A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects

This study will compare the bioavailability of a novel powder for oral suspension formulation of delafloxacin, intended for treatment of community acquired bacterial pneumonia, to that of the licensed delafloxacin oral tablet in healthy adults.

开始日期2024-06-03

申办/合作机构

Melinta Therapeutics, Inc.

[+1]

NCT05977868

/ Terminated临床4期IIT

Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial

This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent effectiveness with improved safety of early transition from intravenous (IV) antimicrobial therapy to complex outpatient oral antimicrobial therapy (COpAT) across various infectious diseases (endovascular, bone and joint, skin and soft tissue, pulmonary, gastrointestinal, and genitourinary infections).
All patients referred for outpatient parenteral antimicrobial therapy (OPAT) will be evaluated by the research team with respect to inclusion/exclusion criteria. If determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT Trial. Once informed consent is obtained, patients will be randomized 2:1 using computer software into experimental or control (standard of care) group, respectively: Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides. Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital discharge. At the 6-week ID Clinic follow-up, patients will be asked to complete a patient satisfaction survey. The following 2 primary outcomes will be assessed: cure at 3 months using clinical (resolution of infection) and laboratory parameters (improvement in inflammatory markers) and adverse events related to antimicrobial therapy/vascular access complication. The following 3 secondary outcomes will be assessed: overall readmission at 3 months, readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months, and patient satisfaction at 6 weeks. The experimental group is being compared to standard of care in current clinical practice.
As this is a pragmatic clinical trial, patients will not undergo additional invasive testing or procedures.

开始日期2023-08-04

申办/合作机构

West Virginia University

CTR20213149

/ Completed临床1期

国产注射用德拉沙星在健康受试者中的安全性、耐受性、药代动力学特征评价以及与原研药的药代动力学比较的I期临床研究

1、评价国产注射用德拉沙星在中国健康受试者中单剂和多剂静脉滴注给药后的安全性、耐受性及药代动力学特征； 2、评价国产注射用德拉沙星试验药与对照药（商品名：Baxdela®）单剂静脉滴注给药后的药代动力学相似性，并评价两制剂单剂给药在中国健康受试者中的安全性。

开始日期2022-02-20

申办/合作机构

扬子江药业集团有限公司

100 项与德拉沙星相关的临床结果

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100 项与德拉沙星相关的转化医学

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100 项与德拉沙星相关的专利（医药）

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302

项与德拉沙星相关的文献（医药）

2025-12-01·JOURNAL OF BIOLOGICAL PHYSICS

Structural insight in understanding the impact of mutation at position 88 and 94 of DNA gyrase A of Mycobacterium tuberculosis in developing resistance against delafloxacin

Article

作者: Singh, Satendra ; Rai, Sumit Kumar ; Singh, Dev Bukhsh

DNA gyrase is a target for treating tuberculosis caused by Mycobacterium tuberculosis. Many cases of antibiotic resistance have been reported due to different point mutations in the Chain A of DNA gyrase. Based on literature information on drug-resistance related study for DNA gyrase, we generated 4 different mutant models 3ILW_G88A, 3ILW_G88C, 3ILW_D94G, and 3ILW_D94H by inserting two mutations at each position 88 and 94 in DNA gyrase chain A. Antibiotics Clinafloxacin, Gatifloxacin, Moxifloxacin, Sitafloxacin, Prulifloxacin, Besifloxacin, Delafloxacin, Ozenoxacin were docked with 3ILW_wild to understand their stability, binding affinity, and interaction pattern with the wild-type DNA gyrase (3ILW_wild). Delafloxacin has shown more stable and favorable binding interaction with the 3ILW_wild (BFE, -8.6 kcal/mol). Docking of Delafloxacin with four mutant models (3ILW_G88A, 3ILW_G88C, 3ILW_D94G, and 3ILW_D94H) was performed to understand the impact of these mutations on binding stability and interaction. A complete loss of binding interaction with Ser118 and Pro119 was observed in mutant complexes as compared to 3ILW_wild, suggesting the role of these residues in developing resistance. Molecular dynamics simulations over 100 ns were carried out for the complex of Delafloxacin with 3ILW_wild and four mutant models. Parameters like RMSD, RMSF, radius of gyration, H-bond, and solvent-accessible surface area revealed that the mutant models are more rigid and less flexible as compared to wild-type DNA gyrase, which in turn results in loss of some interactions. It is worth noting that mutation at position 94 of DNA gyrase A has a very profound effect as it shows a positive contribution towards increased resistance due to reduced binding affinity with delafloxacin. This study explains the structural changes and mechanism behind the resistance against Delafloxacin, and may also guide the structural changes required in existing Delafloxacin or other antibiotics to develop new therapeutics to overcome the issue of resistance.

2025-11-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Delafloxacin and levofloxacin activities on Helicobacter pylori in Bulgaria over four years

Article

作者: Boyanova, Lyudmila ; Katsarov, Nikolay ; Markovska, Rumyana ; Gergova, Galina ; Gergova, Raina ; Boyanova, Liliya Yordanova ; Kandilarov, Nayden ; Kamburov, Victor ; Medeiros, José ; Hadzhiyski, Petyo

Delafloxacin is a potent 4th-generation fluoroquinolone with enhanced activity in acidic environments. However, recently, delafloxacin resistance in facultative anaerobic species has been reported. Thus, we examined levofloxacin and delafloxacin susceptibility of 98 Helicobacter pylori strains in 2020-2023. Minimum inhibitory concentrations (MICs) were detected with E tests. Levofloxacin resistance was 33.7%, while delafloxacin resistance was 2.0% at 1 mg/l (the levofloxacin resistance breakpoint for H. pylori), and 9.2% at 0.125 mg/l (the recently suggested delafloxacin ECOFF for the species). Overall proportion of the strains exhibiting >0.125 mg/l delafloxacin MICs was similar to that in the previous study in 2018-2019 (8.5%). None of the 65 levofloxacin susceptible strains had delafloxacin MICs of >0.125 mg/l. Among levofloxacin resistant strains, delafloxacin MICs >1 mg/l (6.1%, 2/33 strains) were detected only in 2022 and 2023. Briefly, the results showed the much higher activity of delafloxacin over levofloxacin. The high delafloxacin activity in acidic environments is an additional advantage of the newer fluoroquinolone for treating H. pylori infection. Given that fluoroquinolone-based eradication regimens can be used as a second- or third-line therapy for H. pylori, testing the susceptibility of levofloxacin-resistant strains to delafloxacin could provide a useful option for eradication of the frequent and potentially carcinogenic bacteria. New regimens, such as the combination of vonoprazan with delafloxacin and another antibiotic deserve investigation.

2025-07-03·Expert Review of Anti-Infective Therapy

An overview of potential combination therapies with ceftriaxone as a treatment for gonorrhoea

Review

作者: Kenyon, Chris ; Vanbaelen, Thibaut ; Santhini Manoharan-Basil, Sheeba ; Kanesaka, Izumo ; Kong, Fabian Yuh Shiong

INTRODUCTION:

Ceftriaxone is the last available single dose therapy for gonorrhea that effectively treats infections at all sites. Over a quarter of isolates are now resistant to ceftriaxone in some countries. The introduction of carefully chosen combination therapy with ceftriaxone could retard the emergence of ceftriaxone resistance.

AREAS COVERED:

This review summarizes the findings of a PubMed search on the use of partner antimicrobial that could be used with ceftriaxone to prevent the emergence and spread of ceftriaxone resistance. We review 16 antimicrobials that could be partnered with ceftriaxone in terms of pharmacokinetic and pharmacodynamic compatibilities, activity against ceftriaxone resistant isolates and probability of antimicrobial resistance emerging.

EXPERT OPINION:

Of these 16 antimicrobials, we reject antimicrobials such as fosfomycin due to poor clinical efficacy and tigecycline due to its considerably longer half-life which would likely select for tetracycline resistance. The most promising agents for combination with ceftriaxone are zoliflodacin, delafloxacin, sitafloxacin, eravacycline and possibly gepotidacin and gentamicin. Clinical studies should be conducted to evaluate the efficacy of these combinations on the eradication of N. gonorrhoeae and their impact on AMR in N. gonorrhoeae and other bacterial species.

项与德拉沙星相关的新闻（医药）

2025-08-07

·PipelineReview

CorMedix to acquire Melinta Therapeutics, Creating Diversified Specialty Company With Strong Presence in Acute Care Settings

BERKELEY HEIGHTS, NJ, USA I August 07, 2025 I CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, and Melinta Therapeutics LLC (“Melinta”), a private commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced a definitive agreement for CorMedix to acquire Melinta. The selling shareholders will receive $300 million in total consideration at closing, including $40 million of CorMedix equity, and will be eligible to receive a regulatory milestone of up to $25 million and royalties on net sales of MINOCIN ® and REZZAYO™. The proposed acquisition will expand CorMedix’s team and commercial platform, and increase the commercial portfolio with six marketed, highly differentiated, hospital- and clinic-focused infectious disease products, including REZZAYO™ (rezafungin for injection), MINOCIN ® (minocycline) for Injection, VABOMERE ® (meropenem and vaborbactam), KIMYRSA ® (oritavancin), ORBACTIV™ (oritavancin), BAXDELA ® (delafloxacin), and an additional well-established cardiovascular product, TOPROL-XL ® (metoprolol succinate). REZZAYO™ is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. The completion of the Phase III study for REZZAYO™ is expected in 1H 2026. “This acquisition is a transformational step in the evolution of CorMedix, providing an attractive revenue base of highly synergistic assets, as well as multiple opportunities to drive future growth. We are excited to acquire Melinta, which enables us to expand our product portfolio in the hospital space while delivering therapies to patients with high unmet need,” said Joseph Todisco, CEO of CorMedix Inc. “I would like to congratulate Christine Ann Miller, Melinta Therapeutics President & CEO, on building a high-performing organization. The combination with Melinta creates a formidable and diversified specialty platform with a deep and experienced team in the hospital acute care and infectious disease arena. This transaction reflects the type of high-impact, cash-flow generating opportunities we are targeting and strengthens our position to further expand, as we strive to create shareholder value through both organic growth and additional acquisitions in the future.” “The synergistic combination of Melinta and CorMedix represents an exciting new chapter in our company’s evolution,” said Christine Ann Miller, President and CEO of Melinta Therapeutics. “Over the past five years, we have built a robust commercial infrastructure with a high-performing team, deep expertise, and relationships within the hospital and acute care ecosystem, while achieving significant revenue growth and sustained profitability. CorMedix recognizes not just our innovative therapies, but the exceptional capabilities of our organization. I’m confident that Melinta’s commercial excellence and proven track record will augment CorMedix’s team and track record of operational execution and success, to create an even stronger platform for future growth.” Strategic and Financial Benefits Terms and Financing Under the terms of the agreement, which has been approved by the CorMedix and Melinta Board of Directors respectively, CorMedix will pay $300 million in upfront consideration, comprised of $260 million in cash and $40 million in CorMedix equity issued to Melinta shareholders of Deerfield Management Company, L.P. (“Deerfield”). The cash consideration will be funded by a combination of CorMedix’s existing cash on hand and the proceeds of a $150 million convertible debt financing with high quality healthcare focused institutional investors, including Deerfield, the terms of which will be described in a Current Report on Form 8-K to be filed by the Company today. The agreement contains an additional regulatory milestone of up to $25 million (payable in cash or shares at CorMedix’s election) for the FDA approval of the expanded indication of REZZAYO™ for prophylaxis of invasive fungal infections in adults undergoing allogeneic blood and marrow transplantation, if this milestone event is achieved by June 30, 2029. Furthermore, the agreement includes tiered royalties on REZZAYO™ U.S. net sales and low-single-digit royalties on MINOCIN ® U.S. net sales. The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the ‘HSR Act’). The Company expects the transaction to close as early as September 1, 2025. Full Year Financial Guidance Advisors Moelis & Company LLC is acting as exclusive financial advisor for CorMedix in connection with the acquisition of Melinta and sole placement agent for convertible debt financing. Willkie Farr & Gallagher LLP is acting as legal advisor to CorMedix in connection with the acquisition of Melinta and the convertible debt financing. RBC Capital Markets is acting as a financial advisor to CorMedix in connection with the convertible debt financing. Goodwin Procter LLP is acting as a legal advisor to Moelis & Company LLC for the convertible debt financing. Conference Call and Webcast Information Management will host a conference call and a live webcast today, August 7, 2025, at 8:30 a.m. ET, to discuss the transaction and CorMedix’s second quarter 2025 financial results. The conference call can be accessed by dialing 1-844-676-2922 from the United States or 1-412-634-6840 internationally. The live webcast will be accessible in the “ Presentations & Events ” section of the CorMedix Investor Relations website or using the following Webcast Link . About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath ® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath ® in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in Total Parenteral Nutrition and Pediatric patient populations in 2025 and also intends to develop DefenCath ® as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com . About Melinta Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: MINOCIN ® (minocycline), REZZAYO™ (rezafungin), VABOMERE ® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA ® (delafloxacin), KIMYRSA ® (oritavancin), and TOPROL-XL ® (metoprolol succinate). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit www.melinta.com . SOURCE: CorMedix

上市批准临床3期并购引进/卖出

2025-07-01

·米内网

扬子江发威了！手握53个独家品种，20余款1类新药、30个新品出击，6款新药上市可期

精彩内容在刚刚过去的2025年上半年，扬子江药业产品管线进展不断：3个品种获批生产并视同过评，1类新药冲刺上市，5个品种以新注册分类报产等。目前公司有173个品种过评或视同过评（37个为首家/独家），19个品种备战国家集采。在研管线中，25款新药处于申请临床及以上阶段，3款已提交NDA；30个新品瞄准百亿市场，9个暂无首仿获批。进展频频！1类新药报产、3个新品获批......扬子江药业创建于1971年，至今已在医药健康领域深耕半个多世纪。目前公司拥有300余个药品（不含非制剂产品）的生产批文，其中有53个为扬子江药业独家品种（含独家剂型）。米内网数据显示，今年上半年，扬子江药业仿制药管线持续推进，有3个品种获批生产并视同过评，其中艾拉莫德片、泊马度胺胶囊均为国内第3家获批，2024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17亿元、3亿元。2025年以来扬子江药业获批上市的品种来源：米内网中国申报进度（MED）数据库产品申报方面，化药1类新药法赞雷生片提交NDA，中药1类新药ZYY-742凝胶提交IND并获批临床；5个品种以新注册分类报产，分别为美洛昔康纳米晶注射液、钆特酸葡胺注射液、酒石酸布托啡诺注射液、比拉斯汀片、阿瑞匹坦注射液。2025年以来扬子江药业申报的品种来源：米内网中国申报进度（MED）数据库今年上半年，扬子江药业的柴芩清宁胶囊、双花百合片2个独家中药品种申请保护（初保）获受理。2023及2024年，扬子江药业均有1个独家中药品种申请保护（初保）获受理，分别为散风通窍滴丸、苏黄止咳胶囊，其中苏黄止咳胶囊为公司核心产品，2024年在中国三大终端六大市场的销售额超过29亿元。2023年以来扬子江药业申请保护的中药品种来源：国家药监局，米内网整理173个品种过评！19个品种备战国家集采截至目前，扬子江药业有173个品种通过/视同通过一致性评价，在过评品种数TOP10集团中排位第三。从治疗大类看，173个品种涵盖13个治疗大类，集中在全身用抗感染药物（33个）、神经系统药物（22个）、消化系统及代谢药（21个）、抗肿瘤和免疫调节剂（21个）等领域。扬子江药业过评情况（以品种名称计）来源：米内网一致性评价进度数据库173个品种中，有37个为首家或独家过评，其中头孢克洛缓释片(Ⅱ)、盐酸奈康唑乳膏、伏立康唑分散片等品种为独家过评。凭借庞大的过评产品集群，扬子江药业在国家开展的九批十轮化药集采中收获满满，分别有2个、4个、7个、8个、10个、12个、2个、6个、11个品种中选，合计62个品种（盐酸帕洛诺司琼注射液不同批次重复计算），为集采头部供应商之一。米内网数据显示，目前扬子江药业有19个过评品种满足国采入围门槛，符合申报资格企业数达7家及以上，包括7个口服常释剂型、6个口服液体剂、4个注射剂、1个吸入剂及1个滴眼剂。扬子江药业过评且满足国采入围门槛的品种注：销售额低于1亿元用*代替来源：米内网综合数据库从2024年市场竞争格局看，扬子江在15个品种中所占市场份额较低或为0，其中甲苯磺酸艾多沙班片为2025年新获批品种，ω-3脂肪酸乙酯90软胶囊、醋酸加尼瑞克注射液、依托咪酯中/长链脂肪乳注射液、他氟前列素滴眼液、吸入用乙酰半胱氨酸溶液、磷酸特地唑胺片等为2024年获批品种。20余款1类新药出击！30个新品瞄准百亿市场扬子江药业以创新研发为发展驱动力，通过“自主研发+外部引进”的方式，“仿制+创新”双轮驱动，产品研发管线日益丰满。米内网数据显示，含引进的产品在内，目前扬子江药业有25款新药（不含已上市新药及拓展新适应症）处于申请临床及以上阶段，包括16款化学药、8款中成药及1款生物药，其中1类新药占比超八成。6款新药处于III期临床及以上阶段，上市可期。其中，PDE-5抑制剂盐酸妥诺达非片、新型PPI抑制剂盐酸非苏拉生片、食欲素受体OX1/OX2拮抗剂法赞雷生片已提交NDA在审，感冒双解颗粒、复方蓉术颗粒2款中药新药，以及MOR激动剂YZJ-4729酒石酸盐注射液步入III期临床。仿制药方面，目前扬子江药业有30个新注册分类品种在审（不含已有批文、主动撤回、联合申报品种），形成了梯度丰富的研发管线，主要集中在神经系统药物（6个）、消化系统及代谢药（6个）、呼吸系统用药（4个）等。扬子江药业以新注册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30个品种2024年在中国三大终端六大市场的销售额合计超过100亿元。其中，注射用紫杉醇(白蛋白结合型)超过25亿元，酒石酸布托啡诺注射液、洛索洛芬钠凝胶贴膏、糠酸莫米松鼻喷雾剂均超过10亿元，注射用雷贝拉唑钠超过8亿元等。9个品种暂无首仿（含剂型首仿）获批上市，包括布瑞哌唑片、注射用卡非佐米、注射用盐酸达巴万星、奥贝胆酸片、雷诺嗪缓释片、注射用德拉沙星、富马酸卢帕他定口服溶液、甲磺酸沙芬酰胺片等。此外，美洛昔康纳米晶注射液、脂肪乳氨基酸(17)葡萄糖(19%)注射液、普瑞巴林缓释片、糠酸莫米松鼻喷雾剂等品种获批国产企业数均只有1家。资料来源：米内网数据库注：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6月30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

一致性评价

2025-04-25

·米内网

【瞩目】齐都药业大丰收！拿下4大重磅品种，4款新药、43个新品在路上

精彩内容近日，齐都药业申报的2款仿制药复方氨基酸注射液(18AA-Ⅶ)、帕拉米韦注射液获批生产并视同过评，今年以来齐都药业已有4个品种获批生产并视同过评。在过去的2024年，齐都药业共取得28个产品批件（含制剂、原料药、医疗器械等）。近年来，齐都药业持续加大开发投入，产品研发不断提速，目前有43个品种以新注册分类申报在审，其中10余个品种抢首仿。此外，4款新药处于获批临床及以上阶段，中药新药上市可期。拿下4个重磅品种，32个过评品种亮眼4月1日，齐都药业申报的2款仿制药获批生产并视同过评，为复方氨基酸注射液(18AA-Ⅶ)、帕拉米韦注射液。今年以来，齐都药业已有4个品种获批生产并视同过评，分别为硫酸镁钠钾口服用浓溶液、复方葡萄糖/电解质颅脑手术冲洗液、帕拉米韦注射液及复方氨基酸注射液(18AA-Ⅶ)。2025年以来齐都药业获批上市的品种来源：米内网中国申报进度（MED）数据库硫酸镁钠钾口服用浓溶液（商标名：美那佳®）为齐都药业2025年首款获批上市的新品。这是一种高渗透性肠道清洁剂，具有起效时间短、清洁肠道效果好、适用人群广、耐受性和依从性高、显著提高PDR（息肉检出率）和ADR（腺瘤检出率）、降低水电解质紊乱发生风险等优势，为美国胃肠内镜协会(ASGE)、欧洲胃肠内镜协会(ESGE)等国际权威机构推荐的一线方案。米内网数据显示，硫酸镁钠钾口服用浓溶液已被纳入国家医保乙类目录，近年来在中国三大终端六大市场（统计范围详见本文末）快速放量，2023年其销售额突破1亿元，同比增长超过700%，2024上半年以约159%的增速继续增长，市场潜力在逐步释放。近年来中国三大终端六大市场硫酸镁钠钾口服用浓溶液销售情况（单位：万元）来源：米内网格局数据库帕拉米韦注射液（商标名：齐力韦®）主要用于流感病毒引起的普通流行性感冒、甲型流行性感冒，也可以用于奥司他韦不能控制的重症型流感。在帕拉米韦制剂方面，齐都药业还有另一款产品——帕拉米韦氯化钠注射液以新注册分类报产在审。米内网数据显示，2023年中国三大终端六大市场帕拉米韦注射剂销售额合计超过10亿元。近年来中国三大终端六大市场帕拉米韦注射剂销售情况（单位：万元）来源：米内网格局数据库近年来，齐都药业持续加大科研开发投入，获批品种数呈井喷式增长。2024年公司共取得28个产品批件，包括注射剂、片剂、胶囊剂、口服溶液剂、口服混悬剂、原料药、医疗器械等，其中有12个品种过评或视同过评。截至目前，齐都药业过评或视同过评品种数已增加至32个，涉及输液制剂、水针剂、口服固体制剂、外用液体剂等多个用药途径，涵盖抗感染药物、呼吸系统药物、抗肿瘤药物、心脑血管药物、肾科药物、消化系统药物、体液平衡与肠外营养药物、血浆代用品等治疗领域。齐都药业已过评品种在国家开展的药品集采中，齐都药业有10个品种顺利中选，包括左氧氟沙星片、阿昔洛韦片、左氧氟沙星氯化钠注射液、甘油果糖氯化钠注射液、葡萄糖酸钙注射液、己酮可可碱注射液、氯化钾注射液、乳酸钠林格注射液、碳酸氢钠林格注射液及乳酸环丙沙星氯化钠注射液。43个新品在路上！10余个品种抢首仿步入2025年，齐都药业仿制药开发进展不断，至今已有9个品种以新注册分类提交上市或临床申请，既包括碘佛醇注射液等年销超30亿的大品种，也有醋酸地非法林注射液、瑞舒伐他汀依折麦布片(Ⅰ)等国内暂无首仿获批的品种。截至目前，齐都药业有43个品种以新注册分类申报在审（不含已有批文品种），涵盖8个治疗大类，集中在血液和造血系统药物（16个）、消化系统及代谢药（11个）、心脑血管系统药物（5个）、全身用抗感染药物（4个）等治疗领域。齐都药业新注册分类申报且在审的品种来源：米内网中国申报进度（MED）数据库从市场销售看，43个品种2023年在中国三大终端六大市场的销售额合计超过110亿元，不乏碘佛醇注射液、吡格列酮二甲双胍片、甲钴胺片等畅销品种。从市场竞争格局看，10余个品种在国内暂无首仿（含剂型首仿，不含原研地产化）获批，包括醋酸地非法林注射液、瑞舒伐他汀依折麦布片(Ⅰ)、乌帕替尼缓释片、低钙腹膜透析液(碳酸氢盐-G4.25%)、低钙腹膜透析液(碳酸氢盐-G1.5%)、布立西坦口服溶液、复方硫酸钠片、甘露醇山梨醇注射液、磷/碳酸氢钠血滤置换液、注射用德拉沙星、小儿钠钾镁钙葡萄糖注射液、琥珀酰明胶电解质醋酸钠注射液等。其中，乌帕替尼缓释片是艾伯维开发的一款JAK抑制剂，2024上半年在中国三大终端六大市场的销售额超过2亿元，同比增长约525%。仿制药的报产由2024年陆续开始，至今已累计有10多家企业在审。3款1类新药来袭，中药新药上市可期以创新驱动发展，成为了国内大多数药企的目标战略，齐都药业亦不例外。近年来，公司加快布局新型研究平台，以仿制推动创新，化药与中成药并驾齐驱。2023年以来，齐都药业创新药研发进展大大提速：中药3.1类新药清金化痰颗粒提交NDA，中药1.1类新药天川颗粒获批临床，化药1类新药K-5a2片及硫酸心舒帕莎片获批临床等。齐都药业国内在研新药来源：米内网综合数据库清金化痰颗粒为古代经典名方中药复方制剂，其处方来源于明•叶文龄《医学统旨》的清金化痰汤，具有清热润肺、化痰止咳等功效，被认为是治疗肺病的经典方剂之一。齐都药业的清金化痰颗粒于2025年1月11日提交NDA并获受理，为国内首家。天川颗粒是齐都药业开发的一款中药1.1类新药，其临床申请于2024年6月29日获得CDE承办受理，同年9月2日获得临床试验默示许可，适应症为急性缺血性脑卒中。米内网数据显示，2023年中国三大终端六大市场心脑血管疾病中成药销售额超过960亿元，同比增长6.2%。结语一路走来，身处强手如林、竞争激烈的医药市场，齐都药业始终坚持抓投入、上项目、扩规模，成功构建药物制剂、特色原料药、医药包装材料、医用耗材与器械、生物医药、中药与大健康、医药商业与物流配送“6+1”业务板块。未来公司将不断提升企业创新力和生命力，加快由规模增量型向质量效益型转变，努力成为一家综合性、大规模、高科技、外向型制药企业。资料来源：米内网数据库注：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24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

申请上市上市批准

100 项与德拉沙星相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09331	德拉沙星	J01MA23	DB11943

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
细菌感染	加拿大	Xediton Pharmaceuticals, Inc.	2025-01-01
社区获得性肺炎	欧盟	A. Menarini Industrie Farmaceutiche Riunite Srl	2019-12-16
社区获得性肺炎	冰岛	A. Menarini Industrie Farmaceutiche Riunite Srl	2019-12-16
社区获得性肺炎	列支敦士登	A. Menarini Industrie Farmaceutiche Riunite Srl	2019-12-16
社区获得性肺炎	挪威	A. Menarini Industrie Farmaceutiche Riunite Srl	2019-12-16
社区获得性细菌性肺炎	美国	Melinta Subsidiary Corp.	2017-06-19
皮肤和皮肤结构感染	美国	Melinta Subsidiary Corp.	2017-06-19

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
手术伤口感染	临床3期	意大利	A. Menarini Industrie Farmaceutiche Riunite Srl	2019-09-25
淋菌性尿道炎	临床3期	美国	Melinta Therapeutics, Inc.	2014-01-23
丹毒	临床3期	美国	Melinta Therapeutics, Inc.	2013-04-01
丹毒	临床3期	克罗地亚	Melinta Therapeutics, Inc.	2013-04-01
丹毒	临床3期	以色列	Melinta Therapeutics, Inc.	2013-04-01
丹毒	临床3期	拉脱维亚	Melinta Therapeutics, Inc.	2013-04-01
丹毒	临床3期	俄罗斯	Melinta Therapeutics, Inc.	2013-04-01
丹毒	临床3期	西班牙	Melinta Therapeutics, Inc.	2013-04-01
丹毒	临床3期	乌克兰	Melinta Therapeutics, Inc.	2013-04-01
细菌性皮肤疾病	临床3期	美国	Melinta Therapeutics, Inc.	2013-04-01

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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


NCT04042077 (DRESS, CTgov)	临床3期	手术伤口感染	268	Delafloxacin (Delafloxacin)	餘選餘築醖淵壓夢餘範 = 醖鹽膚夢夢鏇餘鹽壓糧鬱構壓糧淵選餘顧網範 (觸鏇衊鹽顧鑰窪夢願顧, 齋遞襯網夢鬱鬱淵膚膚 ~ 廠糧鹹遞壓範觸願築鬱) 更多	-	2021-10-29
				Tigecycline+Piperacillin/Tazobactam+Linezolid+Vancomycin (Best Available Therapy)	餘選餘築醖淵壓夢餘範 = 鹽廠衊壓鹽鏇鹽顧醖願鬱構壓糧淵選餘顧網範 (觸鏇衊鹽顧鑰窪夢願顧, 艱窪範鑰積淵襯繭廠選 ~ 蓋構製夢鹽鏇壓獵鑰壓) 更多
NCT02679573 (DEFINE-CABP, CTgov)	临床3期	社区获得性细菌性肺炎	860	Delafloxacin (Delafloxacin)	淵鏇齋簾製觸鹽衊築齋 = 鬱獵網築蓋顧獵醖壓構範獵構鹽鹽壓壓獵獵顧 (願選築構顧壓淵範餘鹹, 鹹簾網廠憲醖鹽膚襯蓋 ~ 簾願構積憲鏇觸鏇鏇遞) 更多	-	2020-02-27
				Moxifloxacin+Linezolid (Moxifloxacin/Linezolid)	淵鏇齋簾製觸鹽衊築齋 = 積鹽艱構夢選壓齋廠鹹範獵構鹽鹽壓壓獵獵顧 (願選築構顧壓淵範餘鹹, 鏇製構衊築餘鏇憲膚觸 ~ 構夢餘夢觸鏇窪範鏇構) 更多
NCT03534622 (DEFINE-CABP, Pubmed) 人工标引	临床3期	社区获得性细菌性肺炎	-	Delafloxacin	選製築觸範醖製簾衊選(繭觸範願鏇鏇獵積鏇廠) = 蓋構鬱醖獵醖積夢鬱餘範蓋構齋鑰積鏇鏇範選 (築鬱窪構衊糧鹹夢夢餘 ) 更多	非劣	2019-12-05
				Moxifloxacin	選製築觸範醖製簾衊選(繭觸範願鏇鏇獵積鏇廠) = 鹽壓艱艱鑰觸選鹽構夢範蓋構齋鑰積鏇鏇範選 (築鬱窪構衊糧鹹夢夢餘 ) 更多
NCT02015637 (Pubmed \| Sex Transm Dis) 人工标引	临床3期	淋病	328	Delafloxacin	廠餘顧鏇遞鬱鏇獵選齋(獵蓋鏇膚艱鹽衊餘顧醖) = 襯醖遞夢簾積積製鑰衊齋襯繭顧鑰簾鹽衊艱顧 (鏇積餘鹹廠遞鏇壓構鬱 )	非优	2019-05-01
				ceftriaxone	廠餘顧鏇遞鬱鏇獵選齋(獵蓋鏇膚艱鹽衊餘顧醖) = 餘廠艱網蓋範築糧膚遞齋襯繭顧鑰簾鹽衊艱顧 (鏇積餘鹹廠遞鏇壓構鬱 )
NCT01811732 \| NCT01984684 (Pubmed \| Open Forum Infect Dis)	临床3期	皮肤和皮肤结构感染	-	Delafloxacin	範構衊衊衊繭衊觸鏇鬱(簾膚簾構積鑰餘鹽鑰範) = 願壓衊憲衊遞網鑰繭選廠壓觸製範構襯艱選選 (觸膚艱壓膚築繭窪遞鏇 )	-	2018-10-01
				Comparators	範構衊衊衊繭衊觸鏇鬱(簾膚簾構積鑰餘鹽鑰範) = 鹹壓繭艱觸鹹衊顧網鏇廠壓觸製範構襯艱選選 (觸膚艱壓膚築繭窪遞鏇 )
NCT01984684 (Pubmed) 人工标引	临床3期	皮肤和皮肤结构感染一线	850	Delafloxacin	襯願繭鹽簾觸憲衊壓鹽(鏇築艱蓋艱窪網觸壓選) = 鹹範選鬱糧艱網鹽顧鑰膚製糧糧鹹鑰膚鏇鹹齋 (築齋窪鬱鏇醖齋範夢網 ) 更多	非劣	2018-08-16
				vancomycin+aztreonam	襯願繭鹽簾觸憲衊壓鹽(鏇築艱蓋艱窪網觸壓選) = 襯壓艱觸簾醖齋艱觸壓膚製糧糧鹹鑰膚鏇鹹齋 (築齋窪鬱鏇醖齋範夢網 ) 更多
NCT02015637 (CTgov)	临床3期	淋菌性尿道炎	460	Delafloxacin (Delafloxacin)	膚餘願齋鑰艱淵襯鹽鹹: Difference in cure rate = -5.9 (95% CI, -13.18 ~ 1.36) 更多	-	2018-04-26
				Ceftriaxone (Ceftriaxone)
NCT01811732 (Pubmed \| J Antimicrob Chemother) 人工标引	临床3期	皮肤和皮肤结构感染	660	delafloxacin	繭蓋構壓蓋顧廠簾膚遞(遞艱鬱築願鬱製鏇製廠) = 廠顧餘鑰衊鏇鏇繭鬱壓築膚積淵積憲鹽淵鏇築 (簾蓋醖繭淵糧齋鏇窪壓 ) 更多	非劣	2017-12-01
				vancomycin+aztreonam	繭蓋構壓蓋顧廠簾膚遞(遞艱鬱築願鬱製鏇製廠) = 襯襯遞窪製觸衊網獵醖築膚積淵積憲鹽淵鏇築 (簾蓋醖繭淵糧齋鏇窪壓 ) 更多
NCT01984684 (CTgov)	临床3期	细菌性皮肤疾病 \| 丹毒	850	delafloxacin (Delafloxacin)	憲鏇構範淵獵憲鹽鬱鬱: Difference in Responder Rates = 3.1 (95% CI, -2.0 ~ 8.3) 更多	-	2017-08-28
				aztreonam+vancomycin (Vancomycin Plus Aztreonam)
NCT01811732 (CTgov)	临床3期	细菌性皮肤疾病 \| 丹毒	660	Placebo+Delafloxacin (Delafloxacin Plus Placebo)	蓋艱艱顧積衊選鏇襯構 = 築繭構觸構蓋憲醖窪願願繭觸鬱製窪齋艱鹹繭 (襯製網積顧糧鬱鹽憲廠, 淵廠築選範積壓糧鹹淵 ~ 構獵鹽鬱憲獵構衊網鬱) 更多	-	2017-08-24
				Placebo+Aztreonam+Vancomycin (Vancomycin Plus Aztreonam + Placebo)	蓋艱艱顧積衊選鏇襯構 = 蓋願鹽製遞範艱鬱膚窪願繭觸鬱製窪齋艱鹹繭 (襯製網積顧糧鬱鹽憲廠, 膚蓋憲獵簾構襯淵齋衊 ~ 窪淵鏇選齋廠鏇壓築遞) 更多