A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome

The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified classification criteria according to Kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the VAS scale greater than or equal to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.

开始日期2023-12-13

申办/合作机构

Medical Research Agency

CTRI/2023/11/059887 / Not yet recruiting临床4期

Effect of Transforaminal Epidural Etanercept on Lumbar Radicular Pain: A Prospective Interventional Study - NIL

开始日期2023-11-20

申办/合作机构-

NCT05950724 / Enrolling by invitation早期临床1期IIT

RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

The purpose of this study is to assess whether TNFa antibody use before lung transplant can prevent kidney injury after lung transplant.

开始日期2023-09-17

申办/合作机构

Northwestern University

100 项与依那西普相关的临床结果

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100 项与依那西普相关的转化医学

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100 项与依那西普相关的专利（医药）

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9,071

项与依那西普相关的文献（医药）

2024-12-01·Molecular biology reports

Oxidative stress in Alzheimer’s disease: current knowledge of signaling pathways and therapeutics

Review

作者: Sharma, Prajjwal ; Singh, Sunil K ; Dhapola, Rishika ; HariKrishnaReddy, Dibbanti ; Beura, Samir K

Alzheimer's disease's pathophysiology is still a conundrum. Growing number of evidences have elucidated the involvement of oxidative stress in the pathology of AD rendering it a major target for therapeutic development. Reactive oxygen species (ROS) generated by altered mitochondrial function, dysregulated electron transport chain and other sources elevate aggregated Aβ and neurofibrillary tangles which further stimulating the production of ROS. Oxidative stress induced damage to lipids, proteins and DNA result in neuronal death which leads to AD. In addition, oxidative stress induces apoptosis that is triggered by the modulation of ERK1/2 and Nrf2 pathway followed by increased GSK-3β expression and decreased PP2A activity. Oxidative stress exaggerates disease condition by interfering with various signaling pathways like RCAN1, CREB/ERK, Nrf2, PP2A, NFκB and PI3K/Akt. Studies have reported the role of TNF-α in oxidative stress stimulation that has been regulated by drugs like etanercept increasing the level of anti-oxidants. Other drugs like pramipexole, memantine, carvedilol, and melatonin have been reported to activate CREB/RCAN1 and Nrf2 pathways. In line with this, epigallocatechin gallate and genistein also target Nrf2 and CREB pathway leading to activation of downstream pathways like ARE and Keap1 which ameliorate oxidative stress condition. Donepezil and resveratrol reduce oxidative stress and activate AMPK pathway along with PP2A activation thus promoting tau dephosphorylation and neuronal survival. This study describes in detail the role of oxidative stress in AD, major signaling pathways involving oxidative stress induced AD and drugs under development targeting these pathways which may aid in therapeutic advances for AD.

2024-05-01·Arthritis & rheumatology (Hoboken, N.J.)

Incidence of Uveitis in Patients With Axial Spondylarthritis Treated With Biologics or Targeted Synthetics: A Systematic Review and Network Meta‐Analysis

Review

作者: Bechman, Katie ; Galloway, James ; S Uğuzlar, Ali ; Steer, Sophia ; Wilson, Nicky ; Nagra, Deepak ; Yang, Zijing ; Russell, Mark D ; Adas, Maryam ; Norton, Sam

Objective:

Anterior uveitis is a common extra‐articular manifestation of axial spondyloarthritis (AxSpA). We set to evaluate the risk of anterior uveitis (AU) with biologics and synthetic disease‐modifying drugs in AxSpA.

Methods:

We conducted a systematic review and meta‐analysis to identify phase II/III double‐blinded randomized controlled trials of anti–tumor necrosis factor (TNF) monoclonal antibodies (mAb), anti–interleukin‐17 (anti–IL‐17), and Janus kinase inhibitors (JAKi) in AxSpA. Patient‐exposure years (PEY) were calculated using the per‐protocol approach. Incidence rate (IR) of AU/100 person‐years were calculated by treatment group using the random effects approach. Network meta‐analysis (NMA) was used to estimate risk of AU in treatment groups, expressed as IR ratios (IRRs). Bias was assessed using the Cochrane Risk of Bias‐2 tool.

Results:

Forty‐four trials were included: 17 anti‐TNF mAb (1,004 PEY), 9 etanercept (180 PEY), 13 anti–IL‐17 (1,834 PEY), and 6 JAKi (331 PEY). The IR of AU were as follows for anti‐TNF mAb: 4.1, 95% confidence interval (CI) 0–8.5; etanercept: 5.4, 95% CI 0–16.0; anti–IL‐17: 2.8, 95% CI 1.6–4.1; JAKi: 1.5, 95% CI 0.0–3.0; and placebo: 10.8, 95% CI 7.4–14.1. In NMA, IRRs of treatments compared with placebo were as follows for anti‐TNF mAb: 0.32, 95% CI 0.10–1.04; etanercept 0.42, 95% CI 0.08–2.38; anti–IL‐17: 0.43, 95% CI 0.19–0.98; and JAKi: 0.32, 95% CI 0.06–1.67. Comparisons between anti‐TNF mAb, anti–IL‐17, and JAKi did not demonstrate any significant difference in AU risk. Using the surface under the cumulative ranking curve approach to rank AU risk, anti‐TNF mAbs were associated with the lowest risk followed by JAKi, anti–IL‐17, and etanercept. All treatments were ranked superior to placebo.

Conclusion:

Anti‐TNF mAbs, JAKi, and anti–IL‐17 appear protective against AU events in individuals with AxSpA, with no significant differences in risk of AU between treatments.

2024-05-01·Current rheumatology reviews

Refractory Adult-onset Still’s Disease Treated with a Combination of Methotrexate and Etanercept

作者: Ahmad, Yaser ; El Hasbani, Georges ; Cassetta, Michael

Background::

Adult-onset Still’s disease (AOSD) is a challenging diagnosis because of the variability in clinical presentation and lack of gold-standard diagnostic investigations. Even after diagnosis, the treatment is challenging, especially when the disease is refractory to first-line therapy. Multiple pharmacotherapeutic options exist for refractory AOSD, but treatment failures still occur. Etanercept, a Tumor necrosis factor (TNF)-alpha inhibitor, is one of the options that has been rarely used for refractory AOSD, with various outcomes ranging from no response to complete remission.

Case Presentation::

In this case, we highlight how a previously healthy lady had refractory AOSD to glucocorticoids, methotrexate, and hydroxychloroquine combination therapy. There was no response to interleukin (IL)-1 therapy, which necessitated a switch to a combination of etanercept, low-dose methotrexate, and low-dose glucocorticoids with complete remission for a total of three- -year follow-up.

Conclusion::

The combination of methotrexate and Etanercept can maintain remission in patients with refractory AOSD.

296

项与依那西普相关的新闻（医药）

2024-06-24

·生物制品圈

2023年全球畅销药TOP 30专利到期日汇总

如今，许多大型制药企业都正面临着重大的“专利悬崖”，到2030年，这将使其每年面临超过2000亿美元的收入风险。值得注意的是，与过往主要是化学药占主导地位不同，此次许多即将失去市场独占权的药物都是生物药。如艾伯维的抗炎药Humira、默沙东的抗癌药物Keytruda、百时美施贵宝（BMS）的免疫疗法Opdivo、强生的免疫疾病药物Stelara和再生元的眼科治疗药物Eylea等，或是已经专利到期，或是即将在2030年前后结束专利保护。BioPharma Dive汇总了2023年全球销售额排名前30的畅销药物的主要专利到期日期。表1：2023年全球销售额TOP 30畅销药主要专利到期日期在美国授予的专利的标准期限为20年。但实际上，由于制药商通常是在药品上市之前就获得了新药的相关专利，因此药品上市的受保护时间相比标准期限会更短。专利到期意味着仿制药可以进入市场，药物的销售额下降在所难免。根据Evaluate Pharma的数据，就Humira而言，预计该药物销售额将在2024年保留其2022年美国收入的1/3以上，并在2030年之前保持超过20亿美元的收入。图1：美国药品收入与主要专利到期日期后年数的关系，专利到期年份设为0年艾伯维吸取了先前专利悬崖的教训，通过2种新的替代产品——用于牛皮癣和克罗恩病的Skyrizi，以及用于类风湿性关节炎等炎症性疾病的Rinvoq，来抵御Humira销售额下降的预期侵蚀。公司预计到2027年，这两种药物的总收入将达到210亿美元，大约相当于Humira的峰值销售额。此外，利用一些专利策略，制药商也可以延长药物的专利到期时间。对于专利到期的药物，制药企业采取的另一种策略是通过构建“专利丛林（patent thicketing）”来延长仿制药或生物类似物的进入时间。所谓专利丛林，即在围绕药品基本专利层层申请次级专利，形成专利群，不断扩大和延长专利保护的范围和时间，加上药品专利链接制度，使得仿制药公司很难获得仿制药的批准，从而阻碍或延长了仿制药进入市场。这种情况特别容易出现在”重磅炸弹”药（blockbuster drugs）上，如欧委会报告提出的，有的”重磅炸弹”药受到多达100多个产品专利族、1300多个专利和在申请专利的保护，这使得仿制药很难进入市场。如艾伯维的Humira正是采用的这种策略，其在美国拥有数十项专利，将生物仿制药的进入时间在原有的专利期上推迟了七年。其他的如默沙东的Keytruda、强生的多发性骨髓瘤药物Darzalex和BMS的Opdivo，均在试图利用这种策略延长专利期。图2：30款畅销药品的长期专利保护（线条显示了市场垄断的时间跨度，从美国首次获批到目前预期的专利到期日）除了专利丛林外，其他通过专利延长保护期的方法还有：产品跳转（product hopping），即在药品专利即将到期时，对药品进行微小改进并申请专利，形成新一代专利药品，并花大成本进行推广，形成对原专利药的替代，同时在原专利药的仿制药进入市场前将其从市场上撤出，通过这一方式，阻碍仿制药进入市场。专利常青（patent evergreening），专利丛林策略和产品跳转策略相互结合，加上专利药品的各种推广策略，使得专利药品一直受到专利保护，仿制药无法进入相关市场，形成专利常青。通过一个或多个策略的结合，以保持药物的市场独占权。这些策略有时可以避免20年甚至更长时间的仿制药竞争。例如，安进的炎症性疾病药物Enbrel，在2029年关键专利到期时，将享有超过30年的上市保护期。参考资料： [1]Drug patents protect pharma profits. Track when they’ll expire here.By Jonathan Gardner.Published May 8, 2024 • Updated May 13, 2024. [2]Big pharma’s looming threat: a patent cliff of ‘tectonic magnitude’.By Jonathan Gardner.Published Feb. 21, 2023. [3]反垄断系列（二）丨中美欧药品行业反垄断不同情况及其启示.北京市竞天公诚律师事务所.2023-09-12. 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

专利到期上市批准免疫疗法

2024-06-24

·GlobeNewswire-Health Care

Kiniksa Pharmaceuticals Partners with NHL Hall-of-Famer Henrik Lundqvist to Raise Awareness of Recurrent Pericarditis

– Campaign to elevate experiences from the recurrent pericarditis community and provide resources to patients and caregivers – HAMILTON, Bermuda, June 24, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced a partnership with National Hockey League (NHL) Hall-of-Famer, Henrik Lundqvist, to raise awareness in support of patients suffering from recurrent pericarditis. Lundqvist has faced the challenges of living with this painful and debilitating chronic autoinflammatory cardiovascular disease. The campaign will kick off in September of this year. Pericarditis is marked by a profound inflammation of the pericardial tissue in the multi-layered sac that surrounds the heart. The associated sharp chest pain frequently requires urgent care and hospitalization, and patients often believe they are having a heart attack. Patients experiencing recurrent pericarditis flares suffer wide-ranging effects on quality of life, physical activity, and overall well-being. “Despite the significant impact of recurrent pericarditis on patients’ lives, the limited understanding of the disease often results in delayed diagnosis and treatment,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “We are honored to collaborate with Henrik Lundqvist to raise awareness of the realities of suffering from recurrent pericarditis. We believe this collaboration will help educate and inspire individuals to take proactive steps to access appropriate medical care early on to prevent future flares.” For more information on recurrent pericarditis, visit whatispericarditis.com. To learn about the first and only U.S. Food and Drug Administration-approved therapy for recurrent pericarditis, visit arcalyst.com. About Recurrent PericarditisRecurrent pericarditis is a painful and debilitating chronic autoinflammatory cardiovascular disease marked by inflammation of the pericardium and is often associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion. Recurrent pericarditis symptoms have an impact on quality of life, limit physical activities, and lead to frequent emergency department visits and hospitalizations. Data show that approximately 40,000 patients in the U.S. seek and receive treatment for recurrent pericarditis each year. Of that group, approximately 14,000 patients experience two or more recurrences due to persistent underlying disease or inadequate response to conventional therapies, such as nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine and corticosteroids. About KiniksaKiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s immune-modulating assets, ARCALYST®, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more information, please visit www.kiniksa.com. IMPORTANT SAFETY INFORMATION ABOUT ARCALYST ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection).While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection.Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST.Medicines that affect the immune system may increase the risk of getting cancer.Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction.Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides.Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose. For more information about ARCALYST, talk to your doctor and see the Product Information. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify forward- looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: the timing of the campaign, our belief that our collaboration will help educate and inspire individuals to take proactive steps to access appropriate medical care early on to prevent future flares and our belief that all of our product candidates offer the potential for differentiation. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our and our partners’ achievements to be materially different from those expressed or implied by the forward-looking statements. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Every Second Counts! ® Kiniksa Investor and Media ContactRachel Frank(339) 970-9437rfrank@kiniksa.com

疫苗

2024-06-11

·CPHI制药在线

肿瘤、代谢、免疫，三分天下之势已定

关注并星标CPHI制药在线全球药物销售趋势怎样？不同适应症的市场表现最近几年出现了怎样的变化趋势？从有销售额统计的完整两年，即2022和2023年的数据来看，我们可能会发现出一些规律。以销售量排名前50的药物角度来评估，2023年的TOP 50药物总销售量相对于2022年出现大幅下降。2022年50强药物销售额总量为3808亿美元，而2023年下降到了3352亿美元（48款产品），下降率高达12%。背后的部分原因与Comirnaty为首的Covid-19疫苗和疗法销售额暴跌相关联。Comirnaty 2022年销售额559亿美元，2023年则骤降至153亿美元，下降73%。莫德纳的Spikevax疫苗则从2022年的185亿美元下降到2023年的67亿美元。单这两款疫苗就造成了524亿美元的亏空，这已经超过了2023年和2022年的总销售额下降体量（456亿美元）。因此排除了与Covid-19相关的产品，2023年重磅产品的销售额总量相对于2022年实现了略微的上涨。表1. 2023年销售前48名药物明细在Covid-19产品式微的同时，以Mounjaro，Wegovy，Skyrizi，Dupixent为代表的代谢和炎症/免疫类疾病的销售额实现了大幅增长。其中Mounjaro在2023年收获了51.63亿美元的销售额和969%的同比增长率（Moujaro 2022年中上市，因此2022年只有两个季度的销售数据）。而修美乐的"后辈"Skyrizi则在2023年收获了77.6亿美元，同比增长50%。从适应症角度看，肿瘤药物仍然在畅销药物排行榜上占据主导地位，但以2型糖尿病和肥胖症为代表的代谢疾病的市场得到了大幅度的开发（图1）。默沙东的Keytruda 在2023年登上了药王宝座，其全年销售额达到了250 亿美元，较 2022 年增长 19%。其他肿瘤治疗药物，如 Darzalex（97.44亿美元）、Opdivo（90.09亿美元，9.21%）和 Tagrisso（57.99亿美元，6.52%）也都经历了大幅成长。炎症及免疫疾病是位列癌症之后的销售额第二大板块。尽管老药王修美乐2023年销售额（114.04亿美元）相对于2022年（212.37亿美元）大幅下降了32%，但东边日出西边雨，同属艾伯维阵营的免疫学产品Skyrizi异军突起，2023年收获了77.6亿美元，同比增长50.3%。赛诺菲的Dupixent也在2023年收获115.9亿美元，在免疫药物板块中仅次于修美乐位列第二。相对于癌症领域（12款）5款销售率下降的现象，同为12款产品的免疫阵营中只有修美乐和安进的Enbrel 2023年的年销售额同比下降。图1. 2023年全球top 50药物销售额适应症分类图（图片来源：Drug Discovery & Development）尽管癌症疗法仍然是医疗领域最火热的开发领域，但从发展趋势来看，代谢疾病和炎症/免疫疾病的市场表现已经逐渐逼近肿瘤学。如果按照全年销售额前30名的药品为分析对象，我们就能明显地看出这个趋势。2022年全球销售额排名前三十的药物中有8款是肿瘤学产品，总销售额为729.6亿美元，远远领先代谢疾病（3款，163.4亿美元）和炎症/免疫疾病（6款554.2亿美元）。然而2023年，肿瘤学产品在前30名的榜单中的数量降到7款，总销售额也降至657.54亿美元。反观代谢疾病和炎症/免疫疾病，其数量和销售额都得到了显著的提高。5款代谢疾病药物收获了403.05亿美元的收入，而7款炎症/免疫产品的销售总额则达到了600.2亿美元（图2）。出现这种情况的原因，除了几款重磅肿瘤学产品销售额降低（Revlimid：-38.9%，Imbruvica：-56.94%，跌出前30名；）导致前30名中肿瘤学产品绝对数量降低之外，免疫学产品中除了榜首的修美乐销售额因为生物类似药的竞争而暴跌32%之外，包括Dupixent (dupilumab)，Stelara (ustekinumab)，Skyrizi (risankizumab-rzaa)，Ocrevus (ocrelizumab)，Cosentyx (secukinumab)和Privigen在内的多款炎症/免疫学产品的销售额都实现了高位增长。尤其是艾伯维的Skyrizi销售额同比增长50.3%，成为了艾伯维继修美乐之后又一款值得倚重的重磅免疫学产品。赛诺菲的Dupxient和强生的Stelara在2023年的销售额也首次冲上了100亿美元，极大地增加了这个阵营的销售总收入。图2. 2022、2023年全球销售额前30名药物肿瘤、代谢疾病和炎症/免疫疾病对比图（数据来源：Drug Discovery & Development）代谢疾病方面，Ozempic的大幅上扬带动了这个板块的整体走高。Ozempic在2023年实现了139亿美元的销售额，比2022年的101亿美元同比增长38.1%。勃林格殷格翰的Jardiance系列产品2023年也给出了优异的表现，在2022年64亿美元的基础上增长到81.2亿美元。礼来的Mounjaro也首次在2023年以51.6亿美元的成绩跻身TOP 30榜单。根据Evaluate Pharma对2024年和2025年全球药物销售排行榜前十的预测，代谢疾病药物将在今明两年仍然迅猛增长（图3）。2024年Top 10榜中有2款超重磅肿瘤学产品Keytruda（283亿）和Opdivo（109亿），2款代谢疾病产品Ozempic（174亿）和Jardiance（102亿），以及3款炎症/免疫产品Dupixent（142亿）, Stelara（114亿）和Skyrizi（106亿）。2025年Top 10榜的癌症产品将是Keytruda（305亿）和Darzalex（132亿），后者取代了退榜的Opdivo。代谢疾病板块中减肥产品Wegovy（128亿）上榜；Ozempic（205亿）和Jardiance（116亿）仍然位居前十。炎症和免疫学产品中，Stelara因为2023年到期的专利而将于2025年退出Top 10榜，因此榜单上只留下Dupixent（161亿）和Skyrizi（132亿）。图3. 2024、2025年预测全球销售额前10名药物肿瘤、代谢疾病和炎症/免疫疾病对比图（数据来源：Evaluate Pharma）总结从2022年与2023年两个完整年份的药物销售数据来看，肿瘤学仍然是医药开发最热门的领域，2023年全球TOP 50药物销售额中，肿瘤产品占据了将近29%。炎症/免疫和代谢疗法销售将在未来今年内实现快速增长。以GLP-1为代表的代谢疗法不仅在2型糖尿病和肥胖症上大获成功，与代谢紊乱相关联的适应症领域，包括心血管疾病和代谢相关性脂肪性肝炎有望为此类产品带来更丰厚的回报。而随着修美乐的逐渐式微和Skyrizi日益走红，炎症和免疫疾病疗法的开发也将迎来突飞猛进，尤其是CAR-T等肿瘤学资产相继转移至免疫疾病，这个拥有庞大适应症的领域将迎来科学与商业化的齐头并进。 Ref. Buntz, B. Best-selling pharmaceuticals of 2023 reveal a shift in pharma landscape. Drug Discovery & Development. 21. 05. 2024. Buntz, B. The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back. Drug Discovery & Development. 18. 04. 2023. 2024 Preview: Are We There Yet? Evaluate. 17. 01. 2024. 【企业推荐】【智药研习社直播预告】来源：CPHI制药在线声明：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~

疫苗免疫疗法财报紧急使用授权

100 项与依那西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00742	依那西普	L04AB01	DB00005

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
银屑病	中国	C.H. Boehringer Sohn AG & Co. KG	2010-02-26
多关节型幼年特发性关节炎	美国	Immunex Corp.	2002-01-15
强直性脊柱炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	挪威	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
幼年型关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
幼年型关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02

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
疼痛	临床3期	美国	Amgen, Inc.	2016-11-29
疼痛	临床3期	波多黎各	Amgen, Inc.	2016-11-29
青少年少关节慢性关节炎	临床3期	澳大利亚	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	比利时	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	哥伦比亚	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	捷克	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	法国	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	德国	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	匈牙利	Pfizer Inc.	2011-10-10
青少年少关节慢性关节炎	临床3期	意大利	Pfizer Inc.	2011-10-10

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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


NCT02464878 (CTgov)	临床2期	1型糖尿病	2	Islet Transplantation+Thymoglobulin+Basiliximab+Alpha 1-Antitrypsin+Etanercept	簾齋憲積膚繭簾鬱觸襯(願鬱窪製鏇艱艱觸窪襯) = 遞選簾醖廠製壓積憲築衊淵淵蓋範壓簾鏇簾醖 (鏇鏇襯簾鹹醖窪築糧鹽, 遞鹹蓋遞艱廠鏇餘鹹蓋 ~ 夢網鑰簾繭糧範繭鏇鹹) 更多	-	2023-12-22
NCT03636373 (CTgov)	临床4期	原发性痛风	5	Etanercept (Etanercept)	壓製鬱製願簾繭鬱衊餘(範願構願醖選遞憲獵製) = 繭襯範範鹹範醖鏇願網獵顧蓋鏇製糧遞襯餘糧 (簾範餘範夢繭衊鏇繭簾, 齋蓋夢鬱醖顧憲願鹹廠 ~ 餘膚壓廠鹹衊鹽鑰衊顧) 更多	-	2023-10-27
				Triamcinolone Acetonide (Triamcinolone Acetonide)	壓製鬱製願簾繭鬱衊餘(範願構願醖選遞憲獵製) = 夢壓獵衊夢廠衊鬱簾繭獵顧蓋鏇製糧遞襯餘糧 (簾範餘範夢繭衊鏇繭簾, 網壓窪蓋簾願蓋範廠鬱 ~ 簾遞壓觸壓糧選餘廠衊) 更多
FDA 人工标引	N/A	斑块状银屑病	211	Placebo	製鬱構鹹繭觸築繭顧繭(鹹製選艱鹹選築廠鑰觸) = 膚夢鏇製艱遞壓製選衊範夢獵窪網簾構膚鏇繭 (網餘淵築觸築繭積鬱鹽 ) 更多	积极	2023-10-18
				Enbrel 0.8 mg/kg	製鬱構鹹繭觸築繭顧繭(鹹製選艱鹹選築廠鑰觸) = 衊窪淵獵窪蓋構餘顧鹹範夢獵窪網簾構膚鏇繭 (網餘淵築觸築繭積鬱鹽 ) 更多
EULAR2023	N/A	银屑病关节炎一线	54	Etanercept originator	顧夢顧鑰膚顧鬱膚糧艱(積簾積齋襯壓顧夢網艱) = 窪憲選遞顧憲獵鬱憲蓋糧遞襯繭鏇餘廠網製醖 (獵鬱製顧網廠衊構窪衊 ) 更多	-	2023-05-31
				Adalimumab originator	顧夢顧鑰膚顧鬱膚糧艱(積簾積齋襯壓顧夢網艱) = 糧鬱簾鑰鹹獵壓構餘範糧遞襯繭鏇餘廠網製醖 (獵鬱製顧網廠衊構窪衊 ) 更多
EULAR2023	N/A	银屑病关节炎一线	-	Etanercept	憲觸窪簾鑰糧鏇壓網築(淵網選廠窪願鹹糧夢簾) = 鹹鹹廠膚鬱範鏇築壓製網遞製憲構夢觸餘鏇醖 (網廠衊鑰鑰網鏇夢鬱窪 )	-	2023-05-31
				Monoclonal anti-TNF antibodies	憲觸窪簾鑰糧鏇壓網築(淵網選廠窪願鹹糧夢簾) = 蓋顧廠壓醖顧製艱衊廠網遞製憲構夢觸餘鏇醖 (網廠衊鑰鑰網鏇夢鬱窪 )
EBMT2023	N/A	急性移植物抗宿主病	123	Best available therapies	鬱獵繭觸齋繭鬱窪鹹鏇(蓋網遞觸製鹽鏇遞壓繭) = 鬱壓醖顧選獵顧繭願遞構壓廠鹹積夢壓鏇鏇壓 (餘膚鏇範壓壓膚遞鏇襯 )	-	2023-04-23
NCT02509026 (RE-EMBARK, Pubmed)	临床4期	非放射性轴性脊柱关节炎	210	Etanercept	積築夢憲膚憲遞網衊顧(選選積窪憲築遞廠觸顧) = 鏇鹹餘蓋衊齋範選夢廠廠膚範壓繭選鑰選選願 (顧選選簾衊觸願齋鑰艱 )	-	2022-11-15
NCT01421069 (CTgov)	临床3期	附着点炎相关关节炎 \| 青少年少关节慢性关节炎 \| 银屑病关节炎	109	Etanercept	蓋鏇餘積遞鑰願膚憲窪(網遞夢廠選觸積獵餘鹽) = 築製蓋顧選願簾觸衊窪蓋壓廠醖網餘簾齋蓋顧 (積構鹽淵繭製衊壓鹽鹹, 壓繭艱願製糧蓋鹹鑰築 ~ 簾膚廠餘構鏇餘鏇顧衊) 更多	-	2022-11-14
NCT02374021 (TARGET, CTgov)	临床4期	类风湿关节炎	159	Hydroxychloroquine+Sulfasalazine+Methotrexate (Triple Therapy (MTX+SSZ+HCQ))	範簾蓋遞糧齋廠壓餘憲(鹽構鹹繭構襯獵顧遞蓋) = 艱醖蓋顧構醖鹽築願繭窪糧積衊鏇憲憲願積壓 (衊壓鏇壓艱艱顧壓構獵, 襯艱遞醖鏇製選鹹壓齋 ~ 網鑰鏇簾築窪廠夢選選) 更多	-	2022-10-26
				Adalimumab+Methotrexate+Etanercept (TNF Inhibitor (Etanercept or Adalimumab))	範簾蓋遞糧齋廠壓餘憲(鹽構鹹繭構襯獵顧遞蓋) = 願願鑰窪鏇憲鑰壓窪齋窪糧積衊鏇憲憲願積壓 (衊壓鏇壓艱艱顧壓構獵, 構膚鑰顧鑰鑰網壓鏇獵 ~ 鏇願醖網餘積憲壓觸艱) 更多
NCT04507776 (Pubmed)	N/A	脊椎关节炎	763	Etanercept	窪夢獵鬱願糧憲範範廠(遞鏇憲觸觸觸鬱獵淵顧) = 衊襯壓積齋鹹簾鏇繭製醖選構襯膚願鬱艱積鹹 (鹹齋膚蓋餘願積齋獵網 )	积极	2022-09-30