To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).

开始日期2023-05-29

申办/合作机构

University of Lund

CTR20222303 / Completed临床3期

评价盐酸匹美西林片治疗中国单纯性尿路感染的有效性及安全性的随机、双盲双模拟、阳性药物平行对照、多中心III期临床试验

主要试验目的：（1）评价TOC访视(D12±2)时临床疗效的非劣效性；次要试验目的：（1）评价TOC访视(D12±2)时的微生物学疗效和综合疗效；（2）评价D5+1及D21＋7的临床疗效、微生物学疗效及综合疗效；（3）评价两种治疗药物治疗单纯性尿路感染的安全性。

开始日期2022-12-19

申办/合作机构

Recipharm Strängnäs AB

[+2]

NCT05545137 / Completed临床3期

Pivmecillinam Hydrochloride Tablets Versus Fosfomycin Tromethamine Granules for Uncomplicated Urinary Tract Infection in Women -A Randomized, Double-blind, Double Simulation, Positive Drug Parallel-controlled, Multi Center Phase III Clinical Trial in China

the purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China

开始日期2022-09-29

申办/合作机构

泊诺（天津）创新医药研究有限公司

100 项与盐酸匹美西林相关的临床结果

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100 项与盐酸匹美西林相关的转化医学

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100 项与盐酸匹美西林相关的专利（医药）

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333

项与盐酸匹美西林相关的文献（医药）

2024-08-01·FP essentials

Renal and Urinary Conditions: Urinary Tract Infections.

作者: Jones, Darrell Edward

Urinary tract infections (UTIs), including cystitis and pyelonephritis, are common. Each year, they account for more than 10 million outpatient visits and more than 3 million emergency department visits. Recurrent UTIs (defined as three in 1 year or two in 6 months) also are common, occurring in 20% to 30% of women. The annual incidence of UTIs is 12.1% among women and 3% among men. Cystitis symptoms include lower abdominal pain, dysuria, and urinary urgency or frequency. Escherichia coli is the most common pathogen. Cystitis often is diagnosed inappropriately when patients have asymptomatic bacteriuria (ie, positive urine culture result without symptoms). This can result in unnecessary antibiotic therapy. For uncomplicated acute cystitis in women, guidelines recommend nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole for 3 days (if local drug-resistance rates are less than 20%), fosfomycin in a single dose, or pivmecillinam for 5 days. Effective prophylactic options for UTI include antibiotics and vaginal estrogen for postmenopausal women. Antibiotics are most effective but are associated with a risk of increased drug resistance. Patients with pyelonephritis present with costovertebral tenderness, fever, and urinary symptoms. Third-generation cephalosporins are preferred for management. Significant complications of pyelonephritis include sepsis or septic shock, obstructive pyelonephritis, emphysematous pyelonephritis, perinephric abscess, and kidney transplant rejection. For pregnant patients with pyelonephritis, hospitalization and intravenous antibiotics are indicated.

2024-06-03·Open Forum Infectious Diseases

Review of the In Vitro Microbiological Activity of Mecillinam Against Common Uropathogens in Uncomplicated Urinary Tract Infection: Focus on Resistant Pathogens

Review

作者: Kaye, Keith S ; Kahlmeter, Gunnar ; Lodise, Thomas P ; Santerre Henriksen, Anne

AbstractAntimicrobial resistance in uropathogens commonly causing urinary tract infections (UTIs) is a growing problem internationally. Pivmecillinam, the oral prodrug of mecillinam, has been used for over 40 years, primarily in Northern Europe and Canada. It is recommended in several countries as a first-line agent for the treatment of uncomplicated UTIs (uUTIs) and is now approved in the United States. We performed a structured literature search to review the available evidence on susceptibility of common uUTI-causing uropathogens to mecillinam. Among 38 studies included in this literature review, susceptibility rates for Escherichia coli to mecillinam—including resistant phenotypes such as extended-spectrum β-lactamase–producing E. coli—exceed 90% in most studies. High rates of susceptibility were also reported among many other uropathogens including Klebsiella spp., Enterobacter spp., and Citrobacter spp. In the current prescribing climate within the United States, pivmecillinam represents a viable first-line treatment option for patients with uUTI.

2024-03-01·Acta Obstetricia et Gynecologica Scandinavica

Antibiotic use during pregnancy in Sweden: A nationwide utilization study covering 2007–2019

Article

作者: Nakitanda, Aya Olivia ; Odsbu, Ingvild ; Karlsson, Pär ; Pazzagli, Laura ; Pasternak, Björn

AbstractIntroductionAntibiotics are often prescribed during pregnancy. Assessing the current state of prenatal antibiotic use is therefore imperative for optimizing prescribing and identifying emerging research priorities. The study aimed to describe recent trends and patterns in antibiotic use during pregnancy among women who gave birth in Sweden, including user characteristics.Material and methodsPopulation‐based descriptive study using linked nationwide registers. All pregnancies delivered in Sweden from 2007 to 2019 were included. Prevalence of use was defined as the percentage of pregnancies during which at least one prescription forantibiotics was filled. Temporal trends in the prevalence of antibiotic use by calendar year, trimester and weeks of gestation were assessed from time series graphs.ResultsPrescriptions for systemic antibiotics were filled in 20.7% of 1 434 431 pregnancies overall, decreasing from 24.7% in 2007 to 18.0% in 2019. Phenoxymethylpenicillin (8.5%), pivmecillinam (6.5%), nitrofurantoin (4.7%), amoxicillin (1.6%) and cefadroxil (1.5%) use were the most prevalent. Their use decreased over the 13‐year period, except for pivmecillinam, which increased from 4.0% to 7.4%. Prevalence of use was highest in the second trimester (9.5%), with weekly trends peaking at 13 and 34 weeks of gestation. Compared with non‐users, antibiotic users more often belonged to the youngest and oldest age strata, carried multipleton pregnancies, had delivered before, had attained a lower education level and smoked in early pregnancy. A higher body mass index, asthma, chronic renal disease and diabetes mellitus were more prevalent among antibiotic users than among non‐users.ConclusionsAlthough outpatient antibiotic use during pregnancy in Sweden has been declining, one in five pregnancies was exposed to systemic antibiotics.

项与盐酸匹美西林相关的新闻（医药）

2024-06-11

·信狐药迅

百济神州优先品种 HER2双抗泽尼达妥单抗提交上市申请|新受理（6.3-6.10）

本周药品注册受理数据，分门别类呈现，一目了然。(6.3-6.10）新药上市申请药品名称企业注册分类受理号复迈替尼片上海复星医药产业发展有限公司1CXHS2400049复迈替尼片上海复星医药产业发展有限公司1CXHS2400048注射用泽尼达妥单抗百济神州(苏州)生物科技有限公司1CXSS2400056司普奇拜单抗注射液成都康诺行生物医药科技有限公司1CXSS2400055 新药临床申请药品名称企业注册分类受理号HZ-L105片杭州和正医药有限公司1CXHL2400582HZ-L105片杭州和正医药有限公司1CXHL2400581HZ-L105片杭州和正医药有限公司1CXHL2400580K-13片上海懿峰生物科技有限公司1CXHL2400579K-13片上海懿峰生物科技有限公司1CXHL2400578K-13片上海懿峰生物科技有限公司1CXHL2400577FP-208片北京富龙康泰生物技术有限公司1CXHL2400573FP-208片北京富龙康泰生物技术有限公司1CXHL2400572K-13片上海懿峰生物科技有限公司1CXHL2400571K-13片上海懿峰生物科技有限公司1CXHL2400570K-13片上海懿峰生物科技有限公司1CXHL2400569ZG-002片上海致根医药科技有限公司1CXHL2400568ZG-002片上海致根医药科技有限公司1CXHL2400567RP903片君实润佳(上海)医药科技有限公司1CXHL2400566RP903片君实润佳(上海)医药科技有限公司1CXHL2400565SIM0508片上海先祥医药科技有限公司1CXHL2400564SIM0508片上海先祥医药科技有限公司1CXHL2400563BGC515胶囊苏州桥济生物科技有限公司1CXHL2400562BGC515胶囊苏州桥济生物科技有限公司1CXHL2400561BGC515胶囊苏州桥济生物科技有限公司1CXHL2400560TLL-041片杭州高光制药有限公司1CXHL2400559TLL-041片杭州高光制药有限公司1CXHL2400558TLL-041片杭州高光制药有限公司1CXHL2400557注射用SC-102天津星联肽生物科技有限公司1CXHL2400556DAT-2645片北京丹擎医药科技有限公司1CXHL2400555DAT-2645片北京丹擎医药科技有限公司1CXHL2400554甘露醇山梨醇注射液石家庄四药有限公司3CYHL2400104注射用多黏菌素E甲磺酸钠健康元海滨药业有限公司3CYHL2400103PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400576PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400575PG-F01凝胶北京普祺医药科技股份有限公司2.2;2.4CXHL2400574四价重组诺如病毒疫苗(汉逊酵母)华北制药金坦生物技术股份有限公司1.1CXSL2400368四价重组诺如病毒疫苗(汉逊酵母)华北制药金坦生物技术股份有限公司1.1CXSL2400367流感病毒亚单位疫苗江苏中慧元通生物科技股份有限公司3.3CXSL2400370PreS1胶束注射液(冻干)普瑞斯万(武汉)生物科技有限公司1CXSL2400372CC312冻干粉针剂惠和生物技术(上海)有限公司1CXSL2400366GKL-006注射液北京基因启明生物科技有限公司1CXSL2400364外用红色诺卡氏菌细胞壁骨架辽宁天安生物制药股份有限公司2.2CXSL2400369门冬胰岛素30注射液宁波鲲鹏生物科技有限公司3.3CXSL2400365人凝血酶原复合物四川远大蜀阳药业有限责任公司3.4CXSL2400371注射用重组A型肉毒毒素君合盟生物制药(通化)有限公司2.2;2.4CXSL2400373 仿制药申请药品名称企业注册分类受理号ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液福建盛迪医药有限公司3CYHS2401726地奈德乳膏杭州民生药业股份有限公司3CYHS2401736草酸艾司西酞普兰口服溶液江苏长泰药业股份有限公司3CYHS2401733舒必利注射液海南卓科制药有限公司3CYHS2401731舒必利注射液海南卓科制药有限公司3CYHS2401730甲硫酸新斯的明注射液河北一品制药股份有限公司3CYHS2401728重酒石酸卡巴拉汀口服液广州一品红制药有限公司3CYHS2401727苯磺酸氨氯地平口腔崩解片广东万泰科创药业有限公司3CYHS2401715吸入用盐酸丙卡特罗溶液石家庄四药有限公司3CYHS2401717氨磺必利口服溶液宏越科技(湖州)有限公司3CYHS2401713盐酸丙卡特罗口服溶液黑龙江澳利达奈德制药有限公司3CYHS2401710盐酸丙卡特罗口服溶液黑龙江澳利达奈德制药有限公司3CYHS2401709盐酸甲氧氯普胺注射液嘉实(湖南)医药科技有限公司3CYHS2401705吸入用盐酸丙卡特罗溶液浙江福瑞喜药业有限公司3CYHS2401723吸入用盐酸丙卡特罗溶液浙江福瑞喜药业有限公司3CYHS2401722烟酸缓释片北京世桥生物制药有限公司3CYHS2401697盐酸异丙肾上腺素注射液华夏生生药业(北京)有限公司3CYHS2401694马来酸氯苯那敏注射液江苏瑜兴医药科技有限公司3CYHS2401692丙戊酸钠注射用浓溶液广州市联瑞制药有限公司3CYHS2401704注射用硫酸多黏菌素B健康元药业集团股份有限公司3CYHS2401700乙酰半胱氨酸注射液江苏迪赛诺制药有限公司3CYHS2401681左氧氟沙星注射液辰欣药业股份有限公司3CYHS2401672氨溴特罗口服溶液国药控股星鲨制药(厦门)有限公司3CYHS2401667腺苷钴胺胶囊浙江昂利康制药股份有限公司3CYHS2401689盐酸拉贝洛尔注射液遂成药业股份有限公司3CYHS2401686盐酸拉贝洛尔注射液遂成药业股份有限公司3CYHS2401684复方磺胺甲噁唑注射液华夏生生药业(北京)有限公司3CYHS2401671维生素B6注射液宝利化(南京)制药有限公司3CYHS2401674硫酸沙丁胺醇注射液湖北民康药业集团有限公司3CYHS2401659药用炭胶囊海南烨徽源医药科技有限公司3CYHS2401658硫酸沙丁胺醇口服溶液浙江凯润药业股份有限公司3CYHS2401657氯化钾口服溶液安徽茂康药业有限公司3CYHS2401656吸入用盐酸氨溴索溶液济南景笙科技有限公司3CYHS2401655氯化钾口服溶液遂成药业股份有限公司3CYHS2401653重酒石酸去甲肾上腺素注射液遂成药业股份有限公司3CYHS2401652硫酸氨基葡萄糖胶囊吉林道君药业股份有限公司4CYHS2401740艾地骨化醇软胶囊山东简道制药有限公司4CYHS2401739艾地骨化醇软胶囊山东简道制药有限公司4CYHS2401738甲硝唑凝胶合肥启旸生物医药科技有限公司4CYHS2401737克立硼罗软膏山东辰欣佛都药业股份有限公司4CYHS2401735注射用硫酸艾沙康唑合肥亿帆生物制药有限公司4CYHS2401734富马酸伏诺拉生片南京正科医药股份有限公司4CYHS2401732富马酸伏诺拉生片南京正科医药股份有限公司4CYHS2401729恩格列净片佑华医药科技有限公司4CYHS2401721恩格列净片佑华医药科技有限公司4CYHS2401720盐酸伊立替康注射液连云港众维生物医药有限公司4CYHS2401719盐酸伊立替康注射液连云港众维生物医药有限公司4CYHS2401718氟康唑氯化钠注射液哈尔滨三联药业股份有限公司4CYHS2401716尼可地尔片重庆莱美药业股份有限公司4CYHS2401714聚乙二醇钠钾散湖南华纳大药厂股份有限公司4CYHS2401712注射用头孢唑肟钠南京赛瑞谱顿制药有限公司4CYHS2401711盐酸尼卡地平注射液广东君康药业有限公司4CYHS2401707乳果糖口服溶液江苏广承药业有限公司4CYHS2401706注射用头孢他啶阿维巴坦钠海南葫芦娃药业集团股份有限公司4CYHS2401725盐酸纳呋拉啡口腔崩解片郑州泰丰制药有限公司4CYHS2401724注射用硫酸艾沙康唑海南广升誉制药有限公司4CYHS2401708甲氨蝶呤注射液海南卓泰制药有限公司4CYHS2401699甲氨蝶呤注射液海南卓泰制药有限公司4CYHS2401698精氨酸培哚普利片江西施美药业股份有限公司4CYHS2401696精氨酸培哚普利片江西施美药业股份有限公司4CYHS2401695熊去氧胆酸胶囊贵州瑞和制药有限公司4CYHS2401693盐酸达泊西汀片河北万岁药业有限公司4CYHS2401703盐酸达泊西汀片河北万岁药业有限公司4CYHS2401702多索茶碱注射液云南药科院生物医药股份有限公司4CYHS2401701硫酸氢氯吡格雷片重庆药友制药有限责任公司4CYHS2401683那屈肝素钙注射液华北制药华坤河北生物技术有限公司4CYHS2401677艾考糊精腹膜透析液青岛瑞奈医疗科技有限公司4CYHS2401682盐酸西替利嗪片上海强生制药有限公司4CYHS2401676硫酸镁钠钾口服用浓溶液广州合和医药有限公司4CYHS2401675丙酸氯倍他索搽剂江苏知原药业股份有限公司4CYHS2401668蒙脱石散海南斯达制药有限公司4CYHS2401688罗沙司他胶囊湖南埃威格林医药科技有限公司4CYHS2401680罗沙司他胶囊湖南埃威格林医药科技有限公司4CYHS2401679巴瑞替尼片杭州民生药业股份有限公司4CYHS2401678尼可地尔片本溪匠成医药科技有限公司4CYHS2401673依折麦布阿托伐他汀钙片(I)成都倍特药业股份有限公司4CYHS2401670依折麦布阿托伐他汀钙片(II)成都倍特药业股份有限公司4CYHS2401669盐酸尼卡地平注射液河南润弘制药股份有限公司4CYHS2401690氢溴酸伏硫西汀片宁波大红鹰药业股份有限公司4CYHS2401687氢溴酸伏硫西汀片宁波大红鹰药业股份有限公司4CYHS2401685注射用硫酸艾沙康唑广州一品红制药有限公司4CYHS2401691富马酸依美斯汀滴眼液广州仁恒医药科技股份有限公司4CYHS2401666碳酸司维拉姆片浙江昂利康制药股份有限公司4CYHS2401665沙库巴曲缬沙坦钠片江苏利泰尔药业有限公司4CYHS2401664沙库巴曲缬沙坦钠片江苏利泰尔药业有限公司4CYHS2401663间苯三酚注射液杭州和泽坤元药业有限公司4CYHS2401662巴瑞替尼片南京海纳制药有限公司4CYHS2401661莫匹罗星软膏浙江赛默制药有限公司4CYHS2401660注射用替加环素北京融英医药科技有限公司4CYHS2401654 进口申请药品名称企业注册分类受理号伊那利塞片Roche Pharma (Schweiz) AG1JXHS2400038伊那利塞片Roche Pharma (Schweiz) AG1JXHS2400037盐酸匹美西林片Karo Pharma AB5.1JXHS2400040盐酸匹美西林片Karo Pharma AB5.1JXHS2400039利生奇珠单抗注射液AbbVie Inc.2.2JXSS2400047利生奇珠单抗注射液(皮下注射)AbbVie Inc.2.2JXSS2400046利生奇珠单抗注射液(皮下注射)AbbVie Inc.2.2JXSS2400045Bexotegrast片Pliant Therapeutics, Inc.1JXHL2400126Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400131Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400130Upadacitinib片AbbVie Inc.2.4JXHL2400129Upadacitinib片AbbVie Inc.2.4JXHL2400128Upadacitinib片AbbVie Inc.2.4JXHL2400127RO7200220 注射液F. Hoffmann-La Roche Ltd.1JXSL2400112RO7200220 注射液F. Hoffmann-La Roche Ltd.1JXSL2400111Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400108注射用AZD7798AstraZeneca AB1JXSL2400110Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400109 中药相关申请药品名称企业注册分类受理号升陷颗粒吉林敖东洮南药业股份有限公司3.1CXZS2400020三七通舒胶囊成都神鹤药业有限责任公司4CYZS2400002 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

2024-04-25

·药研发

【药研发0426】常山生化GLP-1R激动剂报产 | 和誉肝癌新药获孤儿药资格...

「本文共：17条资讯，阅读时长约：3分钟」今日头条常山生化GLP-1R激动剂报产。河北常山生化药业旗下常山凯捷健生物提交的艾本那肽注射液上市申请获CDE受理，拟用于在饮食控制和运动基础上改善2型糖尿病患者的血糖控制。艾本那肽注射液是一款长效GLP-1受体激动剂，此前已在中国2型糖尿病患者中开展的III期临床研究中达到了主要终点和关键次要终点。患者接受艾本那肽注射液治疗24周后，其血糖水平显著降低，且疗效维持长达52周。国内药讯1.君实PD-1单抗在香港报产。君实生物PD-1抑制剂特瑞普利单抗向香港卫生署药物办公室（DO）提交上市申请并获得受理，拟联合顺铂/吉西他滨一线治疗转移性或复发性局部晚期鼻咽癌成人患者，以及单药治疗复发性、不可切除或转移性鼻咽癌。在Ⅲ期临床JUPITER-02中，特瑞普利单抗联合化疗使患者的疾病进展或死亡风险降低48%，死亡风险降低37%。2.科伦博泰ADC亮相ASCO。科伦博泰宣布将在ASCO2024年会上口头报告Trop2 ADC新药SKB264两项临床研究的最新数据。这两项临床分别为：SKB264用于治疗局部复发性或转移性三阴乳腺癌经治患者的Ⅲ期临床OptiTROP-Breast01；SKB264联合PD-L1单抗KL-A167一线治疗晚期非小细胞肺癌患者的Ⅱ期临床OptiTROP-Lung01。SKB264是科伦博泰采用专有毒素-连接子策略研发的一款创新ADC，抗体药物偶联比（DAR）平均值高达7.4。3.和誉肝癌新药获孤儿药资格。和誉医药自主研发的小分子FGFR4抑制剂依帕戈替尼（irpagratinib/ABSK011）获FDA授予孤儿药资格，用于治疗肝细胞癌（HCC）。在具有过表达FGF19的HCC细胞中，ABSK011可以通过抑制FGFR4的自身磷酸化并阻断FGFR4向下游通路活化的信号转导，最终抑制HCC患者的肿瘤。临床数据显示，ABSK011（每日两次）治疗的客观缓解率（ORR）达40.7%。4.康方双抗实体瘤早期临床积极。康方生物PD-1/VEGF双抗依沃西（AK112/SMT112）在治疗晚期实体瘤（包括卵巢浆液性癌、MSS结直肠癌和其他癌症）的Ⅰa期临床中获积极结果。中位随访为12.8个月时，依沃西在这类被认为对单药免疫治疗缺乏响应的肿瘤患者中达到了25.5%的客观缓解率（ORR），疾病控制率（DCR）为63.8%，且具有良好的安全性。详细数据已发表于《癌症免疫治疗杂志》（JITC）期刊上。5.通化东宝双靶点减肥药获批临床。通化东宝1类化药注射用THDBH120获国家药监局临床试验默示许可，拟开发用于超重/肥胖患者的长期体重管理。THDBH120是一款GLP-1/GIP双靶点激动剂，通过分子设计将GLP-1和GIP这两种促胰岛素的作用整合至一个多肽分子中，同时提高了代谢稳定性，从而改善血糖控制。去年年底，该新药已获批开展用于治疗2型糖尿病的临床研究。6.迈诺威病理性瘢痕新药获批IND。迈诺威医药拟用于预防和治疗病理性瘢痕的创新药MI151凝胶获FDA临床许可。MI151可抑制成纤维细胞增殖和TGF-β1的产生，同时可以影响TNF-α、IL-1β等炎症细胞因子和粘附分子的产生以及基质重塑因子的表达，有望通过抗炎和抗纤维化的双重作用来治疗瘢痕。在临床前研究中，MI151已显示出积极治疗效果；且具有良好的安全性。7.蓝纳成生物完成3亿元B+轮融资。东诚药业宣布，旗下蓝纳成生物已完成B+轮融资金额3亿元，将适时开展IPO融资上市。蓝纳成由东诚药业与国际分子影像及纳米医学领域专家陈小元教授联合创立。目前，该公司多个用于癌症的1类诊疗一体化创新药物已进入临床阶段，包括：靶向PSMA的放射性体内治疗药物177Lu-LNC1003注射液、用于前列腺癌诊断的1类创新核药氟[18F]思睿肽注射液、伴随诊断试剂68Ga-FAPI-46注射液、靶向FAP的放射性体内诊断药物氟[18F]纤抑素注射液、靶向FAP的放射性体内治疗药物177Lu-LNC1004注射液等。国际药讯1.Utility公司创新抗生素获批上市。Utility公司口服β-内酰胺抗生素pivmecillinam（商品名为Pivya）获FDA批准上市，用于治疗由大肠杆菌、奇异变形杆菌和腐生葡萄球菌引起的非复杂性尿路感染（UTIs）。Pivmecillinam是mecilinam的前体化合物，它通过干扰细菌细胞壁的合成来杀死细菌。在临床试验中，Pivya治疗相比安慰剂提高了患者的综合反应率（62%vs10%）；与布洛芬相比，Pivya组患者的综合反应率也显著提高（66%vs22%）。2.诺华放射性配体疗法获批用于儿童。诺华放射性配体疗法Lutathera（Lu 177 dotatate）获FDA批准扩展适用范围，用于治疗生长抑素受体阳性（SSTR+）胃肠胰神经内分泌肿瘤（GEP-NET）的儿童（12-18岁）患者。Lutathera是首款FDA批准的放射性配体疗法，能结合肿瘤细胞表面的生长抑素受体进入细胞，通过放射性对肿瘤细胞造成损伤。2018年，FDA已批准该药物用于治疗经治SSTR阳性的GEP-NET患者。3.安斯泰来前列腺癌新药获批新适应症。安斯泰来AR抑制剂恩扎卢胺（enzalutamide）获欧盟委员会（EC）批准新适应症，单药或与雄激素剥夺治疗（ADT）联合，用于不适合挽救性放疗的高风险生化复发性（BCR）、非转移性激素敏感性前列腺癌（nmHSPC）成年男性。在Ⅲ期EMBARK试验中，与亮丙瑞林相比，恩扎卢胺单药或与亮丙瑞林联合用药分别降低了36.9%和57.6%的癌症扩散或死亡的风险。4.Endeavor公司融资开发肺纤维化新药。Endeavor公司宣布完成1.325亿美元的C轮融资，以用于加速其小分子抑制剂ENV-101以及HER3靶向抗体偶联药物（ADC）ENV-501的临床开发。ENV-101旨在通过抑制过度激活的Hedgehog（Hh）信号通路来提高患者的肺功能，并逆转特发性肺纤维化（IPF）和进行性肺纤维化（PPF）患者肺部的纤维化，该新药目前已处于Ⅱ期临床阶段。此外，Endeavor也计划在今年启动ENV-501的Ⅰ/Ⅱ期临床试验。5.癌症小分子药物公司Flindr完成A轮融资。Flindr Therapeutics宣布完成2000万欧元的A轮融资，主要用于加速其靶向RNF31的潜在“first-in-class”小分子抑制剂的开发，应用于实体瘤和血液恶性肿瘤的治疗。在临床前研究中，该候选药物已在卵巢癌和B细胞淋巴瘤模型中显示出抗肿瘤活性，并识别相关生物标记。此轮融资还将用于该公司使用ImmunoGram药物发现引擎拓宽其产品管线。6.罕见皮肤病创新基因疗法被FDA拒批。Abeona公司基因疗法prademagene zamikeracel（pz-cel）用于治疗隐性营养不良性大疱性表皮松解症（RDEB）的上市申请收到FDA发出的完整回复函（CRL）。FDA要求Abeona必须在申请获得批准之前，“令人满意地解决”CMC问题，提供额外CMC信息。pz-cel是一款自体、COL7A1基因校正表皮片，利用逆转录病毒载体将产生胶原蛋白的功能性COL7A1基因送入患者自身的皮肤细胞。医药热点1.湘雅二医院将建设国家紧急医学救援基地。4月24日，国家卫健委官网发布了关于中南大学湘雅二医院国家紧急医学救援基地建设工程可行性研究报告的批复。国家卫健委原则同意中南大学湘雅二医院国家紧急医学救援基地建设工程可行性研究报告。据批复，该院主要建设内容为批量伤员救治、立体救治转运、应急指挥、培训演练、物资仓储等紧急医学救援相关业务用房及配套设施，建筑面积为81470平方米。其中，地上建筑面积55470平方米，地下建筑面积26000平方米。2.苏大附一院日间手术中心启用。近日，苏州大学附属第一医院正式启用日间手术中心。日间手术设有普外科的疝气胆囊专科、眼科、介入科、骨科、妇产科、耳鼻喉科、甲乳外科、超声科等多个学科领域，眼科的斜视矫正术、介入科的大隐静脉曲张手术、血透中心的动静脉造瘘术、妇科的宫腔镜手术等均能在日间手术中心完成。患者在入院前完成术前检查、麻醉评估、手术预约，手术当天办理住院；术后经过严密观察，当天或24小时后患者即可出院回家。3.今年北京市将新建10所社区医院。近日，北京市卫健委、市中医局联合发布《北京市“优质服务基层行”活动和社区医院建设三年行动方案》，北京市将着力改善基层医疗卫生机构中医药服务条件，今年将新建成10所社区医院。到2025年，社区卫生服务中心（乡镇卫生院）将全部设置中医馆、配备中医医师，能够规范开展10项以上中医药适宜技术。评审动态 1. CDE新药受理情况（04月25日) 2. FDA新药获批情况（北美04月24日）股市资讯上个交易日 A 股医药板块 -0.01%+0.61%涨幅前三跌幅前三常山药业+19.98% ST 吉药 -5.23%康弘药业+10.00% *ST 太安 -5.00%舒泰神 +8.60% 江苏吴中 -4.16%【恒瑞医药]1)公司产品“氟唑帕利胶囊”、“甲磺酸阿帕替尼片”上市许可申请获国家药监局得受理，并被纳入优先审评品种公示名单;2)公司产品“门冬胰岛素注射液”获得临床试验批准。【达安基因]公司产品“甲型流感病毒，乙型流感病毒和新型冠状病毒(2019-nCoV)核酸检测试剂盒(PCR-荧光探针法)”获得器械注册证。【金城医药]公司产品“磷酸奥司他韦”获得上市申请批准。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

孤儿药临床3期抗体药物偶联物ASCO会议免疫疗法

2024-04-25

·FiercePharma

Utility Therapeutics wins FDA nod for UTI antibiotic that has been on the market in Europe for 40-plus years

Nearly half of women will get a urinary tract infection in their lifetime. For the first time in more than 20 years the FDA has approved an antibiotic to treat the condition. For the first time in more than 20 years, the FDA has approved a treatment for uncomplicated urinary tract infections (uUTI). And the nod has come for an oral antibiotic that has been available in Europe for more than 40 years. It’s an odd set of circumstances and a dose of foresight by Utility Therapeutics that bring Pivya (pivmecillinam) to the market in the United States in the therapy’s golden years. The London-based company was formed specifically to develop and commercialize pivmecillinam in the U.S. where antimicrobial resistance is growing to standard of care antibiotics. The decreased “utility” of first-line antibiotics and the void the company is attempting to fill in the U.S. were the inspiration of the name of the company. And the void is significant as more than 30 million uUTIs are diagnosed every year in the U.S., with nearly half of all women contracting the infection at some point in their life. Outside of hospital setting, UTIs account for more antibiotic use than any other disorder. In 2018, Utility inked a licensing agreement with LEO Pharma, acquiring the U.S. rights to pivmecillinam and its subcutaneous formulation mecillinam, which the company has submitted for approval as a first-line therapy for complicated urinary tract infections (cUTI) in the hospital setting. The difference between cUTIs and uUTIs is that the former has reached the kidneys while the latter is limited to the bladder. “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective and Pivya will provide an additional treatment option for uncomplicated UTIs,” Peter Kim, M.D., the director of the Division of Anti-Infectives at the FDA’s Center for Drug Evaluation and Research, said in a release. The year that Utility acquired the rights to pivmecillinam and mecillinam, the FDA signed off on each as a Qualified Infectious Disease Product (QIDP). The status is extended to antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections. When a QIDP treatment is approved, it gains an additional five years of market exclusivity. On the same day in January, when Utility revealed that the FDA had accepted the company’s new drug applications for pivmecillinam and mecillinam, it also announced it had received private funding from the AMR Action Fund. The global initiative—which was established by several prominent drugmakers including Amgen, Bayer, Eli Lilly, GSK, Novo Nordisk and Roche—invests in the development of new antimicrobial therapeutics. In addition to being a prodrug, which means that it is not pharmacologically active until it is digested and absorbed into the system, Pivya has a unique mechanism of action, targeting penicillin binding protein-2 in the cell wall of gram-negative bacteria. Pivya’s efficacy was assessed in separate trials versus placebo, an oral antibacterial and ibuprofen. The primary measure of efficacy in the studies was the composite response rate, which included clinical cure (resolution of the symptoms of the uUTI that were present in patients at trial entry and no new symptoms) and microbiological response (demonstration that the bacteria cultured from patients’ urine at trial entry was reduced). In the placebo trial, 62% of the participants who received Pivya achieved composite response compared to 10% of those on placebo. In the oral antibacterial trial, 72% of the subjects who received Pivya achieved composite response versus 76% of those on the comparator. In the third trial, 66% of the subjects who received Pivya achieved composite response compared to 22% of those on ibuprofen. Commonly prescribed drugs for uUTIs in the U.S. are bactrim (sulphamethoxazole/trimethoprim), nitrofuranatoin and fluoroquinolones. But more than 1 in 5 who receive these are resistant, which can lead to progression of the disease, including life-threatening sepsis. Last month, Germany’s Allecra Therapeutics scored FDA approval for its antibiotic Exblifep, which is a combination of cephalosporin antibacterial cefepime and the beta-lactamase inhibitor enmetazobactam, to treat cUTI. The approval came days after the U.S. regulator rejected another combo therapy in the same indication from Venatorx Pharmaceuticals and Melinta Therapeutics.

引进/卖出上市批准临床结果

100 项与盐酸匹美西林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01499	盐酸匹美西林	J01CA08	DB01605

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
泌尿道感染	美国	UTILITY therapeutics Ltd.初创企业	2024-04-24
膀胱炎	丹麦	Karo Healthcare AB	2014-09-10

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
泌尿道感染	申请上市	中国	泊诺（天津）创新医药研究有限公司	2024-06-04
泌尿道感染	申请上市	中国	Recipharm AB	2024-06-04
泌尿道感染	申请上市	中国	Karo Healthcare AB	2024-06-04
膀胱炎	临床3期	中国	泊诺（天津）创新医药研究有限公司	2022-09-29
沙门氏菌感染	药物发现	中国	Recipharm Strängnäs AB	2021-03-20

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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


FDA_CDER 人工标引	N/A	泌尿道感染	259	PIVYA	(糧製簾壓繭鬱鹹製廠鹽) = 觸膚齋製餘鹽構積鹽鏇餘獵觸淵鏇廠願築製鑰 (醖襯選醖淵獵餘繭蓋願 ) 更多	积极	2024-04-24
FDA_CDER 人工标引	N/A	泌尿道感染	259	Cephalexin	(糧製簾壓繭鬱鹹製廠鹽) = 鏇鹹鏇願願艱蓋顧鑰鹽餘獵觸淵鏇廠願築製鑰 (醖襯選醖淵獵餘繭蓋願 ) 更多	积极	2024-04-24
FDA_CDER 人工标引	N/A	泌尿道感染	84	PIVYA	(糧襯選鹹選願顧憲憲艱) = 繭蓋繭淵鬱襯壓觸鬱願遞糧襯齋遞範網簾鹽積 (築積糧選鏇窪鏇襯蓋襯 )	积极	2024-04-24
NCT01849926 (FDA_CDER) 人工标引	临床3期	泌尿道感染	224	PIVYA	(獵窪膚鹽觸遞襯築壓築) = 壓淵範憲築積範鏇鏇窪膚製艱構廠憲憲顧遞鏇 (餘膚鏇齋繭夢壓憲顧觸 ) 更多	积极	2024-04-24
NCT01849926 (FDA_CDER) 人工标引	临床3期	泌尿道感染	224	ibuprofen	(獵窪膚鹽觸遞襯築壓築) = 蓋鹽選醖觸壓壓繭積蓋膚製艱構廠憲憲顧遞鏇 (餘膚鏇齋繭夢壓憲顧觸 ) 更多	积极	2024-04-24
FDA_CDER 人工标引	N/A	泌尿道感染	282	PIVYA	(艱鬱廠憲範蓋膚鹽艱顧) = 鹹簾築憲顧選襯願簾積憲網膚壓選遞膚糧糧製 (壓構積衊襯鏇願積齋壓 ) 更多	积极	2024-04-24