A concise overview of the key pulmonology stories from Q2 2026
2026 年第二季度关键肺脏病学新闻的简明概述
Tozorakimab Meets Primary Endpoint in Phase 3 MIRANDA COPD Trial
Tozorakimab 在 3 期 MIRANDA COPD 试验中达到主要终点
AstraZeneca announced in April that tozorakimab met its primary endpoint in the phase 3 MIRANDA trial, reducing annualized moderate-to-severe COPD exacerbation rates versus placebo in former smokers and in the overall population — including current smokers across all eosinophil levels and lung function severity stages — when added to inhaled standard of care. The result marks the third consecutive positive phase 3 readout in the LUNA program, following OBERON and TITANIA, and extends the exacerbation reduction signal to a more frequent subcutaneous dosing regimen. The consolidating evidence base positions tozorakimab for anticipated regulatory submissions in COPD.
阿斯利康在 4 月份宣布,在吸入标准治疗的基础上加入 tozorakimab 后,该药在 3 期 MIRANDA 试验中达到了其主要终点,与安慰剂相比,降低了既往吸烟者和总体人群(包括所有嗜酸性粒细胞水平和肺功能严重程度阶段的当前吸烟者)的年化中重度 COPD 急性加重率。该结果标志着 LUNA 项目继 OBERON 和 TITANIA 之后,连续第三次取得积极的 3 期临床结果,并将减少急性加重的信号扩展到了更频繁的皮下给药方案。不断巩固的证据基础使 tozorakimab 有望按预期提交针对 COPD 的监管申请。
FDA Approves BGF Triple Inhaler for Patients Aged 12 and Older
FDA 批准 BGF 三联吸入剂用于 12 岁及以上患者
The FDA approved budesonide/glycopyrrolate/formoterol fumarate (BREZTRI Aerosphere; AstraZeneca) as the first single-inhaler ICS/LABA/LAMA triple combination for patients aged 12 and older, extending a treatment paradigm previously limited to adults into adolescent patients with asthma or COPD. The approval was grounded in phase 3 KALOS and LOGOS data, published in The Lancet Respiratory Medicine, which showed a pooled 76 mL improvement in trough FEV₁ and a reduction in severe exacerbations over dual therapy. The pediatric and adolescent label expansion addresses a population that had previously been managed with separate controller agents.
FDA 批准了布地奈德/格隆溴铵/富马酸福莫特罗(BREZTRI Aerosphere;阿斯利康)作为首个适用于 12 岁及以上患者的单吸入器 ICS/LABA/LAMA 三联组合药物,将以前仅限于成人的治疗模式扩展到了患有哮喘或 COPD 的青少年患者。该批准基于发表在《柳叶刀呼吸医学》上的 3 期 KALOS 和 LOGOS 试验数据,这些数据显示,与双联疗法相比,其在谷值 FEV₁ 方面实现了 76 毫升的汇总改善,并减少了严重急性加重的发生。针对儿童和青少年的标签扩展满足了一个以前需要使用独立控制药物进行管理的人群的需求。
Inhaled Treprostinil Improves IPF Outcomes in Phase 3 TETON-1 Trial
吸入型曲前列尼尔在 3 期 TETON-1 试验中改善 IPF 结果
Nebulized treprostinil (Tyvaso; United Therapeutics) reduced FVC decline by 130.1 mL vs placebo (95% CI, 82.2 to 178.1; P <.001) and cut the risk of a composite clinical worsening endpoint — encompassing ≥10% relative FVC decline, respiratory hospitalization, and all-cause mortality — by 33% (HR, 0.67; P =.003) over 52 weeks in the phase 3 TETON-1 trial, presented at ATS 2026. In a combined analysis with TETON-2, the program met 5 of 6 secondary endpoints, including a 48% reduction in acute exacerbations (P =.0223) and the first significant DLCO improvement demonstrated by any IPF therapy in a phase 3 trial. United Therapeutics plans to submit a supplemental NDA by summer 2026 seeking priority review for the IPF indication, which would make nebulized treprostinil the first inhaled therapy approved for the condition.
在 2026 年 ATS 会议上展示的 3 期 TETON-1 试验中,与安慰剂相比,雾化吸入曲前列尼尔(Tyvaso;联合治疗公司)在 52 周内将 FVC 的下降减少了 130.1 毫升(95% CI,82.2 至 178.1;P <.001),并将复合临床恶化终点(包括 ≥10% 相对 FVC 下降、呼吸系统住院和全因死亡率)的风险降低了 33%(HR,0.67;P =.003)。在与 TETON-2 的联合分析中,该项目达到了 6 个次要终点中的 5 个,包括急性加重减少 48% (P =.0223),以及在 3期 试验中由任何 IPF 疗法证明的首个显著的 DLCO 改善。联合治疗公司计划在 2026 年夏季前提交补充 NDA,寻求针对 IPF 适应症的优先审评,这将使雾化吸入曲前列尼尔成为首个获批用于该疾病的吸入疗法。
Ralinepag Achieves 55% Risk Reduction in PAH in Phase 3 ADVANCE OUTCOMES
Ralinepag 在 3 期 ADVANCE OUTCOMES 试验中实现 PAH 风险降低 55%
Ralinepag, an investigational once-daily oral prostacyclin receptor agonist with higher potency than existing agents in this class, reduced the risk of clinical worsening in pulmonary arterial hypertension by 55% vs placebo (HR, 0.45; P <.0001) in the phase 3 ADVANCE OUTCOMES trial, presented at ATS 2026 by Vallerie McLaughlin, MD. Secondary endpoints showed significant NT-proBNP reductions, improved 6-minute walk distance, and 47% greater odds of clinical improvement. United Therapeutics has announced plans for an FDA new drug application submission in the second half of 2026.
根据 Vallerie McLaughlin 博士在 2026 年 ATS 会议上展示的 3 期 ADVANCE OUTCOMES 试验结果,Ralinepag(一种处于研究阶段、每日一次的口服前列环素受支体激动剂,效力高于该类别的现有药物)与安慰剂相比,将肺动脉高压临床恶化的风险降低了 55% (HR, 0.45; P <.0001)。次要终点显示 NT-proBNP 显著降低,6 分钟步行距离改善,以及临床改善的几率增加了 47%。联合治疗公司已宣布计划在 2026 年下半年向 FDA 提交新药申请。
Tezepelumab Reduces Severe Asthma Across Phenotypes in Phase 4 PASSAGE
Tezepelumab 在 4 期 PASSAGE 试验中减少了跨表型的重度哮喘
Phase 4 PASSAGE data presented at ATS 2026 showed tezepelumab, an anti-TSLP monoclonal antibody, reduced annualized asthma exacerbation rates by 70% (95% CI, 63 to 75) in a 286-patient real-world cohort intentionally enriched for populations excluded from pivotal trials — including active smokers with ≥10 pack-years, patients with mild-to-moderate comorbid COPD, and Black or African American patients. Exacerbation reductions ranged from 54% to 77% across subgroups regardless of eosinophil count or allergic status, and clinically meaningful improvements were observed across validated asthma control and quality-of-life measures. The findings support biologic use in patients previously considered poor candidates due to smoking history or airflow obstruction.
2026 年 ATS 会议上展示的 4 期 PASSAGE 数据显示,抗 TSLP 单克隆抗体 tezepelumab 在一个由 286 名患者组成的真实世界队列中,将年化哮喘加重率降低了 70%(95% CI,63 至 75),该队列特意富集了关键试验中被排除的人群——包括包年数 ≥10 年的活跃吸烟者、伴有轻中度 COPD 的患者以及黑色人种或非洲裔美国人患者。在所有亚组中,无论嗜酸性粒细胞计数或过敏状态如何,急性加重的减少幅度在 54% 到 77% 之间,并在经过验证的哮喘控制和生活质量测量中观察到了具有临床意义的改善。这些发现支持了生物制剂在以前因吸烟史或气流阻塞而被认为不适合治疗的患者中的应用。
Insulin Resistance Linked to CT-Quantified Interstitial Lung Disease
胰岛素抵抗与 CT 量化的间质性肺疾病相关
A Multicenter AIDS Cohort Study analysis presented at ATS 2026 found that each doubling in long-term, time-weighted insulin resistance was associated with a 1.58% greater percentage of lungs with ILD features on cardiac CT (95% CI, 0.38 to 2.78), an effect driven primarily by ground glass opacity rather than established fibrosis and independent of HIV or diabetes status. Investigator Sarath Raju, MD, of Johns Hopkins University, said the predominance of ground glass over scarring may point to metabolic inflammation as an early, potentially modifiable precursor to fibrotic lung disease, with plans to validate the findings in larger population-based cohorts. The analysis raises the question of whether targeting insulin resistance before overt diabetes could have a role in lung disease prevention.
在 2026 年 ATS 会议上展示的一项多中心 AIDS 队列研究分析发现,长期、时间加权胰岛素抵抗每增加一倍,心脏 CT 上显示具有 ILD 特征的肺部百分比就会增加 1.58%(95% CI,0.38 至 2.78),这一效应主要由磨玻璃影而非确立的纤维化所驱动,且独立于 HIV 或糖尿病状态。约翰斯·霍普金斯大学的研究员 Sarath Raju 博士表示,磨玻璃影多于瘢痕形成可能表明,代谢性炎症是纤维化肺部疾病的一种早期的、潜在可调控的前驱病变,并计划在更大的基于人群的队列中验证这些发现。该分析提出了一个问题:在发展为显性糖尿病之前针对胰岛素抵抗进行干预,是否能在预防肺部疾病中发挥作用。
Unified Airway Disease: Rhinitis, Nasal Polyps, and NERD as Drivers of Asthma Burden
统一气道疾病:鼻炎、鼻息肉和 NERD 作为哮喘负担的驱动因素
At the APAPP National Conference, Heather O'Connell, PA-C, MS, presented the unified airway concept — the principle that the nose, sinuses, and lungs function as a single inflammatory unit — and outlined how allergic rhinitis, chronic sinusitis with and without nasal polyps, and NSAID-exacerbated respiratory disease (NERD) are systematically underrecognized contributors to asthma severity and hospitalization risk. She cited data identifying rhinitis as the most prevalent risk factor for 30-day asthma readmission and noted that allergy immunotherapy has demonstrated up to 75% exacerbation reduction in seasonal allergic rhinitis, approaching biologic-level efficacy. O'Connell also recommended that clinicians proactively screen patients with severe asthma and nasal polyps for NERD, noting that reduced NSAID use means the classic aspirin-triggered reaction may never have occurred at presentation.
在 APAPP 全国会议上,Heather O'Connell(PA-C,MS)提出了统一气道概念——即鼻子、鼻窦和肺部作为一个单一的炎症单元发挥作用的原理——并概述了过敏性鼻炎、伴有和不伴有鼻息肉的慢性鼻窦炎以及非甾体抗炎药加重性呼吸系统疾病(NERD)是如何成为系统性被低估的哮喘严重程度和住院风险的因素。她引用的数据表明,鼻炎是 30 天内哮喘再次住院最普遍的风险因素,并指出过敏原免疫疗法已显示在季节性过敏性鼻炎中可减少高达 75% 的急性加重,接近生物制剂级别的疗效。O'Connell 还建议临床医生主动筛查重度哮喘和鼻息肉患者是否患有 NERD,并指出由于非甾体抗炎药(NSAID)使用的减少,经典的阿司匹林诱发反应在就诊时可能从未发生过。
推荐阅读
Celea Therapeutics 宣布获得 1.8 亿美元融资,以推进 Deupirfenidone 作为治疗特发性肺纤维化 (IPF) 的潜在新标准疗法
肺部网式雾化器(Pulmonary Mesh Nebulizers)市场规模预计将在2036年达到38亿美元
Polyrizon 宣布 NASARIX™ 生物相容性项目取得成功,支持推进首次人体临床试验
政府资助吸入 RNA 疗法,有望改变慢性肺部疾病治疗的未来
吸入药物研发进展报告 (2026年6月)
吸入药物研发进展报告 (2026年5月)
吸入药物研发进展报告 (2026年4月)
【DPI商业化技术】Inbrija® 左旋多巴生产技术揭秘——高剂量、高分散性吸入粉雾剂(DPI)的商业化技术
肺纤维化——美国临床1期、2期、3期、已获批上市药物概览
如果您对技术交流感兴趣,欢迎扫码加入群聊。期待与您一起探讨技术问题,共同进步!
免责声明 本公众号发布的内容仅供学术交流与行业参考,部分内容来自公开渠道和研究文献,不代表本公众号完全准确或权威。鉴于互联网的开放性和文章创作的复杂性,我们无法保证所有文章均已获得原作者的明确授权。如果您是原作者或拥有相关权益,请与我们联系,我们将立即删除未经授权的文章。本公众号提供的信息和观点仅为个人看法,不构成投资、决策或法律建议。请读者自行判断并承担相关风险,因使用本公众号内容而产生的任何损失,本公众号不承担责任。本公众号可能涉及广告或合作内容,所涉及的第三方产品或服务不代表本公众号立场,使用风险由用户自行承担。用户在使用本公众号时,应遵守相关法律法规,若因用户行为引起法律纠纷,责任由用户自行承担。感谢您的理解与支持!