The value of bronchodilators and anti-inflammatory medication in patients with posttraumatic rib fractures, a multicenter prospective cohort study (RIB-Inhalation)

开始日期2021-09-01

申办/合作机构

Erasmus University Medical Center

NCT03772223

/ Completed临床1期

A Phase 1, Randomized, Open-label, Single-dose, 3-way Cross-over Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared With PT007 and PT008 Administered Separately (LOGAN).

This is a Phase 1 study to compare the pharmacokinetics of budesonide and albuterol delivered by PT027 compared with PT007 and PT008 administered separately.

开始日期2019-01-21

申办/合作机构

AstraZeneca PLC

100 项与异丙托溴铵/硫酸沙丁胺醇相关的临床结果

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100 项与异丙托溴铵/硫酸沙丁胺醇相关的转化医学

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100 项与异丙托溴铵/硫酸沙丁胺醇相关的专利（医药）

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4,868

项与异丙托溴铵/硫酸沙丁胺醇相关的文献（医药）

2025-12-31·Pulmonology

Bronchodilators in bronchiectasis: A story difficult to understand

作者: Bekki, Amina ; Oscullo, Grace ; Martínez-García, Miguel Ángel

2025-11-01·Current pediatric reviews

Insights from Overviewing Selective International Guidelines for Pediatric Asthma

Article

作者: Ng, Daniel K.K. ; Leung, Alexander K.C. ; Hon, Kam L.E. ; Chiu, Wa K.

Background::

Asthma is a chronic atopic and inflammatory bronchial disease characterized by recurring symptoms and, episodic reversible bronchial obstruction and easily triggered bronchospasms. Asthma often begins in childhood. International guidelines are widely accepted and implemented; however, there are similarities and differences in the management approaches. There is no national guideline in many cities in Asia. This review aims to provide a practical perspective on current recommendations in the management of childhood asthma, specifically in the following aspects: diagnosis, classification of severity, treatment options, and asthma control, and to provide physicians with up-to-date information for the management of asthma

Methods::

We used the PubMed function of Clinical Queries and searched keywords of “Asthma”, “Pediatric,” AND “Guidelines” as the search engine. “Clinical Prediction Guides”, “Etiology”, “Diagnosis”, “Therapy,” “Prognosis,” and “Narrow” scope were used as filters. The search was conducted in November 2022. The information retrieved from this search was used in compiling the present article.

Results::

Diagnosis is clinically based on symptom pattern, response to therapy with bronchodilators and inhaled corticosteroids, and spirometric pulmonary function testing (PFT). Asthma is classified in accordance with symptom frequency, peak expiratory flow rate (PEFR), forced expiratory volume in one second (FEV1), atopic versus nonatopic etiology, where atopy means a predisposition toward a type 1 hypersensitivity reaction. Asthma is also classified as intermittent or persistent (mild to severe). Unfortunately, there is no disease cure for asthma. However, symptoms can be prevented by trigger avoidance and suppressed with inhaled corticosteroids. Antileukotriene agents or long-acting beta-agonists (LABA) may be used together with inhaled corticosteroids if symptoms of asthma are not controlled. Rapidly worsening symptoms are usually treated with an inhaled short-acting beta-2 agonist (SABA, e.g., salbutamol) and oral corticosteroids. Intravenous corticosteroids and hospitalization are required in severe cases of asthma attacks. Some guidelines also provide recommendations on the use of biologics and immunotherapy.

Conclusion::

Asthma is diagnosed clinically, with supporting laboratory testing. Treatment is based on severity classification, from intermittent to persistent. Inhaled bronchodilator and steroid anti-inflammatory form the main stay of management.

2025-10-01·CELLULAR SIGNALLING

Dual blockade of TLR-4 and mu-opioid receptor by very low-dose naltrexone prevents respiratory depression via modulating redox homeostasis and airway inflammation in chronic obstructive pulmonary disease

Article

作者: Pandey, Vinita ; Subhashini ; Gaglani, Pratikkumar ; Yadav, Vandana ; Srivastava, Atul ; Soni

Chronic Obstructive Pulmonary Disease (COPD), is characterized by poorly irreversible airflow obstruction and abnormal inflammatory response in lungs. It represents an innate and adaptive immune response to long term exposure to noxious particles and gases, particularly cigarette smoke (CS). The current pharmacological treatment of COPD is symptomatic and mainly based on the use of bronchodilators reducing the lung function progression. The present study explores a comprehensive exploration into the therapeutic potential of Naltrexone (NTX), an FDA-approved non-peptide opioid antagonist, in managing COPD pathogenesis. NTX exhibits distinct responses across varying dosages where it implies a dose pharmacological profile, with dose-dependent targets yielding diverse effects. The study aims to uncover its efficacy in experimental mice model of COPD by observing redox homeostasis, inflammatory responses, and apoptosis encompassing variable doses. Our findings reveal promising outcomes, particularly with VLDN (100 μg/kgbw and 50 μg/kgbw), where a significant reduction in ROS, NO and positive impacts on TOS and TAS, was observed which indicates its potential as an oxidative stress modulator. Furthermore, VLDN modulated the antioxidant enzymatic activity thereby reducing the apoptotic phenomenon via caspase-3. VLDN significantly reduced the inflammatory response by inhibiting the inflammatory mediators (histamine, LDH and CRP) and suppressing cytokine production (TNF-α, IFN-γ and IL-6). The study also delved into intricate pathway where mechanistically VLDN exerted anti-inflammatory effect by inhibiting the activation of NF-kB/MAPK signalling via TLR4. These findings collectively highlight VLDN multifaceted impact in mitigating oxidative stress, inflammation influencing apoptosis in COPD management, offering valuable insights for future therapeutic strategies.

项与异丙托溴铵/硫酸沙丁胺醇相关的新闻（医药）

2025-08-10

·信狐药迅

石药集团司美格鲁肽和君实生物特瑞普利单抗提交2.2类新适应症上市申请|新受理（8.4-8.10）

本周药品注册受理数据，分门别类呈现，一目了然。(8.4-8.10）新药上市申请药品名称企业注册分类受理号司美格鲁肽注射液石药集团百克(山东)生物制药股份有限公司2.2CXHS2500090司美格鲁肽注射液石药集团百克(山东)生物制药股份有限公司2.2CXHS2500091特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2500080特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2500079 新药临床申请药品名称企业注册分类受理号HRS-7058片山东盛迪医药有限公司1CXHL2500832HRS-7058片山东盛迪医药有限公司1CXHL2500831HRS-7058胶囊山东盛迪医药有限公司1CXHL2500830HRS-7058胶囊山东盛迪医药有限公司1CXHL2500829HRS-4642注射液上海恒瑞医药有限公司1CXHL2500827HRS-4642注射液上海恒瑞医药有限公司1CXHL2500826TQB3122胶囊正大天晴药业集团股份有限公司1CXHL2500825TQB3122胶囊正大天晴药业集团股份有限公司1CXHL2500824HRS-4642注射液上海恒瑞医药有限公司1CXHL2500821HRS-4642注射液上海恒瑞医药有限公司1CXHL2500820注射用TQB3142正大天晴药业集团股份有限公司1CXHL2500819HECN30227注射液广东东阳光药业股份有限公司1CXHL2500818ZN-F-6418胶囊苏州赞荣医药科技有限公司1CXHL2500817ZN-F-6418胶囊苏州赞荣医药科技有限公司1CXHL2500816IPG7236片南京艾美斐生物医药科技有限公司1CXHL2500814IPG7236片南京艾美斐生物医药科技有限公司1CXHL2500813HRS-2430注射液江苏恒瑞医药股份有限公司1CXHL2500810HRS-2430注射液江苏恒瑞医药股份有限公司1CXHL2500811SYH2061注射液石药集团中奇制药技术(石家庄)有限公司1CXHL2500812FNX020片成都凡诺西生物医药科技有限公司1CXHL2500805FNX020片成都凡诺西生物医药科技有限公司1CXHL2500804DM2080贴北京德默高科医药技术有限公司2.2CXHL2500807DM2080贴北京德默高科医药技术有限公司2.2CXHL2500808多替拉韦拉米夫定替诺福韦片上海迪赛诺医药集团股份有限公司2.3CXHL2500806苹果酸法米替尼胶囊江苏恒瑞医药股份有限公司2.4CXHL2500828羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2500823羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2500822瑞维鲁胺片江苏恒瑞医药股份有限公司2.4CXHL2500815注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL250080920价肺炎球菌多糖结合疫苗艾美探索者生命科学研发有限公司2.2CXSL2500667注射用SHR-1826苏州盛迪亚生物医药有限公司1CXSL2500689注射用SHR-A2009苏州盛迪亚生物医药有限公司1CXSL2500688注射用FH-006上海甫弘生物医药有限公司1CXSL2500687SHR-4610注射液上海盛迪医药有限公司1CXSL2500686注射用SHR-9839 (sc)苏州盛迪亚生物医药有限公司1CXSL2500685注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500683注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500682注射用BL-M24D1成都百利多特生物药业有限责任公司1CXSL2500680QX029N注射液江苏荃信生物医药股份有限公司1CXSL2500679IBI363信达生物制药(苏州)有限公司1CXSL2500672IBI363信达生物制药(苏州)有限公司1CXSL2500671SCTC21C注射液神州细胞工程有限公司1CXSL2500670GK01细胞注射液北京极客基因科技有限公司1CXSL2500669JH032注射液百泰生物药业有限公司1CXSL2500668SHR-1701注射液苏州盛迪亚生物医药有限公司1CXSL2500677SHR-7367注射液上海恒瑞医药有限公司1CXSL2500675注射用GenSci139长春金赛药业有限责任公司1CXSL2500673注射用HS-20093上海翰森生物医药科技有限公司1CXSL2500666异体自然杀伤(NK)细胞注射液苏州迈德通医药科技有限公司1CXSL2500665异体自然杀伤(NK)细胞注射液苏州迈德通医药科技有限公司1CXSL2500664异体自然杀伤(NK)细胞注射液苏州迈德通医药科技有限公司1CXSL2500663HM2002注射液上海环码生物医药有限公司1CXSL2500662注射用间充质干细胞(脐带)天津昂赛细胞基因工程有限公司1CXSL2500661IBI3026信达生物科技有限公司1CXSL2500660SYS6002石药集团巨石生物制药有限公司1CXSL2500654IBI3009信达生物制药(苏州)有限公司1CXSL2500657SYS6043石药集团巨石生物制药有限公司1CXSL2500656SYS6010石药集团巨石生物制药有限公司1CXSL2500658DP303c注射液石药集团巨石生物制药有限公司1CXSL2500655QLS2309注射液齐鲁制药有限公司1CXSL2500659注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司2.2CXSL2500684阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500681SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500678贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500676阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500674 仿制药申请药品名称企业注册分类受理号格隆溴铵注射液河南普瑞药业有限公司3CYHS2502894格隆溴铵注射液河南普瑞药业有限公司3CYHS2502893艾拉戈克钠片南京正大天晴制药有限公司3CYHS2502892艾拉戈克钠片南京正大天晴制药有限公司3CYHS2502891盐酸纳洛酮注射液云南药科院生物医药股份有限公司3CYHS2502890氯化钾缓释片澳美制药(海南)有限公司3CYHS2502865西咪替丁片河北新石制药有限公司3CYHS2502862盐酸普萘洛尔片寿光富康制药有限公司3CYHS2502861吸入用盐酸丙卡特罗溶液成都康泰源医药科技有限责任公司3CYHS2502860吸入用盐酸丙卡特罗溶液成都康泰源医药科技有限责任公司3CYHS2502859醋酸葡萄糖维持液西安万隆制药股份有限公司3CYHS2502880注射用奈达铂吉斯美(武汉)制药有限公司3CYHS2502879复方匹可硫酸钠口服溶液湖南科伦制药有限公司3CYHS2502878注射用奈达铂吉斯美(武汉)制药有限公司3CYHS2502877法莫替丁片安若维他药业泰州有限公司3CYHS2502875阿仑膦酸钠口服溶液北京民康百草医药科技有限公司3CYHS2502869中性低钙腹膜透析液(碳酸氢盐-G1.5%)成都青山利康药业股份有限公司3CYHS2502887对乙酰氨基酚维生素C泡腾片新乡市常乐制药有限责任公司3CYHS2502868中性低钙腹膜透析液(碳酸氢盐-G1.5%)成都青山利康药业股份有限公司3CYHS2502886中性低钙腹膜透析液(碳酸氢盐-G1.5%)成都青山利康药业股份有限公司3CYHS2502885注射用氨苄西林钠/氯化钠注射液湖南科伦制药有限公司3CYHS2502884注射用氨苄西林钠/氯化钠注射液湖南科伦制药有限公司3CYHS2502883醋酸葡萄糖维持液西安万隆制药股份有限公司3CYHS2502881酮咯酸氨丁三醇片浙江华海制药科技有限公司3CYHS2502900氨溴特罗口服溶液千海始德堂(鹤壁)制药有限公司3CYHS2502856氢溴酸加兰他敏口服溶液(Ⅱ)湖北民康制药有限公司3CYHS2502854吡拉西坦注射液华中药业股份有限公司3CYHS2502825吡拉西坦注射液华中药业股份有限公司3CYHS2502824重酒石酸去甲肾上腺素注射液广东南国药业有限公司3CYHS2502844注射用盐酸多西环素江苏联环药业股份有限公司3CYHS2502839异丙托溴铵沙丁胺醇吸入喷雾剂南昌谷森生物制药有限公司3CYHS2502820盐酸溴己新口服溶液江西科为制药有限公司3CYHS2502813依巴斯汀口服溶液重庆希尔安药业有限公司3CYHS2502814盐酸肾上腺素注射液辰欣药业股份有限公司3CYHS2502823注射用硫酸多黏菌素B河北锐健医药科技有限公司3CYHS2502821聚普瑞锌颗粒福建海西新药创制股份有限公司3CYHS2502808倍他米松磷酸钠注射液安徽均大高科医药科技有限公司3CYHS2502807中性腹膜透析液(乳酸盐-G2.5%)石家庄四药有限公司3CYHS2502806中性低钙腹膜透析液(乳酸盐-G2.5%)石家庄四药有限公司3CYHS2502805硫酸镁注射液酒泉大得利制药股份有限公司3CYHS2502804法莫替丁注射液绪必迪药业(沧州)有限公司3CYHS2502800苯甲酸阿格列汀片石家庄四药有限公司4CYHS2502905来特莫韦注射液浙江海正药业股份有限公司4CYHS2502904复方氨基酸(15)双肽(2)注射液西安力邦制药有限公司4CYHS2502903苯磺酸左氨氯地平片辽宁康博士制药有限公司4CYHS2502902苯磺酸左氨氯地平片辽宁康博士制药有限公司4CYHS2502901注射用头孢他啶阿维巴坦钠浙江普洛巨泰药业有限公司4CYHS2502899乙酰半胱氨酸注射液武汉先路医药科技股份有限公司4CYHS2502898乳果糖口服溶液浙江康恩贝制药股份有限公司4CYHS2502896乳果糖口服溶液浙江康恩贝制药股份有限公司4CYHS2502895非奈利酮片浙江贝得药业有限公司4CYHS2502889非奈利酮片浙江贝得药业有限公司4CYHS2502888美阿沙坦钾片江苏天士力帝益药业有限公司4CYHS2502864美阿沙坦钾片江苏天士力帝益药业有限公司4CYHS2502863替尔泊肽注射液礼来苏州制药有限公司4CYHS2502874磷酸奥司他韦胶囊海南赛科药业有限公司4CYHS2502873替尔泊肽注射液礼来苏州制药有限公司4CYHS2502872替尔泊肽注射液礼来苏州制药有限公司4CYHS2502871替尔泊肽注射液礼来苏州制药有限公司4CYHS2502870腹膜透析液(乳酸盐-G4.25%)辰欣药业股份有限公司4CYHS2502867注射用甲苯磺酸奥马环素湖南科伦制药有限公司4CYHS2502882氟马西尼注射液浙江华海药业股份有限公司4CYHS2502897左卡尼汀口服溶液烟台万润药业有限公司4CYHS2502857瑞维那新吸入溶液广东洛斯特制药有限公司4CYHS2502855他克莫司软膏山东辰欣佛都药业股份有限公司4CYHS2502853他克莫司软膏山东辰欣佛都药业股份有限公司4CYHS2502852注射用醋酸卡泊芬净浙江华海药业股份有限公司4CYHS2502866瑞舒伐他汀依折麦布片(Ⅰ)陕西白鹿制药股份有限公司4CYHS2502858脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液沈阳海思科制药有限公司4CYHS2502876莫匹罗星软膏上海理想制药有限公司4CYHS2502835莫匹罗星软膏上海理想制药有限公司4CYHS2502834褪黑素颗粒宿州亿帆药业有限公司4CYHS2502833雌二醇片/雌二醇地屈孕酮片复合包装华润紫竹药业有限公司4CYHS2502832雌二醇片/雌二醇地屈孕酮片复合包装华润紫竹药业有限公司4CYHS2502831舒更葡糖钠注射液石药集团欧意药业有限公司4CYHS2502830注射用头孢哌酮钠舒巴坦钠/氯化钠注射液湖南科伦制药有限公司4CYHS2502829注射用头孢哌酮钠舒巴坦钠/氯化钠注射液湖南科伦制药有限公司4CYHS2502828沙库巴曲缬沙坦钠片北京双鹭药业股份有限公司4CYHS2502827沙库巴曲缬沙坦钠片北京双鹭药业股份有限公司4CYHS2502826丁二磺酸腺苷蛋氨酸肠溶片成都赛璟生物医药科技有限公司4CYHS2502845达格列净二甲双胍缓释片(IV)上海现代制药股份有限公司4CYHS2502843达格列净二甲双胍缓释片(I)上海现代制药股份有限公司4CYHS2502842乙酰半胱氨酸注射液浙江恒研医药科技有限公司4CYHS2502841盐酸乐卡地平片福建省宝诺医药研发有限公司4CYHS2502840达格列净二甲双胍缓释片(Ⅰ)浙江普洛康裕制药有限公司4CYHS2502838头孢托仑匹酯颗粒沐源(安徽)药业有限公司4CYHS2502837头孢托仑匹酯颗粒沐源(安徽)药业有限公司4CYHS2502836阿达帕林凝胶广州乐宓医药科技有限公司4CYHS2502851苯磺酸美洛加巴林片华北制药股份有限公司4CYHS2502850富马酸伏诺拉生片湖南迪诺制药股份有限公司4CYHS2502849罗沙司他胶囊杭州仟源保灵药业有限公司4CYHS2502848罗沙司他胶囊杭州仟源保灵药业有限公司4CYHS2502847盐酸罗哌卡因注射液峨眉山通惠制药有限公司4CYHS2502846非奈利酮片山东百诺医药股份有限公司4CYHS2502822双氯芬酸钠缓释片湖南九典制药股份有限公司4CYHS2502819羟考酮纳洛酮缓释片甘肃农垦药物碱厂有限公司4CYHS2502818左乙拉西坦片山东普瑞曼药业有限公司4CYHS2502815左乙拉西坦片山东普瑞曼药业有限公司4CYHS2502816左乙拉西坦片山东普瑞曼药业有限公司4CYHS2502817精氨酸布洛芬颗粒海南赛立克药业有限公司4CYHS2502812注射用硫酸艾沙康唑湖南华纳大药厂股份有限公司4CYHS2502811氧长春巨洋气体有限责任公司4CYHS2502810盐酸二甲双胍缓释片白云山东泰商丘药业有限公司4CYHS2502809阿托伐他汀钙片宁波大红鹰药业股份有限公司4CYHS2502803阿托伐他汀钙片宁波大红鹰药业股份有限公司4CYHS2502802碘普罗胺注射液鲁南贝特制药有限公司4CYHS2502801硫酸氨基葡萄糖胶囊郑州韩都药业集团有限公司4CYHS2502799西妥昔单抗注射液广东安普泽生物医药股份有限公司3.3CXSS2500081破伤风人免疫球蛋白广东丹霞生物制药有限公司3.4CXSS2500078注射用多黏菌素E甲磺酸钠南京正科医药股份有限公司3CYHL2500139普瑞巴林缓释片宜昌人福药业有限责任公司3CYHL2500138普瑞巴林缓释片宜昌人福药业有限责任公司3CYHL2500137精蛋白人胰岛素混合注射液(30R)恒敬合创生物医药(浙江)有限公司3.3CXSL2500653 进口申请药品名称企业注册分类受理号泊沙康唑口服混悬液Hetero Labs Limited5.2JYHS2500039司来帕格片MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500038司来帕格片MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500037司来帕格片MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500036司来帕格片MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500035MK-1084片Merck Sharp & Dohme LLC1JXHL2500210MK-1084片Merck Sharp & Dohme LLC1JXHL2500209MK-4280A注射液Merck Sharp & Dohme LLC1JXSL2500143ALXN1920注射液Alexion Pharmaceuticals, Inc.1JXSL2500142BAY 3401016 注射液Bayer AG1JXSL2500141AZD0486AstraZeneca AB1JXSL2500139AZD0486AstraZeneca AB1JXSL2500138Lebrikizumab注射液Eli Lilly and Company2.2JXSL2500140 中药相关申请药品名称企业注册分类受理号川芎定痛颗粒北京阳光合和中医药科技开发有限公司1.1CXZL2500064黄葶肺心平颗粒重庆希尔安药业有限公司1.1CXZL2500063杜仲木脂素胶囊江西普正制药股份有限公司1.2CXZL2500061杜仲木脂素提取物江西普正制药股份有限公司1.2CXZL2500060小儿肺热咳喘口服液黑龙江葵花药业股份有限公司2.3CXZL2500062清肺汤颗粒江西药都樟树制药有限公司3.1CXZS2500032颈舒颗粒黄山精制药业有限公司4CYZS2500008 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请

2025-07-23

·PRNewswire

HBM9378/WIN378, a Long-Acting, Fully Human Anti-TSLP Antibody, Enters Global Phase 2 POLARIS Trial for Asthma

Phase 2 POLARIS trial will evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma, with an initial data readout expected in mid-2026 HBM9378/WIN378 has the potential to be the first-to-market long-acting anti-TSLP antibody with twice-yearly dosing for asthma Extended dosing intervals could reduce treatment burden and improve outcomes for patients with advanced respiratory diseases Global COPD clinical program planned to start in mid-2026 CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SHANGHAI, July 23, 2025 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, today announced that its partner, Windward Bio AG ("Windward Bio"), has initiated the POLARIS clinical study, a global, randomized, double-blind, placebo-controlled Phase 2 study evaluating the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma. Initial data are expected in mid-2026. Asthma is a chronic respiratory condition affecting approximately 300 million people worldwide, with prevalence continuing to rise. Despite the availability of treatment options, many patients experience persistent symptoms, frequent exacerbations, and reduced quality of life. Current therapies - mainly inhaled corticosteroids (ICS) and bronchodilators - are inadequate for some patients, underscoring the urgent need for more effective, long-acting treatments that address the underlying disease mechanisms. HBM9378/WIN378 is a potentially best-in-class, long-acting monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological diseases, including asthma and chronic obstructive pulmonary disease (COPD). This molecule has fully human sequences, offering a lower risk of immunogenicity and improved bioavailability compared to other TSLP-targeting therapies. It has been engineered to achieve a half-life extension and a silenced effector function and is subcutaneously administered. In a Phase 1 trial, HBM9378/WIN378 demonstrated an extended half-life, showed a low incidence of antidrug antibodies, and was safe and well tolerated up to the highest tested dose. "We are pleased to see HBM9378/WIN378 advancing rapidly into global clinical development," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "This long-acting, fully human anti-TSLP antibody has demonstrated strong potential in previous preclinical and clinical studies. We believe it has the potential to address significant unmet needs for patients with asthma." HBM9378/WIN378 (also known as SKB378) started as a co-development project jointly conducted by Harbour BioMed and Kelun-Biotech, with both parties equally sharing global rights. Earlier this year, Harbour BioMed and Kelun-Biotech entered into a strategic partnership with Windward Bio, granting Windward Bio an exclusive license to research, develop, manufacture, and commercialize this antibody globally, excluding Greater China and several Southeast and West Asian countries. In addition to asthma, HBM9378/WIN378 is also being evaluated in clinical trials for COPD, another major respiratory condition. In November 2024, the Company submitted an Investigational New Drug (IND) application for HBM9378/WIN378 in COPD to the National Medical Products Administration (NMPA) of China, which was approved in January 2025. Additionally, Windward Bio plans to initiate global clinical trials in COPD in 2026. The continued progress of HBM9378/WIN378 in both asthma and COPD highlights the versatility and potential of this innovative therapy. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Harbour BioMed's proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit . About Windward Bio AG Windward Bio is a clinical-stage biotechnology company with deep discovery, development and commercialization expertise committed to transforming the treatment of people living with advanced immunological conditions. Its lead program is WIN378, a potential best-in-disease, long-acting, anti-TSLP monoclonal antibody in Phase 2 for asthma. The company is planning additional clinical studies of WIN378 in COPD and other respiratory indications and is also building a pipeline of long-acting bi-specific antibodies targeting validated biology in respiratory and dermatological conditions. Windward Bio launched earlier this year with a $200M Series A led by top-tier investors. SOURCE Harbour BioMed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期引进/卖出免疫疗法临床2期

2025-07-23

·harbourbiomed.com

HBM9378/WIN378, a Long-Acting, Fully Human Anti-TSLP Antibody, Enters Global Phase 2 POLARIS Trial for Asthma

Cambridge, MA, Rotterdam, NL, Shanghai, CN – July 23, 2025 Harbour BioMed (the "Company”; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, today announced that its partner, Windward Bio AG (“Windward Bio”), has initiated the POLARIS clinical study, a global, randomized, double-blind, placebo-controlled Phase 2 study evaluating the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma. Initial data are expected in mid-2026. Asthma is a chronic respiratory condition affecting approximately 300 million people worldwide, with prevalence continuing to rise. Despite the availability of treatment options, many patients experience persistent symptoms, frequent exacerbations, and reduced quality of life. Current therapies - mainly inhaled corticosteroids (ICS) and bronchodilators - are inadequate for some patients, underscoring the urgent need for more effective, long-acting treatments that address the underlying disease mechanisms. HBM9378/WIN378 is a potentially best-in-class, long-acting monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological diseases, including asthma and chronic obstructive pulmonary disease (COPD). This molecule has fully human sequences, offering a lower risk of immunogenicity and improved bioavailability compared to other TSLP-targeting therapies. It has been engineered to achieve a half-life extension and a silenced effector function and is subcutaneously administered. In a Phase 1 trial, HBM9378/WIN378 demonstrated an extended half-life, showed a low incidence of antidrug antibodies, and was safe and well tolerated up to the highest tested dose. “We are pleased to see HBM9378/WIN378 advancing rapidly into global clinical development,” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. “This long-acting, fully human anti-TSLP antibody has demonstrated strong potential in previous preclinical and clinical studies. We believe it has the potential to address significant unmet needs for patients with asthma.” HBM9378/WIN378 (also known as SKB378) started as a co-development project jointly conducted by Harbour BioMed and Kelun-Biotech, with both parties equally sharing global rights. Earlier this year, Harbour BioMed and Kelun-Biotech entered into a strategic partnership with Windward Bio, granting Windward Bio an exclusive license to research, develop, manufacture, and commercialize this antibody globally, excluding Greater China and several Southeast and West Asian countries. In addition to asthma, HBM9378/WIN378 is also being evaluated in clinical trials for COPD, another major respiratory condition. In November 2024, the Company submitted an Investigational New Drug (IND) application for HBM9378/WIN378 in COPD to the National Medical Products Administration (NMPA) of China, which was approved in January 2025. Additionally, Windward Bio plans to initiate global clinical trials in COPD in 2026. The continued progress of HBM9378/WIN378 in both asthma and COPD highlights the versatility and potential of this innovative therapy. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Harbour BioMed's proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com. About Windward Bio AG Windward Bio is a clinical-stage biotechnology company with deep discovery, development and commercialization expertise committed to transforming the treatment of people living with advanced immunological conditions. Its lead program is WIN378, a potential best-in-disease, long-acting, anti-TSLP monoclonal antibody in Phase 2 for asthma. The company is planning additional clinical studies of WIN378 in COPD and other respiratory indications and is also building a pipeline of long-acting bi-specific antibodies targeting validated biology in respiratory and dermatological conditions. Windward Bio launched earlier this year with a $200M Series A led by top-tier investors.

临床2期引进/卖出临床1期免疫疗法临床申请

100 项与异丙托溴铵/硫酸沙丁胺醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	R03AL02	-

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	中国	鲁南贝特制药有限公司	2006-04-18
支气管痉挛	美国	Pharmobedient, Inc.	2001-03-21
慢性阻塞性肺疾病	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	1996-10-24

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
持续性哮喘	临床2期	美国	Boehringer Ingelheim GmbH	2004-11-01

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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


NCT01059786 (CTgov)	临床2期	毛细胞白血病	69	Epinephrine+Saline+Bronchodilators+Acetaminophen+bendamustine+Pentostatin+Diphenhydramine+Rituximab	簾範蓋築鏇蓋齋衊簾觸 = 製網糧鏇顧夢觸願選鹹艱醖網願糧齋遞遞鏇獵 (願齋願積網餘鏇觸餘醖, 夢範糧艱選鏇網選製鏇 ~ 襯鹽廠積繭簾選築觸壓) 更多	-	2024-05-01
NCT01019694 (CTgov)	临床3期	慢性阻塞性肺疾病	470	albuterol+ipratropium (Combivent Respimat)	範遞簾鹹艱繭淵網醖觸(醖憲鹽獵齋蓋襯顧糧膚) = 窪廠願衊觸築膚壓顧艱夢獵獵鑰鏇鏇憲醖艱糧 (構積顧夢積齋築觸鬱夢, 1.27) 更多	-	2012-05-01
NCT01019694 (CTgov)	临床3期	慢性阻塞性肺疾病	470	albuterol sulfate+ipratropium bromide (Combivent Inhalation Aerosol)	範遞簾鹹艱繭淵網醖觸(醖憲鹽獵齋蓋襯顧糧膚) = 膚衊襯願簾選獵積鏇醖夢獵獵鑰鏇鏇憲醖艱糧 (構積顧夢積齋築觸鬱夢, 1.31) 更多	-	2012-05-01