噻托溴铵(Tiotropium Bromide) - 药物靶点：M3 receptor_在研适应症：哮喘，支气管痉挛，慢性支气管炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

STXA、Tiotropium Bromide Hydrate、Tiotropium bromide hydrate (JAN)

+ [16]

靶点

M3 receptor

作用方式

拮抗剂

作用机制

M3 receptor拮抗剂(毒蕈碱型乙酰胆碱受体M3拮抗剂)

治疗领域

免疫系统疾病感染呼吸系统疾病

在研适应症

哮喘支气管痉挛慢性支气管炎+ [2]

非在研适应症

囊性纤维化呼吸困难持续性哮喘+ [2]

原研机构

C.H. Boehringer Sohn AG & Co. KG

在研机构

Boehringer Ingelheim Pharmaceuticals, Inc.Boehringer Ingelheim International GmbH

Boehringer Ingelheim GmbH

+ [8]

非在研机构

Pulmatrix, Inc.

Nagoya City University

权益机构

Boehringer Ingelheim GmbH中寰医药有限公司

Vectura Group Ltd.

+ [3]

最高研发阶段批准上市

首次获批日期

英国 (2002-04-02),

慢性阻塞性肺疾病

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)

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结构/序列

分子式C19H24BrNO5S2

InChIKeyMQLXPRBEAHBZTK-SEINRUQRSA-M

CAS号411207-31-3

关联

366

项与噻托溴铵相关的临床试验

CTR20250492

/ CompletedN/A

评估受试制剂噻托溴铵吸入喷雾剂与参比制剂噻托溴铵吸入喷雾剂（思力华®能倍乐®）作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究

研究健康成年受试者空腹状态下经口腔吸入受试制剂噻托溴铵吸入喷雾剂（2.5μg/喷）与参比制剂噻托溴铵吸入喷雾剂（思力华®能倍乐®，2.5μg/喷）的药代动力学特征，评价空腹状态下经口腔吸入两种制剂的生物等效性和安全性。

开始日期2025-02-23

申办/合作机构

齐鲁安替制药有限公司

NCT06679465

/ Not yet recruiting临床4期IIT

Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response

Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.

开始日期2025-01-01

申办/合作机构

University of Saskatchewan

CTR20244439

/ CompletedN/A

噻托溴铵吸入粉雾剂在中国成年健康受试者中的一项随机、开放、空腹单次给药、两制剂、两周期交叉的生物等效性试验

主要研究目的：考察空腹状态下单次经口吸入受试制剂噻托溴铵吸入粉雾剂[规格：18μg（按噻托铵计，相当于噻托溴铵水合物22.5μg）]与参比制剂噻托溴铵吸入粉雾剂[商品名：思力华®，规格：18μg（按噻托铵计，相当于噻托溴铵水合物22.5μg）]，在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要研究目的：评价空腹状态下使用受试制剂和参比制剂在中国成年健康受试者中的安全性。

开始日期2024-12-26

申办/合作机构

艾特美（苏州）医药科技有限公司

100 项与噻托溴铵相关的临床结果

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100 项与噻托溴铵相关的转化医学

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100 项与噻托溴铵相关的专利（医药）

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2,374

项与噻托溴铵相关的文献（医药）

2025-07-01·Drug Delivery and Translational Research

Dendrimer-mediated proton sponge effect in the treatment of pulmonary acidosis

Article

作者: Borse, Kadambari ; Shende, Pravin

The present study aimed to synthesize tiotropium bromide (TIO)-loaded generation 5 polyamidoamine dendrimers (TIO-PAMAM-G5-DMs) using a solvent-free microwave assisted synthesis (MAS) for the treatment of pulmonary acidosis, a condition associated with decreased blood pH due to bronchoconstriction. The encapsulation of TIO into PAMAM-G5-DMs was achieved using MAS Michael addition and amidation reactions, following green chemistry principles. The DMs demonstrated particle size of 460.68 ± 1.38 nm, entrapment efficiency of 92.4 ± 0.44%, controlled release profiles of 90.4 ± 0.62% and 76 ± 0.84% in media of pH 6.8 and 7.4, respectively, and high buffering capacity (25 mL/pH units) using a proton sponge effect for the release of the drug into the system as compared to the conventional formulation. A synergistic rat model was used to compare the pharmacokinetics (PK) of marketed and DM-based formulations. The results showed a mean C_max of 1987 ng/mL, t_max of 6 h, AUC of 10013863.5 ng.h/mL, and t½ of 18.59 h, respectively. The DMs exhibited low cytotoxicity, good biocompatibility, and higher IC₅₀ value (> 10 µg) on human lung epithelial cell line BEAS-2B. Thus, our study introduces a cutting-edge alternative approach for treating pulmonary acidosis using PAMAM-DMs with proton sponge effect.

2025-06-16·Journal of Chemical Information and Modeling

Adiabatic-Bias Molecular Dynamics Simulations Reveal the Impact of Mutations on Muscarinic Antagonist Unbinding Kinetics.

Article

作者: Coricello, Adriana ; Bottegoni, Giovanni ; Tehan, Benjamin Gerald ; Elisi, Gian Marco ; Chiaravalle, Anna Lisa ; Musgaard, Maria

Ligand-target dissociation rates (k_off) strongly correlate with efficacy and safety profiles, as well as with the therapeutic effect of drugs. As a prototypical example, muscarinic receptor antagonists used as bronchodilators show similar affinity profiles toward the muscarinic M3 receptors (M3R) and M2 receptors (M2R), whereas their kinetic selectivity toward M3R avoids the adverse effects that a prolonged inhibition of M2R would induce at the cardiac level. Previous studies on the dissociation kinetics of human M3R showed that the residence time and binding affinity of muscarinic antagonists are deeply affected by the presence of specific mutations. The aim of our work was to reproduce the rankings of these experimental kinetic rates through an approach based on the application of adiabatic-bias molecular dynamics (ABMD) simulations using Path Collective Variables (PCVs), PCV-ABMD. Employing this methodology, we simulated the translocation of tiotropium, a long-acting bronchodilator targeting M3R, from the orthosteric site to the extracellular vestibule, without considering the whole unbinding process. The estimated times necessary for translocation displayed a strong correlation with the experimental pk_off values. Moreover, a thorough analysis of protein-ligand contacts provided deeper insights into the mechanism of unbinding of muscarinic antagonists. The newly described PCV-ABMD protocol captured relevant metastable states and offered a reliable approach for the prediction of kinetic selectivity in sets of mutants.

2025-06-01·Pulmonary Therapy

A Brief Report on a Systematic Review of Real-World Effectiveness Studies of ICS/LAMA/LABA for Treatment of Adults with Asthma in the US

Review

作者: Paczkowski, Rosirene ; Noorduyn, Stephen G ; Forero-Schwanhaeuser, Sergio ; Moore, Alison ; Martin, Amber ; Schaible, Kassandra ; Begaj, Kejsi

INTRODUCTION:

Long-acting muscarinic antagonist (LAMA) addition to inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) dual therapy is recommended for severe asthma, but its real-world effectiveness is not well established.

METHODS:

A systematic literature review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) to investigate clinical outcomes in US adults with asthma receiving ICS + LABA + LAMA as multiple-/single-inhaler triple therapy (MITT/SITT). Real-world/observational studies published in English in Embase/MEDLINE databases (2014-2024) and conference abstracts presented 2022-2024 were eligible for inclusion.

RESULTS:

From 588 identified records, only 8 articles reporting 6 unique studies were included; 2 assessed SITT and 4 assessed MITT, and 4 treatments were investigated. Exacerbation rates reported in two studies were significantly reduced with tiotropium (TIO) + ICS + LABA MITT versus high-dose ICS + LABA within 6 (64% lower) and 12 months (73%), and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg SITT versus pre-treatment after 12 months (41%). Oral corticosteroid (OCS) use was reported in two studies. The proportion of patients with ≥ 1 rescue OCS dispensing decreased with TIO 1.25 mcg + ICS + LABA MITT, with greatest reductions for MITT ± leukotriene receptor antagonist (pre-treatment: 68.4%, post treatment: 54.2%). Mean number of OCS dispensings/patient/year significantly decreased (29%, p < 0.001) following FF/UMEC/VI 100/62.5/25 mcg SITT initiation. Treatment adherence/persistence was reported in three studies. Mean (standard deviation) proportion of days covered was significantly higher (p < 0.001) for FF/UMEC/VI SITT versus MITT after 6 (0.56 [0.31] versus 0.46 [0.31]) and 12 months (0.46 [0.33] versus 0.35 [0.30]). Persistence at 12 months was 25.9% and 12.0%, respectively. Lung function, clinical remission, quality of life, and safety outcomes were not reported in any study.

CONCLUSIONS:

This brief communication reports a systematic review that identified few sources of SITT or MITT in US patients with asthma. Although inclusion of observational studies can result in reporting/selection bias, we identified greater clinical benefits with triple therapies versus dual therapies.

137

项与噻托溴铵相关的新闻（医药）

2025-06-24

·PRNewswire

Pulmonary Drug Delivery System Market Size to Worth USD 73.14 Billion by 2031 | The Insight Partners

NEW YORK, June 24, 2025 /PRNewswire/ -- According to a new comprehensive report from The Insight Partners, the global pulmonary drug delivery system market is observing significant growth owing to the increasing prevalence of chronic respiratory diseases and growing technological advancements in drug delivery. The pulmonary drug delivery system market is expected to reach US$ 73.14 billion by 2031 from US$ 54.14 billion in 2024, registering a CAGR of 4.4% during the forecast period. Pulmonary drug delivery is a targeted system that directs medications specifically to the lower respiratory tract. This system utilizes devices designed to administer drugs through the pulmonary route. Inhalation is an effective method for delivering treatments for asthma, chronic obstructive pulmonary disease (COPD), and other conditions. This approach offers rapid action, providing quick relief during asthmatic attacks and acute bronchitis. Aerosols are specially designed devices commonly used for pulmonary drug delivery. The report runs an in-depth analysis of market trends, key players, and future opportunities. In general, the pulmonary drug delivery system market comprises a vast array of products and services that are expected to register strength during the forecast period. To explore the valuable insights in the Pulmonary Drug Delivery System Market report, you can easily download a sample PDF of the report - Overview of Report Findings Increasing Burden of Chronic Respiratory Diseases: As per the World Health Organization, the prevalence of asthma is increasing, with a projected growth of more than 100 million additional cases by 2025. Asthma is a chronic respiratory disease characterized by inflammation and narrowing of the airways. It is one of the major non-communicable diseases worldwide, affecting over 300 million individuals. The prevalence of asthma continues to increase each year, particularly in low and middle-income countries. According to the article published in the National Library of Medicine, in 2020, the global prevalence of COPD was estimated at 10.6%, resulting in ~480 million cases among both males and females. By 2050, the number of COPD cases is projected to rise by 112 million, reaching a total of 592 million, which would represent 9.5% of the total eligible population. This indicates a relative increase of 23.3% in COPD cases from 2020 to 2050. The increasing global burden of asthma, COPD, and cystic fibrosis is a significant factor driving the market for pulmonary drug delivery systems. Inhalers, nebulizers, and other pulmonary devices provide targeted administration of medications directly to the lungs, thereby enhancing treatment outcomes and patient adherence. This trend is fostering the global adoption of advanced pulmonary drug delivery systems. Surging Technological Advancements in Drug Delivery Systems: Ongoing advancements in drug delivery technologies, such as smart inhalers, metered-dose inhalers (MDIs), and dry powder inhalers (DPIs), are significantly transforming the pulmonary drug delivery market. The development of more efficient, precise, and user-friendly devices improves patient adherence and ensures better targeting of medications. In June 2024, Aseptika launched the PUFFClicker3, a universal smart inhaler dose tracker designed to be compatible with both pressurized metered dose inhalers (pMDI) and DPIs. The PUFFClicker3 aims to enhance inhaler adherence for patients of all ages and those with respiratory conditions that require inhalers for treatment. It supports 101 SNOMED-coded inhalers and includes built-in graphical instructions, making it easy to transition to a new type of inhaler. Such developments in the market make treatments for chronic respiratory diseases more effective and convenient for patients. Geographical Insights: In 2024, North America led the market with a substantial revenue share, followed by Europe and APAC. Asia Pacific is expected to register the highest CAGR during the forecast period. Stay Updated on The Latest Pulmonary Drug Delivery System Market Trends: Market Segmentation Based on product, the pulmonary drug delivery system market is segmented into dry powder inhalers, metered dose inhalers, and nebulizers. The dry powder inhalers segment held the largest share of the pulmonary drug delivery system market in 2024. In terms of application, the pulmonary drug delivery system market is categorized into cystic fibrosis, asthma, allergic rhinitis, COPD, and other applications. The cystic fibrosis segment held the largest share of the pulmonary drug delivery system market in 2024. In terms of end user, the pulmonary drug delivery system market is divided into hospitals, diagnostic centers, and other end users. The hospitals segment held the largest share of the pulmonary drug delivery system market in 2024. The pulmonary drug delivery system market is segmented into five major regions: North America, Europe, APAC, Middle East and Africa, and South and Central America. Competitive Strategy and Development Key Players: A few major companies operating in the pulmonary drug delivery system market are GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Novartis, Merck & Co., Pfizer, Teva Pharmaceutical Industries, Mylan N.V., Hovione, and Vectura Group. Trending Topics: Advanced Pulmonary Drug Delivery Systems, AI in Pulmonary Drug Delivery Systems, Drug Delivery Systems for COPD, and Increasing Asthma Prevalence, among others. Global Headlines on Pulmonary Drug Delivery System Aseptika launched the PUFFClicker3, a universal smart inhaler dose tracker that is compatible with both pMDI and DPI. The PUFFClicker3 supports 101 SNOMED-coded inhalers and includes built-in graphical instructions, making it easy for users to switch to a new inhaler type. Glenmark Pharma launched the Tiotropium Bromide Dry Powder Inhaler, branded as Tiogiva, for the treatment of COPD in the UK. PARI Pharma GmbH has received market authorization for the LAMIRA Nebulizer System, which delivers Insmed's drug product ARIKAYCE (amikacin liposome inhalation suspension) in Japan. GlaxoSmithKline Pharmaceuticals introduced Trelegy Ellipta, a once-daily single-inhaler triple therapy (SITT) for patients suffering from chronic obstructive pulmonary diseases in India. Conclusion The mounting incidence of chronic respiratory diseases, such as asthma and COPD, and increasing technological developments in drug delivery systems drive the pulmonary drug delivery system market growth. Chronic conditions are becoming more common, affecting millions of individuals across the world. According to the WHO, over 400 million people globally have asthma, highlighting the urgent need for innovative treatment options to ensure effective disease management. Additionally, the growing recognition of asthma and COPD as major public health challenges has encouraged the development and accessibility of advanced pulmonary drug delivery systems, contributing to market expansion. Technological innovation is crucial to the growth of the pulmonary drug delivery systems market. pMDIs, DPIs, soft mist inhalers (SMIs), and nebulizers, including vibrating mesh nebulizers, are advanced inhaler technologies that have enhanced drug delivery efficiency, improved patient compliance and yielded better therapeutic outcomes. These modern devices offer precise dosing, ease of use, portability, and increased drug deposition in the lungs. The report from The Insight Partners, therefore, provides several stakeholders—including pharmaceutical companies, academic and research organizations, healthcare facilities, and others—with valuable insights to successfully navigate this evolving market landscape and unlock new opportunities. Purchase Premium Copy of Global Pulmonary Drug Delivery System Market Size and Growth Report (2021-2031) at: Trending Related Reports: About Us: The Insight Partners is a one-stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We specialize in industries such as Semiconductor and Electronics, Aerospace and Defense, Automotive and Transportation, Biotechnology, Healthcare IT, Manufacturing and Construction, Medical Device, Technology, Media and Telecommunications, Chemicals and Materials. Contact Us: If you have any queries about this report or if you would like further information, please contact us: Contact Person: Ankit Mathur E-mail: [email protected] Phone: +1-646-491-9876 Home - Logo: SOURCE The Insight Partners WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2025-06-19

·米内网

第十一批集采5个吸入剂备战，2个20亿大品种在列！正大天晴、普锐特、齐鲁……猛攻超200亿市场

精彩内容近日，吸入剂市场波澜再起。普锐特的瑞维那新吸入溶液、南新制药的盐酸左沙丁胺醇雾化吸入溶液报产在审，海南斯达制药的硫酸特布他林雾化吸入用溶和北京柏雅联合药物研究所的盐酸丙卡特罗吸入溶液获批上市。截至目前，吸入剂有超过40个品种报产在审，普锐特、正大天晴、齐鲁制药、长风药业等多家企业冲刺首仿。米内网数据显示，吸入剂在近年中国公立医疗机构终端销售规模均超过200亿元，2024年同比下滑1%。第十一批集采蓄势待发，5个吸入剂备战，其中2个品种销售额超过20亿元。40个吸入剂接连获批，5个产品备战第十一批集采今年以来获批上市的吸入剂来源：米内网中国申报进度（MED）数据库日前，海南斯达制药的硫酸特布他林雾化吸入用溶和北京柏雅联合药物研究所的盐酸丙卡特罗吸入溶液均以新分类报产同日获批。米内网数据显示，今年以来，吸入剂已有40个新产品获批上市。截至目前，吸入剂已有24个品种（274个品规）通过/视同通过一致性评价，吸入用乙酰半胱氨酸溶液、硫酸特布他林雾化吸入用溶液、吸入用异丙托溴铵溶液、吸入用硫酸沙丁胺醇溶液、盐酸左沙丁胺醇雾化吸入溶液过评企业均超过20家，吸入用地氟烷（恒瑞医药）、氮䓬斯汀氟替卡松鼻喷雾剂/盐酸氮䓬斯汀丙酸氟替卡松鼻喷雾剂（长风药业）、沙美特罗替卡松吸入粉雾剂（健康元药业）等8个品种为独家过评。从集团过评品种数量来看，仁合益康、倍特药业各有10个，健康元药业有9个，海南斯达制药、山东京卫制药各有6个，科伦药业、湖南华纳大药厂、苏州弘森药业、天津医药、合肥力成药业、长风药业各有5个。满足7家及以上的吸入剂产品竞争格局来源：米内网中国上市药品（MID）数据库5个吸入剂产品满足7家及以上的竞争格局，涉及康恩贝、葫芦娃药业、倍特药业、鲁南制药、长风药业等数十家企业。其中，吸入用七氟烷和吸入用乙酰半胱氨酸溶液在2024年中国城市公立医院、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）终端是20亿元级别大品种，分别是吸入剂TOP2、TOP3产品。TOP20洗牌！60亿大品种“腰斩”后回升，6个品牌大涨近年中国公立医疗机构终端吸入剂（化+生+中）保持200亿元以上销售规模，2024年同比略有下滑。从TOP20集团来看，阿斯利康、葛兰素史克、恒瑞医药、正大制药、健康元药业位居前五，济南景笙科技增速翻倍，倍特药业、长风药业、仁合益康等增速均超过10%。2024年中国公立医疗机构终端吸入剂产品TOP20来源：米内网中国公立医疗机构药品终端竞争格局注：标红为增速超10%产品TOP20中，吸入用布地奈德混悬液、吸入用七氟烷、吸入用乙酰半胱氨酸溶液位居前三，富马酸福莫特罗吸入溶液凭借超过300%的强劲增速上榜，也是TOP20增速最快的产品。2024年中国公立医疗机构终端吸入剂品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局注：标红为增速超10%品牌TOP20中，阿斯利康的布地奈德福莫特罗吸入粉雾剂(Ⅱ)以超20亿元销售规模领跑，上海恒瑞医药的吸入用七氟烷、阿斯利康的吸入用布地奈德混悬液和布地格福吸入气雾剂、葛兰素史克的沙美特罗替卡松吸入粉雾剂、正大天晴药业集团的吸入用布地奈德混悬液均超过10亿元。从企业品牌数量来看，阿斯利康（布地奈德福莫特罗吸入粉雾剂(Ⅱ)、吸入用布地奈德混悬液、布地格福吸入气雾剂）和葛兰素史克（沙美特罗替卡松吸入粉雾剂、氟替美维吸入粉雾剂、丙酸氟替卡松雾化吸入用混悬液）各有3个上榜，健康元（吸入用布地奈德混悬液、盐酸左沙丁胺醇雾化吸入溶液）和正大天晴药业集团（吸入用布地奈德混悬液、噻托溴铵粉雾剂）各有2个上榜。6个品牌销售额有双位数增速，阿斯利康的布地格福吸入气雾剂和葛兰素史克的氟替美维吸入粉雾剂均大涨超过30%。6个集采品种近年中国公立医院终端市场份额变化来源：米内网中国公立医疗机构药品终端竞争格局目前，吸入剂已有6个产品被纳入集采，除了吸入用复方异丙托溴铵溶液外，其余5个均在吸入剂产品TOP20之列。其中，吸入用布地奈德混悬液在中国公立医疗机构终端吸入剂产品中连续多年稳居“销冠”宝座，2021年销售规模超过60亿元，2022年受集采影响下跌超过50%，2023年-2024年止跌回升，分别同比增长22.61%、6.34%。在品牌TOP20中，吸入用布地奈德混悬液占据5个席位，4个国产品牌均为正增长，四川普锐特药业大涨27.08%、长风药业大涨26.86%、正大天晴药业集团大涨16.84%。首仿、1类新药蜂拥而至，正大天晴、普锐特、齐鲁……猛攻超200亿市场6月19日，CDE官网显示，四川普锐特药业的瑞维那新吸入溶液以仿制4类报产在审，该产品用于慢性阻塞性肺病（COPD）的维持治疗。在此之前，广州南新制药的盐酸左沙丁胺醇雾化吸入溶液以仿制3类报产在审。截至目前，吸入剂有超过40个品种（超过150个受理号）报产在审，4个产品火热，吸入用乙酰半胱氨酸溶液、富马酸福莫特罗吸入溶液、盐酸丙卡特罗吸入溶液、盐酸左沙丁胺醇雾化吸入溶液均超过10家企业报产。瑞维那新吸入溶液、乌美溴铵维兰特罗吸入粉雾剂、布地奈德福莫特罗吸入粉雾剂(Ⅱ)、沙美特罗替卡松吸入气雾剂、糠酸氟替卡松鼻用喷雾剂、酒石酸阿福特罗雾化吸入溶液等多个品种暂无仿制药获批，四川普锐特药业、正大天晴药业集团、上海新黄河制药、齐鲁制药、长风药业等多家企业冲刺首仿。今年以来获批临床的吸入剂1类新药来源：米内网中国申报进度（MED）数据库今年以来，吸入剂1类新药已有6个产品获批临床，包括四川普锐特药业的PRT-064040鼻喷雾剂、北京泰德制药的CPD704吸入混悬液、西藏海思科制药的HSK39004吸入粉雾剂等。目前，吸入剂1类新药已有29个获批临床，其中25个是呼吸系统用药。资料来源：米内网数据库、公司公告等注：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。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

一致性评价上市批准医药出海带量采购

2025-06-16

·ETPharma

Lupin inks pact with China's Sino Universal Pharmaceuticals for Tiotropium dry powder inhaler

New Delhi: Pharma major Lupin Ltd on Monday said it has signed a license and supply agreement with China's Sino Universal Pharmaceuticals for the commercialisation of Tiotropium dry powder inhaler in the Chinese market. The agreement pertains to the commercialisation of the Tiotropium dry powder inhaler of strength 18 mcg/capsule, which is used in the treatment of Chronic Obstructive Pulmonary Disease (COPD), Lupin said in a regulatory filing. Under the agreement, Sino Universal Pharmaceuticals (SUP) will obtain regulatory approvals for selling Tiotropium DPI in China, while Lupin will be the marketing authorisation holder and responsible for manufacturing of the product, it added. "This partnership demonstrates our commitment to developing critical products for the treatment of respiratory diseases such as COPD and establishing our leadership in the global respiratory health sector," Lupin President Corporate Development, Fabrice Egros said. With SUP, the company aim to enhance patient access to innovative and high-quality healthcare solutions , Egros added. Commenting on the partnership, SUP President Wang Li said, "Lupin's deep commitment to respiratory disease treatment and its innovation-driven approach to high-quality products align perfectly with SUP's strategic vision. We believe this collaboration will strengthen our synergy in respiratory care." By bringing more efficient and superior products to market, Li said, "We aim to make significant breakthroughs in respiratory disease treatment in China, allowing more patients to benefit from international high-quality and innovative products and enjoy respiratory health." Lupin said the partnership will enable it to expand its footprint in China. Tiotropium dry powder inhaler is known for its efficacy in improving lung function and quality of life for patients suffering from respiratory conditions, Lupin said.

引进/卖出

100 项与噻托溴铵相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01929	噻托溴铵	R03BB04	DB01409

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	日本	Pfizer Inc.	2014-11-18
哮喘	日本	Nippon Boehringer Ingelheim Co., Ltd.	2014-11-18
支气管痉挛	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2004-01-30
慢性支气管炎	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2004-01-30
肺气肿	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2004-01-30
慢性阻塞性肺疾病	奥地利	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	比利时	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	保加利亚	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	塞浦路斯	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	捷克	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	丹麦	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	芬兰	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	法国	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	德国	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	希腊	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	匈牙利	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	冰岛	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	爱尔兰	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	意大利	Boehringer Ingelheim International GmbH	2002-04-02
慢性阻塞性肺疾病	拉脱维亚	Boehringer Ingelheim International GmbH	2002-04-02

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
囊性纤维化	临床3期	美国	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	奥地利	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	比利时	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	加拿大	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	捷克	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	法国	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	德国	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	匈牙利	Boehringer Ingelheim GmbH	2010-09-01
囊性纤维化	临床3期	爱尔兰	Boehringer Ingelheim GmbH	2010-09-01

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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


NCT03199976 (CTgov)	临床4期	哮喘 \| 气道阻塞 \| 喘息性支气管炎	80	Tiotropium Bromide+salbutamol (Tiotropium Bromide & Salbutamol)	衊齋願積醖製艱願遞廠(襯蓋鏇淵淵淵蓋衊築鬱) = 願襯顧願築鹽齋淵襯窪獵壓選選觸觸顧衊窪構 (鏇壓鹽蓋衊範鏇鏇鹽壓, 鬱壓網壓艱襯願選淵繭 ~ 齋醖餘範鑰構鏇襯顧顧) 更多	-	2024-09-19
				salbutamol+Fluticasone Propionate (Fluticasone Propionate & Salbutamol)	衊齋願積醖製艱願遞廠(襯蓋鏇淵淵淵蓋衊築鬱) = 醖選膚製鹹窪齋襯憲醖獵壓選選觸觸顧衊窪構 (鏇壓鹽蓋衊範鏇鏇鹽壓, 淵選艱鹽醖膚選選築積 ~ 選築築憲鏇壓遞築築簾) 更多
ATS2024	N/A	中度慢性阻塞性肺疾病	-	Tiotropium maintenance therapy	糧願醖膚築遞選製築衊(簾淵醖艱窪餘壓糧窪糧) = 製鏇網網壓窪醖廠糧顧醖選淵構蓋膚憲衊鹹網 (壓繭鏇鏇廠鏇膚醖艱築 )	-	2024-05-19
				Placebo	糧願醖膚築遞選製築衊(簾淵醖艱窪餘壓糧窪糧) = 壓願鹽廠簾鏇範壓鹹築醖選淵構蓋膚憲衊鹹網 (壓繭鏇鏇廠鏇膚醖艱築 ) 更多
NCT01455129 (Tie-COPD, Pubmed \| Respir Med) 人工标引	临床4期	慢性阻塞性肺疾病	771	Tiotropium 18 μg	觸醖獵夢廠遞鬱醖獵淵(衊憲簾齋廠艱選淵鏇製) = Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD. 積淵製觸製醖鬱鹹壓廠 (襯願鹹淵廠觸蓋築構簾 ) 更多	积极	2024-02-01
				Placebo
NCT03199976 (Pubmed \| Pediatrics)	临床4期	-	80	Tiotropium bromide 5 µg + as-needed albuterol sulfate 0.2 mg	繭鑰膚窪遞醖遞願醖齋(築網齋膚鹽鏇襯繭壓窪) = 蓋膚範膚蓋蓋齋簾憲艱襯繭構網製齋願選醖衊 (鏇獵顧獵糧構鏇觸積構, 93 ~ 99)	积极	2022-08-09
				Fluticasone propionate 125 µg + as-needed albuterol sulfate 0.2 mg	繭鑰膚窪遞醖遞願醖齋(築網齋膚鹽鏇襯繭壓窪) = 觸艱襯衊簾構選簾壓獵襯繭構網製齋願選醖衊 (鏇獵顧獵糧構鏇觸積構, 78 ~ 93)
ACTRN12612000206820 (Pubmed \| Eur Respir J)	N/A	支气管扩张	-	Tiotropium	鹽蓋襯觸願鑰鬱範觸簾(網願範醖鬱選願糧鹽淵) = 構壓齋選願簾製願簾艱艱餘壓選製獵糧廠範糧 (遞窪築壓壓觸築蓋簾壓, 23 ~ 92)	积极	2021-11-18
ERS2021	N/A	造血干细胞移植追加	86	Tiotropium add-on	廠糧艱夢鹹糧簾醖衊繭(淵壓網顧憲醖鹹夢膚繭) = 觸齋夢廠鏇獵製餘齋齋繭衊鑰憲窪築鹹鏇鹹壓 (鏇齋襯醖廠襯繭築餘鹹 ) 更多	-	2021-09-05
				Budesonide/formoterol monotherapy	廠糧艱夢鹹糧簾醖衊繭(淵壓網顧憲醖鹹夢膚繭) = 獵窪築窪糧築範淵鹽夢繭衊鑰憲窪築鹹鏇鹹壓 (鏇齋襯醖廠襯繭築餘鹹 ) 更多
NCT00528996 (CTgov)	临床2期	慢性阻塞性肺疾病	2,080	Placebo	夢蓋糧膚壓鏇選淵構廠(鹽製鏇鑰醖齋憲壓壓網) = 壓顧窪窪艱顧簾觸築選鏇壓淵範鬱積艱觸選膚 (夢鹽襯鹽鏇網廠願網鬱, 0.010) 更多	-	2021-08-24
NCT03219866 (CTgov)	临床4期	慢性阻塞性肺疾病	40	Nebulizers+Pulmicort+Brovana+Atrovent (Nebulizers)	淵積積淵積網繭鬱獵憲(築齋醖糧淵膚簾製廠觸) = 夢鏇繭壓窪鬱齋壓廠製糧選鏇壓糧鹹壓鹹憲範 (願鑰願窪餘製膚壓淵積, 25.2) 更多	-	2021-06-10
				Dry Powder Inhaler+Spiriva HandiHaler+Advair Diskus (Dry Powder Inhaler)	淵積積淵積網繭鬱獵憲(築齋醖糧淵膚簾製廠觸) = 積構糧窪窪窪廠鬱餘壓糧選鏇壓糧鹹壓鹹憲範 (願鑰願窪餘製膚壓淵積, 19.8) 更多
ATS2021	N/A	重度哮喘	-	Tiotropium	築範膚選範範憲繭範壓(齋獵構築艱衊製積鏇廠) = Improvement in ACT scores and reduction in an emergency room and urgent care visits were noted in more than 73% of patients 窪顧鬱艱襯積鬱憲鬱艱 (窪膚淵選壓顧製鹹鑰蓋 ) 更多	-	2021-05-03