Male urinary tract infections (MUTI) are often less recognised compared to those in women. French clinical guidelines practices recommend the use of antibiotics called fluoroquinolones, which are highly effective in treating MUTIs. However, these antibiotics can lead to rare but serious side effects, such as tendonitis or heart rhythm disturbances. Additionally, fluoroquinolones can contribute to the development of bacterial resistance, making their use inadvisable within six months of treatment.
In response to these concerns, we aim to explore a well-established alternative, fosfomycin trometamol (known by the brand name MONURIL®). This antibiotic has a strong track record in treating UTIs in women, with well-documented benefits and minimal associated risks.
The primary goal of this study is to assess the effectiveness of fosfomycin trometamol in treating urinary tract infections in men, as well as to evaluate any potential treatment failures.

开始日期2025-06-01

申办/合作机构-

CTIS2024-513465-39-00

/ Recruiting临床4期IIT

Clinical Efficacy of oral Fosfomycin Trometamol and Cefixime in the Treatment of Acute Bacterial Prostatitis (CEFOSPROST): a comparative, randomized, open, multicenter trial. - CEFOSPROST

开始日期2024-12-17

申办/合作机构-

CTR20242961

/ CompletedN/A

江苏联环药业股份有限公司研制的磷霉素氨丁三醇颗粒（3 g）与Zambon Switzerland Ltd.生产的磷霉素氨丁三醇颗粒（3 g）在中国健康受试者中进行的随机、开放、单剂量、两序列、两周期、交叉、空腹状态下的生物等效性研究

以江苏联环药业股份有限公司研制的磷霉素氨丁三醇颗粒（规格：3 g）为受试制剂，以Zambon Switzerland Ltd.生产的磷霉素氨丁三醇颗粒（商品名：Monurol®，规格：3 g）为参比制剂，考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性；同时评价两种制剂在健康人体中的安全性和耐受性。

开始日期2024-08-21

申办/合作机构

江苏联环药业股份有限公司

100 项与磷霉素氨丁三醇相关的临床结果

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100 项与磷霉素氨丁三醇相关的转化医学

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100 项与磷霉素氨丁三醇相关的专利（医药）

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346

项与磷霉素氨丁三醇相关的文献（医药）

2025-03-01·Prostate International

Single-dose vs prolonged antibiotic prophylaxis of fosfomycin for transrectal prostate biopsy: a single-center prospective, randomized, controlled trial

Article

作者: Bajory, Zoltán ; Rárosi, Ferenc ; Fehér, Ádám Miklós ; Köves, Béla ; Burián, Katalin ; Czimbalmos, Nándor ; Lázár, Andrea ; Fehér, Ádám M

Background:

Transrectal prostate biopsy is a commonly performed urological procedure in which antibiotic prophylaxis is recommended. Fluoroquinolone-type antibiotics are no longer acceptable in the EU. Fosfomycin-trometamol may be used, but there is no evidence regarding its ideal dose and administration time.

Methods:

Patients who underwent prostate biopsy between 2021 and 2023 were evaluated prospectively. 204 patients were randomized into two arms: 102 patients (Arm A) received a single-dose of fosfomycin-trometamol one hour before surgery, and 102 patients (Arm B) received one additional dose of fosfomycin-trometamol 48 hours after the first dose. Urine tests and questionnaires were administered during the postoperative period and the subsequent four weeks to identify any symptoms, infectious, or other complications.

Results:

There was no statistical difference in the rate of asymptomatic bacteriuria (4.90% (5) vs. 8.82% (9), P = 0.27) symptomatic urinary tract infection (0% (0) vs. 1.96% (2), P = 0.50), or febrile urinary tract infection (0% (0) vs. 0.98% (1), P = 1) between the groups. Only hematuria was significantly more common in Arm B (6.86% (7) vs. 16.67% (17), P = 0.03), whereas other complications did not differ significantly. There was no statistical difference in hospitalization (0.98% (1) vs. 2.94 (3), P = 0.62) or mortality rate (0 % (0) vs. 0.98% (1), P = 1). Sub-group analysis of previous antibiotic users showed no difference in terms of complications.

Conclusion:

There is no significant difference in infectious complications between single-dose and prolonged prophylaxis of fosfomycin-trometamol for transrectal prostate biopsy. A single-dose of fosfomycin one hour before biopsy is an ideal choice with a better ecological impact compared with prolonged antibiotic prophylaxis for transrectal prostate biopsy.

2025-01-01·ENVIRONMENTAL RESEARCH

A phenotypic study of the resistome in a peri-urban ecosystem

Article

作者: González Domenech, Carmen María ; López Guarnido, Olga ; González Román, Ana Carmen ; García Valdés, Luz María ; Espigares Rodríguez, Elena ; Dib, Amira Leila ; Román, Ana Carmen González

Since the discovery of antibiotics, the dispersion of resistance genes has increased exponentially, leading to the current state in which it has become increasingly difficult to achieve an effective treatment for infectious diseases. The enormous capacity for genetic exchange between microorganisms is causing resistance genes to be able to reach all environments, even those where there is no anthropogenic impact or exposure to these drugs. In this work, a phenotypic study of the resistome has been conducted in a peri-urban ecosystem (Granada, Spain), wherein the resistance to 32 antibiotics of 710 bacterial strains isolated from 70 samples from different ecological niches with varying levels of exposure to antibiotics and anthropic action has been determined. The study of resistances using phenotypic procedures constitutes a very useful and complementary alternative to genomic methods. The obtained results show a high percentage of resistance in all the subsystems analysed, stating high multi-resistance profiles. Vancomycin and erythromycin were the antibiotics to which the highest levels of resistance were observed, whereas the lowest levels were obtained in chloramphenicol. Regarding the environments studied, the highest percentages of resistance were found in wastewater, farms and food. It should be noted that in natural soil samples (not exposed to antibiotics or anthropogenic activities), worrying levels of resistance to practically all the groups of antibiotics analysed were detected. These results support the generally accepted conclusion that an appropriate control and management of wastewater and solid waste that may contain antibiotics or resistant bacteria is really important to prevent the wide propagation of the resistome in the environment.

2024-09-02·Urologiia (Moscow, Russia : 1999)

New Prospects for Conservative Treatment of Chronic Recurrent Cystitis in Women: Experience with the Drug Superlymph®

Article

作者: Khanaliev B, V ; Gankovskaya L, V ; Gankovskaya, Gankovskaya L.V. ; Khasanova, Khasanova E.M. ; Sudilovskaya, Sudilovskaya V.V. ; Tevlina E, V ; Sudilovskaya V, V ; Tevlin, Tevlin K.P. ; Nasaeva E, D ; Nasaeva, Nasaeva E.D. ; Tevlin K, P ; Khasanova E, M ; Khanaliev, Khanaliev B.V. ; Tevlina, Tevlina E.V.

INTRODUCTION:

Chronic recurrent cystitis is a common and difficult problem of modern urology. Traditional use of antimicrobial drugs often cannot lead to the long-term remission.

AIM:

To evaluate the efficacy and safety of using different dosages and routes of the drug Superlymph in rectal and vaginal suppositories 10 U and 25 U in patients with chronic recurrent cystitis.

MATERIALS AND METHODS:

A randomized comparative clinical study in parallel groups included 60 patients aged from 18 to 80 years with a diagnosis of chronic recurrent bacterial uncomplicated cystitis. All study participants were randomized into three groups. In Group 1 (n=25), Superlymph suppositories 25 U were prescribed rectally once a day for 20 days. In group 2 (n=25), Superlymph suppositories 10 U were administered vaginally 2 times a day, for 20 days. In accordance with the prescription information, Superlymph 10 U/25 U can be used vaginally or rectally depending on the gender. In addition, it is possible to change the route of administration, for example, Superlymph 25 U one suppository once a day or Superlymph 10 U, one suppository 2 times a day in the morning and in the evening. The duration of the course is from 10 to 20 days. The main aim of the study was to compare an influence of various route of administration of Superlymph in women with frequent relapses of cystitis on the urothelium according to biopsy results, as well as on the symptoms of recurrent cystitis. The reparative effect of Superlymph was evaluated as well. In the control group (n=10), standard therapy was administered (fosfomycin trometamol 3.0 g once, and then, on the next day from the start of therapy, nitrofurantoin 100 mg three times a day for 5 days). The study consisted of screening, therapy and follow-up stages. The duration of therapy was 20 days. All groups did not differ significantly in the main baseline characteristics.

RESULTS:

The drug Superlymph demonstrated efficacy as monotherapy of uncomplicated lower urinary tract infection in women compared with standard treatment. Rectal administration of the drug was more effective than vaginal. This was primarily manifested by a decrease in the level of urothelial metaplasia by the end of the study by 41% in the group of rectal suppositories and by 9% for the vaginal suppositories. In the control group, no changes in the level of metaplasia were found. A symptom scale showed an improvement of 36% in the group of rectal suppositories, 25% in the group of vaginal suppositories, and 19% in the control group. Improvements in the quality-of-life score were 50.8%, 33.9%, and 31.1%, respectively. The mean pelvic pain symptom scale score improved by 30%, 23%, and 13%, while a decrease in the mean leukocytes level in urine was most significant in the group of vaginal suppositories, by 39%. The respective indicators in the group of rectal suppositories and the control group were 27% and 21%, respectively. Innate immune factors were also assessed. The evaluation of gene expression levels in the bladder mucosa after using Superlymph was also performed. A significant decrease in TLR4 gene expression by 3 times, TNF gene expression by 4.2 times, and HBD1 expression by 2.7 times was found, which indicates a significant decrease in the level of inflammation in the bladder mucosa.

CONCLUSION:

The immunomodulator Superlymph, representing a complex of natural antimicrobial peptides and cytokines, has demonstrated efficacy as monotherapy of chronic recurrent cystitis in women compared to standard treatment. Rectal route of administration was more effective than vaginal. This was primarily manifested by a decrease in the level of urothelial metaplasia by the end of the study. Therefore, the rectal suppositories should be used in older patients with a long history of the cystitis as intermittent therapy.

项与磷霉素氨丁三醇相关的新闻（医药）

2025-04-07

·信狐药迅

北京永泰首款实体瘤细胞治疗爱可仑赛注射液提交上市申请|新受理（3.31-4.6）

本周药品注册受理数据，分门别类呈现，一目了然。(3.31-4.6）新药上市申请药品名称企业注册分类受理号爱可仑赛注射液北京永泰生物制品有限公司1CXSS2500039新药临床申请药品名称企业注册分类受理号VCT220片苏州闻泰医药科技有限公司1CXHL2500355VCT220片苏州闻泰医药科技有限公司1CXHL2500354VCT220片苏州闻泰医药科技有限公司1CXHL2500353JMKX005425片上海济煜医药科技有限公司1CXHL2500352SHR2554片江苏恒瑞医药股份有限公司1CXHL2500347SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500346SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500345SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500344枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司2.4CXHL2500351枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司2.4CXHL2500350枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司2.4CXHL2500349枸橼酸舒芬太尼注射液江苏恩华药业股份有限公司2.4CXHL2500348自复制RNA带状疱疹疫苗嘉晨西海(杭州)生物技术有限公司1.2CXSL2500259Cizutamig注射液上海坦蒂生物医药科技有限公司1CXSL2500265ZHB118舌下片江苏众红生物工程创药研究院有限公司1CXSL2500264LM-168注射液礼新医药科技(上海)有限公司1CXSL2500260ZHB118舌下片江苏众红生物工程创药研究院有限公司1CXSL2500263MRG007乐普生物科技股份有限公司1CXSL2500262IMC-003宜明凯尔生物医药技术(上海)有限公司1CXSL2500261注射用SHR-A1904苏州盛迪亚生物医药有限公司1CXSL2500258注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500256重组抗CD19m-CD3抗体注射液天劢源和生物医药(上海)有限公司1CXSL2500255注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2500254SHR-1701注射液苏州盛迪亚生物医药有限公司1CXSL2500253阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500257仿制药申请药品名称企业注册分类受理号二羟丙茶碱注射液山东益健药业有限公司3CYHS2501299乙酰半胱氨酸片海南赛立克药业有限公司3CYHS2501292氯化钙注射液武汉市小铂生物科技有限公司3CYHS2501282吲哚布芬片郑州韩都药业集团有限公司3CYHS2501281维生素B6注射液扬州中宝药业股份有限公司3CYHS2501245右酮洛芬氨丁三醇片四川科瑞德制药股份有限公司3CYHS2501242右酮洛芬氨丁三醇片四川科瑞德制药股份有限公司3CYHS2501241托伐普坦口腔崩解片浙江和泽医药科技股份有限公司3CYHS2501277乙酰半胱氨酸注射液广东君康药业有限公司3CYHS2501276富马酸酮替芬口服溶液江苏润恒制药有限公司3CYHS2501275维生素B6注射液江苏悦兴医药技术有限公司3CYHS2501255盐酸溴己新口服溶液湖北海美纳医药科技有限公司3CYHS2501253复合磷酸氢钾注射液安徽双鹤药业有限责任公司3CYHS2501270依巴斯汀口服溶液江西心正药业有限责任公司3CYHS2501258硫代硫酸钠注射液江苏九旭药业有限公司3CYHS2501257泛昔洛韦片浙江车头制药股份有限公司3CYHS2501240泛昔洛韦片浙江车头制药股份有限公司3CYHS2501239注射用硫酸多黏菌素B福安药业集团烟台只楚药业有限公司3CYHS2501237氟哌啶醇口服溶液上海理想制药有限公司3CYHS2501233盐酸戊乙奎醚注射液国药集团工业有限公司廊坊分公司4CYHS2501254阿那曲唑片海南日中天制药有限公司4CYHS2501251布瑞哌唑片昆山龙灯瑞迪制药有限公司4CYHS2501248玻璃酸钠滴眼液四川禾亿制药有限公司4CYHS2501298玻璃酸钠滴眼液四川禾亿制药有限公司4CYHS2501297钆特酸葡胺注射液广州康臣药业有限公司4CYHS2501296甘油磷酸钠注射液山东华鲁制药有限公司4CYHS2501295甘油磷酸钠注射液山东华鲁制药有限公司4CYHS2501294复方托吡卡胺滴眼液浙江尖峰药业有限公司4CYHS2501293复方托吡卡胺滴眼液浙江尖峰药业有限公司4CYHS2501291碳酸镧咀嚼片浙江仟源海力生制药有限公司4CYHS2501290长链脂肪乳注射液(OO)江苏盈科生物制药有限公司4CYHS2501289低钙腹膜透析液(乳酸盐-G4.25%)宁波天益药业科技有限公司4CYHS2501288低钙腹膜透析液(乳酸盐-G4.25%)宁波天益药业科技有限公司4CYHS2501287低钙腹膜透析液(乳酸盐-G2.5%)宁波天益药业科技有限公司4CYHS2501286低钙腹膜透析液(乳酸盐-G2.5%)宁波天益药业科技有限公司4CYHS2501285低钙腹膜透析液(乳酸盐-G1.5%)宁波天益药业科技有限公司4CYHS2501284低钙腹膜透析液(乳酸盐-G1.5%)宁波天益药业科技有限公司4CYHS2501283夫西地酸乳膏杭州民生药业股份有限公司4CYHS2501246来特莫韦注射液苏州第壹制药有限公司4CYHS2501244妥布霉素滴眼液润尔眼科药物(广州)有限公司4CYHS2501243枸橼酸钠血滤置换液山东齐都药业有限公司4CYHS2501280盐酸伐地那非片江西施美药业股份有限公司4CYHS2501279盐酸伐地那非片江西施美药业股份有限公司4CYHS2501278艾拉莫德片山东现代医药科技有限公司4CYHS2501274米库氯铵注射液中玉制药(海口)有限公司4CYHS2501273复方氨基酸注射液(18AA-VII)湖北长联杜勒制药有限公司4CYHS2501272双氯芬酸钠缓释片江苏万高药业股份有限公司4CYHS2501252乳果糖口服溶液大玮(安徽)药业有限公司4CYHS2501271西甲硅油乳剂南通广承制药有限公司4CYHS2501250腹膜透析液(乳酸盐-G4.25%)宁波天益药业科技有限公司4CYHS2501269蛋白琥珀酸铁口服溶液海南康成药业有限公司4CYHS2501249腹膜透析液(乳酸盐-G4.25%)宁波天益药业科技有限公司4CYHS2501268夫西地酸乳膏杭州民生药业股份有限公司4CYHS2501247腹膜透析液(乳酸盐-G2.5%)宁波天益药业科技有限公司4CYHS2501267腹膜透析液(乳酸盐-G2.5%)宁波天益药业科技有限公司4CYHS2501266腹膜透析液(乳酸盐-G1.5%)宁波天益药业科技有限公司4CYHS2501265腹膜透析液(乳酸盐-G1.5%)宁波天益药业科技有限公司4CYHS2501264他达拉非片国大(吉林)制药集团有限公司4CYHS2501263他达拉非片国大(吉林)制药集团有限公司4CYHS2501262他达拉非片国大(吉林)制药集团有限公司4CYHS2501261注射用头孢他啶阿维巴坦钠山东致泰医药技术有限公司4CYHS2501260枸橼酸托法替布缓释片南京易亨制药有限公司4CYHS2501259非奈利酮片杨凌科森生物制药有限责任公司4CYHS2501256阿达帕林凝胶珠海市汇通达医药有限公司4CYHS2501238盐酸罗哌卡因注射液河南普瑞药业有限公司4CYHS2501236盐酸罗哌卡因注射液河南普瑞药业有限公司4CYHS2501235亚甲蓝肠溶缓释片南京正大天晴制药有限公司4CYHS2501234司美格鲁肽注射液杭州中美华东制药江东有限公司3.3CXSS2500043司美格鲁肽注射液杭州中美华东制药江东有限公司3.3CXSS2500042司美格鲁肽注射液杭州中美华东制药江东有限公司3.3CXSS2500041司美格鲁肽注射液杭州中美华东制药江东有限公司3.3CXSS2500040西帕依固龈液宁波卓仑医药科技有限公司4CYZS2500005进口申请药品名称企业注册分类受理号Clesrovimab注射液Merck Sharp & Dohme B.V.1JXSS2500042本瑞利珠单抗注射液AstraZeneca AB3.1JXSS2500040本瑞利珠单抗注射液AstraZeneca AB3.1JXSS2500039注射用德曲妥珠单抗Daiichi Sankyo Europe GmbH3.1JXSS2500041磷霉素氨丁三醇颗粒LABIANA Pharmaceuticals, S.L.U.5.2JYHS2500016氯巴占口服混悬液MARTINDALE PHARMACEUTICALS LIMITED5.2JYHS2500017Bimagrumab注射液Eli Lilly and Company1JXSL2500050Bimagrumab注射液Eli Lilly and Company1JXSL2500049Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500052Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500051注射用佐妥昔单抗Astellas Pharma Global Development,Inc.2.2JXSL2500048中药相关申请药品名称企业注册分类受理号芪桂络痹通片北京以岭药业有限公司1.1CXZS2500014二冬汤颗粒浙江维康药业股份有限公司3.1CXZS2500013西帕依固龈液宁波卓仑医药科技有限公司4CYZS2500005注：绿色字体部分为潜在首仿品种；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。

申请上市疫苗细胞疗法ASH会议临床申请

2025-04-02

·米内网

国药现代爆发了！净利润大涨56.6%，拿下23个重磅品种，34个新品掘金280亿市场

精彩内容近日，国药现代披露2024年业绩，报告期内实现营收109.38亿元，归母净利润10.84亿元。近年来，国药现代产品线逐渐步入收获期，2023年至今有23个重磅品种获批，目前过评品种数已扩增至85个，8大品种备战第十一批国采。此外，34个新品以新注册分类申报在审，剑指国内超280亿市场。净利润大涨56.6%！28个过亿产品亮眼国药现代为国药集团旗下的化药工业平台，经过多年发展和整合，目前拥有包括医药中间体与原料药、化学制剂、动物疫苗、大健康等业务板块，产品涵盖抗感染、心血管、抗肿瘤及免疫调节剂、中枢神经、代谢及内分泌、泌尿生殖系统、呼吸系统等治疗领域，剂型有片剂、胶囊剂、粉针剂、小容量注射剂、颗粒剂、混悬剂、栓剂和软膏剂等30多种。3月28日，国药现代披露2024年业绩，报告期内实现营业总收入109.38亿元，其中过亿产品28个，销售规模占比69.69%；归母净利润10.84亿元，同比增长56.62%；归母扣除非净利润10.43亿元，同比增长52.72%。近年来国药现代净利润情况（单位：亿元）来源：公司公告，米内网整理国药现代主要业务涵盖原料药及医药中间体、制剂、大健康三大板块，其中原料药及医药中间体收入51.98亿元，占总收入比重47.53%；制剂收入54.51亿元，占总收入比重49.84%。从分产品收入看，国药现代主营产品以全身用抗感染药为主，2024年收入约20.91亿元；心血管系统用药、神经系统用药紧接在后，收入均超过6亿元；此外，泌尿生殖系统用药及激素制剂收入超过5亿元，骨骼肌肉系统用药收入超过3亿元等。国药现代主营业务分产品情况来源：公司公告，米内网整理近年来，国药现代坚持“科技引领，创新驱动”策略，紧紧围绕中长期战略发展目标，加大研发投入力度，加快研发成果转化，为可持续发展奠定坚实基础。2024年公司研发投入6.75亿元，占营业收入的6.17%，比上年同期提高0.41个百分点。23个品种获批！34个新品掘金280亿市场3月11日及15日，国药现代先后公告称，其子公司申报的3类仿制药磷酸奥司他韦干混悬剂、4类仿制药阿加曲班注射液及甲泼尼龙片获批生产并视同过评。米内网数据显示，上述3个品种2023年在中国三大终端六大市场（统计范围详见本文末）的销售额分别超过2亿元、4亿元、2亿元。自2023年以来，国药现代累计有23个品种获批生产，其中有22个视同过评，不乏碳酸司维拉姆片、注射用头孢他啶阿维巴坦钠(4:1)、硫酸氢氯吡格雷片等临床畅销品种。近年来国药现代获批上市的品种来源：米内网中国申报进度（MED）数据库目前国药现代还有34个品种以新注册分类申请生产/临床在审，涵盖10个治疗大类，包括8个心脑血管系统药物、6个抗肿瘤和免疫调节剂、6个神经系统药物、5个消化系统及代谢药等。国药现代新分类申报且在审的品种来源：米内网中国申报进度（MED）数据库米内网数据显示，34个品种2023年在中国三大终端六大市场的销售额合计超过280亿元，其中达格列净片超50亿元，沙库巴曲缬沙坦钠片超30亿元，玻璃酸钠滴眼液、阿卡波糖片超20亿元，硫酸羟氯喹片、盐酸纳布啡注射液、左卡尼汀注射液、盐酸氨溴索注射液超10亿元。环磷酰胺注射液、托匹司他片、磷霉素氨丁三醇颗粒3个品种在国内暂无仿制药获批，其中环磷酰胺注射液、磷霉素氨丁三醇颗粒由国药现代首家/独家申报，拿下首仿的几率较大。85个过评品种亮眼！8大品种备战第11批国采目前国药现代有85个品种（134个受理号）过评或视同过评，其中盐酸米那普仑片、头孢地尼分散片、头孢呋辛酯片、头孢克肟颗粒、头孢呋辛酯胶囊、注射用达卡巴嗪、注射用阿糖胞苷、双氯芬酸钠缓释片等品种为国内首家/独家过评。85个品种涵盖12个治疗大类，集中在全身用抗感染药物（34个）、心脑血管系统药物（12个）、神经系统药物（8个）、抗肿瘤和免疫调节剂（6个）、消化系统及代谢药（6个）等治疗领域。国药现代已过评品种来源：米内网一致性评价进度数据库在国家开展的九批十轮化药集采中，国药现代合计有25个品种顺利中选，其中第七批国采中选8个，第九批国采中选5个，第十批国采中选4个，包括帕拉米韦注射液、碳酸司维拉姆片、氟尿嘧啶注射液、奥美沙坦酯氢氯噻嗪片等新品。余下的品种中，有17个暂未纳入国采，其中有8个品种已满足入围门槛，符合申报资格企业数达7家及以上，包括4款注射剂、2款口服液体剂、1款口服常释剂型、1款缓释控释剂型，不乏头孢他啶阿维巴坦注射剂、地氯雷他定口服液体剂等“光脚”品种（指公司在该品种中占比为0或较低）。国药现代已过评但暂未纳入国采且已满足门槛的品种来源：米内网综合数据库从竞争情况看，二羟丙茶碱注射剂、头孢唑肟注射剂、氨溴索口服液体剂、地氯雷他定口服液体剂遭“围攻”，目前符合申报资格企业数分别达30家、29家、28家、24家，其中头孢唑肟注射剂、二羟丙茶碱注射剂2023年在中国公立医疗机构终端的销售额分别超过44亿元、10亿元。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至4月1日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

财报疫苗核酸药物

2025-03-05

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赞邦与维健携手再启新篇章——富露施®注射剂中国区独家合作正式签约 | 会员动态

临床3期上市批准

100 项与磷霉素氨丁三醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00925	磷霉素氨丁三醇	J01XX01	DBSALT000781

研发状态

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	-	Zambon GmbH	1988-01-01

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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


NCT02641639 (FOCUS, CTgov)	临床2/3期	铂耐药性输卵管癌 \| 铂耐药性卵巢癌	70	Fosbretabulin tromethamine (Fosbretabulin Tromethamine)	顧淵蓋顧壓憲襯鬱遞鏇(鏇齋鏇觸願衊鹹遞獵鑰) = 觸窪顧襯艱憲網糧鏇積網製淵鏇遞鹽蓋衊膚蓋 (構範網觸鏇壓鏇膚窪繭, 遞顧糧製膚鹹顧艱鏇膚 ~ 襯顧鹽蓋醖淵網襯襯憲) 更多	-	2025-03-24
				Placebo (Placebo)	顧淵蓋顧壓憲襯鬱遞鏇(鏇齋鏇觸願衊鹹遞獵鑰) = 鬱鹹膚築網鏇顧窪觸鑰網製淵鏇遞鹽蓋衊膚蓋 (構範網觸鏇壓鏇膚窪繭, 襯蓋選窪構淵獵廠壓鏇 ~ 鹽衊艱願願鹽壓鹽憲夢) 更多
NCT06017479 (CTgov)	临床1/2期	泌尿道感染 \| 术后并发症	126	Fosfomycin 3000 MG (Pre-urodynamic Fosfomycin)	窪廠簾窪鹹夢衊選淵醖: Odds Ratio (OR) = 0.8 (95% CI, 0.4 ~ 1.95), P-Value = 0.660	-	2024-10-09
				Levofloxacin 500mg (Pre-urodynamic Levofloxacin)
NCT04209192 (MP34-16, AUA2023)	临床2期	-	-	Oral Fosfomycin Tromethamine 3 gr	壓選壓鹽鏇製選鏇構窪(築衊艱膚願蓋餘襯淵範) = 築積夢膚鹹蓋餘獵獵餘餘觸願鹹顧願艱鏇鏇憲 (膚遞鹽築遞網觸鹹願艱 ) 更多	积极	2023-04-01
				Preoperative Amikacin 1 gr I.V.	壓選壓鹽鏇製選鏇構窪(築衊艱膚願蓋餘襯淵範) = 顧鹹齋壓蓋壓襯鑰觸觸餘觸願鹹顧願艱鏇鏇憲 (膚遞鹽築遞網觸鹹願艱 ) 更多
NCT03697993 (CTgov)	临床4期	泌尿道感染	62	Fosfomycin tromethamine (Strategy 1)	積鹽齋築糧衊遞淵網襯 = 製醖簾觸網醖襯鑰網壓鹽構築憲衊淵餘齋鏇顧 (壓糧鬱鑰膚積觸簾餘鬱, 膚鏇糧網獵艱顧淵顧範 ~ 淵衊構襯醖繭獵範鹽憲) 更多	-	2020-12-19
				Levofloxacin (Strategy 2)	積鹽齋築糧衊遞淵網襯 = 顧艱膚餘壓構鏇積網夢鹽構築憲衊淵餘齋鏇顧 (壓糧鬱鑰膚積觸簾餘鬱, 窪製鬱觸蓋顧餘遞網鏇 ~ 衊醖窪窪遞廠範遞簾觸) 更多
NCT01820897 (Pubmed \| Transpl Infect Dis)	临床4期	下尿路感染性疾病	-	Fosfomycin trometamol + trimethoprim-sulfamethoxazole (Group 1)	選糧鏇構憲選網鏇鏇簾(膚簾壓觸憲艱觸鏇窪艱) = 鑰齋窪膚願鹹遞窪壓積選願鏇願鏇繭餘鹹構網 (襯齋窪艱夢願膚構築糧 )	-	2018-10-01
				Trimethoprim-sulfamethoxazole (Group 2)	選糧鏇構憲選網鏇鏇簾(膚簾壓觸憲艱觸鏇窪艱) = 餘鹽遞壓襯夢製廠製觸選願鏇願鏇繭餘鹹構網 (襯齋窪艱夢願膚構築糧 )
NCT02132468 (GI-NETorPNET, CTgov)	临床2期	类癌	18	fosbretabulin tromethamine	繭繭繭簾醖膚繭憲遞選 = 齋遞網齋膚糧遞壓憲襯蓋選蓋選鏇網築顧鑰醖 (壓艱觸鑰淵繭鏇遞襯淵, 獵鑰遞糧廠廠齋醖鹽齋 ~ 壓憲獵網獵蓋範鹹夢鏇) 更多	-	2017-10-19