Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

开始日期2025-05-01

申办/合作机构

AstraZeneca PLC

NCT06723756

/ Not yet recruiting临床1期

A Phase I, Randomized, Double-blind, Single-dose, Partial Replicate, 3-way Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA in Healthy Adult Participants

This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.

开始日期2025-01-23

申办/合作机构

AstraZeneca PLC

[+1]

NCT06712563

/ Not yet recruitingN/A

Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.

开始日期2025-01-13

申办/合作机构

AstraZeneca PLC

100 项与布地格福相关的临床结果

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100 项与布地格福相关的转化医学

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100 项与布地格福相关的专利（医药）

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项与布地格福相关的文献（医药）

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: Yoshida, Yuri ; Argoubi, Ramzi ; 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.

2024-11-01·AMERICAN JOURNAL OF MEDICINE

Effectiveness of Single Versus Multiple Inhaler Triple Therapy on Mortality and Cardiopulmonary Risk Reduction in COPD: The SKOPOS-MAZI Study

Article

作者: Müllerová, Hana ; Vogelmeier, Claus F. ; Hawkins, Nathaniel M ; Rhodes, Kirsty ; Vogelmeier, Claus F ; Marshall, Jonathan ; Pollack, Michael ; Anzueto, Antonio ; Hawkins, Nathaniel M. ; Rapsomaniki, Eleni

BACKGROUND:

Patients with chronic obstructive pulmonary disease (COPD) have elevated cardiopulmonary and mortality risk, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce cardiopulmonary risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes with SITTs versus multiple inhaler triple therapies (MITTs).

METHODS:

SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's deidentified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference >0.1) in baseline characteristics.

RESULTS:

In the primary cohort, risk (hazard ratio [95% confidence intervals]) of all-cause mortality and a first severe cardiopulmonary event were 18% (0.82 [0.75, 0.91]) and 12% (0.88 [0.83, 0.93]) lower in patients initiating BGF versus MITT; results were consistent across censoring definitions, landmark periods, and sensitivity cohorts.

CONCLUSION:

In this real-world comparative effectiveness study of patients with COPD initiating BGF or MITT, BGF was associated with lower all-cause mortality and severe cardiopulmonary event risk versus MITT after accounting for between-group differences in baseline sociodemographic and clinical characteristics. This study supports the benefits of BGF over MITT and the need to consider proactive use of SITTs in COPD management.

2024-10-01·MOLECULAR NUTRITION & FOOD RESEARCH

Garlic Bioconverted by Bacillus subtilis Stimulates the Intestinal Immune System and Modulates Gut Microbiota Composition

Article

作者: Suh, Hyung Joo ; Lee, Sanghyun ; Jeong, Hyeleen ; Moon, Sung‐Kwon ; Kim, Kwang Bin ; Yu, Hyeonjun ; Tonog, Genevieve ; Kim, Hae Soung ; Kim, Hoon

Scope:

This study evaluates the potential of bioconverted garlic ferments (BGFs) to stimulate the intestinal immune system and modulate cecal microbiota composition.

Methods and results:

In vitro, BGF significantly enhances Peyer's patch (PP)‐mediated bone marrow cell proliferation and increases the production of interferon‐gamma (IFN‐γ), granulocyte macrophage‐colony stimulating factor (GM‐CSF), interleukin (IL)‐6, and immunoglobulin A (IgA) but not IL‐4, IL‐5, and immunoglobulin E (IgE). Oral administration of BGF to C3H/HeN mice for 4 weeks significantly increases the GM‐CSF (42.1–45.8 pg mL−1) and IFN‐γ (6.5–12.1 pg mL−1) levels in PP cells. BGF also significantly elevates the levels of tumor necrosis factor‐alpha (TNF‐α, 165.0–236.3 pg mg−1), GM‐CSF (2.4–3.0 ng mg−1), and IFN‐γ (1.5–3.2 ng mg−1) in the small intestinal fluid, and TNF‐α (2.2–3.1 pg mL−1) and IFN‐γ (10.3–0.21.5 pg mL−1) in the mouse serum. Cecal microbial analysis reveals that BGF increases Bacteroidota and Verrucomicrobiota and decreases Actinobacteria and Bacillota at the phylum level in mice. At the genus level, BGF significantly increases the abundance of Fusimonas (250 mg kg−1 BW−1 day−1), Bacteroides (125 and 250 mg kg−1 BW−1 day−1), and Akkermansia (125 mg kg−1 BW−1 day−1) and decreases that of Bifidobacterium (62.5 and 250 mg kg−1 BW−1 day−1) and Limosilactobacillus (125 and 250 mg kg−1 BW−1 day−1).

Conclusion:

This study provides the first evidence of BGF's ability to modulate the intestinal immune system and gut microbiota, supporting its potential as a novel functional material to enhance gut immunity.

项与布地格福相关的新闻（医药）

2025-01-15

·Pharmaceutical Technology

JP Morgan 2025: AstraZeneca promises a ‘catalyst-rich’ year ahead

AstraZeneca CFO Aradhana Sarin promised Phase III readouts and revenue growth in 2025 despite ongoing investigations of its Chinese operations. Credit: Bloomberg/ Getty Images AstraZeneca says a strong 2024 and stacked pipeline spells potential for further growth in 2025 as the company aims to bring in $80bn in revenue by 2030. CFO Aradhana Sarin outlined AstraZeneca’s plans at the 2025 JP Morgan Healthcare Conference in San Francisco on 15 January. The company maintains a confident outlook for the new year, said Sarin, despite its share price decline in the latter half of 2024. During her presentation, Sarin focussed on the company’s performance during the first nine months of 2024, during which AstraZeneca increased total revenue by 19% against the same period in 2023 . Additionally, cash flow rose by almost $1bn over the prior year. The company’s growth was largely attributed to its expanded clinical pipeline, which includes late-stage trials that have increased in number from 77 in 2022 to 91 in 2024. This year promises to be a “catalyst-rich” year for AstraZeneca, according to Sarin, with 21 new molecular entities (NMEs) in late-stage development, seven of which are expected to yield Phase III readouts within the next year. Among these are gefurulimab, being trialled in myasthenia gravis (NCT05556096), and efzimfotase alfa, trialled in hypophosphatasia (NCT06079281), the progress of which Sarin attributed to accelerated recruitment rates. Sarin did, however, note negatively impacted revenues in China given ongoing investigations of AstraZeneca’s operations in the country by authorities. On 30 October 2024, AstraZeneca’s Chinese operations president Leon Wang stood down and was detained along with other current and former employees amidst accusations of insurance fraud, data breaches, and import of unlicenced medicines. Revenues for AstraZeneca in the US, in comparison, increased by 20% in the first nine months of 2024, comprising 43% of total revenue and are expected to account for half of the company’s revenues by 2030 according to Sarin. She identified respiratory and immunology as the company’s foremost sectors, growing by 39% in Q4 of 2024. Additionally, she said assets like Breztri (budesonide + formoterol fumarate + glycopyrrolate) and Fasenra (benralizumab) are positioned for indication expansion into severe asthma and chronic obstructive pulmonary disorder (COPD), respectively, during 2025. Sarin said AstraZeneca’s capital allocation priorities are unchanged for the coming year and that the company remains focussed on antibody-drug conjugates, bispecific antibodies, and cell therapies, in addition to continuing its foray into the metabolic and gene editing space. Like many other companies that rose to prominence during the Covid-19 pandemic, AstraZeneca has made concerted efforts to break into the obesity market, and has tried going through the deal rout with its potential acquisition agreement with SixPeaks Bio , announced in May 2024.

并购临床3期

2025-01-03

·米内网

【市场】8个新药进院可期，超12亿中药大品种在列

精彩内容近日，内江市第一人民医院发布公告称，拟公开引进8款新药以满足临床用药需求，包括6款化学药和2款中成药。其中，不乏强力枇杷露、盐酸昂丹司琼片、布地格福吸入气雾剂等2023年在中国公立医疗机构终端销售额超7亿元的大品种。 8款拟进院的新药均为医保用药，其中3款为基药品种；按治疗大类统计，呼吸系统用药为主力军，有3个产品在列，消化系统及代谢药（2个）、肌肉-骨骼系统（1个）、五官科用药（1个）和呼吸系统疾病用药（1个）分别位居其后。拟进院新药名单来源：内江市第一人民医院官网，米内网整理强力枇杷露主要由枇杷叶、百部、桑白皮、桔梗等中药材制成，具有养阴敛肺、止咳祛痰的功效，用于支气管炎咳嗽等，目前已纳入国家基药及全国医保甲类药目录。米内网数据显示，目前该产品已有112家企业拥有生产批文，2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售规模超12亿元，同比增长47.11%，是止咳祛痰平喘中成药TOP4产品。 2023年中国公立医疗机构终端止咳祛痰平喘中成药产品TOP10 来源：米内网中国公立医疗机构药品终端竞争格局盐酸昂丹司琼片属于止吐药，对于由药物刺激、放射治疗、术后治疗等多种情况引起的恶心、呕吐、反酸等症状具有显著改善作用。它通过与肠道组织分泌的5-HT受体发生提前结合性反应，抑制呕吐中枢神经组织的触发作用，从而达到止呕的目的。作为国家基药及全国医保甲类药品种，盐酸昂丹司琼片近年来在中国公立医疗机构终端销售额逐年攀升，2023年突破7亿元，同比增长8.67%；2024上半年以8.88%的增速增长至超4亿元，预计全年销售额或再创新高。米内网数据显示，目前国内有6家企业的盐酸昂丹司琼片获批上市；一致性评价方面，齐鲁制药、福安药业、石四药、浙江和泽医药4家企业获批过评/视同过评，另有北大医药提交补充申请在审，成都通德药业、杭州沐源生物2家企业以新分类报产在审。近年来中国公立医疗机构终端盐酸昂丹司琼片销售趋势（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局此外，本次院内药品遴选的要求还包括：①采用集采中选厂家优先、最低价中选原则；②最终中选价格不得高于四川省药品和医用耗材招采系统上参考价中最低值，同通用名品种绿区价格换算成最小制剂单位后不能高于红区或黄区厂家价格；③中选品种需保证至少持续稳定供货半年以上，因恶意低价中选，又不能按时保量配送的，该药品配送公司在今后1年内不得参与本院药品院内遴选活动；④对于中选的配送公司不能配送的药品，依次按价格从低到高的顺序选择符合要求的配送企业，不再挂网确定配送公司。资料来源：米内网数据库、内江市第一人民医院注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至2025年1月3日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准放射疗法一致性评价

2024-12-27

·药闻康策

这类抗哮喘及慢阻肺药物，2023年市场规模破百亿

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策前言作为最主要的支气管扩张药，β2受体激动剂在支气管哮喘、慢性阻塞性肺疾病等慢性气道疾病的治疗中得到了广泛的应用。根据法伯全渠道数据显示，2023年β2受体激动剂及复方制剂在我国总体医疗机构抗哮喘和慢阻肺药物市场合计占比超过40%，销售规模近110亿元，2021-2023年复合增长13.9%。两大外资企业阿斯利康和葛兰素史克以明显的优势领先，一众内资仿制药企在集采利好下增长强劲。补充说明 *本文所述的β2受体激动剂及复方制剂市场范围（按照药物解剖学、治疗学及化学分类法ATC编码）：R03A、R03E、R03F、R03L。 *中国医疗机构：包括两个医院渠道（城市医院、县域医院）和两个基层医疗机构渠道（社区卫生中心、乡镇卫生院）。市场规模破百亿，两年复合增长13.9% β2受体激动剂是一类能够激动分布在气道平滑肌上的β2受体产生支气管扩张作用的哮喘治疗药物，最初在20世纪60年代开发，包括沙丁胺醇和特布他林。后续在20世纪70年代又开发了一批受体选择性更高、作用时间更长的β2受体激动剂，代表药物有福莫特罗、沙美特罗等。近年来，β2受体激动相关复方制剂得到愈加广泛的应用，以吸入糖皮质激素和长效β2受体激动剂联合用药为例，这两者具有协同的抗炎和平喘作用，可获得相当于（或优于）应用加倍剂量吸入型糖皮质激素时的疗效，并可增加患者的依从性、减少不良反应（表1）。表1-β2受体激动剂及复方制剂主要类别及代表分子数据来源：法伯全渠道数据根据法伯全渠道数据显示，2023年β2受体激动剂及复方制剂在总体医疗机构抗哮喘和慢阻肺药物市场合计占比超过40%，其总体销售额从2021年的84.6亿增长至2023年的近110亿，两年复合增长13.9%（图1）。图1-总体医疗机构β2受体激动剂及复方制剂市场规模及增速数据来源：法伯全渠道数据分渠道来看，法伯数据显示，2021-2023年四个医疗机构渠道销售占比稳定，其中城市医院和县域医院合计占据超过90%份额。2023年处在城市区域的城市医院和社区卫生中心渠道增速较快，分别达22.1%和22.3%（图2）。图2-2021-2023年总体医疗机构β2受体激动剂及复方制剂渠道分布数据来源：法伯全渠道数据四个分子纳入集采，多为吸入剂型关注β2受体激动剂及复方制剂市场的头部分子，根据法伯全渠道数据显示，2023年在总体医疗机构销售额逾10亿的分子共6个，其中布地奈德福莫特罗以近30亿元稳居第一；排名第二的布地格福和第八的氟替美维相较于其他分子增速更快（图3）。图3-2023年总体医疗机构β2受体激动剂及复方制剂市场TOP10分子数据来源：法伯全渠道数据此外，目前已经纳入历次国家带量采购的4个β2受体激动剂及复方制剂分子（表2）亦进入前十名，其中，除了硫酸特布他林有两个剂型（吸入剂和注射剂）分别在第七批和第十批集采被纳入外，其余集采品种均为吸入剂型，原研厂家涉及阿斯利康、葛兰素史克等，无原研中标。表2-已纳入国家集采的β2受体激动剂及复方制剂品种数据来源：法伯全渠道数据具体品种的市场表现方面，法伯数据显示，相较于2021年，2023年第四批集采品种硫酸沙丁胺醇吸入剂销售额增长103%，主要源于弘森药业、普锐特药业（成都倍特药业子公司）、仁合益康、福瑞喜药业这四家中标仿制药企相关产品销售额的大幅增长。此外，第五批品种复方异丙托溴铵吸入剂和第七批品种硫酸特布他林吸入剂市场规模降幅在30%左右；截至2023年第九批品种盐酸左沙丁胺醇吸入剂受集采影响尚不显著（图4）。图4-β2受体激动剂及复方制剂VBP品种总体医疗机构销售额变化数据来源：法伯全渠道数据两大外资领衔市场，内资增长备受瞩目企业格局方面，根据法伯全渠道数据显示，β2受体激动剂及复方制剂市场近年来一直由外资企业主导，占比持续在65%以上，且2023年增速高于内资企业。分渠道来看，以2023年为例，发现外资企业主要是在除了乡镇卫生院之外的渠道占比高于内资，尤其是社区卫生中心，占比达到78.2%（图5）。图5-2021-2023年β2受体激动剂及复方制剂内外资占比及增速数据来源：法伯全渠道数据目前，β2受体激动剂及复方制剂市场主要由阿斯利康和葛兰素史克（GSK）引领。法伯数据显示，2023年这两家外资企业在总体医疗机构该细分领域合计占据超过60%市场，分别位居第一、二名，且2023年保持增长。内资企业虽然份额较外资尚有差距，但是增速较快，尤其是成都倍特药业，2021-2023年复合增长高达183.6%（图6）。图6-2023年β2受体激动剂及复方制剂市场销售额TOP10企业表现数据来源：法伯全渠道数据从头部企业销售额的渠道分布来看，城市医院渠道占比较高的是诺华和健康元；县域医院渠道贡献较高的是福瑞喜药业和仁合益康，这两家内资企业在整体广阔市场渠道的合计占比也高于其他企业（图7）。图7-2023年总体医疗机构β2受体激动剂及复方制剂市场头部企业渠道分布数据来源：法伯全渠道数据阿斯利康/葛兰素史克绝对优势稳居前二深耕呼吸领域50多年，阿斯利康在该细分市场已处于领先地位。聚焦β2受体激动剂及复方制剂市场，其主要产品包括信必可都保（布地奈德福莫特罗粉吸入剂（I），布地奈德福莫特罗粉吸入剂（II））、倍择瑞令畅（布地格福吸入气雾剂）、百沃平令畅（格隆溴铵福莫特罗吸入气雾剂）、博利康尼（硫酸特布他林片、硫酸特布他林雾化吸入用溶液）等（图8）。其中，信必可都保是国内治疗哮喘和慢性阻塞性肺疾病的首选吸入糖皮质激素/长效β2受体激动剂（ICS/LABA）联合疗法。根据法伯全渠道数据显示，2023年信必可都宝以近30亿元销售额稳居总体医疗机构β2受体激动剂及复方制剂市场榜首，且遥遥领先于其他产品。图8-阿斯利康β2受体激动剂及复方制剂产品市场表现数据来源：法伯全渠道数据位居第二名的葛兰素史克，旗下也有多款产品市场增长强劲。其中，全再乐于2019年11月在中国获批上市，该吸入制剂含有吸入性糖皮质激素（ICS）、长效抗胆碱能药物（LAMA）和长效β2受体激动剂（LABA）三种药物成分，通过GSK独有的易纳器（Ellipta®）干粉吸入装置进行每日一次给药。法伯数据显示，2023年全再乐在总体医疗机构市场同比大涨92.6%。另一GSK旗下重磅产品舒利迭（沙美特罗替卡松）是沙美特罗与丙酸氟替卡松的复方吸入粉雾剂，作为全球首款支气管扩张剂和皮质激素联用复方吸入制剂，在上市后快速成为治疗哮喘和慢阻肺疾病的重要产品。根据法伯全渠道数据显示，2023年舒利迭在总体医疗机构依旧保持了超10%的增长（图9）。图9-葛兰素史克β2受体激动剂及复方制剂产品市场表现数据来源：法伯全渠道数据事实上，舒利迭在国内的化合物专利在2013年已过期，GSK之所以能长期独占市场，主要源于该品种仿制难度较大。而这一局面在今年6月被打破，健康元发布公告称，其以化学药品4类报产的沙美特罗替卡松吸入粉雾剂获得批准，可用于可逆性气道阻塞性气道疾病的规律治疗，包括成人和儿童哮喘，成为国内首仿。随着更多国内仿制药企入局，沙美特罗替卡松的竞争格局将如何变化，值得期待。内资企业全面发力借助集采快速打开市场值得一提的是，在2023年总体医疗机构β2受体激动剂及复方制剂市场排名靠前的企业中，虽然两家头部外资以明显的份额优势领先，但是其2021-2023年复合增长率却不及排名三至五位的内资企业强劲，而众多仿制药企的快速发展与其产品陆续纳入集采不无关联。以前文提到的健康元为例，旗下舒坦琳（复方异丙托溴铵）、硫酸特布他林雾化吸入用溶液、丽舒同（盐酸左沙丁胺醇）分别在第五、七和九批集采中标。根据法伯全渠道数据显示，上述三个产品在总体医疗机构β2受体激动剂及复方制剂市场的份额从2021年的4.4%上升至2023年的9.9%（表3）。表3-部分健康元旗下β2受体激动剂及复方制剂产品市场表现数据来源：法伯全渠道数据再如成都倍特药业，其控股子公司四川普锐特药业旗下的普立畅（硫酸沙丁胺醇）、普吸清（复方异丙托溴铵）、特美静（硫酸特布他林）、普吸畅（盐酸左沙丁胺醇）相继在第四、五、七和九批集采中标（表4），受益于加速放量后的强劲市场增长，成都倍特药业2021-2023年复合增长183.6%，2023年同比大涨175.8%，排名上升7位，冲进TOP10榜单前五。表4-部分成都倍特药业旗下β2受体激动剂及复方制剂产品市场表现数据来源：法伯全渠道数据（来源：法伯科技Pharbers）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】 1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

核酸药物医药出海申请上市带量采购

100 项与布地格福相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	R03AL11	-

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
慢性支气管炎	日本	AstraZeneca KK	2019-06-18
慢性阻塞性肺疾病	日本	AstraZeneca KK	2019-06-18
肺气肿	日本	AstraZeneca KK	2019-06-18

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
哮喘	临床3期	美国	AstraZeneca PLC	2020-12-15
哮喘	临床3期	日本	AstraZeneca PLC	2020-12-15
哮喘	临床3期	阿根廷	AstraZeneca PLC	2020-12-15
哮喘	临床3期	比利时	AstraZeneca PLC	2020-12-15
哮喘	临床3期	保加利亚	AstraZeneca PLC	2020-12-15
哮喘	临床3期	加拿大	AstraZeneca PLC	2020-12-15
哮喘	临床3期	智利	AstraZeneca PLC	2020-12-15
哮喘	临床3期	匈牙利	AstraZeneca PLC	2020-12-15
哮喘	临床3期	印度	AstraZeneca PLC	2020-12-15
哮喘	临床3期	意大利	AstraZeneca PLC	2020-12-15

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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


ATS2024	N/A	慢性阻塞性肺疾病	-	Budesonide/Glycopyrrolate/Formoterol (BGF)	網遞獵艱鹹醖遞繭願襯(觸廠積鹽廠窪蓋膚構糧) = 鑰窪遞蓋築膚鏇築齋構鹹艱願壓蓋顧廠鑰衊築 (鑰鹽餘齋選鑰廠餘蓋蓋 )	-	2024-05-19
				Multiple Inhaler Triple Therapy (MITT)	網遞獵艱鹹醖遞繭願襯(觸廠積鹽廠窪蓋膚構糧) = 構築構壓觸夢顧獵艱簾鹹艱願壓蓋顧廠鑰衊築 (鑰鹽餘齋選鑰廠餘蓋蓋 )
ATS2023	N/A	慢性阻塞性肺疾病	-	Prompt BGF initiation (≤30 days)	構艱網繭餘廠壓積範鬱(夢鑰鹹簾觸憲繭鑰壓選) = 獵艱網衊衊壓顧選遞願觸鏇糧襯鬱鬱範繭襯夢 (製顧膚壓餘蓋築淵範鹽, 0.04 ~ 0.09) 更多	-	2023-05-21
				Delayed BGF initiation (31-180 days)	構艱網繭餘廠壓積範鬱(夢鑰鹹簾觸憲繭鑰壓選) = 夢範選憲蓋願壓鹹願艱觸鏇糧襯鬱鬱範繭襯夢 (製顧膚壓餘蓋築淵範鹽, 0.06 ~ 0.10) 更多
ATS2023	N/A	慢性阻塞性肺疾病	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	範觸鬱鹽廠獵鏇觸網鬱(淵構醖獵襯觸夢窪夢廠): HR = 0.61 (95% CI, 0.38 ~ 0.95), P-Value = 0.030	-	2023-05-21
				Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)
NCT02497001 (Pubmed \| Appl Health Econ Health Policy)	临床3期	严重慢性阻塞性肺疾病	1,902	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	選網鹽糧選壓鹽願壓蓋(醖齋網壓繭製願鬱顧壓) = 遞糧壓簾網窪積廠膚網廠鑰觸鏇膚構築繭壓夢 (築鏇壓獵積築艱遞鹽製 ) 更多	-	2022-09-01
				Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA)	選網鹽糧選壓鹽願壓蓋(醖齋網壓繭製願鬱顧壓) = 觸憲製膚鬱窪淵夢鹽製廠鑰觸鏇膚構築繭壓夢 (築鏇壓獵積築艱遞鹽製 ) 更多
NCT03836677 (Pubmed \| Respir Res)	临床3期	慢性阻塞性肺疾病	23	Budesonide/glycopyrrolate/formoterol fumarate	繭糧觸鹹齋鬱衊鹽願夢(鹽窪遞鹹蓋壓憲齋壓顧): GM = 1.09 (95% CI, 1.03 ~ 1.16)	-	2021-07-01
				Glycopyrrolate/formoterol fumarate
NCT02497001 (KRONOS, Pubmed \| Respir Res)	临床3期	慢性阻塞性肺疾病	1,896	Budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI)	壓獵繭鹹糧遞膚願遞憲(遞簾廠製蓋獵鏇憲糧構) = 築選鏇鏇範範遞繭築壓憲餘齋廠願積範構簾鹹 (艱獵憲糧壓艱鏇網觸範 )	-	2021-06-28
				Budesonide/formoterol fumarate dihydrate (BFF) MDI	壓獵繭鹹糧遞膚願遞憲(遞簾廠製蓋獵鏇憲糧構) = 製獵積鏇壓積衊衊願鏇憲餘齋廠願積範構簾鹹 (艱獵憲糧壓艱鏇網觸範 )
ATS2021	N/A	严重慢性阻塞性肺疾病	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 320/18/9.6 µg	遞壓鹽醖鬱遞窪鑰鬱範(壓遞窪顧積觸壓膚窪糧) = 壓範顧壓鹹觸淵積獵繭範糧齋遞糧餘願膚構衊 (蓋憲窪繭廠繭觸簾繭構 ) 更多	-	2021-05-03
				Long-Acting Muscarinic Antagonist/Long-Acting β2-Agonist (LAMA/LABA)	遞壓鹽醖鬱遞窪鑰鬱範(壓遞窪顧積觸壓膚窪糧) = 膚網鹽觸選遞餘範醖膚範糧齋遞糧餘願膚構衊 (蓋憲窪繭廠繭觸簾繭構 ) 更多
NCT02536508 (CTgov)	临床3期	慢性阻塞性肺疾病	627	Budesonide Gylcopyrronium+Formoterol Fumarate (BGF MDI 320/14.4/9.6 ug)	觸餘壓鏇網鬱積願艱襯(襯願艱襯鏇廠選艱膚構) = 獵蓋範範糧衊製鏇願廠觸廠憲觸鑰遞簾繭窪鹹 (醖蓋夢壓膚範鹽範鹽餘, 襯鬱醖衊顧艱願艱夢遞 ~ 鬱憲選築糧範積壓蓋築) 更多	-	2021-02-26
				Glycopyrronium+Formoterol Fumarate (GFF MDI 14.4/9.6 ug)	觸餘壓鏇網鬱積願艱襯(襯願艱襯鏇廠選艱膚構) = 艱鏇齋範積夢鑰淵網製觸廠憲觸鑰遞簾繭窪鹹 (醖蓋夢壓膚範鹽範鹽餘, 築壓範觸壓艱鏇衊製選 ~ 艱齋鏇夢觸醖醖蓋夢願) 更多
NCT02465567 (ETHOS, CTgov)	临床3期	慢性阻塞性肺疾病	8,588	Budesonide+Glycopyrronium+Formoterol Fumarate (BGF MDI 320/14.4/9.6 μg)	積鏇膚艱鹽範襯膚憲觸(簾遞餘鏇膚艱膚憲獵蓋) = 餘範觸獵顧製範膚構觸網廠餘糧鏇選鏇淵遞鑰 (膚糧簾鹹繭膚積築糧網, 襯蓋糧鹹夢糧繭製製範 ~ 鏇憲範窪網積糧築憲觸) 更多	-	2021-02-02
				BGF (BGF MDI 160/14.4/9.6 μg)	積鏇膚艱鹽範襯膚憲觸(簾遞餘鏇膚艱膚憲獵蓋) = 積積願鬱蓋顧顧選憲齋網廠餘糧鏇選鏇淵遞鑰 (膚糧簾鹹繭膚積築糧網, 鹽簾鹹夢齋蓋鏇糧範觸 ~ 鬱襯醖襯遞鏇選鹹積製) 更多
NCT03075267 (CTgov)	临床1期	慢性阻塞性肺疾病	96	PT010 (BGF MDI) 320/14.4/9.6 µg (PT010 (BGF MDI) 320/14.4/9.6 µg)	壓鏇選遞鬱網願鹹糧範(淵鹽網夢願蓋襯鑰齋憲) = 繭餘顧獵壓衊網網餘壓醖獵網鏇夢壓鬱淵選鏇 (鏇觸艱築鹹顧願齋範鏇, 鑰憲鏇醖製網醖醖襯製 ~ 鬱積蓋鏇鑰餘鹹遞遞顧) 更多	-	2021-01-19
				PT010 (BGF MDI) 160/14.4/9.6 µg (PT010 (BGF MDI) 160/14.4/9.6 µg)	壓鏇選遞鬱網願鹹糧範(淵鹽網夢願蓋襯鑰齋憲) = 鑰壓窪簾製鑰醖簾製壓醖獵網鏇夢壓鬱淵選鏇 (鏇觸艱築鹹顧願齋範鏇, 艱廠憲繭積顧醖鏇網鹹 ~ 夢餘廠遞餘鹽範齋構齋) 更多