FDA批准BRINSUPRI™（布伦索卡替）作为首个且唯一用于治疗非囊性纤维化支气管扩张症的药物，这是一种严重、慢性的肺部疾病-动脉网

FDA Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease

CISION 等信源发布 2025-08-12 23:34

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可切换为仅中文

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— Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage —

—— 大约有50万名美国患者被诊断为非囊性纤维化支气管扩张症 (NCFB)，这是一种可能导致永久性肺损伤的进行性疾病 ——

—

BRINSUPRI

布林苏普里

10 mg and 25 mg Doses Approved for the Treatment of NCFB —

批准10毫克和25毫克剂量用于治疗NCFB —

—

BRINSUPRI, a First-in-Class DPP1 Inhibitor Targeting Neutrophilic Inflammation,

BRINSUPRI，一种针对中性粒细胞炎症的首创DPP1抑制剂，

Is Available by Prescription Through a Comprehensive Specialty Pharmacy Network —

可通过综合专业药房网络凭处方购买 —

—

Insmed to Host Investor Conference Call Today at

Insmed今天将举办投资者电话会议

12:00 PM ET

中午12点（东部时间）

—

BRIDGEWATER, N.J.

布里奇沃特，新泽西州

，

Aug. 12, 2025

2025年8月12日

/PRNewswire/ -- Insmed Incorporated (Nasdaq:

/PRNewswire/ -- Insmed公司（纳斯达克股票代码：

INSM

), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class BRINSUPRI™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.

），一家以人为本的全球生物制药公司，致力于提供首创新药和同类最佳疗法，以改变面临严重疾病患者的命运，今天宣布美国食品药品监督管理局（FDA）已批准首创药物BRINSUPRI™（布伦索卡替10毫克和25毫克片剂），这是一种口服、每日一次的治疗非囊性纤维化支气管扩张症（NCFB）的药物，适用于12岁及以上的成人和儿童。

BRINSUPRI is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline..

BRINSUPRI 是首个也是唯一获得 FDA 批准的 NCFB 治疗方法，为美国各地数十万患者和临床医生提供了一种管理这种慢性且进展性疾病的选择，该疾病可能导致永久性肺损伤和肺功能下降。

This press release features multimedia. View the full release here:

此新闻稿包含多媒体。请点击此处查看完整发布：

https://www.multivu.com/insmed/9347351-en-fda-approves-brinsupri-brensocatib

'This FDA approval represents a potential paradigm shift in how we approach non-cystic fibrosis bronchiectasis,' said

“这一FDA的批准代表了我们在应对非囊性纤维化支气管扩张症方面的潜在范式转变，”

Doreen Addrizzo-Harris

多琳·阿德里佐-哈里斯

, M.D., FCCP, the Fiona and Stanley Druckenmiller Professor of Pulmonary, Critical Care and Sleep Medicine at NYU Grossman School of Medicine and Director of the NYU Langone Health Bronchiectasis and NTM Program, and

医学博士，FCCP，纽约大学格罗斯曼医学院肺、重症监护和睡眠医学系 Fiona 和 Stanley Druckenmiller 教授，纽约大学朗格尼健康中心支气管扩张和非结核分枝杆菌项目主任，

ASPEN

白杨

investigator. 'For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Based on the strength of the data and the impact we've seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care.' .

调查员表示：“我们首次拥有了一种直接针对中性粒细胞性炎症并解决支气管扩张恶化根本原因的治疗方法。基于数据的强度以及我们在患者身上看到的影响，我相信这可能成为非囊性纤维化支气管扩张护理的新标准。”

There are approximately 500,000 people in the U.S. diagnosed with NCFB, and it is estimated that millions more are living with this disease globally. Unlike other respiratory diseases that are characterized by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection.

美国大约有 50 万人被诊断为 NCFB，据估计，全球还有数百万人患有此病。其他呼吸道疾病的特点是气道变窄，而支气管扩张症会导致气道永久性地变宽，使得清除粘液和细菌的难度增大，从而导致持续的炎症和感染。

A hallmark of bronchiectasis is frequent exacerbations, or flares, when symptoms worsen, such as coughing, increased mucus, shortness of breath and fatigue..

支气管扩张症的一个标志是频繁的病情加重或突发，症状恶化，例如咳嗽、痰液增多、呼吸急促和疲劳。

'Non-cystic fibrosis bronchiectasis deeply affects the lives of people living with this chronic lung condition, impacting both their physical health and emotional well-being,' added

‘非囊性纤维化支气管扩张症深刻影响着患有这种慢性肺病的人们的生活，对他们的身体健康和情感健康都有影响，’他补充道。

Elisha Malanga

以利沙·马兰加

, Executive Director of the Bronchiectasis and NTM Association. 'Many patients experience frequent flares, which can disrupt daily life and potentially lead to disease progression. The FDA approval of brensocatib represents a significant and long-awaited advancement as the first approved therapy for non-cystic fibrosis bronchiectasis.

支气管扩张症和非结核分枝杆菌病协会执行主任表示：“许多患者经常出现病情恶化，这会扰乱日常生活并可能导致疾病进展。布伦索卡蒂布获得FDA批准，代表了作为首个获批用于非囊性纤维化支气管扩张症的疗法，是一项重要且期待已久的进展。

Our hope is that treatments like this will enable people with bronchiectasis to manage their condition.'.

我们的希望是，像这样的治疗将使支气管扩张症患者能够管理他们的病情。

This approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the

该批准基于来自第 3 阶段 ASPEN 和第 2 阶段 WILLOW 研究的数据，这两项研究均发表在

New England Journal of Medicine

新英格兰医学杂志

. In

。在

ASPEN

白杨树

, patients taking BRINSUPRI 10 mg or 25 mg had a 21.1% and 19.4% reduction in annual rate of exacerbations respectively, as compared to placebo. Both dosage strengths of BRINSUPRI also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients who received BRINSUPRI 25 mg experienced statistically significant less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52.

服用BRINSUPRI 10毫克或25毫克的患者，其年恶化率分别比安慰剂组降低了21.1%和19.4%。BRINSUPRI的两种剂量均达到了多项与恶化相关的次要终点，包括显著延长首次恶化的时间，并显著提高治疗期间无恶化患者的比例。接受BRINSUPRI 25毫克治疗的患者在第52周时，使用支气管扩张剂后通过一秒用力呼气量（FEV₁）测量的肺功能下降幅度显著较小。

The safety of BRINSUPRI was also evaluated in both studies. The most common adverse reactions ≥2% in the .

两项研究中也评估了BRINSUPRI的安全性。最常见的不良反应≥2%。

ASPEN

白杨树

trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to

试验包括上呼吸道感染、头痛、皮疹、皮肤干燥、角化过度和高血压。WILLOW 中成人 NCFB 患者的安全状况总体上与

ASPEN

白杨树

, except for a higher incidence of gingival and periodontal adverse reactions in WILLOW.

，除了在WILLOW中牙龈和牙周不良反应的发生率较高外。

'The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed,' said

“FDA批准了首个非囊性纤维化支气管扩张症的治疗方法，这对患者和Insmed来说都是一个历史性的里程碑，”

Martina Flammer

玛蒂娜·弗拉默

, M.D., MBA, Chief Medical Officer of Insmed. 'By keeping patients at the center of everything we do, we have once again delivered a first-in-class medicine for a disease with no prior approved treatments. This is an incredible achievement in medicine. We're deeply grateful to the patients, providers, and advocates who made this possible – this is just the beginning of what we can accomplish together for this community.'.

医学博士、工商管理硕士、Insmed首席医学官表示：“通过始终将患者置于我们一切工作的核心，我们再次推出了一种针对此前尚无获批治疗方案的疾病的首创药物。这是医学领域的一项非凡成就。我们深切感谢使这一切成为可能的患者、医疗提供者和倡导者——这仅仅是我们为这一群体共同所能取得成就的开始。”

BRINSUPRI is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. BRINSUPRI is the first approved therapy to address the underlying inflammatory process of NCFB..

BRINSUPRI 是一种首创的二肽基肽酶 1（DPP1）抑制剂，旨在抑制中性粒细胞中驱动 NCFB 慢性气道炎症的关键酶（中性粒细胞丝氨酸蛋白酶）的激活。BRINSUPRI 是首个获批用于解决 NCFB 潜在炎症过程的疗法。

In parallel, applications for brensocatib with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been accepted, and the Company plans to file in

同时，布伦索卡提布在欧洲药品管理局（EMA）和英国药品与健康产品管理局（MHRA）的申请已被受理，公司计划提交文件。

Japan

日本

in 2025. Commercial launches are anticipated in 2026, pending approval in each territory.

2025年。商业发布预计在2026年，等待各地区批准。

BRINSUPRI is now available in the U.S. by prescription through a comprehensive specialty pharmacy network.

BRINSUPRI现在可以通过美国的专业药房网络凭处方购买。

Conference Call Information

电话会议信息

Insmed will host a conference call today at

Insmed 将于今天举办电话会议

12:00 PM

中午12点

Eastern Time to discuss the FDA approval. The call can be accessed by dialing (888) 210-2654 (U.S. and Canada) or (646) 960-0278 (international) and entering the conference ID number 6364918. The call will also be webcast live on the Company's website at

东部时间讨论FDA批准。可以通过拨打（888）210-2654（美国和加拿大）或（646）960-0278（国际）并输入会议ID号6364918来接入电话。该电话还将在公司网站上进行实时网络直播。

www.insmed.com

。

A replay of the conference call will be accessible approximately two hours after its completion through August 19, 2025, by dialing (800) 770-2030 (domestic) or (609) 800-9909 (international) and referencing conference ID number 6364918. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at .

会议电话的重播将在其结束后大约两小时提供，直至2025年8月19日，可拨打 (800) 770-2030（国内）或 (609) 800-9909（国际）并引用会议ID号码6364918进行访问。此次电话的网络广播也将在公司网站的投资者关系部分存档90天。

www.insmed.com

。

About

关于

BRINSUPRI

布林苏普里

™ (brensocatib)

™（布雷诺卡替）

BRINSUPRI™ (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.

BRINSUPRI™（布伦索卡替）是一种小分子、每日一次、口服、可逆的二肽基肽酶1（DPP1）抑制剂，用于治疗12岁及以上成人和儿童的非囊性纤维化支气管扩张症（NCFB）。布伦索卡替旨在抑制中性粒细胞中激活的酶（中性粒细胞丝氨酸蛋白酶），这些酶是NCFB慢性气道炎症的关键驱动因素。

Brensocatib is also being evaluated for its potential role in other neutrophil-mediated diseases..

布伦索卡蒂布在其他中性粒细胞介导的疾病中的潜在作用也在评估中。

About InLighten Patient Support Program

关于InLighten患者支持计划

Insmed is committed to providing access to its products by providing eligible patients with financial assistance options. Patients using Insmed products may also enroll to receive ongoing education and support through its inLighten Patient Support Program.

Insmed致力于通过为符合条件的患者提供经济援助选项，使其产品能够被获取。使用Insmed产品的患者还可以注册参加其inLighten患者支持计划，以获得持续的教育和支持。

About

关于

ASPEN

白杨

ASPEN

白杨

was a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis (NCFB). As part of the

是一项全球性、随机、双盲、安慰剂对照的 3 期研究，旨在评估布伦索卡蒂布在非囊性纤维化支气管扩张症 (NCFB) 患者中的疗效、安全性和耐受性。作为

ASPEN

白杨

study's conduct, more than 460 trial sites were engaged in nearly 40 countries. After excluding sites that did not enroll any patients and all sites in

研究的开展，超过460个试验地点参与了近40个国家。在排除未招募任何患者的地点以及所有位于

Ukraine

乌克兰

, the total number of active sites in

，活跃站点的总数在

ASPEN

白杨

was 391 sites in 35 countries. Adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to <18 years) were randomized 2:2:1 for treatment with brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment. The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients..

在35个国家的391个地点进行。成年患者（18至85岁）以1:1:1的比例随机分组，青少年患者（12至<18岁）以2:2:1的比例随机分组，接受每日一次布雷诺卡替10毫克、布雷诺卡替25毫克或安慰剂治疗，持续52周，随后停止治疗4周。主要疗效分析包括1680名成年患者和41名青少年患者的数据。

About WILLOW

关于柳树

WILLOW was a randomized, double-blind, placebo-controlled, parallel-group, multi-center, multi-national, Phase 2 study to assess the efficacy, safety and tolerability, and pharmacokinetics of brensocatib administered once daily for 24 weeks in patients with non-cystic fibrosis bronchiectasis (NCFB).

WILLOW 是一项随机、双盲、安慰剂对照、平行组、多中心、多国的 II 期研究，旨在评估每日一次口服布伦索卡蒂布（brensocatib）在非囊性纤维化支气管扩张症（NCFB）患者中持续 24 周的疗效、安全性和耐受性以及药代动力学。

WILLOW was conducted at 116 sites and enrolled 256 adult patients diagnosed with NCFB who had at least two documented pulmonary exacerbations in the 12 months prior to screening. Patients were randomized 1:1:1 to receive either 10 mg or 25 mg of brensocatib or matching placebo. The primary efficacy endpoint was the time to first pulmonary exacerbation over the 24-week treatment period in the brensocatib arms compared to the placebo arm..

WILLOW 研究在 116 个地点进行，招募了 256 名成年患者，这些患者被诊断为 NCFB，并在筛选前的 12 个月内至少有两次记录在案的肺部恶化。患者以 1:1:1 的比例随机分配接受 10 毫克或 25 毫克的 brensocatib 或匹配的安慰剂。主要疗效终点是与安慰剂组相比，brensocatib 组在 24 周治疗期内首次肺部恶化的时间。

About Bronchiectasis

关于支气管扩张症

Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition.

支气管扩张症是一种严重的慢性肺部疾病，其中由于感染、炎症和肺组织损伤的循环，支气管永久性扩张。该病症的特点是频繁的肺部急性加重，需要抗生素治疗和/或住院。症状包括慢性咳嗽、过多的痰液分泌、呼吸急促以及反复的呼吸道感染，这些都可能加重基础病情。

Most bronchiectasis cases in adults are non-cystic fibrosis bronchiectasis. Today, approximately 500,000 patients in the U.S., 600,000 patients in the EU5 (.

大多数成年患者的支气管扩张症为非囊性纤维化支气管扩张症。目前，美国约有50万名患者，欧盟五大国家（EU5）约有60万名患者。

France

法国

，

Germany

德国

，

Italy

意大利

，

Spain

西班牙

, and UK), and 150,000 patients in

，英国），以及15万名患者在

Japan

日本

have been diagnosed with NCFB. Outside the U.S. there are currently no approved therapies specifically targeting bronchiectasis in these regions.

已被诊断为NCFB。在美国以外的地区，目前尚无专门针对支气管扩张症的获批疗法。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNINGS AND PRECAUTIONS

警告和注意事项

Dermatologic Adverse Reactions

皮肤病学不良反应

Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.

使用BRINSUPRI治疗会增加皮肤不良反应的风险，包括皮疹、皮肤干燥和过度角化。监测患者是否出现新的皮疹或皮肤状况，并将患者转诊给皮肤科医生以评估新的皮肤发现。

Gingival and Periodontal Adverse Reactions

牙龈和牙周不良反应

Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.

使用BRINSUPRI治疗会增加牙龈和牙周不良反应的发生率。在服用BRINSUPRI期间，建议患者定期进行牙齿检查，并参考牙科护理服务。提醒患者保持日常的口腔卫生习惯。

Live Attenuated Vaccines

活减毒疫苗

It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.

目前尚不清楚在BRINSUPRI治疗期间接种减毒活疫苗是否会影响这些疫苗的安全性或有效性。接受BRINSUPRI的患者应避免使用减毒活疫苗。

ADVERSE REACTIONS

不良反应

The most common adverse reactions ≥2% in the

最常见的不良反应≥2%在

ASPEN

白杨

trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to

试验包括上呼吸道感染、头痛、皮疹、皮肤干燥、角化过度和高血压。WILLOW 中成人 NCFB 患者的安全状况总体上与之前相似。

ASPEN

白杨

, except for a higher incidence of gingival and periodontal adverse reactions.

，除了牙龈和牙周不良反应的发生率较高外。

Less Common Adverse Reactions

较少见的不良反应

Liver Function Test Elevations

肝功能测试升高

在

ASPEN

白杨

, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. .

与安慰剂相比，在BRINSUPRI 10 mg和25 mg组中，从第4周到第56周的所有时间点，平均ALT、AST和碱性磷酸酶水平均较基线有所升高。ALT >3倍正常上限（ULN）的发生率为0%、1.2%和0.9%；AST >3倍ULN的发生率为0.2%、0.3%和0.5%；碱性磷酸酶>1.5倍ULN的发生率在安慰剂和BRINSUPRI 10 mg及25 mg治疗的患者中分别为2.5%、4.1%和4.0%。

Skin Cancers

皮肤癌

在

ASPEN

白杨树

, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients.

，接受BRINSUPRI 10毫克和25毫克治疗的患者皮肤癌的发生率分别为0.5%和1.9%，而接受安慰剂治疗的患者为1.1%。

Alopecia

脱发

在

ASPEN

白杨

, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients.

布林索匹10毫克和25毫克治疗的患者中，脱发发生率分别为1.5%和1.6%，而安慰剂治疗的患者为0.4%。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Pregnancy:

怀孕：

There are no clinical data on the use of BRINSUPRI in pregnant women.

没有关于孕妇使用BRINSUPRI的临床数据。

Lactation:

泌乳：

There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition. .

目前尚无关于BRINSUPRI及其代谢物在人乳中是否存在、对哺乳婴儿的影响或对乳汁分泌影响的相关信息。在考虑母乳喂养的发育和健康益处时，应同时权衡母亲使用BRINSUPRI的临床需求，以及BRINSUPRI或潜在母体状况可能对哺乳婴儿造成的不良影响。

Pediatric use:

儿科使用：

The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in

BRINSUPRI 治疗 NCFB 的安全性和有效性已在 12 岁及以上的儿科患者中得到证实。在 12 岁及以上参与的儿科患者中常见的不良反应包括

ASPEN

白杨

were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.

与成人一致。BRINSUPRI在12岁以下儿科患者中的安全性和有效性尚未确定。

Please see full

请查看完整内容

Prescribing Information

处方信息

。

INDICATION

适应症

BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.

BRINSUPRI 适用于治疗 12 岁及以上成人和儿童患者的非囊性纤维化支气管扩张症 (NCFB)。

About Insmed

关于Insmed

Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest.

Insmed公司是一家以人为本的全球生物制药公司，致力于提供首屈一指和同类最佳的疗法，以改变面临严重疾病患者的命运。该公司正在推进一系列已获批和处于中期至后期研究阶段的药物，以及专注于服务需求最迫切的患者群体的尖端药物发现。

Insmed's most advanced programs are in pulmonary and inﬂammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue..

Insmed最先进的项目集中在肺部和炎症疾病，包括两种获批的用于治疗慢性、衰弱性肺病的疗法。公司早期的项目涵盖了广泛的技术和模式，包括基因治疗、人工智能驱动的蛋白质工程、蛋白质制造、RNA末端连接以及合成救援。

Headquartered in

总部位于

Bridgewater, New Jersey

新泽西州布里奇沃特

, Insmed has offices and research locations throughout

，Insmed在各地设有办公室和研究地点

the United States

美国

，

Europe

欧洲

, and

，以及

Japan

日本

. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending four consecutive years as the No. 1

Insmed很荣幸被公认为生物制药行业最佳雇主之一，包括连续四年位居第一名。

Science

科学

Top Employer. Visit

顶级雇主。访问

www.insmed.com

to learn more or follow us on

要了解更多或关注我们，请访问

领英

，

Instagram

，

YouTube

, and

，以及

。

Forward-looking Statements

前瞻性声明

This press release contains forward-looking statements that involve substantial risks and uncertainties. 'Forward-looking statements,' as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties.

本新闻稿包含涉及重大风险和不确定性的前瞻性陈述。 “前瞻性陈述”一词根据 1995 年《私人证券诉讼改革法案》中的定义，是指并非历史事实的陈述，并涉及许多风险和不确定性。

Words herein such as 'may,' 'will,' 'should,' 'could,' 'would,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'estimates,' 'projects,' 'predicts,' 'intends,' 'potential,' 'continues,' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements..

诸如“可能”、“将”、“应该”、“可以”、“会”、“预期”、“计划”、“预期”、“相信”、“估计”、“预测”、“打算”、“潜力”、“持续”等词语（以及其它引用未来事件、条件或情况的词语或表达）可能识别为前瞻性陈述。

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements.

本新闻稿中的前瞻性陈述基于公司当前的预期和信念，涉及已知和未知的风险、不确定性及其他因素，这些因素可能导致公司的实际结果、业绩和成就以及某些事件的时间与任何前瞻性陈述中讨论、预测、预期或暗示的结果、业绩、成就或时间存在重大差异。

Such risks, uncertainties and other factors include, among others, the following: failure to successfully commercialize BRINSUPRI in the U.S. or to maintain U.S. approval for BRINSUPRI; failure to obtain, or delays in obtaining, regulatory approvals for BRINSUPRI in .

此类风险、不确定性和其他因素包括但不限于以下方面：未能成功在美国将BRINSUPRI商业化或未能维持BRINSUPRI在美国的上市许可；未能获得BRINSUPRI的监管批准，或在获得批准时出现延误。

Europe

欧洲

或

Japan

日本

, including the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; uncertainties in the degree of market acceptance of BRINSUPRI by physicians, patients, third-party payors and others in the healthcare community; inaccuracies in the Company's estimates of the size of the potential markets for BRINSUPRI or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company's inability to obtain adequate reimbursement from government or third-party payors for BRINSUPRI or acceptable prices for BRINSUPRI; development of unexpected safety or efficacy concerns related to BRINSUPRI, including the risk that data generated in further clinical trials of brensocatib may not be consistent with the results of the .

，包括任何监管批准（如果获得）可能受到使用上的重大限制，或可能被相关监管机构撤销或采取其他不利行动的风险；医生、患者、第三方支付方及医疗保健领域的其他人对BRINSUPRI的市场接受程度的不确定性；公司对BRINSUPRI潜在市场规模的估计或用于识别医生的数据不准确；预期的患者采用率、预期治疗持续时间、预期患者依从性或停药率的不确定性；公司无法从政府或第三方支付方获得对BRINSUPRI的充分报销或无法获得可接受的价格；与BRINSUPRI相关的意外安全性或有效性问题的发展，包括进一步的brensocatib临床试验生成的数据可能与之前结果不一致的风险。

ASPEN

白杨

study, which may result in changes to the product label and may adversely affect sales, or result in withdrawal of BRINSUPRI from the market; failure by us to comply with agreements related to brensocatib, including our license agreement with AstraZeneca AB; failure to successfully conduct future clinical trials for brensocatib, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; failure to obtain regulatory approval for potential future brensocatib indications; and failure of third parties on which the Company is dependent to manufacture sufficient quantities of brensocatib for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company..

研究，这可能导致产品标签的更改，并可能对销售产生不利影响，或导致BRINSUPRI退出市场；我们未能遵守与brensocatib相关的协议，包括我们与AstraZeneca AB的许可协议；未能成功开展brensocatib未来的临床试验，包括由于公司可能无法招募或保留足够的患者以进行和完成试验或生成监管批准所需的数据等原因；未能获得潜在未来brensocatib适应症的监管批准；以及公司所依赖的第三方未能生产足够数量的brensocatib以满足商业或临床需求、未能进行公司的临床试验，或未能遵守公司的协议或影响公司业务或与公司签订的协议的法律法规。

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future.

公司可能无法实际达成其前瞻性陈述所表明的结果、计划、意图或预期，因为前瞻性陈述本质上涉及风险和不确定性，它们与未来可能或可能不会发生的事件相关，并取决于这些情况。

For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, 'Risk Factors,' in the Company's Annual Report on Form 10-K for the year ended .

有关可能影响公司业务的风险和不确定性的更多信息，请参阅公司年度报告 Form 10-K 中项目 1A“风险因素”部分讨论的因素。

December 31, 2024

2024年12月31日

and any subsequent Company filings with the Securities and Exchange Commission (SEC).

以及公司随后向美国证券交易委员会（SEC）提交的任何文件。

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements..

公司提醒读者不要过分依赖任何此类前瞻性声明，这些声明仅在本新闻稿发布之日有效。公司不承担任何义务（除非法律及美国证券交易委员会的规定特别要求），公开更新或修改任何此类声明以反映任何预期变化或事件、条件或情况的变化，或可能影响实际结果与前瞻性声明中所述结果产生差异的可能性。

Contact:

联系人：

Investors:

投资者：

Bryan Dunn

布赖恩·邓恩

Vice President, Investor Relations

副总裁，投资者关系

(732) 487-7043

bryan.dunn@insmed.com

Media: