主要试验目的：考察山东京卫制药有限公司生产的倍氯米松福莫特罗吸入气雾剂（受试制剂，每瓶120揿，每揿含丙酸倍氯米松100μg和富马酸福莫特罗6μg）与Chiesi Farmaceutici SPA持证的倍氯米松福莫特罗吸入气雾剂（参比制剂，商品名：启尔畅®，每瓶120揿，每揿含丙酸倍氯米松100μg和富马酸福莫特罗6μg）在健康受试者体内空腹给药的药代动力学，评价两种制剂的生物等效性。次要试验目的：观察受试制剂倍氯米松福莫特罗吸入气雾剂和参比制剂（启尔畅®）在健康受试者中的安全性。

开始日期2024-12-27

申办/合作机构

山东京卫制药有限公司

CTR20243827

/ Active, not recruitingN/A

倍氯米松福莫特罗吸入气雾剂人体药代动力学生物等效性（PK-BE）研究

主要目的：以鲁南贝特制药有限公司生产的倍氯米松福莫特罗吸入气雾剂（规格：每瓶120揿，每揿含丙酸倍氯米松100μg和富马酸福莫特罗6μg）为受试制剂，CHIESI FARMACEUTICI SPA持证的倍氯米松福莫特罗吸入气雾剂（商品名：启尔畅®/FOSTER®；规格：每瓶120揿，每揿含丙酸倍氯米松100μg和富马酸福莫特罗6μg）为参比制剂，考察两制剂在空腹状态下单次给药吸收速度和程度的差异，评价两制剂是否具有生物等效性。

开始日期2024-11-28

申办/合作机构

鲁南贝特制药有限公司

CTIS2024-512792-13-00

/ Recruiting临床1期

- CLI-05993BB1-01

开始日期2024-11-13

申办/合作机构

CHIESI Farmaceutici SpA

100 项与二丙酸倍氯米松/富马酸福莫特罗相关的临床结果

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100 项与二丙酸倍氯米松/富马酸福莫特罗相关的专利（医药）

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项与二丙酸倍氯米松/富马酸福莫特罗相关的文献（医药）

2025-01-01·Respiratory Medicine

Particularities of deposition of two ICS-LABA fixed dose combination dry powder aerosol drugs in the airways of COPD patients

Article

作者: Kis, Erika ; Havadtői, Botond ; Sánta, Balázs ; Kovács, Tamás ; Böcskei, Renáta Marietta ; Réti, Izolda ; Ilyés, Norbert ; Horváth, Alpár ; Gálffy, Gabriella ; Bártfai, Zoltán ; Farkas, Árpád

The aim of this study was to analyse the effect of breathing parameters, age, gender and disease status on the lung doses of the two ICS + LABA fixed combination dry powder drugs. Breathing parameters of 113 COPD patients were measured while inhaling through emptied NEXThaler® and Ellipta® inhalers and the corresponding lung doses were calculated. Lung dose of Foster® NEXThaler® was superior to the lung dose of Relvar® Ellipta® in around 85 % of the patients. The average value of the ratio of bronchiolar to bronchial deposition fractions was 5.0 for Foster® NEXThaler® and 2.6 for Relvar® Ellipta®. Lung dose was sensitive to the inhalation parameters, such as peak inhalation flow, inhaled volume and breath-hold time. For both studied drugs the dose to the lungs was relatively high for moderate PIF values, but it declined for low (<35 L/min) and high (>95 L/min) PIFs. The lung dose increased by the increase of the inhaled volume, but saturated over 1.0 L of inhaled air. Longer breath-hold time led to higher lung deposition, but the dependence was drug-specific. FEV₁ (%) and FEV₁/FVC (%) did not influence the lung dose significantly (p = 0.05). Exacerbating patients had lower lung doses (28.8 ± 5.8 % for Foster® NEXThaler® and 23.7 ± 3.8 % for Relvar® Ellipta®) than their non-exacerbating counterparts (33.7 ± 6.1 % for Foster® NEXThaler® and for 24.9 ± 3.9 % for Relvar® Ellipta®). The exact clinical consequences of the differences between the deposition distributions of the two drugs could be assessed only by systematic clinical trials.

2024-12-31·COPD: Journal of Chronic Obstructive Pulmonary Disease

Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study

Article

作者: Chen, Yongxing ; Amodio, Sergio ; Wu, Yanmin ; Mei, Xiaodong ; Cappellini, Glauco ; Zhu, Yingqun ; Calabro, Emanuele ; Corradi, Massimo ; Wen, Fuqiang ; Galkin, Dmitry ; Xing, Chunyan ; Zhu, Cissy

The fixed-dose combination of beclometasone dipropionate/formoterol fumarate (BDP/FF) delivered via pressurised metered-dose inhaler (pMDI) has demonstrated efficacy in chronic obstructive pulmonary disease (COPD), in studies predominantly conducted in Caucasian adults. The current study evaluated the efficacy and safety of BDP/FF pMDI in Chinese patients with COPD, as part of registration for COPD in China. This double-blind, double-dummy, randomised, parallel-group study was conducted in patients with COPD of Chinese ethnicity aged ≥40 years. After a 4-week open-label budesonide/formoterol fumarate (BUD/FF) run-in period, patients were randomised to BUD/FF or BDP/FF for 24 weeks. The primary objective was to demonstrate non-inferiority of BDP/FF to BUD/FF in terms of change from baseline in pre-dose morning forced expiratory volume in 1 sec (FEV₁) at Week 24 (i.e. the lower 95% CI limit of the difference was above the pre-defined non-inferiority margin of -0.07 L). Of 750 patients randomised (377 BDP/FF; 373 BUD/FF), 87.6% completed the study. The primary endpoint was met in both the per-protocol (adjusted mean difference -0.001 L [95% CI: -0.025, 0.022], non-inferiority p < 0.001) and intention-to-treat populations (-0.001 L [-0.024, 0.022]; non-inferiority p < 0.001). There were no statistically significant BDP/FF-BUD/FF differences for the secondary endpoints, and a similar proportion of patients had adverse events (BDP/FF, 51.7%; BUD/FF, 51.2%), with most mild/moderate in severity. In conclusion, BDP/FF pMDI was non-inferior to BUD/FF in terms of pre-dose morning FEV₁, supported by a range of secondary endpoints. Both treatments were similarly tolerated. The study supports the use of BDP/FF pMDI in Chinese patients with COPD.STUDY REGISTRATIONChina Centre for Drug Evaluation (CTR20180475).

2024-10-03·Journal of Pharmacy and Pharmacology

Advances in inhaler therapy for asthma and chronic obstructive pulmonary disease: a comprehensive review of Fostair™ and Trimbow™

Review

作者: Foster, Katie ; Wong, Chun Yuen Jerry

AbstractThe management of asthma and chronic obstructive pulmonary disease (COPD) poses considerable challenges due to the intricate nature of these respiratory conditions. Fostair™ and Trimbow™, two pressurized metered dose inhalers, have emerged as noteworthy therapeutic options for treating both asthma and COPD. Fostair combines an inhaled corticosteroid, specifically beclometasone dipropionate, with a long-acting beta2-agonist, formoterol fumarate dihydrate, offering a dual-action approach to mitigate airway inflammation and bronchoconstriction. Conversely, Trimbow integrates a tri-particulate formulation consisting of beclometasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium bromide, providing a comprehensive strategy to target the pathophysiology of COPD and asthma. Recent clinical trials have underscored Trimbow’s superior efficacy compared with Fostair, particularly in terms of reducing exacerbation rates and enhancing lung function. However, despite their therapeutic promise, both inhalers encounter challenges, including limited generalizability of study findings and a disparity between in vitro and human trial results. This literature review offers an in-depth analysis of Fostair and Trimbow, delving into their mechanisms of action, clinical applications, and outcomes in human studies for asthma and COPD. Additionally, the review discusses the role of combination therapy in managing respiratory diseases and underscores the necessity for further research to address existing knowledge gaps and optimize therapeutic outcomes.

项与二丙酸倍氯米松/富马酸福莫特罗相关的新闻（医药）

2024-12-08

·药筛

先声依达拉奉右莰醇舌下片获批上市 | 新药周报（12.2-12.08）

统计每周新药申报、上市申请（12.2-12.08） 1、新药上市申请获批药品名称企业名称分类受理号奥德昔巴特胶囊Albireo AB5.1JXHS2400025奥德昔巴特胶囊Albireo AB5.1JXHS2400023奥德昔巴特胶囊Albireo AB5.1JXHS2400022奥德昔巴特胶囊Albireo AB5.1JXHS2400024吸入用倍氯米松福莫特罗粉雾剂Chiesi Farmaceutici S.p.A.5.1JXHS2300060多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300092多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300091多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300093呋喹替尼胶囊和记黄埔医药（上海）有限公司2.4CXHS2400023呋喹替尼胶囊和记黄埔医药（上海）有限公司2.4CXHS2400024氟唑帕利胶囊江苏恒瑞医药股份有限公司2.4CXHS2400032甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHS2400031甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHS2400030磷酸森格列汀片盛世泰科生物医药技术（苏州）股份有限公司;南京海纳制药有限公司1CXHS2300022帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSS2300013普托马尼片Mylan Ireland Limited5.1JXHS2300120甲磺酸沙芬酰胺片Zambon S.p.A.5.1JXHS2200035甲磺酸沙芬酰胺片Zambon S.p.A.5.1JXHS2200034斯鲁利单抗注射液上海复宏汉霖生物制药有限公司2.2CXSS2300094信迪利单抗注射液信达生物制药（苏州）有限公司2.2CXSS2400038戊二酸利那拉生酯胶囊上海生诺医药科技有限公司;上海合全医药有限公司1CXHS2300027依达拉奉右莰醇舌下片先声药业有限公司;药源生物科技（启东）有限公司2.2CXHS2300058注射用芦比替定PharmaMar AG5.1JXHS2300049注射用亚西瑞来Merck Sharp & Dohme B.V.5.1JXHS2300066注射用亚西瑞来Merck Sharp & Dohme B.V.5.1JXHS2300065 注：灰色字体部分受理号结论为不批准。 2、新药上市申请受理药品名称企业名称分类受理号草酸艾司西酞普兰片Maxmind Pharmaceutical S.L.5.2JYHS2400060草酸艾司西酞普兰片Maxmind Pharmaceutical S.L.5.2JYHS2400059静注人免疫球蛋白(pH4)广东丹霞生物制药有限公司3.4CXSS2400136静注人免疫球蛋白(pH4)广东丹霞生物制药有限公司3.4CXSS2400135利拉鲁肽注射液重庆宸安生物制药有限公司3.3CXSS2400132帕妥珠单抗注射液上海复宏汉霖生物医药有限公司3.3CXSS2400134人免疫球蛋白成都蓉生药业有限责任公司3.2CXSS2400133重组质粒-肝细胞生长因子注射液武汉光谷人福生物医药有限公司;江苏耀海生物制药有限公司1CXSS2400137 数据来源：摩熵药筛用摩熵药筛小程序，随时随地查周报

上市批准申请上市

2023-12-05

·FiercePharma

Chiesi, buffing up environmental credentials, works with BBC to spread message about greener inhalers

A screenshot from the episode sponsored by Chiesi Chiesi is working with the BBC to show off its climate-conscious credentials, partnering with the British broadcaster on a web series episode about redesigning inhalers to reduce their environmental impact. Pressurized metered dose inhalers such as Chiesi’s Fostair and Trimbow use propellants to get the active ingredient into the respiratory system. Evidence of the effect of the old propellant, chlorofluorocarbons, on the ozone led the industry to switch to hydrofluorocarbons (HFCs). However, it is now clear that HFCs are a powerful greenhouse gas, spurring a push to again change the propellants used in inhalers. Chiesi has highlighted its own work in the area by sponsoring an episode of the series “The Climate and Us” by BBC StoryWorks, the branded content wing of the British broadcaster. The episode looks at the life of Lara, an asthmatic patient with several comorbidities. In the episode, Lara, who lives in the Italian city Livorno, discusses how industrial and exhaust fumes affect her and her son. Inhalers that help Lara cope with poor air quality also contribute to emissions of greenhouse gasses. The episode, which was paid for and presented by Chiesi, goes on to discuss how the development of carbon-minimal inhalers could reduce the impact of asthma drugs on the environment. “Striking the delicate balance between advancing respiratory health treatments and mitigating the environmental footprint of these treatments is a complex challenge. At Chiesi, we strongly believe that patients should not have to shoulder the burden of environmental responsibility when considering treatment options that affect their health,” Chiesi CEO Giuseppe Accogli said in a statement. In the statement to publicize the episode, Chiesi discussed its “significant investments in the development of a new carbon-minimal inhalers platform that will reduce the carbon footprint of its pressurized metered dose inhalers by up to 90%.” The inhalers are still in development. Chiesi is far from the only manufacturer working to make greener inhalers. Last month, GSK disclosed plans to start a phase 3 trial of a low-carbon version of Ventolin, positioning it to cut the use of a propellant that accounts for 49% of its carbon footprint. AstraZeneca and Boehringer Ingelheim have also promoted their work to reduce emissions from their inhalers. The initiatives may help improve the standing of the companies with the large number of patient groups that judge drugmakers based on their green credentials. A recent survey found the impact a pharma company has on the environment is important to 75% of patient groups.

临床3期

2023-10-30

·信狐药迅

强生长效HIV新药利匹韦林注射液获批进口，万邦奥希替尼首仿 | 新获批（10.23-10.29）

每周药品注册受理数据，分门别类呈现，一目了然。（10.23-10.29）新药上市申请无。新药临床申请药品名称企业名称分类受理号ABSK112胶囊上海和誉生物医药科技有限公司1CXHL2300866ABSK112胶囊上海和誉生物医药科技有限公司1CXHL2300865ARTS-021片安锐生物医药科技(广州)有限公司1CXHL2300879ARTS-021片安锐生物医药科技(广州)有限公司1CXHL2300880BA2101注射液山东博安生物技术股份有限公司1CXSL2300544CM313(SC)注射液康诺亚生物医药科技(成都)有限公司1CXSL2300556ELPIS人脐带间充质干细胞注射液华夏源(上海)生物科技有限公司1CXSL2300501ES004注射液科望(苏州)生物医药科技有限公司1CXSL2300546HB0017注射液华博生物医药技术(上海)有限公司1CXSL2300533HW091077片武汉人福创新药物研发中心有限公司1CXHL2300884HW091077片武汉人福创新药物研发中心有限公司1CXHL2300885IMM27M注射液宜明昂科生物医药技术(上海)股份有限公司1CXSL2300553JS015注射液上海君实生物医药科技股份有限公司1CXSL2300541MAX-10181片广州再极医药科技有限公司1CXHL2300881MAX-10181片广州再极医药科技有限公司1CXHL2300882MAX-10181片广州再极医药科技有限公司1CXHL2300883NWRD08裸质粒DNA注射液诺未生物技术(无锡)有限公司1CXSL2300507SSGJ-621注射液三生国健药业(上海)股份有限公司1CXSL2300550STSA-1301 皮下注射液舒泰神(北京)生物制药股份有限公司1CXSL2300552TGRX-814片深圳市塔吉瑞生物医药有限公司1CXHL2300874TGRX-814片深圳市塔吉瑞生物医药有限公司1CXHL2300875TGRX-814片深圳市塔吉瑞生物医药有限公司1CXHL2300876VUM02注射液武汉光谷中源药业有限公司1CXSL2300509WXWH0240片辰欣药业股份有限公司1CXHL2300894WXWH0240片辰欣药业股份有限公司1CXHL2300895XS-03片江苏星盛新辉医药有限公司1CXHL2300856XS-03片江苏星盛新辉医药有限公司1CXHL2300857XS-03片江苏星盛新辉医药有限公司1CXHL2300858XY0206片石家庄以岭药业股份有限公司1CXHL2300871XY0206片石家庄以岭药业股份有限公司1CXHL2300872XY0206片石家庄以岭药业股份有限公司1CXHL2300873多抗原自体免疫细胞注射液恒瑞源正(上海)生物科技有限公司1CXSL2300514德谷胰岛素利拉鲁肽注射液惠升生物制药股份有限公司3.3CXSL2300515注射用HLX42上海复宏汉霖生物医药有限公司1CXSL2300548注射用HLX43上海复宏汉霖生物医药有限公司1CXSL2300549注射用IMM2510宜明昂科生物医药技术(上海)股份有限公司1CXSL2300554注射用NBL-028上海新石生物医药有限公司1CXSL2300538注射用TGI-6合肥天港免疫药物有限公司1CXSL2300476皮肤试验用结核分枝杆菌抗原(EM)安博智联(苏州)生物科技有限公司1CXSL2300519皮肤试验用结核分枝杆菌抗原(EM)安博智联(苏州)生物科技有限公司1CXSL2300520皮肤试验用结核分枝杆菌抗原(EM)安博智联(苏州)生物科技有限公司1CXSL2300521皮肤试验用结核分枝杆菌抗原(EM)安博智联(苏州)生物科技有限公司1CXSL2300522盐酸钩吻素子片福建医科大学1CXHL2300850盐酸钩吻素子片福建医科大学1CXHL2300851重组带状疱疹疫苗(CHO细胞)江苏瑞科生物技术股份有限公司3.3CXSL2300518马破伤风免疫球蛋白F(ab')2兰州生物制品研究所有限责任公司3.4CXSL2300527仿制药申请药品名称企业名称分类受理号乙酰半胱氨酸颗粒海南赛立克药业有限公司4CYHS2201578他达拉非片海达舍画阁药业有限公司4CYHS2102065他达拉非片海达舍画阁药业有限公司4CYHS2102066依帕司他片浙江恒研医药科技有限公司3CYHS2200799依帕司他片石家庄四药有限公司3CYHS2200777倍氯米松福莫特罗吸入气雾剂山东京卫制药有限公司4CYHL2300091利伐沙班片宜昌人福药业有限责任公司4CYHS2200602利伐沙班片天地恒一制药股份有限公司4CYHS2200573利伐沙班片天地恒一制药股份有限公司4CYHS2200574利托那韦片广东东阳光药业股份有限公司4CYHS2200417吸入用异丙托溴铵溶液湖南华纳大药厂股份有限公司4CYHS2200227地高辛注射液朗天药业(湖北)有限公司3CYHS2200029培哚普利叔丁胺片保定天浩制药有限公司4CYHS2102101培哚普利叔丁胺片保定天浩制药有限公司4CYHS2102100复方电解质注射液河北仁合益康药业有限公司4CYHS1700313左乙拉西坦口服溶液黑龙江珍宝岛药业股份有限公司4CYHS2200130左乙拉西坦片浙江江北药业有限公司4CYHS2200608左乙拉西坦片浙江江北药业有限公司4CYHS2200609布洛芬注射液福安药业集团宁波天衡制药有限公司3CYHS2300162布洛芬注射液福安药业集团宁波天衡制药有限公司3CYHS2300163恩那度司他片深圳信立泰药业股份有限公司3CYHL2300100恩那度司他片深圳信立泰药业股份有限公司3CYHL2300101恩那度司他片深圳信立泰药业股份有限公司3CYHL2300102普瑞巴林缓释片上海信谊天平药业有限公司3CYHS2300016曲伏前列素滴眼液远大医药(中国)有限公司4CYHS2200594枸橼酸西地那非口腔崩解片青岛黄海制药有限责任公司4CYHS2200532枸橼酸西地那非口腔崩解片上海金城素智药业有限公司4CYHS2102013沙库巴曲缬沙坦钠片江苏华瀚医药科技有限公司4CYHS2200132沙库巴曲缬沙坦钠片江苏华瀚医药科技有限公司4CYHS2200131沙库巴曲缬沙坦钠片四川科伦药物研究院有限公司4CYHS2101285沙库巴曲缬沙坦钠片四川科伦药物研究院有限公司4CYHS2101286沙库巴曲缬沙坦钠片成都倍特药业股份有限公司4CYHS2000711沙库巴曲缬沙坦钠片成都倍特药业股份有限公司4CYHS2000710沙格列汀二甲双胍缓释片合肥合源药业有限公司4CYHS2200738沙格列汀二甲双胍缓释片合肥合源药业有限公司4CYHS2200739泊沙康唑注射液湖南科伦制药有限公司4CYHS2200839注射用哌拉西林钠杭州沐源生物医药科技有限公司3CYHS2200615注射用紫杉醇(白蛋白结合型)浙江海昶生物医药技术有限公司4CYHS2200034泮托拉唑钠肠溶片浙江海翔药业股份有限公司4CYHS2200868泮托拉唑钠肠溶片浙江海翔药业股份有限公司4CYHS2200869洛索洛芬钠口服溶液湖南普道医药技术有限公司3CYHS2200434瑞巴派特片重庆圣华曦药业股份有限公司3CYHS2200541瑞舒伐他汀钙片石药集团远大(大连)制药有限公司4CYHS2200261瑞舒伐他汀钙片石药集团远大(大连)制药有限公司4CYHS2200262甲硫酸新斯的明注射液山西振东泰盛制药有限公司3CYHS2301276甲磺酸奥希替尼片江苏万邦生化医药集团有限责任公司4CYHS2101144甲磺酸奥希替尼片江苏万邦生化医药集团有限责任公司4CYHS2101145盐酸乌拉地尔注射液成都利尔药业有限公司4CYHS2201020盐酸乌拉地尔注射液成都利尔药业有限公司4CYHS2201021盐酸乌拉地尔注射液陕西丽彩药业有限公司4CYHS2200995盐酸乌拉地尔注射液陕西丽彩药业有限公司4CYHS2200996盐酸乌拉地尔注射液黑龙江福和制药集团股份有限公司4CYHS2200837盐酸乌拉地尔注射液华夏生生药业(北京)有限公司4CYHS2200567盐酸伊伐布雷定片江苏万高药业股份有限公司4CYHS2200625盐酸伐昔洛韦片山东裕欣药业有限公司4CYHS2200922盐酸多巴胺注射液北京阜康仁生物制药科技有限公司3CYHS2200965盐酸多巴胺注射液广东赛烽医药科技有限公司3CYHS2200925盐酸多巴胺注射液成都苑东生物制药股份有限公司3CYHS2200863盐酸多巴胺注射液成都苑东生物制药股份有限公司3CYHS2200864盐酸多巴酚丁胺注射液上海旭东海普药业有限公司3CYHS2102337盐酸奥洛他定颗粒北京四环科宝制药股份有限公司3CYHS2102147盐酸托莫西汀口服溶液江苏长泰药业股份有限公司4CYHS2200637盐酸托莫西汀口服溶液山东道齐生物医药科技有限公司4CYHS2200326盐酸昂丹司琼片石家庄四药有限公司3CYHS2200546盐酸昂丹司琼片石家庄四药有限公司3CYHS2200547盐酸曲美他嗪片北京嘉林药业股份有限公司4CYHS2200444盐酸氨溴索口服溶液安徽永生堂药业有限责任公司3CYHS2200305盐酸罗哌卡因注射液湖南科伦制药有限公司4CYHS2101351盐酸罗哌卡因注射液湖南科伦制药有限公司4CYHS2101352盐酸艾司洛尔注射液杭州沐源生物医药科技有限公司3CYHS2200896盐酸莫西沙星滴眼液浙江尖峰药业有限公司4CYHS2200194盐酸莫西沙星滴眼液浙江尖峰药业有限公司4CYHS2200195盐酸莫西沙星滴眼液南京华盖制药有限公司4CYHS2102077盐酸达泊西汀片烟台市东盛生物科技有限公司4CYHS2200537盐酸达泊西汀片苏州第三制药厂有限责任公司4CYHS2200461盐酸达泊西汀片苏州第三制药厂有限责任公司4CYHS2200462硫酸沙丁胺醇口服溶液南京泽恒医药技术开发有限公司3CYHS2200744硫酸沙丁胺醇注射液石家庄四药有限公司3CYHS2201078碘佛醇注射液上海司太立制药有限公司4CYHS1800512磷酸西格列汀片北京福元医药股份有限公司4CYHS2200697米力农注射液湖南恒生制药股份有限公司3CYHS2200620米力农葡萄糖注射液广州绿十字制药股份有限公司3CYHS2101246苹果酸舒尼替尼胶囊山东朗诺制药有限公司4CYHS2200622葡萄糖酸钙氯化钠注射液湖北欣泽霏药业有限公司3CYHS2200792葡萄糖酸钙氯化钠注射液江苏正大丰海制药有限公司3CYHS2200815重酒石酸去甲肾上腺素注射液成都硕德药业有限公司3CYHS2200733阿加曲班注射液沈阳双鼎制药有限公司4CYHS2200202阿立哌唑口服溶液广东南国药业有限公司3CYHS2300595阿立哌唑口服溶液山东朗诺制药有限公司3CYHS2200519非洛地平片湖南九典制药股份有限公司3CYHS2200623非诺贝特胶囊辰欣药业股份有限公司4CYHS2200899马来酸噻吗洛尔滴眼液武汉五景医药科技有限公司3CYHS2200033进口申请药品名称企业名称分类受理号ASKC200搽剂Propella Therapeutics, Inc.2.2JXHL2300183ASKC200搽剂Propella Therapeutics, Inc.2.2JXHL2300184ASKC200搽剂Propella Therapeutics, Inc.2.2JXHL2300185MEDI3506注射液AstraZeneca AB1JXSL2300150乌帕替尼缓释片AbbVie Deutschland GmbH & Co.KG5.1JXHS2300008乌帕替尼缓释片AbbVie Deutschland GmbH & Co.KG5.1JXHS2300007依托考昔片Sun Pharmaceutical Industries Limited5.2JYHS2101050依托考昔片Sun Pharmaceutical Industries Limited5.2JYHS2101049依托考昔片Sun Pharmaceutical Industries Limited5.2JYHS2101048利匹韦林注射液Janssen-Cilag International NV5.1JXHS2101066利匹韦林注射液Janssen-Cilag International NV5.1JXHS2101067利特昔替尼胶囊Pfizer Inc.1JXHS2200081左甲状腺素钠片Aristo Pharma GmbH5.2JYHS2200096左甲状腺素钠片Aristo Pharma GmbH5.2JYHS2200097氘可来昔替尼片Bristol-Myers Squibb Pharma EEIG1JXHS2200061盐酸缬更昔洛韦片阿拉宾度制药有限公司5.2JXHS2000070碳酸镧咀嚼片Mylan Laboratories Limited5.2JYHS2101062中药相关申请药品名称企业名称分类受理号奥兰替胃康片江西青峰药业有限公司1.2CXZS2200008小儿紫贝止咳糖浆健民药业集团股份有限公司1.1CXZS2200010枳实总黄酮苷提取物江西青峰药业有限公司1.2CXZS2200009芍药舒筋片江苏万邦生化医药集团有限责任公司1.1CXZS2200015芪黄明目胶囊石家庄以岭药业股份有限公司1.1CXZS2200007注：灰色字体部分结论为不批准或收到通知件；

申请上市临床申请

100 项与二丙酸倍氯米松/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
-	-	R03AK08	-

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
慢性阻塞性肺疾病	中国	凯西医药咨询（上海）有限公司	2024-12-01
哮喘	中国	CHIESI Farmaceutici SpA	2013-02-04

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
特发性肺纤维化	临床前	英国	CHIESI Farmaceutici SpA	2014-03-01
哮喘	临床前	德国	CHIESI Farmaceutici SpA	2009-02-01
轻度持续性哮喘	临床前	英国	CHIESI Farmaceutici SpA	2008-02-01
持续性哮喘	临床前	-	CHIESI Farmaceutici SpA	2004-08-01
支气管扩张	药物发现	荷兰	CHIESI Farmaceutici SpA	2019-01-29
儿童哮喘	药物发现	丹麦	CHIESI Farmaceutici SpA	2011-09-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CTR20180475 (CTR20180475, Pubmed \| COPD)	临床3期	慢性阻塞性肺疾病	750	Beclometasone Dipropionate/Formoterol Fumarate	顧簾醖顧網鬱艱憲積餘(廠鬱鹹蓋顧網繭廠鑰艱) = 壓齋廠艱壓網顧積醖齋鹹艱顧簾願襯製網齋遞 (網淵壓齋蓋獵艱衊範製, -0.025 ~ 0.022)	积极	2024-12-31
				Budesonide/Formoterol Fumarate	顧簾醖顧網鬱艱憲積餘(廠鬱鹹蓋顧網繭廠鑰艱) = 鏇遞憲鹽築廠獵餘選廠鹹艱顧簾願襯製網齋遞 (網淵壓齋蓋獵艱衊範製, -0.024 ~ 0.022)
ATS2021	N/A	哮喘	-	Beclomethasone Dipropionate/Formoterol Fumarate (Smokers with asthma)	壓網鬱壓糧蓋鏇鬱鏇餘(膚觸鏇艱遞鬱鹽鹹願範) = 鏇憲膚衊觸壓鑰艱製願願積繭餘鑰糧築網壓鏇 (艱積衊顧鹽廠繭蓋願網 ) 更多	-	2021-05-03
				Beclomethasone Dipropionate/Formoterol Fumarate (Nonsmoking asthma patients)	壓網鬱壓糧蓋鏇鬱鏇餘(膚觸鏇艱遞鬱鹽鹹願範) = 顧觸構醖選積遞壓築鬱願積繭餘鑰糧築網壓鏇 (艱積衊顧鹽廠繭蓋願網 ) 更多
ERS2019	N/A	呼吸道过敏 \| 哮喘	37	Foster ®	廠範積衊繭壓憲簾願夢(鹹衊餘廠醖醖艱窪遞鹹) = 窪憲製選範獵蓋襯構壓鬱壓鏇廠淵遞築選醖壓 (範襯襯構顧憲鹹鹹夢齋 ) 更多	-	2019-09-28
ERS2018	N/A	哮喘	211	BDP/FF + GB 25 μg	鬱醖簾衊鬱鹹簾窪範鏇(襯鏇壓簾衊網鑰淵鬱憲) = 廠夢製衊遞範鹹網衊糧觸鹽願衊窪鑰構繭顧選 (醖網鹽鬱膚憲鹹齋壓襯, 0.021 ~ 0.096)	积极	2018-09-15
				BDP/FF + GB 50 μg	鬱醖簾衊鬱鹹簾窪範鏇(襯鏇壓簾衊網鑰淵鬱憲) = 獵鑰鹽餘衊積廠淵夢範觸鹽願衊窪鑰構繭顧選 (醖網鹽鬱膚憲鹹齋壓襯, 0.047 ~ 0.121)
NCT02000609 (Pubmed \| Pulm Pharmacol Ther)	临床2期	慢性阻塞性肺疾病	49	BDP/FF DPI 200/12 μg	積廠衊製築夢鬱遞廠窪(網餘遞齋鏇廠醖糧醖餘) = 糧製鑰簾齋構鏇願鏇選餘鹹餘餘獵鹹構鏇鬱製 (憲憲簾網鏇遞鏇繭夢壓 )	-	2017-02-01
				BDP/FF DPI 800/48 μg	積廠衊製築夢鬱遞廠窪(網餘遞齋鏇廠醖糧醖餘) = 構衊願範願醖壓獵餘範餘鹹餘餘獵鹹構鏇鬱製 (憲憲簾網鏇遞鏇繭夢壓 )
NCT01917331 (TRILOGY, Pubmed \| Lancet) 人工标引	临床3期	慢性阻塞性肺疾病	1,368	beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide	(醖鹽選膚鏇艱繭齋構廠) = 積網鬱襯衊壓簾憲夢膚鹹鏇選餘餘獵鏇願簾遞 (鬱積艱壓衊衊選窪網顧 ) 更多	优效	2016-09-03
				beclometasone dipropionate and formoterol fumarate	(醖鹽選膚鏇艱繭齋構廠) = 淵糧觸繭鹹淵齋鬱製淵鹹鏇選餘餘獵鏇願簾遞 (鬱積艱壓衊衊選窪網顧 ) 更多
NCT00929851 (FORWARD, ERS2016)	临床3期	慢性阻塞性肺疾病	1,186	BDP/FF	艱壓積鬱範衊膚鏇構襯(夢範鹹餘醖範獵鏇鏇遞) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 餘製廠遞壓餘齋艱網窪 (壓網顧繭積遞簾衊鏇構 )	积极	2016-09-01
				FF
ERS2014	临床3期	哮喘	359	BDP/FF 200/6 μg	(獵窪廠憲憲衊醖築衊願) = 鏇衊獵願鹽衊鏇築範範範衊餘築壓積積夢製廠 (製蓋願鏇襯窪構繭遞願 )	积极	2014-09-01
ERS2013	N/A	持续性哮喘	-	Beclomethasone dipropionate/formoterol (BCL/FOR)	顧願顧廠廠廠壓淵遞簾(獵餘鬱積蓋網鬱鬱鬱簾) = 簾鏇製顧壓繭鹹願鏇鏇觸蓋築襯鏇觸餘艱鬱獵 (範鹽餘顧觸遞襯衊蓋鑰 )	积极	2013-09-01
				Budesonide/formoterol fumarate (BUD/FOR)	顧願顧廠廠廠壓淵遞簾(獵餘鬱積蓋網鬱鬱鬱簾) = 顧選範餘糧醖鏇鏇觸鏇觸蓋築襯鏇觸餘艱鬱獵 (範鹽餘顧觸遞襯衊蓋鑰 )
ERS2013	N/A	哮喘	253	Beclomethasone/Formoterol	(鏇築襯鑰壓顧積糧膚艱) = 蓋艱醖積鹹觸鏇選範鏇製繭積憲齋餘蓋鬱齋糧 (網鑰獵淵願餘蓋簾蓋膚 ) 更多	-	2013-09-01
				Fluticasone/Salmeterol	(鏇築襯鑰壓顧積糧膚艱) = 鏇選簾齋觸鹹襯鑰簾鹹製繭積憲齋餘蓋鬱齋糧 (網鑰獵淵願餘蓋簾蓋膚 ) 更多