Insmed在日本推出 BRINSUPRI®片剂 25 mg（brensocatib hydrate），用于治疗非囊性纤维化支气管扩张症-动脉网

Insmed Launches BRINSUPRI® Tablets 25 mg (brensocatib hydrate) for the Treatment of Non-Cystic Fibrosis Bronchiectasis in Japan

CISION 等信源发布 2026-10-19 19:00

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—BRINSUPRI, a First-in-Disease and First-in-Class Treatment for Patients With Non-Cystic Fibrosis Bronchiectasis (NCFB), Is Now Available by Prescription in Japan—

—BRINSUPRI，一种针对非囊性纤维化支气管扩张症（NCFB）患者的首创疾病疗法及首创类别药物，现可在日本凭处方获得—

BRIDGEWATER, N.J.

新泽西州布里奇沃特

，

Oct. 19, 2026

2026年10月19日

/PRNewswire/ -- Insmed Incorporated (Nasdaq:

/美通社/ -- Insmed Incorporated（纳斯达克：

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 the commercial launch in Japan of BRINSUPRI

），一家以人为本的全球生物制药公司，致力于为面临严重疾病的患者提供首创新药和同类最优疗法，以改变他们的生活，今日宣布BRINSUPRI在日本正式上市。

Tablets 25 mg (brensocatib hydrate), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older.

25毫克片剂（布雷诺西替水合物），一种用于成人及12岁及以上儿童非囊性纤维化支气管扩张症（NCFB）的口服每日一次治疗药物。

'The commercial availability of BRINSUPRI in Japan is a meaningful step forward for the bronchiectasis community and a proud moment for our team,' said Samuele Butera, Senior Vice President, General Manager, Global Respiratory for Insmed. 'As the first approved therapy specifically designed to address the underlying inflammatory process of NCFB, we are pleased that BRINSUPRI can be made widely available to appropriate patients in Japan who have long needed a treatment option that addresses an unmet driver of their disease.'.

“BRINSUPRI在日本的商业上市，对支气管扩张症患者群体而言是向前迈出的有意义的一步，也是我们团队引以为傲的时刻。”Insmed公司全球呼吸业务高级副总裁兼总经理Samuele Butera表示。“作为首款专为解决非囊性纤维化支气管扩张症（NCFB）潜在炎症过程而获批的疗法，我们很高兴BRINSUPRI能够广泛惠及日本合适的患者，他们长期以来一直缺乏针对其疾病未满足驱动因素的治疗选择。”

BRINSUPRI is the first and only approved and commercially available treatment for patients diagnosed with NCFB in Japan. The Japan Ministry of Health, Labour, and Welfare (MHLW) approved BRINSUPRI in August 2026 based on results from the Phase 3 ASPEN study.

BRINSUPRI是日本首个也是唯一获批且已上市的治疗确诊为非囊性纤维化支气管扩张症（NCFB）患者的药物。日本厚生劳动省（MHLW）基于III期ASPEN研究的结果，于2026年8月批准了BRINSUPRI。

'In patients living with bronchiectasis, recurrent exacerbations represent a substantial disease burden, making daily life harder to manage and affecting long-term clinical outcomes,' said Makoto Nakamura, Senior Vice President, General Manager, Japan for Insmed. 'By offering BRINSUPRI as a new treatment option for appropriate patients in Japan, we hope to contribute to better disease management for eligible patients.

Insmed日本公司高级副总裁兼总经理中村诚表示：“对于支气管扩张症患者而言，反复急性加重构成了沉重的疾病负担，使日常生活更难管理，并影响长期临床结局。通过为日本合适的患者提供BRINSUPRI这一新的治疗选择，我们希望有助于改善符合条件患者的疾病管理。”

Insmed remains committed to supporting the bronchiectasis community through appropriate information provision to healthcare professionals and advancing the proper use of this therapy.'.

Insmed 仍然致力于通过向医疗保健专业人员提供适当的信息，并推动该疗法的规范使用，来支持支气管扩张症患者群体。

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，其特征是由于感染、炎症和肺组织损伤的恶性循环，导致支气管发生永久性扩张。该病的标志是频繁的肺部急性加重，需要抗生素治疗和/或住院治疗。症状包括慢性咳嗽、咳大量痰、气短以及反复发生的呼吸道感染，这些感染可能会加剧基础病情。

Most bronchiectasis cases in adults are non-cystic fibrosis bronchiectasis (NCFB)..

大多数成人支气管扩张病例为非囊性纤维化支气管扩张（NCFB）。

About BRINSUPRI

关于 BRINSUPRI

BRINSUPRI

布林苏普里

(brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in non-cystic fibrosis bronchiectasis (NCFB). The therapy is approved in the United States as BRINSUPRI (brensocatib 10 mg and 25 mg tablets) and indicated for the treatment of NCFB in adult and pediatric patients 12 years of age or older.

（brensocatib）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，旨在抑制中性粒细胞中酶的激活（中性粒细胞丝氨酸蛋白酶），这些酶是非囊性纤维化支气管扩张症（NCFB）中慢性气道炎症的关键驱动因素。该疗法在美国已获批上市，商品名为BRINSUPRI（brensocatib 10 mg和25 mg片剂），适用于治疗12岁及以上成人和儿科患者的NCFB。

In the European Union and United Kingdom, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In Japan, BRINSUPRI Tablets 25 mg (brensocatib hydrate) is approved for the treatment of NCFB in adults and pediatric patients 12 years and older..

在欧盟和英国，BRINSUPRI（布雷诺司他 25 mg 片剂）已获批用于治疗过去 12 个月内发生过两次或更多次加重的 12 岁及以上非囊性纤维化支气管扩张症（NCFB）患者。在日本，BRINSUPRI 25 mg 片剂（布雷诺司他水合物）已获批用于治疗成人及 12 岁及以上儿科非囊性纤维化支气管扩张症（NCFB）患者。

INDICATION AND

适应症及

IMPORTANT SAFETY INFORMATION FOR BRINSUPRI IN THE U.S.

美国布林苏普里的重要安全信息

U.S. Indication

美国适应症

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

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

Important Safety Information

重要安全信息

WARNINGS AND PRECAUTIONS

警告与注意事项

Dermatologic Adverse Reactions

皮肤不良反应

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.

BRINSUPRI 治疗与皮肤不良反应的增加相关，包括皮疹、皮肤干燥和角化过度。应监测患者是否出现新发皮疹或皮肤状况，并将患者转诊至皮肤科医生处对新出现的皮肤表现进行评估。

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与牙龈和牙周不良反应的增加有关。在服用BRINSUPRI期间，建议患者定期前往牙科服务机构进行口腔检查。指导患者保持常规口腔卫生。

Live Attenuated Vaccines

减毒活疫苗

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

在ASPEN试验中，发生率≥2%的最常见不良反应包括上呼吸道感染、头痛、皮疹、皮肤干燥、角化过度和高血压。WILLOW试验中非囊性纤维化支气管扩张（NCFB）成年患者的安全性特征与ASPEN试验总体相似，但牙龈和牙周不良反应的发生率较高。

Less Common Adverse Reactions

较少见的不良反应

Liver Function Test Elevations

肝功能检查指标升高

In ASPEN, 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. .

在ASPEN研究中，与安慰剂相比，BRINSUPRI 10 mg和25 mg组在第4周至第56周的所有时间点，平均ALT、AST和碱性磷酸酶水平均较基线升高。安慰剂组、BRINSUPRI 10 mg组和25 mg组患者中，ALT >3倍正常值上限（ULN）的发生率分别为0%、1.2%和0.9%；AST >3倍ULN的发生率分别为0.2%、0.3%和0.5%；碱性磷酸酶 >1.5倍ULN的发生率分别为2.5%、4.1%和4.0%。

Skin Cancers

皮肤癌

In ASPEN, 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.

在ASPEN研究中，接受BRINSUPRI 10 mg和25 mg治疗的患者皮肤癌发生率分别为0.5%和1.9%，而安慰剂组为1.1%。

Alopecia

脱发

In ASPEN, 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.

在ASPEN研究中，接受BRINSUPRI 10 mg和25 mg治疗的患者脱发发生率分别为1.5%和1.6%，而安慰剂组为0.4%。

USE IN SPECIFIC POPULATIONS

在特定人群中的使用

Pregnancy:

妊娠：

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

目前尚无关于孕妇使用BRINSUPRI的临床数据。

Lactation:

哺乳期：

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. .

目前尚无关于人乳中是否存在BRINSUPRI和/或其代谢物、对母乳喂养婴儿的影响或对乳汁分泌影响的信息。在决定用药时，应综合考虑母乳喂养的发育和健康益处、母亲对BRINSUPRI的临床需求，以及BRINSUPRI或潜在母体疾病对母乳喂养婴儿可能产生的任何不良影响。

Pediatric use:

儿童用药：

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 ASPEN 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. .

BRINSUPRI 用于治疗非囊性纤维化支气管扩张症（NCFB）的安全性和有效性已在 12 岁及以上的儿科患者中得到确立。在 ASPEN 研究中入组的 12 岁及以上儿科患者的常见不良反应与成人一致。BRINSUPRI 在 12 岁以下儿科患者中的安全性和有效性尚未确立。

Please see full

请参见全文

US Prescribing Information

美国处方信息

。

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 — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest.

Insmed Incorporated 是一家以人为本的全球性生物制药公司，致力于提供首创和同类最佳的疗法，以改变患有严重疾病患者的生活。公司正在推进一个多元化的产品组合，包括已获批和处于中后期研究阶段的 investigational 药物——其中包含两款用于治疗慢性、致残性肺病的已获批疗法——以及专注于服务需求最迫切的患者群体的前沿药物研发。

Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates..

Insmed的商业产品组合和临床研发管线围绕三大治疗领域进行布局：呼吸系统、免疫与炎症，以及神经与其他罕见病。公司的研发引擎正在推进广泛的技术和治疗模式，包括基因疗法、人工智能驱动的蛋白质工程、RNA末端连接以及合成救援技术，以发掘未来的管线候选药物。

Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Visit

Insmed 总部位于新泽西州布里奇沃特，在美国、欧洲和日本设有办事处和研究中心。访问

www.insmed.com

to learn more or follow us on

了解更多或关注我们

领英

，

Instagram

，

YouTube

, and

，和

。

Forward-looking Statements

前瞻性陈述

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。根据1995年《私人证券诉讼改革法案》的定义，“前瞻性陈述”是指非历史事实的陈述，并涉及多种风险和不确定性。

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. .

本文中的“可能”、“将”、“应当”、“可以”、“会”、“预期”、“计划”、“预计”、“相信”、“估计”、“预测”、“打算”、“潜在”、“持续”等词语以及类似表述（以及其他提及未来事件、条件或情形的词语或表述）可能用于识别前瞻性陈述。

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本公司当前的预期和信念，涉及已知和未知的风险、不确定性和其他因素，这些可能导致本公司的实际结果、业绩和成就以及某些事件的发生时间与任何前瞻性陈述中讨论、预测、预期或指出的结果、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., Europe, or Japan, or to maintain U.S., European, or Japanese approval for BRINSUPRI; uncertainties in the degree of market acceptance of BRINSUPRI by physicians, patients, third-party payors and others in the health care 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 ASPEN 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; risk that health care legislation or other government action materially adversely affects .

此类风险、不确定性及其他因素包括但不限于以下各项：未能成功在美国、欧洲或日本实现BRINSUPRI的商业化，或未能维持BRINSUPRI在美国、欧洲或日本的监管批准；医生、患者、第三方付款人及医疗保健社区其他各方对BRINSUPRI的市场接受程度存在不确定性；公司对BRINSUPRI潜在市场规模的估计不准确，或公司用于识别医生群体的数据不准确；预期的患者采用率、预期治疗持续时间、或预期的患者依从性或停药率存在偏差；公司无法就BRINSUPRI从政府或第三方付款人处获得充分的报销或可接受的价格；出现与BRINSUPRI相关的意外安全性或有效性问题，包括进一步的布雷诺西替（brensocatib）临床试验所生成的数据可能与ASPEN研究结果不一致的风险，这可能导致产品标签变更并对销售产生不利影响，或导致BRINSUPRI撤市；我们未能遵守与布雷诺西替相关的协议，包括我们与阿斯利康公司（AstraZeneca AB）签订的许可协议；医疗保健立法或其他政府行动可能产生重大不利影响的风险。

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.

公司可能无法实际实现其前瞻性陈述中所指示的结果、计划、意图或预期，因为前瞻性陈述就其性质而言涉及风险和不确定性，因其与未来可能发生也可能不发生的事件相关，并取决于未来可能出现也可能不出现的情况。

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 December 31, 2025, and any subsequent Company filings with the Securities and Exchange Commission (SEC). .

有关可能影响本公司业务的风险和不确定性的更多信息，请参阅本公司截至2025年12月31日止年度的10-K表格年度报告中第1A项“风险因素”所讨论的因素，以及本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. .

本公司提醒读者，不要过度依赖任何此类前瞻性陈述，这些陈述仅反映本新闻稿发布之日的情况。除法律和证券交易委员会（SEC）规则明确要求的以外，本公司不承担任何公开更新或修订此类陈述的义务，以反映预期、事件、条件或情况的任何变化（此类陈述可能基于这些因素），或反映可能影响实际结果与前瞻性陈述中所述结果存在差异的可能性的任何变化。

Contact:

联系方式：

Investors:

投资者：

Gianna De Palma

吉安娜·德帕尔马

Associate Director, Investor Relations

投资者关系副总监

[email protected]

Media:

媒体：

Claire Mulhearn