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更新于：2025-07-29

Budesonide

布地奈德

更新于：2025-07-29

概要

基本信息

简介布地奈德是一种作为激动剂与糖皮质激素受体（GR）结合能力强的小分子药物，早在1981年就获批上市，至今已有40多年的历史。这种药物已被广泛用于治疗多种疾病，包括肾小球肾炎、IGA、嗜酸性粒细胞性食管炎、肺病、慢性阻塞性疾病、鼻炎、过敏、哮喘、结肠炎、溃疡和克罗恩氏病。其显着功效被认为源于其调节免疫系统的能力，从而减少炎症和防止组织损伤。

药物类型

小分子化药

别名

Budenofalk Granules、Budesolv、Budesonide gastro-resistant granules

+ [72]

靶点

作用方式

激动剂

作用机制

GR激动剂(糖皮质激素受体激动剂)

治疗领域

免疫系统疾病感染消化系统疾病+ [4]

在研适应症

免疫球蛋白a肾病嗜酸粒细胞性食管炎溃疡性结肠炎+ [10]

非在研适应症

急性哮喘急性移植物抗宿主病过敏+ [18]

原研机构

阿斯利康制药有限公司

在研机构

Takeda Pharmaceuticals U.S.A., Inc.

云顶新耀医药科技有限公司

Unither Pharmaceuticals SASU

+ [28]

非在研机构

Bausch Health Americas, Inc.云屹药业（上海）有限公司

Takeda Pharmaceutical Co., Ltd.

+ [7]

权益机构

Kissei Pharmaceutical Co., Ltd.Ferring Holding SA

Calliditas Therapeutics AB

+ [24]

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、突破性疗法 (中国)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、附条件批准 (欧盟)、附条件批准 (英国)、快速通道 (韩国)、加速批准 (中国台湾)、优先审评 (中国)

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结构/序列

分子式C25H34O6

InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N

CAS号51333-22-3

关联

638

项与布地奈德相关的临床试验

NCT06860542

/ Not yet recruiting临床2期IIT

Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis

The introduction of immune checkpoint inhibitors (immunotherapy) that stimulate our immune system to recognize and attack cancer cells has been one of the most exciting advances in oncology over the last decade. These medications are now employed across almost half of cancer types and settings, however they come with a cost. In some patients, instead of attacking cancer cells alone, the stimulated immune system damages healthy tissues (immune related adverse events), with one of the most severe and potentially deadly such complications being immune attack on the lungs, or checkpoint inhibitor pneumonitis (CIP). When treated promptly with oral or intravenous steroids, acute CIP improves in many cases, however for approximately one-fifth of patients the lung inflammation is difficult to control, resulting in recurrent shortness of breath, the need for extended courses of oral or intravenous steroids, impacting quality of life and cancer therapy decisions. The goal of the trial is to assess whether use of inhaled steroids, a type of medication commonly used in asthma patients, for one year after a first diagnosis of CIP may help the lung inflammation resolve and not return, without the repeated use of oral or intravenous medications that carry more side effects.

开始日期2025-09-01

申办/合作机构

AHS Cancer Control Alberta

NCT06855043

/ Not yet recruiting临床2期IIT

Pilot Study of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Infants

This clinical trial is being done to evaluate the clinical response and safety of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.
The main questions it aims to answer are:
* Do the combined drugs improve the respiratory severity score (RSS)
* Is the combination safe
Participants will receive three doses of the study drug.

开始日期2025-08-01

申办/合作机构

University of Wisconsin Madison

CTR20252038

/ Active, not recruitingN/A

布地奈德肠溶胶囊餐后人体生物等效性研究

研究餐后状态下单次口服受试制剂布地奈德肠溶胶囊（4 mg）与参比制剂布地奈德肠溶胶囊（TARPEYO®，4 mg）在健康成年受试者体内的药代动力学，评价两种制剂的生物等效性和安全性。

开始日期2025-06-19

申办/合作机构

齐鲁制药有限公司

100 项与布地奈德相关的临床结果

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100 项与布地奈德相关的转化医学

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100 项与布地奈德相关的专利（医药）

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10,539

项与布地奈德相关的文献（医药）

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

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

Article

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

Background:

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

Methods:

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

Results:

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

Conclusions:

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

2025-12-01·LUNG

Supratherapeutic Inhaled Corticosteroid Use in Patients Initiating on Biologic Therapies for Severe Asthma: A Nationwide Cohort Study

Article

作者: Soendergaard, Marianne Baastrup ; Hansen, Susanne ; Johnsen, Claus Rikard ; Hjortdahl, Frederikke ; Walls, Anne Byriel ; Bonnesen, Barbara ; Håkansson, Kjell Erik Julius ; Bjerrum, Anne-Sofie ; Hilberg, Ole ; Ulrik, Charlotte Suppli ; von Bülow, Anna ; Johansson, Sofie Lock ; Porsbjerg, Celeste ; Rasmussen, Linda Makowska ; Schmid, Johannes Martin

Abstract:

Background:

In severe asthma, intensive (“supratherapeutic”) doses of inhaled corticosteroids (ICS) are often used. The prevalence of supratherapeutic ICS use and its impact on corticosteroid-related comorbidities is poorly understood. We aimed to describe the prevalence of supratherapeutic ICS use in severe asthma, its relation to corticosteroid-related comorbidities, and changes in prescribed and redeemed ICS dose after 12 months of biologic therapy.

Methods:

Patients from the nationwide Danish Severe Asthma Register (DSAR) receiving biologic therapy > 12 months were included. Supratherapeutic doses were defined as > 1600 µg budesonide daily. Baseline characteristics, comorbidity burden, and change in ICS use after 12 months of biologic therapy was stratified according to ICS use at baseline.

Results:

We included 652 patients in our analyses and 156 (24%) were supratherapeutic ICS users prior to initiation of biologic therapy. Supratherapeutic ICS users had a higher baseline prevalence of cataracts at 14 vs 8.1%; p = 0.025. No differences in other corticosteroid-related comorbidities were observed.No change in prevalence of prescribed supratherapeutic ICS was seen after 12 months of biologic therapy. However, a reduction in ICS adherence among supratherapeutic users was observed with 72% of patients demonstrating > 80% adherence at 12 months, compared to 83% at baseline (p < 0.001).

Conclusion:

Supratherapeutic doses of ICS were used by almost one-fourth of the patients prior to initiation of biologic therapy and were associated with a higher prevalence of cataracts. Physician-driven ICS reduction was rare, yet supratherapeutic ICS users were found to self-regulate ICS therapy when treated with biologic therapy.

2025-12-01·LUNG

Efficacy of Nebulized Budesonide and Systemic Corticosteroids During Hospitalization on All-Cause Mortality in AECOPD Patients: A Real-World Study

Article

作者: Meng, Weiwei ; Chen, Yan ; Zhao, Rui ; Zeng, Huihui ; Wu, Jiankang ; Wang, Jiayu ; He, Xue ; Zhao, Zhiqi ; Cui, Yanan ; Xiong, Ruoyan

BACKGROUND:

Guidelines specify steroids as therapy for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, the duration of survival benefit associated with steroids and the optimal dosage of nebulized budesonide (NB) during hospitalization remain unclear.

METHODS:

We conducted a retrospective study of hospitalized AECOPD patients. The primary endpoint was all-cause mortality after discharge. Cox regression analysis was used to determine the impact of steroid therapy on survival.

RESULTS:

Wilcoxon analysis showed the positive impact of systemic corticosteroids (SCs) therapy on survival during the early stage of follow-up (P = 0.038). NB therapy was associated with a significantly reduced risk of death within six months after discharge (adjusted Hazard ratio (HR), 0.36; 95% confidence interval (CI) 0.15-0.88). Subgroup analysis suggested that fewer than two AEs in the previous year (adjusted HR 0.05; 95% CI 0.01-0.38), age > = 65 years (adjusted HR 0.31; 95% CI 0.11-0.90), body mass index (BMI) < 25 kg/m² (adjusted HR 0.33; 95% CI 0.12-0.92), and smoking index > 40 packets/year (adjusted HR 0.17; 95% CI 0.04-0.79) were involved in this association. Finally, treatment with a total dose of NB < = 60 mg during hospitalization reduced six-month mortality compared to treatment without steroids (adjusted HR 0.39; 95% CI 0.17-0.92), but not the total dose of NB > 60 mg.

CONCLUSIONS:

NB therapy for hospitalized AECOPD patients significantly reduced six-month mortality. Subgroup analysis showed that certain populations benefited more from NB therapy, and < = 60 mg NB might be suitable treatment for hospitalized AECOPD patients.

958

项与布地奈德相关的新闻（医药）

2025-07-25

·云顶新耀

云顶新耀宣布配售股份拟集资约15.725亿港元

云顶新耀（HKEX 1952.HK）是一家专注于创新药研发、临床开发、制造和商业化的生物制药公司，今日宣布以先旧后新配售22,561,000股，集资约15.725亿港元，发行股份数占现有股本约6.87%, 占经扩大后的总股数约6.43%。云顶新耀、卖方（控股股东康桥资本）与配售代理签订先旧后新方式的配股协议，配售22,561,000股份，每股配售价69.70港元，较于最后交易日（即配售及认购协议日期前一天）在联交所报所报收市价每股77.55港元折让约10.12%，亦较于紧接最后交易日（包括该日）前连续五个交易日在联交所所报平均收市价每股73.35港元折让约4.98%，较于紧接最后交易日（包括该日）前连续三十个交易日在联交所所报成交量加权平均价每股60.01港元溢价16.15%。所得款项总额预期约为15.725亿港元，而所得款项净额（经扣除所有相关成本及开支，包括佣金及征费）将约为15.534亿港元。云顶新耀预计配售所得款项，其中50%（约7.767亿港元）用于开发自主全球研发平台及新产品管线；另外40%（约6.214亿港元）用于推进新产品商业化，包括推出新产品；及10%（约1.553亿港元）用作营业资金以及一般及行政用途。罗永庆云顶新耀首席执行官此次配售受到多家国际长线持有基金青睐，获得超额认购，反映了资本市场对云顶新耀商业化能力与创新研发实力的高度认可，也体现出投资者对公司长期发展战略的充分信心。我们将充分利用此次融资所得，加快创新药物和AI+mRNA平台的开发，同时推进现有产品的商业化进程。凭借更为充足的资本基础，我们有信心在商业化拓展与研发创新双线并进，不断为患者与投资者创造更大价值。公司已构建国际领先的、完全整合且本地化的AI+mRNA平台，重点推进肿瘤和自身免疫疾病领域的产品管线开发，包括通用型现货肿瘤治疗性疫苗EVM14、个体化肿瘤治疗性疫苗EVM16，以及自体生成CAR-T项目。云顶新耀自主研发的首款个性化mRNA治疗性肿瘤疫苗EVM16的IIT研究已在今年3月于北京大学肿瘤医院顺利完成首例患者给药。该临床试验初步数据显示，即使低起始剂量也能激发晚期肿瘤患者特异性T细胞反应，具有良好的免疫原性。通用型现货肿瘤治疗性疫苗EVM14注射液的新药临床试验申请（IND）已获中国国家药品监督管理局和美国食品药品监督管理局（FDA）受理，成为公司首个实现“中美双报”的mRNA肿瘤治疗性疫苗。云顶新耀嘉善工厂已于2025年6月9日顺利放行首批GMP临床试验样品，该批样品将用于支持云顶新耀在中美两地开展EVM14的临床试验。自体生成CAR-T项目也已在人源化小鼠与非人灵长类（猴）模型中验证有效，具备现货型、无需淋巴耗竭、剂量可控等优势，展现了开发用于肿瘤及自身免疫疾病的潜力。拥有全球权益的新一代共价可逆BTK抑制剂EVER001正开展全球多中心临床研究，主要用于治疗原发性膜性肾病（pMN）等多种原发性肾小球疾病。其在原发性膜性肾病1b/2a期研究中展现出起效快、缓解持续、耐受性好、口服便捷等综合优势，有望为全球患者带来更优治疗选择。耐赋康®作为首个且唯一在中国、美国和欧洲获得完全批准的IgA肾病对因治疗药物，自纳入中国国家医保目录以来快速放量，已惠及超过两万名患者。公司亦正加快推进Gd-IgA1诊断试剂的转化，致力打造覆盖诊断、治疗、长期管理的一体化IgA肾病疾病管理生态。伊曲莫德（维适平®）在中国大陆的新药上市申请也已获受理，预计2025年底至2026年初获批，其新药上市申请也已获韩国受理。伊曲莫德已相继在中国澳门，新加坡和中国香港获批，并被纳入粤港澳大湾区内地9市临床急需进口港澳药品医疗器械目录（2024年），已在大湾区先行使用惠及溃疡性结肠炎患者，成为云顶新耀第三款商业化新药。2025年3月，云顶新耀启动了伊曲莫德位于嘉善工厂的生产建设项目，为伊曲莫德的本地化生产提供支持。云顶新耀正加快推进多个核心管线及技术平台的战略布局，进一步巩固其在亚洲领先创新药企中的市场地位。关于云顶新耀云顶新耀是一家专注于创新药和疫苗研发、临床开发、制造和商业化的生物制药公司，致力于满足亚洲市场尚未满足的医疗需求。云顶新耀的管理团队在中国及全球领先制药企业从事过高质量研发、临床开发、药政事务、化学制造与控制（CMC）、业务发展和商业化运营，拥有深厚的专长和丰富的经验。云顶新耀已打造多款疾病首创或者同类最佳的药物组合，公司的治疗领域包括肾科疾病、感染性和传染性疾病、自身免疫性疾病。有关更多信息，请访问公司网站：www.everestmedicines.com。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述，乃基于本公司或管理层在做出表述时对公司业务运营情况及财务状况的现有看法、相信、和现有预期，可能会使用“将”、“预期”、“预测”、“期望”、“打算”、“计划”、“相信”、“预估”、“确信”及其他类似词语进行表述。这些前瞻性表述并非对未来业绩的保证，会受到风险、不确定性及其他因素的影响，有些乃超出本公司的控制范围，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等各种因素及假设的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司及各附属公司、各位董事、管理人员、顾问及代理未曾且概不承担更新该稿件所载前瞻性表述以反映在本新闻稿发布日后最新信息、未来项目或情形的任何义务，除非法律要求。

免疫疗法细胞疗法临床申请IPO信使RNA

2025-07-25

·astrazeneca.com

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

AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, endorsing it for use in the European Union (EU) with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP).1 Trixeo is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) using a propellant that offers 99.9% lower GWP than propellants used in currently available pMDIs.2 This fixed-dose triple-combination therapy, marketed as Breztri Aerosphere in the US, China and Japan, will now have a low carbon footprint comparable to inhaled medicines that do not require a propellant.3 Based on the CHMP positive opinion, AstraZeneca will now begin to transition its Trixeo supply to the next-generation propellant in Europe. The CHMP positive opinion is based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant and Trixeo with the current propellant.4,5 The safety and tolerability profile for Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Frederik Trinkmann, Professor and Senior Pulmonologist at the Thoracic Clinic at Heidelberg University Hospital, Germany, said: “Respiratory medicines delivered by pressurised metered-dose inhalers are essential for millions of people living with respiratory diseases in Europe, including specific vulnerable populations such as children and the elderly. The transition of Trixeo to the propellant with near-zero Global Warming Potential ensures clinicians’ treatment decisions can focus on clinical needs while also supporting environmental goals.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The CHMP positive opinion of Trixeo Aerosphere with the next-generation propellant allows us to address the needs of both patients and the planet and is a significant milestone in our commitment to delivering innovations for sustainable healthcare in the EU. Starting with Trixeo, the transition to the near-zero Global Warming Potential propellant across our pressurised metered-dose inhaled respiratory medicines is an important step towards achieving our Ambition Zero Carbon strategy.” Susanna Palkonen, Director of the European Federation of Allergy and Airways Diseases Patients' Associations, said: “COPD is a devastating disease and the third leading cause of mortality in the world. People living with COPD need access to a treatment which is right for them as well as a healthy environment and clean air. We welcome the positive opinion from the CHMP for the inhaled respiratory medicine containing the next-generation propellant with a significantly reduced carbon footprint.” Trixeo with the next-generation propellant received its first approval in the UK in May 2025 with regulatory applications also currently under review in China and additional countries. Trixeo is the first medicine in AstraZeneca’s portfolio of medicines delivered by pMDIs to transition to the new propellant. AstraZeneca aims to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of the Company’s Ambition Zero Carbon strategy. In the EU, the Company plans to initiate the transition of Trixeo to the next-generation propellant in the coming months. Chronic respiratory diseases, including COPD, affect hundreds of millions of people around the world.6 Respiratory inhaled medicines delivered by pMDIs account for 76% of all inhaler use in Europe, and contribute 0.04% of global greenhouse gases.7,8 Studies show that the largest environmental contribution from respiratory diseases comes from patients’ symptoms not being adequately controlled and resulting increased healthcare utilisation.9,10 Implementing evidence-based guidelines into clinical practice can reduce exacerbations and unscheduled healthcare utilisation, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care.11 Notes AstraZeneca’s next-generation propellant clinical development programme The clinical development programme has been initiated to assess the efficacy and safety of the next-generation, near-zero Global Warming Potential propellant with the AstraZeneca portfolio of inhaled medicines delivered by pressurised metered-dose inhalers (pMDIs). The first medicine to be assessed in the programme was Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.12-17 The programme established bioequivalence between Breztri/Trixeo with the next-generation propellant and Breztri/Trixeo with the current propellant.4,5 The safety and tolerability profile for Breztri/Trixeo with the next-generation propellant was consistent with the known profile of the medicine. Additional studies are underway to assess the bioequivalence of the next-generation propellant to the current propellant with AstraZeneca’s other medicines delivered by pMDIs. Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Trixeo Aerosphere in the EU and UK and Breztri Aerosphere in Japan, China and the US, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting β2 agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an inhaled corticosteroid (ICS), and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat COPD in more than 80 countries worldwide including the US, EU, China, Japan, and has been prescribed to more than five million patients globally. Breztri/Trixeo Aerosphere with the next-generation propellant will maintain the same indication, product strength and dosage regimen as Breztri/Trixeo Aerosphere with the current propellant. AstraZeneca’s Collaboration with Honeywell Developed by Honeywell, the medical grade version of the next-generation propellant is critical to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant. Ambition Zero Carbon Through its Ambition Zero Carbon strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Corporate and financial

上市批准

2025-07-21

·CPHI制药在线

IgA肾病新药大爆发，Sibeprenlimab获优先审评，多款进入3期临床

关注并星标CPHI制药在线IgA肾病是沉默的"肾脏杀手"，是全球范围内最常见的原发性肾小球疾病之一。IgA肾病"偏爱"青壮年，临床表现多样，包括水肿、疲劳、肉眼血尿等，严重影响患者的生活质量。若不及时干预，绝大多数IgA肾病患者在10~15年内进展为终末期肾病（ESRD），最终需要透析或肾移植。IgA肾病的发病和发展机制复杂，目前普遍认为与免疫系统紊乱相关，比较公认的是"四重打击"学说。第一重打击：在遗传易感性基础上，个体遭遇潜在的细菌或者病毒感染后激发黏膜免疫反应，身体免疫应答失调，产生致病性半乳糖缺陷的IgA1（Gd-IgA1），Gd-IgA1不能被唾液酸糖蛋白受体识别，从而肝细胞无法将其清除，导致Gd-IgA1在体内异常蓄积；第二重打击：针对致病性IgA1抗原，产生抗Gd-IgA1分子抗体（主要为IgG）；第三重打击：这些致病性IgA1抗原与抗体形成免疫复合物；第四重打击：抗原抗体免疫复合物沉积在肾脏系膜区，激活补体系统和其他介质，刺激系膜细胞增殖、分泌系膜基质、细胞因子等而致肾小球炎症反应，最终导致肾小球硬化和间质纤维化。传统IgA肾病治疗以支持治疗为主，如生活方式干预、肾素血管紧张素系统抑制剂（RASi）、钠葡萄糖协同转运蛋白 2 抑制剂（SGLT2i），以及糖皮质激素等免疫抑制剂治疗等。然而传统治疗手段疗效有限，残留肾衰风险较高。IgA肾病迎来多款新药近年来，随着对IgA肾病发病机制研究的深入，多款IgA肾病新药获批上市，其治疗策略也逐渐向多靶点的综合治疗策略转变，从传统糖皮质激素治疗时代走向基于发病机制的靶向治疗时代。据不完全统计，近年来全球监管机构批准了四款IgA肾病新药，即Nefecon（布地奈德肠溶胶囊）、Sparsentan（司帕生坦）、iptacopan（伊普可泮）和atrasentan（阿曲生坦），这四款药物均通过口服给药。其中Nefecon是一种布地奈德的缓释制剂，2021年12月被FDA加速批准用于降低有疾病快速进展风险(通常为尿蛋白与肌酐之比(UPCR) ≥1.5g/g)的成人原发性IgA肾病患者的蛋白尿。Sparsentan是一款双重内皮素血管紧张素受体拮抗剂，2023年2月被FDA批准用于具有疾病快速进展风险，且尿蛋白与肌酐比值（UPCR）≥1.5 g·g－1的原发性IgAN成人患者。iptacopan是一种口服的、补体旁路途径的B因子抑制剂，2024年8月被FDA批准用于降低成人IgA肾病患者的蛋白尿水平，这些患者有疾病迅速进展的风险。atrasentan是一款强效选择性ETA（内皮素A）受体拮抗剂，2025年4月被FDA加速批准用于降低有疾病进展风险的原发性IgA肾病成人患者的蛋白尿。遗憾的是，上述药物中仅Nefecon在国内获批治疗IgA肾病。据悉Nefecon自2024年5月在国内上市以来，7个月为云顶新耀贡献了3.53亿元收入，为公司贡献了一半的销售额。多款在研药物蓄势待发据不完全统计，全球还有多款在研IgA肾病新疗法进入临床后期，如Visterra/大冢制药的Sibeprenlimab（上市申请）、诺华/Chinook Therapeutics的Zigakibart（3期临床）、荣昌生物的泰它西普（3期临床）、Vertex /Alpine的povetacicept（3期临床）、渤健的Felzartamab（3期临床）、Vera Therapeutics的atacicept（3期临床）。其中Sibeprenlimab（VIS649）是大冢制药收购Visterra获得的一款抗增殖诱导配体（APRIL）单抗，通过结合和中和APRIL，减少IgA和致病性Gd-IgA1的数量。已公布的临床试验结果显示sibeprenlimab可减少IgA肾病蛋白尿，延缓eGFR下降。2025年5月，该药治疗IgAN的BLA获FDA受理，并被授予优先审评资格，PDUFA日期为2025年11月28日。Sibeprenlimab给药便捷，每4周皮下注射一次。值得一提的是，Sibeprenlimab已在国内申请上市，并被纳入优先审评。Zigakibart是诺华收购Chinook Therapeutics获得的一款抗APRIL人源化单抗。已公布的1/2期临床试验结果显示：Zigakibart可实现3个月内有临床意义的蛋白尿减少，并在研究期间持续降低血清Gd-IgA1，且在IgAN患者中耐受性良好。给药频率上，Zigakibart每2周皮下注射一次。泰它西普是一种新型重组融合蛋白，由跨膜激活剂、钙调节剂和亲环蛋白配体相互作用物（TACI）受体的配体结合结构域和人免疫球蛋白（IgG）的Fc段组成，通过靶向BLyS/APRIL双通路，抑制异常活化的B细胞和自身抗体生成，从源头干预IgAN的免疫病理过程。既往2期临床研究显示：泰它西普治疗24周（尤其是每周240mg的剂量）可有效降低IgAN患者蛋白尿。进一步分析表明，泰它西普还可降低IgAN患者的循环Gd-IgA1和IgA免疫复合物。Povetacicept是一种 Fc 融合蛋白，通过定向进化技术优化了TACI（跨膜激活剂和钙调磷酸酶配体相互作用分子）结构域，能够更有效地实现对BAFF和APRIL的双重抑制。该药每4周皮下注射一次，已公布的1b/2a期研究研究RUBY-3 的初步结果显示：Povetacicept在IgA肾病患者中显示出良好的耐受性和疾病活动度的改善，包括UPCR的降低和肾功能的稳定，同时伴随Gd-IgA1的减少。Felzartamab是一种抗CD38单克隆抗体，临床研究证实其能选择性地清除CD38阳性细胞，包括浆细胞，而浆细胞正是产生自身抗体（这些抗体错误地攻击身体自身组织）的源头。已公布的2a期临床试验结果显示：Felzartamab靶向抑制CD38的治疗可以持续减少IgA肾病患者的蛋白尿，改善IgAN的疾病预后。Atacicept是一种人源化的TACI-Fc融合蛋白，能够抑制BAFF和APRIL，从而减少B细胞的激活和自身抗体的产生。Atacicept治疗IgAN的2期临床数据显示：第36周时，与安慰剂相比，全Atacicept组都观察到蛋白尿的进一步减少；eGFR变化稳定；GD-IgA1持续降低。安全性、耐受性良好。2025年5月，atacicept治疗IgA肾病的 3期临床试验ORIGIN达到主要终点，受试者蛋白尿水平显著降低。此外，恒瑞医药的HR19042、Biohaven的BHV-1400等也被开发用于治疗IgA肾病，其中HR19042胶囊是由恒瑞医药自主研发并具有知识产权的改良型新药，为口服肠溶缓释胶囊。BHV-1400是Biohaven基于其胞外蛋白分子降解剂（MoDE）技术平台开发的一款靶向去除异常蛋白（TRAP）降解剂，据悉其可以实现在精准降低IgA肾病的致病性抗体水平且同时维持正常的正常免疫球蛋白水平。已公布的1期临床试验结果显示：BHV-1400可以在单次给药4h内迅速、强效、选择性降低IgA肾病患者的致病性Gd-IgA1抗体水平，同时将IgA等免疫球蛋白的水平保持在正常范围内。总结据弗若斯特沙利文数据，全球IgA肾病治疗药物市场保持快速增长，预计从2020年的5.67亿美元增至2025年的11.96亿美元。随着越来越多IgA肾病新药的获批上市，该领域势必将展开激烈进展，市场规模不断膨胀。END来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

优先审批临床3期上市批准加速审批临床结果

100 项与布地奈德相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00246	布地奈德	A07EA06 D07AC09 R01AD05	DB01222

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
免疫球蛋白a肾病	美国	Calliditas Therapeutics AB	2021-12-15
嗜酸粒细胞性食管炎	欧盟	Dr. Falk Pharma GmbH	2018-01-08
嗜酸粒细胞性食管炎	冰岛	Dr. Falk Pharma GmbH	2018-01-08
嗜酸粒细胞性食管炎	列支敦士登	Dr. Falk Pharma GmbH	2018-01-08
嗜酸粒细胞性食管炎	挪威	Dr. Falk Pharma GmbH	2018-01-08
溃疡性结肠炎	美国	Salix Pharmaceuticals, Inc.	2013-01-14
克罗恩病	美国	Padagis US LLC	2001-10-02
季节性常年性变应性鼻炎	美国	Johnson & Johnson de Colombia SA	1999-10-01
哮喘	韩国	Astrazeneca Korea Ltd.	1993-12-17

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
变应性结膜炎	临床3期	奥地利	Marinomed Biotech AG	2018-11-19
终末期肾脏病	临床3期	美国	Calliditas Therapeutics AB	2018-09-05
终末期肾脏病	临床3期	美国	云屹药业（上海）有限公司	2018-09-05
终末期肾脏病	临床3期	阿根廷	Calliditas Therapeutics AB	2018-09-05
终末期肾脏病	临床3期	阿根廷	云屹药业（上海）有限公司	2018-09-05
终末期肾脏病	临床3期	澳大利亚	云屹药业（上海）有限公司	2018-09-05
终末期肾脏病	临床3期	澳大利亚	Calliditas Therapeutics AB	2018-09-05
终末期肾脏病	临床3期	白俄罗斯	Calliditas Therapeutics AB	2018-09-05
终末期肾脏病	临床3期	白俄罗斯	云屹药业（上海）有限公司	2018-09-05
终末期肾脏病	临床3期	比利时	云屹药业（上海）有限公司	2018-09-05

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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


NCT02605837 (Pubmed \| Am J Gastroenterol)	临床3期	嗜酸粒细胞性食管炎	318	Budesonide Oral Suspension 2.0 mg twice daily	艱鑰廠獵遞觸鹽醖積襯(築製範淵鹹構醖襯製夢) = 壓鹽觸膚鏇網糧鹹齋築窪構網壓窪顧鏇願醖範 (鹹築網簾廠願糧築範選 )	积极	2025-07-01
				Placebo	艱鑰廠獵遞觸鹽醖積襯(築製範淵鹹構醖襯製夢) = 襯願壓構繭積製膚繭衊窪構網壓窪顧鏇願醖範 (鹹築網簾廠願糧築範選 )
NCT02907593 (SASSIE, CTgov)	临床1/2期	支气管肺发育不良	25	Budesonide in Calfactant (0.025 mg/kg Budesonide)	廠艱遞顧簾構網蓋鑰遞 = 鏇壓艱網遞鏇襯鑰衊廠網醖鹽憲鹽鬱蓋鑰願範 (廠網積憲憲鏇鹽獵壓簾, 蓋鹹艱鹹遞蓋網齋艱構 ~ 顧範繭繭壓壓憲製齋鏇) 更多	-	2025-04-04
				Budesonide in Calfactant (0.050 mg/kg Budesonide)	廠艱遞顧簾構網蓋鑰遞 = 蓋壓鏇網餘襯鬱齋壓觸網醖鹽憲鹽鬱蓋鑰願範 (廠網積憲憲鏇鹽獵壓簾, 觸膚襯觸鬱艱窪憲觸簾 ~ 網鏇鏇壓鏇簾艱窪蓋膚) 更多
NCT03245840 (SHP621-303, Pubmed \| Clin Gastroenterol Hepatol)	临床3期	嗜酸粒细胞性食管炎	131	Budesonide Oral Suspension 2.0 mg twice daily	獵淵製窪艱網壓壓餘廠(鑰鹽蓋鹽壓廠襯艱衊衊) = 3.1% (4/131) 範齋鹽鏇築鏇獵鬱鬱願 (壓築網製鹽壓築鑰製鬱 ) 更多	积极	2025-02-01
				Placebo-Budesonide Oral Suspension 2.0 mg twice daily
NCT04294641 (CTgov)	临床2期	慢性移植物抗宿主病	10	Ibrutinib	簾積獵廠夢淵糧蓋製齋 = 夢顧廠淵獵網構網衊膚膚網積憲選壓窪鬱構淵 (糧淵醖蓋網顧膚顧鹽鹽, 簾蓋蓋膚製構網願獵淵 ~ 鬱艱衊淵齋積構鹽積糧) 更多	-	2025-01-22
NCT04541043 (Nefigard-OLE, CTgov)	临床3期	免疫球蛋白a肾病	119	Nefecon (Retreatment - Previously Treated With Nefecon in Nef-301 Study)	膚餘廠願糧範醖憲繭願(積蓋膚鹽積醖膚築選遞) = 積夢憲憲壓鑰蓋壓廠築願網鹹淵選壓壓顧願範 (窪艱鹹衊網獵鹽餘網遞, 網築蓋築選鬱鏇衊蓋鹹 ~ 窪鑰窪齋廠鏇觸夢艱餘) 更多	-	2025-01-03
				Placebo (Delayed Treatment - Previously Treated With Placebo in Nef-301 Study)	膚餘廠願糧範醖憲繭願(積蓋膚鹽積醖膚築選遞) = 願鏇網蓋糧積鑰窪願觸願網鹹淵選壓壓顧願範 (窪艱鹹衊網獵鹽餘網遞, 製襯蓋顧餘簾糧獵構醖 ~ 鬱網構餘壓襯窪遞網淵) 更多
ASH2024	N/A	急性移植物抗宿主病	-	PTCy-based GVHD prophylaxis + Budesonide	願淵積膚餘製鹹壓醖壓(夢餘構鬱餘餘範網鏇範) = 鬱夢壓襯製簾簾壓積顧遞繭夢網獵夢憲構顧製 (鹹襯鑰窪繭遞醖餘憲構, 1.68 ~ 11.74) 更多	-	2024-12-09
NCT03643965 (Nefigard, CTgov)	临床3期	终末期肾脏病 \| 免疫球蛋白a肾病	365	Nefecon (Nefecon)	積積醖選夢窪網積壓積(網構夢鑰醖築觸鑰鏇廠) = 壓鏇膚鹽繭壓憲選壓壓構廠製醖繭齋衊簾衊夢 (襯窪製顧繭積鏇鬱蓋憲, 構鬱鑰淵艱憲網遞積獵 ~ 衊鹹壓鏇鬱網廠製衊製) 更多	-	2024-12-03
				Placebo oral capsule (Placebo Oral Capsule)	積積醖選夢窪網積壓積(網構夢鑰醖築觸鑰鏇廠) = 膚膚範窪鏇淵鏇觸觸網構廠製醖繭齋衊簾衊夢 (襯窪製顧繭積鏇鬱蓋憲, 鏇遞糧範選艱網選觸蓋 ~ 鹹簾餘壓廠襯顧夢餘鹽) 更多
NCT02493335 (Pubmed \| Clin Gastroenterol Hepatol)	临床3期	嗜酸粒细胞性食管炎维持	186	Budesonide Orodispersible Tablets 0.5 mg	鹽壓襯鏇淵簾窪選窪蓋(觸餘艱觸顧窪築顧壓餘) = occurred at similar rates to prior BOT studies, and was predominantly mild and resolved with treatment 憲醖鹽餘糧襯淵醖網築 (廠醖觸鬱鬱衊觸餘構鹽 )	积极	2024-12-01
				Budesonide Orodispersible Tablets 1.0 mg
NCT04541043 (Nefigard-OLE, NEWS) 人工标引	临床3期	免疫球蛋白a肾病	119	耐赋康	築製簾鏇網築獵製廠廠(醖顧製襯艱餘網獵鬱願) = 鹹鹹鏇蓋鑰簾襯鬱繭構餘構齋夢夢鬱鹽艱淵繭 (簾膚膚糧蓋製範遞壓襯 ) 更多	积极	2024-11-11
				耐赋康 (既往接受耐赋康)	築製簾鏇網築獵製廠廠(醖顧製襯艱餘網獵鬱願) = 廠憲構鹹構夢獵製鬱艱餘構齋夢夢鬱鹽艱淵繭 (簾膚膚糧蓋製範遞壓襯 ) 更多