Ridgefield, Conn., and Ingelheim, Germany, Feb. 19, 2025 -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (.

康涅狄格州里奇菲尔德和德国英戈尔施塔特，2025年2月19日——勃林格殷格翰公司今日宣布，美国食品药品监督管理局（FDA）已对其新药zongertinib（BI 1810631）的申请授予优先审查资格，该药物用于治疗肿瘤具有HER2（不可切除或转移性非小细胞肺癌（NSCLC）的成年患者。

ERBB2) mutations and who have received prior systemic therapy. The FDA grants Priority Review to applications for drugs that would offer significant improvements in the treatment, diagnosis, or prevention of serious conditions, with action expected within six months compared to 10 months under standard review.

ERBB2）突变并且已经接受过先前的系统治疗的患者。FDA授予优先审查资格给那些在严重疾病的治疗、诊断或预防方面提供显著改进的药物申请，预计将在六个月内采取行动，而标准审查则需要10个月。

The Prescription Drug User Fee Act (PDUFA) action date is in the third quarter of 2025..

《处方药使用者费用法案》（PDUFA）的行动日期在2025年第三季度。

“We believe zongertinib has the potential to transform the care of previously treated patients with HER2

“我们相信，zongertinib 有潜力改变先前接受过治疗的 HER2 患者的护理方式

-mutant advanced non-small cell lung cancer and are hopeful about the continued research in other tumor types and lines of therapy,” said Shashank Deshpande, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “Priority Review illustrates the urgent need in this patient population and the possibility for zongertinib to be a groundbreaking innovation for patients with limited treatment options.”.

“突变型晚期非小细胞肺癌患者，并对其他肿瘤类型和治疗方案的持续研究充满希望，”勃林格殷格翰公司董事会成员兼人药部门负责人Shashank Deshpande表示。“优先审评体现了这一患者群体的迫切需求，也为zongertinib成为治疗选择有限患者的突破性创新提供了可能。”

The application was based on results from the positive Phase Ib Beamion LUNG-1 trial. Data from Cohort 1 (N=75) of the study demonstrated an objective response rate (ORR) of 71% with six-month progression-free survival (PFS) and duration of response (DoR) rates of 69% and 73%, respectively, in patients with mutations in the HER2 tyrosine kinase domain.

该申请基于阳性Ib期Beamion LUNG-1试验的结果。研究的第1队列（N=75）数据显示，在HER2酪氨酸激酶结构域突变的患者中，客观缓解率（ORR）为71%，六个月无进展生存率（PFS）和缓解持续时间（DoR）分别为69%和73%。

Zongertinib had a safety profile with a low incidence of dose reductions (5%) and treatment discontinuations (3%). The majority of treatment-related adverse events (TRAEs) with zongertinib were mild in nature with diarrhea and rash being the most common all grade TRAEs, at 51% and 27% respectively. No new safety signals were observed.

宗格替尼的安全性特征表现为剂量减少（5%）和治疗中断（3%）的发生率较低。大多数与宗格替尼相关的治疗不良事件（TRAEs）为轻度，其中腹泻和皮疹是最常见的所有等级TRAEs，分别占51%和27%。未观察到新的安全性信号。

Grade 3 or higher TRAEs occurred in one patient treated with zongertinib. No treatment-related interstitial lung disease (ILD) cases were reported. .

接受Zongertinib治疗的一名患者发生了3级或更高级别的TRAE。未报告与治疗相关的间质性肺病（ILD）病例。

“Personalized medicine has revolutionized cancer treatment,” said GO2 for Lung Cancer’s Chief Scientific Officer, Courtney Granville. “Early screening and biomarker testing for mutations provide critical information to guide targeted therapies in personalized medicine. This filing acceptance represents a significant step toward offering another option for individuals with a HER2 (.

“个性化医疗已经彻底改变了癌症治疗，”GO2肺癌首席科学官Courtney Granville表示。“早期筛查和基因突变的生物标志物检测为个性化医疗中的靶向治疗提供了关键信息。这一申请的接受标志着为HER2（患者提供另一种选择迈出了重要一步。”

Zongertinib was previously granted Breakthrough Therapy Designation and Fast Track Designation by the FDA. The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a medicine that is intended to treat a serious or life-threatening disease, and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available treatments.

宗格替尼之前获得了FDA的突破性疗法认定和快速通道认定。FDA的突破性疗法认定旨在加速开发和审查用于治疗严重或危及生命疾病的药物，初步临床证据表明该药物可能比现有疗法有显著改善。

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. In addition to the FDA designations, Japan’s Pharmaceuticals and Medical Devices Agency recently granted Orphan Drug Designation to zongertinib.

美国食品药品监督管理局（FDA）的快速通道计划旨在促进用于治疗严重疾病并满足未满足医疗需求的药物的开发，并加快其审查进程。除了FDA的认定外，日本药品和医疗器械管理局最近还授予了zongertinib孤儿药资格。

About the Beamion clinical trial program

关于Beamion临床试验计划

Beamion LUNG-1 ( NCT04886804) is an open-label, Phase I dose escalation trial, with dose confirmation and expansion, of zongertinib as monotherapy in people with unresectable or metastatic solid tumors with HER2 (ERBB2) alterations. Beamion LUNG-2 is a Phase III, open label, randomized, active-controlled study that is enrolling patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain mutations to evaluate zongertinib compared with standard of care.

Beamion LUNG-1 ( NCT04886804）是一项开放标签、I 期剂量递增试验，对 zongertinib 单药治疗不可切除或转移性 HER2（ERBB2）改变。Beamion LUNG-2 是一项 III 期、开放标签、随机、活性对照研究，正在招募携带 HER2 的不可切除或转移性非鳞状非小细胞肺癌（NSCLC）患者 （ERBB2 ）酪氨酸激酶结构域突变，以评估宗格替尼与标准治疗方案的比较。

About zongertinib

关于宗格替尼

Zongertinib (also known as BI 1810631) is an investigational, irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2) while sparing EGFR, thereby limiting associated toxicities. This orally administered, targeted treatment is being developed for HER2 (ERRB2

宗格替尼（也称为 BI 1810631）是一种研究性、不可逆的酪氨酸激酶抑制剂 (TKI)，可选择性抑制 HER2 (ERBB2) 同时保留EGFR，从而限制相关毒性。这种口服的靶向治疗正在被开发用于HER2 (ERRB2

mutant advanced non-small cell lung cancer (NSCLC) and additional clinical studies with zongertinib are ongoing in solid tumors with HER2 alterations.

突变型晚期非小细胞肺癌（NSCLC），并且正在进行宗格替尼在HER2变异实体瘤中的更多临床研究。

About Boehringer Ingelheim in Oncology

关于勃林格殷格翰在肿瘤学领域

We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the

我们有一个明确的愿望——通过提供有意义的进步来改变癌症患者的生活，

ultimate goal

最终目标

of curing a range of cancers. Boehringer Ingelheim’s generational commitment to driving scientific innovation is reflected by the company’s robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer’s ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research.

治愈一系列癌症。勃林格殷格翰世代致力于推动科学创新，这体现在公司强大的癌症细胞导向和免疫肿瘤学研究治疗管道，以及这些方法的智能组合上。勃林格在肿瘤学领域的雄心是采取勤奋而广泛的方法，创建一个协作研究网络，以利用多样化的思维，这对解决一些最具挑战性但潜在最有影响力的癌症研究领域至关重要。

Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations..

简而言之，对勃林格殷格翰而言，癌症护理是个人化的，无论是现在还是未来几代人。

About Boehringer Ingelheim

关于勃林格殷格翰

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain.

勃林格殷格翰是一家活跃于人类和动物健康的生物制药公司。作为行业内在研发领域投资最多的公司之一，该公司专注于开发针对高度未满足医疗需求的创新疗法。自1885年成立以来，勃林格始终保持独立，以长远视角为导向，并将可持续发展贯穿于整个价值链。

More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at .

超过 53,500 名员工为 130 多个市场服务，共同建设一个更健康、更可持续和更公平的明天。请访问 了解更多信息。