Multicenter, Randomized Clinical Trial to Compare the Efficacy and Tolerance of Prenatal Therapy With Pyrimethamine + Sulfadiazine vs Spiramycine to Reduce Vertical Transmission of Toxoplasma Gondii Following Primary Infection in Pregnancy

Background : When a mother contracts toxoplasmosis during pregnancy, the parasite may be transmitted from to her unborn child. This results in congenital toxoplasmosis, which may cause damage to the eyes and nervous system of the child. To date, no method has been proved effective to prevent this transmission. In France, spiramycin is usually prescribed to women who have toxoplasma seroconversion in pregnancy, however its efficacy has not been determined. The standard treatment for toxoplasmosis is the combination of the antiparasitic drugs pyrimethamine and sulfadiazine, but this strategy has not been evaluated for the prevention of mother-to-child transmission.
Purpose : Randomized phase 3 trial to determine whether pyrimethamine + sulfadiazine is more effective than spiramycin to prevent congenital toxoplasmosis.

开始日期2010-11-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

IRCT20170201032346N5 / CompletedN/AIIT

The effect of spiramycin in prevention of toxoplasma gondii infection from mothers with acute toxoplasmosis

开始日期2007-09-23

申办/合作机构-

NCT00004317 / Recruiting临床4期IIT

Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis

RATIONALE: Congenital toxoplasmosis is an infection caused by the parasitic organism Toxoplasma gondii, and it may be passed from an infected mother to her unborn child. The mother may have mild symptoms or no symptoms; the fetus, however, may experience damage to the eyes, nervous system, skin, and ears. The newborn may have a low birth weight, enlarged liver and spleen, jaundice, anemia, petechiae, and eye damage. Giving the antiparasitic drugs pyrimethamine and sulfadiazine is standard treatment for congenital toxoplasmosis, but it is not yet known which regimen of pyrimethamine is most effective for the disease.
PURPOSE: Randomized phase IV trial to determine which regimen of pyrimethamine is most effective when combined with sulfadiazine and leucovorin in treating patients who have congenital toxoplasmosis.

开始日期2000-07-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

100 项与螺旋霉素相关的临床结果

登录后查看更多信息

100 项与螺旋霉素相关的转化医学

登录后查看更多信息

100 项与螺旋霉素相关的专利（医药）

登录后查看更多信息

1,575

项与螺旋霉素相关的文献（医药）

2025-01-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Optimized analysis for related substances in spiramycin based on high performance liquid chromatography with hybrid particle column and characterization of its impurities by single heartcut two-dimensional liquid chromatography coupled with quadrupole time-of-flight mass spectrometer

Article

作者: Lu, Yue ; Yao, Weifeng ; Zhang, Jinlin ; Wang, Qian ; Yuan, Yaozuo ; Yao, Yuan

This article described the development and validation of a method for spiramycin related substances based on hybrid particle column. The chromatographic conditions were as follows: water - 0.2 mol/L dipotassium hydrogen phosphate (the pH value adjusted to 9.5 using a 1 mol/L KOH solution) - acetonitrile - methanol (10: 60: 28.5: 1.5, v/v/v/v) as mobile phase A, water - 0.2 mol/L dipotassium hydrogen phosphate (pH 9.5) - acetonitrile - methanol (10: 30: 57: 3, v/v/v/v) as mobile phase B and gradient elution was performed. Compared with previous analytical methods, this method has strong specificity, excellent sensitivity and stability, which could be used for the daily testing of related substances of spiramycin. Furthermore, impurities above 0.1 % were characterized using two-dimensional liquid chromatography coupled with quadrupole time-of-flight mass spectrometer (2D LC-QTOF-MS/MS) and there were 6 impurities reported for the first time.

2024-12-31·Human vaccines & immunotherapeutics

Cost-effectiveness analysis of vaccination strategies against meningococcal disease for children under nine years of age in China

Article

作者: Zhang, Haijun ; Fang, Hai ; Zhang, Haonan

Meningococcal vaccination strategies in China are intricate, including multiple vaccines targeting different serogroups. The current National Immunization Program (NIP) includes two polysaccharide vaccines for serogroups A and C (MPV-A and MPV-AC), covering limited serogroups and requiring adaptation. This study aims to evaluate the cost-effectiveness of replacing the current strategy with alternative strategies utilizing non-NIP vaccines to inform policy decisions. From a societal perspective, a decision tree-Markov model was constructed to simulate the economic and health consequences of meningococcal disease in a 2019 birth cohort with four vaccination strategies. Epidemiology, vaccine efficacy, cost, and other parameters were derived from previous studies. We conducted sensitivity analyses to assess the robustness of the findings and explored prices for non-NIP vaccines that enable cost-effective strategies. Compared to the current strategy, alternative strategies using quadrivalent polysaccharide vaccine (MPV-4), bivalent conjugate vaccine (MCV-AC), and quadrivalent conjugate vaccine (MCV-4) could avoid 91, 286, and 455 more meningococcal cases. The ICERs were estimated at approximately $250 thousand/QALY, $450 thousand/QALY, and $1.5 million/QALY, all exceeding the threshold of three times GDP per capita. The alternative strategies were not cost-effective. However, if vaccine prices were reduced to $3.9 for MPV-4, $9.9 for MCV-AC, and $12 for MCV-4, the corresponding strategy would be cost-effective. The current meningococcal vaccination strategy in China could effectively prevent the disease at a low cost, but with limited serogroup coverage. Strategies using MPV-4, MCV-AC, or MCV-4 could increase health benefits at a substantial cost, and might become cost-effective if vaccine prices decrease.

2024-12-01·PREVENTIVE VETERINARY MEDICINE

Establishing defined daily and course doses for antimicrobials used in Pakistani broilers to enable farm-level quantification and comparison of antimicrobial use

Article

作者: Yasir, Ammar ; Mahmood, Qamer ; Chantziaras, Ilias ; Dewulf, Jeroen

Monitoring antimicrobial use (AMU) is crucial, as it plays a key role in driving antimicrobial resistance (AMR). Animals account for a significant share of AMU, making it essential to accurately quantify AMU exposure at the species, farm, and country levels. In Pakistan, prophylactic use of antimicrobials remains common alongside therapeutic use. This study aimed to establish defined daily and course doses for both therapeutic and prophylactic use of antimicrobials in commercial broiler production in Pakistan. A list of antimicrobial products was compiled from the daily treatment records from 100 commercial broiler farms in Punjab, Pakistan. For each active substance (AS), a defined daily dose (DDD_vetPK) was assigned for treatment, prevention or both, by averaging the recommended doses of all similar AS with the same administration route. A defined course dose (DCD_vetPK) was calculated by multiplying the average recommended dose by the average treatment duration for each AS, based on the Summary of Product Characteristics (SmPC). A total of 41 AS, categorized into 17 antimicrobial classes, were identified from 139 antimicrobial products. The most frequently reported AS were colistin (polymyxins) at 15.9 %, amoxicillin (aminopenicillins) at 7.5 %, neomycin (aminoglycosides) at 7.3 %, enrofloxacin (fluoroquinolones) at 6.7 %, and tylosin (macrolides) at 6.4 % of the total treatments (n = 358) reported at farms. Notably, 51 % of AS were classified as critically important for human medicine by WHO. Among AS indicated for treatment in SmPC, the defined daily doses for Pakistan (DDD_vetPK) varied substantially from the European Medicines Agency (EMA) values (DDD_vet), with the top deviations being Tiamulin (+147.8 %), Sulfadimidine_TMP (+111.2 %), Flumequine (+88.6 %), Spiramycin (-87.8 %), and Tylosin (-84.3 %). This study presents a list of defined daily doses and defined course doses for AMU quantification in Pakistani broilers using dose-based indicators. The observed differences between Pakistani and EMA doses, and lack of EMA doses for preventive antimicrobials, suggest using Pakistani DDD_vetPK values to quantify antimicrobial usage in Pakistan. A huge variation in recommended doses was reported in SmPC. There is an urgent need to establish a list of approved veterinary antimicrobials used in Pakistan, along with harmonization in recommended doses and maintenance of standardized SmPC by the drug regulatory authorities. Setting up a national-level list of defined daily doses is crucial to accurately monitor and quantify AMU.

项与螺旋霉素相关的新闻（医药）

2024-03-15

·FiercePharma

EuroAPI's troubles mount as audit reveals manufacturing lapses in Italy, spurring 2024 guidance suspension

As EuroAPI investigates the situation, production at its Italian facility in Brindisi will remain suspended until further notice. Beleaguered Sanofi spinout EuroAPI can’t seem to catch a break. After reporting ballooning losses and a four-year restructuring plan last month, the company revealed Thursday that manufacturing lapses at an Italian plant have temporarily derailed its guidance for the year. EuroAPI’s Italian subsidiary is suspending production of all active pharmaceutical ingredients (APIs) at its plant in Brindisi after an internal audit uncovered quality control deficiencies “due to potential local misconduct,” the company said in a release. As the manufacturer investigates the situation, production at the facility will remain suspended until further notice, EuroAPI added. The situation is likely to weigh on the company's operational and financial performance for 2024, EuroAPI warned, so it's suspending its guidance for the year. A revised 2024 outlook is being planned for release in the year’s second quarter. The Brindisi site produces 11 APIs and intermediates, which primarily consist of anti-infectives including spiramycin, rifaximin, rifampicin and teicoplanin. Last year, sales from the Italian facility clocked in at 63 million euros (around $69 million). While sales from the site are "limited," the production lapse could have an “image impact” on the company in relation to its clients, ODDO BHF analysts wrote to clients. Given the evolving situation at EuroAPI, the ODDO team has slashed 52 million euros from its topline forecast for the company and is now predicting a sales decline of 11%, versus the 6% revenue slump the analysts had previously projected. Since EuroAPI’s market debut as a standalone API maker and CDMO in May 2022, the company has encountered numerous hurdles that have threatened its goal to become a “partner of choice for all pharmaceutical and biotech companies.” Last month, in tandem with the company’s 2023 earnings report, EuroAPI appointed a new CEO and unveiled a four-year restructuring scheme dubbed FOCUS-27, which will involve streamlining the company’s API portfolio, focusing its CDMO activities, rationalizing its industrial footprint and becoming an altogether “leaner organization.” Naturally, potential layoffs are a part of the plan, which could see job cuts across “all functions” at the company, including industrial operations, quality, R&D and support roles. As part of the plan, EuroAPI said at the time that its attempt to focus on higher-value APIs could result in potential sales of its sites in Brindisi, Italy, and Haverhill, England. As the ODDO BHF team sees it, the transformation and restructuring costs under FOCUS-27 could be “made worse” now that EuroAPI will need to get its Brindisi plant up to standard before a potential sale. For all of 2023, EuroAPI reported net sales growth of 4% to 1.01 billion euros (about $1.09 billion). The company logged a net loss of 189.7 million euros.

财报

2024-03-14

·GlobeNewswire-Health Care

Full-year 2024 guidance suspended due to the temporary pause of API production at the Brindisi site in Italy

Press Release Paris – March 14th, 2024 – EUROAPI today announces that its Italian subsidiary, EUROAPI Italy S.R.L., is suspending the production of all APIs1 in Brindisi. Following an internal audit, quality control deficiencies due to potential local misconduct have been identified and are being further investigated. Production will remain suspended until further notice. The relevant health authorities have been informed. The company has initiated a forensic audit and will inform its customers. The Brindisi site produces 11 APIs and intermediates, mostly anti-infectives (including spiramycin, rifaximin, rifampicin and teicoplanin). In 2023, sales related to the Brindisi site amounted to 63 million euros, of which 43% related to Sanofi. The value of Brindisi non-current assets has been fully impaired in 2023 Consolidated Accounts. This situation is expected to impact the Group's operational and financial performance. Consequently, the full-year 2024 guidance is suspended. A revised full-year 2024 outlook will be provided in Q2 2024, along with the planned communication on the implementation and the financing of the FOCUS-27 project announced on February 28th, 2024. Conference call today at 07:45 PM CET EUROAPI management will hold a live audio webcast today at 07:45 PM CET (https://channel.royalcast.com/landingpage/euroapi-eng/20240314_1/). To participate in the Q&A session, please dial in the following numbers: France: +33 (0) 1 70 37 71 66UK: +44 (0) 33 0551 0200US: +1 786 697 3501 Media Relations contact:Laurence BollackTel.: +33 (0)6 81 86 80 19mr@euroapi.com Investor Relations contact:Sophie Palliez-CapianTel.: +33 (0)6 87 89 33 51Sophie.palliez@euroapi.com Camile RicotierTel : +33 (0)6 43 29 93 79Camille.ricotier@euroapi.com Financial Calendar March 26th, 2024: Publication of the 2023 Universal Registration Document May 22nd, 2024: Annual Shareholder General MeetingQ2 2024: Further information on FOCUS-27 projectJuly 31st, 2024 (before market opening): H1 2024 Results About EUROAPI EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn. Forward-looking statements Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, including social risks, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors” of the Universal Registration Document approved by the French Financial Markets Authority (Autorité des marchés financiers, AMF) on April 14, 2023, under number R.23-009 and the Amendment to Universal Registration Document approved by the AMF on April 25, 2023 under number R.23-015 (which are both available at www.euroapi.com). These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.” 1 API : Active Pharmaceutical Ingredients Attachment EUROAPI press release - March 14, 2024

2024-02-29

·CPHI制药在线

抗生素之迷失，创新与商业价值的选择

关注并星标CPHI制药在线抗生素的研发面临一个悖论：抗生素使用得越多，细菌变异得越快，药物越容易失效。由于耐药性问题的日益严重，新型抗生素的研发迫在眉睫；但与此同时，同样出于耐药性的考虑，抗生素药物的使用不断被限制，90%的美国医院建立了管理项目来限制抗生素的使用。这对于药企来说，市场需求虽极其旺盛，但抗生素购买成本越来越低，研发成本高昂，即便成功上市，除非患者对已有抗生素产生耐药性，否则新型抗生素也不会被使用，而且可能平均两年左右就会出现耐药性。这导致，抗生素研发成本回收周期十分漫长，几乎所有药企对于研发新型抗生素均兴趣乏乏，阿斯利康、赛诺菲、诺华等巨头更是早已先后宣布终止抗生素的研发。在生物科技领域，商业价值和创新往往是正相关的，创新总是意味着巨大的商业价值。即使是“天坑”阿尔茨海默症，埋葬了无数资金与药企的泪水后，依旧有许多药企愿意为之奋斗。但在抗生素领域，却是相反的。整个市场几近枯竭。根据医药魔方数据，2016年至今，全球范围内获批上市的抗细菌感染药物创新药只有5款，依拉环素、奥玛环素、妥布霉素、非达霉素、螺旋霉素。作为对比，仅在2023年，FDA便批准了45种抗癌新药。虽然药企的商业行为无需与道德绑定，但毫无疑问，要与耐药菌斗争，我们需要不断升级自己的武器库，而这需要药企投入更多。/ 01 /“无声的大流行病”人类使用抗生素与细菌进行斗争已有接近一百年的时间。但随着抗生素长期的不合理使用，其滥用和供应短缺问题也引起了人们的关注。自抗生素商业化开始，抗生素滥用的现象一直很普遍。有统计显示，在初级保健层面，45%-66%的抗生素处方是不必要的；约50%的处方中，抗生素种类、剂量或治疗时间不合适。为了在抗生素大潮中生存下来，细菌进化出耐药性，成为“超级细菌”，甚至于少数细菌已经进化出将抗菌药物泵出自身、破坏进入内部的抗生素，以及以其他“逃避”抗菌分子的方法。由于耐药性，抗生素药物无效，细菌感染变得越来越难以治疗。当前，全球的抗生素耐药性已经攀升到高危水平且仍在持续蔓延和恶化，《柳叶刀》上一篇《2019年全球细菌耐药性负担：系统分析》报告指出，2019年，有495万人死于抗生素失效。另据世卫组织预测，到2050年抗生素耐药性每年可能导致1000万人死亡，比癌症引起的死亡人数还要多。因此，这也被称作“无声的大流行病”。而早在1945年12月11日，青霉素的发现者弗莱明在诺贝尔获奖演讲中便警告道，细菌会对抗生素产生耐药性，人们会因此而死亡。彼时，其他科学家和医生并非没有意识到细菌耐药性进化的问题，但当时，人们对药企和科学家研发新抗生素的能力十分乐观，认为总有新的抗生素不断被发现，即便细菌对青霉素产生耐药性，还有红霉素、链霉素、氯霉素……然而，研究表明，抗生素有效时间在逐渐缩短，细菌已经进化出多种机制对抗抗生素。数据显示，1930-1950年间抗生素产生耐药性的平均时间为11年，1970-2000年抗生素耐药性产生的平均时间已降至2-3年。不仅如此，耐药性还会在不同菌株之间传播。一旦一个菌株产生耐药基因，这种基因会传播给其他菌株，使原本不耐药的菌类也被传染成具有耐药性。当耐药性普遍存在于多个菌类时，抗生素的作用自然就会大大地被削弱。全球范围内看，解决抗生素耐药性的方案主要有两种，一是开发新的抗生素，取代现已失效的抗生素。二是更明智地使用现有抗生素，即抗生素的管理。90%的美国医院建立了管理项目来限制抗生素的使用；国内也在早2012年，我国便下达了史上最严的限抗令《抗菌药物临床应用管理办法》。但现实是，抗生素管理只能作为一种缓解措施，减慢抗生素耐药性上升的步伐，无法解决抗生素的耐药性。最根本的解决办法仍是开发新型抗生素。但面对如此巨大且迫切的市场需求，药企却兴趣乏乏。/ 02 /破碎的抗生素市场抗生素市场几近枯竭。根据医药魔方数据库，2016年至今，全球范围内获批上市的抗细菌感染药物创新药只有5款，依拉环素、奥玛环素、妥布霉素、非达霉素、螺旋霉素。而仅仅在2023年，FDA便批准了45种抗癌新药，这一数量是过去8年获批的新抗生素的9倍。另外，2021年世卫组织的抗生素研发管线分析指出，全球在开发新的、急需的抗生素以应对耐药性感染方面几乎没有取得任何进展。显然，新型抗生素的研发数量和速度已无法满足人们的需求。药企层面，抗生素几乎已经成为了跨国大药企的“弃子”，阿斯利康、赛诺菲、诺华等巨头先后宣布终止抗生素的研发。这背后的核心原因在于，相比肿瘤药等产品，抗感染药物的投入产出比太低。由于抗感染领域耐药性是永久存在的问题，这会导致两个问题：其一，开发一种新的抗生素，需要10年甚至更长时间，但新产品研发速度远远跟不上耐药菌出现的速度。并且，大多数新药在上市后的平均2-3年内会出现耐药性，红利期不会持续太长时间。加上抗感染药物的挖掘已经非常充分，新分子发现困难重重，一款抗感染药物的开发难度，丝毫不亚于肿瘤药物。这一点，与疫苗市场类似。做疫苗，公认的投入大、风险高、费时费力。有任何变数，都可能前功尽弃。正因此，在面对突发疫情的时候，疫苗企业的抉择至关重要。这一点，新冠疫苗是最好的诠释。疫情前，疫苗市场四大龙头葛兰素史克、赛诺菲、默沙东、辉瑞，合计占有全球疫苗市场90%以上的市场份额。但四巨头中，辉瑞是最早下注新冠疫苗研发的，也只有它赚到了大钱。为何其他巨头没有第一时间研发新冠疫苗？原因非常简单，风险太大了。当时，新冠疫情爆发不假，但疫情走向仍难以预测。很有可能出现像当年SARS一样的情况：产品还未被研发出来，疫情就消散了，届时研发费用只能打水漂。辉瑞和其它冲在疫苗研发最前线的药企一样，都是冒险者。但与抗生素冒险者不同的是，疫苗企业在为人类防疫事业做出贡献的同时，还有几率获得高额回报。而前者要面对的却是一个“破碎”的抗生素市场。全球范围内，抗感染药物的使用都会受到更多限制，为了避免新药过快产生耐药性，通常在明确耐药细菌感染的情况下才能使用，销售受限。这也是另一个关键问题所在。新药研发的高风险、高投入和长周期特点，尤其抗生素产品的投资回报局限性，研发成本回收周期十分漫长，是限制这一领域创新的关键问题。换言之，现有商业模式对于抗生素创新是不可持续的。/ 03 /创新与商业价值的选择新药研发是一场成本高、风险高、回报高的“三高”豪赌，吸引着无数药企前赴后继。典型如阿尔兹海默症、RSV疫苗的研发，无数药企折戟，无数研发资金打水漂，但在足够高的回报预期下，依然有药企愿意在黑暗中坚持。因为，风险虽巨大，但冒险依旧是值得的。反过来看抗生素的研发，却是一场成本高、风险高、回报低的豪赌。在看不到回报的市场上，尽管耐药性问题日益严重，市场需求极其旺盛，但药企却没有动力研发新型抗生素。关于这一点，我们不能用道义去简单评判。毕竟，任何一家药企都需要盈利，也只有这样，才会反哺药物研发，诞生更多患者亟需的治疗药物。更何况，在商业世界，不论有何种宏伟愿景，一家公司最基本的职责，始终是赚钱回报股东，尤其是对于上市公司。药企的商业行为无需与道德绑定，但围绕着破碎的抗生素市场，如何衡量创新与商业价值，如何重塑抗生素创新生态，显然值得关注。正如美国，今日所拥有的极为发达的医疗环境，并不是一蹴而就的。一方面，这需要药企长年累月的研发投入。头部大药企在过去几年，均投入了数百亿美金的研发费用，仅默沙东一家，去年的研发费用就超过了300亿美元；另一方面，这需要创新生态环境的支持。创新生态系统对创新药行业的未来至关重要。当创新生态系统按预期运行，患者和整个医疗系统，将会受益于改变我们战斗方式的新一代药物来对抗疾病。而如果药企面临利润空间越来越小的局面，那必然不利于药企的发展。这意味着，创新生态系统会受到损害。显然，抗生素的创新生态已经受到了损害。一个资金充足、回报适当的创新生态系统，对于促进新型抗生物的研究和开发，无疑是至关重要的。而过去几年，全球各国家面对抗生素耐药性挑战，均通过提供大量的公共资金，广泛补贴研究和临床试验，以及激励措施，如市场准入奖励、更快的许可、美国新抗生素的补充价格，以及英国国家医疗服务系统新的“Netflix模式”（即药企开发和生产的抗生素无论使用与否，都会得到一笔定期的固定费用），来推进抗生素的研究，但见效甚微。市场正在期盼一种新的模式，来解决抗生素产品的创新驱动问题。因为这是一场持久战，除了产品管线挑战，更亟待寻找解决深层次商业模式问题的解决方案。在这场持久战中，开发抗生素的生物制药公司需要考虑什么？一个重要的考量是新型抗生素投放市场的运营。每个单独的市场都相对较小，但市场的总和很大。因此，重要的是要看地理宽度，而不是深度，以确保产品的商业可行性。也就是说，不能只盯着传统药物的核心市场美国，目前美国之外的市场对新型抗生素的需求极高，比美国高出一个数量级。因此，即使降价，公司也可能期望从销售中获得可观的收入。除此之外，噬菌体、活体生物药以及抗病毒项目，也被认为是可期待的解决方案。时至今日，并没有一个简单的机制和系统可以理想地解决抗生素耐药性问题，但当前正处于一个关键时刻。文／武月【智药研习社近期课程预告】来源：氨基观察声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

放射疗法

100 项与螺旋霉素相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D05908	螺旋霉素	J01FA02	DB06145

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
弓形虫病	日本	Sanofi	2018-07-02
原虫感染	中国	国药控股股份有限公司	1984-01-01
急性支气管炎	日本	Sandoz KK	1967-06-24
附件炎	日本	Sandoz KK	1967-06-24
烧伤	日本	Sandoz KK	1967-06-24
泪囊炎	日本	Sandoz KK	1967-06-24
睑腺炎	日本	Sandoz KK	1967-06-24
喉炎	日本	Sandoz KK	1967-06-24
肺脓肿	日本	Sandoz KK	1967-06-24
淋巴结炎	日本	Sandoz KK	1967-06-24
淋巴管炎	日本	Sandoz KK	1967-06-24
乳腺炎	日本	Sandoz KK	1967-06-24
骨髓炎	日本	Sandoz KK	1967-06-24
中耳炎	日本	Sandoz KK	1967-06-24
肺炎	日本	Sandoz KK	1967-06-24
脓皮症	日本	Sandoz KK	1967-06-24
猩红热	日本	Sandoz KK	1967-06-24
继发感染	日本	Sandoz KK	1967-06-24
皮肤和皮肤结构感染	日本	Sandoz KK	1967-06-24
梅毒	日本	Sandoz KK	1967-06-24