A randomised, parallel group trial comparing two stepwise treatment tracks for the pharmacological management of adult asthma: ICS/formoterol reliever vs SABA reliever-based therapy

开始日期2025-04-11

申办/合作机构

Medical Research Institute of New Zealand

NCT06865040

/ Not yet recruitingN/AIIT

Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications

The objective of the study is to evaluate, in a clinical trial, the efficacy of peri operative administration of long-acting inhaled ß-2 mimetics on the occurrence of postoperative pulmonary complications

开始日期2025-03-04

申办/合作机构

Centre Hospitalier Universitaire Amiens-Picardie

CTRI/2024/10/075606

/ Recruiting临床3期

A randomized, double-blind, double-dummy clinical trial to assess the efficacy and safety of fixed dose combination of Glycopyrronium 25 µg, Formoterol Fumarate 20 µg, Budesonide 500 µg Inhalation Suspension (for nebulization) in comparison with fixed dose combination of Formoterol Fumarate Dihydrate 5 µg, Glycopyrronium 7.2 µg and Budesonide 160 µg pressured inhalation suspension in patients with chronic obstructive pulmonary disease. - NIL

开始日期2024-11-07

申办/合作机构

Glenmark Pharmaceuticals Ltd.

100 项与富马酸福莫特罗相关的临床结果

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100 项与富马酸福莫特罗相关的转化医学

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100 项与富马酸福莫特罗相关的专利（医药）

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3,367

项与富马酸福莫特罗相关的文献（医药）

2025-12-31·Pulmonology

Adherence to inhaled corticosteroids and long-acting β2-agonists in asthma: A MASK-air study

Article

作者: Bedbrook, A. ; Makela, M. ; Samolinski, B. ; Klimek, L. ; Rivero Yeverino, D. ; Kuna, P. ; Canonica, G.W. ; Ollert, M. ; Agache, I. ; Usmani, O.S. ; Jutel, M. ; Gemicioglu, B. ; Shamji, M.H. ; Puggioni, F. ; Cecchi, L. ; Ivancevich, J.C. ; Buhl, R. ; Kraxner, H. ; Anto, J.M. ; Pétré, B. ; Haahtela, T. ; Nadif, R. ; Amaral, R. ; Boulet, L.-P. ; Papadopoulos, N.G. ; Robalo Cordeiro, C. ; Bonini, M. ; Zuberbier, T. ; Bousquet, J. ; Ventura, M.T. ; Morais-Almeida, M. ; Costa, E.M. ; Patella, V. ; Czarlewski, W. ; Fonseca, J.A. ; Roche, N. ; Brusselle, G. ; Sá-Sousa, A. ; Chaves Loureiro, C. ; Louis, R. ; Kupczyk, M. ; Bergmann, K.C. ; Becker, S. ; Sastre, J. ; Brussino, L. ; Sousa-Pinto, B. ; Romantowski, J. ; Laune, D. ; Regateiro, F.S. ; Sheikh, A. ; Niedoszytko, M. ; Valiulis, A. ; Yorgancioglu, A. ; Savouré, M. ; Scichilone, N. ; Charpin, D. ; Suppli Ulrik, C. ; Bosnic-Anticevich, S. ; Larenas-Linnemann, D.E. ; de Blay, F. ; Pfaar, O. ; Papi, A. ; Taborda-Barata, L. ; Cruz, A.A. ; Pham-Thi, N. ; Okamoto, Y. ; Kvedariene, V. ; Rouadi, P.W. ; Del Giacco, S.

INTRODUCTION:

Adherence to controller medication is a major problem in asthma management, being difficult to assess and tackle. mHealth apps can be used to assess adherence. We aimed to assess the adherence to inhaled corticosteroids+long-acting β2-agonists (ICS+LABA) in users of the MASK-air® app, comparing the adherence to ICS+formoterol (ICS+F) with that to ICS+other LABA.

MATERIALS AND METHODS:

We analysed complete weeks of MASK-air® data (2015-2022; 27 countries) from patients with self-reported asthma and ICS+LABA use. We compared patients reporting ICS+F versus ICS+other LABA on adherence levels, symptoms and symptom-medication scores. We built regression models to assess whether adherence to ICS+LABA was associated with asthma control or short-acting beta-agonist (SABA) use. Sensitivity analyses were performed considering the weeks with no more than one missing day.

RESULTS:

In 2598 ICS+LABA users, 621 (23.9%) reported 4824 complete weeks and 866 (33.3%) reported weeks with at most one missing day. Higher adherence (use of medication ≥80% of weekly days) was observed for ICS+other LABA (75.1%) when compared to ICS+F (59.3%), despite both groups displaying similar asthma control and work productivity. The ICS+other LABA group was associated with more days of SABA use than the ICS+F group (median=71.4% versus 57.1% days). Each additional weekly day of ICS+F use was associated with a 4.1% less risk in weekly SABA use (95%CI=-6.5;-1.6%;p=0.001). For ICS+other LABA, the percentage was 8.2 (95%CI=-11.6;-5.0%;p<0.001).

CONCLUSIONS:

In asthma patients adherent to the MASK-air app, adherence to ICS+LABA was high. ICS+F users reported lower adherence but also a lower SABA use and a similar level of control.

2025-12-31·Journal of Pharmaceutical Policy and Practice

Access to single-inhaler triple medicines for chronic obstructive pulmonary disease in China: a national survey on accessibility and utilisation

Article

作者: Wang, Menglei ; Yu, Shule ; Yang, Qingqing ; Lu, Wei ; Guo, Wei ; Zheng, Fangfang ; Wu, Huanhuan ; Chen, Hongdou ; Li, Wei

Background:

The maintenance medicines for chronic obstructive pulmonary disease (COPD) include inhaled corticosteroids (ICS), long-acting muscarinic antagonists (LAMA) and long-acting β2-agonists (LABA). Budesonide/glycopyrronium/formoterol (BUD/GLY/FOR) and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) are two representative drugs for prefixed ICS/LAMA/LABA association in a single inhaler and have shown comparable efficacy and safety with other ICS/LAMA/LABA open combination therapies in patients with moderate-to-very severe COPD. This study aimed to investigate the availability, price, affordability, and utilisation of single-inhaler triple medicines for COPD in China.

Methods:

Quarterly data about the use of BUD/GLY/FOR and FF/UMEC/VI from 2020 to 2022 were collected from the Chinese Medicine Economic Information Network. We used the adjusted World Health Organization and Health Action International methodology to calculate the availability and affordability of the two investigated medicines in 596 tertiary general hospitals and 299 secondary general hospitals in 31 provincial administrative regions in China.

Results:

The availability and consumption of BUD/GLY/FOR were significantly higher than those of FF/UMEC/VI during the study period. At the end of 2022, the availability of BUD/GLY/FOR and FF/UMEC/VI in tertiary general hospitals was 69.80% and 52.01% respectively, while in secondary general hospitals, it was 52.51% and 28.76% respectively. Both medications were equally affordable at 1.3 days of the minimum wage after reimbursement in 2022. In the first quarter of 2021, with the inclusion of both drugs in the Medicare catalog, their DDDc decreased significantly, which was accompanied by notable improvements in their availability, affordability and consumption.

Conclusions:

The overall accessibility and consumption of BUD/GLY/FOR and FF/UMEC/VI were improved in China from 2020 to 2022. The implementation of the national drug price negotiation policy reduces the cost of drugs in China and plays an important role in improving the availability of the investigated drugs.

2025-09-01·Respiratory Investigation

Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study

Article

作者: Kawayama, Tomotaka ; Nishida, Kenichiro ; Kato, Yuki ; Yoshida, Yuri ; Hirai, Takehiro ; Sugiura, Hisatoshi ; Makita, Naoyuki ; Muro, Shigeo ; Hozawa, Soichiro

BACKGROUND:

There are limited real-world data regarding triple therapy with inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist on symptoms and patient-reported outcomes (PROs) in patients with chronic obstructive pulmonary disease (COPD), without current/history of asthma. We investigated the effects of budesonide/glycopyrronium/formoterol fumarate (BGF) metered dose inhaler (MDI) triple therapy on health status and PROs in patients with COPD in daily clinical practice.

METHODS:

This was a 12-week, prospective, multicenter, observational study (NCT05219630). The primary endpoint was mean change from baseline in the COPD Assessment Test (CAT) over 12 weeks. Secondary and exploratory endpoints included mean change from baseline in the St George's Respiratory Questionnaire (SGRQ) over 12 weeks and CAT score subgroup analyses.

RESULTS:

In total, 102 patients were analyzed; mean age at baseline was 73.8 years, mean forced expiratory volume in 1 s was 57.7 %, CAT total score was 15.6, and SGRQ score was 33.3. The adjusted mean change from baseline over 12 weeks in CAT was -2.9 (standard error [SE] 0.5) (P < 0.001), and in SGRQ was -2.7 (SE 0.9) (P = 0.004). As early as Week 4, these scores were significantly improved from baseline. In subgroup analyses, CAT scores were improved, regardless of blood eosinophil counts at baseline and exacerbation history in the previous year.

CONCLUSIONS:

Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD who have persistent symptoms without current asthma or a history of asthma.

TRIAL REGISTRATION:

ClinicalTrials.gov (NCT05219630).

251

项与富马酸福莫特罗相关的新闻（医药）

2025-07-28

·国家药品监督管理局

2025年07月28日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CXHS2200059国利培酮口溶膜齐鲁制药有限公司国药准字H202500532025年07月22日2CXHS2200060国利培酮口溶膜齐鲁制药有限公司国药准字H202500542025年07月22日3CXHS2300035、CXHB2400004、CXHB2400069、CXHB2400113、CXHB2400166盐酸妥诺达非片扬子江药业集团有限公司国药准字H202500522025年07月22日4CYHB2300163复方氨酚烷胺胶囊悦康药业集团股份有限公司————2025年07月24日5CYHB2302600氢溴酸山莨菪碱注射液成都第一制药有限公司————2025年07月24日6CYHB2350947注射用磷霉素钠东北制药集团沈阳第一制药有限公司————2025年07月24日7CYHB2350948注射用磷霉素钠东北制药集团沈阳第一制药有限公司————2025年07月24日8CYHB2350949注射用磷霉素钠东北制药集团沈阳第一制药有限公司————2025年07月24日9CYHB2400334奥卡西平片武汉人福药业有限责任公司国药准字H202581402025年07月24日10CYHB2401667盐酸氨溴索注射液四川宏明博思药业有限公司————2025年07月24日11CYHB2450237盐酸格拉司琼注射液江苏朗欧药业有限公司————2025年07月24日12CYHB2450314维生素B₆注射液裕松源药业有限公司国药准字H202581382025年07月24日13CYHB2450323盐酸苯海拉明注射液上海朝晖药业有限公司————2025年07月24日14CYHB2450327盐酸苯海拉明注射液上海朝晖药业有限公司国药准字H202581392025年07月24日15CYHB2450338腹膜透析液（乳酸盐-G2.5%）津药和平（天津）制药有限公司————2025年07月24日16CYHB2450339腹膜透析液（乳酸盐-G1.5%）津药和平（天津）制药有限公司————2025年07月24日17CYHB2450377乳酸环丙沙星氯化钠注射液辰欣药业股份有限公司————2025年07月24日18CYHB2450449盐酸甲氧氯普胺注射液华润双鹤药业股份有限公司————2025年07月24日19CYHB2450458盐酸林可霉素注射液新乡市常乐制药有限责任公司————2025年07月24日20CYHB2450480盐酸甲氧氯普胺注射液山东齐都药业有限公司国药准字H202581422025年07月24日21CYHB2450515碳酸氢钠注射液江苏正大丰海制药有限公司国药准字H202581412025年07月24日22CYHB2500875达格列净片北京伟林恒昌医药科技有限公司————2025年07月23日23CYHB2500876达格列净片北京伟林恒昌医药科技有限公司————2025年07月23日24CYHB2500930富马酸比索洛尔片浙江京新药业股份有限公司————2025年07月22日25CYHB2500931富马酸比索洛尔片浙江京新药业股份有限公司————2025年07月22日26CYHB2500971盐酸多巴酚丁胺注射液湖南先施制药有限公司————2025年07月24日27CYHB2500981琥珀酸美托洛尔缓释片浙江普洛康裕制药有限公司————2025年07月24日28CYHS2302229奥美拉唑碳酸氢钠干混悬剂（Ⅱ）浙江同伍生物医药有限公司国药准字H202548802025年07月22日29CYHS2302230奥美拉唑碳酸氢钠干混悬剂（Ⅰ）浙江同伍生物医药有限公司国药准字H202548812025年07月22日30CYHS2302471普瑞巴林口服溶液山东道齐生物医药科技有限公司国药准字H202548782025年07月22日31CYHS2302553草酸艾司西酞普兰口服溶液北京海步医药科技有限公司国药准字H202548792025年07月22日32CYHS2302675克林霉素磷酸酯外用溶液安徽省先锋制药有限公司国药准字H202548902025年07月22日33CYHS2302676克林霉素磷酸酯外用溶液安徽省先锋制药有限公司国药准字H202548912025年07月22日34CYHS2302766马来酸噻吗洛尔滴眼液扬州中宝药业股份有限公司国药准字H202549272025年07月22日35CYHS2302810氢溴酸替格列汀片浙江星月药物科技有限公司国药准字H202549022025年07月22日36CYHS2302811氢溴酸替格列汀片浙江星月药物科技有限公司国药准字H202549032025年07月22日37CYHS2302855克立硼罗软膏杭州领业医药科技有限公司国药准字H202548922025年07月22日38CYHS2302876注射用盐酸万古霉素重庆药友制药有限责任公司国药准字H202549042025年07月22日39CYHS2303263盐酸昂丹司琼片杭州沐源生物医药科技有限公司国药准字H202548872025年07月22日40CYHS2303264盐酸昂丹司琼片杭州沐源生物医药科技有限公司国药准字H202548882025年07月22日41CYHS2303308复方聚乙二醇（3350）电解质散圣嘉（滨海）生物医药科技有限公司国药准字H202549282025年07月22日42CYHS2303444盐酸拉贝洛尔注射液南京海科瑞医药科技有限公司国药准字H202549052025年07月22日43CYHS2303445盐酸拉贝洛尔注射液南京海科瑞医药科技有限公司国药准字H202549062025年07月22日44CYHS2303446、CYHB2500271夫西地酸乳膏漳州水仙药业股份有限公司国药准字H202549442025年07月22日45CYHS2303485复方醋酸钠林格注射液广东科泓药业有限公司国药准字H202549072025年07月22日46CYHS2303486复方醋酸钠林格注射液广东科泓药业有限公司国药准字H202549082025年07月22日47CYHS2303494氯化钾颗粒南京海鲸药业股份有限公司国药准字H202549452025年07月22日48CYHS2303649地氯雷他定口服溶液江苏东科康德药业有限公司国药准字H202548822025年07月22日49CYHS2400012夫西地酸钠软膏北京诚济制药股份有限公司国药准字H202548932025年07月22日50CYHS2400055中/长链脂肪乳注射液（C₆~₂₄）安徽富邦药业有限公司国药准字H202549292025年07月22日51CYHS2400056中/长链脂肪乳注射液（C₆~₂₄）安徽富邦药业有限公司国药准字H202549302025年07月22日52CYHS2400108注射用丁二磺酸腺苷蛋氨酸福安药业集团烟台只楚药业有限公司国药准字H202549362025年07月22日53CYHS2400164氯化钾口服溶液沈阳天邦药业有限公司国药准字H202549092025年07月22日54CYHS2400179瑞舒伐他汀依折麦布片（I）石家庄四药有限公司国药准字H202549102025年07月22日55CYHS2400187盐酸甲氧氯普胺注射液湖北民康药业集团有限公司国药准字H202549112025年07月22日56CYHS2400194联苯苄唑溶液福元药业有限公司国药准字H202549372025年07月22日57CYHS2400255尼莫地平口服溶液常州四药制药有限公司国药准字H202549312025年07月22日58CYHS2400299苯磺酸氨氯地平片山东普瑞曼药业有限公司国药准字H202548942025年07月22日59CYHS2400311二羟丙茶碱注射液湖南尔康制药股份有限公司国药准字H202549122025年07月22日60CYHS2400339门冬氨酸钾注射液广州合和医药有限公司国药准字H202549132025年07月22日61CYHS2400351利培酮口崩片河北龙海药业有限公司国药准字H202549462025年07月22日62CYHS2400431注射用醋酸西曲瑞克江苏诺泰澳赛诺生物制药股份有限公司国药准字H202548952025年07月22日63CYHS2400441盐酸缬更昔洛韦片浙江车头制药股份有限公司国药准字H202548832025年07月22日64CYHS2400523二羟丙茶碱注射液浙江同伍生物医药有限公司国药准字H202549322025年07月22日65CYHS2400540克立硼罗软膏江苏万高药业股份有限公司国药准字H202548962025年07月22日66CYHS2400561孟鲁司特钠颗粒牡丹江恒远药业股份有限公司国药准字H202549472025年07月22日67CYHS2400574富马酸伏诺拉生片石家庄龙泽制药股份有限公司国药准字H202548842025年07月22日68CYHS2400609盐酸咪达普利片国药集团容生制药有限公司国药准字H202548972025年07月22日69CYHS2400612美阿沙坦钾片重庆圣华曦药业股份有限公司国药准字H202549382025年07月22日70CYHS2400613美阿沙坦钾片重庆圣华曦药业股份有限公司国药准字H202549392025年07月22日71CYHS2400615非那雄胺片江苏润邦药业有限公司国药准字H202549402025年07月22日72CYHS2400640复方氨基酸注射液（17AA-Ⅲ）四川太平洋药业有限责任公司国药准字H202548852025年07月22日73CYHS2400711亚叶酸钙注射液国药一心制药有限公司国药准字H202548982025年07月22日74CYHS2400725卡泊三醇搽剂湖北恒安芙林药业股份有限公司国药准字H202548992025年07月22日75CYHS2400744间苯三酚注射液山东新时代药业有限公司国药准字H202549142025年07月22日76CYHS2400749维格列汀片新天地药业股份有限公司国药准字H202549482025年07月22日77CYHS2400763培哚普利氨氯地平片（Ⅲ）杭州康恩贝制药有限公司国药准字H202549152025年07月22日78CYHS2400850他达拉非片湘北威尔曼制药股份有限公司国药准字H202549162025年07月22日79CYHS2400851他达拉非片湘北威尔曼制药股份有限公司国药准字H202549172025年07月22日80CYHS2400852他达拉非片湘北威尔曼制药股份有限公司国药准字H202549182025年07月22日81CYHS2400862硫酸沙丁胺醇注射液江苏开元药业有限公司国药准字H202549002025年07月22日82CYHS2400873阿司匹林肠溶片河北汇德旭盛医药科技有限公司国药准字H202549332025年07月22日83CYHS2400891硫酸氨基葡萄糖胶囊山西德元堂药业有限公司国药准字H202549192025年07月22日84CYHS2400942布美他尼注射液成都瑞尔医药科技有限公司国药准字H202549202025年07月22日85CYHS2400943布美他尼注射液成都瑞尔医药科技有限公司国药准字H202549212025年07月22日86CYHS2400951醋酸加尼瑞克注射液辰欣药业股份有限公司国药准字H202549012025年07月22日87CYHS2400990奥美沙坦酯口崩片吉林省德商药业股份有限公司国药准字H202549222025年07月22日88CYHS2400991奥美沙坦酯口崩片吉林省德商药业股份有限公司国药准字H202549232025年07月22日89CYHS2401022腺苷钴胺胶囊华北制药股份有限公司国药准字H202548892025年07月22日90CYHS2401023富马酸福莫特罗吸入溶液成都海德康药业有限公司国药准字H202549242025年07月22日91CYHS2401077硫酸镁钠钾口服用浓溶液珠海横琴国研医药科技有限公司国药准字H202549412025年07月22日92CYHS2401172普拉洛芬滴眼液湖北远大天天明制药有限公司国药准字H202548862025年07月22日93CYHS2401223培哚普利氨氯地平片（Ⅲ）成都硕德药业有限公司国药准字H202549252025年07月22日94CYHS2401379恩格列净片浙江宏元药业股份有限公司国药准字H202549492025年07月22日95CYHS2401461聚乙烯醇滴眼液苏州欧康维视生物科技有限公司国药准字H202549262025年07月22日96CYHS2401484地屈孕酮片浙江高跖医药科技股份有限公司国药准字H202549422025年07月22日97CYHS2401492平衡盐溶液（供灌注用）海南爱科制药有限公司国药准字H202549342025年07月22日98CYHS2401827左卡尼汀口服溶液江苏盈科生物制药有限公司国药准字H202549502025年07月22日99CYHS2402890硫酸氨基葡萄糖胶囊西安信百欣医药科技有限公司国药准字H202549432025年07月22日100CYHS2403307氧（液态）林德（上海）半导体气体有限公司国药准字H202549352025年07月22日101CYSB2400119人表皮生长因子外用溶液（Ⅰ）深圳市华生元基因工程发展有限公司————2025年07月23日102CYSB2400120人表皮生长因子外用溶液（Ⅰ）深圳市华生元基因工程发展有限公司————2025年07月23日103CYSB2400121人表皮生长因子（ARI加长型）滴眼液深圳市华生元基因工程发展有限公司————2025年07月23日104CYSB2500116重组人干扰素α1b喷雾剂北京三元基因药业股份有限公司————2025年07月24日105CYSB2500123贝那鲁肽注射液上海仁会生物制药股份有限公司————2025年07月24日106CYZB2501291七宝美髯丸广东和香生物医药有限公司————2025年07月23日107JXHS2400027眼内注射用曲安奈德深圳市罗素医药有限公司国药准字HJ202500872025年07月22日108JXHS2400082甲磺酸仑伐替尼胶囊卫材（中国）药业有限公司国药准字HJ202000442025年07月22日109JXHS2400083甲磺酸仑伐替尼胶囊卫材（中国）药业有限公司国药准字HJ202000452025年07月22日110JXHS2400084塞利尼索片德琪（浙江）医药科技有限公司国药准字HJ202100832025年07月22日111JXHS2400099替尔泊肽注射液礼来苏州制药有限公司国药准字HJ202400202025年07月22日112JXHS2400100替尔泊肽注射液礼来苏州制药有限公司国药准字HJ202400232025年07月22日113JXHS2400101替尔泊肽注射液礼来苏州制药有限公司国药准字HJ202400212025年07月22日114JXHS2400102替尔泊肽注射液礼来苏州制药有限公司国药准字HJ202400222025年07月22日115JXSS2400090纳武利尤单抗注射液百时美施贵宝（中国）投资有限公司国药准字SJ201800142025年07月22日116JXSS2400091纳武利尤单抗注射液百时美施贵宝（中国）投资有限公司国药准字SJ201800152025年07月22日117JXSS2400092伊匹木单抗注射液百时美施贵宝（中国）投资有限公司国药准字SJ202100192025年07月22日118JXSS2400093伊匹木单抗注射液百时美施贵宝（中国）投资有限公司国药准字SJ202100202025年07月22日119JYHB2400273英克司兰钠注射液北京诺华制药有限公司————2025年07月24日120JYHS2300125特立氟胺片安若维他药业泰州有限公司国药准字HJ202500852025年07月22日121JYHS2300126特立氟胺片安若维他药业泰州有限公司国药准字HJ202500862025年07月22日122JYHZ2500046马来酸伊索拉定片北京艾努爱世医药科技有限公司国药准字HJ201502602025年07月24日123JYHZ2500047马来酸伊索拉定片北京艾努爱世医药科技有限公司国药准字HJ201502592025年07月24日124JYHZ2500067左西孟旦注射液广州汉光药业股份有限公司国药准字HJ202000282025年07月24日125JYSB2500092乌司奴单抗注射液西安杨森制药有限公司————2025年07月23日126JYSB2500093乌司奴单抗注射液西安杨森制药有限公司————2025年07月23日127JYSB2500102罗泽利昔珠单抗注射液优时比贸易（上海）有限公司————2025年07月24日

申请上市临床申请

2025-07-25

·astrazeneca.com

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential

AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, endorsing it for use in the European Union (EU) with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP).1 Trixeo is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) using a propellant that offers 99.9% lower GWP than propellants used in currently available pMDIs.2 This fixed-dose triple-combination therapy, marketed as Breztri Aerosphere in the US, China and Japan, will now have a low carbon footprint comparable to inhaled medicines that do not require a propellant.3 Based on the CHMP positive opinion, AstraZeneca will now begin to transition its Trixeo supply to the next-generation propellant in Europe. The CHMP positive opinion is based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant and Trixeo with the current propellant.4,5 The safety and tolerability profile for Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Frederik Trinkmann, Professor and Senior Pulmonologist at the Thoracic Clinic at Heidelberg University Hospital, Germany, said: “Respiratory medicines delivered by pressurised metered-dose inhalers are essential for millions of people living with respiratory diseases in Europe, including specific vulnerable populations such as children and the elderly. The transition of Trixeo to the propellant with near-zero Global Warming Potential ensures clinicians’ treatment decisions can focus on clinical needs while also supporting environmental goals.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The CHMP positive opinion of Trixeo Aerosphere with the next-generation propellant allows us to address the needs of both patients and the planet and is a significant milestone in our commitment to delivering innovations for sustainable healthcare in the EU. Starting with Trixeo, the transition to the near-zero Global Warming Potential propellant across our pressurised metered-dose inhaled respiratory medicines is an important step towards achieving our Ambition Zero Carbon strategy.” Susanna Palkonen, Director of the European Federation of Allergy and Airways Diseases Patients' Associations, said: “COPD is a devastating disease and the third leading cause of mortality in the world. People living with COPD need access to a treatment which is right for them as well as a healthy environment and clean air. We welcome the positive opinion from the CHMP for the inhaled respiratory medicine containing the next-generation propellant with a significantly reduced carbon footprint.” Trixeo with the next-generation propellant received its first approval in the UK in May 2025 with regulatory applications also currently under review in China and additional countries. Trixeo is the first medicine in AstraZeneca’s portfolio of medicines delivered by 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 Ambition Zero Carbon strategy. In the EU, the Company plans to initiate the transition of Trixeo to the next-generation propellant in the coming months. Chronic respiratory diseases, including COPD, affect hundreds of millions of people around the world.6 Respiratory inhaled medicines delivered by pMDIs account for 76% of all inhaler use in Europe, and contribute 0.04% of global greenhouse gases.7,8 Studies show that the largest environmental contribution from respiratory diseases comes from patients’ symptoms not being adequately controlled and resulting increased healthcare utilisation.9,10 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.11 Notes AstraZeneca’s next-generation propellant clinical development programme The clinical development programme has been initiated to assess the efficacy and safety of the next-generation, near-zero Global Warming Potential propellant with the AstraZeneca portfolio of inhaled medicines delivered by pressurised metered-dose inhalers (pMDIs). The first medicine to be assessed in the programme was Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.12-17 The programme established bioequivalence between Breztri/Trixeo with the next-generation propellant and Breztri/Trixeo with the current propellant.4,5 The safety and tolerability profile for Breztri/Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Additional studies are underway to assess the bioequivalence of the next-generation propellant to the current propellant with AstraZeneca’s other medicines delivered by pMDIs. Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Trixeo Aerosphere in the EU and UK and Breztri Aerosphere 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 Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat COPD in more than 80 countries worldwide including the US, EU, China, Japan, and has been prescribed to more than five million patients globally. Breztri/Trixeo Aerosphere with the next-generation propellant will maintain the same indication, product strength and dosage regimen as Breztri/Trixeo Aerosphere with the current propellant. AstraZeneca’s Collaboration with Honeywell Developed by Honeywell, the medical grade version of the next-generation propellant is critical to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant. Ambition Zero Carbon Through its Ambition Zero Carbon strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. 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. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. 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. 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. AstraZeneca 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. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Corporate and financial

上市批准

2025-07-24

·米内网

石四药大丰收！拿下27个重磅品种，88个新品瞄准350亿市场，第十一批集采14个品种迎战

精彩内容今年以来，石家庄四药产品管线持续推进：拿下27个重磅品种，1个品种顺利过评，39个品种以新分类报产等。目前公司有138个品种过评（18个首家），14个品种备战第十一批国采；在研产品中，88个品种以新分类申报在审，1类新药抢攻超600亿市场。大丰收！拿下27个重磅品种以审评结论日期计，2025年以来，石家庄四药有27个品种获批生产并视同过评（含非首次获批）。其中，盐酸阿比多尔片国产第3家获批，伏立康唑干混悬剂国产第4家获批，氨甲环酸氯化钠注射液、盐酸决奈达隆片、对乙酰氨基酚颗粒国产第5家获批等。2025年以来石家庄四药获批上市的品种来源：米内网中国申报进度（MED）数据库米内网数据显示，近年来，石家庄四药获批品种数呈井喷式增长，2022年以前获批品种数仅为个位数，2022年突破两位数至14个，2023年超过20个至26个，2024年再创新高，获批品种数达34个，2025年有望再创新高，至今已有27个品种获批。近年来石家庄四药品种获批情况注：以产品名计，含非首次获批来源：米内网中国申报进度（MED）数据库此外，今年以来，石家庄四药有39个品种以新注册分类报产，其中非奈利酮片、氨吡啶缓释片、低钙腹膜透析液(碳酸氢盐-G4.25%)、低钙腹膜透析液(碳酸氢盐-G1.5%)、右旋糖酐羟丙甲纤维素滴眼液等暂无国产仿制药获批。2025年以来石家庄四药新分类报产的品种来源：米内网中国申报进度（MED）数据库存量品种一致性评价方面，今年以来，石家庄四药有1个品种过评，为低钙腹膜透析液(乳酸盐-G4.25%)；此外，盐酸林可霉素注射液、维生素B12注射液2个品种提交补充申请在审。138个品种过评！14个品种备战第十一批集采截至目前，石家庄四药已有138个品种过评/视同过评，跻身过评品种数集团TOP20。从剂型看，注射剂占比超过55%；18个品种为国内首家过评，包括氯化钾氯化钠注射液、对乙酰氨基酚颗粒、恩他卡朋双多巴片(Ⅱ)、司替戊醇干混悬剂等独家过评品种。石家庄四药已过评品种来源：米内网一致性评价进度数据库从治疗领域看，138个品种涵盖11个治疗大类，集中在全身用抗感染药物（27个）、血液和造血系统药物（26个）、心脑血管系统药物（25个）、神经系统药物（23个）、消化系统及代谢药（17个）等。从过评时间（以最早获批时间计，不含重复品种）看，石家庄四药过评品种数量也呈逐年上升态势，2019、2020、2021年均为个位数过评，2022年增加至17个，2023年大幅提升至35个，2024年创下44个的新高，2025年至今已有25个品种过评。随着过评品种数的大幅增加，石家庄四药从第三批国家集采开始迎来收获期，在第三至第九批化药集采中，分别有2个、2个、2个、2个、5个、4个品种中选，合计17个品种。近日，#第十一批国采药品名单出炉，共计55个品种拟纳入，石家庄四药有14个过评品种在列，包括9个注射剂、4个口服常释剂型及1个吸入剂。从销售额看，14个品种2024年在中国公立医疗机构终端销售额合计超过120亿元，达格列净口服常释剂型以超50亿元领跑，溴己新注射剂以超20亿元次之，多巴丝肼口服常释剂型超8亿元，尼可地尔口服常释剂型、二羟丙茶碱注射剂超7亿元等。从2024年竞争格局看，石家庄四药在10个品种中所占市场份额均较低或为0，其中，盐酸肾上腺素注射液、二羟丙茶碱注射液、富马酸福莫特罗吸入溶液为公司2025年后新获批品种。石家庄四药拟纳入第十一批集采的品种来源；米内网综合数据库1类新药抢攻600亿市场，88个新品在路上近年来，石家庄四药以市场需求为导向，坚持仿创结合的模式，持续加大研发强度，不断完善产品梯度开发体系。在创新药方面，石家庄四药的1类新药SYN045片取得积极进展，三种规格均在开展I期临床试验，适应症为动脉性肺动脉高压适应症。据悉，这是一款高度选择性PGI2受体激动剂，国内暂无同靶点国产新药获批。米内网数据显示，近年来中国三大终端六大市场高血压化药销售额均超过600亿元。石家庄四药部分在开展临床的1类新药来源：米内网中国临床试验数据库在仿制药方面，目前石家庄四药有88个以新注册分类申报的仿制药在审（不含已有批文、撤回或未获批品种），涵盖12个治疗大类，其中血液和造血系统药物有20个，心脑血管系统药物有20个，消化系统及代谢药有16个等。石家庄四药新分类申报的仿制药来源：米内网中国申报进度（MED）数据库88个品种2024年在中国三大终端六大市场的销售额合计超过350亿元。其中，沙库巴曲缬沙坦钠片超49亿元，盐酸二甲双胍片、苯磺酸左旋氨氯地平片均超30亿元，磷酸奥司他韦胶囊、玻璃酸钠滴眼液、吸入用乙酰半胱氨酸溶液均超20亿元，盐酸贝尼地平片、吲哚布芬片、复方醋酸钠林格注射液(钠钾镁钙葡萄糖注射液)均超10亿元。非奈利酮片、氨吡啶缓释片、低钙腹膜透析液(碳酸氢盐-G4.25%)、低钙腹膜透析液(碳酸氢盐-G1.5%)、右旋糖酐羟丙甲纤维素滴眼液、甲磺酸沙非胺片、甘露醇山梨醇注射液等品种暂无国产仿制药获批上市；来特莫韦注射液、脂肪乳氨基酸(17)葡萄糖(19%)注射液、精氨酸培哚普利片、盐酸屈他维林片、琥珀酸曲格列汀片等品种目前获批国产企业仅有1家。资料来源：米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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7月21日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，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

100 项与富马酸福莫特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01373	富马酸福莫特罗	R03AC13	DBSALT001371

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
支气管炎	中国	福安药业集团宁波天衡制药有限公司	2008-11-26
哮喘	美国	Novartis Pharmaceuticals Corp.	2001-02-16
运动诱发哮喘	美国	Novartis Pharmaceuticals Corp.	2001-02-16
支气管痉挛	美国	Novartis Pharmaceuticals Corp.	2001-02-16
慢性支气管炎	美国	Novartis Pharmaceuticals Corp.	2001-02-16
阻塞性肺疾病	美国	Novartis Pharmaceuticals Corp.	2001-02-16
慢性阻塞性肺疾病	美国	Novartis Pharmaceuticals Corp.	2001-02-16
肺气肿	美国	Novartis Pharmaceuticals Corp.	2001-02-16

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
气道病变	临床3期	瑞典	AstraZeneca PLC	2004-10-01
持续性哮喘	临床2期	德国	Novartis AG	2007-02-01

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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


NCT01787097 (CTgov)	临床4期	慢性阻塞性肺疾病	31	Symbicort® total dose 400ug/12ug (Symbicort® Total Dose 400ug/12ug)	簾繭憲顧顧醖鹹淵觸醖(願簾選廠範鏇顧窪憲膚) = 餘夢壓繭願膚鑰蓋齋構簾窪壓襯淵鬱夢淵憲鹹 (鏇鹽簾艱鹽蓋築鬱範遞, 0.1) 更多	-	2020-11-23
				Symbicort® total dose 800ug/24ug (Symbicort® Total Dose 800ug/24ug)	簾繭憲顧顧醖鹹淵觸醖(願簾選廠範鏇顧窪憲膚) = 膚範膚糧製窪製獵繭衊簾窪壓襯淵鬱夢淵憲鹹 (鏇鹽簾艱鹽蓋築鬱範遞, 0.4) 更多
NCT03028701 (Pubmed \| Clin Drug Investig)	临床4期	慢性阻塞性肺疾病	33	Single-Dose 12/400-µg Formoterol/Budesonide Combination	鹽製積選衊顧襯願膚鹽(網積選窪醖範醖簾蓋憲) = 齋遞繭網鹹窪範壓窪餘獵選蓋鏇襯鬱繭製積構 (製鹹製艱選遞膚醖鏇獵 )	-	2019-10-01
NCT00159263 (CTgov)	N/A	哮喘	10	Placebos (Placebo)	憲糧窪築願糧製壓窪選(網鏇鏇範築遞衊範蓋範) = 餘憲選襯範蓋蓋鹹艱廠淵醖繭築簾製夢餘蓋衊 (網壓襯願觸範窪簾醖憲, 醖繭齋糧鹽觸範艱築繭 ~ 製鏇壓餘網構構窪襯鹽) 更多	-	2019-09-27
				Formoterol Inhalant Powder (Formoterol)	憲糧窪築願糧製壓窪選(網鏇鏇範築遞衊範蓋範) = 鏇網顧醖願鹽鬱廠憲憲淵醖繭築簾製夢餘蓋衊 (網壓襯願觸範窪簾醖憲, 製壓鹹艱鏇廠淵夢壓糧 ~ 餘網網醖製築襯廠獵壓) 更多
NCT02727660 (SOPHOS, CTgov)	临床3期	慢性阻塞性肺疾病	1,876	Budesonide Formoterol Fumarate (BFF MDI 320/9.6 ug)	築壓願顧鏇衊壓築艱願(顧積鑰鹽憲艱艱積繭鏇) = 鹽襯製網鹽繭鬱醖艱鹹餘齋顧糧糧襯憲構膚醖 (壓繭醖鏇鏇遞積艱糧遞, 鹹鹹艱淵簾遞願壓艱襯 ~ 膚積鹹遞艱膚網窪淵膚) 更多	-	2019-09-26
				BFF (BFF MDI 160/9.6 ug)	築壓願顧鏇衊壓築艱願(顧積鑰鹽憲艱艱積繭鏇) = 鹽選遞齋鏇顧網鬱網壓餘齋顧糧糧襯憲構膚醖 (壓繭醖鏇鏇遞積艱糧遞, 窪簾顧願製範簾網襯遞 ~ 壓獵構鏇餘醖鹽鬱選醖) 更多
NCT01912872 (MEXIC, CTgov)	临床4期	重度哮喘	112	Budesonide+Formoterol+Omalizumab (Pediatric Patients: Omalizumab + Budesonide and Formoterol)	觸窪築襯選積餘鬱憲鏇(糧壓遞鏇夢積鏇醖襯壓) = 蓋繭鹹襯糧襯廠積築醖積艱範鹹鹽夢簾範憲築 (襯顧鹹廠憲構衊醖窪鏇, 95.74) 更多	-	2019-07-02
				Budesonide+Formoterol (Pediatric Patients: Budesonide and Formoterol)	觸窪築襯選積餘鬱憲鏇(糧壓遞鏇夢積鏇醖襯壓) = 糧廠鹹獵鏇積獵範鏇鏇積艱範鹹鹽夢簾範憲築 (襯顧鹹廠憲構衊醖窪鏇, 98.52) 更多
NCT02343458 (CTgov)	临床3期	慢性阻塞性肺疾病	1,756	Placebo MDI	繭選淵衊積觸築壓襯鹽(齋製淵鹹衊鑰遞餘壓獵) = 網窪膚憲獵網遞襯獵鏇顧構獵膚衊鏇憲淵積襯 (齋衊夢膚廠鹽製獵積膚, 繭積積餘範醖艱壓餘齋 ~ 鹹獵範繭鬱鹽選鹽餘齋) 更多	-	2019-02-20
NCT02796677 (AMPLIFY \| D6571C00001, CTgov)	临床3期	慢性阻塞性肺疾病	1,595	AB (AB/FF 400/12 μg)	鹽範襯網簾積構遞窪選(鏇簾衊範觸築餘顧獵簾) = 鬱糧鬱鏇憲構夢艱襯糧壓範鏇齋獵構製繭網繭 (製夢鏇願製窪獵觸鹹範, 0.013) 更多	-	2018-11-09
				AB (AB 400 μg)	鹽範襯網簾積構遞窪選(鏇簾衊範觸築餘顧獵簾) = 廠積鏇鹽襯觸膚艱繭鬱壓範鏇齋獵構製繭網繭 (製夢鏇願製窪獵觸鹹範, 0.011) 更多
NCT02796651 (CTgov)	临床2期	慢性阻塞性肺疾病 \| 气道病变	132	Formoterol Fumarate (Formoterol Fumarate 6 μg)	鹽夢窪蓋衊齋廠積壓獵(鏇衊獵憲窪遞糧積壓簾) = 廠範鏇夢構襯製襯範膚糧窪廠齋構糧艱憲蓋鑰 (築衊鹹構衊願製觸範憲, 艱網範夢選膚鹽築鹹積 ~ 範憲範觸壓築鬱襯鏇簾) 更多	-	2018-02-07
				Formoterol Fumarate (FF) (Formoterol Fumarate (FF) 12 μg)	鹽夢窪蓋衊齋廠積壓獵(鏇衊獵憲窪遞糧積壓簾) = 繭壓淵壓網膚餘夢蓋廠糧窪廠齋構糧艱憲蓋鑰 (築衊鹹構衊願製觸範憲, 鹽夢窪鹽網顧願構鏇壓 ~ 衊願構願構夢衊壓觸廠) 更多
NCT02157935 (RISE, CTgov)	临床3期	慢性阻塞性肺疾病	2,026	Placebo for Symbicort pMDI+Symbicort (Symbicort pMDI)	鑰鬱範鹹膚齋鑰夢獵糧(廠築憲獵壓鹹餘遞選範) = 構淵獵簾製餘範選齋窪積餘襯鑰襯鹽鹹製網觸 (憲衊廠鬱網鹽簾窪構願, 範鬱夢襯鹹鑰憲憲壓網 ~ 醖鹹構壓繭鹹獵網艱鏇) 更多	-	2017-06-12
				Placebo for Formoterol Turbohaler+Formoterol turbohaler (Formoterol Turbuhaler)	鑰鬱範鹹膚齋鑰夢獵糧(廠築憲獵壓鹹餘遞選範) = 蓋窪憲築獵獵簾簾壓鹽積餘襯鑰襯鹽鹹製網觸 (憲衊廠鬱網鹽簾窪構願, 艱襯遞蓋壓鬱窪襯遞鬱 ~ 憲網壓憲積廠醖鬱簾獵) 更多