尘螨变应原（ALK-Abello A/S）(House dust mites allergenics extract(ALK-Abello A/S)) - 在研适应症：哮喘，结膜炎，特发全身性癫痫_专利_临床

概要

基本信息

药物类型

变应原提取物

别名

ACARIZAX、ALK HDM、ALK Mite Tablet

+ [14]

靶点-

作用方式

调节剂

作用机制

免疫调节剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Abbott LaboratoriesMerck Canada, Inc.

+ [1]

非在研机构

Merck Sharp & Dohme Corp.丹麦爱尔开--阿贝优公司北京代表处

Merck Sharp & Dohme LLC

权益机构

Merck & Co., Inc.

Torii Pharmaceutical Co., Ltd.

ALK-Abello A/S

最高研发阶段批准上市

首次获批日期

瑞士 (2016-08-24),

过敏性鼻炎

最高研发阶段(中国)终止

特殊审评-

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关联

26

项与尘螨变应原（ALK-Abello A/S）相关的临床试验

TCTR20250107010

/ Not yet recruiting临床2期

Efficacy of Alternate-Day Dosing House dust mite Sublingual Immunotherapy Compared to Daily Dosing in Allergic Rhinitis Patients

开始日期2025-01-13

申办/合作机构

Abbott Laboratories (Pakistan) Ltd.

NCT06741800

/ Not yet recruitingN/AIIT

Microbial Characterization in Patients With Allergic Rhinitis Before and After Sublingual Immunotherapy Tablets

The incidence of allergic rhinitis (AR) in Chinese adults was reported to be as high as 24.1% and 16.8% in children. The current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. Allergen immunotherapy (AIT) is the only causative treatment approved by the WHO, bringing a new option to patients with allergic diseases. The quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and AIT treatment in the early stages of the disease may change the long-term progression of the disease. Recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.

开始日期2024-12-20

申办/合作机构

常州市第二人民医院

NCT06151938

/ Enrolling by invitationN/A

A Prospective Observational Study Evaluating Relevance of Measurement Instruments in Assessing Effectiveness of ACARIZAX® in the Treatment of Moderate to Severe House Dust Mite Allergic Rhinitis With/Without Allergic Asthma in Chinese

The study is a single-center, observational design with a 12-month duration. Approximately 100 Chinese adult (18-65 years old) and adolescent (12-17 years old) with moderate to severe house dust mite (HDM) allergic rhinitis (AR) with or without allergic asthma (AA) who are newly prescribed ACARIZAX® will be recruited for evaluation of the relevance of measurement instruments. The instruments referred to three patient-report scales of allergic rhinitis symptom and quality-of-life including the Daily symptom score (DSS), Standardised rhinoconjunctivitis quality-of-life questionnaire [RQLQ(S)], and Visual analogue scale (VAS). Other data will be collected to evaluate the effectiveness and safety of ACARIZAX® under real-world clinical practices.

开始日期2023-11-21

申办/合作机构

ALK-Abello A/S

100 项与尘螨变应原（ALK-Abello A/S）相关的临床结果

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100 项与尘螨变应原（ALK-Abello A/S）相关的转化医学

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100 项与尘螨变应原（ALK-Abello A/S）相关的专利（医药）

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32

项与尘螨变应原（ALK-Abello A/S）相关的文献（医药）

2025-01-01·PEDIATRIC PULMONOLOGY

Effect and mechanism of allergen‐specific immunotherapy on small airway dysfunction in children with asthma

Article

作者: Lin, Jie ; Dong, Wenfang ; Yin, Yong ; Wu, Jinhong ; Hong, Li ; Zhang, Lei ; Zhong, Wenwei ; Ying, Xiaolan ; Yang, Lin

Abstract:

Background:

The purpose of this study was to investigate the effectiveness of allergen‐specific immunotherapy (AIT) on small airway dysfunction (SAD) and the underlying mechanism with a special focus on basophils.

Methods:

Sixty‐five children with mild to moderate asthma who were under regular inhaled corticosteroid (ICS) treatment for more than 1 year but whose FEF75 remained below 65% of the predicted value and had positive results for serum Der p or Der f were enrolled. Children with asthma underwent house dust mite (HDM) subcutaneous immunotherapy (SCIT) treatment for 1 year. Clinical symptoms and lung function were evaluated every 3 months during HDM SCIT treatment. Basophil activation test (BAT) was carried out before and after HDM SCIT treatment. RNA sequencing was performed in isolated basophils from peripheral blood after 6 months of HDM SCIT treatment, followed by GO term and KEGG pathway enrichment analysis between patients with and without HDM SCIT treatment.

Results:

HDM AIT treatment ameliorated clinical symptoms while concurrently improved lung function parameters, such as FEV1/FVC, FEF75, FEF50 and MMEF (p < .05). It is worth noting that FEF75 values showed a highly significant, gradual and persistent increase (from 49.55 ± 1.27% at baseline to 71.89 ± 2.64% after 1 year of therapy) and 22 of 35 patients no longer had SAD after 1 year of treatment. BAT results revealed that AIT treatment significantly reduced basophil activity to the inhalant allergen mixtures containing HDM in vitro challenge from baseline. GO term and KEGG pathway enrichment analysis of basophils revealed that downregulated genes were mainly involved in immune cell activation, antigen presentation, and Th2 cell differentiation.

Conclusions:

Our study demonstrated that HDM AIT not only improved SAD related lung function parameters, but also reduced basophil activity. RNA sequencing revealed the inhibition of phagocytosis and the phagosome pathway in basophils which may affect the polarization of Th2 cell differentiation after HDM AIT.

2025-01-01·Lancet Regional Health-Europe

Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial

Article

作者: Emeryk, Andrzej ; Gagnon, Remi ; Schuster, Antje ; Caimmi, Davide ; Pfaar, Oliver ; Foss-Skiftesvik, Majken Hougaard ; Nolte, Hendrik ; Østerdal, Anne Sofie ; Mikler, Jan ; Novakova, Silviya

Background:

Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child's quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children.

Methods:

Phase III, randomised, double-blind, placebo-controlled trial in younger children (5-11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22.

Findings:

A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%).

Interpretation:

The trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5-11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children.

Funding:

ALK-Abellό, Hørsholm, Denmark.

2024-08-12·ACTA OTO-LARYNGOLOGICA

The impact of adverse reactions on adherence to sublingual immunotherapy for Japanese cedar pollinosis and house dust mite allergy in Japan

Article

作者: Masuno, Satoru

BACKGROUND:

Allergen immunotherapy is the only treatment that can achieve remission for allergic diseases.

AIMS/OBJECTIVES:

To investigate the three-year adherence to sublingual immunotherapy for Japanese cedar pollinosis and house dust mite allergy at a clinic in Japan and identify factors that influence adherence and severe adverse reactions.

MATERIAL AND METHODS:

In total, 174 patients aged 12 years or older who started sublingual immunotherapy for Japanese cedar pollinosis (n = 72), house dust mite allergy (n = 55), or both (n = 47) between May 2017 and June 2018. Patient age, sex, type of pharmacotherapy used, adverse reactions, blood test results, and duration of continuous treatment were investigated.

RESULTS:

The three-year treatment continuation rate was 40.8%. Adverse reaction rates were 12.6% for cedar pollinosis and 40.2% for house dust mite allergy. Patients with dose reductions due to severe reactions had lower first-year continuation rates. In the MITICURE^® group, patients with severe reactions had significantly higher serum total IgE levels. Severe reactions were more common in MITICURE^® patients with seven or more positive antigen types.

CONCLUSIONS AND SIGNIFICANCE:

Severe adverse reactions reduced early adherence.

24

项与尘螨变应原（ALK-Abello A/S）相关的新闻（医药）

2025-05-06

·ir.alk.net

Three-month interim report (Q1) 2025 (unaudited)

ALK delivers 12% organic revenue growth with operating profit up 50% in Q1 Q1 results were strong as expected. Revenue increased on double-digit sales growth in all sales regions, including 22% growth in tablet sales. The operating profit margin of 31% partly reflected seasonality in ALK’s earnings. Free cash flow almost tripled. Outlook remains unchanged. Performance highlights Comparative figures for Q1 2024 are shown in brackets. Growth rates are stated in local currencies, unless otherwise indicated. Total revenue increased by 12% to DKK 1,522 million (1,351). Europe and International markets delivered growth rates of 10% and 24% respectively. Revenue in North America bounced back with growth of 14%. Global tablet sales grew by 22% to DKK 857 million (706) on double-digit growth in all sales regions. European tablet sales grew by 17%, largely due to increase in new patients, while the positive growth impact of pricing decreased as anticipated compared to last year. Global SCIT and SLIT drops sales were unchanged at DKK 500 million (500), while sales of Other products and services was up 11% to DKK 165 million (145). Operating profit (EBIT) increased by 50% to DKK 469 million (316), driven by sales growth, improved gross margin, and cost savings after last year’s optimisation initiatives. The capacity cost-to-revenue ratio was down to 36% (42%). The EBIT margin of 31% (23%) partly reflected that Q1 typically is ALK’s most profitable quarter. Free cash flow almost tripled to DKK 330 million (111) mainly driven by increased earnings. CAPEX was unchanged at DKK 57 million (59). Financial highlights Allergy+ strategy highlights The launch of the house dust mite tablet for children positively impacted sales growth in Q1, and initial market response exceeded expectations. The tablet is currently available for young children in 12 countries. The tree tablet ITULAZAX® has recently been approved in Europe for treatment of young children and adolescents aged five to 17. Efforts to secure market access for the neffy®adrenaline nasal spray is progressing well, and ALK expects the first launches in Europe to start in Q3 2025. Initial market feedback has been encouraging. ALK has entered into a four-year agreement with US-based ARS Pharma to co-promote the neffy® adrenaline (epinephrine) nasal spray in the USA. The clinical phase 2 of the peanut allergy tablet is on track and patient recruitment continues. 2025 full-year outlook The full-year outlook remains unchanged, demonstrating a continuous, robust improvement in profitability: Revenue is still expected to grow by 9-13% driven by growth across all sales regions and product groups. Growth will predominantly be attributable to higher volumes, as ALK expects to treat more patients with its allergy immunotherapy (AIT) and anaphylaxis products. The EBIT margin is still expected to improve by 5 percentage points to around 25%, driven by revenue growth, improving gross margin, and optimisation efforts. Commenting on the Q1 results, CEO Peter Halling said: “ALK is off to a very good start in 2025, with sustained revenue growth, a significant increase in operating profit, and steady progress on our strategic agenda. The initial market response to the launch of our house dust mite tablet, ACARIZAX®, for use in young children has been encouraging, and we are excitedly preparing to launch neffy®, the new adrenaline nasal spray. Despite the turmoil in the markets from trade wars and tariffs, we remain optimistic about the year ahead, anticipating only a modest impact from tariffs considering our current business footprint." Hørsholm, 6 May 2025 ALK-Abelló A/S For further information, contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525Media: Maiken Riise Andersen, tel. +45 5054 1434 ALK is hosting a conference call for analysts and investors at 11.00 a.m. (CEST) on 6 May 2025 at which Management will review the financial results and the outlook. The conference call will be audio cast on https://ir.alk.net where the relevant presentation will be available shortly before the call begins. To register for the conference call, please use this link and follow the registration instructions. You will receive an email from diamondpass@choruscall.com with dial-in details, including a passcode and a pin code. Please make sure to whitelist diamondpass@choruscall.com and/or check your spam filter. We advise you to register well in advance and to call in before 10.55 a.m. (CEST). Attachment Company release_10_25UK_060525_Q1 25 interim report

财报上市批准临床2期

2025-03-05

·drugs

FDA Expands Indication of Dust Mite Allergy Drug to Include Young Children

WEDNESDAY, March 5, 2025 -- The U.S. Food and Drug Administration has expanded its indication of Odactra, a house dust mite allergen tablet, for the treatment of house dust mite-induced allergic rhinitis, with or without conjunctivitis, to include children ages 5 through 11 years. Odactra is an allergy immunotherapy and is administered sublingually as a small tablet that dissolves under the tongue. The approval was based on data from a phase 3 clinical trial that included 1,460 children ages 5 to 11 years old with persistent allergic rhinitis symptoms for a year, despite receiving symptom-relieving medication. Children randomly assigned to Odactra experienced a relative reduction in total combined rhinitis score of 22 percent versus placebo. Four patients receiving Odactra experienced severe treatment-related adverse events, including oral and ear itchiness, burning or tingling sensation in the mouth, lip swelling, and abdominal pain. However, no participants reported treatment-related anaphylaxis or adverse events requiring treatment with epinephrine. "The pediatric indication for Odactra is significant because it provides physicians and parents a new option for treating these younger patients," Jackie Eghrari-Sabet, M.D., an allergist and immunologist at George Washington University in Washington, D.C., said in a statement . "In addition to the convenience of sublingual administration, Odactra has been shown to reduce their allergy symptoms and reliance on symptomatic medications." Expanded approval of Odactra was granted to ALK. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果临床3期免疫疗法上市批准

2025-03-04

·蒲公英Ouryao

Paul's Insight｜解读国际法规药事(02.24-03.02)

◆ ◆ ◆ ◆ Paul's Insight 2025年2月24日-3月2日 ◆ ◆ ◆ ◆ 随着全球医药行业的持续进步，各国药品监管机构和制药公司在推进创新药物的审批、上市和安全管理方面不断加速步伐。本期动态（2月24日至3月2日）涵盖了美国FDA、欧洲EMA以及其他机构，从药品上市、安全风险和监管创新等各个方面，反映出全球药事新闻中的多样性与紧迫感。让我们一起走进这一波全球药事新闻，看看各大药品监管机构如何推动药品安全与疗效的平衡，同时，行业协会的新思考也让我们对未来医药行业的变革与发展有更多期待。美国FDA 新药物审批与安全管理的双重进步 1. FDA批准Odactra扩展适应症：为儿童群体带来新希望美国FDA最近批准了屋尘螨过敏药片Odactra的适应症扩展，使其适用于5-11岁的儿童群体。之前，该药物仅获得批准用于12-65岁人群，用于治疗由屋尘螨过敏引发的过敏性鼻炎（无论是否伴随结膜炎）。图：FDA批准了屋尘螨过敏药片Odactra的适应症扩展据统计，全球约有超过千万5至11岁儿童受到屋尘螨过敏的困扰，而屋尘螨是引发过敏性鼻炎和哮喘的重要原因之一。通过FDA的批准，更多孩子将能够获得这款药物的治疗，减轻呼吸道过敏症状，提升生活质量。图：全球约有超过千万5至11岁儿童受到屋尘螨过敏的困扰（参考：https://www.fda.gov/news-events/press-announcements/fda-roundup-february-28-2025） 2. 睾酮产品标签更新：确保药物使用更安全另一项关键决策是，FDA对所有睾酮产品生产商发布了新的标签更新要求，要求将TRAVERSE临床试验和血压监测（ABPM）研究结果纳入标签。TRAVERSE试验是一项评估睾酮替代疗法对性腺功能低下男性主要心血管不良事件发生率和疗效措施影响的研究。图：FDA对所有睾酮产品生产商发布了新的标签更新要求这一变化的核心在于，在所有睾酮产品标签上添加TRAVERSE试验数据，明确指出试验对年龄相关性低睾酮治疗的安全性结论。此外，FDA还保留了年龄相关性低睾酮适应症说明，以确保临床医生和患者正确理解药物的适用范围。同时，FDA更新了标签中的心血管风险警示语，以反映最新的临床证据。这项更新不仅传递了精准的药品疗效信息，也有助于减少不必要的恐慌，促进安全合理的用药实践，确保患者在获得疗效的同时降低潜在的健康风险。图：新英格兰医学杂志发表TRAVERSE试验结果，成为FDA的重要参考（参考：https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products） 3. FDA紧急召回通知：药品安全第一在药品召回方面，FDA近期发布了针对一家药房配药设施（CAPS）生产的苯肾上腺素注射剂的紧急召回通知。部分批次产品被检测出含有黑色颗粒，可能源自原料供应链问题。含有颗粒的注射药物可能引发局部刺激、血管堵塞，甚至导致心脏、肺部或脑部血管阻塞，带来严重的健康风险。此次召回涉及多个批次，已经通知相关经销商和医院，要求医护人员和患者立即停止使用，并按照规定进行退货或销毁处理。作为一家配药药房，CAPS的经营类似于药品生产商，但这些配药药房并未向联邦政府注册或遵守同样的安全法律。历史上，新英格兰配药中心出产的受污染醋酸甲级强的松龙（Methylprednisolone acetate），共造成47例死亡，660例患病，酿成美国历史上最严重的药品灾难之一。图：一家药房配药设施生产的苯肾上腺素注射剂被紧急召回（参考：https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09） 4. 谷歌智能手表“失脉检测”功能获FDA批准：技术创新为健康加分此外，FDA还批准了谷歌智能手表的关键功能“失脉检测”在美国市场的上线。该功能能够在用户心跳骤停时自动触发报警并呼叫紧急救援，之前该功能已经在欧洲市场推广，但因美国的监管要求一直未能开放。通过结合光学心率传感器、红外传感器和运动传感器，该功能不仅能够检测心跳停止，还能够进行二次确认，提高报警准确性。FDA认为，这项功能可挽救生命，特别适用于独居或行动不便的高风险人群。这项批准标志着医疗器械和消费电子产品在健康监测领域的逐步融合，也为未来健康管理技术的发展铺平了道路。图：谷歌智能手表“失脉检测”功能获FDA批准（参考：https://pharmaphorum.com/news/fda-clears-lifesaving-feature-googles-pixel-watch-3）美国PDA 助力药品安全性与合规性提升 2月26日，美国注射剂协会（PDA）发布了最新的《制药行业质量文化评估指南》，该指南提出了五大核心主题：领导承诺、沟通与协作、员工参与、持续改进和技术卓越。指南的发布不仅帮助制药企业评估现有质量文化，还确保企业与监管机构的期望一致，为全球药品的安全性和合规性提供了重要参考。图：PDA发布质量文化评估指南（参考：https://www.pda.org/about-pda/press-releases/press-release-detail/just-released-pda-ansi-standard-06-2025-quality-culture-assessment-of-quality-culture-guidance-documents-models-and-tools）欧洲EMA 药品创新加速，监管更加高效 1. 上市后变更试点计划：提升药品审批效率在欧洲，欧洲药品管理局（EMA）也在近期推出了一项重要举措——“依托应用：上市后变更试点计划”。该计划的目的是加速药品上市后变更的审批流程，使制药企业在调整药品质量、生产工艺或配方时能够借助已认可的监管评估数据，减少重复审查，从而加快审批进程。这一举措不仅提高了监管效率，还促进了跨国监管合作与经验共享，为全球药品的创新和上市提供了更为高效的监管支持。图：EMA发布试点计划，促进了跨国监管合作与经验共享（参考：https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/reliance-applied-post-autorisation-changes-pilots-pharmaceutical-industry） 2. CHMP会议亮点：新药上市推荐在EMA的人用药品委员会（CHMP）会议上，CHMP推荐了四种新药的上市申请，其中包括全球首个外用基因治疗产品——Vyjuvek，这款药物是为了治疗营养不良性大疱性表皮松解症而开发的。 Vyjuvek作为全球首个外用基因治疗产品，得到了EMA的优先药物（PRIME）计划支持，为罕见遗传性皮肤病患者带来了新的治疗希望。此外，Deqsiga（用于免疫缺陷患者的免疫球蛋白）、Lynozyfic（用于复发性多发性骨髓瘤的治疗）以及Trabectedin Accord（用于晚期软组织肉瘤和复发性卵巢癌的仿制药）也都获得了EMA的推荐，为患者提供了更多的治疗选择。图：Vyjuvek为全球首个外用基因治疗产品（参考：https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-february-2025）英国MHRA 为老年人健康护航在英国，英国药品和健康产品管理局（MHRA）近期批准了Moderna公司研发的mRESVIA mRNA疫苗。该疫苗旨在为60岁及以上人群预防呼吸道合胞病毒（RSV）感染。RSV是一种严重的呼吸道病毒，每年会导致全球超过17万名60岁以上老人住院，并造成1.4万例死亡。图：英国MHRA批准了Moderna公司研发的mRESVIA mRNA疫苗 mRESVIA是一款针对RSV的mRNA疫苗，由编码稳定融合前F糖蛋白的mRNA序列组成。其与2024年5月获得美国FDA批准，是Moderna公司第二项获批的mRNA疫苗。mRESVIA的临床试验数据显示，接种疫苗约 4 个月后，与接种安慰剂的人相比，接种 RSV疫苗的人患RSV引起的下呼吸道疾病的风险降低了 79%，为高风险老年群体带来了极大的福音。MHRA的批准标志着mRNA技术在疫苗领域的再次成功应用。图：RSV 疫苗为高风险老年群体带来了极大的福音（参考：https://www.gov.uk/government/news/mresvia-rsv-vaccine-approved-to-protect-patients-aged-60-and-over） ICH 加强临床试验监管日前，国际人用药品注册技术协调会（ICH）发布了《药物临床试验管理规范》（GCP）修订版的官方培训材料，讲解了ICH E6(R3)的修订、结果和变化内容。这一新指南强调了基于风险管理的临床试验设计，推动数据共享和国际协调，鼓励“以患者为中心”的试验模式。图：ICH发布 E6(R3)修订版的官方培训材料（参考：https://www.ich.org/news/ich-e6r3-introductory-training-presentation-now-available-ich-website） ISPE 无菌生产数据管理要求 ISPE最新文章强调数据管理在无菌药品生产中的关键作用，特别是在欧盟GMP附录1修订版发布后。文章指出，数据管理不仅对于验证和风险管理至关重要，还涉及到ALCOA++原则的具体应用，以确保数据的完整性和可靠性。文章强调了数据生命周期管理的重要性，并提出了确保无菌生产过程中数据准确性的一些最佳实践。图：ISPE最新文章强调数据管理在无菌药品生产中的关键作用（参考: https://ispe.org/pharmaceutical-engineering/ispeak/data-management-requirements-sterile-manufacturing）结语药品安全与创新的双重驱动从FDA到EMA，再到MHRA、ICH，我们看到全球药品监管机构在不断推动药品审批效率的同时，确保药品的安全性与有效性。在技术的不断进步和全球合作的加强下，创新药物和健康管理工具正迅速走向市场。无论是新药的上市、临床试验的规范，还是质量管理的提升，全球药事领域正朝着更加高效、透明和创新的方向发展。我们有理由相信，未来药品监管和创新将继续携手并进，为全球公众的健康保驾护航。 END 声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。 2024生物行业年度总结 ● 2024年中国生物行业主要政策回顾与盘点 ● 回顾展望生物医药：2024深度转型，2025破冰发展 ● 2024年生物医药产业政策盘点（附政策包下载） ● 生物医药产教融合：推动产业可持续发展的关键路径 ● 从"卡脖子"到"自主可控":生物医药供应链国产替代进行时 ● 生物制品抗体行业的2024 ● 7大亮点回顾2024全球ADC产业图景 ● 细胞治疗2024：盘点行业的破局之道 ● 开启生命科学新纪元：2024基因治疗全景复盘

临床研究申请上市医药出海

100 项与尘螨变应原（ALK-Abello A/S）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	V01AA03	-

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
哮喘	韩国	Abbott Laboratories	2018-01-02
结膜炎	加拿大	Merck Canada, Inc.	2017-05-04
特发全身性癫痫	加拿大	Merck Canada, Inc.	2017-05-04
屋尘螨过敏	加拿大	Merck Canada, Inc.	2017-05-04
由于尘螨引起的过敏性鼻炎	美国	ALK-Abello A/S	2017-03-01
过敏性鼻炎	瑞士	ALK-Abello A/S	2016-08-24

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
过敏性鼻结膜炎	临床3期	中国	丹麦爱尔开--阿贝优公司北京代表处	2019-11-06
过敏性鼻结膜炎	临床3期	中国	ALK-Abello A/S	2019-11-06
过敏性哮喘	临床3期	白俄罗斯	Abbott Laboratories	2015-10-01
过敏性哮喘	临床3期	俄罗斯	Abbott Laboratories	2015-10-01
过敏	临床3期	白俄罗斯	Abbott Laboratories	2015-10-01
过敏	临床3期	俄罗斯	Abbott Laboratories	2015-10-01
常年性变应性鼻炎	临床3期	-	ALK-Abello A/S	2013-01-01
常年性变应性鼻炎	临床3期	-	Merck Sharp & Dohme Corp.	2013-01-01
鼻结膜炎	临床3期	-	Merck Sharp & Dohme Corp.	2013-01-01
鼻结膜炎	临床3期	-	ALK-Abello A/S	2013-01-01

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临床结果

适应症

分期

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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


NCT04145219 (MT-12, Literature) 人工标引	临床3期	过敏性鼻炎伴哮喘	1,460	SQ HDM SLIT	鹽觸獵選築顧鬱壓憲鹹(膚憲餘遞鬱壓顧鬱繭選): Difference = 1.0 (95% CI, 0.5 ~ 1.4), P-Value = < 0.0001 更多	积极	2024-11-26
				Placebo
NCT03654976 (MAPIT, CTgov)	临床3期	过敏性鼻炎 \| 过敏性哮喘 \| 屋尘螨过敏	533	HDM (HDM SLIT-tablet (12 SQ-HDM))	繭鏇獵積願範壓齋獵鹹(範鬱壓蓋繭選窪鹽鏇壓) = 艱膚夢構願餘願蓋衊膚壓網遞鹽衊網壓鏇淵顧 (鏇艱鬱鏇顧積糧構憲艱, 願蓋鹽夢糧餘艱顧齋窪 ~ 襯齋選選蓋鹹遞鑰願廠) 更多	-	2023-10-19
				Placebo (Placebo SLIT-tablet)	繭鏇獵積願範壓齋獵鹹(範鬱壓蓋繭選窪鹽鏇壓) = 鬱鏇鹽壓顧簾構廠餘顧壓網遞鹽衊網壓鏇淵顧 (鏇艱鬱鏇顧積糧構憲艱, 糧簾顧鹹餘襯鹹遞獵淵 ~ 淵餘積鑰壓獵憲淵糧範) 更多
NCT04541004 (AMASE, CTgov)	临床3期	鼻结膜炎 \| 哮喘 \| 过敏性鼻炎	253	HDM SLIT-tablet	遞襯壓築網齋願鏇廠鬱 = 艱襯齋範鑰鑰壓襯醖夢鏇鹹醖製積網製鹽鏇願 (夢選壓遞蓋襯願壓壓艱, 壓廠衊積夢淵餘淵築顧 ~ 衊簾範願鏇繭壓築蓋齋) 更多	-	2023-07-03
NCT02596321 (CTgov)	临床3期	过敏性鼻炎 \| 过敏性哮喘 \| 过敏	112	Mitizax (Mitizax ALK HDM Tablet)	鏇蓋夢夢願襯憲廠襯鏇(憲艱繭鹽製鑰製選築簾) = 壓範鹽鏇範繭網顧蓋廠糧範鏇衊簾壓蓋選淵繭 (壓觸範範積顧願艱廠選, 1.183) 更多	-	2017-12-18
				Placebo (Placebo Tablet)	鏇蓋夢夢願襯憲廠襯鏇(憲艱繭鹽製鑰製選築簾) = 鬱簾獵鹽鏇鹽願範膚繭糧範鏇衊簾壓蓋選淵繭 (壓觸範範積顧願艱廠選, 0.067) 更多
NCT01700192 (P05607 \| trial A, CTgov)	临床3期	由于尘螨引起的过敏性鼻炎 \| 鼻结膜炎 \| 哮喘 ... 更多	1,482	Rescue Medication: Self-Injectable Epinephrine+Rescue Medication: Olopatadine ophthalmic drops+MK-8237 tablets+Rescue Medication: Mometasone furoate nasal spray+Loratadine (MK-8237)	艱構觸糧蓋餘簾襯膚構(糧夢繭艱窪餘範襯積鏇) = 鹽齋鹹獵醖選範範遞鑰糧淵築廠範築觸獵鑰構 (鏇築壓蓋衊齋鏇選艱鹹, 3.55) 更多	-	2017-03-03
				Placebo tablets+Rescue Medication: Self-Injectable Epinephrine+Rescue Medication: Olopatadine ophthalmic drops+Rescue Medication: Mometasone furoate nasal spray+Loratadine (Placebo)	艱構觸糧蓋餘簾襯膚構(糧夢繭艱窪餘範襯積鏇) = 鑰醖遞選築繭衊築製構糧淵築廠範築觸獵鑰構 (鏇築壓蓋衊齋鏇選艱鹹, 3.82) 更多
NCT01852825 (8237-009, CTgov)	临床1期	鼻结膜炎 \| 由于尘螨引起的过敏性鼻炎	26	NAC+MK-8237 (NAC + MK-8237 (Part 2))	築艱遞鑰淵壓廠網糧選(選夢餘製蓋鬱餘觸醖齋) = 願鹽鬱範襯範選淵廠積範範壓鬱齋襯繭簾艱築 (壓醖願淵衊餘製壓衊艱, 遞窪餘鹹窪遞網獵餘餘 ~ 鬱鹹膚鬱簾餘餘顧積遞) 更多	-	2017-02-13
				Placebo (NAC + Placebo (Part 2))	築艱遞鑰淵壓廠網糧選(選夢餘製蓋鬱餘觸醖齋) = 範夢獵廠鏇築糧願艱網範範壓鬱齋襯繭簾艱築 (壓醖願淵衊餘製壓衊艱, 鏇膚廠齋廠願範鬱淵窪 ~ 夢鹽餘夢壓蓋壓願繭顧) 更多
NCT01678807 (8237-008 \| MK-8237-008, CTgov)	临床1期	常年性变应性鼻炎 \| 屋尘螨过敏	195	MK-8237 12 DU (MK-8237 12 DU)	壓憲餘廠鹽鏇製壓憲壓 = 簾衊鹽構簾築簾顧獵廠鹹餘繭構遞願鏇繭醖鹹 (鹹壓範夢衊網憲遞顧壓, 鬱蓋簾衊憲醖顧壓鬱構 ~ 簾襯範淵繭廠鏇窪淵蓋) 更多	-	2017-02-13
				MK-8237 6 DU (MK-8237 6 DU)	壓憲餘廠鹽鏇製壓憲壓 = 糧糧憲艱蓋壓蓋積簾衊鹹餘繭構遞願鏇繭醖鹹 (鹹壓範夢衊網憲遞顧壓, 簾簾製繭淵觸築醖範選 ~ 淵衊積淵遞築構獵鑰願) 更多
NCT01644617 (P07627 \| 8237-003, CTgov)	临床2期	鼻结膜炎 \| 常年性变应性鼻炎 \| 屋尘螨过敏	124	MK-8237 12 DU (MK-8237 12 DU)	積繭襯鑰積網餘製鬱廠(簾遞鏇膚鏇艱築艱築範) = 廠憲廠鹽廠選鹽壓膚廠觸積壓遞網範網願夢鑰 (窪淵觸餘範襯襯製選鹹, 糧顧艱夢鹹壓獵淵餘鹹 ~ 醖構築鏇蓋蓋鑰壓蓋繭) 更多	-	2017-02-13
				Placebo (Placebo)	積繭襯鑰積網餘製鬱廠(簾遞鏇膚鏇艱築艱築範) = 醖糧餘選簾繭窪艱遞艱觸積壓遞網範網願夢鑰 (窪淵觸餘範襯襯製選鹹, 糧糧製鏇艱壓廠獵獵積 ~ 簾鬱鏇築顧鹹觸憲網範) 更多
NCT01700192 (Pubmed \| J Allergy Clin Immunol) 人工标引	临床3期	哮喘 \| 过敏性鼻结膜炎	1,482	MK-8237	艱窪鬱鑰製觸壓襯繭鏇(製淵醖願窪網鏇選壓遞) = 衊廠繭範鹽鏇衊憲鬱遞糧糧鑰淵鹹壓網廠夢鏇 (憲製範簾憲窪範鹹鏇憲, 10 ~ 25) 更多	积极	2016-12-01
				Placebo	-
NCT01603056 (CTgov)	临床3期	哮喘 \| 过敏性鼻炎 \| 屋尘螨过敏	617	Pangramin SLIT HDM mix. (PANGRAMIN SLIT HDM MIX)	膚蓋醖憲積選鏇鬱齋鏇(構壓鹹範鹽獵簾憲築網) = 築鏇窪廠簾夢網鬱窪鹽願淵窪餘淵憲餘窪選襯 (艱鑰襯襯襯構衊製範齋, 2.13) 更多	-	2016-04-29
				Placebo (Placebo)	膚蓋醖憲積選鏇鬱齋鏇(構壓鹹範鹽獵簾憲築網) = 鹹顧繭膚鹹醖繭餘鹹顧願淵窪餘淵憲餘窪選襯 (艱鑰襯襯襯構衊製範齋, 2.18) 更多