主要目的：以北京抗创联生物制药技术研究有限公司研发的茚达特罗莫米松吸入粉雾剂（Ⅲ）（规格：150 μg /320 μg）为受试制剂，按生物等效性试验的有关规定，以Novartis Pharma AG 持证的茚达特罗莫米松吸入粉雾剂（Ⅲ）（规格：150 μg /320 μg；商品名：Atectura® Breezhaler®）为参比制剂，对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂茚达特罗莫米松吸入粉雾剂（Ⅲ）和参比制剂茚达特罗莫米松吸入粉雾剂（Ⅲ）（Atectura® Breezhaler®）在健康受试者中的安全性。

开始日期2024-05-30

申办/合作机构

北京抗创联生物制药技术研究有限公司

NCT05562466

/ Recruiting临床3期

Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate / Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.
* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.
* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.

开始日期2023-05-11

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT04589663

/ Completed临床2期

An Open-label, Two-period, Single-sequence, Crossover Study to Compare the Systemic Exposure of a Single Inhaled Dose of Mometasone Furoate (MF) When Administered Alone Via the MF Twisthaler® (TH) to a Single Inhaled Dose of QMF149 Indacaterol Acetate/MF Fixed Dose Combination When Administered Via the Concept 1 (C1) Breezhaler® Device in ≥ 6 to < 12 Year Old Asthma Patients

This clinical study was designed to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed dose combination (QMF149) via the Concept 1 (C1) device in pediatric asthma patients.

开始日期2021-06-07

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与醋酸茚达特罗/莫米松糠酸酯相关的临床结果

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100 项与醋酸茚达特罗/莫米松糠酸酯相关的转化医学

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100 项与醋酸茚达特罗/莫米松糠酸酯相关的专利（医药）

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项与醋酸茚达特罗/莫米松糠酸酯相关的文献（医药）

2023-10-01·Respiratory medicine

Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study.

Article

作者: Chapman, Kenneth R ; van Zyl-Smit, Richard ; Kostikas, Konstantinos ; Jaumont, Xavier ; Lawrence, David ; Maspero, Jorge F ; Mezzi, Karen

BACKGROUNDBaseline characteristics could potentially guide asthma treatments. We evaluated whether baseline eosinophil levels affect the efficacy of mometasone/indacaterol/glycopyrronium (MF/IND/GLY) in patients with inadequately controlled asthma.METHODIn this post hoc analysis of IRIDIUM study, efficacy of high-dose MF/IND/GLY (160/150/50 μg, once-daily [o.d.]) versus high-dose MF/IND (320/150 μg o.d.) and high-dose fluticasone/salmeterol (FLU/SAL [500/50 μg, twice-daily [b.i.d.]); and efficacy of pooled MF/IND/GLY (160/150/50 μg and 80/150/50 μg) versus pooled MF/IND (320/150 μg and 160/150 μg) was evaluated in patient subgroups with baseline blood eosinophil count of <300 cells/μL or ≥300 cells/μL.RESULTSOverall, 3065 patients were included. At Week 26, high-dose MF/IND/GLY showed improved trough FEV₁ versus high-dose MF/IND (Δ78mL [<300 cells/μL]; Δ54mL [≥300 cells/μL]) and FLU/SAL (Δ112mL [<300 cells/μL]; Δ98mL [≥300 cells/μL]). Similarly, pooled MF/IND/GLY also showed improved trough FEV₁ versus pooled MF/IND (Δ75mL [<300 cells/μL]; Δ68mL [≥300 cells/μL]). Over 52 weeks, high-dose MF/IND/GLY reduced the annualized rate of moderate or severe asthma exacerbations by 23% and 10%, severe exacerbations by 31% and 15%, and all exacerbation by 33% and 10% versus high-dose MF/IND for subgroups with <300 cells/μL and ≥300 cells/μL, respectively; and by 33% and 41%, 45% and 42%, 42% and 39% versus FLU/SAL, respectively. Similarly, pooled MF/IND/GLY reduced exacerbations by 22% and 8%, 21% and 7%, 27% and 8%, versus pooled MF/IND, for the respective subgroups.CONCLUSIONMF/IND/GLY showed improvement in lung function and reduction in asthma exacerbations over MF/IND and FLU/SAL independent of baseline eosinophil levels, indicating that eosinophil levels did not affect the efficacy of MF/IND/GLY in patients with inadequately controlled asthma.TRIAL REGISTRATIONClinicalTrials.gov, NCT02571777 (IRIDIUM).

2022-06-01·Advances in Therapy3区 · 医学

A Review of the Unique Drug Development Strategy of Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate: A First-in-Class, Once-Daily, Single-Inhaler, Fixed-Dose Combination Treatment for Asthma

3区 · 医学

Review

作者: Hosoe, Motoi ; Brittain, Dominic ; Tillmann, Hanns-Christian ; Jain, Devendra ; D'Andrea, Peter ; Jauernig, Juergen ; Pethe, Abhijit ; Tanase, Ana-Maria ; Gruen, Emilie ; Scosyrev, Emil

A novel, once-daily (o.d.), fixed-dose combination (FDC) of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF), delivered by the inhaler Breezhaler^® device, is the first long-acting beta2-adrenergic agonist/long-acting muscarinic antagonist/inhaled corticosteroid (LABA/LAMA/ICS) therapy to be approved for maintenance treatment of asthma in adults inadequately controlled on LABA/ICS. The approval of IND/GLY/MF in the European Union (EU) also included an optional electronic sensor and smartphone (or other suitable device) application, making it the first "digital companion" that can be prescribed with an asthma medication. As a result, the European Medicines Agency included this approval as one of the "outstanding contributions to public health" (for Pneumology/Allergology) in their 2020 highlights report. Alongside IND/GLY/MF, an o.d. LABA/ICS FDC, IND/MF, was also developed and approved. This review outlines the unique strategy used in the accelerated development of IND/GLY/MF that combined various approaches: (1) selecting individual components with established efficacy/safety, (2) bridging doses to optimize efficacy/safety of IND/GLY/MF and IND/MF delivered via the Breezhaler^® device, (3) developing IND/GLY/MF and IND/MF in parallel, and (4) submission for regulatory approval before formal completion of the pivotal phase III studies. IND/GLY/MF and IND/MF were combined in a single-development plan (PLATINUM program), which comprised four phase III studies: QUARTZ and PALLADIUM evaluated IND/MF while IRIDIUM and ARGON evaluated IND/GLY/MF. A unique feature was the inclusion of two LABA/ICS comparators in the pivotal IRIDIUM study-IND/MF as an internal comparator, and high-dose salmeterol xinafoate/fluticasone propionate (SAL/FLU) as a marketed comparator. In the ARGON study, IND/GLY/MF was compared against o.d. tiotropium (via Respimat^®) plus twice-daily (b.i.d.) high-dose SAL/FLU (via Diskus^®). As a result of this development strategy, the development and approval of IND/GLY/MF was accelerated by ca. 4 years as against what would be expected from a traditional approach, novel data were generated, and a unique optional digital companion was approved in the EU. A Video Abstract by Dr Dominic Brittain, Global Drug Development, Novartis. (MP4 228293 kb).

2021-10-01·Pulmonary Pharmacology & Therapeutics

Pharmacokinetics of mometasone furoate delivered via two dry powder inhalers

Article

作者: Kanniess, Frank ; Vaidya, Soniya ; Malmqvist, Ulf ; Hosoe, Motoi ; Tanase, Ana-Maria ; Ziegler, Dominik ; Hederer, Bettina

BACKGROUNDQMF149 is an inhaled fixed-dose combination of indacaterol acetate and mometasone furoate (MF) delivered via Breezhaler®, under development for once-daily treatment of asthma. MF delivered via Twisthaler® is approved as Asmanex® Twisthaler® for the treatment of asthma. Bridging of MF delivered via Twisthaler® to MF delivered via Breezhaler® was undertaken as part of QMF149 development to enable dose comparisons between the devices. Pharmacokinetics (PK) of MF were characterized in two studies; a single dose PK study in healthy volunteers and a pharmacokinetic/pharmacodynamic (PK/PD) study in asthma patients.OBJECTIVESThe PK study in healthy volunteers evaluated the PK of single doses of MF via Breezhaler® (50-400 μg) and compared systemic exposure of MF following administration via Breezhaler® and Twisthaler® 400 μg (2 inhalations of 200 μg). The study in patients with asthma characterized the MF PK profile following once-daily inhalation of MF via Breezhaler® and Twisthaler® devices for 4 weeks.METHODSIn the open-label, single-dose, crossover study, healthy subjects sequentially received MF via Twisthaler® (400 μg, medium-dose inhaled corticosteroid [ICS]) and escalating doses via Breezhaler® (50, 100, 200, 400 μg). PK data were obtained up to 72 h post-dose. In the double-blind, double-dummy, parallel-group study, asthma patients were randomised to receive either MF 80 μg (low-dose ICS) or 320 μg (high-dose ICS) via Breezhaler®, or 200 μg (low-dose ICS) or 800 μg (2 inhalations of 400 μg; high-dose ICS) via Twisthaler® once daily for 4 weeks. PK sampling was performed on Days 1 and 28 at pre-dose and up to 24 h post-dose.RESULTSIn the healthy volunteer PK study, 20 healthy subjects completed all treatments. Dose-normalised AUC_last of MF was 1.8-1.9-fold higher when delivered via Breezhaler® versus Twisthaler®. AUC and C_max of MF increased in a dose-proportional manner over the range of 50-400 μg via Breezhaler®. Results from this study guided dose selection of MF via Breezhaler® for the asthma study. In the asthma study, in a subset of 96 patients, mean systemic exposure (AUC_last and C_max) for MF 80 and 320 μg via Breezhaler® was comparable with MF 200 and 800 μg via Twisthaler®, respectively, on Day 28.CONCLUSIONPK characterization in a healthy volunteer PK study and subsequently an asthma study enabled selection of 80 μg (low), 160 μg (medium), and 320 μg (high) delivered via Breezhaler® as MF doses comparable to the 200 μg, 400 μg and 800 μg doses delivered by Twisthaler®, respectively, as part of QMF149 formulation development.

项与醋酸茚达特罗/莫米松糠酸酯相关的新闻（医药）

2025-04-22

·远大医药官微

远大医药丙酸氟替卡松鼻喷雾剂获批上市

丙酸氟替卡松鼻喷雾剂为中国首仿上市产品，且已被纳入国家医保目录和国家基本用药目录；远大医药首仿的布地奈德鼻喷雾剂自上市以来放量显著，充分证明此类产品国产替代的市场潜力巨大；远大医药丙酸氟替卡松鼻喷雾剂的首仿上市将有望进一步打破原研产品的市场垄断。近日，远大医药(0512.HK)开发的用于治疗过敏性鼻炎的丙酸氟替卡松鼻喷雾剂获得国家药监局颁发的药品注册证书。该产品为中国首仿上市产品，且已被纳入国家医保目录和国家基本用药目录。该产品的获批上市是公司在呼吸及危重症领域的又一次重大研发进展。关于过敏性鼻炎及其治疗中国是世界上过敏性鼻炎发病率最高的国家之一。根据中国相关流行病学调查结果，中国成人过敏性鼻炎患病率约17.6%，患病群体已近2.5亿人口，患者群体庞大。中国过敏性鼻炎诊断率仅37.3%，治疗率为45.0%，而美国的诊断率和治疗率分别达到49.6%和85.0%，我国过敏性鼻炎用药方面存在极大的临床未满足需求。根据《过敏性鼻炎及其对哮喘的影响(ARIA)》指南，鼻用皮质类固醇药是过敏性鼻炎的首选用药。根据米内网数据显示，2023年鼻用制剂市场规模近35亿人民币，销量前三的通用名产品分别是糠酸莫米松、布地奈德以及丙酸氟替卡松，合计市场规模约23亿人民币，占整个鼻用制剂市场规模的65%，且2019-2023年复合增长率达10.4%，临床需求巨大。其中，布地奈德和丙酸氟替卡松的销售基本以外资为主。远大医药首仿的布地奈德鼻喷雾剂自上市以来放量显著，充分证明此类产品国产替代的市场潜力巨大。此次，公司丙酸氟替卡松鼻喷雾剂的首仿上市将有望进一步打破原研产品的市场垄断。此外，公司开发的糠酸莫米松鼻喷雾剂的注册工作也在积极推进中。关于呼吸及危重症板块呼吸及危重症领域为远大医药核心战略领域之一，在售产品覆盖鼻炎、支气管炎、肺炎、哮喘、慢性阻塞性肺部疾病等多个适应症，在呼吸疾病治疗领域已形成了较为完备的产品组合。其中，核心产品切诺为中国独家品种，并获得了多项指南和专家共识的明确推荐；公司用于治疗哮喘的两款全球创新复方制剂恩卓润®比斯海乐®和恩明润®比斯海乐®于2023年1月成功进入国家医保目录，目前已经进入快速放量期。在研产品方面，公司针对未被满足的重大临床需求进行创新布局，已有多款在研产品覆盖过敏性鼻炎、脓毒症、急性呼吸窘迫综合征(ARDS)等。其中，用于治疗成人和儿童过敏性鼻炎的全球创新药Ryaltris®复方鼻喷剂已于2024年2月在中国递交了新药上市申请并获得药监局的受理；全球创新药STC3141用于治疗脓毒症的II期临床研究于2024年12月完成全部患者入组并给药，且将于近期公布临床结果。未来，公司将继续采用自主研发与全球拓展的研发理念，打造气道慢病全周期管理产品集群和危重症产品管线，不断巩固远大医药在该领域的行业地位。远大医药集团有限公司董事会表示：“本集团一直高度重视创新产品和先进技术的研发，未来将持续加大对全球创新产品和先进技术的投入，丰富和完善产品管线及产业布局，坚持‘全球化运营布局，双循环经营发展’策略，充分发挥本集团的产业优势和研发实力，快速将科技创新产品落地上市，为全球患者提供更先进更多样的治疗方案。”大家都在看▲世界地球日｜让健康与地球同频，远大医药在行动▲ 远大医药全球创新RDC产品GPN02006中国临床研究取得里程碑式突破▲远大医药全球创新RDC产品TLX101海外II期临床试验公布初步结果↑↓ 上下滑动了解更多➤关于远大医药远大医药（0512.HK）是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。集团以医药及生物工业为基础，以患者需求为核心，以科技创新为源动力，针对尚未满足的临床需求，加大对全球创新产品和先进技术的投入，丰富和完善产品管线，巩固和强化产业链布局，充分发挥本集团的产业优势和研发实力，为全球患者提供更先进更多样的治疗方案。经过近年的不懈努力，本集团发展基础更加稳健，经营规模更加巩固，业务结构逐步优化，经营方式持续提升，转型升级步伐加快，创新布局多点开花。本集团盈利能力持续增强，助力研发创新；良好的并购与整合能力，继续巩固发展规模；原料制剂一体化，完善产业链结构；业务与实体多元化，有效加强综合优势。“稳增长、强创新、谋布局”，本集团将继续秉承“综合优势、创新引领和全球拓展”的发展理念，采用“自主研发和全球拓展双轮驱动，全球化运营布局和双循环经营发展”策略，形成国内国外双循环联动发展并相互促进的新格局，致力于成为一家受医生和患者尊重并还原于社会的科技创新型国际化医药企业。 ➤前瞻性声明本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本集团有关的，均属于前瞻性表述。本集团并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本集团管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险不确性及其他因素的影响，有些是超出本集团的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本集团、本集团董事及雇员代理概不承担(1)更正或更新本网站所载前瞻性表述的任何义务;及(2)若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

上市批准

2024-03-12

·药渡

化学药进口注册概览：四种情形你了解多少？

来源：药渡撰文：书本滑编辑：维他命工作中，发现有不少注册人员对于进口注册的系统性存在认知偏差，对于5.1类和5.2类很容易理解，往往很片面地认为进口注册仅有以上两类，殊不知，按照化药新注册分类的划分，1类和2类中不仅包括国产也包括进口，所以进口注册理应包含4种情形。按照上文所述，化药进口注册共有4种情况，1类；2类；5.1类和5.2类。表1. 化药进口注册的4种分类PART.01原研进口，全球新原研进口，全球新，按照注册分类属于1类。随着药品审评审批改革的推进，新政策为境外药企带来同步申报的机遇，同时可以加快原研在国内上市的时间。对于1类进口的注册，自2016年新政以及审评审批以来，据不完全统计，1类进口新药共批准8个品种。表2. 自2016年以来已批准的1类进口新药，来源：笔者个人统计对于以上批准的1类进口新药，均是将中国人群纳入到国际多中心（MRCT），用以支持在中国的注册申请，但是未必一定在中国进行I期临床，以上8个品种中，有6个在MRCT之前均在中国人群中开展I期临床，利司扑兰口服溶液用散和琥珀酸莫博赛替尼胶囊没有在中国人群中开展I期临床。另外，关于1类进口的注册路径可以单独在中国开展完整的临床，不加入MRCT，但从批准的品种看，此种路径没有，主要是因为加入MRCT可以加快上市速度以及节约开发资源。PART.02改良型进口改良型进口在现行的注册分类下为2类（2.1-2.4），改良型进口分为2种细分情况，一是原研以1类或者5.1类已在中国上市，二是原研未在中国上市，直接作为改良型新药在中国申请进口上市。12.1类改良进口2.1类改良进口，则需要经历I期、II期、III期完整的临床试验过程，至于具体路径可以是I期之后参加国际多中心，以及单独在中国开展。具体案例经统计发现，至2016年来未见有2.1类的进口批准。22.2类改良进口2.2类进口批准仅有一个利伐沙班干混悬剂，同时也是新增适应症2.4类。32.3类改良进口2.3类仅有2个品种获得批准，分别是茚达特罗糠酸莫米松吸入粉雾剂和布地奈德格隆溴铵福莫特罗吸入气雾剂。茚达特罗糠酸莫米松01吸入粉雾剂茚达特罗糠酸莫米松吸入粉雾剂为诺华原研产品，在欧盟、日本、中国同步申报NDA。欧洲于2020年5月，日本于2020年6月批准本品上市，中国于2021年6月批准，批准依据为一项中国人群参加的国际多中心以及一项单独中国人群的PK试验。布地奈德格隆溴铵福莫特罗02吸入气雾剂布地奈德格隆溴铵福莫特罗吸入气雾剂是ICS/LAMA/LABA三联复方吸入制剂，于 2019年先后在美国、欧盟、日本、中国同步申报上市，中国批准基于一项针对慢性阻塞性肺疾病（COPD）患者肺功能改善的国际多中心试验（方案号PT010006），一项降低COPD患者急性加重风险的国际多中心试验（方案号PT010005）和一项中国人群药代动力学试验（方案号PT010010）。表2. 自2016年以来已批准的改良型进口新药42.4类改良进口批准最多的是2.4类，2.4类的申报注册有2种情形，一是原适应症已在中国获得批准，比如达格列净，然后再申请新增适应症。二是原适应症未在中国批准，比如乌帕替尼，直接在中国申报新增适应症。具体路径以以上2个品种作为案例进行分析。案例01恩格列净恩格列净首次于2014年4月获得澳大利亚药品监督管理局批准上市，用于治疗2型糖尿病（T2DM）；2017年9月在中国获批上市，商品名为欧唐静，用于治疗2型糖尿病。另外，降低患有心血管疾病的T2DM患者的心血管死亡风险的适应症，恩格列净已在10多个国家（包括美国、加拿大和澳大利亚）批准。2021年6月，恩格列净在欧盟获批用于治疗射血分数降低的心力衰竭。2021年8月，恩格列净在美国获批用于治疗射血分数降低的心力衰竭。FDA于2022年2月批准恩格列净片新增HFpEF适应症的上市申请。由于国内已上市原适应症，对于国内以2.4类批准的2个新增适应症均依据国际多中心开展III期临床（包含中国人群）。案例02乌帕替尼乌帕替尼则是另一种情形，乌帕替尼原研原适应症未在中国上市，直接在中国申报新增适应症。乌帕替尼是AbbVie研发的JAK1抑制剂，开发用于多个适应症。分别于2019年8月和2019年12月在美国、欧盟获批上市，用于治疗类风湿关节炎（RA）， 2020年1月23日在日本获批上市，适应症为RA。RA适应症未在中国批准，在中国直接以2.4类申请进口上市，适应症为适用于适合系统性治疗的成人和12岁及12岁以上青少年中重度特应性皮炎患者（批准依据为含有中国人群参加的国际多中心III期以及单独中国人群参加的I期临床（M15-558））。之后又以2.4类申报新增适应症，为用于对一种或多种改善病情抗风湿药（DMARD）应答不佳或不耐受的活动性银屑病关节炎成人患者（提供了支持乌帕替尼PsA注册的2个关键性研究的全球多中心数据。作为全球多中心研究的一部分，中国参加了研究 M15-572）。PART.03原研进口，已在境外上市对于境外生产的5.1类药品在中国注册申报，主要分为两种情况。一是直接用海外临床数据提交在中国的上市申请，且国际多中心中有中国人群数据。第二种情况则需要在中国开展II期或III期临床试验。另外，需要注意的是以上两种均需在国内开展I期临床研究。从国内已经批准上市的5.1类实际案例来看，基本都是按照以上两种情况开展的注册申报。案例01诺华：赛瑞替尼胶囊比如诺华开发的赛瑞替尼胶囊，首次于2014年4月获得FDA的批准，NMPA于2018年5月批准上市。该品种的MRCT研究中不包含中国人群，于是在中国另外完成了I期研究和II期临床。案例02阿斯利康：奥拉帕利片奥拉帕利片由阿斯利康开发，2014年12月首次在美国上市， 2018年8月中国批准，境外开展I期、II期临床，其中II期国际多中心未有中国人群参加，单独在中国开展III期，用以支持中国的注册申报。另外单独在中国人群中开展I期研究。案例03第一三共：甲苯磺酸艾多沙班片而甲苯磺酸艾多沙班片则属于第二种情况，甲苯磺酸艾多沙班片由第一三共开发，2011年4月首次在日本上市，2018年12月在中国批准上市。在境外完成了I期、II期、III期，其中III期为国际多中心，包含中国人群参加，因此用以在中国申报的数据，另外在中国人群中单独开展I期研究。PART.04仿制进口5.2类药品在中国的申报路径主要有三种：一是无法豁免临床，需先申请IND后开展注册临床试验，再申报上市；二是豁免临床但需要进行BE试验；三是可以利用国外的BE试验数据直接申请上市，前提是符合豁免临床试验条件，且无种族差异。*声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！这十款药物，今年有望获FDA批准！舒沃哲上市四个月卖9128 万，迪哲医药做对了什么？药物研发新动向：靶向蛋白降解新型策略全盘点

上市批准临床1期

2021-04-27

·BioSpace

Valeo Pharma Upsizes And Closes $6.6 Million Non-Brokered Private Placement

Valeo insiders participation of $2.6 million MONTRÉAL, April 27, 2021 /PRNewswire/ - Valeo Pharma Inc. (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) ("Valeo" or the "Company"), a Canadian pharmaceutical company, announced today that it has upsized and closed a $6.645 million non-brokered private placement of unsecured non-convertible debenture units (the "Private Placement"). The Company issued 6,645 unsecured non-convertible debentures units (the "Debenture Units") at a purchase price of $1,000 per Debenture Unit for gross proceeds of $6,645,000. Each Debenture Unit consist of one (1) unsecured non-convertible debenture of the Company in the principal amount of $1,000 (each, a "Debenture") and 200 Class "A" share purchase warrants (each, a "Warrant"). Each Warrant entitles the holder thereof to purchase one Class "A" Share of the Company (each, a "Share") at an exercise price of $1.60 at any time up to 24 months following the closing date of the Offering (the "Closing Date"). The Debentures will mature at the latest 9 months after the closing and bear interest at a rate of 8% per annum from the date of issue, payable in cash, semi-annually in arrears. "The closing of this upsized placement is testament to the confidence and support our insiders and those close to the Company have in management and Valeo's business model", said Steve Saviuk, CEO. "I cannot over emphasize what a pivotal year 2021 is becoming with the recent launch of Redesca® and the imminent launches of Enerzair® Breezhaler® and Atectura® Breezhaler®". The securities issued under the Private Placement are subject to a four-month hold period in accordance with applicable securities legislation. The Company has paid $38,500 as finder's fees to arm's-length parties in connection with the Private Placement and issued a total of 7,700 broker warrants in compliance with applicable securities laws. Insiders, Senior Executives, staff members and 3 Directors of the Company all participated in the Private Placement for an aggregate amount of $2.6 million. The net proceeds of the Offering will be used for working capital and general corporate purposes. Participation of insiders of the Company in the Private Placement constitutes a "related party transaction" as defined under Regulation 61-101 respecting Protection of Minority Security Holders in Special Transactions ("Regulation 61-101"). The Company intends to rely on exemptions from the formal valuation and minority shareholder approval requirements provided under sections 5.5(a) and 5.7(a) of Regulation 61-101 on the basis that participation in the Private Placement by insiders will not exceed 25% of the fair market value of the Company's market capitalization and also because the Company's Common Shares trade only on the Canadian Securities Exchange (CSE). A material change report was not filed in connection with the participation of the insiders in at least 21 days in advance of the closing of the Private Placement, which the Company deemed reasonable in the circumstances, in order to close the transaction as soon as practicable to enable it to use the funds. About Valeo Pharma Valeo Pharma is a Canadian pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Respiratory Diseases, Neurology, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit and follow us on LinkedIn and Twitter. Forward Looking Statements This press release contains forward-looking statements about Valeo's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Company Codes: OTC-QB:VPHIF, CNSX:VPH, Frankfurt:VP2, OTC-PINK:VPHIF

100 项与醋酸茚达特罗/莫米松糠酸酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	R03AK	-

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
哮喘	加拿大	Novartis Pharmaceuticals Canada, Inc.	2020-05-06

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	墨西哥	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床3期	危地马拉	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床3期	南非	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床前	埃及	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床前	中国	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床前	印度	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床前	俄罗斯	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床前	塞尔维亚	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床前	美国	Novartis Pharmaceuticals Corp.	2015-12-29
哮喘	临床前	韩国	Novartis Pharmaceuticals Corp.	2015-12-29

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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


NCT04589663 (CTgov)	临床2期	哮喘	24	Standard of Care (Soc)+QMF149+Mometasone furoate	製襯蓋窪鹹艱繭製憲壓(蓋觸顧蓋鹹蓋繭製獵願) = 廠簾顧廠廠餘憲製築網鏇積積蓋築願襯構鏇構 (願蓋壓繭鏇廠獵鑰廠築, 糧繭窪膚窪範憲網鏇願 ~ 壓鹹選壓齋壓窪顧範網) 更多	-	2023-07-27
Pubmed 人工标引	临床3期	哮喘	145	indacaterol acetate+glycopyrronium bromide+mometasone furoate	(餘醖襯築壓顧壓網範繭) = 餘積醖醖鹽鹹鏇範遞膚憲鏇積獵廠齋構簾膚膚 (憲獵積選膚鏇艱獵醖壓 ) 更多	积极	2022-05-30
				indacaterol acetate+mometasone furoate	(餘醖襯築壓顧壓網範繭) = 鹹鬱網醖鹹餘蓋積鏇廠憲鏇積獵廠齋構簾膚膚 (憲獵積選膚鏇艱獵醖壓 ) 更多
NCT02571777 \| NCT02554786 (PALLADIUM and IRIDIUM, Pubmed \| BMJ Open Respir Res)	临床3期	哮喘	3,154	Mometasone furoate/indacaterol acetate (high-dose)	糧醖鹹顧觸憲衊蓋壓糧(網構夢夢襯繭製衊蓋鏇) = 廠襯鹽襯範選鏇鹹製繭製築餘觸遞蓋製窪襯夢 (獵糧齋鏇蓋艱遞觸糧夢 ) 更多	积极	2021-08-01
				Fluticasone propionate/salmeterol xinafoate (high-dose)	鑰範鏇夢鏇憲鬱齋築壓(齋範廠鑰顧壓築壓製衊) = 夢醖觸積膚夢鹹築憲選構簾襯壓鬱廠窪製築衊 (構齋鬱餘衊膚廠築糧艱 )
AAAAI2021	N/A	-	37	Indacaterol/Mometasone Furoate low-dose	鹽糧鹹艱鬱鬱窪糧壓鹹(齋觸鬱襯顧網餘窪鹹鏇) = 淵製簾壓壓壓鹹夢糧膚襯遞餘鏇艱鏇獵夢廠顧 (鑰範顧鬱餘廠積獵鬱鹽 ) 更多	-	2021-02-01
				Indacaterol/Mometasone Furoate medium-dose	鹽糧鹹艱鬱鬱窪糧壓鹹(齋觸鬱襯顧網餘窪鹹鏇) = 鹹製廠鹽選膚繭衊製築襯遞餘鏇艱鏇獵夢廠顧 (鑰範顧鬱餘廠積獵鬱鹽 ) 更多
NCT02571777 (IRIDIUM, Pubmed \| Lancet Respir Med)	临床3期	哮喘	4,851	Mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY)	(鑰鏇顧製蓋鹽繭齋鑰構): Δ = 76 (95% CI, 41 ~ 111), P-Value = <0·001	积极	2020-07-09
				Mometasone furoate and indacaterol acetate (MF-IND)
NCT03100500 (CTgov)	临床3期	哮喘	51	QMF-149 (QMF-149 150/320 μg)	(醖膚襯顧憲膚觸窪顧醖) = 鬱繭積醖廠獵範觸衊獵鏇繭製醖廠積築齋繭憲 (鏇遞醖繭網廠鹽衊膚鬱, 鬱衊構選蓋願衊襯網艱 ~ 窪鏇觸構構築範鹽選醖) 更多	-	2020-02-07
				QMF149 (QMF149 150/320 µg)	餘廠艱憲鏇繭夢築艱網(簾遞構鹽廠襯鏇構願獵) = 淵夢鬱夢夢憲繭夢範遞醖壓範鹹蓋鏇壓構獵壓 (憲廠艱蓋齋糧鹹夢鑰壓, 糧膚廠艱艱齋齋餘糧遞 ~ 艱醖製衊範膚積遞構糧) 更多
NCT02892344 (QUARTZ, ERS2019)	临床3期	哮喘	802	Indacaterol acetate/mometasone furoate 150/80 µg	(製膚繭膚範獵憲製蓋簾) = 製窪餘鬱窪構網醖淵選積獵憲壓淵襯壓鏇廠簾 (鑰艱範鏇簾鹹齋繭衊範, 0.182)	积极	2019-09-28
NCT02892344 (QUARTZ, CTgov)	临床3期	轻度哮喘	802	QMF149 150/80 μg (QMF149 150/80 μg)	(願範衊餘觸鑰簾鬱憲壓) = 積糧膚糧鑰範繭顧鏇鬱繭蓋簾顧構醖膚窪積鑰 (簾遞蓋觸範餘醖衊顧窪, 襯鑰憲糧夢壓鏇齋鏇襯 ~ 壓繭積鬱遞鹽衊齋鑰範) 更多	-	2019-09-12
				MF 200 μg (MF 200 µg)	(願範衊餘觸鑰簾鬱憲壓) = 遞鬱簾顧夢糧襯選醖餘繭蓋簾顧構醖膚窪積鑰 (簾遞蓋觸範餘醖衊顧窪, 衊簾餘製觸蓋鑰鬱壓繭 ~ 製簾鏇餘構糧鬱窪廠夢) 更多
NCT01636076 (Pubmed \| Int J Chron Obstruct Pulmon Dis) 人工标引	临床2期	慢性阻塞性肺疾病	629	Indacaterol acetate/mometasone furoate	(壓簾範夢鑰窪觸鏇築積): difference = 56, P-Value = <0.001	优效	2018-12-06
				salmeterol xinafoate/fluticasone propionate
NCT00941798 (Pubmed \| BMJ Open) 人工标引	临床2期	哮喘	1,519	QMF149	(蓋膚衊窪壓艱鬱遞淵獵) = 鑰顧齋繭蓋鹹繭膚繭遞鬱夢網積餘顧艱築膚窪 (蓋簾餘蓋餘醖範淵膚艱 ) 更多	积极	2015-02-03
				mometasone furoate	(蓋膚衊窪壓艱鬱遞淵獵) = 壓膚餘簾繭醖遞繭遞廠鬱夢網積餘顧艱築膚窪 (蓋簾餘蓋餘醖範淵膚艱 ) 更多