—New Data in Non-Cystic Fibrosis Bronchiectasis Further Define Impact of BRINSUPRI —非囊性纤维化支气管扩张新数据进一步明确BRINSUPRI的影响® ®on Respiratory Symptoms— 关于呼吸道症状———Findings from a Pharmacokinetic Study Continue to Support Further Evaluation of Treprostinil Palmitil Inhalation Powder Phase 3 Development Program— —药代动力学研究的发现继续支持对曲前列尼尔棕榈酸酯吸入粉剂的3期开发计划进行进一步评估——Additionally, Insmed Provides Independent Research Grant to the American Thoracic Society for a Landmark Quality Initiative to Improve Diagnosis of Bronchiectasis across the U.S.— —此外,Insmed 向美国胸科学会提供独立研究基金,用于开展一项具有里程碑意义的质量改进计划,以改善全美范围内支气管扩张症的诊断水平。—BRIDGEWATER, N.J. 新泽西州布里奇沃特, ,May 4, 2026 2026年5月4日/PRNewswire/ -- Insmed Incorporated (Nasdaq: /PRNewswire/ -- Insmed公司(纳斯达克:INSM 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 it will present six abstracts from across its respiratory portfolio and pipeline at the American Thoracic Society International Conference 2026 (ATS 2026), taking place May 17–20 in Orlando, Florida.. ),一家以人为本的全球生物制药公司,致力于提供一流和最佳疗法以改变面临严重疾病患者的命运,今天宣布将在2026年美国胸科学会国际会议(ATS 2026)上展示来自其呼吸系统产品组合和研发管线的六篇摘要,该会议将于5月17日至20日在佛罗里达州奥兰多举行。Notably, data will be presented from the Phase 3b ENCORE study evaluating ARIKAYCE 值得注意的是,将展示来自评估ARIKAYCE的3b期ENCORE研究的数据。® ®(amikacin liposome inhalation suspension) with multidrug therapy (azithromycin 250 mg + ethambutol 15 mg/kg) once-daily versus placebo with multidrug therapy once-daily in diagnosed adult patients with a new occurrence of (阿米卡星脂质体吸入混悬液)联合多药疗法(阿奇霉素250毫克+乙胺丁醇15毫克/公斤)每日一次,与安慰剂联合多药疗法每日一次,用于诊断为新发的成年患者。Mycobacterium avium 鸟分枝杆菌complex (MAC) lung infection who had not received antibiotics. Additional presentations include a post-hoc analysis from the Phase 3 ASPEN trial of BRINSUPRI 复杂的(MAC)肺部感染,且未接受抗生素治疗。其他表现包括来自BRINSUPRI的3期ASPEN试验的事后分析。® ®(brensocatib), real-world experience data in patients with non-cystic fibrosis bronchiectasis (NCFB), a pharmacokinetic analysis of investigational treprostinil palmitil inhalation powder (TPIP), and data highlighting disease burden in pulmonary hypertension associated with interstitial lung disease (PH-ILD).. (布伦索卡替),非囊性纤维化支气管扩张症(NCFB)患者的现实世界经验数据,研究性曲前列尼尔帕米蒂吸入粉(TPIP)的药代动力学分析,以及与间质性肺病相关的肺动脉高压(PH-ILD)疾病负担的数据。'At Insmed, our work in respiratory disease is guided by the experiences of people living with serious and rare pulmonary conditions, where meaningful treatment advances are still urgently needed,' said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. 'The research we're presenting at ATS 2026 reflects the strength of Insmed's respiratory portfolio and pipeline, and our unwavering commitment to patients. “在Insmed,我们在呼吸系统疾病方面的工作受到那些身患严重和罕见肺部疾病患者经历的指引,这些患者仍然迫切需要有意义的治疗进展,”Insmed首席医学官Martina Flammer医学博士、工商管理硕士说道。“我们将在ATS 2026上展示的研究反映了Insmed在呼吸系统产品组合和研发管线方面的实力,以及我们对患者的坚定承诺。”Additionally, we're honored to present the Phase 3b ENCORE study findings as a late breaker, which will highlight compelling evidence of ARIKAYCE's potential use earlier in the treatment journey for patients living with . 此外,我们很荣幸作为最新突破性研究公布 3b 期 ENCORE 研究结果,这将突显ARIKAYCE 在患者治疗过程早期使用的潜力的有力证据。Mycobacterium avium 鸟分枝杆菌complex lung disease.' 复杂的肺部疾病。Presentations: 演示文稿: Late Breaking Science A71, 晚期突破科学A71, Sunday, May 17, 11:30 AM – 1:15 PM EDT 5月17日星期日,上午11:30 - 下午1:15(东部夏令时间)Amikacin Liposome Inhalation Suspension for Newly Diagnosed Mycobacterium Avium Complex Lung Disease: Efficacy and Safety From a Phase 3b Study (ENCORE) 阿米卡星脂质体吸入混悬液治疗新诊断的鸟分枝杆菌复合体肺病:来自3b期研究(ENCORE)的疗效与安全性Poster Session B45, 海报会议 B45,Monday, May 18, 11:30 AM – 1:15 PM EDT 5月18日星期一,上午11:30 - 下午1:15(东部夏令时间)Effect of Brensocatib on Patient-Reported Symptoms in Patients with Non-Cystic Fibrosis Bronchiectasis: A Post Hoc Analysis of QOL-B RSS Individual Items from the ASPEN Phase 3 Trial 布伦索卡替对非囊性纤维化支气管扩张症患者报告症状的影响:ASPEN 三期试验中QOL-B RSS单个条目的事后分析Poster Session B106, 海报展示 B106,Monday, May 18, 2:15 – 4:15 PM EDT 5月18日星期一,下午2:15 – 4:15(东部夏令时间)Population Pharmacokinetics Analysis of Treprostinil Using Data From Phase 1 and 2 Studies of Treprostinil Palmitil Inhalation Powder 使用Treprostinil棕榈酸酯吸入粉剂的1期和2期研究数据进行Treprostinil的群体药代动力学分析Poster Session B107, 海报展示 B107,Monday, May 18, 2:15 – 4:15 PM EDT 5月18日星期一,下午2:15 – 4:15(东部夏令时)Patient and Caregiver Survey of Burden of Bronchiectasis in the US and Europe 美国和欧洲支气管扩张症负担的患者与护理者调查Poster Session C58, 海报会议 C58,Tuesday, May 19, 11:30 AM – 1:15 PM EDT 5月19日星期二,上午11:30 - 下午1:15(东部夏令时间)Long-term Hospitalizations, Comorbidities, and Survival in Patients with Pulmonary Hypertension Associated With Interstitial Lung Disease in Real-World Settings Using the NorstellaLinQ Claims Database 使用NorstellaLinQ索赔数据库在真实世界环境中研究与间质性肺病相关的肺动脉高压患者的长期住院、合并症和生存率 Mini Symposium D92, 小型研讨会 D92,Wednesday, May 20, 11:00 AM – 1:00 PM EDT 5月20日星期三,上午11:00 – 下午1:00(东部夏令时间)Exposure-response Relationships of Brensocatib in Adult and Adolescent Patients With Non-Cystic Fibrosis Bronchiectasis 成人和青少年非囊性纤维化支气管扩张症患者中布伦索卡替的暴露-反应关系In addition to its scientific presentations, Insmed will also host a Medical Affairs exhibit booth (location #937) at the ATS conference. 除了科学展示之外,Insmed还将在ATS会议举办医学事务展览展位(位置#937)。American Thoracic Society (ATS) Bronchiectasis Diagnosis Quality Initiative 美国胸科学会 (ATS) 支气管扩张症诊断质量倡议As announced by the ATS, Insmed is supporting the organization with an independent research grant for a landmark quality improvement initiative aimed at addressing the widespread underdiagnosis of bronchiectasis across the United States. Working with seven academic medical systems, the ATS will independently conduct a large-scale electronic health record study to identify patients misdiagnosed with asthma or COPD, pilot scalable diagnostic interventions, and disseminate findings nationally, with the goal of ensuring patients receive timely, accurate diagnoses and guideline-directed care.. 根据ATS的公告,Insmed公司正在通过一项独立研究基金支持该组织,用于开展一项具有里程碑意义的质量改进计划,旨在解决美国各地支气管扩张症普遍存在的漏诊问题。ATS将与七个学术医疗系统合作,独立开展一项大规模的电子健康记录研究,以识别被误诊为哮喘或慢性阻塞性肺病(COPD)的患者,试行可扩展的诊断干预措施,并在全国范围内推广研究成果,目标是确保患者能够及时获得准确的诊断和遵循指南的治疗。About ARIKAYCE 关于ARIKAYCEARIKAYCE 阿米卡星吸入混悬液® ®is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. 在美国被批准为ARIKAYCE(阿米卡星脂质体吸入混悬液),在欧洲被批准为ARIKAYCE脂质体590毫克雾化分散液,在日本被批准为ARIKAYCE吸入剂590毫克(硫酸阿米卡星吸入药物产品)。当前的国际治疗指南推荐对合适的患者使用ARIKAYCE。ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIAKAYCE 是一种新型的、每日一次的吸入式阿米卡星制剂,阿米卡星是一种已广泛应用的抗生素,以往通过静脉注射给药,常伴随严重的听力、平衡和肾功能毒性。Insmed 专有的 PULMOVANCE™ 脂质体技术能够将阿米卡星直接递送至肺部,脂质体阿米卡星被肺部感染部位的肺巨噬细胞摄取,同时限制了全身暴露。ARIKAYCE is administered once daily using the Lamira. 使用Lamira每日给药一次ARIKAYCE。® ®Nebulizer System manufactured by PARI Pharma GmbH (PARI). 由PARI Pharma GmbH(PARI)制造的雾化器系统。About 关于BRINSUPRI BRINSUPRIBRINSUPRI BRINSUPRI® ®(brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). BRINSUPRI (brensocatib 10 mg and 25 mg tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (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。BRINSUPRI(brensocatib 10 毫克和 25 毫克片剂)在美国适用于治疗 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)。In the European Union, 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. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.. 在欧盟,BRINSUPRI(布伦索卡替25毫克片剂)被批准用于治疗12岁及以上在过去12个月内有两次或以上病情加重的NCFB患者。布伦索卡替旨在抑制中性粒细胞中酶(中性粒细胞丝氨酸蛋白酶)的激活,这些酶是NCFB慢性气道炎症的关键驱动因素。About TPIP 关于TPIPTreprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and other rare and serious pulmonary disorders. 曲前列尼尔棕榈酸酯吸入性粉末(TPIP)是一种处于研究阶段的曲前列尼尔棕榈酸酯干粉制剂,该前药由通过酯键连接到16碳链的曲前列尼尔组成。TPIP完全在Insmed实验室开发,作为一种潜在高度差异化的前列腺素类药物,正在被评估用于每日一次治疗肺动脉高压(PAH)、与间质性肺病相关的肺动脉高压(PH-ILD)以及其他罕见和严重的肺部疾病。TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. . TPIP 通过胶囊型吸入装置给药。TPIP 是一种研究性药物,尚未在任何司法管辖区获批用于任何适应症。IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR 重要安全信息和加框警告ARIKAYCE IN THE U.S. 美国的ARIAKAYCEWARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS 警告:呼吸不良反应风险增加ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. ARIAKAYCE 与呼吸系统不良反应的风险增加有关,包括过敏性肺炎、咯血、支气管痉挛以及潜在肺部疾病的恶化,这些情况在某些病例中已导致住院。Hypersensitivity Pneumonitis 过敏性肺炎has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). 在临床试验中,使用ARIKAYCE已报告出现过敏性肺炎(报告为过敏性肺泡炎、肺炎、间质性肺病、对ARIKAYCE的过敏反应)。接受ARIKAYCE加背景治疗方案的患者(3.1%)比仅接受背景治疗方案的患者(0%)报告的频率更高。Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.. 大多数对ARIKAYCE产生过敏性肺炎的患者停止了该药物的治疗,并接受了皮质类固醇的治疗。如果发生过敏性肺炎,应停止使用ARIKAYCE,并根据医学需要对患者进行适当管理。Hemoptysis 咯血has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate.. 在临床试验中使用ARIKAYCE时已有报道。接受ARIKAYCE加背景治疗方案的患者(17.9%)比单独接受背景治疗方案的患者(12.5%)出现咯血的频率更高。如果发生咯血,应根据医学需要对患者进行适当管理。Bronchospasm 支气管痉挛has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). 在临床试验中,使用ARIKAYCE时报告了以下情况。支气管痉挛(报告为哮喘、支气管高反应性、支气管痉挛、呼吸困难、劳力性呼吸困难、呼气延长、喉咙紧缩、喘息)在接受ARIKAYCE加背景治疗方案的患者中的发生频率较高(28.7%),相比之下,仅接受背景治疗方案的患者发生率为10.7%。If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate. . 如果在使用 ARIKAYCE 期间发生支气管痉挛,应根据医学判断对患者进行适当治疗。Exacerbations of underlying pulmonary disease 基础肺疾病的恶化has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). 在临床试验中使用ARIKAYCE时已报告出现以下情况。接受ARIKAYCE加背景治疗方案的患者(14.8%)相比仅接受背景治疗方案的患者(9.8%),基础肺病恶化(报告为慢性阻塞性肺病(COPD)、COPD感染性加重、支气管扩张感染性加重)的发生频率更高。If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.. 如果在使用ARIKAYCE期间基础肺病加重,应根据医学判断对患者进行治疗。Anaphylaxis and Hypersensitivity Reactions 过敏反应和超敏反应: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). 严重且可能危及生命的超敏反应,包括过敏性反应,已在使用ARIKAYCE的患者中报告。体征和症状包括皮肤和黏膜组织超敏反应的急性发作(荨麻疹、瘙痒、潮红、嘴唇/舌头/悬雍垂肿胀)、呼吸困难(气短、喘息、喉鸣、咳嗽)、胃肠道症状(恶心、呕吐、腹泻、腹部绞痛)以及过敏性反应的心血管体征和症状(心动过速、低血压、晕厥、失禁、头晕)。Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.. 在开始使用ARIKAYCE治疗之前,评估对氨基糖苷类药物既往是否出现过超敏反应。如果发生过敏反应或超敏反应,应停止使用ARIKAYCE并采取适当的支援措施。Ototoxicity 耳毒性has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). 在临床试验中,使用ARIKAYCE时已报告了耳毒性(包括耳聋、头晕、晕厥前兆、耳鸣和眩晕)。接受ARIKAYCE加背景治疗方案的患者(17%)比仅接受背景治疗方案的患者(9.8%)更频繁地报告出现耳毒性。This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. 这主要是由耳鸣(ARIKAYCE加背景治疗方案组为7.6%,而单独背景治疗方案组为0.9%)和头晕(ARIKAYCE加背景治疗方案组为6.3%,而单独背景治疗方案组为2.7%)引起的。在使用ARIKAYCE治疗期间,应密切监测已知或疑似听觉或前庭功能障碍的患者。If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.. 如果发生耳毒性,应根据医学判断管理患者,包括可能停止使用ARIAKAYCE。Nephrotoxicity 肾毒性was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.. 在对MAC肺病患者进行的ARIAKAYCE临床试验中观察到肾毒性,但其发生频率并不高于单独使用背景治疗方案。肾毒性与氨基糖苷类药物有关。当开具ARIKAYCE处方时,可能需要密切监测已知或疑似肾功能不全的患者。Neuromuscular Blockade 神经肌肉阻滞: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.. 神经肌肉疾病患者未纳入 ARIKAYCE 临床试验。已知或疑似患有神经肌肉疾病(如重症肌无力)的患者应密切监测,因为氨基糖苷类药物可能会通过阻断神经肌肉接头处乙酰胆碱的释放而加重肌肉无力。Embryo-Fetal Toxicity 胚胎-胎儿毒性: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.. 氨基糖苷类药物给予孕妇时可能对胎儿造成伤害。包括ARIKAYCE在内的氨基糖苷类药物可能与子宫内暴露的儿科患者发生完全、不可逆的双侧先天性耳聋有关。在怀孕期间使用ARIKAYCE或在服用ARIKAYCE期间怀孕的患者应被告知对胎儿的潜在危害。Contraindications 禁忌症: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside. :ARIKAYCE禁用于已知对任何氨基糖苷类药物过敏的患者。Most Common Adverse Reactions 最常见的不良反应: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).. 在试验1中,使用ARIKAYCE加背景治疗方案的患者相比仅使用背景治疗方案的患者,最常见的不良反应(发生率≥5%)为:发声困难(47% vs 1%)、咳嗽(39% vs 17%)、支气管痉挛(29% vs 11%)、咯血(18% vs 13%)、耳毒性(17% vs 10%)、上呼吸道刺激(17% vs 2%)、肌肉骨骼疼痛(17% vs 8%)、疲劳和乏力(16% vs 10%)、基础肺病恶化(15% vs 10%)、腹泻(13% vs 5%)、恶心(12% vs 4%)、肺炎(10% vs 8%)、头痛(10% vs 5%)、发热(7% vs 5%)、呕吐(7% vs 4%)、皮疹(6% vs 2%)、体重减轻(6% vs 1%)、痰液变化(5% vs 1%)以及胸闷(5% vs 3%)。Drug Interactions 药物相互作用: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.. :避免将ARIAKAYCE与具有神经毒性、肾毒性和耳毒性的药物同时使用。一些利尿剂通过改变血清和组织中的氨基糖苷类浓度,可能加剧氨基糖苷类的毒性。避免将ARIAKAYCE与依他尼酸、呋塞米、尿素或静脉注射甘露醇同时使用。Overdosage 过量: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.. :尚未确定与ARIKAYCE过量特别相关的不良反应。急性毒性应通过立即停用ARIKAYCE来处理,并应进行肾功能的基线检测。血液透析可能有助于从体内清除阿米卡星。在所有疑似过量的情况下,医生应联系地区中毒控制中心以获取有关有效治疗的信息。U.S. INDICATION 美国适应症LIMITED POPULATION: ARIKAYCE 有限人群:ARIAKAYCE® ®is indicated in adults, who have limited or no alternative treatment options, for the treatment of 适用于成人,这些成人患者治疗选择有限或没有其他替代治疗方案,用于治疗Mycobacterium avium 鸟分枝杆菌complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. 作为联合抗菌药物治疗方案的一部分,用于治疗那些在至少连续6个月的多药背景治疗后痰培养仍为阳性的复杂性(MAC)肺病患者。由于目前关于ARIKAYCE的临床安全性和有效性数据有限,仅将其用于治疗选择有限或无其他替代治疗方案的成人患者。This drug is indicated for use in a limited and specific population of patients.. 该药物适用于有限且特定的患者群体。This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.. 该适应症是基于在第6个月前实现痰培养转化(定义为连续3次每月痰培养阴性)而获得加速批准的。目前尚未确定临床益处。该适应症的持续批准可能取决于在确证性试验中对临床益处的验证和描述。 Limitation of Use 使用限制: :ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.. ARIAKAYCE仅在难治性MAC肺病患者中进行过研究,这些患者被定义为在至少连续6个月的多药背景治疗方案后仍未达到痰培养阴性的患者。不建议将ARIAKAYCE用于非难治性MAC肺病患者。Patients are encouraged to report negative side effects of prescription drugs to the FDA. 患者被鼓励向 FDA 报告处方药的负面副作用。Visit 访问www.fda.gov/medwatch www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED. ,或者拨打1‑800‑FDA‑1088。您也可以拨打公司电话1-844-4-INSMED。Please see 请参见Full Prescribing Information 完整处方信息 . 。BRINSUPRI BRINSUPRI® ®(brensocatib) U.S. INDICATION AND (brensocatib) 美国适应症和IMPORTANT SAFETY INFORMATION 重要安全信息Indication in the U.S. 美国的适应症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)。Important Safety Information in the U.S. 美国重要的安全信息WARNINGS AND PRECAUTIONS 警告与注意事项Dermatologic Adverse Reactions 皮肤病不良反应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,包括皮疹、皮肤干燥和角化过度。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。在服用BRINSUPRI期间,建议患者定期进行牙科检查,并建议保持日常的口腔卫生。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. 在BRINSUPRI治疗期间接种活减毒疫苗是否会影响这些疫苗的安全性或有效性尚不清楚。接受BRINSUPRI的患者应避免使用活减毒疫苗。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,最常见的不良反应(≥2%)包括上呼吸道感染、头痛、皮疹、皮肤干燥、角化过度和高血压。在WILLOW试验中,NCFB成年患者的安全性特征与ASPEN大致相似,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 肝功能测试升高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,从第4周到第56周的所有时间点,与安慰剂相比,BRINSUPRI 10 mg和25 mg组的平均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%,对应于接受安慰剂、BRINSUPRI 10 mg和25 mg治疗的患者。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%,而接受安慰剂治疗的患者为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中,接受BRINSUPRI 10毫克和25毫克治疗的患者中,脱发的发生率分别为1.5%和1.6%,而接受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. 目前尚无关于孕妇使用BRINSUPRI的临床数据。Lactation: 哺乳: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. . 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产量的影响的信息。应该权衡母乳喂养对发育和健康的益处,同时考虑母亲对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任何不良影响。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 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 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证实。在 ASPEN 试验中,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 请参见完整内容US Prescribing Information 美国处方信息. 。About Insmed 关于InsmedInsmed 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,致力于提供一流和最佳的治疗方法,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批准和处于中期到晚期研究阶段的药物,并且专注于前沿药物的发现,以服务那些需求最为迫切的患者群体。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末端连接以及合成拯救技术。Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 总部位于新泽西州布里奇沃特的Insmed公司在美国、欧洲和日本均设有办公室和研究机构。Insmed很自豪被评为生物制药行业最佳雇主之一,包括连续五年名列第一。Science 科学Top Employer. Visit 最佳雇主。访问www.insmed.com www.insmed.comto learn more or follow us on 了解更多或关注我们LinkedIn 领英, ,Instagram 图片分享社交平台 , ,YouTube YouTube, and ,以及X X. 。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”一词按照《1995年私人证券诉讼改革法案》中的定义,是指并非历史事实且涉及诸多风险和不确定性的陈述。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”、“继续”等词语(以及其他引用未来事件、条件或情况的词语或表达)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公司的当前预期和信念,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: risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for Lamira. 此类风险、不确定性和其他因素包括但不限于以下内容:我们不时宣布或发布的临床试验的中期、高层或初步数据可能会随着更多患者数据的可用而发生变化,或者如果披露了额外数据,可能会有不同的解读;无法成功开展针对我们已上市产品或候选产品的未来临床试验,或我们可能无法招募或保留足够的患者以进行和完成试验,或生成我们候选产品监管审批所需的数据;与我们已上市产品或候选产品相关的意外安全性或有效性问题的出现;我们的临床研究可能延迟的风险,在药物开发过程中可能会发现严重副作用,或提交的任何方案修订可能会被拒绝;我们无法从FDA获得ARIKAYCE的完全批准,或未能获得扩大ARIKAYCE适应症至更广泛患者群体的监管批准;在美国、欧洲或日本未能获得或延迟获得我们候选产品的监管批准,在美国、欧洲或日本以外地区未能获得ARIKAYCE的监管批准,包括Lamira的单独监管批准。® ®in each market and for each usage, or for brensocatib in NCFB in Japan; and failure to successfully commercialize our marketed products and product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for our marketed products and product candidates, if approved.. 在每个市场和每种用途,或在日本的NCFB中使用brensocatib;以及无法成功将已上市产品和候选产品商业化(如获相关监管机构批准),或无法维持已上市产品和候选产品的适用监管批准(如获批准)。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声明所示的结果、计划、意图或期望,因为前瞻性声明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,并取决于相应的情况。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).. 有关可能影响公司业务的风险和不确定性的更多信息,请参阅公司截至2025年12月31日的年度报告Form 10-K中第1A项“风险因素”中讨论的因素,以及公司随后向证券交易委员会(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,这些声明仅截至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影响该等声明所基于的事件、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不同可能性的变化。Contact: 联系人:Investors: 投资者:Bryan Dunn 布赖恩·邓恩Vice President, Investor Relations 投资者关系副总裁(646) 812-4030 (646) 812-4030[email protected] 电子邮件地址Media: 媒体:Claire Mulhearn 克莱尔·穆赫恩Vice President, Corporate Communications 副总裁,企业传播(862) 842-6819 (862) 842-6819[email protected] 电子邮件地址SOURCE Insmed Incorporated 来源:Insmed公司21 21% %more press release views with 更多新闻发布视图与 Request a Demo 请求演示