A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment

This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments.
Study details include:
* The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study.
* The investigational treatment duration will be up to approximately 52 weeks.
* The number of visits will be 18.

开始日期2024-11-07

申办/合作机构

Sanofi

NCT06590740

/ RecruitingN/A

Establishment of a FeNO Cutoff Value for Evaluating the Response to Budesonide-formoterol in Patients With Chronic Cough Suggestive of Cough Variant Asthma: a Multicenter Prospective Clinical Study

This is a multicenter, prospective, single-arm, interventional clinical study to predict the response to budesonide-formoterol treatment in patients with chronic dry or nocturnal cough by determining a cut off value of FeNO. In this study, the response to ICS/LABA treatment is defined as reduction in cough VAS score from baseline of ≥30 mm after 8 weeks of ICS/LABA treatment. Subjects will be treated with Symbicort® 160/4.5 mcg, 1 puff, BID for 8 weeks with 4 study visits: Visit 1 (Day 0), Visit 2 (week 4) and Visit 3, end of study (week 8) and Visit 4, 4 weeks after treatment discontinuation, (week 12). Baseline data will be collected at Day-5 to Day0.
This study will be conducted at around 40 study sites in China. Approximately 1000 patients (age ≥18 years old) with dry cough or nocturnal cough symptoms for at least 8 weeks and no other obvious cause for their cough will be enrolled into this study.

开始日期2024-10-25

申办/合作机构

AstraZeneca PLC

CTR20242591

/ Recruiting临床3期

一项评估BGF MDI、BFF MDI和安慰剂MDI对慢性阻塞性肺疾病参与者运动参数影响的双盲、多中心、随机、三阶段、三种治疗、交叉研究（ATHLOS）

本研究的主要目的是研究布地奈德、格隆溴铵和富马酸福莫特罗（BGF）定量吸入器（MDI）与安慰剂MDI相比以及BGF MDI与布地奈德和富马酸福莫特罗（BFF）MDI相比对等时IC的影响。布地奈德、格隆溴铵和富马酸福莫特罗MDI可减少动态过度充气并提高IC，从而改善COPD参与者的运动耐量。本研究的次要目的是研究BGF MDI与安慰剂MDI相比以及随后的BFF MDI对运动耐受时间的影响。通过恒定功率测试（CWT）评估的运动耐受时间被认为是对COPD治疗干预应答的一项有价值的评估。

开始日期2024-10-18

申办/合作机构

AstraZeneca AB

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100 项与布地奈德福莫特罗相关的临床结果

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100 项与布地奈德福莫特罗相关的转化医学

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100 项与布地奈德福莫特罗相关的专利（医药）

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495

项与布地奈德福莫特罗相关的文献（医药）

2025-02-01·BIOMEDICAL CHROMATOGRAPHY

Unique Research for Developing a Full Factorial Design Evaluated Liquid Chromatography Technique for Estimating Budesonide and Formoterol Fumarate Dihydrate in the Presence of Specified and Degradation Impurities in Dry Powder Inhalation

Article

作者: Bandaru, Lova Gani Raju ; Kanuparthy, Phani Raja ; Katari, Naresh Kumar ; Konduru, Naresh ; Gundla, Rambabu ; Kowtharapu, Leela Prasad

ABSTRACT:

A simple LC method has been developed and validated for estimating budesonide (epimer B + A) and formoterol fumarate dihydrate in dry powder inhalation. The development results of this study make it very significant. The degradation and process impurities in EP and ChP were identified in addition to budesonide and formoterol fumarate. As of yet, no one has reported all impurities using a single method. It is a unique research because it analyzes APSD (Aerodynamic Particle Size Distribution), DDU (Delivered Dose Uniformity), BU (Blend Uniformity), Assay, and cleaning test samples. It enhances the quality of medicine and separates all organic impurities and isomers through a suitable stationary phase (YMC‐Pack Pro C18, 150 × 4.6 mm × 3 μm). We optimized the chromatographic conditions: Injection volume was 20 μL, and flow rate was 1.0 mL/min. The wavelength was optimized at 220 nm. After experimental and validation results. An example is A, which contains sodium dihydrogen orthophosphate monohydrate, sodium 1‐decane sulfonate, adjusted pH 3.0, and acetonitrile at a ratio of 80:20 (v/v), and B, which contains pH 3.0 buffer and acetonitrile at a ratio of 20:80 (v/v) respectively. In addition to being optimized, the test method was validated according to ICH Q2(R2).

2025-01-15·The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians

Prenatal medication use in a prospective pregnancy cohort by pre-pregnancy obesity status

Article

作者: Smarr, Melissa M. ; Wing, Deborah A. ; Yeung, Edwina H. ; Vafai, Yassaman ; Gerlanc, Nicole ; Skupski, Daniel ; Sciscione, Anthony ; Ranzini, Angela C. ; Newman, Roger B. ; Grewal, Jagteshwar ; Grobman, William A. ; Sundaram, Rajeshwari ; Chien, Edward K. ; Grantz, Katherine L. ; Hinkle, Stefanie N. ; Zhang, Cuilin

BACKGROUND:

The association between obesity (body mass index (BMI) ≥ 30 kg/m²) and pattern of medication use during pregnancy in the United States is not well-studied. Higher pre-pregnancy BMI may be associated with increases or decreases in medication use across pregnancy as symptoms (e.g. reflux) or comorbidities (e.g. gestational diabetes) requiring treatment that may be associated with higher BMI could also change with advancing gestation.

OBJECTIVES:

To determine whether prenatal medication use, by the number and types of medications, varies by pre-pregnancy obesity status.

METHODS:

In a secondary data analysis of a racially/ethnically diverse prospective cohort of pregnant women with low risk for fetal abnormalities enrolled in the first trimester of pregnancy and followed to delivery (singleton, 12 United States clinical sites), free text medication data were obtained at enrollment and up to five follow-up visits and abstracted from medical records at delivery.

RESULTS:

In 436 women with obesity and 1750 women without obesity (pre-pregnancy BMI, 19-29.9 kg/m²), more than 70% of pregnant women (77% of women with and 73% of women without obesity) reported taking at least one medication during pregnancy, respectively (adjusted risk ratio (aRR)=1.10, 95% confidence interval (CI)=1.01, 1.20), with 81% reporting two and 69% reporting three or more. A total of 17 classes of medications were identified. Among medication classes consumed by at least 5% of all women, the only class that differed between women with and without obesity was hormones and synthetic substitutes (including steroids, progesterone, diabetes, and thyroid medications) in which women with obesity took more medications (11 vs. 5%, aRR = 1.9, 95% CI = 1.38, 2.61) compared to women without obesity. Within this class, a higher percentage of women with obesity took diabetes medications (2.3 vs. 0.7%) and progesterone (3.4 vs. 1.3%) than their non-obese counterparts. Similar percentages of women with and without obesity reported consuming medications in the remaining medication classes including central nervous system agents (50 and 46%), gastrointestinal drugs (43 and 40%), anti-infective agents (23 and 21%), antihistamines (20 and 17%), autonomic drugs (10 and 9%), and respiratory tract agents (7 and 6%), respectively (p > 0.05 for all adjusted comparisons). There were no differences in medication use by obesity status across gestation. Since the study exclusion criteria limited the non-obese group to women without thyroid disease, in a sensitivity analysis we excluded all women who reported thyroid medication intake and still a higher proportion of women with obesity took the hormones and synthetic substitutes class compared to women without obesity.

CONCLUSION:

Our findings suggest that pre-pregnancy obesity in otherwise healthy women is associated with a higher use of only selected medications (such as diabetes medications and progesterone) during pregnancy, while the intake of other more common medication types such as analgesics, antibiotics, and antacids does not vary by pre-pregnancy obesity status. As medication safety information for prenatal consumption is insufficient for many medications, these findings highlight the need for a more in-depth examination of factors associated with prenatal medication use.

2024-12-01·ADVANCES IN THERAPY

Characteristics of Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol or Other Triple Therapies in Japan: A Real-World Healthcare Claims Database Study (MITOS-AURA)

Article

作者: Argoubi, Ramzi ; Yoshida, Yuri ; Müllerová, Hana ; Makita, Naoyuki ; Takahashi, Koichiro ; Issa, Seham ; Nowacki, Grégoire ; Castañeda-Sanabria, Johann ; Matsumoto, Isao

INTRODUCTION:

In Japan, patients with chronic obstructive pulmonary disease (COPD) can be escalated to treatment with inhaled triple therapy. Two single-inhaler triple therapies combining an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist (ICS/LAMA/LABA) are approved maintenance therapies for patients with COPD, and multiple-inhaler triple therapies (MITTs) are also available. There is limited evidence regarding real-life treatment patterns and characteristics of patients with COPD initiating triple therapies.

METHODS:

This observational, retrospective cohort study identified patients with COPD in Japan from an administrative claims database (May 2018-December 2021). Demographics, clinical characteristics, and healthcare resource utilization (HCRU) were assessed in four cohorts initiating a triple therapy: budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) early adopters (initiated ≤ 12 months after market approval [September 1, 2019]), contemporary BGF users (initiated > 12 months after market approval), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) users, and any MITT users.

RESULTS:

A total of 636 patients were BGF early adopters, 2558 were contemporary BGF users, 11,187 used FF/UMEC/VI, and 5931 used MITT. The percentage of patients with concomitant asthma in each cohort was 73.0%, BGF early adopter; 74.2%, contemporary BGF; 75.7%, FF/UMEC/VI; and 84.5%, MITT. During the 12-month baseline period, the frequency of patients with ≥ 1 moderate/severe exacerbation was 18.2%, BGF early adopter; 14.3%, contemporary BGF; 13.1%, FF/UMEC/VI; and 14.0%, MITT. ICS/LABA treatment during baseline was the most frequent pathway to triple therapy, ranging from 38.2% to 51.7% across cohorts. HCRU was relatively high across cohorts (range of hospital outpatient visits/patient during the 12-month baseline period, 11.0-14.1). Multimorbidity was observed in > 80% of patients in all cohorts; cardiovascular diseases were among the most common.

CONCLUSION:

Many patients initiating triple therapy for COPD had concomitant asthma and had previously received ICS/LABA maintenance therapy. Patients prescribed BGF in the initial post-launch period were more likely to have a previous exacerbation history versus other cohorts, indicating more severe disease.

136

项与布地奈德福莫特罗相关的新闻（医药）

2025-02-09

·药通社

一日过评两款，凝胶贴膏将被集采？

统计每周仿制药一致性评价通过、上市申请、临床申请及审批情况（2025.1.25-2025.2.7）注：此次统计包含两周数据，周统计截止数据定为每周五，周六周日数据将统计入下周，依此类推。两周过评124条（按受理号计算），首家过评11个品种，分别是： 2月7日，NMPA发布的批准文件中，前段时间热议的两大化药凝胶贴膏在同一日迎来了新过评，北京泰德制药的洛索洛芬钠凝胶贴膏继苏州乐明后再过评，武汉法玛星的氟比洛芬凝胶贴膏顺利过评。北京泰德在同一天是既有喜也有忧，顺利拿下老对手九典药业的爆品洛索洛芬钠凝胶贴膏；首家过评全身起效治疗呼吸系统疾病的妥洛特罗贴剂，算是双喜临门。担忧在于，自己家的独家品种氟比洛芬凝胶贴膏被其他企业拿下了，有了首家之后，过评的企业会越来越多。化药凝胶贴膏疗效明确，过敏反应少，市场规模不小，本周有过评的两大凝胶贴膏就占了化药贴膏80%以上的市场份额，目前拥有洛索洛芬钠凝胶贴膏批文的企业已经到达了3家，也许很快，凝胶贴膏也将步入集采时代。同一天，审评中心最新显示，上海新黄河制药有限公司按注册分类4类申报的布地奈德福莫特罗吸入粉雾剂Ⅱ上市申请获受理。布地奈德福莫特罗吸入粉雾剂Ⅱ于2004年在中国上市。截至目前为止，布地奈德福莫特罗吸入粉雾剂仅原研厂家阿斯利康在国内获得生产批文，独霸20余年，尚未有仿制药上市。本周临床信息里有两个企业比较有意思，云南白药集团在1月25日申请了洛索洛芬钠凝胶贴膏的临床；宜昌人福获得了布瑞哌唑片的临床批件，注册分类3类，布瑞哌唑片的原研在国内已上市，这款预定的“卷王”品种按照化药4类申报上市的企业已达26家。依据公开信息，人福药业这个临床批件的适应症为：与其他抗抑郁药联合用于抑郁症的治疗。 1、仿制药一致性评价过评&驳回情况 2、仿制药一致性评价申报情况 3、仿制药一致性评价申请&批准临床数据来源：摩熵医药注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。

一致性评价

2025-02-07

·GBIHealth

2024年 MNC财报：阿斯利康、百时美施贵宝、波士顿科学

阿斯利康：2024年财报亮眼，将全力配合中国相关部门调查阿斯利康（纳斯达克股票代码：AZN）近日公布2024年财报显示，该公司业绩超出分析师预期，总收入同比增长21%（按固定汇率计算，下同），达到540.7亿美元。其中，产品销售额达到509.8亿美元，在12个月内同比增长19%。第四季度的产品销售额也增长了19%，达到133.6亿美元。 AZ大多数领先产品都实现了两位数的增长。按治疗领域划分，2024年肿瘤学销售额增长了24%，达到223.5亿美元；生物制药销售额增长了21%，达到218.6亿美元；罕见病产品组合增长了16%，达到87.7亿美元。该公司2024年最畅销的药物是糖尿病药物安达唐（达格列净），销售额为77.1亿美元，同比增长31%。其他表现优异的药物包括：肺癌药物泰瑞沙（奥希替尼），销售额增长16%，达到65.8亿美元。PD-L1抑制剂英飞凡（度伐利尤单抗）增长21%到47.2亿美元；BTK抑制剂康可期（阿可替尼）增长25%至31.3亿美元；PARP抑制剂利普卓（奥拉帕利）增长22%至36.7亿美元；呼吸系统药物信必可增长25%至28.8亿美元；抗体药物偶联物（ADC）优赫得（德曲妥珠单抗）的销售额为19.8亿美元，同比增长58%（加上第一三共报告数值，该药全球总计销售额37.54）。涉嫌在华逃税，AZ面临罚款 2024年第四季度，AZ中国市场收入下降3%，至13.64亿美元；不过全年收入同比增长12%。第四季度收入下降的主要原因是年终医院预算变化，加上优赫得被纳入医保后采取的库存补偿措施影响了销售。 2024年12月，AZ宣布任命Iskra Reic为全球执行副总裁、国际业务负责人，全面负责包括中国、亚洲和欧亚市场、中东和非洲、拉丁美洲、澳大利亚和新西兰在内的地区整体战略，接替因涉嫌走私重磅抗癌药物在中国被捕的王磊。AZ至今仍然受到该案件的影响。财报显示，2025年1月，2025年1月，该公司收到深圳海关出具的《移送审查起诉告知书》以及《鉴定意见通知书》，意见书显示阿斯利康涉嫌偷逃进口税款，金额达90万美元。阿斯利康认为《鉴定意见通知书》中提及的进口税款涉及度伐利尤单抗（Imfinzi）和替西木单抗（Imjudo）。若阿斯利康被最终判定需承担法律责任，还可能被处以偷逃税款一至五倍的罚金。阿斯利康将继续全力配合中国相关部门。按此说法，阿斯利康或面临最高450万美元的罚金。 AZ预计2025年的总收入将实现高个位数百分比的增长，同时核心每股收益也有望达到两位数的百分比增幅。 BMS 2024年报：新产品贡献增量，全年增收7%至483亿美元 2025年2月6日，百时美施贵宝（简称“BMS”，NYSE：BMY）公布2024年第四季度（2024Q4）及全年业绩报告。公司2024Q4营收达到123亿美元，同比增长8%；全年营收483亿美元，同比增长7%。按区域划分，BMS 2024Q4在美国市场的营收同比增长9%至86亿美元，在国际市场的营收同比增长5%至37亿美元；全年在美国市场录得341亿美元（+9%），在国际市场录得142亿美元（+3%）。 BMS近年来新推出的“增长产品组合”在2024Q4录得64亿美元（+21%），全年录得226亿美元（+17%），与老牌心血管药物阿哌沙班（艾乐妥/Eliquis）共同贡献了主要增长。其中，PD-1抑制剂纳武利尤单抗（欧狄沃/Opdivo）全年营收达到93.04亿美元，同比增长3%（不含日本小野制药在亚洲授权区域的销售额）。全球首创的红细胞成熟剂罗特西普（利布洛泽/Reblozyl）、靶向CD19的CAR-T疗法利基迈仑赛（Breyanzi）、全球首创心肌病疗法玛伐凯泰（迈凡妥/Camzyos）也增势强劲，分别录得17.73亿美元（+76%）、7.47亿美元（+105%）、6.02亿美元（+161%）。然而，抗癌药达沙替尼（施达赛/Sprycel）、来那度胺（瑞复美/Revlimid）、白蛋白紫杉醇（凯素/Abraxane）和泊马度胺（Pomalyst）因受到仿制药冲击销量下滑，抵消了部分增长。 BMS在2024Q4达成了多项临床和监管里程碑，包括纳武利尤单抗皮下注射剂Opdivo Qvantig获得美国FDA批准，以及精神分裂症新药Cobenfy在美国上市；首席执行官Christopher Boerner博士指出，Cobenfy有望为公司提供“新的增长动力”。BMS发布的2025年业绩指导显示，预计公司全年营收可达到约455亿美元。波士顿科学2024年报：全年净销售额增长17.6%至167.47亿美元 2025年2月5日，波士顿科学（NYSE：BSX）公布2024年第四季度（2024Q4）及全年业绩报告。公司2024Q4净销售额达到45.61亿美元，同比增长22.4%；全年净销售额达到167.47亿美元，同比增长17.6%。按业务划分，波士顿科学2024Q4医疗外科（MedSurg）收入同比增长12.4%至16.19亿美元，心血管业务收入同比增长28.8%至29.42亿美元。按地区划分，波士顿科学2024Q4在美国的收入同比增长30.7%至28.93亿美元，在欧洲、中东和非洲（EMEA）的收入同比增长10.8%至8.30亿美元，亚太（APAC）市场收入增长11.1%至6.84亿美元，拉丁美洲和加拿大（LACA）市场收入增长4.6%至1.55亿美元；除美国、西欧和中欧、日本、澳大利亚、新西兰和加拿大以外的新兴市场收入增长12.4%至6.68亿美元。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ xujingou@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报抗体药物偶联物高管变更

2025-02-06

·Business Wire

AstraZeneca’s Full Year and Q4 2024 results

CAMBRIDGE, England--( BUSINESS WIRE )--AstraZeneca: Revenue and EPS summary FY 2024 % Change Q4 2024 % Change $m Actual CER i $m Actual CER - Product Sales 50,938 16 19 13,362 18 19 - Alliance Revenue 2,212 55 55 714 68 69 - Collaboration Revenue 923 56 54 815 >2x >2x Total Revenue 54,073 18 21 14,891 24 25 Reported EPS $4.54 18 29 $0.97 56 71 Core ii EPS $8.21 13 19 $2.09 44 49 Financial performance for FY 2024 (Growth numbers at constant exchange rates) Total Revenue up 21% to $54,073m, driven by a 19% increase in Product Sales, continued growth of partnered medicines (Alliance Revenue) and the achievement of sales-based milestones (Collaboration Revenue) Total Revenue growth from Oncology was 24%, CVRM 20%, R&I 25%, V&I 8% and Rare Disease 16% Core EPS increased 19% to $8.21 Second interim dividend declared of $2.10 per share, making a total annual dividend declared for FY 2024 of $3.10 per share, an increase of 7%. Dividend to be further increased in FY 2025 Guidance for FY 2025: Total Revenue is expected to increase by a high single-digit percentage and Core EPS is expected to increase by a low double-digit percentage, both at CER Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “ Our company delivered a very strong performance in 2024 with Total Revenue and Core EPS up 21% and 19% respectively. We also delivered nine positive high value Phase III studies in the year, which coupled with increasing demand for our medicines in all key regions, will help sustain our growth momentum into 2025. This year marks the beginning of an unprecedented, catalyst-rich period for our company, an important step on our Ambition 2030 journey to deliver $80 billion Total Revenue by the end of the decade. In 2025 alone, we anticipate the first Phase III data for seven new medicines, along with several important new indication opportunities for our existing medicines. We are also investing in and making significant progress with transformative technologies that have the potential to drive our growth well beyond 2030, many of which have now entered pivotal trials.” Key milestones achieved since the prior results announcement Positive read-outs for Truqap in combination with abiraterone and androgen deprivation therapy in PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) and Tagrisso with or without chemotherapy in resectable early-stage EGFR m NSCLC (NeoADAURA) US approvals for Imfinzi in limited-stage small cell lung cancer (ADRIATIC), Calquence in combination with bendamustine and rituximab in mantle cell lymphoma (ECHO), Datroway (datopotamab deruxtecan) in HR+ HER2- metastatic breast cancer (TROPION-Breast01) and Enhertu in chemotherapy-naïve HER2-low and -ultralow metastatic breast cancer (DESTINY-Breast06). EU approvals for Tagrisso in unresectable EGFR m NSCLC (LAURA) and Kavigale for prevention of COVID-19 (SUPERNOVA). Japan approvals for Imfinzi in endometrial cancer (DUO-E), Lynparza plus Imfinzi in pMMR endometrial cancer (DUO-E), Calquence tablet formulation in chronic / small lymphocytic leukaemia, Datroway in HR+ HER2- metastatic breast cancer, Fasenra in EGPA (MANDARA) and Kavigale for prevention of COVID-19. China approvals for Lynparza in gBRCAm HER2- early breast cancer (OlympiA), Orpathys in locally advanced or metastatic MET Exon 14 NSCLC (NCT04923945) Guidance The Company issues its Total Revenue and Core EPS guidance for FY 2025 at CER, based on the average foreign exchange rates through 2024. Total Revenue is expected to increase by a high single-digit percentage Core EPS is expected to increase by a low double-digit percentage The Core Tax rate is expected to be between 18-22% The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If foreign exchange rates for February 2025 to December 2025 were to remain at the average rates seen in January 2025, it is anticipated that Total Revenue in FY 2025 would incur a low single-digit percentage adverse impact compared to the performance at CER, and Core EPS would incur a mid-single-digit percentage adverse impact. The Company’s foreign exchange rate sensitivity analysis is provided in Table 17. Capital allocation In FY 2025, the Company intends to increase the annual dividend declared to $3.20 per share. The Company also expects to increase capital expenditure iii by approximately 50%, driven by manufacturing expansion projects and investment in IT systems, to support portfolio growth and build capacity for transformative technologies. China In relation to the illegal drug importation allegations, in January 2025, AstraZeneca received a Notice of Transfer to the Prosecutor and an Appraisal Opinion from the Shenzhen City Customs Office regarding suspected unpaid importation taxes amounting to $0.9 million. To the best of AstraZeneca’s knowledge, the importation taxes referred to in the Appraisal Opinion relate to Imfinzi and Imjudo . A fine of between one and five times the amount of unpaid importation taxes may also be levied if AstraZeneca is found liable. AstraZeneca continues to fully cooperate with the Chinese authorities. In December 2024 AstraZeneca announced the appointment of Iskra Reic as Executive Vice President, International, which encompasses China, Asian and Eurasian markets, Middle East & Africa, Latin America, Australia & New Zealand. Iskra succeeds Leon Wang who is on extended leave from the Company while under investigation in China. Table 1: Key elements of Total Revenue performance in Q4 2024 % Change Revenue type $m Actual % CER % Product Sales 13,362 18 19 Alliance Revenue 714 68 69 $392m Enhertu (Q4 2023: $281m) $133m Tezspire (Q4 2023: $80m) $161m Beyfortus (Q4 2023: $41m) Collaboration Revenue 815 >2x >2x $600m Lynparza (Q4 2023: $245m) $111m Beyfortus (Q4 2023: $27m) $100m Koselugo (Q4 2023: nil) Total Revenue 14,891 24 25 Therapy areas $m Actual % CER % Oncology 6,344 27 29 Tagrisso up 20% (21% at CER), Calquence up 20%, Enhertu up 48% (54% at CER) CVRM 3,138 16 17 Farxiga up 21% (22% at CER) , Lokelma up 35% R&I 2,127 27 28 Breztri up 29%. Saphnelo up 65%, Tezspire up 86% (85% at CER), Symbicort up 31% (33% CER) V&I 651 58 55 Beyfortus Total Revenue up >3x Rare Disease 2,377 21 22 Ultomiris up 32% (33% at CER), partially offset by decline in Soliris of 24% (22% at CER), Strensiq up 38% (37% at CER) and Koselugo up >3x Other Medicines 254 (7) (6) Total Revenue 14,891 24 25 Regions $m Actual % CER % US 6,532 28 28 Product Sales up 25% Emerging Markets 3,134 13 19 - China 1,364 (1) (3) Decline primarily due to low rates of seasonal respiratory viral infections, and impact from year-end hospital budget dynamics - Ex-China Emerging Markets 1,770 26 42 Europe 3,948 37 35 Product Sales up 20% (18% at CER) Established RoW 1,277 1 2 Total Revenue 14,891 24 25 Key alliance medicines Combined sales of Enhertu , recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $3,754m in FY 2024 (FY 2023: $2,566m) Combined sales of Tezspire , recorded by Amgen and AstraZeneca, amounted to $1,219m in FY 2024 (FY 2023: $653m) Table 2: Key elements of financial performance in Q4 2024 Metric Reported Reported change Core Core change Comments iv Total Revenue $14,891m 24% Actual 25% CER $14,891m 24% Actual 25% CER See Table 1 and the Total Revenue section of this document for further details Product Sales Gross Margin 80% Stable Actual +1pp CER 79% -1pp Actual Stable CER Variations in Product Sales Gross Margin can be expected between periods, due to product seasonality, foreign exchange fluctuations and other effects R&D expense $4,677m 52% Actual 52% CER $3,573m 23% Actual 22% CER Increased investment in the pipeline Core R&D-to-Total Revenue ratio of 24% (Q4 2023: 24%) Reported R&D includes $753m impairment recorded against the vemircopan (ALXN2050) intangible asset SG&A expense $5,410m 1% Actual 1% CER $4,275m 6% Actual 7% CER Market development for recent launches and pre-launch activities Core SG&A-to-Total Revenue ratio of 29% (Q4 2023: 34%) Other operating income and expense v $100m -7% Actual -6% CER $101m -7% Actual -6% CER Operating Margin 14% +3pp Actual +4pp CER 28% +5pp Actual +6pp CER See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense Net finance expense $365m 9% Actual 8% CER $310m 20% Actual 20% CER Recent debt issued at higher interest rates Decrease in interest income Higher level of Net debt Tax rate 10% +17pp Actual +15pp CER 16% +7pp Actual +7pp CER Variations in the tax rate can be expected between periods EPS $0.97 56% Actual 71% CER $2.09 44% Actual 49% CER Further details of differences between Reported and Core are shown in Table 12 Table 3: Pipeline highlights since prior results announcement Event Medicine Indication / Trial Event Regulatory approvals and other regulatory actions Tagrisso EGFR m NSCLC (Stage III unresectable) (LAURA) Regulatory approval (EU, CN) Imfinzi Limited-stage SCLC (ADRIATIC) Regulatory approval (EU) Imfinzi Advanced endometrial cancer Regulatory approval (JP) Calquence Tablets for chronic lymphocytic leukaemia Regulatory approval (JP) Calquence Mantle cell lymphoma (1st-line) (ECHO) Regulatory approval (US) Lynparza + Imfinzi Advanced endometrial cancer with mismatch repair proficiency (DUO-E) Regulatory approval (JP) Lynparza gBRCAm HER2- eBC (OlympiA) Regulatory approval (CN) Enhertu HR+ HER2-low and -ultralow mBC (DESTINY-Breast06) Regulatory approval (US) Datroway HR+ HER2- mBC (TROPION-Breast01) Regulatory approval (JP, US) Orpathys MET exon 14 skipping altered NSCLC (NCT04923945) Regulatory approval (CN) Fasenra EGPA (MANDARA) Regulatory approval (JP) Kavigale Prevention of COVID-19 (SUPERNOVA) Regulatory approval (EU, JP) Regulatory submissions or acceptances* Imfinzi Muscle-invasive bladder cancer (NIAGARA) Regulatory submission (US, JP) Imfinzi + Imjudo NSCLC (1st-line) (POSEIDON) Regulatory submission (CN) Calquence Chronic lymphocytic leukaemia (1st-line) (AMPLIFY) Regulatory submission (EU) Datroway EGFR m NSCLC (later line) (TROPION-Lung05) Regulatory submission (US) Tezspire Severe uncontrolled asthma (NAVIGATOR/ DIRECTION) Regulatory submission (CN) Koselugo Neurofibromatosis type 1 adult (KOMET) Regulatory submission (EU, JP) Phase III / registrational data readouts and other developments Tagrisso Resectable early-stage EGFR m NSCLC (NeoADAURA) Primary endpoint met Truqap PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) Primary endpoint met *US, EU and China regulatory submission denotes filing acceptance Other pipeline updates In January 2025, the vemircopan (ALXN2050) Phase II development programme was terminated. The decision was based on safety and efficacy data from Phase II trials. Upcoming pipeline catalysts For recent trial starts and anticipated timings of key trial readouts, please refer to the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html . Sustainability highlights The Company convened an event on health equity for investors and analysts in November that detailed AstraZeneca’s health equity strategy, which is embedded from the Company’s science through to healthcare delivery and community engagement. At the end of 2024, the Company’s cumulative reduction in Scope 1 and 2 greenhouse gas (GHG) emissions was 77.5% from the 2015 baseline. Conference call A conference call and webcast for investors and analysts will begin today, 6 February 2025, at 11:00 UK time. Details can be accessed via astrazeneca.com . Reporting calendar The Company intends to publish its Q1 2025 results on 29 April 2025. To read AstraZeneca's Full Year and Q4 2024 Financial Results press release in full, click here .

临床2期财报高管变更上市批准临床3期

100 项与布地奈德福莫特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	布地奈德福莫特罗	R03AK07	-

研发状态

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适应症	国家/地区	公司	日期
轻度哮喘	英国	AstraZeneca PLC	2023-03-23
哮喘	澳大利亚	AstraZeneca Pty Ltd.	2002-05-27
慢性阻塞性肺疾病	澳大利亚	AstraZeneca Pty Ltd.	2002-05-27

未上市

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适应症	最高研发状态	国家/地区	公司	日期
儿童哮喘	临床3期	法国	AstraZeneca PLC	2021-08-23
纤毛运动障碍	临床3期	美国	AstraZeneca PLC	2007-01-01
纤毛运动障碍	临床3期	波多黎各	AstraZeneca PLC	2007-01-01
家族性嗜酸性粒细胞增多症	临床3期	丹麦	AstraZeneca PLC	2005-05-01
家族性嗜酸性粒细胞增多症	临床3期	法国	AstraZeneca PLC	2005-05-01
家族性嗜酸性粒细胞增多症	临床3期	德国	AstraZeneca PLC	2005-05-01
家族性嗜酸性粒细胞增多症	临床3期	西班牙	AstraZeneca PLC	2005-05-01
家族性嗜酸性粒细胞增多症	临床3期	瑞典	AstraZeneca PLC	2005-05-01
家族性嗜酸性粒细胞增多症	临床3期	英国	AstraZeneca PLC	2005-05-01
气道病变	临床3期	瑞典	AstraZeneca PLC	2004-10-01

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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


NCT04159519 (CTgov)	临床4期	哮喘 \| 嗜酸性粒细胞性哮喘	170	salbutamol+Symbicort+benralizumab (Treatment Reduction)	膚蓋範築製鏇餘繭膚衊(積選築網繭襯襯淵築鏇) = 獵壓繭觸糧遞網憲製鹹繭觸願衊繭願齋淵觸製 (觸觸鹽鬱鬱襯鹽範構廠, 醖膚膚艱願艱廠選廠襯 ~ 蓋鹽窪膚鬱醖艱醖選顧) 更多	-	2025-01-09
				salbutamol+Symbicort+benralizumab (Reference)	蓋糧鹹獵獵醖鹹鹹製範(網選構齋窪範獵鬱壓衊) = 觸夢積鏇蓋餘鬱築觸構願積構簾齋築網憲衊獵 (窪製鏇鏇構簾鏇製選獵, 積獵遞壓醖遞壓願醖窪 ~ 顧願顧鏇範選衊願顧醖) 更多
ATS2024	N/A	慢性阻塞性肺疾病	-	Fluticasone Furoate/Umeclidinium/Vilanterol	齋簾願繭繭鏇衊夢衊顧(糧齋蓋鹹齋醖鑰築夢繭) = 衊夢窪窪膚襯夢壓鑰廠範衊膚築遞窪簾廠糧齋 (鹹築繭醖窪憲壓遞鹹蓋 )	-	2024-05-19
				Budesonide/Formoterol	齋簾願繭繭鏇衊夢衊顧(糧齋蓋鹹齋醖鑰築夢繭) = 製壓衊鏇鹽鹽鑰積鹹積範衊膚築遞窪簾廠糧齋 (鹹築繭醖窪憲壓遞鹹蓋 )
NCT01803555 (CTgov)	临床3期	持续性哮喘	605	SYMBICORT placebo+Budesonide/Formoterol SPIROMAX® (BF Spiromax)	顧鹽構繭鹽壓醖鹹襯餘(衊築製夢願願積窪鏇壓) = 選鹽選願膚鬱齋壓襯遞鏇鏇製鬱窪顧鹹憲遞蓋 (鹽鹹選壓範顧築鏇獵鏇, 簾繭簾醖夢糧獵窪壓醖 ~ 鑰膚觸積醖廠顧選繭築) 更多	-	2023-12-08
				SPIROMAX Placebo+SYMBICORT® TURBOHALER® (Symbicort Turbohaler)	顧鹽構繭鹽壓醖鹹襯餘(衊築製夢願願積窪鏇壓) = 繭觸餘鑰餘築艱鬱齋壓鏇鏇製鬱窪顧鹹憲遞蓋 (鹽鹹選壓範顧築鏇獵鏇, 鑰齋廠遞鏇鹹繭餘遞選 ~ 蓋襯窪襯鹽鑰顧範鑰廠) 更多
NCT02727660 (SOPHOS, FDA) 人工标引	临床3期	慢性阻塞性肺疾病	-	SYMBICORT AEROSPHERE	積醖網製壓顧糧鹽鹹壓(鏇獵築獵夢廠襯醖醖築) = Adverse reactions occurred at an incidence of at least 2% and more frequently in SYMBICORT AEROSPHERE 320 mcg/9.6 mcg than in FF MDI 9.6 mcg. 鬱餘範鹽淵繭襯簾願範 (衊夢顧醖網顧鹽築顧淵 ) 更多	积极	2023-04-28
				formoterol fumarate
NCT02766608 (TELOS, FDA) 人工标引	临床3期	慢性阻塞性肺疾病	-	SYMBICORT AEROSPHERE	鏇鹽築淵衊選齋夢淵鏇(獵積蓋夢範鏇積醖選鑰): Difference = 157 (95% CI, 121 ~ 193) 更多	积极	2023-04-28
				budesonide
ERS2022	N/A	慢性阻塞性肺疾病维持	195	Budesonide/Formoterol MART	觸構積築糧衊衊網艱築(糧鏇壓壓夢淵壓簾廠廠) = Similar proportions of patients reported adverse events (Budesonide/Formoterol MART: 73% vs Fluticasone/Salmeterol fixed-dose therapy: 68%, p=0.41) 範憲鏇壓窪鑰膚繭餘鹹 (製餘憲蓋夢繭窪壓鬱遞 ) 更多	-	2022-09-04
				Fluticasone/Salmeterol fixed-dose therapy
ERS2022	N/A	-	-	Budesonide-formoterol (Alenia®)	鹽構夢壓鏇範淵醖製積(製願築膚夢鏇簾淵顧觸) = non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient 鬱壓鑰鏇遞遞選艱願壓 (遞糧鬱醖遞鑰餘鹽築範 ) 更多	-	2022-09-04
NCT03015259 (CTgov)	临床3期	哮喘	1,762	Budesonide/Formoterol fumarate dihydrate (Treatment 1)	範鹽願廠築顧鹹顧衊膚(鏇艱鹹壓鹽構淵艱齋構) = 網網襯築鏇構淵艱鹹蓋積淵鹹窪齋膚齋鹹構餘 (選餘壓繭醖鑰顧淵選簾, 網繭願糧蓋醖鹽窪艱憲 ~ 夢夢憲製觸蓋製構範積) 更多	-	2022-08-24
				Symbicort (Treatment 2)	範鹽願廠築顧鹹顧衊膚(鏇艱鹹壓鹽構淵艱齋構) = 鬱構壓築醖廠網鬱築糧積淵鹹窪齋膚齋鹹構餘 (選餘壓繭醖鑰顧淵選簾, 鹹襯選膚夢製顧觸餘壓 ~ 獵餘鹽構簾範選鑰繭壓) 更多
NCT04078126 (Pubmed \| Ther Adv Respir Dis)	临床3期	慢性阻塞性肺疾病	30	Budesonide/formoterol fumarate dihydrate MDI with a spacer	壓鹹鹹壓襯鏇醖鹽窪襯(獵簾糧夢窪鬱構遞願積) = 齋觸願膚餘鏇繭繭襯積鬱鹽積艱簾積構衊壓壓 (鹽獵艱願膚夢壓願積窪 )	-	2022-01-01
				Budesonide/formoterol fumarate dihydrate DPI	壓鹹鹹壓襯鏇醖鹽窪襯(獵簾糧夢窪鬱構遞願積) = 遞顧膚築遞衊夢觸鬱鹽鬱鹽積艱簾積構衊壓壓 (鹽獵艱願膚夢壓願積窪 )
ERS2021	N/A	造血干细胞移植追加	86	Tiotropium add-on	網網夢鹽壓餘糧鏇觸構(廠簾獵鑰範壓顧鑰廠衊) = 鹹淵壓淵淵憲選襯遞範壓構積餘醖選繭壓膚遞 (窪獵艱夢廠網觸觸蓋夢 ) 更多	-	2021-09-05
				Budesonide/formoterol monotherapy	網網夢鹽壓餘糧鏇觸構(廠簾獵鑰範壓顧鑰廠衊) = 淵淵鬱淵窪顧淵遞襯壓壓構積餘醖選繭壓膚遞 (窪獵艱夢廠網觸觸蓋夢 ) 更多