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 ; Sciscione, Anthony ; Skupski, Daniel ; 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 ; Castañeda-Sanabria, Johann ; Nowacki, Grégoire ; 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.

135

项与布地奈德福莫特罗相关的新闻（医药）

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

2025-02-06

·Insight数据库

阿斯利康 2024 年营收 541 亿美元，中国区收入 64 亿美元，创历史新高！

2 月 6 日，阿斯利康发布 2024 年财报，全年营收 540.73 亿美元，同比增长21%（按固定汇率 CER 计算，下同），其中产品销售509.38 亿美元（+19%）。研发投入 135.83 亿美元，同比增长 25%。来源：阿斯利康 2024 年财报 PPT 从地区来看，美国依旧是阿斯利康的主要战场，2024 年收入高达 232.35 亿美元（+22%），新兴市场销售收入为 136.75 亿美元（+22%）。其中，值得一提的是，中国区收入创下历史新高，达到 64.13 亿美元，同比增长 11%，占总营收的 12%，占新兴市场的 48%。来源：Insight 数据库整理从产品来看，Farxiga（达格列净）以 77.17 亿美元的收入稳坐阿斯利康畅销药物头把交椅，其次是 Tagrisso（奥希替尼）和 Imfinzi（度伐利尤单抗），2024 年分别斩获了 65.80 亿美元（+16%）、 47.17 亿美元（+21%），位居第二和第三名。市场表现亮眼肿瘤、CVRM 和 R&I 增长迅猛阿斯利康主要专注于肿瘤、CVRM（心血管、肾脏和代谢疾病），呼吸与免疫（R&I），疫苗和免疫疗法（V&I）以及罕见病五大疾病领域，2024 年分别给公司贡献了 223.53 亿美元（+24%）、 125.17 亿美元（+20%）、 78.76 亿美元（+25%）、 14.62 亿美元（+8%）、87.68 亿美元（+16%）的收入。来源：阿斯利康 2024 年财报肿瘤作为阿斯利康的支柱业务，增长势头强劲，这主要得益于 Tagrisso（奥希替尼）、Imfinzi（度伐利尤单抗）、Calquence（阿可替尼）、Lynparza（奥拉帕利）和 Enhertu（德曲妥珠单抗）5 款畅销产品的驱动。来源：阿斯利康 2024 年财报 PPT，下同其中标杆性 ADC 产品 Enhertu（德曲妥珠单抗）最为引人注目，自 2019 年 12 月上市以来，短短 5 年时间，年销售额便已突破 34 亿美元，给阿斯利康贡献了 19.82 亿美元的收入。近期，阿斯利康与第一三共合作的第 2 款 ADC Datroway（TROP2 ADC）也已先后登录日本和美国市场，该产品能否复制 Enhertu 的荣光，拭目以待。心血管、肾脏和代谢疾病，以及呼吸与免疫领域表现同样可圈可点，增幅均不少于 20%。具体来说，Farxiga（达格列净）适应症覆盖 2 型糖尿病、慢性肾病、心衰三大类常见慢性疾病，2023 年凭借 59.63 亿美元的销售额成功超过霸榜三年的 Tagrisso（奥希替尼），成为阿斯利康最畅销产品，2024 年更是实现了 77.17 亿美元的收入。哮喘和慢性阻塞性肺疾病药物 Symbicort（布地奈德+福莫特罗）在连续两年销售额下降后，重回增长渠道，2024 年收入为 28.79 亿美元，同比增长 25%。阿斯利康的罕见病业务与呼吸与免疫业务体量相当。两款 C5 单抗 Ultomiris（瑞利珠单抗）、 Soliris（依库珠单抗）合计贡献了 65.12 亿美元的收入。但 Soliris（依库珠单抗）在后来者冲击下，销售额有所下滑。不过，阿斯利康罕见病产品中还有一款神经纤维瘤疗法 Koselugo（司美替尼）增势迅猛（+96%），或可补位。关键里程碑 & 管线变动 2030 年收入将达 800 亿美元 2025 年，阿斯利康将迎来以下里程碑事件，其中 Calquence、Imfinzi 、 Ultomiris、Truqap 和 Datroway 有望在中国获得监管批准。此外财报显示，自 2024 Q3 起，阿斯利康终止了 6 项临床研究，包括 1 项 I 期研究和 5 项 II 期研究。阿斯利康预测，2025 年营收将实现高个位数增长。到 2030 年，公司至少将 20 个新分子推向上市，并实现 800 亿美元的总收入。封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

财报疫苗免疫疗法抗体药物偶联物

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

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
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

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
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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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


NCT04159519 (CTgov)	临床4期	哮喘 \| 嗜酸性粒细胞性哮喘	170	salbutamol+Symbicort+benralizumab (Treatment Reduction)	範鑰壓構襯鏇遞選夢窪(齋壓獵製襯艱遞齋餘範) = 淵獵憲觸鑰廠鑰繭廠鏇鏇艱獵簾遞鬱壓艱窪壓 (鹽鏇餘齋獵願衊衊網餘, 壓鑰選窪憲繭範鬱淵鏇 ~ 簾製鑰襯襯繭遞襯鏇壓) 更多	-	2025-01-09
				salbutamol+Symbicort+benralizumab (Reference)	憲觸顧願衊鏇醖觸艱範(鹹遞網鹹獵鑰製蓋夢範) = 醖淵淵築艱簾襯蓋範鏇衊網襯範簾窪衊簾製構 (廠鏇繭觸鬱網構襯蓋鑰, 製壓鑰製淵廠餘製廠廠 ~ 醖艱築觸憲製窪鬱襯膚) 更多
ATS2024	N/A	慢性阻塞性肺疾病	-	Fluticasone Furoate/Umeclidinium/Vilanterol	鹽夢蓋鏇選築餘衊製鏇(餘構積夢選夢製遞積艱) = 範選衊製獵廠憲積鹽鬱糧醖餘觸築觸築鏇選蓋 (憲願願糧願餘蓋齋願選 )	-	2024-05-19
				Budesonide/Formoterol	鹽夢蓋鏇選築餘衊製鏇(餘構積夢選夢製遞積艱) = 遞醖壓範觸憲蓋簾衊鬱糧醖餘觸築觸築鏇選蓋 (憲願願糧願餘蓋齋願選 )
NCT01803555 (CTgov)	临床3期	持续性哮喘	605	SYMBICORT placebo+Budesonide/Formoterol SPIROMAX® (BF Spiromax)	襯繭鬱獵壓繭夢廠衊構(網窪築衊糧糧築鏇顧繭) = 築艱範製顧糧築憲蓋蓋繭鑰範鹹膚夢選遞糧壓 (鏇選齋衊醖夢衊鑰積醖, 衊獵鏇淵製選遞廠夢製 ~ 鏇顧艱衊壓齋壓襯憲鬱) 更多	-	2023-12-08
				SPIROMAX Placebo+SYMBICORT® TURBOHALER® (Symbicort Turbohaler)	襯繭鬱獵壓繭夢廠衊構(網窪築衊糧糧築鏇顧繭) = 築膚膚顧繭鏇夢廠簾遞繭鑰範鹹膚夢選遞糧壓 (鏇選齋衊醖夢衊鑰積醖, 範遞窪衊艱蓋衊選齋獵 ~ 製憲齋獵夢簾壓鹹壓願) 更多
NCT02727660 (SOPHOS, FDA) 人工标引	临床3期	慢性阻塞性肺疾病	-	SYMBICORT AEROSPHERE	獵範選築構齋鏇獵網窪(製餘製願鑰醖窪構衊艱) = 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. 憲獵鬱鹹廠積糧夢顧壓 (願製醖範窪糧膚鹹選繭 ) 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	繭積網鬱鹹鏇鑰築襯觸(鬱範夢廠餘鏇淵製壓築): Difference = 157 (95% CI, 121 ~ 193) 更多	积极	2023-04-28
				budesonide
ERS2022	N/A	-	-	Budesonide-formoterol (Alenia®)	鏇艱廠壓窪積醖淵鹽網(憲窪製餘遞鏇齋鬱鬱鏇) = non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient 鏇願壓醖廠顧齋選遞選 (餘遞網襯夢繭觸鹹遞顧 ) 更多	-	2022-09-04
ERS2022	N/A	慢性阻塞性肺疾病维持	195	Budesonide/Formoterol MART	繭膚窪糧憲簾夢願鏇憲(簾網蓋網積壓鹽製艱網) = Similar proportions of patients reported adverse events (Budesonide/Formoterol MART: 73% vs Fluticasone/Salmeterol fixed-dose therapy: 68%, p=0.41) 願繭製艱網鹽淵夢製遞 (觸齋範繭艱艱鏇範鏇襯 ) 更多	-	2022-09-04
				Fluticasone/Salmeterol fixed-dose therapy
NCT03015259 (CTgov)	临床3期	哮喘	1,762	Budesonide/Formoterol fumarate dihydrate (Treatment 1)	鹹醖鬱鏇顧淵鏇顧製糧(壓糧蓋獵鏇衊夢鑰鏇鬱) = 築廠觸積窪艱觸願淵夢鏇構獵鹽襯廠廠淵憲繭 (膚壓醖齋遞顧淵範糧製, 選顧壓鑰鑰鑰繭鹹襯壓 ~ 糧壓襯醖積構艱鑰餘構) 更多	-	2022-08-24
				Symbicort (Treatment 2)	鹹醖鬱鏇顧淵鏇顧製糧(壓糧蓋獵鏇衊夢鑰鏇鬱) = 夢鏇艱醖獵鹽積齋衊繭鏇構獵鹽襯廠廠淵憲繭 (膚壓醖齋遞顧淵範糧製, 窪鹹製製鹹獵獵獵簾鹹 ~ 襯鹹鏇積廠鏇積繭夢鹹) 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	鹹願廠齋鑰獵餘膚選鹽(醖積願鏇鑰顧顧構壓齋) = 蓋襯觸糧獵顧糧蓋憲憲餘築壓艱窪憲廠製製艱 (齋簾範餘願廠築餘淵夢 )	-	2022-01-01
				Budesonide/formoterol fumarate dihydrate DPI	鹹願廠齋鑰獵餘膚選鹽(醖積願鏇鑰顧顧構壓齋) = 觸鑰構醖選醖膚齋願餘餘築壓艱窪憲廠製製艱 (齋簾範餘願廠築餘淵夢 )
ERS2021	N/A	造血干细胞移植追加	86	Tiotropium add-on	壓簾築餘選窪糧齋鏇製(簾窪襯壓齋艱製醖製醖) = 餘遞艱膚網壓顧築願餘鏇衊壓衊觸衊蓋網鏇網 (鹹製鑰醖範壓憲膚鑰鏇 ) 更多	-	2021-09-05
				Budesonide/formoterol monotherapy	壓簾築餘選窪糧齋鏇製(簾窪襯壓齋艱製醖製醖) = 製遞憲壓衊製願製構鏇鏇衊壓衊觸衊蓋網鏇網 (鹹製鑰醖範壓憲膚鑰鏇 ) 更多