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更新于：2025-10-14

Budesonide

布地奈德

更新于：2025-10-14

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

+ [73]

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

AstraZeneca PLC

Calliditas Therapeutics AB正大天晴（广州）医药有限公司

+ [28]

非在研机构

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

Pearl Therapeutics, Inc.

+ [7]

权益机构

Kissei Pharmaceutical Co., Ltd.Ferring Holding SA

Calliditas Therapeutics AB

+ [25]

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)、优先审评 (中国)、突破性疗法 (中国)、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)、孤儿药 (日本)、附条件批准 (中国)

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结构/序列

分子式C25H34O6

InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N

CAS号51333-22-3

关联

714

项与布地奈德相关的临床试验

NCT05976802

/ Not yet recruiting临床4期

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (UC).

开始日期2027-06-01

申办/合作机构

Bausch Health Americas, Inc.

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2026-03-01

申办/合作机构

University of Wisconsin Madison

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2025-12-01

申办/合作机构

AHS Cancer Control Alberta

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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8,524

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 ; Lu, Wei ; Guo, 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·BIOCHEMICAL PHARMACOLOGY

Inhibition of macrophage extracellular traps by Metrnl/IL-41 suppresses airway remodeling in asthma

Article

作者: Li, Hongtao ; Lin, Yusen ; Feng, Kangni ; Zhang, Tiantuo ; Zou, Xiaoling ; Cen, Jiemei ; Yang, Hailing ; He, Chunyan

Macrophage extracellular traps (METs) are crucial for initiating airway inflammation and modulating the immune microenvironment of asthmatic airways. Metrnl/IL-41 is a negative regulator of airway inflammatory responses. However, the role of Metrnl/IL-41 in the cross-talk between METs and airway epithelial cells, as well as its effect on the pathophysiology of asthma airway remodeling, are still unclear. We aimed to elucidate the role of METs and Metrnl/IL-41 in airway epithelial cells and chronic asthma. Immunofluorescence and scanning electron microscopy were used to visualize METs formation. The effects of Metrnl/IL-41 on the proliferation, epithelial‒mesenchymal transition (EMT), and migration of METs-treated 16-HBE cells were determined. The role of Metrnl/IL-41 in macrophage polarization was analyzed. A chronic asthmatic murine model was established to explore the effects of rm-Metrnl/IL-41 and budesonide on lung histopathology changes, airway hyperresponsiveness, and airway inflammation and airway remodeling. Exposure to house dust mite (HDM) induced METs production in macrophages. Metrnl/IL-41 partially abrogated METs-mediated migration and EMT in 16-HBE cells by inhibiting the nuclear factor-κB (NF-κB) and extracellular signal-regulated kinase 1/2 (ERK1/2) signaling pathways. Rm-Metrnl/IL-41 reduced airway inflammation, airway hyperresponsiveness, mucus secretion, collagen deposition, transforming growth factor-β1 (TGF-β1) levels, and EMT-related protein levels in asthmatic mice. Additionally, Metrnl/IL-41 significantly reduced neutrophils, M1 macrophages, and Th17 cells numbers in the lungs of asthmatic mice. METs play critical roles in EMT and airway remodeling, inhibiting METs formation may constitute a prospective therapeutic approach for asthma. Metrnl/IL-41 is a crucial protective cytokine against airway inflammation, indicating its potential as a therapeutic target in asthma.

1,044

项与布地奈德相关的新闻（医药）

2025-10-14

·正大天晴药业集团

再获国际认可！正大天晴安罗替尼生产线“零缺陷”通过欧亚经济联盟GMP检查

近日，正大天晴一次性、零缺陷通过了盐酸安罗替尼胶囊（福可维®）的欧亚经济联盟（EAEU）GMP符合性检查。继氟维司群注射液（晴可依®）与吸入用布地奈德混悬液（天晴速畅®）相继通过EAEU GMP认证后，本次口服固体制剂的成功认证，进一步彰显了公司在多剂型质量管理体系上的国际合规能力。高标准生产体系将进一步加速企业全球化布局。欧亚经济联盟（EAEU）成员国是“一带一路”沿线的关键市场，获得EAEU GMP证书是药品在这些国家注册和销售的必要条件。在此次现场检查中，官方检查员对正大天晴海州生产基地的质量体系、生产控制、物料管理、实验室控制、文件记录等环节进行了全面、严格的审核。检查员对基地先进的硬件设施、成熟的质量管理体系、员工的专业能力均给予高度评价。盐酸安罗替尼胶囊是正大天晴自主研发的1类创新小分子酪氨酸激酶抑制剂（TKI），目前已在中国获批包括非小细胞肺癌、小细胞肺癌、甲状腺髓样癌、子宫内膜癌、软组织肉瘤等九项适应症。此次认证的顺利通过，将有力推动公司核心产品加快进入欧亚经济联盟成员国市场。海州生产基地作为公司重要的制剂生产基地之一，自建设之初即严格遵循欧盟及美国FDA标准进行设计与运营，现已建成覆盖固体制剂、吸入粉雾剂、吸入液体制剂、预充式小容量注射剂、冻干粉针剂等多条高标准生产线。凭借持续的技术投入与严格的质量管控，该基地已有多条生产线通过欧盟、美国FDA及EAEU的认证，10多个产品出口到全球60多个国家/地区。去年，正大天晴润众生产基地同样以“零缺陷”的表现，第三次通过美国FDA现场检查。此次EAEU GMP认证，不仅是对公司质量管理实力的再次肯定，也为公司进一步推进创新产品国际注册与商业化、深化全球产业布局奠定基础。公司将继续秉持高标准、严要求的质量管理理念，持续强化全球供应链能力，为更多国际市场提供高品质的药物选择。声明： 1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2.本公司不对任何药品和/或适应症作推荐。 3.本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● 正大天晴双抗ADC TQB2102再获突破性治疗认定，惠及HER2高表达晚期肠癌患者 ● ERS 2025 | “头对头”临床等效，正大天晴乌美溴铵维兰特罗吸入粉雾剂加速上市 ● ERS 2025 | PDE3/4抑制剂TQC3721Ⅱ期临床数据公布：4周改善肺功能与症状 ● 用格莱美慢镜头，打开中国生物制药

抗体药物偶联物一致性评价突破性疗法上市批准引进/卖出

2025-10-13

·Pharmaceutical Technology

AstraZeneca inks Trump drug pricing deal amid tariff threats

AstraZeneca has inked a deal with the US government to offer three of its branded respiratory drugs at up to 80% discounts through DTC platform, TrumpRx.gov. Image credit: MMPhoto21 via ShutterStock.com. UK-Swedish pharmaceutical giant AstraZeneca has signed a drug pricing deal with the US government, becoming the second industry titan to do so this month. After convening with President Donald Trump at the White House, the company’s CEO, Pascal Soriot, shook hands with the president on drug price reductions of up to 80% within its chronic disease portfolio. The agreement will see AstraZeneca provide three branded respiratory medications to cash-paying patients at a concession through the US government’s direct-to-consumer (DTC) platform, TrumpRx.gov, which is set to launch in January 2026. Medications tied to the deal include chronic obstructive pulmonary disease (COPD) meds Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate), as well as asthma treatment, Airspura (albuterol 90 mcg/budesonide 80 mcg). All three drugs will also be available to State Medicaid programmes at MFN prices. In return for penning a deal with the Trump administration, AstraZeneca will escape three years’ worth of 100% branded pharmaceutical import tariffs , which were threatened in September 2025. Though these taxes were set to come into effect on 1 October, they are yet to be implemented amid Trump’s ongoing pricing negotiations with the industry. In a 10 October statement, AstraZeneca noted that a tariff exemption will allow it to “fully onshore medicines manufacturing” to the US, meaning that all its branded products sold in America will be produced on home soil. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The UK-Swedish pharma will achieve this through a $50bn investment into its American operations, which will see it pour $4.5bn into a new drug production facility in Virginia – the biggest manufacturing investment in the company’s history. Following its US onshoring push, AstraZeneca forecasts to attain $80bn in total revenue by 2030, of which half will come from US drug sales. MFN deals gain traction AstraZeneca has now become the second big pharma along with Pfizer to close a Most Favoured Nation (MFN) deal with the US government, marking another potential shift in global drug pricing policy. According to the Trump administration, MFN deals will see US patients gain access to branded pharmaceuticals for cheaper. This would likely be welcome news for them, as many are struggling to pay sky-high prescription costs compared with other developed nations worldwide. Pfizer’s CEO, Albert Bourla broke the stalemate between big pharma and Trump earlier this month. Bourla offered up a select range of the pharma company’s branded drugs through the TrumpRx.gov platform for 50% less, on average, than their respective list prices. However, analysts at GlobalData, parent company of Pharmaceutical Technology , are sceptical about the impact MFN drug pricing deals will have on healthcare costs , as many choose to obtain prescriptions through an insurance plan, which already offers concessions. While the true impact of MFN deals on drug pricing are yet to be seen, Cyrus Fan, healthcare and life sciences analyst at GlobalData noted that “more deals will likely be announced soon,” citing Amgen as the potential third company to reach a deal with the Trump administration. GlobalData is the parent company of Pharmaceutical Technology . Meanwhile, on the R&D front, key opinion leaders (KOLs) note that rising MFN costs are unlikely to impact the space , while Ambassador Jeffrey Gerrish, deputy US Trade Representative for Asia, Europe and the Middle East noted that the move could actually “turbocharge R&D investments” in the future. Editor’s note: This article was amended on 13 October, 2025 to add comment from healthcare and life science analyst at GlobalData, Cyrus Fan. Navigate the shifting tariff landscape with real-time data and market-leading analysis. Request a free demo for GlobalData’s Strategic Intelligence here . Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

2025-10-11

·深蓝观

罕见病寒冬里的NewCo：中美创新合作的逆行实验

王晨 | 撰文吴妮 | 编辑最近几个月，在波士顿的生物制药界人士，又开始了往返中美的旅程。家在波士顿的生物制药投资人、康桥资本运营合伙人曹武雄，就是其中一员，过去两年多次在中国考察。他的举动，在此刻，让人觉得无比合理。相比于美国生物制药依旧处在寒冬期，中国生物制药一下子从寒冬进入盛夏。港股创新药企率先炙手可热，半年前还在挣扎于现金流衰竭，困于融资和难以上市困境的中国biotech，一下子成了港股18A上市仪式上大宴宾客、风头无二的主角。在烫手的二级市场中，一级市场的回温只是时间的问题。在嗅到未来的机会方面，投资人，一直是嗅觉最敏锐的人群之一。曹武雄所在的康桥，在生物制药领域，以大胆的资本运作、从头开始选择项目、搭建团队闻名，在创新药热潮中独辟蹊径。他参与了多家康桥孵化公司的运营。因此，经历过寒冬的投资人和产业界人士，应该更能知道哪里的水是暖的。但他最近几个月的行为却制造了一个悬念。他回国考察并准备落地成立的公司，是一个和罕见病相关的项目。罕见病，反倒是现在中国生物制药大环境下，为数不多的“极寒之地”。中国医保支付改革为普惠百姓，将一些高价药品低价纳入医保，价格高但病人群体极少的罕见病药物，却一下子因降价陷入商业化困境。罕见病外企，近年裁员或开始撤离，罕见病biotech北海康成，近年来一直挣扎受困于现金流，最近港股市场火爆才因为板块热度暂时脱离困局。中国罕见病市场，进入了一种“在里面的要逃出来，在外面的也不想进去”的局面。虽然价值投资还有一句话“在别人贪婪的时候保持警惕，在别人恐惧时要勇于出手。”但这是基于大环境的逆向思维，在产业界和投资人眼中，在中国逐步步入盛夏的创新药市场中，罕见病依旧是“让人恐惧”的存在，是资本和产业的避险之地。为什么在机会遍地的此刻，还有人要涉足险境？ -01-罕见病向左走，向右走曹武雄还有一个身份，是康桥在美国孵化的一家公司MLAB的CEO。这家4年前开始立项、3年前成立的公司正在研发一款罕见病杜氏肌肉营养症的药品。另外两位联合创始人朱云祥和陈扬德，是曹武雄在赛诺菲健赞（Sanofi Genzyme）的前同事——三位都在罕见病领域工作多年。三人一起工作过的健赞是被赛诺菲收购的一家罕见病公司，成功商业化多款罕见病药品，其中一款治疗晚发型庞贝病的Nexviazyme（学名 avalglucosidase alfa-ngpt），现在每年的销售额已在8亿美金左右，朱云祥是这款药物的唯一专利发明人。和中国不同的是，美国VC一直很愿意投资罕见病药物。罕见病在欧美市场有明确的商业价值。对投资而言，研发投入相对较低，临床周期短，病人数少，相对成本可控；在监管方面，FDA对极大临床价值的罕见病药物，有许多绿色通道。同时这类药物的研发非常考验创新能力——因此在全球创新中心波士顿成立罕见病公司，非常普遍。“在波士顿，让项目能够从早期科学研究逐步推进到毒理试验，再到临床阶段，是非常快速的。” 正好在四年多前，早期以中国市场为主的康桥，正处于转型期，逐渐开始向全球扩展。曹武雄卸任康桥投资孵化的biotech云顶新耀CEO之后，开始研究全球市场。先在日本做了一家罕见病公司，同时也在美国做一些早期孵化的工作——思路类似VC基金，早期创新项目孵化全都由基金掌控。 MLAB应运而生。杜氏肌肉营养症在美国大约有1.5万名患者，在罕见病中属于患者数量相对较多的类型，既具备研发意义，也有市场潜力。一开始成立时，这就是一家美国公司。那个时候，整个战略规划并没有在中国落地的打算。在过去十年间，虽然中国创新药蓬勃发展，但是罕见病药物却遭遇困境。十多年前，在美国罕见病领域如赛诺菲工作的华人科学家们，常常讨论当时的中国药监体制改革。那个时候中国创新药的评审直接对标FDA，资本市场改革配套进行。“大家很乐观，觉得整个顶层设计，包括支付市场会和药物评审改革一同进行”。一位华人科学家回忆。早期归国的创业者，最先看中的是中国庞大患者基数造就的商业市场。2012年，在健赞担任中国区高管的薛群，创立了北海康成，一家专注罕见病药物研发的公司。它的模式和中国最早期的biotech如再鼎一样：从海外引进后期或已上市药物的中国权益，利用中国临床速度优势，在本土完成注册和商业化。 3年以后2015年，康桥也孵化了一家biotech公司云顶新耀，和北海康成一样，也是引进海外创新药在中国进行商业化运作。但两个奔向中国商业化市场的公司却走向了不同的命运。北海康成在中国商业化了三款罕见病药物，是中国第一个做出罕见病药物上市的公司。但药上市了，却由于罕见病患者的规模太小，公司赚不到钱。北海康城在2022年和2023年分别砸下了3.11亿和2.57亿人民币的研发重金成功将产品推向市场，2023年营收突破1亿元大关，同比增长30.3%。这足以证明其团队强大的执行力。然而，这份看似亮眼的成绩单背后，是同期高达3.788亿元的巨额亏损。2025年5月，一度传来北海康城现金流不足的问题。它的底层逻辑有一个根本性错配：引入的是一个基于全球市场价值预期的成本结构，去博弈一个支付能力受限的本土市场回报。而云顶新耀的唯一一款商业化的产品耐赋康项目，和北海康成一样，在欧美市场也是罕见病药物。不一样的是，耐赋康治疗的IgA肾病在欧美是罕见病，但在中国及东亚却是很常见的肾小球疾病——在中国这属于常见病。 “我们当时就在找这种病：在欧美非常罕见，但在中国并不少见，”曹武雄解释道，”IgA肾病在欧美只有几万病人，不受关注。但我们发现这个病在中国可能有上百万病人。”这个数字彻底颠覆了罕见病的商业逻辑。据估计，中国IgA肾病患者高达220万至500万，这是一片广阔的蓝海。耐赋康2023年底在中国获批，仅2024年销售额就达到3.53亿元，业界预测其首个完整年度销售额有望突破10亿，远期峰值甚至上看50亿。云顶新耀之后，也有不少公司步其后尘，开始做IgA肾病的创新药。但耐赋康在中国市场商业化的成功，并非罕见病药的成功；但北海康成上市罕见病药商业化的远低于预期，却是罕见病药品在中国市场的失败。当商业化在国内成为海市蜃楼时，以罕见病项目在中国立项、拿投资更成为不可能的事情。 -02-中国临床加速度 2022年成立的MLAB，开始就是一个美国故事。一直到2025年，它也没有掺杂中国叙事。公司临床前阶段，进行的比较顺利。一年后，即将开启临床试验。在这一阶段，他们发现美国市场和中国市场的极大不同。一般而言，创新药公司在做临床试验时，公司通常会在美国、中国和澳大利亚三地中选择。美国IND审批流程相对快，且市场认可度高；中国监管最严格，审批周期长，但病人数量多；澳大利亚监管宽松，审批最快，但患者少。对于常见病的一期临床，许多中国公司倾向在澳大利亚先做小规模实验，因为健康志愿者充足；而肿瘤或罕见病药物则更偏向美国，既审批快又有较多患者可入组。在他们最初规划罕见病临床试验的时候，美国本来是首选。杜氏肌营养症（DMD）的患者群体庞大，美国大约有1万多名患者——这在罕见病中已经算不小的群体了。然而，美国市场的挑战也在于它的创新性——太多公司都在做DMD的基因治疗或小核酸药物，病人经常被不同临床中心“抢走”，入组像打仗一样，需要和其他公司争夺患者资源。相比之下，中国的情况则像另一番景象。虽然之前中国的患者人数众多已经是一个成型的概念，但曹武雄在中国跟罕见病医生交流后，对这一概念才有在时间和成本投入方面的清晰认知：中国的患者数量多得惊人，而且高度集中在少数大型儿童医院——复旦儿童医院、北京儿童医院、同济医院、中山医院以及华西医院。 “一个科室、一个医生就可能有三千名患者。这种集中度让临床入组变得高效得多。而一个美国医生，手头只有十几个病人，还有十家公司抢。”他的这句话意味着，在美国入组DMD病人可能需要一年，在中国只需要3到6个月——利用中国平台能将全球研发时间表缩短近一年。而这种临床速度的时间差，能够对冲中国监管比美国时间慢的时间窗口。此外，在中国进行临床试验，直接花费通常比美国低30%左右。 -03-交易架构的设计在创新药领域中，美国有研发优势、中国有临床优势，这些并不是秘密。许多大型MNC选择和中国biotech合作，也往往基于中国的临床效率。在美国进行早期研发，临床试验阶段落地中国，是很多产业界人士的共识。曹武雄忽然有一个想法，如何在投资架构上进行设计，能让中国投资人对罕见病项目重燃热情，并快速分享投资回报红利？而中国患者也能分享到这种红利？而罕见病药品在中国的困境，是因为在中国市场商业价值暂时难以实现，并非罕见病药品缺乏价值。一个大家都不愿看到的可能性是：如果国外的MNC商业化长期难以实现，中国的罕见病公司融不到资金，那么中国患者可及的罕见病药物势必会减少。是否有一种可以整合中美创新药产业链优势，将风险与价值在牌桌两端重新分配的创新架构？在商业和产业逻辑上，曹武雄逐渐想清楚了一个交易架构。在传统模式下，区域性BD和投资交易的价值核心是：产品在各自区域的商业化价值。每个项目在各自区域投入的研发费用是否能得到合理的回报，必然是由这个产品在这个区域的商业化价值决定的。这就意味着罕见病创新药项目在中国的研发投入很难回本。要想打破这种局面，必须让中国在罕见病创新药研发的投入，能够分到国际市场商业化的利益。解决这个问题的核心是如何利用商业化前研发数据，特别是临床试验数据的价值分配，来平衡不同区域投资人的回报。首先利用美元基金与美国创新生态，在海外完成高风险的技术攻坚至IND阶段；随后在中国成立公司，引入人民币基金，凭借中国的临床资源与成本优势高效推进早期临床；其核心在于，中国公司不仅获得本土权益，更能从后续全球权益授权中分享数据变现的收益，这使得中国投资人能精准押注临床这一高价值阶段，并大幅加速资金回报周期。而在中国和美国，曹武雄所在的康桥资本，采用从零开始创建并运营生物科技公司的模式，这些经验已成为其独特的竞争优势。在这种交易架构下，资源、价值和收益重新分配：中国的投资者能以更低风险、更短周期，参与到全球最前沿创新药的研发并获得相应的回报。美国的孵化方能以更高的资本效率，加速管线推进；而中国的患者，不仅能更早接触到前沿疗法，当药物最终上市时，由于研发成本被全球分摊，其定价和医保谈判的压力也将大大减小。它将药物开发价值链的各个环节，匹配到全球最高效的资源所在地，是一个能够催生多方共赢的良性生态。而且，如果这种交易架构最终能成功落地，不只是投资者能够分享临床数据license out的红利，会有价格更普惠的罕见病药，进入中国市场。这一结果，始于商业逻辑，最终却可能达成“罕见病药品普惠中国病人”的价值闭环。 “而‘普惠病人’的情怀，不能脱离商业和产品逻辑，也不能错了顺序。”曹武雄很诚实的表示，“情怀是一种结果，而不是前提条件”。在曹武雄2023年刚参与创办MLAB时，并没有想到顶层设计上交易架构的创新。当时建立公司，是一种非常明晰的技术和商业逻辑——选择在美国做罕见病公司，“因为技术、人才和钱都在这里”，只是随着项目的推进进程，逐步发现各个阶段、不同地方资源效率的异同。在他从产业界进入投资界，并参与孵化项目运营多年的经验中，他认为投融资的顺序是：先谈技术和产品，再谈钱，逐渐落地后，才谈情怀。而在很多投融资的场景中，先谈情怀，再圈钱，最后才是技术和产品，这种顺序的错配，导致了很多泡沫的产生。只谈情怀，罕见病项目依旧很难融资。但如果在技术和回报率可以算清楚的时候，情怀就不是问题：如果一款罕见病药物在美国市场商业化、上市，而且公司能分享到这部分的回报，那么在中国的价格就更有弹性，可以承担进入医保支付的降价。在未来一年中，这种产品、商业和情怀的闭环，这场中美资本、产业链高效合作叙事，是否真能如期落地？ ...... 欢迎添加作者交流：王晨：fanxinbeijing2007

并购

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,

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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,

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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	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	澳大利亚	Calliditas Therapeutics AB	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	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	Calliditas Therapeutics AB	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


NCT04545866 (Pubmed \| JAMA)	临床3期	支气管肺发育不良	641	Budesonide + Surfactant	壓醖範鏇繭積憲窪繭獵(積壓構鹹選襯鑰襯鹽蓋) = 壓鹹鹹衊醖觸網壓廠鬱簾製艱繭構窪鬱繭鏇糧 (艱觸築鑰鹽醖艱醖積積 ) 更多	不佳	2025-09-30
				Surfactant alone	壓醖範鏇繭積憲窪繭獵(積壓構鹹選襯鑰襯鹽蓋) = 蓋廠製繭選獵糧選淵艱簾製艱繭構窪鬱繭鏇糧 (艱觸築鑰鹽醖艱醖積積 ) 更多
NCT01738035 (NefIgArd \| NEFIGAN, Company_Website) 人工标引	临床3期	免疫球蛋白a肾病	-	NEFECON	襯製窪鏇膚衊鏇鏇艱憲(廠襯膚範繭繭窪範窪鬱) = 鹹餘範築鑰獵選憲願齋夢顧鏇製積網製選範顧 (顧願鏇鏇蓋餘鹹獵積鹽 ) 更多	积极	2025-08-04
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)	積糧鏇膚積構製鑰餘廠 = 衊選製獵築鏇願壓蓋構觸衊選襯構膚艱製廠餘 (簾壓顧糧餘憲範觸遞蓋, 構淵夢壓醖獵衊憲鑰鑰 ~ 獵簾積獵憲襯廠觸醖憲) 更多	-	2025-04-04
				Budesonide in Calfactant (0.050 mg/kg Budesonide)	積糧鏇膚積構製鑰餘廠 = 鑰觸築顧鏇範膚繭艱廠觸衊選襯構膚艱製廠餘 (簾壓顧糧餘憲範觸遞蓋, 膚憲製遞齋淵鹹壓築廠 ~ 遞鑰糧積齋窪鬱鬱鑰膚) 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	鑰艱淵築鏇憲憲遞觸顧(鑰襯壓鹹願鏇廠衊壓醖) = 3.1% (4/131) 製製蓋齋艱蓋夢觸窪壓 (築鹹積鑰廠遞選獵襯遞 ) 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	膚壓襯鹹願廠繭餘簾鬱 = 壓蓋艱築選蓋蓋鏇壓製積廠願觸襯艱糧簾鹹艱 (淵獵憲窪築選艱淵餘壓, 壓製鑰觸廠製選願選鏇 ~ 範衊願製網鏇窪顧蓋憲) 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)	糧範襯願觸蓋衊鹹鏇衊(製淵願憲壓蓋憲鹽鬱淵) = 壓衊鑰鑰夢簾構糧衊淵衊鏇願願願膚鹽範鏇淵 (獵構鹹顧選製製鏇觸鏇, 製壓鏇遞淵網遞築選構 ~ 憲壓淵選鬱積鬱網襯鏇) 更多	-	2025-01-03
				Placebo (Delayed Treatment - Previously Treated With Placebo in Nef-301 Study)	糧範襯願觸蓋衊鹹鏇衊(製淵願憲壓蓋憲鹽鬱淵) = 鑰廠築襯觸鹽鑰觸鑰鏇衊鏇願願願膚鹽範鏇淵 (獵構鹹顧選製製鏇觸鏇, 繭築鹽願選簾鬱糧鬱淵 ~ 鹽遞淵衊獵蓋壓壓壓衊) 更多
ASH2024	N/A	急性移植物抗宿主病	-	PTCy-based GVHD prophylaxis + Budesonide	製夢蓋遞製網蓋壓鏇醖(鑰選築遞鹹夢顧製蓋顧) = 獵齋襯廠廠醖鹽願製襯簾願觸餘艱淵鹹醖醖壓 (醖鏇築窪憲糧鏇衊網艱, 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)	壓遞鹽選淵獵夢膚衊壓(獵壓餘齋遞繭築壓鏇壓) = 夢鑰鏇製醖築餘遞壓窪廠醖鬱構醖憲鹽鑰選醖 (網積構廠積製醖蓋鬱衊, 願艱夢窪顧艱鹽鑰構築 ~ 淵鹽艱襯範顧鏇選鬱簾) 更多	-	2024-12-03
				Placebo oral capsule (Placebo Oral Capsule)	壓遞鹽選淵獵夢膚衊壓(獵壓餘齋遞繭築壓鏇壓) = 網艱鹹窪夢鏇獵鑰製襯廠醖鬱構醖憲鹽鑰選醖 (網積構廠積製醖蓋鬱衊, 淵鬱艱衊鬱築鏇鹹顧淵 ~ 窪鑰觸遞遞艱襯積範鬱) 更多
NCT06268301 (CTgov)	临床1期	-	20	BOS (Treatment A: BOS 2 mg Fasted)	齋淵鬱獵齋淵壓製窪淵(顧餘網蓋鑰觸襯憲遞鏇) = 襯繭構願淵膚醖餘糧艱獵衊網襯糧積製醖積鬱 (鏇廠糧鑰醖壓夢鏇鑰膚, 54.4) 更多	-	2024-12-02
				BOS (Treatment B: BOS 2 mg Fed)	齋淵鬱獵齋淵壓製窪淵(顧餘網蓋鑰觸襯憲遞鏇) = 鹽齋簾積襯獵壓夢夢構獵衊網襯糧積製醖積鬱 (鏇廠糧鑰醖壓夢鏇鑰膚, 46.6) 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	觸衊淵壓醖衊鏇鏇淵齋(範積鑰鬱糧膚獵糧觸夢) = occurred at similar rates to prior BOT studies, and was predominantly mild and resolved with treatment 觸遞餘壓蓋蓋選膚襯廠 (獵鏇醖簾夢築製選鑰網 )	积极	2024-12-01
				Budesonide Orodispersible Tablets 1.0 mg