PRISM-TB is an international, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, noninferiority Phase 3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB).
The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDR/RR-TB, defined by a pre-specified risk stratification algorithm, have noninferior efficacy to a one-size-fits-all control regimen (the local standard-of-care [SOC] regimen consistent with preferred regimen(s) in international guidelines), as measured by TB-related unfavorable outcomes at Week 73.

开始日期2025-01-15

申办/合作机构

The University of California, San Francisco

[+1]

NCT06253715 / Not yet recruiting临床3期IIT

Shortened Regimen for Drug-susceptible TB in Children

While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.

开始日期2024-12-13

申办/合作机构

The Johns Hopkins University

100 项与盐酸莫西沙星相关的临床结果

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100 项与盐酸莫西沙星相关的转化医学

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100 项与盐酸莫西沙星相关的专利（医药）

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6,070

项与盐酸莫西沙星相关的文献（医药）

2025-02-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Successful treatment of infections caused by mycobacterium abscessus complex following aesthetic procedures: A case series in China

Article

作者: Yu, Zhenwei ; Zhu, Jianping ; Ying, Miaofa ; Zhao, Rui

BACKGROUND:

Aesthetic procedure-associated infections caused by Mycobacterium abscessus complex (MABC) have been an emerging concern. However, limited evidence is available on this topic, and there are no standard treatments. The selection of antimicrobial regimens for the effective treatment of MABC infections poses a significant challenge.

CASE PRESENTATION:

In this case series, we present three patients in China who developed MABC infections following various aesthetic procedures. Two patients presented with localized skin and soft tissue infections, whereas one patient developed a disseminated infection. Treatment involved a combination of intravenous amikacin and cefoxitin for more than two weeks, followed by an oral regimen comprising clarithromycin, linezolid, and moxifloxacin based on drug susceptibility testing results. Despite the treatment's efficacy, the patients experienced adverse reactions to the antibiotics, including gastrointestinal symptoms, anaemia, and hearing loss. All patients achieved successful outcomes with shorter treatment courses and no relapse during the 3-year follow-up period.

CONCLUSION:

This case series emphasizes the importance of employing appropriate combination antibiotic therapies based on drug susceptibility testing results for aesthetic procedure-associated infection caused by MABC when specific subspecies are unidentified. The combination of intravenous aminoglycosides and cefoxitin, followed by oral sequential therapy, with the course of treatment specifically tailored to the severity of the infection, provides a valuable treatment reference for patients with MABC infections in China.

2025-02-01·ANALYTICAL BIOCHEMISTRY

Comparative validation of UV-spectrophotometry and RP-HPLC methods for cefixime and moxifloxacin analysis

Article

作者: Parmar, Parul K ; Chaudhari, Mahesh ; Dudhat, Kiran

AIM:

This study presents the development and validation of UV-spectrophotometry and RP-HPLC methods for the simultaneous quantification of Cefixime Trihydrate (CEFI) and Moxifloxacin Hydrochloride (MOXI) in pharmaceutical formulations.

METHODOLOGY:

Two UV-spectrophotometric methods, including the absorbance ratio (Q-Absorption) and First Order Derivative Spectroscopy, were developed and validated for their linearity, precision, accuracy, and sensitivity. Additionally, a robust RP-HPLC method using a C18 column and optimized mobile phase was employed for efficient separation and simultaneous estimation of CEFI and MOXI. All methods were validated in accordance with ICH guidelines, with system suitability parameters confirming the reliability of the RP-HPLC method for routine analysis.

RESULTS:

The absorbance ratio and First Order Derivative methods demonstrated low %R.S.D values, high accuracy, and satisfactory sensitivity for both drugs. Similarly, the RP-HPLC method achieved high resolution, precision, and robustness. Statistical analysis through ANOVA revealed no significant differences between the methods in terms of accuracy and precision. The methods were applied to analyze marketed formulations, further confirming their applicability in routine quality control.

CONCLUSION:

In conclusion, the validated methods provide accurate, precise, and sensitive techniques for the simultaneous estimation of CEFI and MOXI, making them suitable for pharmaceutical quality control and regulatory compliance.

2025-02-01·FOOD CHEMISTRY

High sensitivity distinguishing detection of fluoroquinolones with a cage-based lanthanide metal-organic framework in food

Article

作者: Jia, Lei ; Zhao, Xiaolei ; Zhao, Tongqian ; Zhao, Dan ; Xu, Jun ; Jia, Ruoqin ; Zhang, Lina ; Huang, Yuanyuan

Sensitive and selective detection of fluoroquinolones, especially from different sources, is challenging. This study reported an uncommon three-cage lanthanide metal-organic framework (1-Eu) with a Eu³⁺ cluster as its structural primitive using a C₂-symmetric 5,5-(Pyrazine-2,6-diyl) diisophthalic acid ligand. The 1-Eu probe effectively detected four fluoroquinolones through distinct color changes and spectral emission bands, demonstrating excellent performance with low detection limits: moxifloxacin (LOD: 9.3 nM), danofloxacin (LOD: 33.7 nM), gatifloxacin (LOD: 67.9 nM), and ofloxacin (LOD: 238.6 nM). Mechanistic studies revealed that internal filtration and photoinduced electron transfer (a-PET) effects were key factors. Furthermore, 1-Eu was successfully used to detect fluoroquinolones in food samples. Additionally, portable paper-based sensors were developed to quickly semi-quantify analyte concentrations using a smartphone color recognition app, underscoring the practical potential of this probe. This study introduces a novel methodology for the identification and detection of fluoroquinolones to enhance food safety.

267

项与盐酸莫西沙星相关的新闻（医药）

2024-12-11

·Business Wire

Meitheal Pharmaceuticals Grows Specialty Biopharmaceuticals Portfolio with Exclusive Commercial Licensing Agreement for XENLETA® (lefamulin acetate)

CHICAGO--( BUSINESS WIRE )--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago focused on the development and commercialization of generic, fertility, biologic, and branded injectable products, announced it has secured exclusive commercial rights in the U.S. to XENLETA ® (lefamulin acetate) through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industrial Co., Ltd. (HKF). XENLETA ® belongs to a new class of novel antibiotics and is approved in intravenous and oral formulations in the U.S. and multiple other countries for the treatment of community-acquired bacterial pneumonia (CABP) in adults. HKF has acquired global rights to XENLETA ® (with the exception of Greater China) from Nabriva Therapeutics. Through the acquisition, HKF has obtained substantially all global assets related to XENLETA ® , including results of development and regulatory activities. “The licensing of XENLETA ® bolsters our portfolio of novel antibiotics and reflects our focus on addressing the growing issue of antimicrobial resistance,” said Tom Shea, Chief Executive Officer of Meitheal. “As the first approved medicine of an entirely new class of antibiotics, XENLETA ® is an innovative therapeutic option that will be available to the patients affected by CABP and has been shown to be active against various bacterial strains. We look forward to leveraging our end-to-end expertise in biopharmaceutical development and commercialization to bring this important therapeutic to patients in need.” XENLETA ® is a first-in-class semi-synthetic pleuromutilin antibiotic. As a monotherapy offering a complete spectrum of coverage for the main CABP pathogens and with a low propensity for the development of bacterial resistance, XENLETA ® represents a critical step in addressing the growing global public health crisis of antimicrobial resistance (AMR) and supports the principles of antimicrobial stewardship. “Antimicrobial resistance, unfortunately, undermines the treatment paradigms of many infectious diseases globally, leading to poor patient outcomes and increased costs to healthcare systems,” said Brett Novak, Meitheal’s Senior Vice President of Commercial Operations. “XENLETA ® provides a unique and well-tolerated product profile for the more than five million annual cases of CABP in the U.S., where it has the potential to serve as a first-line monotherapy option in both the inpatient and outpatient settings. We are pleased that this agreement will allow us to unlock synergies with our existing franchises and deliver critical medicines that address large gaps in the antibiotic treatment landscape.” Global approvals of XENLETA ® in CABP are based on the results of two global, pivotal Phase 3 trials, LEAP 1 and LEAP 2, in which XENLETA ® met all primary endpoints. Meitheal recently added the first anti-infective to its portfolio through an exclusive commercialization agreement with HKF—CONTEPO™. Meitheal will leverage its new aligned-to-CONTEPO ™ marketing, sales, and medical science liaison teams to support the launch of XENLETA ® , which shares similar hospital call points. Meitheal will further establish practice-based support for key prescribers and patients that could benefit from XENLETA ® . “We are pleased to have acquired the rights to XENLETA ® and look forward to supporting Meitheal as it delivers this important medication to patients in the U.S.,” said Eric Tang, President of HKF. “We are committed to supporting Meitheal’s work to deliver accessible, sustainable, and innovative healthcare solutions and we remain focused on continuing to invest in the research, development, and commercialization of branded pharmaceuticals to achieve this goal.” HKF and its related entities have invested over $300 million in capital and research and development in recent years to support sustainable product supply across key focus areas, including branded biopharmaceuticals. The licensing agreement for XENLETA ® adds a third branded biopharmaceutical and first on-market branded product to Meitheal’s portfolio. ABOUT COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (CABP) Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. CABP is among the most common types of pneumonia, with five million cases in the U.S. each year. 1 In the U.S., CABP is the leading cause of infection-related death 2 and the fourth leading cause of hospitalization, 3 a setting where mortality rates are approximately 15% 4 . Certain bacteria that cause CABP have become resistant to one common antibiotic, macrolides, at a rate on average of 50%. 5 The U.S. FDA has also issued multiple warnings about the resistance of one current class of CABP treatments called fluoroquinolones. 6 Antimicrobial resistance (AMR) is a top global public health threat that creates challenges treating infections and performing medical procedures and increases the risk of death and disability. 7 Novel antibiotics that kill bacteria, including those that cause CABP, in a different way are essential to addressing AMR. 8 ABOUT XENLETA ® XENLETA ® (lefamulin acetate) is a first-in-class, semi-synthetic pleuromutilin antibiotic for systemic administration in humans. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA ® ’s binding occurs with high affinity, high specificity, and at molecular sites that are different than other antibiotic classes. Two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP demonstrated XENLETA ® ’s efficacy. In these trials, XENLETA ® was compared with moxifloxacin, and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA ® had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. CONTRAINDICATIONS XENLETA ® is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA ® . Concomitant use of XENLETA ® tablets with CYP3A substrates that prolong the QT interval is contraindicated. WARNINGS AND PRECAUTIONS QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. Clostridioides difficile-associated Diarrhea: Evaluate patients who develop diarrhea. ADVERSE REACTIONS The most common adverse reactions associated with XENLETA ® Injection include administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia and headache. The most common adverse reactions associated with XENLETA ® Tablets include diarrhea, nausea, vomiting, hepatic enzyme elevation. Please see Full Prescribing Information for more information. ABOUT MEITHEAL PHARMACEUTICALS, INC. Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of October 2024, Meitheal, directly or through its partners, has 18 products in the research and development phase, 6 additional products planned for launch in 2024, and 21 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly-priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com . ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF) Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of Nanjing King-Friend Biochemical Pharmaceutical Company, founded in 2010. ABOUT NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL COMPANY (NKF) Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of the world’s leading manufacturers of heparin-related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA-approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. NKF is publicly listed on the Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion. ABOUT NABRIVA THERAPEUTICS PLC Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. FDA approval for XENLETA ® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics also previously developed CONTEPO™ (fosfomycin for injection), a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI). ___________________________ 1 National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) 2009 -2010. https://archive.cdc.gov/#/details?url=https://www.cdc.gov/nchs/data/ahcd/combined_tables/2009-2010_combined_web_table01.pdf (Last Accessed December 4, 2024). 2 el Bcheraoui C, Mokdad AH, Dwyer-Lindgren L, et al. Trends and Patterns of Differences in Infectious Disease Mortality Among US Counties, 1980-2014. JAMA.2018;319(12):1248–1260. doi:10.1001/jama.2018.2089. 3 McDermott KW, Roemer M. Most frequent principal diagnoses for inpatient stays in U.S. Hospitals, 2018: Statistical Brief, no 277. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, MD: Agency for Healthcare Research and Quality. 2021. https://hcup-us.ahrq.gov/reports/statbriefs/sb277-Top-Reasons-Hospital-Stays-2018.pdf . 4 2017 CHARTBOOK STATIC ANALYSES -Trends in mortality rates following admission for acute myocardial infarction, chronic obstructive pulmonary disease, heart failure, pneumonia, and acute ischemic stroke. Prepared for CMS by Yale New Haven Health Services Corporation -Center for Outcomes Research and Evaluation (YNHHSC/CORE) September 2017. 5 Classi P, Landsman-Blumberg P, Carroll C, et al. The relationship between macrolide-resistant streptococcus pneumoniae and treatment failure in adults with community-acquired pneumonia by CDC region in the United States. Abstract J03. In: Meeting abstracts, Academy of Managed Care Pharmacy Nexus 2016; October 3-6, 2016; National Harbor, MD. 6 Food and Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics-risks-mental-health-and-low-blood-sugar-adverse . Accessed December 4, 2024. 7 World Health Organization. Antimicrobial resistance. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance . Accessed December 4, 2024. 8 Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013, US Department of Health and Human Services.

临床3期引进/卖出上市批准临床结果

2024-12-10

·米内网

【火热】超2亿注射剂，最新国家药品标准曝光

精彩内容日前，国家药典委员会（ChPC）发布公示，拟修订曲克芦丁注射液的国家药品标准。该药可用于闭塞综合征、血栓性静脉炎、毛细血管出血等，2023年在中国三大终端六大市场（统计范围详见本文末）销售规模超过2亿元，为脑部血管保护剂TOP3产品。来源：ChPC官网曲克芦丁注射液主要化学成分为曲克芦丁，具有抑制血小板聚集、防止血栓形成的作用，同时能对抗5-羟色胺、缓激肽引起的血管损伤，增加毛细血管和抵抗力，降低毛细血管的通透性，可防止血管通透性升高引起的水肿。该药主要用于闭塞综合征、血栓性静脉炎、毛细血管出血等，目前已纳入全国医保乙类药目录，医保限制使用范围为：新发的缺血性脑梗死，支付不超过14天。米内网数据显示，目前曲克芦丁注射液共有81家企业拥有生产批文，2023年在中国三大终端六大市场销售额超过2亿元，同比涨幅近7%；2024上半年收获超1亿元，是脑部血管保护剂TOP3产品。近年来中国三大终端六大市场曲克芦丁注射液销售趋势（单位：万元）来源：米内网格局数据库今年以来，ChPC至少公示了30多款化学药（仅统计制剂）的国家药品标准草案，其中注射剂占比超六成，包括依诺肝素钠注射液、盐酸莫西沙星氯化钠注射液、复方氨基酸注射液(14AA-SF)等2023年在中国三大终端六大市场销售额超10亿元的大品种；按治疗大类统计，血液和造血系统药物占主导，有12个产品在列，呼吸系统用药、抗肿瘤和免疫调节剂、全身用抗感染药物等五个品类各占3个及以上席位。今年以来ChPC公示的国家药品标准化学药（制剂）名单资料来源：米内网数据库、ChPC官网等注：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12月9日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，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

2024-12-08

·信狐药迅

上海生诺1类抑酸新药-信诺拉生酯和盛世泰科 DPP-4抑制剂降糖药-磷酸盛格列汀获批上市| 新获批(12.2-12.8）

每周药品注册获批数据，分门别类呈现，一目了然。(12.2-12.8）新药上市申请药品名称企业注册分类受理号信诺拉生酯胶囊上海生诺医药科技有限公司1CXHS2300027磷酸盛格列汀片盛世泰科生物医药技术(苏州)股份有限公司1CXHS2300022依达拉奉右莰醇舌下片先声药业有限公司2.2CXHS2300058氟唑帕利胶囊江苏恒瑞医药股份有限公司2.4CXHS2400032甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHS2400031甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHS2400030呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS2400024呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS2400023信迪利单抗注射液信达生物制药(苏州)有限公司2.2CXSS2400038斯鲁利单抗注射液上海复宏汉霖生物制药有限公司2.2CXSS2300094 新药临床申请药品名称企业注册分类受理号[177Lu]Lu-XT117注射液北京先通国际医药科技股份有限公司1CXHL2401036BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2401031BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2401030BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2401029HRS-4729注射液福建盛迪医药有限公司1CXHL2401028HRS-4729注射液福建盛迪医药有限公司1CXHL2401027HRS-4357注射液天津恒瑞医药有限公司1CXHL2401018ZL-85FA片成都赜灵生物医药科技有限公司1CXHL2401009ZL-85FA片成都赜灵生物医药科技有限公司1CXHL2401008FHND6091胶囊江苏正大丰海制药有限公司1CXHL2401007FHND6091胶囊江苏正大丰海制药有限公司1CXHL2401006Kylo-12注射液厦门甘宝利生物医药有限公司1CXHL2401011HSK46575片西藏海思科制药有限公司1CXHL2400992HSK46575片西藏海思科制药有限公司1CXHL2400991HSK46575片西藏海思科制药有限公司1CXHL2400990IN10018片应世生物科技(上海)有限公司1CXHL2401004IN10018片应世生物科技(上海)有限公司1CXHL2401003JMKX001899片浙江杭煜制药有限公司1CXHL2401002JMKX001899片浙江杭煜制药有限公司1CXHL2401001Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401000Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2400999Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2400998Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2400997BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2400996BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2400995MWN109注射液上海民为生物技术有限公司1CXHL2401005JMKX003676片浙江杭煜制药有限公司1CXHL2400925JMKX003676片浙江杭煜制药有限公司1CXHL2400924JMKX003676片浙江杭煜制药有限公司1CXHL2400921注射用JMX-2006南京恒生制药有限公司2.2CXHL2401017SMF-211江西施美药业股份有限公司2.3CXHL2400981四价肠道病毒灭活疫苗(Vero细胞)北京科兴生物制品有限公司1.4CXSL2400619四价流感病毒裂解疫苗(MDCK细胞)艾美诚信生物制药有限公司2.2CXSL2400629RGB-5088胰岛细胞注射液杭州瑞普晨创科技有限公司1CXSL2400698KJ015注射液(皮下注射)上海宝济药业股份有限公司1CXSL2400672HLX22单抗注射液上海复宏汉霖生物技术股份有限公司1CXSL2400663注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2400652注射用HLX43上海复宏汉霖生物技术股份有限公司1CXSL2400668注射用SHR-4602苏州盛迪亚生物医药有限公司1CXSL2400662MG-K10人源化单抗注射液上海麦济生物技术有限公司1CXSL2400664注射用SHR-1501上海恒瑞医药有限公司1CXSL2400642注射用FH-006江苏恒瑞医药股份有限公司1CXSL2400637HC022注射液上海宏成药业有限公司1CXSL2400645注射用SKB500四川科伦博泰生物医药股份有限公司1CXSL2400644JS019注射液北京恩瑞尼生物科技股份有限公司1CXSL2400641IBI3009信达生物制药(苏州)有限公司1CXSL2400648重组安菲博肽注射液兆科药业(合肥)有限公司1CXSL2400638重组安菲博肽注射液兆科药业(合肥)有限公司1CXSL2400639ZL-1102凝胶再鼎医药(上海)有限公司1CXSL2400646SHR-2173注射液广东恒瑞医药有限公司1CXSL2400643ZL-1102凝胶再鼎医药(上海)有限公司1CXSL2400647MC-1-50细胞制剂重庆精准生物技术有限公司1CXSL2400632HF50杭州高田生物医药有限公司1CXSL2400621外用RGL-2102上海瑞宏迪医药有限公司1CXSL2400615RG002注射液仁景(苏州)生物科技有限公司1CXSL2400614TAEST16001注射液香雪生命科学技术(广东)有限公司1CXSL2400618靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液上海医药集团生物治疗技术有限公司1CXSL2400604GKL-006注射液北京基因启明生物科技有限公司1CXSL2400602注射用VRT106广州威溶特医药科技有限公司1CXSL2400590阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400651SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2400654阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400640重组人透明质酸酶注射液北京诺博特生物科技有限公司2.4CXSL2400670重组人透明质酸酶注射液北京诺博特生物科技有限公司2.4CXSL2400669 仿制药申请药品名称企业注册分类受理号米诺地尔搽剂乐福思健康产业股份公司3CYHS2400414米诺地尔搽剂乐福思健康产业股份公司3CYHS2400412米诺地尔搽剂乐福思健康产业股份公司3CYHS2400410盐酸多巴酚丁胺注射液陕西顿斯制药有限公司3CYHS2302377美沙拉秦缓释胶囊北京福元医药股份有限公司3CYHS2302305盐酸异丙肾上腺素注射液成都米子生物医药科技有限公司3CYHS2302299重酒石酸去甲肾上腺素注射液武汉久安药业有限公司3CYHS2302220氯化钾注射液黑龙江博宇制药有限公司3CYHS2302209注射用尼可地尔海南皇隆制药股份有限公司3CYHS2302095注射用尼可地尔海南皇隆制药股份有限公司3CYHS2302094甲硫酸新斯的明注射液东阳祥昇医药科技有限公司3CYHS2302055甲硫酸新斯的明注射液东阳祥昇医药科技有限公司3CYHS2302054盐酸甲氧氯普胺注射液安徽长江药业有限公司3CYHS2301976盐酸丙卡特罗口服溶液江苏万高药业股份有限公司3CYHS2301818间苯三酚口崩片浙江高跖医药科技股份有限公司3CYHS2301786盐酸甲氧氯普胺注射液东阳祥昇医药科技有限公司3CYHS2301782地高辛注射液江苏联环药业股份有限公司3CYHS2301735间苯三酚口崩片湖南先施制药有限公司3CYHS2301727氯化钾注射液北京柏雅联合药物研究所有限公司3CYHS2301723盐酸甲氧氯普胺注射液西洲医药科技(浙江)有限公司3CYHS2301711酮咯酸氨丁三醇注射液福建天泉药业股份有限公司3CYHS2301620美索巴莫注射液福安药业集团庆余堂制药有限公司3CYHS2301612呋塞米注射液武汉久安药业有限公司3CYHS2301607呋塞米注射液武汉久安药业有限公司3CYHS2301606氯化钾注射液成都米子生物医药科技有限公司3CYHS2301596氯化钾注射液成都欣捷高新技术开发股份有限公司3CYHS2301578二羟丙茶碱注射液森淼(山东)药业有限公司3CYHS2301556氯化钾注射液南京恩泰医药科技有限公司3CYHS2301547帕拉米韦注射液山西阳和医药技术有限公司3CYHS2301504盐酸艾司洛尔注射液湖南赛隆药业(长沙)有限公司3CYHS2301503盐酸左沙丁胺醇雾化吸入溶液海南斯达制药有限公司3CYHS2301485二羟丙茶碱注射液浙江和泽医药科技股份有限公司3CYHS2301480法莫替丁注射液南京康发生物科技有限公司3CYHS2301437氟尿嘧啶注射液湖南赛隆药业(长沙)有限公司3CYHS2301428重酒石酸卡巴拉汀口服液百善科技(湖州)有限公司3CYHS2301390吲哚布芬片北京诚济制药股份有限公司3CYHS2301349注射用尼可地尔重庆德诚永道医药有限公司3CYHS2301328硫酸特布他林口服溶液成都利尔药业有限公司3CYHS2301327硫酸特布他林口服溶液成都利尔药业有限公司3CYHS2301326帕拉米韦注射液湖北民康药业集团有限公司3CYHS2301271注射用盐酸罗沙替丁醋酸酯海南倍特药业有限公司3CYHS2301212盐酸甲哌卡因注射液济南辰欣医药科技有限公司3CYHS2301195氯化钾颗粒山西普德药业有限公司3CYHS2301126缩宫素注射液安徽百奥药业有限公司3CYHS2301105醋酸维持液石家庄四药有限公司3CYHS2301104醋酸维持液石家庄四药有限公司3CYHS2301103巴氯芬口服溶液江苏天士力帝益药业有限公司3CYHS2301070氨溴特罗口服溶液江西仁齐制药有限公司3CYHS2301066异烟肼注射液嘉实(湖南)医药科技有限公司3CYHS2301054托拉塞米注射液海南斯达制药有限公司3CYHS2301009托拉塞米注射液海南斯达制药有限公司3CYHS2301008聚乙烯醇滴眼液上海阿尔福斯医药科技有限公司3CYHS2300992磷酸奥司他韦干混悬剂北京斯利安药业有限公司3CYHS2300958二羟丙茶碱注射液安徽长江药业有限公司3CYHS2300942重酒石酸间羟胺注射液河南蓝图制药有限公司3CYHS2300889氨溴特罗口服溶液海南天盛保和生物科技有限公司3CYHS2300745奥沙利铂注射液贵州阜康仁制药有限公司3CYHS2300670氨溴特罗口服溶液南京卡文迪许生物工程技术有限公司3CYHS2300568注射用吲哚菁绿南京亚东启天药业有限公司3CYHS2300560己酮可可碱注射液江苏慧聚药业股份有限公司3CYHS2300543达格列净二甲双胍缓释片南京正大天晴制药有限公司3CYHS2300499达格列净二甲双胍缓释片南京正大天晴制药有限公司3CYHS2300498氨溴特罗口服溶液浙江康润制药有限公司3CYHS2300383氨溴特罗口服溶液浙江康润制药有限公司3CYHS2300382氨己烯酸口服溶液用散远大医药(中国)有限公司3CYHS2300027国;CYHS2300027羧甲司坦口服溶液北京康晟百春生物科技有限公司3CYHS2202114国;CYHS2202114腺苷注射液北京布霖生物科技有限公司3CYHS2202062国;CYHS2202062利奈唑胺干混悬剂广州一品红制药有限公司3CYHS2202052国;CYHS2202052卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201632国;CYHS2201632卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201631国;CYHS2201631卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201630国;CYHS2201630注射用盐酸多西环素海南普利制药股份有限公司3CYHS2201636国;CYHS2201636注射用盐酸多西环素海南普利制药股份有限公司3CYHS2201635国;CYHS2201635腺苷注射液华夏生生药业(北京)有限公司3CYHS2201223国;CYHS2201223氟比洛芬钠滴眼液武汉先路医药科技股份有限公司3CYHS2200829国;CYHS2200829磷酸奥司他韦干混悬剂广东万方药业科技有限公司3CYHS2200236国;CYHS2200236注射用头孢米诺钠山东宜和生物医药科技有限公司4CYHS2400781磷酸奥司他韦胶囊浙江普洛康裕制药有限公司4CYHS2400689哌柏西利片石药集团欧意药业有限公司4CYHS2400665氧(液态)天津盈德气体有限公司4CYHS2400629磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400588磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400586磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400585盐酸罗匹尼罗缓释片植恩生物技术股份有限公司4CYHS2400314罗沙司他胶囊重庆煜洋药业有限公司4CYHS2303610阿昔莫司胶囊浙江高跖医药科技股份有限公司4CYHS2303120注射用盐酸地尔硫䓬舒美奇成都生物科技有限公司4CYHS2303042马来酸氟伏沙明片湖南省湘中制药有限公司4CYHS2303021盐酸氮斯汀滴眼液合肥华威药业有限公司4CYHS2302951磷酸特地唑胺片石药集团中诺药业(石家庄)有限公司4CYHS2302958马来酸氟伏沙明片山东京卫制药有限公司4CYHS2302834硝酸异山梨酯注射液安徽誉恒生物科技有限公司4CYHS2302801枸橼酸坦度螺酮片山东京卫制药有限公司4CYHS2302794枸橼酸坦度螺酮片山东京卫制药有限公司4CYHS2302793依折麦布片江苏德源药业股份有限公司4CYHS2302773盐酸贝尼地平片重庆华邦制药有限公司4CYHS2302718地夸磷索钠滴眼液浙江尖峰药业有限公司4CYHS2302723普拉洛芬滴眼液苏州欧康维视生物科技有限公司4CYHS2302684吸入用硫酸沙丁胺醇溶液山东新时代药业有限公司4CYHS2302678吸入用乙酰半胱氨酸溶液陕西丽彩药业有限公司4CYHS2302648硫酸羟氯喹片西安海欣制药有限公司4CYHS2302632西他沙星片浙江麒正药业有限公司4CYHS2302628乙酰半胱氨酸泡腾片江苏和晨药业有限公司4CYHS2302616注射用伏立康唑陕西博森生物制药股份集团有限公司4CYHS2302591磷酸奥司他韦胶囊天方药业有限公司4CYHS2302571阿戈美拉汀片深圳市泛谷药业股份有限公司4CYHS2302531阿帕他胺片齐鲁制药(海南)有限公司4CYHS2302520精氨酸培哚普利片杭州仟源保灵药业有限公司4CYHS2302479精氨酸培哚普利片杭州仟源保灵药业有限公司4CYHS2302478左卡尼汀口服溶液江苏百奥信康医药科技有限公司4CYHS2302472普伐他汀钠片北京柏雅联合药物研究所有限公司4CYHS2302458尼莫地平注射液成都倍特药业股份有限公司4CYHS2302461普拉洛芬滴眼液圣嘉(滨海)生物医药科技有限公司4CYHS2302440阿司匹林肠溶片仁合益康集团有限公司4CYHS2302409马来酸氟伏沙明片安徽省先锋制药有限公司4CYHS2302391马来酸氟伏沙明片安徽省先锋制药有限公司4CYHS2302390尼可地尔片东阳祥昇医药科技有限公司4CYHS2302379间苯三酚注射液福建天泉药业股份有限公司4CYHS2302371亚叶酸钙注射液石家庄荣雾迪医药科技有限公司4CYHS2302359骨化三醇软胶囊湖南银泽华浩生物科技有限公司4CYHS2302334二甲双胍维格列汀片(Ⅱ)宁波美诺华天康药业有限公司4CYHS2302306富马酸福莫特罗吸入溶液合肥国药诺和药业有限公司4CYHS2302287阿戈美拉汀片杭州领业医药科技有限公司4CYHS2302278卡前列素氨丁三醇注射液北京仁众药业有限公司4CYHS2302262比索洛尔氨氯地平片福建海西新药创制股份有限公司4CYHS2302208地夸磷索钠滴眼液国药集团三益药业(芜湖)有限公司4CYHS2302234马来酸阿伐曲泊帕片山东良福制药有限公司4CYHS2302166替米沙坦氨氯地平片山西德元堂药业有限公司4CYHS2302154溴莫尼定噻吗洛尔滴眼液山东威智百科药业有限公司4CYHS2302136布洛芬混悬滴剂江苏万高药业股份有限公司4CYHS2302104铝碳酸镁咀嚼片江右制药(常德)有限公司4CYHS2302099莫匹罗星软膏珠海联邦制药股份有限公司中山分公司4CYHS2302064哌柏西利片南京正大天晴制药有限公司4CYHS2302061哌柏西利片南京正大天晴制药有限公司4CYHS2302060硝苯地平控释片山东新时代药业有限公司4CYHS2302043氯雷他定糖浆合肥远志医药科技开发有限公司4CYHS2302039恩格列净片湖南迪诺制药股份有限公司4CYHS2302022曲伏前列素滴眼液兆科(广州)眼科药物有限公司4CYHS2302009苯磺酸氨氯地平片吉林敖东药业集团延吉股份有限公司4CYHS2301986曲伏噻吗滴眼液兆科(广州)眼科药物有限公司4CYHS2301974盐酸伐地那非片山东海雅医药科技有限公司4CYHS2301955达格列净片浙江华义制药有限公司4CYHS2301953达格列净片浙江华义制药有限公司4CYHS2301952替米沙坦氨氯地平片康缘华威医药有限公司4CYHS2301967注射用头孢他啶阿维巴坦钠海南海灵化学制药有限公司4CYHS2301941瑞巴派特片苏州旺山旺水生物医药股份有限公司4CYHS2301934注射用头孢唑肟钠陕西东科制药有限责任公司4CYHS2301918注射用头孢唑肟钠陕西东科制药有限责任公司4CYHS2301917瑞巴派特片北京金城泰尔制药有限公司4CYHS2301916硫酸镁钠钾口服用浓溶液丽珠集团丽珠制药厂4CYHS2301893氢溴酸伏硫西汀片杭州和康药业有限公司4CYHS2301881阿戈美拉汀片重庆华森制药股份有限公司4CYHS2301877硫辛酸注射液江苏开元药业有限公司4CYHS2301872盐酸达泊西汀片齐鲁制药有限公司4CYHS2301837熊去氧胆酸胶囊宜昌人福药业有限责任公司4CYHS2301832罗库溴铵注射液中玉制药(海口)有限公司4CYHS2301828钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301817钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301816钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301815阿普米司特片常州制药厂有限公司4CYHS2301812阿普米司特片常州制药厂有限公司4CYHS2301811阿普米司特片常州制药厂有限公司4CYHS2301810盐酸罗匹尼罗缓释片杭州和泽坤元药业有限公司4CYHS2301805卡铂注射液吉斯美(武汉)制药有限公司4CYHS2301789钆布醇注射液常州四药制药有限公司4CYHS2301788氧氟沙星滴耳液山东光明药业有限公司4CYHS2301752卡贝缩宫素注射液成都诺和晟鸿生物制药有限公司4CYHS2301732盐酸奥布卡因滴眼液苏州欧康维视生物科技有限公司4CYHS2301731氯沙坦钾氢氯噻嗪片宁波科尔康美诺华药业有限公司4CYHS2301692盐酸氟西汀胶囊江西施美药业股份有限公司4CYHS2301682注射用氯诺昔康福安药业集团湖北人民制药有限公司4CYHS2301667玻璃酸钠滴眼液华熙生物科技股份有限公司4CYHS2301663盐酸坦索罗辛缓释胶囊昆明积大制药股份有限公司4CYHS2301617碘佛醇注射液成都倍特药业股份有限公司4CYHS2301602碘佛醇注射液成都倍特药业股份有限公司4CYHS2301601马来酸阿伐曲泊帕片上海迪赛诺医药集团股份有限公司4CYHS2301559碳酸司维拉姆片国药集团致君(深圳)坪山制药有限公司4CYHS2301555间苯三酚注射液湖北午时医药研究院有限公司4CYHS2301535盐酸多柔比星脂质体注射液南京绿叶制药有限公司4CYHS2301507阿普米司特片广东迈恒医药研发有限公司4CYHS2301478阿普米司特片广东迈恒医药研发有限公司4CYHS2301477阿普米司特片广东迈恒医药研发有限公司4CYHS2301476布洛芬缓释胶囊南京华兴医药科技有限公司4CYHS2301450氨甲环酸注射液广州泽盛药业科技有限公司4CYHS2301436氨甲环酸注射液广州泽盛药业科技有限公司4CYHS2301435氨甲环酸注射液广州泽盛药业科技有限公司4CYHS2301434西格列汀二甲双胍片(II)浙江英格莱制药有限公司4CYHS2301433丙戊酸钠口服溶液安徽海斯美医药有限公司4CYHS2301421复方聚乙二醇电解质散(III)安徽省先锋制药有限公司4CYHS2301384乳果糖口服溶液海南斯达制药有限公司4CYHS2301323硫酸镁钠钾口服用浓溶液南京知和医药科技有限公司4CYHS2301299阿奇霉素干混悬剂迪沙药业集团有限公司4CYHS2301207异氟烷山东新时代药业有限公司4CYHS2301172异氟烷山东新时代药业有限公司4CYHS2301171吗啉硝唑氯化钠注射液山东齐都药业有限公司4CYHS2301112非诺贝特酸胆碱缓释胶囊鲁南贝特制药有限公司4CYHS2301088非诺贝特酸胆碱缓释胶囊鲁南贝特制药有限公司4CYHS2301087培哚普利氨氯地平片(III)江苏万高药业股份有限公司4CYHS2300948舒更葡糖钠注射液弘和制药有限公司4CYHS2300937左氧氟沙星滴眼液上海阿尔福斯医药科技有限公司4CYHS2300873盐酸莫西沙星氯化钠注射液湖北长联杜勒制药有限公司4CYHS2300870舒更葡糖钠注射液中国大冢制药有限公司4CYHS2300867注射用唑来膦酸浓溶液岳阳新华达制药有限公司4CYHS2300851二甲双胍恩格列净片(V)杭州云柏医药科技有限公司4CYHS2300815二甲双胍恩格列净片(I)杭州云柏医药科技有限公司4CYHS2300814甲磺酸仑伐替尼胶囊江苏康缘药业股份有限公司4CYHS2300794达格列净片浙江华海药业股份有限公司4CYHS2300694达格列净片浙江华海药业股份有限公司4CYHS2300693乳果糖口服溶液黑龙江中桂制药有限公司4CYHS2300690乳果糖口服溶液黑龙江中桂制药有限公司4CYHS2300689甲磺酸艾立布林注射液成都西岭源药业有限公司4CYHS2300657地诺孕素片博瑞制药(苏州)有限公司4CYHS2300580注射用丁二磺酸腺苷蛋氨酸海南倍特药业有限公司4CYHS2300451吗啉硝唑氯化钠注射液南京卡文迪许生物工程技术有限公司4CYHS2300474ω-3脂肪酸乙酯90软胶囊扬子江药业集团有限公司4CYHS2300357奥美沙坦酯氢氯噻嗪片宁波科尔康美诺华药业有限公司4CYHS2300248碘比醇注射液重庆圣华曦药业股份有限公司4CYHS2300167碘比醇注射液重庆圣华曦药业股份有限公司4CYHS2300166伊布替尼胶囊北京海步医药科技有限公司4CYHS2300103注射用丁二磺酸腺苷蛋氨酸重庆药友制药有限责任公司4CYHS2300037国;CYHS2300037吗啉硝唑氯化钠注射液成都国为生物医药有限公司4CYHS2202045国;CYHS2202045盐酸莫西沙星氯化钠注射液河北凯威恒诚制药有限公司4CYHS2201999国;CYHS2201999复方托吡卡胺滴眼液南京恒道医药科技股份有限公司4CYHS2201645国;CYHS2201645盐酸多奈哌齐片宝龙药业有限公司4CYHS2201419国;CYHS2201419屈螺酮炔雌醇片南通联亚药业股份有限公司4CYHS2200411国;CYHS2200411盐酸多奈哌齐片保定天浩制药有限公司4CYHS2101423国;CYHS2101423盐酸多奈哌齐片泰荣(福建)药业有限公司4CYHS2101184国;CYHS2101184马来酸阿法替尼片甘肃兰药药业有限公司4CYHS2101074国;CYHS2101074马来酸阿法替尼片甘肃兰药药业有限公司4CYHS2101073国;CYHS2101073盐酸西替利嗪滴眼液浙江莎普爱思药业股份有限公司3CYHL2400186利多卡因凝胶贴膏北京阳光诺和药物研究股份有限公司4CYHL2400192琥珀酰明胶注射液南京正大天晴制药有限公司4CYHL2400187吸附破伤风疫苗艾美坚持生物制药有限公司3.3CXSL2400596 进口申请药品名称企业注册分类受理号Odevixibat胶囊Albireo AB5.1JXHS2400025Odevixibat胶囊Albireo AB5.1JXHS2400024Odevixibat胶囊Albireo AB5.1JXHS2400023Odevixibat胶囊Albireo AB5.1JXHS2400022普托马尼片Mylan Ireland Limited5.1JXHS2300120多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300093多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300092多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300091注射用亚西瑞来Merck Sharp & Dohme B.V.5.1JXHS2300066注射用亚西瑞来Merck Sharp & Dohme B.V.5.1JXHS2300065倍氯米松福莫特罗粉吸入剂Chiesi Farmaceutici S.p.A.5.1JXHS2300060注射用芦比替定PharmaMar AG5.1JXHS2300049沙芬酰胺片Zambon S.p.A.5.1JXHS2200035国;JXHS2200035沙芬酰胺片Zambon S.p.A.5.1JXHS2200034国;JXHS2200034帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSS2300013钆特酸葡胺注射液Joint Stock Company “FARMAK”5.2JYHS2300001泊沙康唑肠溶片Hetero Labs Limited5.2JYHS2200053国;JYHS2200053苹果酸舒尼替尼胶囊Dr. Reddy's Laboratories Ltd.5.2JYHS2200003国;JYHS2200003达比加群酯胶囊印度熙德隆制药有限公司5.2JYHS2000002国;JYHS2000002达比加群酯胶囊印度熙德隆制药有限公司5.2JYHS2000003国;JYHS2000003达比加群酯胶囊印度熙德隆制药有限公司5.2JYHS2000006国;JYHS2000006E7386Eisai Co., Ltd.1JXHL2400237E7386Eisai Co., Ltd.1JXHL2400236E7386Eisai Co., Ltd.1JXHL2400235GDC-0077F. Hoffmann-La Roche Ltd.1JXHL2400226GDC-0077F. Hoffmann-La Roche Ltd.1JXHL2400225AMG 193Amgen Inc.1JXHL2400228AMG 193Amgen Inc.1JXHL2400227AMG 193Amgen Inc.1JXHL2400231AMG 193Amgen Inc.1JXHL2400230AMG 193Amgen Inc.1JXHL2400224AMG 193Amgen Inc.1JXHL2400223AMG 193Amgen Inc.1JXHL2400233AMG 193Amgen Inc.1JXHL2400232Lazertinib片Janssen Research & Development, LLC2.4JXHL240022920价肺炎球菌多糖结合疫苗Pfizer Europe MA EEIG3.1JXSL2400166MEDI5752AstraZeneca AB1JXSL2400186AZD2936AstraZeneca AB1JXSL2400184MEDI5752AstraZeneca AB1JXSL2400185PF-08046047Seagen Inc.1JXSL2400182AZD2936AstraZeneca AB1JXSL2400174DS-7300aDaiichi Sankyo, Inc.1JXSL2400175ABBV-706注射用冻干粉AbbVie Inc.1JXSL2400179AZD2936AstraZeneca AB1JXSL2400173MEDI5752AstraZeneca AB1JXSL2400178Amivantamab注射液(皮下注射)Janssen Research & Development, LLC2.1JXSL2400176Amivantamab注射液(皮下注射)Janssen Research & Development, LLC2.1JXSL2400177DS-8201aASTRAZENECA AB2.2JXSL2400183 中药相关申请药品名称企业注册分类受理号MYL软膏马应龙药业集团股份有限公司1.1CXZL2400059MYL软膏马应龙药业集团股份有限公司1.1CXZL2400058MYL软膏马应龙药业集团股份有限公司1.1CXZL2400057MYL软膏马应龙药业集团股份有限公司1.1CXZL2400056四仙颗粒四川省中医药科学院1.1CXZL2400053金蚕颗粒四川省中医药科学院1.1CXZL2400051黄蛭益肾胶囊雷允上药业集团有限公司2.3CXZL2400054 注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请

100 项与盐酸莫西沙星相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00874	盐酸莫西沙星	J01MA14 S01AE07	DB00218

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
鼠疫	美国	Bayer HealthCare Pharmaceuticals, Inc.	2016-09-27
复杂腹腔感染	美国	Fresenius Kabi USA LLC	2015-04-03
呼吸道感染	中国	Bayer Vital GmbH	2009-08-11
睑缘炎	日本	Novartis Pharma AG	2006-07-26
结膜炎	日本	Novartis Pharma AG	2006-07-26
角膜溃疡	日本	Novartis Pharma AG	2006-07-26
泪囊炎	日本	Novartis Pharma AG	2006-07-26
睑腺炎	日本	Novartis Pharma AG	2006-07-26
角膜炎	日本	Novartis Pharma AG	2006-07-26
脓肿	美国	Bayer HealthCare Pharmaceuticals, Inc.	2005-11-22
腹腔感染	美国	Bayer HealthCare Pharmaceuticals, Inc.	2005-11-22
简单的皮肤和皮肤结构感染(uSSSI)	美国	Bayer HealthCare Pharmaceuticals, Inc.	2005-11-22
急性支气管炎	日本	Bayer Yakuhin Ltd.	2005-10-11
细菌感染	日本	Bayer Yakuhin Ltd.	2005-10-11
咽喉炎	日本	Bayer Yakuhin Ltd.	2005-10-11
肺炎	日本	Bayer Yakuhin Ltd.	2005-10-11
慢性呼吸道感染	日本	Bayer Yakuhin Ltd.	2005-10-11
继发感染	日本	Bayer Yakuhin Ltd.	2005-10-11
鼻窦炎	日本	Bayer Yakuhin Ltd.	2005-10-11
扁桃体炎	日本	Bayer Yakuhin Ltd.	2005-10-11

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
耐多药结核病	临床3期	巴西	Global Alliance for TB Drug Development	2018-07-30
耐多药结核病	临床3期	格鲁吉亚	Global Alliance for TB Drug Development	2018-07-30
耐多药结核病	临床3期	马来西亚	Global Alliance for TB Drug Development	2018-07-30
耐多药结核病	临床3期	菲律宾	Global Alliance for TB Drug Development	2018-07-30
耐多药结核病	临床3期	俄罗斯	Global Alliance for TB Drug Development	2018-07-30
耐多药结核病	临床3期	南非	Global Alliance for TB Drug Development	2018-07-30
耐多药结核病	临床3期	坦桑尼亚	Global Alliance for TB Drug Development	2018-07-30
耐多药结核病	临床3期	乌干达	Global Alliance for TB Drug Development	2018-07-30
多重耐药性肺结核	临床3期	格鲁吉亚	Global Alliance for TB Drug Development	2015-02-01
多重耐药性肺结核	临床3期	肯尼亚	Global Alliance for TB Drug Development	2015-02-01

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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


NCT04179500 (PaSEM, CTgov)	临床2期	多重耐药性肺结核 \| 耐多药结核病	26	BPaMZ	憲築襯顧觸膚艱壓遞蓋(遞顧糧鬱窪願鏇襯醖醖) = 蓋壓繭鬱築築襯繭願衊選範遞壓構窪艱獵齋選 (襯齋構窪窪選夢願壓選, 選鹹鹽選製鹽遞獵鑰獵 ~ 廠衊膚鹹憲選夢簾願鏇) 更多	-	2024-09-19
NCT02589782 (TB-PRACTECAL, Pubmed) 人工标引	临床2/3期	广泛耐药结核病	552	rifampicin (Standard care)	壓積糧餘顧糧製構淵選(範衊憲壓積蓋簾範廠願) = 鬱壓鹽構鏇餘獵衊衊鬱糧衊廠壓選繭淵網糧鬱 (壓艱襯觸範觸糧積構膚 ) 更多	积极	2024-02-01
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	壓積糧餘顧糧製構淵選(範衊憲壓積蓋簾範廠願) = 膚艱獵鹽選鹽淵襯獵鑰糧衊廠壓選繭淵網糧鬱 (壓艱襯觸範觸糧積構膚 ) 更多
APAO2023	N/A	-	131	Topical Levofloxacin 1.5%	襯築範構繭糧憲範壓襯(顧餘壓顧膚襯淵襯壓鹹) = 鹹憲襯選壓鑰衊衊鏇積築製壓蓋選鹽鏇鑰願壓 (憲蓋選窪獵衊襯獵襯製 ) 更多	积极	2023-02-23
				Topical Moxifloxacin Hydrochloride 0.5%	襯築範構繭糧憲範壓襯(顧餘壓顧膚襯淵襯壓鹹) = 餘選憲構淵壓範遞選繭築製壓蓋選鹽鏇鑰願壓 (憲蓋選窪獵衊襯獵襯製 ) 更多
ERS2022	N/A	-	-	Moxifloxacin	齋淵築夢夢淵遞壓簾憲(齋鬱網繭淵遞糧艱積範) = 鑰繭構廠齋網壓鏇壓構鹹壓繭鏇遞衊蓋廠襯鬱 (獵衊顧餘齋積構鑰鏇餘 )	-	2022-09-04
				Silver nanoparticles	齋淵築夢夢淵遞壓簾憲(齋鬱網繭淵遞糧艱積範) = 築糧遞鹹醖廠蓋鹽繭糧鹹壓繭鏇遞衊蓋廠襯鬱 (獵衊顧餘齋積構鑰鏇餘 )
EURETINA2022	N/A	眼内炎	-	moxifloxacin (Before prophylactic ICM)	網壓醖醖範積獵齋網網(鏇夢蓋繭齋鹹範獵觸觸) = 鏇範淵窪壓築艱憲艱願鑰簾衊鏇鹽構觸壓鏇糧 (夢鑰醖繭製選淵餘憲願 ) 更多	-	2022-09-01
				moxifloxacin (After prophylactic ICM)	網壓醖醖範積獵齋網網(鏇夢蓋繭齋鹹範獵觸觸) = 糧淵鹽範鏇鬱壓鬱餘鑰鑰簾衊鏇鹽構觸壓鏇糧 (夢鑰醖繭製選淵餘憲願 ) 更多
S31/A5349 (Pubmed)	临床3期	肺结核	-	Rifapentine-moxifloxacin regimen	鏇選蓋顧淵糧簾願醖夢(選構範鬱鏇顧膚製遞鏇): absolute difference in unfavorable outcomes = -7.4 (95% CI, -20.8 ~ 6.0)	积极	2022-08-30
				Control regimen
Pubmed 人工标引	N/A	肺结核	77	optimized background regimen+Moxifloxacin	醖鬱鹹夢鏇積鹽製鬱構(簾網網淵廠衊獵範憲鑰) = 糧鬱獵憲顧糧獵構願餘遞糧壓簾鹽憲築衊餘壓 (衊製廠鹽糧網選衊製壓 ) 更多	积极	2022-05-04
				optimized background regimen+Bedaquiline	醖鬱鹹夢鏇積鹽製鬱構(簾網網淵廠衊獵範憲鑰) = 蓋鹽築憲範簾積鹽鬱構遞糧壓簾鹽憲築衊餘壓 (衊製廠鹽糧網選衊製壓 ) 更多
ARVO2022	N/A	-	-	Moxifloxacin	壓繭築窪憲餘簾淵顧鑰(齋餘繭築鹽憲餘醖廠鹹) = 鬱窪淵積構簾壓製蓋夢鑰顧窪衊鬱襯網網製膚 (觸襯鑰鏇艱積獵鏇網築 )	-	2022-05-01
				Antibiotic use	壓繭築窪憲餘簾淵顧鑰(齋餘繭築鹽憲餘醖廠鹹) = 鑰觸鬱選糧顧廠鹹鬱觸鑰顧窪衊鬱襯網網製膚 (觸襯鑰鏇艱積獵鏇網築 )
ARVO2022	N/A	撕裂	-	Moxifloxacin NPs	襯積膚積願壓顧繭鑰構(鏇繭鏇鬱衊窪鹹憲窪鹹) = 衊廠鬱鹹夢顧衊憲膚製夢製鹹築選鹽蓋窪觸選 (網構築蓋齋艱願糧餘網 ) 更多	-	2022-05-01
				Moxifloxacinglycidyl methacrylate-hyaluronic acid (HAGM) (Gelatin methacryloyl (GelMA) and glycidyl methacrylate-hyaluronic acid (HAGM) hydrogel)	積齋壓獵蓋製構窪廠衊(構壓鬱觸繭醖築鏇願憲) = 齋淵獵網獵鏇簾襯醖範製糧範獵憲遞製願積遞 (廠膚糧鹽餘夢膚淵鹹夢 )
NCT02410772 (S31/A5349, CTgov)	临床3期	肺结核	2,516	control (Regimen 1)	廠艱網選鹹淵構襯鏇範(壓積窪齋鹹鬱積簾獵築) = 觸鹽遞膚蓋醖鑰醖範糧獵鏇鹹醖膚簾繭簾製顧 (觸積壓積醖簾積艱願齋, 觸構襯鏇積選壓網齋淵 ~ 艱顧簾簾醖鏇襯鏇夢網)	-	2021-09-28
				rifapentine (Regimen 2)	廠艱網選鹹淵構襯鏇範(壓積窪齋鹹鬱積簾獵築) = 襯夢壓鏇獵醖齋遞窪壓獵鏇鹹醖膚簾繭簾製顧 (觸積壓積醖簾積艱願齋, 構壓獵簾鹹淵窪蓋鹽衊 ~ 淵淵齋鑰繭觸獵襯餘鬱)