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阿斯利康Trixeo Aerosphere在英国获批,成为首个使用全球变暖潜能值接近于零的下一代推进剂的吸入式呼吸道药物

Trixeo Aerosphere approved in the UK as first inhaled respiratory medicine using next-generation propellant with near-zero Global Warming Potential

阿斯利康 等信源发布 2025-05-12 10:38

可切换为仅中文


AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has now been approved for use in the UK with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP).1,2 This is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) approved with the propellant that has 99.9% lower GWP than propellants used in currently available pMDIs.2 Trixeo with the next-generation propellant will have a low carbon footprint, comparable to inhaled medicines that do not require a propellant.3 Trixeo, a fixed-dose triple-combination therapy, is marketed as Breztri Aerosphere in the US, China and Japan.

阿斯利康的Trixeo Aerosphere(布地奈德/格隆溴铵/富马酸福莫特罗或 BGF)已获准用于治疗成人慢性阻塞性肺病 (COPD),现在已获准在英国使用创新的下一代推进剂,其全球变暖潜能值 (GWP) 接近于零。1,2这是第一种通过压力定量吸入器 (pMDI) 输送的药物,该吸入器与推进剂一起批准使用,其 GWP 比目前可用的 pMDI 中使用的推进剂低 99.9%。2采用下一代推进剂的 Trixeo将 具有低碳足迹,可与不需要推进剂的吸入药物相媲美。3 Trixeo是一种固定剂量三联疗法,在美国、中国和日本以Breztri Aerosphere 的名称销售。

The approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) was based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between

英国药品和健康产品管理局 (MHRA) 的批准是基于下一代推进剂临床开发计划的结果,该计划证明了生物等效性。

Trixeo

特里克索

with the next-generation propellant, HFO-1234ze(E), and

使用下一代推进剂 HFO-1234ze(E),以及

Trixeo

特里克索

with the current propellant, HFA-134a.

使用当前的推进剂HFA-134a。

The safety and tolerability profile for

安全性和耐受性特征

Trixeo

特里克索

with the next-generation propellant was consistent with the known profile of the medicine.

下一代推进剂与该药物的已知特性相符。

Beyond the UK, regulatory applications for

英国以外,监管申请

Trixeo/Breztri

特里普乔/布雷泽里

with the next-generation propellant are currently under review in Europe, China and additional countries.

使用下一代推进剂的审查目前在欧洲、中国和其他国家进行。

Omar Usmani, Professor of Respiratory Medicine at Imperial College London, said: “Pressurised metered-dose inhaled medicines are essential for millions of people living with respiratory diseases in the UK. The transition of

伦敦帝国学院呼吸医学教授奥马尔·乌斯马尼表示:“对于英国数百万患有呼吸道疾病的人来说,加压定量吸入药物是必不可少的。这种过渡

Trixeo

特里克索

to the propellant with near-zero Global Warming Potential means that healthcare professionals can focus on optimising outcomes for their COPD patients based on clinical need, while also supporting climate goals. Clinicians and their patients shouldn’t feel that they have to choose between the most appropriate treatment and the planet.”.

接近零全球变暖潜能值的推进剂意味着医疗专业人员可以专注于根据临床需求优化其慢性阻塞性肺病 (COPD) 患者的治疗效果,同时支持气候目标。临床医生及其患者不应感到必须在最合适的治疗方案和地球之间做出选择。

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The UK approval of

鲁德·多伯,阿斯利康生物制药业务部执行副总裁表示:“英国的批准是

Trixeo Aerosphere

特里克索气雾剂

with the next-generation propellant is an industry first and a major milestone in AstraZeneca’s commitment to transition our pMDI portfolio to the propellant with near-zero Global Warming Potential. Starting with

采用下一代推进剂是行业首创,也是阿斯利康致力于将我们的pMDI产品组合过渡到具有接近零全球变暖潜值的推进剂的一个重要里程碑。首先从

Trixeo,

特里克索,

we are addressing the needs of both patients and the environment in devastating diseases like COPD, which affects hundreds of millions of people and is a leading cause of death globally.”

我们正在应对像慢性阻塞性肺病(COPD)这样毁灭性疾病中患者和环境的需求,这种疾病影响着数亿人,并且是全球主要的死亡原因之一。

Tom Keith-Roach, President, AstraZeneca UK, said: “The UK approval of

阿斯利康英国总裁汤姆·基思-罗奇表示:“英国的批准是

Trixeo

特里克索

Aerosphere

气溶胶层

with the near-zero Global Warming Potential propellant marks a world ‘first’ and an important step in improving the environmental impact of our portfolio of inhaled respiratory medicines to support the NHS in achieving its net zero carbon goals.

使用近乎零全球变暖潜值的推进剂标志着世界“首创”,也是改善我们吸入式呼吸系统药物组合环境影响的重要一步,有助于支持英国国家医疗服务体系实现其净零碳排放目标。

Trixeo

特里克索

with our next-generation propellant allows us to address the needs of both patients and the planet.”

我们下一代的推进剂能够让我们满足患者和地球的需求。

Trixeo

特里克索

is the first medicine in AstraZeneca’s portfolio of pMDIs to transition to the new propellant. AstraZeneca aims to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of the Company’s

是阿斯利康推出的首款过渡到全新抛射剂的pMDI类药物。阿斯利康旨在2030年前,将其广泛的pMDI产品组合过渡到接近零GWP的抛射剂,作为公司计划的一部分。

Ambition Zero Carbon

零碳雄心

strategy. In the UK, the Company plans to initiate the transition of

战略。在英国,公司计划启动转型

Trixeo

特里克索

to the next-generation propellant in the coming months.

在未来几个月内,下一代推进剂。

Chronic respiratory diseases, including COPD, affect hundreds of millions of people around the world.

慢性呼吸系统疾病,包括慢性阻塞性肺病,影响着全球数亿人。

Respiratory inhaled medicines delivered by pMDIs account for 78% of inhaler usage globally and contribute 0.04% of global greenhouse gases.

由pMDIs递送的吸入性呼吸系统药物占全球吸入器使用量的78%,并贡献了全球温室气体排放的0.04%。

In the UK, pMDIs make up 70% of all inhaled medicines use with inhaler emissions representing 3% of the total NHS carbon footprint.

在英国,pMDIs 占所有吸入药物使用的 70%,其中吸入器排放量占 NHS 总碳足迹的 3%。

Studies show that the largest environmental contribution from respiratory diseases comes from patients not being adequately controlled and resulting increased healthcare utilisation.

研究表明,呼吸系统疾病对环境的最大影响来自于患者未能得到充分控制,从而导致医疗资源利用增加。

Implementing evidence-based guidelines into clinical practice can reduce exacerbations and unscheduled healthcare utilisation, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care.

将基于证据的指南实施到临床实践中,可以减少病情加重和非计划的医疗资源使用,而由此带来的患者预后改善还可能降低与呼吸系统护理相关的总体碳足迹。

AstraZeneca’s next-generation propellant clinical development programme

阿斯利康的下一代推进剂临床开发计划

The clinical development programme has been initiated to assess the efficacy and safety of the next-generation, near-zero Global Warming Potential propellant, HFO-1234ze(E), with the AstraZeneca portfolio of inhaled medicines delivered by pressurised metered-dose inhalers (pMDIs).

临床开发计划已经启动,以评估下一代接近零全球变暖潜值的推进剂 HFO-1234ze(E) 与阿斯利康通过加压定量吸入器(pMDIs)递送的吸入药物组合的疗效和安全性。

The first medicine to be assessed in the programme was

该计划中评估的第一种药物是

Breztri/Trixeo Aerosphere

布雷兹里/特里克索 雾化球

(budesonide/glycopyrronium/formoterol fumarate or BGF) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.

通过体外、体内生物等效性(PK)、安全性和有效性临床研究(布地奈德/格隆溴铵/富马酸福莫特罗或BGF)。

The programme established bioequivalence between

该计划建立了生物等效性

Breztri/Trixeo

布雷兹里/特里克索

with the next-generation propellant, HFO-1234ze(E), and

采用下一代推进剂 HFO-1234ze(E),以及

Breztri/Trixeo

布雷兹里/特里克索

with the current propellant, HFA-134a.

使用当前的推进剂HFA-134a。

The safety and tolerability profile for

安全性和耐受性特征

Breztri/Trixeo

布雷兹里/特里克索

with

带有

the next-generation propellant was consistent with the known profile of the medicine.

下一代推进剂与该药物的已知特性一致。

Additional studies are underway to assess the bioequivalence of HFO-1234ze(E) to the current propellant with AstraZeneca’s other medicines delivered by pMDIs.

正在进行更多的研究,以评估HFO-1234ze(E)与阿斯利康其他通过pMDIs递送的药物当前使用的推进剂的生物等效性。

Breztri/Trixeo Aerosphere

布雷兹里/特里克索 雾化器

Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name

布地奈德/格隆溴铵/富马酸福莫特罗(BGF),获批的商品名为

Trixeo Aerosphere

特里克索气雾剂

in the EU and

在欧盟和

Breztri Aerosphere

布雷兹里气雾剂

in Japan, China and the US, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting β2 agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an inhaled corticosteroid (ICS), and delivered via the

在日本、中国和美国,是一种单吸入器、固定剂量的三联组合药物,包含富马酸福莫特罗(一种长效β2激动剂(LABA))、溴化格隆铵(一种长效毒蕈碱拮抗剂(LAMA))和布地奈德(一种吸入型皮质类固醇(ICS)),并通过以下方式递送:

is approved to treat COPD in more than 80 countries worldwide including the US, EU, China and Japan, and has been prescribed to more than five million patients globally.

在全球超过80个国家(包括美国、欧盟、中国和日本)获批用于治疗慢性阻塞性肺疾病,并已在全球范围内开出处方超过500万名患者。

Breztri/Trixeo Aerosphere

布雷兹里/特里克索 雾化器

with the next-generation propellant, HFO-1234ze(E), will maintain the same indication, product strength and dosage regimen as

使用下一代推进剂 HFO-1234ze(E),将保持相同的适应症、产品强度和剂量方案

Breztri/Trixeo Aerosphere

布雷兹里/特里克索 雾化球

with the current propellant, HFA-134a.

使用目前的推进剂HFA-134a。

AstraZeneca’s Collaboration with Honeywell

阿斯利康与霍尼韦尔的合作

Developed by Honeywell, the medical grade version of HFO-1234ze(E) is a critical propellant to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in

霍尼韦尔开发的医用级HFO-1234ze(E)是一种关键的推进剂,可帮助过渡到气候影响较小的pMDI药物,因为它的全球变暖潜能值(GWP)接近于零。阿斯利康宣布在

its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant.

它与霍尼韦尔合作,使用这种新抛射剂开发呼吸吸入药物。

strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. The Company is on track to reduce greenhouse gas (GHG) emissions from its global operations and fleet (Scope 1 and 2) by 98% by 2026 (from a 2015 baseline). AstraZeneca aims to halve its entire value chain footprint (Scope 3) by 2030, on the way to a 90% absolute emissions reduction (from a 2019 baseline) by 2045.

战略上,阿斯利康正在追求大胆的、基于科学的脱碳目标,加快实现净零排放的进程。公司有望到2026年将其全球运营和车队(范围1和范围2)的温室气体(GHG)排放量减少98%(以2015年为基准)。阿斯利康旨在到2030年将其整个价值链的碳足迹(范围3)减半,并在2045年之前实现绝对排放量减少90%(以2019年为基准)。

By 2030, the Company will become carbon negative for residual emissions. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard..

到 2030 年,公司将在剩余排放方面实现碳负排放。阿斯利康是全球率先通过科学基础目标倡议组织 (SBTi) 企业净零标准验证净零目标的七家公司之一。

AstraZeneca in Respiratory & Immunology

阿斯利康在呼吸与免疫学领域

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

呼吸与免疫学是阿斯利康生物制药公司的一部分,是公司的一个关键疾病领域和增长驱动力。

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets.

阿斯利康在呼吸系统护理领域拥有50年的传承,是公认的领导者,并在免疫介导疾病药物方面拥有不断扩展的产品组合。公司致力于通过吸入式药物、生物制剂以及针对以往难以触及的生物靶点的新型治疗模式,满足这些慢性且常使人衰弱的疾病的巨大未满足需求。

Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases..

我们的目标是提供改变生命的药物,帮助消除慢性阻塞性肺病作为主要死亡原因,消除哮喘发作,并在免疫介导的疾病中实现临床缓解。

AstraZeneca

阿斯利康

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

阿斯利康(LSE/STO/Nasdaq:AZN)是一家全球领先的、以科学为导向的生物制药公司,专注于肿瘤学、罕见病以及包括心血管、肾病与代谢、呼吸与免疫在内的生物制药领域的处方药发现、开发和商业化。

Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit .

总部位于英国剑桥的阿斯利康公司的创新药物在全球 125 多个国家销售,全世界数百万患者使用。请访问 。