures).
Secondary Outcomes: Mortality rates and adverse drug events, such as nephrotoxicity, hepatotoxicity, chemical meningitis, or seizures.

开始日期2024-12-01

申办/合作机构

Ain Shams University

CTR20243990

/ RecruitingN/A

评估注射用多黏菌素E甲磺酸钠单次和多次给药在中国健康成年受试者中的药代动力学研究。

研究受试制剂注射用多黏菌素E甲磺酸钠与参比制剂注射用多黏菌素E甲磺酸钠（Coly-Mycin® M）在健康成年受试者单次给药的药代动力学相似性。研究受试制剂注射用多黏菌素E甲磺酸钠在健康成年受试者多次给药的药代动力学特征和安全性

开始日期2024-10-28

申办/合作机构

齐鲁制药（海南）有限公司

100 项与多黏菌素E甲磺酸钠相关的临床结果

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100 项与多黏菌素E甲磺酸钠相关的转化医学

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100 项与多黏菌素E甲磺酸钠相关的专利（医药）

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1,274

项与多黏菌素E甲磺酸钠相关的文献（医药）

2024-12-01·Applied microbiology and biotechnology

Sensing chemical-induced DNA damage using CRISPR/Cas9-mediated gene-deletion yeast-reporter strains

Article

作者: Eki, Toshihiko ; Hirose, Yuu ; Matsunobu, Shogo ; Miura, Yuuki ; Yamamoto, Kosuke ; Tochikawa, Shintaro

Abstract:

Microorganism-based genotoxicity assessments are vital for evaluating potential chemical-induced DNA damage. In this study, we developed both chromosomally integrated and single-copy plasmid–based reporter assays in budding yeast using a RNR3 promoter–driven luciferase gene. These assays were designed to compare the response to genotoxic chemicals with a pre-established multicopy plasmid–based assay. Despite exhibiting the lowest luciferase activity, the chromosomally integrated reporter assay showed the highest fold induction (i.e., the ratio of luciferase activity in the presence and absence of the chemical) compared with the established plasmid-based assay. Using CRISPR/Cas9 technology, we generated mutants with single- or double-gene deletions, affecting major DNA repair pathways or cell permeability. This enabled us to evaluate reporter gene responses to genotoxicants in a single-copy plasmid–based assay. Elevated background activities were observed in several mutants, such as mag1Δ cells, even without exposure to chemicals. However, substantial luciferase induction was detected in single-deletion mutants following exposure to specific chemicals, including mag1Δ, mms2Δ, and rad59Δ cells treated with methyl methanesulfonate; rad59Δ cells exposed to camptothecin; and mms2Δ and rad10Δ cells treated with mitomycin C (MMC) and cisplatin (CDDP). Notably, mms2Δ/rad10Δ cells treated with MMC or CDDP exhibited significantly enhanced luciferase induction compared with the parent single-deletion mutants, suggesting that postreplication and for nucleotide excision repair processes predominantly contribute to repairing DNA crosslinks. Overall, our findings demonstrate the utility of yeast-based reporter assays employing strains with multiple-deletion mutations in DNA repair genes. These assays serve as valuable tools for investigating DNA repair mechanisms and assessing chemical-induced DNA damage.

Key points:

• Responses to genotoxic chemicals were investigated in three types of reporter yeast.• Yeast strains with single- and double-deletions of DNA repair genes were tested.• Two DNA repair pathways predominantly contributed to DNA crosslink repair in yeast.

2024-12-01·APPLIED RADIATION AND ISOTOPES

Radiolabeling and preclinical evaluation of technetium-99m labeled colistin

Article

作者: Shanbhag#, Nagesh C ; Chaudhari, Pradip ; Sasidharan, Gopalakrishnan M ; Shanbhag, Nagesh ; Thakur, Riptee ; Gopalakrishnan, M.S. ; Mohanty, Bhabani ; Kumar, Pardeep ; Shanbhag, Nagesh C

INTRODUCTION:

Antibiotic resistance is a burden on the healthcare system. In present study, we have labeled an antibiotic named Colistimethate sodium (CMS) with technetium-99m (^99mTc) to develop a SPECT based imaging tracer.

METHODS:

We standardised the labeling using 0.5-2 mg of CMS (in water) using stannous chloride dihydrate as a reducing agent followed by addition of 370 ± 74 MBq of ^99mTc. A group of mice were injected intravenously (in tail vein) with 4-6 MBq of [^99mTc]Tc-CMS diluted with saline and euthanized at various time intervals. microSPECT Imaging (ϒ-eye) was acquired to study the biodistribution in the healthy mice.

RESULTS:

We standardised the labeling using 0.5 mg of colistin in 0.5 ml of saline with addition of 30 μg stannous chloride dihydrate. The retention factor value was 0.1-0.3 as compared to 0.9-1.0 for free ^99mTc by TLC and retention time was found to be 14.2 ± 1.3 min as evaluated by HPLC. The biodistribution data showed uptake in lungs, spleen, and liver at 30 min but the uptake decreased in lung at 60 min. The imaging data corroborated with the biodistribution data.

CONCLUSIONS:

We could successfully label [^99mTc]Tc-CMS ^99mTc and we could study its biodistribution in healthy mice.

2024-11-01·ANALYTICA CHIMICA ACTA

Ultrasensitive mass spectrometric quantitation of apurinic/apyrimidinic sites in genomic DNA of mammalian cell lines exposed to genotoxic reagents

Article

作者: Liu, Ying ; Xue, Chen-Yu ; Liu, Ya-Hong ; Zhang, Xin-Xiang ; Yu, Yue ; Zhou, Ying-Lin

The apurinic/apyrimidinic (AP) site is an important intermediate in the DNA base excision repair (BER) pathway, having the potential of being a biomarker for DNA damage. AP sites could lead to the stalling of polymerases, the misincorporation of bases and DNA strand breaks, which might affect physiological function of cells. However, the abundance of AP sites in genomic DNA is very low (less than 2 AP sites/10⁶ nts), which requires a sensitive and accurate method to meet its detection requirements. Here, we described an ultrasensitive quantification method based on a hydrazine-s-triazine reagent (i-Pr₂N) labeling for AP sites combining with high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). The limit of detection reached an ultralow level (40 amol), realizing the most sensitive MS-based quantification for the AP site. To guarantee the accuracy of the quantitative results, the labeling reaction was carried out directly on DNA strands instead of labeling after DNA enzymatic digestion to reduce artifacts that might be produced during the enzymatic process of DNA strands. And selective detection was realized by MS to avoid introducing the false-positive signals from other aldehyde species, which could also react with i-Pr₂N. Genomic DNA samples from different mammalian cell lines were successfully analyzed using this method. There were 0.4-0.8 AP sites per 10⁶ nucleotides, and the values would increase 16.1 and 2.75 times when cells were treated with genotoxic substances methyl methanesulfonate and 5-fluorouracil, respectively. This method has good potential in the analysis of a small number of cell samples and clinical samples, is expected to be useful for evaluating the damage level of DNA bases, the genotoxicity of compounds and the drug resistance of cancer cells, and provides a new tool for cell function research and clinical precise treatment.

项与多黏菌素E甲磺酸钠相关的新闻（医药）

2025-01-31

·药智网

消化药一哥「浴火重生」

过去的一年，对奥赛康而言，是“逆袭”的一年。在净利润连续两年亏损之后，奥赛康在2024年前三季度强势扭亏为盈，营收和净利润分别同比增长23.64%及168.79%。伴随着基本面改善，资本开始悄悄布局，现身于众多基金的重仓股名单之中，市值也逐渐修复，重回百亿市值医药股行列。从消化药“一哥”，到陷入“困境”，再成功摆脱阴霾，重回增长轨道，在困境中实现华丽转身。 1 阴霾散尽 1992年，从医院辞职的陈庆财博士创立了江苏省首家民营新药研发机构——南京海光应用化学研究所。凭借深厚的专业积累与不懈的科研攻关，1997年成功研发出中国第一支国产质子泵抑制剂注射剂并实现上市，填补了国内该领域的空白。六年后的2003年，脱胎于南京海光应用化学研究所的奥赛康药业成立。此后二十余载，奥赛康凭借其强大的研发能力以及精准的市场策略，迅速崛起为国内消化领域的领军企业。并于2019年通过借壳上市的方式成功登陆A股资本市场。 2019年上市之际，奥赛康的质子泵抑制剂（PPI）产品线已涵盖国内已经上市的六个PPI中的五个，分别是注射用奥美拉唑钠、注射用兰索拉唑、注射用泮托拉唑钠、注射用雷贝拉唑钠、注射用艾司奥美拉唑钠，均为国产首家或首批上市。其中，作为首个国产质子泵抑制剂，奥赛康的奥美拉唑长期占据市场主导地位，2017、2018和2019年奥美拉唑在样本医院的总销售额分别为13.02亿元、12.05亿元、12.90亿元，2019年市占率高达49.95%，力压第二名原研药企阿斯利康的不到15%。然而，自2019年起，受集采、新冠疫情等因素影响，奥赛康的消化类产品收入大幅下降。从2019年的峰值33.7亿元，降至2023年的3亿元。在第四批到第七批国采中，奥赛康共13款产品参与集采，其重点产品奥西康（注射用奥美拉唑钠）未中选，其余12款产品价格平均降幅超过90%。奥赛康清楚地认识到，中国药企依靠仿制药获取高额利润的时代已经结束，必须积极主动适应集采政策。截至2024年9月，奥赛康已有32个产品通过一致性评价，13个产品中标国采，其中沙格列汀片和注射用地西他滨在院内市场的占有率位居首位。在第十批国采中，奥赛康两款产品泊沙康唑注射液、哌柏西利胶囊成功中选，为公司未来业绩增长提供增量。经过多轮、多省份的药品集中采购后，奥赛康在消化领域的仿制药收入逐步趋于稳定，新品种开始为公司带来收入增长，营收结构也在不断优化。至此，奥赛康已经摆脱最艰难的发展阶段。 2 扭亏为盈 2024年前三季度，奥赛康营收13.84亿元，同比增长23.64%；净利润1.27亿元，同比增长168.79%。这一扭亏为盈的关键因素在于其抗肿瘤、抗感染、慢病领域产品收入的迅速增长，使得公司营收结构发生了积极转变，不再主要依赖消化类产品。在抗肿瘤产品方面，2024年上半年，该类产品销售收入3.34亿元，同比增长7.54%，占总营收的36.23%，取代消化类产品，成为奥赛康营收占比最高的类别。 2021年-2024年上半年，奥赛康共有13款抗肿瘤仿制药获批上市，其中艾司奥美拉唑镁肠溶干混悬剂、甲磺酸仑伐替尼胶囊、注射用替莫唑胺以及哌柏西利胶囊成功中选集采。除此以外，还有3款抗肿瘤仿制药已处于上市申请阶段。抗感染产品方面，2024年上半年，其销售收入2.59亿元，同比增长132.31%，占总营收的28.08%，成为奥赛康增速最快的板块。针对耐药细菌、真菌感染，奥赛康布局了特色抗耐药菌感染产品群，包括已经上市的广谱抗耐药菌药物注射用替加环素、抗G+耐药菌药物注射用达托霉素、广谱抗真菌药物泊沙康唑注射液/肠溶片、针对多重耐药G-菌的注射用多黏菌素E甲磺酸钠等。其中替加环素、艾沙康唑、泊沙康唑、多黏菌素E甲磺酸钠均为首家上市或首批上市。此外，奥赛康还于2024年2月完成了新一代广谱氟喹诺酮抗菌素——注射用德拉沙星的临床III期研究，其上市申请已获受理，该产品目前尚无进口或国内产品上市。抗感染产品组群图片来源：奥赛康半年报慢病产品同样表现出色，2024年上半年实现销售收入1.55亿元，同比增长60.23%，占总营收的16.84%。主要产品涵盖沙格列汀片、恩格列净片、地拉罗司分散片、艾曲泊帕乙醇胺片。其中，沙格列汀片在第五批国采中中标，为该板块贡献了主要收入。随着高毛利的抗肿瘤类产品和抗感染类产品在总营收中的占比逐步提高，奥赛康的整体毛利率也实现了小幅提升，达到81.83%。除产品销售收入增长外，奥赛康通过强化成本管理，优化各项费用支出，有力推动了公司业绩的快速扭亏为盈。在研发费用方面，部分新药已完成研发投入较大的关键临床研发阶段，无需再进行大规模资金投入，研发费用同比减少60.06%。销售费用率从2023年的58.21%降至55.83%，管理费用率也由2023年的9.22%下降至6.71%。通过一系列降本增效的有力举措，奥赛康不仅成功重回增长轨道，更在激烈的市场竞争中，展现出更为强劲的竞争力与广阔的发展潜力。 3 转型创新在积极优化产品结构的进程中，奥赛康全力加速创新药布局。通过自主研发与引进合作双向发力，重点聚焦小分子靶向创新药和肿瘤免疫生物创新药的研发。2021年-2024年上半年，奥赛康研发投入分别为4.14亿元、7.23亿元、5.94亿元、1.82亿元，这一投入规模在A股医药股中属于第一梯队。经过多年在创新领域的持续投入与积累，奥赛康创新药开始步入收获期，截至2024年6月，主要在研项目共计48项，包括已公开的11项重点在研化学、生物创新药，另有多款创新药处于临床前研究阶段。奥赛康重点在研管线图片来源：奥赛康官网其中，ASK120067片（利厄替尼）是一款第三代EGFR-TKI，用于非小细胞肺癌（NSCLC）的治疗，已于今年1月16日获批上市。虽然国内已有六款第三代EGFR-TKI获批上市，市场竞争较为激烈，但国内第三代EGFR-TKI市场规模仍在增长，奥赛康与信达生物在2024年9月达成协议，由信达生物负责销售推广。凭借信达生物在肺癌领域强大的推广销售能力，利厄替尼有望在市场中占据一定份额。 ASKB589是一款高亲和力的靶向CLDN18.2的单克隆抗体，拟开发适应症为胃及胃食管结合部腺癌、胰腺癌等，正在开展针对胃癌一线治疗的临床III期研究。同靶点目前全球仅有安斯泰来的佐妥昔单抗获批上市，国内除了奥赛康外还有明济生物的FG-M108、创胜集团的Osemitamab处在III期临床阶段。值得一提的是，奥赛康子公司AskGene自主开发的具有全球知识产权的细胞因子前药技术平台SmartKine，通过技术手段解决了细胞因子类药物成药性不佳的问题，能够实现免疫系统的选择性激活，进而精准杀灭肿瘤细胞。基于该平台孵化的研发管线中，细胞因子前药ASKG315（IL-15-Fc融合蛋白）、ASKG915（PD-1/IL-15抗体融合蛋白）已进入临床阶段，另有多个分子处于早期开发及筛选阶段。其中IL-15作为肿瘤治疗的潜在靶点，一直备受关注，然而此前由于成药性方面的难题，导致其研发进程缓慢。奥赛康的SmartKine平台有效解决了这一问题，后续该平台相关产品在临床试验中所产生的数据值得密切关注，有望为肿瘤治疗带来新的突破和进展。 4 结语 “杀不死我的，终将使我更强大”。奥赛康凭借强大的韧性与前瞻性，积极拓展新业务，主动拥抱集采政策，实现了营收结构优化，成功扭亏为盈。未来随着创新药管线逐步兑现价值，奥赛康不仅有望重回行业巅峰，更有潜力突破过往。参考资料 1.奥赛康年报、季报； 2.《奥赛康：高端首仿+创新药陌上花开，国产PPI龙头众星闪耀》，天风医药，2020年05月10日； 3.《奥赛康：集采出清，轻装上阵，创新转型成果已现》，华福医药，2024年11月17日友情推荐：医药行业深度技术内容，点击“博药”查看详情~ 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

财报一致性评价带量采购

2025-01-22

·正大天晴药业集团

抗感染战线新成员正大天晴注射用头孢他啶阿维巴坦钠获批上市

近年来，随着广谱抗菌药物的广泛应用，多重耐药革兰氏阴性菌的检出率逐年增高，对公共卫生造成巨大挑战[1]。1月20日，正大天晴开发的新型抗菌药物注射用头孢他啶阿维巴坦钠收到国家药品监督管理局（NMPA）颁发的《药品注册证书》，这是公司本年度第二款获批上市的产品。新型抗菌生力军，获国内外多部指南推荐正大天晴注射用头孢他啶阿维巴坦钠本次获批的适应症为：1）复杂性腹腔内感染（cIAI）；2）医院获得性肺炎和呼吸机相关性肺炎（HAP/VAP）；3）在治疗方案选择有限的成人患者中治疗由下列对本品敏感的革兰阴性菌引起的感染：肺炎克雷伯菌、阴沟肠杆菌、大肠埃希菌、奇异变形杆菌和铜绿假单胞菌。注射用头孢他啶阿维巴坦钠作为一种新型抗菌药物，对革兰阴性菌感染尤其是耐药菌感染的治疗具有明显临床优势。本产品是新型酶抑制剂复合制剂，由第3代头孢菌素头孢他啶和阿维巴坦的钠盐组成，头孢他啶与青霉素结合蛋白结合后可抑制细菌细胞壁肽聚糖合成，导致细菌细胞裂解和死亡。同时，阿维巴坦可抑制多种类型的β-内酰胺酶，有效阻止头孢他啶被β-内酰胺酶水解失活，保护头孢他啶对多种耐药菌株的抗菌活性。注射用头孢他啶阿维巴坦钠被《IDSA指南：抗菌药物耐药性革兰氏阴性菌感染的治疗（2022）》《β-内酰胺类抗生素/β-内酰胺酶抑制剂复方制剂临床应用专家共识（2020）》《产超广谱β内酰胺酶肠杆菌感染急诊诊疗中国专家共识（2020）》等国内外诸多权威指南推荐为耐碳青霉烯肠杆菌科（CRE）和耐碳青霉烯铜绿假单胞菌（CRPA）感染治疗的一线选择之一。正大天晴抗感染产品矩阵再扩容在抗感染领域，正大天晴已形成完善的产品矩阵，除本次上市的注射用头孢他啶阿维巴坦钠，注射用替加环素（商标名：天解）、多黏菌素E甲磺酸钠（商标名：天韵）等已上市产品在治疗特别针对耐药性的革兰氏阴性菌的感染均具有显著的临床疗效。此外，正大天晴和普莱医药签订中国独家商业合作协议的1类新药培来加南喷雾剂上市申请已于上月获CDE受理。本次注射用头孢他啶阿维巴坦钠的上市，有望为感染人群提供更多保护。未来，随着在抗感染领域的不断深耕和探索，正大天晴将为临床提供更多抗感染用药选择，造福更多患者，为国人健康保驾护航。参考文献： [1]卓佳驹,周维英,梁蓓蓓,蔡芸,张欢,袁梽漪.注射用头孢他啶阿维巴坦钠临床应用合理性分析[J].中国医院用药评价与分析,2023,23(07):868-871+876. 声明： 1. 本新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2. 本公司不对任何药品和/或适应症作推荐。 3. 本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● 祝贺！肺癌重磅创新药zongertinib在华成功递交上市许可申请 ● 正大天晴罗伐昔替尼在美获批临床国内治疗骨纤维化适应症上市申请已获受理 ● “纳米药物”中的佼佼者！正大天晴白蛋白结合型紫杉醇获批上市 ● 高光2024：挖潜“人制户品” 解锁奋进新维度

上市批准

2024-12-12

·GlobeNewswire-Health Care

Essential Pharma announces €900 million recapitalisation through a Gyrus Capital Continuation Vehicle led by AlpInvest and new strategic financing from Sixth Street

Essential Pharma announces €900 million recapitalisation through a Gyrus Capital Continuation Vehicle led by AlpInvest and new strategic financing from Sixth Street Provides significant resources to build on diversified portfolio of established and rare disease medicines Egham, UK – 12 December 2024 – Essential Pharma (“Essential” or “the Company”), an international specialty pharma group focused on ensuring that patients have access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, today announces the completion of a €900 million financing, through a Gyrus Capital single-asset Continuation Vehicle led by AlpInvest, a subsidiary of Carlyle Global Investment Solutions, and a new strategic financing facility with Sixth Street. Essential Pharma was acquired in 2019 by Gyrus Capital, who have supported the transformation of the Company into a global, high-growth specialty pharma group with significant development opportunities. The transaction will enable Essential to deploy additional capital to build on its diversified portfolio and late-stage pipeline across established and rare disease medicines. This will be achieved through its successful acquisition and development strategy under the leadership of CEO, Emma Johnson. This additional capital will support Essential’s mission to ensure access to essential medicines for patients across new and existing markets. Since her appointment in 2023, Emma has driven the Company’s expansion into rare diseases, with the addition of marketed product Colobreathe® and Hu14.18, an immunotherapy in late-stage clinical development for the treatment of high-risk neuroblastoma. Following the transaction, Lee Morley, appointed as Non-Executive Director to the Board in 2023, will assume the role of Chairman of Essential Pharma, succeeding Dr Patrick Vink. Lee has more than 30 years’ experience in the biopharmaceutical industry, with extensive knowledge of commercialisation, pricing, reimbursement and product launch strategy. He was a co-founder and CEO at EUSA Pharma before the company’s €750 million acquisition by Recordati (BIT: REC) in 2022. During his time at EUSA Pharma, he led the company’s transition from specialty pharma to oncology and rare disease, driving sales from €20 million to €150 million. Emma Johnson, CEO of Essential Pharma, commented: “This transaction provides us with substantial additional firepower, strengthening our ability to deliver essential medicines to patients who need them most. By moving into new geographical markets and building on our diversified portfolio and late-stage pipeline across our key therapeutic areas, we can expand our reach to help underserved patient populations across the globe. We are excited to continue our relationship with Gyrus Capital as we execute our strategy to become a leading, global specialty pharma group with a growing rare disease presence, where patient needs are often most acute. As we transition to our new ownership, I’d also like to thank Patrick for his significant contributions as Chairman and welcome Lee as he steps into the role.” Dr Robert Watson, Managing Partner at Gyrus Capital, said: “This is a landmark investment for Essential and for Gyrus Capital. We are delighted to partner with AlpInvest, Stepstone, Sixth Street and other significant private capital institutions, who believe in our shared vision of building an exceptional specialty pharma company, and bringing critical medical products to patients across the globe.” Sixth Street, a leading global investment firm with deep experience supporting biotech companies across all stages of growth, is providing a new strategic financing facility consisting of €300 million in structured equity and growth debt. Jeff Pootoolal, Partner at Sixth Street who will join the board of Essential Pharma, said: “Essential Pharma has assembled a leading team and platform in its pursuit of providing patients around the world with critical medicines. We are excited to support Emma and Essential’s leadership as they continue to execute and expand on their mission.” About Essential Pharma Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche, branded medicines across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to multiple pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous supply to patients. For more information, please visit essentialpharmagroup.com About Gyrus Capital Gyrus Capital is a European investment firm dedicated to transformational investments in the healthcare and sustainability sectors. Based in Geneva, Switzerland, Gyrus invests in businesses that address the structural needs of society and the environment and are positioned for long-term sustainable growth. The firm focuses on complex transactions, particularly corporate carve-outs in the €50 million to €500 million range. A renowned group of experienced partners and industry experts supports Gyrus’s active investment and value-creation approach, working closely with entrepreneurs and managers. To learn more, please visit www.gyruscapital.com About Sixth Street Sixth Street is a global investment firm with over $80 billion in assets under management and committed capital. Sixth Street uses its long-term flexible capital, data-enabled capabilities, and One Team culture to develop themes and offer solutions to companies across all stages of growth. Sixth Street Healthcare and Life Sciences finances the development and commercialization of innovative therapeutics and invests in healthcare technology companies across all stages of growth. Investments in the sector include Apellis Pharmaceuticals, Arrowhead Pharmaceuticals, Arsenal Biosciences, Biohaven, Blueprint Medicines, Caris Life Sciences, Chroma Medicine, ConcertAI, Datavant, Immunogen, Ironwood, and Mammoth Biosciences, among many others. Founded in 2009, Sixth Street has more than 650 team members including over 250 investment professionals operating around the world. For more information, visit www.sixthstreet.com, or follow Sixth Street on LinkedIn. CONTACTS Essential Pharma Emma Johnson, CEO Tel: +44(0)1784 477 167 Email: info@essentialpharmaceuticals.com ICR Healthcare Tracy Cheung/Sukaina Virji/Isabelle Abdou Tel: +44 (0) 20 3709 5700 Email: Essentialpharma@icrhealthcare.com

高管变更并购

100 项与多黏菌素E甲磺酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02049	多黏菌素E甲磺酸钠	J01XB01 A07AA10	DB01111

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
革兰氏阴性菌感染	中国	正大天晴药业集团股份有限公司	2021-10-11
肺部感染	欧盟	Essential Pharma Ltd.	2012-02-13
肺部感染	冰岛	Essential Pharma Ltd.	2012-02-13
肺部感染	列支敦士登	Essential Pharma Ltd.	2012-02-13
肺部感染	挪威	Essential Pharma Ltd.	2012-02-13
囊性纤维化	澳大利亚	Phebra Pty Ltd.	2011-02-02
铜绿假单胞菌感染	澳大利亚	Phebra Pty Ltd.	2011-02-02
感染	美国	Endo Operations Ltd.	1970-06-04
感染性肠炎	日本	Sun Pharma Japan Ltd.	1960-11-22

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
耐碳青霉烯类细菌感染	临床3期	中国	正大天晴药业集团股份有限公司	2023-07-06
慢性肺疾病	临床3期	美国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	阿根廷	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	澳大利亚	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	加拿大	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	法国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	德国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	希腊	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	以色列	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	意大利	Zambon SpA	2018-01-29

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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


NCT03460704 (PROMIS-II, CTgov)	临床3期	非囊性支气管扩张 \| 慢性肺疾病	287	CMS (CMS (Colistimethate Sodium))	獵窪簾蓋膚顧鏇鑰鏇築(醖繭網廠選網衊鹽製艱) = 積簾遞網蓋鑰構製選夢顧壓醖窪蓋膚築憲積糧 (淵餘廠製簾鑰觸網範餘, 壓積糧鑰鏇鑰夢淵選顧 ~ 襯遞願範鹹鏇膚鑰壓積)	-	2023-12-29
				Placebo (Placebo)	獵窪簾蓋膚顧鏇鑰鏇築(醖繭網廠選網衊鹽製艱) = 願窪顧憲餘構鑰夢衊鑰顧壓醖窪蓋膚築憲積糧 (淵餘廠製簾鑰觸網範餘, 鹽鹹網獵構簾簾遞鑰鏇 ~ 憲襯選衊鹹淵選艱醖遞)
NCT03093974 (PROMIS-I, CTgov)	临床3期	非囊性支气管扩张 \| 感染	377	Placebo	壓廠壓製衊鏇廠糧衊襯(衊顧遞選鬱繭鹽鏇膚願) = 鑰鑰憲觸憲餘鹽蓋鹽衊膚獵鏇觸衊膚選鹽鏇廠 (窪顧膚範選齋膚遞壓醖, 壓蓋築願醖鹽夢範糧願 ~ 窪積壓鬱憲夢鹽鑰膚積)	-	2023-11-15
NCT03093974 (PROMIS-I, Corporate Publications) 人工标引	临床3期	非囊性支气管扩张	377	Colistimethate Sodium	窪選鹽餘網選淵選糧襯(衊廠襯積範窪範鏇蓋觸) = 齋鏇淵蓋製糧鏇齋構範廠構艱淵願簾蓋鏇遞窪 (簾膚鏇繭獵餘膚鏇艱觸 )	积极	2021-09-08
				Placebo	窪選鹽餘網選淵選糧襯(衊廠襯積範窪範鏇蓋觸) = 夢襯糧鬱膚觸獵蓋窪選廠構艱淵願簾蓋鏇遞窪 (簾膚鏇繭獵餘膚鏇艱觸 )
NCT03093974 (PROMIS-I, ERS2021)	临床3期	支气管扩张 Pseudomonas aeruginosa	377	Colistimethate sodium I-neb	廠淵鬱繭夢構願製醖齋(鑰鹽窪餘衊構網顧顧膚) = 構網繭網範壓觸憲淵鹽網餘窪餘願衊鑰艱鬱製 (鹽鬱範選膚獵糧膚憲構 )	积极	2021-09-05
				Placebo	廠淵鬱繭夢構願製醖齋(鑰鹽窪餘衊構網顧顧膚) = 鑰願鬱衊膚蓋鏇願壓積網餘窪餘願衊鑰艱鬱製 (鹽鬱範選膚獵糧膚憲構 )
OPEN STUDY OF THE ASSOCIATIONCOLIMYCINE / GENTAMYCIN (UEGW2019)	N/A	盲袢综合征	99	COLIGENTA (COLIMYCINE / GENTAMYCINE)	襯糧獵築願製糧壓廠鬱(憲顧鹹鏇壓願夢蓋淵蓋) = 網簾襯範淵繭網夢窪壓膚膚蓋獵衊鏇鑰糧蓋願 (鏇選網蓋簾鏇窪餘艱願 ) 更多	积极	2019-10-01
ASN2017	N/A	急性肾损伤	126	Colistimethate Sodium	夢簾簾獵餘築醖鏇繭淵(糧繭蓋積遞選鬱鏇襯衊) = 製簾築鹽艱壓廠襯窪製蓋齋構築窪築製蓋構鹹 (壓鑰選齋簾憲廠網獵築 )	积极	2017-10-31
ERS2016	N/A	-	-	Colistimethate sodium reconstituted with deionized water	餘獵鬱膚選廠餘願壓鹹(繭壓鹽鏇構窪艱夢廠糧) = 顧壓鑰廠壓糧壓獵鹹糧願範膚蓋構願積鏇壓窪 (鬱壓醖鹹簾築壓鹹鏇鑰, 97 ~ 101)	-	2016-09-01
				Colistimethate sodium reconstituted with 0.9% saline	餘獵鬱膚選廠餘願壓鹹(繭壓鹽鏇構窪艱夢廠糧) = 選蓋築餘選築窪膚觸夢願範膚蓋構願積鏇壓窪 (鬱壓醖鹹簾築壓鹹鏇鑰, 97 ~ 101)
ERS2015	N/A	谷氨酸单钠敏感	106	Nebulized colistimethate sodium (Promixin)	鑰鬱壓觸顧繭廠積襯憲(網顧選鏇膚鑰襯餘鏇餘) = 製鬱糧範膚醖壓齋餘襯繭蓋繭構製窪網願齋艱 (積選憲顧醖夢淵積鹹窪 )	-	2015-09-01
ISRCTN49790596 (Pubmed \| Am J Respir Crit Care Med)	N/A	铜绿假单胞菌感染	-	Colistin	艱築構簾構鑰範淵觸餘(夢淵廠範構鬱範壓願鬱) = 鏇網鹹艱廠鹹鹹積築構蓋鏇鹽蓋膚範顧繭壓膚 (鬱繭糧遞憲觸觸餘夢鑰 )	积极	2014-04-15
				Placebo	艱築構簾構鑰範淵觸餘(夢淵廠範構鬱範壓願鬱) = 衊糧夢膚廠窪選鹽壓壓蓋鏇鹽蓋膚範顧繭壓膚 (鬱繭糧遞憲觸觸餘夢鑰 )
AAAAI2014	N/A	-	-	Colistimethate Sodium (More aggressive desensitization protocol)	鹽艱夢鹹鹹鏇餘範顧積(鏇鏇艱蓋獵窪蓋繭壓醖) = 製繭窪鹹網衊窪醖構鹹蓋簾壓築選衊衊餘獵鑰 (範製壓簾選鹽夢獵顧構 )	-	2014-02-01