Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.

Acute on chronic liver failure patients are at high risk for nosocomial infections due to liver dysfunction, which impairs immune responses and increases vulnerability to infections. Key factors contributing to nosocomial infections in ACLF patients include ascites, use of invasive devices, and recent hospitalization, frequent need for broad spectrum antibiotics. Multidrug resistance is a growing issue, making treatment more challenging, common pathogens involved are gram negative bacteria such as Escherichia Coli and Klebsiella pneumoniae. Surveillance data show increasing carbapenem resistant enterobacterales (CRE) infection rates in cirrhotics, with high morbidity and mortality rates. The impact of these nosocomial infections is profound, significantly worsen outcomes in ACLF patients, leading to prolonged hospitalizations, increased health care costs and higher mortality rates. Early detection and effective antibiotic stewardship are essential to manage antibiotic resistance and improve patient outcomes. In this study we aim to compare efficacy and safety of Ceftazidime avibactam versus extended infusions of high dose Meropenem in patients of ACLF with nosocomial infections.

开始日期2025-02-10

申办/合作机构

Institute of Liver & Biliary Sciences

NCT06426212

/ RecruitingN/AIIT

Use of Teicoplanin on a Three-weekly Administration in the Complex Outpatient Macroactivity Regimen of Infectious Diseases Unit in the Alessandro Manzoni Hospital (Lecco, Italy)

Teicoplanin is an antibiotic belonging to the class of glycopeptides, in use since 1986. Like its older "classmate" vancomycin, it inhibits protein synthesis by interfering with the synthesis of peptidoglycan, and is active on Gram-positive bacteria such as Staphilococcus spp (including MRSA), Streptococcus spp and Enterococcus spp (both faecalis and faecium).
Teicoplanin is characterized by poor gastrointestinal absorption, which requires intramuscular or intravenous administration; has a binding to plasma proteins greater than 90%; and a high volume of distribution. It reaches high levels in deep tissues (bone, abdomen, lung, kidney, heart) on the contrary it has poor penetration at the central nervous system level; it is approved for the treatment of skin and soft tissue infections, osteo-articular infections, pneumonia, endocarditis, complicated urinary tract infections, peritonitis and bacteremia associated with the aforementioned clinical conditions. Furthermore, teicoplanin has a markedly long half-life (between 30 and 180h) which allows it to be administered even every 48-72h. Dose and duration of treatment should be adjusted according to the location and severity of the infection and based on patient characteristics such as renal function. The possibility of carrying out therapeutic drug monitoring (TDM) allows maintaining plasma levels adequate for the treatment of deep infections (e.g. >20 mg/l for endocarditis) and avoiding overdose.
Thanks to the possibility of administering teicoplanin on a three-weekly schedule, patient access to hospital is further reduced.
The investigators therefore propose a retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme by comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs).

开始日期2024-05-07

申办/合作机构-

EUCTR2023-000005-12-IT

/ Not yet recruiting临床2期IIT

An open-label study to evaluate the safety and tolerability of inhaled Teicoplanin in the treatment of Staphylococcus aureus (including mrsa) infections in CYSTIC FIBROSIS PATIENTS - study to evaluate the safety of inhaled Teicoplanin in the treatment of Stafilococco infections

开始日期2024-02-21

申办/合作机构

Azienda Ospedaliera Universitaria Integrata Verona

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100 项与替考拉宁相关的转化医学

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100 项与替考拉宁相关的专利（医药）

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4,272

项与替考拉宁相关的文献（医药）

2025-12-31·Emerging Microbes & Infections

Genomic islands and molecular mechanisms relating to drug-resistance in Clostridioides ( Clostridium ) difficile PCR ribotype 176

Article

作者: Soltesova, Anna ; Pituch, Hanna ; Kuijper, Ed ; Brajerova, Marie ; Balikova Novotna, Gabriela ; Prasad, Suhanya ; Zikova, Jaroslava ; Demay, Fanny ; Novakova, Elena ; Kovarovic, Vojtech ; Krutova, Marcela ; Smits, Wiep Klaas

OBJECTIVES:

To analyse characteristics of Clostridioides difficile PCR ribotype 176 clinical isolates from Poland, the Czech Republic and Slovakia with regard to the differences in its epidemiology.

METHODS:

Antimicrobial susceptibility testing and whole genome sequencing were performed on a selected group of 22 clonally related isolates as determined by multilocus variable-number tandem repeat analysis (n = 509). Heterologous expression and functional analysis of the newly identified methyltransferase were performed.

RESULTS:

Core genome multilocus sequence typing found 10-37 allele differences. All isolates were resistant to fluoroquinolones (gyrA_p. T82I), aminoglycosides with aac(6')-Ie-aph(2'')-Ia in six isolates. Erythromycin resistance was detected in 21/22 isolates and 15 were also resistant to clindamycin with ermB gene. Fourteen isolates were resistant to rifampicin with rpoB_p. R505K or p. R505K/H502N, and five to imipenem with pbp1_p. P491L and pbp3_p. N537K. PnimB^G together with nimB_p. L155I were detected in all isolates but only five were resistant to metronidazole on chocolate agar. The cfrE, vanZ1 and cat-like genes were not associated with linezolid, teicoplanin and chloramphenicol resistance, respectively. The genome comparison identified six transposons carrying antimicrobial resistance genes. The ermB gene was carried by new Tn7808, Tn6189 and Tn6218-like. The aac(6')-Ie-aph(2'')-Ia were carried by Tn6218-like and new Tn7806 together with cfrE gene. New Tn7807 carried a cat-like gene. Tn6110 and new Tn7806 contained an RlmN-type 23S rRNA methyltransferase, designated MrmA, associated with high-level macrolide resistance in isolates without ermB gene.

CONCLUSIONS:

Multidrug-resistant C. difficile PCR ribotype 176 isolates carry already described and unique transposons. A novel mechanism for erythromycin resistance in C. difficile was identified.

2025-08-01·MICROBIOLOGICAL RESEARCH

Emergence and spread of ST5 methicillin-resistant Staphylococcus aureus with accessory gene regulator dysfunction: genomic insights and antibiotic resistance

Article

作者: Zhuang, Hemu ; Hong, Yueqin ; Sun, Lu ; Wang, Zhengan ; Chen, Yiyi ; Chen, Mengzhen ; Matuszewska, Marta ; Holmes, Mark A ; Wu, Xueqing ; Ba, Xiaoliang ; Yu, Yunsong ; Zhu, Feiteng ; Jiang, Shengnan ; Chen, Yan ; Ji, Shujuan ; Wang, Haiping

The globally disseminated Staphylococcus aureus ST5 clone poses a major public health threat due to its multidrug resistance and virulence. Here, we identified an agr-dysfunctional (agrA-I238K) ST5 MRSA clone that has spread across East and Southeast Asia, with recent increases in China since its emergence in the 1970s. Comparative genomic analyses identified distinct single-nucleotide polymorphisms and mobile genetic elements linked to enhanced resistance and virulence. This clone exhibits resistance to seven antimicrobial classes, including third-generation tetracyclines and fusidic acid, and shares phenotypic and genetic similarities with the vancomycin-intermediate S. aureus Mu50 strain, including reduced susceptibility to vancomycin, teicoplanin, and daptomycin. The agrA-I238K mutation attenuates hemolytic activity, increases biofilm formation, and reduces daptomycin susceptibility, suggesting a key role in the clone's success. Our results demonstrate the important role of agrA-I238K mutation in the widespread distribution of agr-dysfunctional MRSA and highlight the importance of genomic surveillance in tracking the spread of agr-dysfunctional ST5 MRSA.

2025-08-01·MICROBIAL PATHOGENESIS

Antibiofilm activity of arachidonic acid against linezolid-resistant Enterococcus faecalis: A potential strategy for combating biofilm-related infections

Article

作者: Wang, Yu ; He, Meibo ; Shen, Hong ; Gu, Li ; Wei, Ming ; Wang, Shuai ; Li, Tianmeng ; Liu, Jun ; Wang, Peng

Enterococcus faecalis, a prevalent opportunistic pathogen, readily forms biofilms on surfaces, contributing to its virulence and antibiotic resistance. Previous studies have highlighted arachidonic acid (AA) as a promising antibiofilm agent. This investigation aimed to elucidate the antibiofilm activity of AA against linezolid-resistant E. faecalis and explore its potential molecular mechanisms. A total of 21 E. faecalis strains were included in this study: the standard strain ATCC 29212 and 20 linezolid-resistant clinical isolates. To determine the minimum inhibitory concentrations (MICs) of antibiotics and AA, the microbroth dilution method was performed. Checkerboard microdilution assays were also performed to assess the interaction between AA and linezolid. The crystal violet method was performed to evaluate the biofilm formation abilities of E. faecalis and the biofilm inhibition activities of different concentrations of AA (0.25 mM, 0.5 mM, and 1 mM). In addition, the expression levels of biofilm-related genes (ebpA, ebpB, ebpC, gelE, ace, atlA, and esp) were measured employing quantitative reverse transcription PCR (qRT-PCR). All clinical strains exhibited resistance to linezolid and tetracycline while remaining susceptible to other antibiotics, including penicillin, ampicillin, vancomycin, teicoplanin, and tigecycline. The MICs of AA against all 21 E. faecalis isolates were >1 mM. Synergy was observed in 75 % of strains (15/20), while additivity was observed in 25 % strains (5/20). All isolates displayed strong biofilm-forming abilities. AA significantly reduced biofilm formation with average inhibition rates of 68.16 %, 69.64 %, and 72.01 % at concentrations of 0.25 mM, 0.5 mM, and 1 mM, respectively (P < 0.001). AA treatment resulted in decreased expression of ebpB, ebpC, ace, and atlA (P < 0.001), while simultaneously increasing gelE expression (P < 0.05). In conclusion, AA exhibited potent inhibitory effects on E. faecalis biofilm formation probably by influencing bacterial adhesion. The addition of AA can restore the susceptibility of linezolid against E. faecalis. These findings suggest that AA may serve as a potential therapeutic agent for preventing and treating E. faecalis infections, particularly those associated with biofilm formation.

项与替考拉宁相关的新闻（医药）

2025-04-15

·米内网

【重磅】汇宇制药1类新药来袭！猛攻2200亿市场

精彩内容日前，汇宇制药公告称，其全资子公司汇宇海玥提交的1类新药注射用HY0001a的临床申请获得受理，用于治疗晚期实体瘤。目前公司有4款1类新药在国内处于申请临床及以上阶段，且均为抗肿瘤药。米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）抗肿瘤和免疫调节剂（化药+生物药）销售额超过2200亿元。注射用HY0001a是一款靶向CDCP1的抗体偶联药物，研究表明，CDCP1在胃癌、乳腺癌、肺癌、结直肠癌、胰腺癌等多种肿瘤中高表达而正常组织不表达或低表达，是ADC药物开发的重要潜力靶点。目前国内外尚无同靶点药物获批上市，注射用HY0001a为全球首个披露针对该靶点且推向临床的药物。米内网数据显示，目前汇宇制药在国内有4款1类新药处于申请临床及以上阶段，均为抗肿瘤药。近年来，随着越来越多的创新药获批上市并实现销售，叠加临床刚需属性拉动，中国三大终端六大市场抗肿瘤和免疫调节剂（化药+生物药）销售额逐年上涨，2023年超过2200亿元，2024上半年以约8%的增速继续攀升。汇宇制药国内处于申请临床及以上阶段的1类新药来源：米内网综合数据库注射用HY07121是靶向PD-1/TIGIT/IL-15的三靶点抗体融合蛋白，目前国内外尚无同类产品获批上市，汇宇制药研发进展最快，相关新药正在开展晚期实体瘤适应症的I/II期临床试验。HYP-2090PTSA胶囊是一款KRAS G12C/PI3K双靶点小分子抑制剂，目前国内外尚无同类产品获批上市，汇宇制药研发进展最快，相关新药正在开展KRAS G12C突变的晚期实体瘤适应症的I/II期临床试验。HYP-6589片是一款高选择性SOS1小分子抑制剂，目前国内外尚无同靶点药物获批上市，在研新药包括汇宇制药的HYP-6589、Mirati的MRTX-0902、石药的SYH-2038等。除了创新药，汇宇制药在海外产品注册方面也收获颇丰，今年以来，公司的注射用替考拉宁获得葡萄牙、爱尔兰、法国上市许可，普乐沙福注射液获得沙特阿拉伯、秘鲁上市许可，注射用环磷酰胺获得荷兰、意大利上市许可，唑来膦酸注射液、丙戊酸钠注射用浓溶液获得意大利上市许可，注射用培美曲塞二钠获得土库曼斯坦上市许可，注射用帕瑞昔布钠获得英国上市许可，多西他赛注射液获得埃及上市许可，氟维司群注射液获得巴基斯坦上市许可，盐酸伊立替康注射液获得哥斯达黎加上市许可等。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15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

抗体药物偶联物上市批准申请上市免疫疗法临床1期

2025-04-13

·信狐药迅

恒瑞医药-夫那奇珠单抗注射液银屑病新适应症获批上市| 新获批(4.7-4.13）

每周药品注册获批数据，分门别类呈现，一目了然。(4.7-4.13）新药上市申请药品名称企业注册分类受理号SHR0302片江苏恒瑞医药股份有限公司1CXHS2300097夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司1CXSS2400018夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司1CXSS2400017新药临床申请药品名称企业注册分类受理号注射用BH259珠海贝海生物技术有限公司1CXHL2500168HRS9531注射液福建盛迪医药有限公司1CXHL2500157HRS9531注射液福建盛迪医药有限公司1CXHL2500156HRS9531注射液福建盛迪医药有限公司1CXHL2500155HRS-9813胶囊广东恒瑞医药有限公司1CXHL2500147TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2500137TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2500136AC699片冰洲石生物科技(上海)有限公司1CXHL2500145AC699片冰洲石生物科技(上海)有限公司1CXHL2500142TQB3019胶囊正大天晴药业集团股份有限公司1CXHL2500138TT-9701片中国科学院上海药物研究所1CXHL2500129TT-9701片中国科学院上海药物研究所1CXHL2500128INR102注射液云核医药(天津)有限公司1CXHL2500121FY101注射液北京福元医药股份有限公司1CXHL2500100DNV001注射液杭州鼎乐新为生物科技有限公司1CXHL2500095奥格特韦钠胶囊浙江艾森药业有限公司1CXHL2500093SYH2046片上海翊石医药科技有限公司1CXHL2500091SYH2046片上海翊石医药科技有限公司1CXHL2500090RN1871 注射液大睿生物医药科技(上海)有限公司1CXHL2500078注射用IMBZ18g广州艾奇西新药研究有限公司1CXHL2500053DM2065贴北京德默高科医药技术有限公司2.2CXHL2500148司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500127司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500126司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500125司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2500124LH-2103胶囊江苏联环药业股份有限公司2.3CXHL2500114注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500134带状疱疹mRNA疫苗上海生物制品研究所有限责任公司1.2CXSL2500040AK139注射液中山康方生物医药有限公司1CXSL2500100AK139注射液中山康方生物医药有限公司1CXSL2500099BNT327百欧恩泰(上海)医药有限公司1CXSL2500096BNT326百欧恩泰(上海)医药有限公司1CXSL2500095注射用SIM0686上海先祥医药科技有限公司1CXSL2500097注射用QLS31905齐鲁制药有限公司1CXSL2500084ADG126注射液天演药业(苏州)有限公司1CXSL2500089注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2500083注射用ASKG915江苏奥赛康生物医药有限公司1CXSL2500092SHR-1819注射液广东恒瑞医药有限公司1CXSL2500086SHR-4658注射液上海恒瑞医药有限公司1CXSL2500067EA5注射液上海览屹医药科技有限公司1CXSL2500051P134细胞注射液天士力医药集团股份有限公司1CXSL2500032XS411细胞注射液士泽生物医药(苏州)有限公司1CXSL2500035卡度尼利单抗注射液康方药业有限公司2.2CXSL2500102QL2107注射液齐鲁制药有限公司2.2CXSL2500085SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500088阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500093阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500081纳基奥仑赛注射液广东合源生物医药有限公司2.2CXSL2500030仿制药申请药品名称企业注册分类受理号法莫替丁注射液广州一品红制药有限公司3CYHS2401785盐酸纳美芬注射液福建新迪医药科技有限公司3CYHS2401361帕拉米韦注射液山东齐都药业有限公司3CYHS2400400氯化钾注射液福建新迪医药科技有限公司3CYHS2303635盐酸阿比多尔片武汉人福利康药业有限公司3CYHS2303169普瑞巴林口服溶液浙江浙北药业有限公司3CYHS2302826钠钾镁钙注射用浓溶液南京正科医药股份有限公司3CYHS2302809普瑞巴林口服溶液广西维威制药有限公司3CYHS2302626磷酸奥司他韦干混悬剂江苏加友药业集团有限公司3CYHS2302613生理氯化钠溶液山东科伦药业有限公司3CYHS2302543生理氯化钠溶液山东科伦药业有限公司3CYHS2302542福多司坦口服溶液昆明南疆制药有限公司3CYHS2302476复方匹可硫酸钠颗粒江西科睿药业有限公司3CYHS2302428氨茶碱注射液华夏生生药业(北京)有限公司3CYHS2302129昂丹司琼口溶膜江苏和晨药业有限公司3CYHS2302092昂丹司琼口溶膜江苏和晨药业有限公司3CYHS2302091依巴斯汀口服溶液海南元盈医药科技有限公司3CYHS2302066熊去氧胆酸口服混悬液成都赛璟生物医药科技有限公司3CYHS2302006洛索洛芬钠口服溶液云南先施药业有限公司3CYHS2301966氢溴酸依他佐辛注射液合肥亿帆生物制药有限公司3CYHS2301841复方聚乙二醇(3350)电解质散南京同仁堂黄山精制药业有限公司3CYHS2301730奥硝唑注射液海南海灵化学制药有限公司3CYHS2301608注射用苯唑西林钠广东金城金素制药有限公司3CYHS2301449注射用苯唑西林钠广东金城金素制药有限公司3CYHS2301448米诺地尔外用溶液江苏润邦药业有限公司3CYHS2301430米诺地尔外用溶液江苏润邦药业有限公司3CYHS2301429右酮洛芬氨丁三醇片湖南诺纳医药科技有限公司3CYHS2301107盐酸左西替利嗪口服溶液吉林省辉南长龙生化药业股份有限公司3CYHS2300981聚乙烯醇滴眼液浙江莎普爱思药业股份有限公司3CYHS2300976维生素K滴剂广西铭磊维生制药有限公司3CYHS2201025国;CYHS2201025复方氨基酸注射液(18AA-IX)辽宁民康制药有限公司4CYHS2500159沙美特罗替卡松吸入粉雾剂润生药业有限公司4CYHS2403268硫酸氢氯吡格雷片四川鲁徽制药有限责任公司4CYHS2400549西洛他唑片烟台万润药业有限公司4CYHS2400480硫酸氨基葡萄糖胶囊广州汇元医药科技有限公司4CYHS2400433达格列净片江苏万高药业股份有限公司4CYHS2400293达格列净片江苏万高药业股份有限公司4CYHS2400292甲磺酸多沙唑嗪缓释片四川科伦药业股份有限公司4CYHS2400244地夸磷索钠滴眼液武汉五景药业有限公司4CYHS2400230吸入用丙酸倍氯米松混悬液江西艾施特制药有限公司4CYHS2400132达格列净片福元药业有限公司4CYHS2303637达格列净片福元药业有限公司4CYHS2303636黄体酮软胶囊浙江神洲药业有限公司4CYHS2303548二甲双胍恩格列净片(VI)山东朗诺制药有限公司4CYHS2303456二甲双胍恩格列净片(I)山东朗诺制药有限公司4CYHS2303455注射用头孢他啶阿维巴坦钠成都倍特药业股份有限公司4CYHS2303429注射用替考拉宁福安药业集团烟台只楚药业有限公司4CYHS2303391注射用盐酸万古霉素海南倍特药业有限公司4CYHS2303276枸橼酸西地那非片遂成药业股份有限公司4CYHS2303272枸橼酸西地那非片遂成药业股份有限公司4CYHS2303271氧(液态)南宁市卓越气体有限公司4CYHS2303098复方氨基酸注射液(18AA-VII)山东齐都药业有限公司4CYHS2303086盐酸屈他维林注射液北京沃邦医药科技有限公司4CYHS2303060培哚普利叔丁胺片安若维他药业泰州有限公司4CYHS2302967培哚普利叔丁胺片安若维他药业泰州有限公司4CYHS2302966培哚普利叔丁胺片安若维他药业泰州有限公司4CYHS2302965盐酸贝尼地平片四川科瑞德制药股份有限公司4CYHS2302931长链脂肪乳注射液(OO)广东嘉博制药有限公司4CYHS2302821利丙双卡因乳膏浙江沣华医药科技有限公司4CYHS2302779乳果糖口服溶液哈药集团中药二厂4CYHS2302709缬沙坦氨氯地平片(I)河北万岁药业有限公司4CYHS2302651甲磺酸倍他司汀片厦门恩成制药有限公司4CYHS2302477左卡尼汀口服溶液东药集团沈阳施德药业有限公司4CYHS2302431骨化三醇软胶囊广州艾格生物科技有限公司4CYHS2302406沙库巴曲缬沙坦钠片沐邦(北京)医药科技有限公司4CYHS2302076沙库巴曲缬沙坦钠片沐邦(北京)医药科技有限公司4CYHS2302075沙库巴曲缬沙坦钠片沐邦(北京)医药科技有限公司4CYHS2302074头孢地尼颗粒重庆吉斯瑞制药有限责任公司4CYHS2302029硝酸甘油喷雾剂北京双鹭药业股份有限公司4CYHS2301947二甲双胍恩格列净片(I)杭州朱养心药业有限公司4CYHS2301801甲磺酸溴隐亭片浙江泰利森药业有限公司4CYHS2301125进口申请药品名称企业注册分类受理号盐酸伊普可泮胶囊Novartis Pharma Schweiz AG2.4JXHS2400061环索奈德吸入气雾剂Covis Pharma GmbH5.1JXHS2400019环索奈德吸入气雾剂Covis Pharma GmbH5.1JXHS2400018枸橼酸艾瑞芬净片SCYNEXIS, Inc.5.1JXHS2300072地诺孕素片Laboratoires Besins International5.2JYHS2400030注射用厄他培南Savior Lifetec Corporation5.2JYHS2300070布地奈德福莫特罗吸入气雾剂Mylan Pharmaceuticals Inc.5.2JYHS2300039布地奈德福莫特罗吸入气雾剂Mylan Pharmaceuticals Inc.5.2JYHS2300038MT-7117 片Mitsubishi Tanabe Pharma Corporation1JXHL2500014PF-07275315注射液Pfizer Inc.1JXSL2500035度伐利尤单抗注射液MedImmune LLC2.2JXSL2500018艾氟洛芬贴剂齐鲁制药有限公司3CYHL2500032氟比洛芬贴剂江西康恩贝中药有限公司3CYHL2500030双氯芬酸钠贴剂深圳珐玛易药品科技有限公司3CYHL2500027帕立骨化醇软胶囊青岛国信制药有限公司3CYHL2500029帕立骨化醇软胶囊青岛国信制药有限公司3CYHL2500028无水甜菜碱散剂伊春五加参药业有限责任公司3CYHL2500026瑞卢戈利片浙江和泽医药科技股份有限公司3CYHL2500017阿瑞匹坦注射液山东齐都药业有限公司3CYHL2500016尿素[13C]呼气试验药盒辐瑞森生物科技(昆山)有限公司3CYHL2500015尿素[13C]呼气试验药盒辐瑞森生物科技(昆山)有限公司3CYHL2500014甘露醇山梨醇注射液湖南先施制药有限公司3CYHL2500008皮下注射人免疫球蛋白华润博雅生物制药集团股份有限公司3.2CXSL2500031中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

疫苗信使RNA申请上市上市批准临床申请

2025-03-28

·士研生命科学

【产业周报】超90万家医药机构接入医保药品耗材追溯平台；弘和仁爱医疗：周向亮获委任为提名委员会成员

WEEKLY REPORT03/282025产业简报本期导读本周要闻产业洞察产业研报近期活动最新课程本周要闻SHINE CONSULTANT行业快讯News Flashes讯飞医疗科技涨超9% 公司去年B端业务收入同比翻倍增长讯飞医疗科技(02506)涨超9%，截至发稿，涨9.03%，报126.8港元，成交额2292.24万港元。消息面上，讯飞医疗科技于发布2024年全年业绩报告。公司全年实现营收7.34亿元，同比增长32.0%；毛利达4.04亿元，同比增长28.4%；毛利率保持在55.1%。其中，B端业务表现亮眼，收入由2023年的6491万元增至1.32亿元，同比增长103%，成为公司增长新引擎。患者服务收入同比增长56.6%，区域管理平台解决方案增长31.8%。公司收入结构持续优化，B端和C端业务占总收入比例从2023年的26%提升至2024年的47%。（智通财经）超90万家医药机构接入医保药品耗材追溯平台据国家医保局消息，国家医保药品耗材追溯信息采集应用平台已接入90多万家定点医药机构，接入率超过95%。医保部门可实现药品生产流通全程监管，确保药品质量和医保基金安全。（新京报）罗氏制药与默克达成战略合作，推进中国肺癌精准治疗3月26日，罗氏制药和默克共同宣布双方正式签订协议，就特泊替尼（商品名：拓得康）在中国大陆市场的商业化达成合作。特泊替尼是全球首个获批上市的MET抑制剂，于2023年12月在中国获批上市，通过靶向METex 14跳跃突变等特定靶点，用于非小细胞肺癌患者的精准治疗。（每日经济新闻）汇宇制药：子公司产品获境外上市许可汇宇制药3月26日公告，子公司Seacross Pharma(Europe) Ltd.及Seacross Pharmaceuticals Ltd.分别收到意大利卫生部、葡萄牙国家药品和健康产品管理局、沙特阿拉伯食品药品管理局核准签发的公司产品丙戊酸钠注射用浓溶液、唑来膦酸注射液、注射用替考拉宁、普乐沙福注射液的上市许可。（界面新闻）君实生物：特瑞普利单抗获得新加坡卫生科学局批准上市君实生物晚间公告，特瑞普利单抗（新加坡商品名：LOQTORZI®）联合顺铂和吉西他滨用于复发、不能手术或放疗的，或转移性鼻咽癌成人患者的一线治疗的上市许可申请获得新加坡卫生科学局（HSA）批准。特瑞普利单抗成为新加坡首个且唯一获批用于鼻咽癌的肿瘤免疫治疗药物。（第一财经）人事变动Personnel Changes弘和仁爱医疗：周向亮获委任为提名委员会成员弘和仁爱医疗(03869)发布公告，公司现任执行董事潘建丽女士和独立非执行董事周向亮先生获委任为公司提名委员会成员，自2025年3月26日起生效。（智通财经）太美医疗科技(02576.HK)：倪晓梅及冯志伟获委任为董事会提名委员会成员太美医疗科技(02576.HK)公告，于2025年3月24日，执行董事倪晓梅及独立非执行董事冯志伟已获委任为董事会提名委员会成员，变动自2025年3月24日起生效。（格隆汇）产业洞察SHINE CONSULTANT01喜报！和黄医药引进FIC抗肿瘤新药「他泽司他」在中国获批：滤泡淋巴瘤治疗迎来新突破0290%的企业都可能踩坑！做对这件事很有必要点击阅读全文产业研报SHINE CONSULTANT012023年中国企业医疗健康管理白皮书022022年中国康复医疗行业研究报告03合成生物学产业链及应用场景042023年家用医疗智能器械商业路径发展报告05医疗产业链中数字化场景发展现况及挑战062022年药品市场生命周期研究之GLP-1RA篇07中国医疗器械蓝皮书（2023版）点击阅读全文近期活动SHINE CONSULTANT2025医药数智营销创新峰会，3月27日-28日 · 上海（点击查看）最新课程SHINE CONSULTANT生物医药行业研究与投资逻辑（点击查看）全面汇总：医药全行业研究分析框架与投资逻辑详解（点击查看）联系我们Sunny Sun 孙女士T:021 6095 0241M:189 6294 0579（微信同号）E:sunny.sun@shine-consultant.com会议咨询媒体合作商务合作欢迎详询洽谈！SHINE CONSULTANT上海士研管理咨询有限公司成立于2005年，致力于为组织领导者提供沟通交流与专家智库平台。通过二十年沉淀与积累，覆盖了金融与投资、交通与运输、消费与文旅、医药与医疗、能源与资源、高科与电信、公用与政府等产业领域，服务着全球500强和万余家领导型企业，汇聚了百万余名机构决策者，并与千余家产业权威机构建立了战略伙伴关系。士研咨询秉承专业立身的理念发展队伍，现拥有百余名专业的资深人员，核心管理团队都具有十五年以上的专业经验。

高管变更上市批准财报

100 项与替考拉宁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02142	替考拉宁	J01XA02	DB06149

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
脓胸	日本	Sanofi	1998-04-10
出血性败血症	日本	Sanofi	1998-04-10
肺炎	日本	Sanofi	1998-04-10
皮肤和皮肤结构感染	日本	Sanofi	1998-04-10
皮肤疾病	日本	Sanofi	1998-04-10
革兰氏阳性细菌感染	中国	Gruppo Lepetit SRL	-

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
囊性纤维化	临床1期	意大利	苏州润新生物科技有限公司	2019-10-25
囊性纤维化	临床1期	意大利	Neupharma Srl	2019-10-25
埃博拉病毒性疾病	临床前	中国	中山大学	2016-04-01
严重急性呼吸综合征	临床前	中国	中山大学	2016-04-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AAAAI2024	N/A	特应性皮炎	-	antistaphylococcal drugs (Group 1 (positive initial BC for S.aureus))	願鏇鹽構築鹹顧構積窪(鑰壓蓋膚夢鑰獵醖築簾) = 選鑰願築淵鑰築繭鏇淵範繭遞窪觸鹽構廠醖蓋 (襯範艱壓醖醖餘獵餘觸 ) 更多	-	2024-02-23
				antistaphylococcal drugs (Group 2 (negative BC for S.aureus))	願鏇鹽構築鹹顧構積窪(鑰壓蓋膚夢鑰獵醖築簾) = 築蓋繭範簾醖製繭構顧範繭遞窪觸鹽構廠醖蓋 (襯範艱壓醖醖餘獵餘觸 ) 更多
EHA2021	N/A	造血干细胞移植	190	Aerobic antibiotics	顧壓顧獵網範憲蓋鹽顧(蓋獵壓襯積窪鹽觸廠夢) = 構窪糧襯願遞範窪膚鏇衊憲簾醖網餘築窪繭蓋 (積齋簾遞醖鏇醖鹽鑰衊 )	-	2021-06-09
NCT01592032 (Pubmed \| Int J Antimicrob Agents)	临床4期	菌血症	44	Teicoplanin lock therapy	遞艱構膚艱顧願淵製鑰(衊醖簾鹹網鹹築鏇壓觸) = 憲齋鏇築膚窪鹹鏇鏇鹽鏇餘壓鑰齋鹽遞廠選蓋 (衊淵遞製範鑰簾廠蓋憲 ) 更多	积极	2009-11-01
				Vancomycin lock therapy	遞艱構膚艱顧願淵製鑰(衊醖簾鹹網鹹築鏇壓觸) = 顧糧願壓鏇顧窪獵積獵鏇餘壓鑰齋鹽遞廠選蓋 (衊淵遞製範鑰簾廠蓋憲 )