Boehringer Ingelheim’s HERNEXEOS® has been approved as monotherapy by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received at least one line of prior systemic therapy.1 The accelerated approval followed a Breakthrough Therapy Designation and Priority Review status, reflecting the high recognition of its clinical benefit.

勃林格殷格翰的HERNEXEOS® 已经获得中国国家药品监督管理局（NMPA）批准，作为单药治疗携带激活HER2（ERBB2）突变且既往接受过至少一种系统性治疗的不可切除、局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。此项加速批准基于突破性疗法认定和优先审评资格，反映了对其临床获益的高度认可。

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'The absence of a well-tolerated oral drug targeting HER2, has been a long-standing challenge in the treatment of non-small cell lung cancer. The approval of zongertinib will change this landscape, setting a new treatment benchmark for HER2-mutant advanced non-small cell lung cancer,” said Professor Wu Yilong from Guangdong Provincial People's Hospital, Chairman of the Chinese Thoracic Oncology Group (CTONG).

“长期以来，缺乏一种耐受性良好的针对HER2的口服药物一直是非小细胞肺癌治疗中的挑战。宗格替尼的获批将改变这一局面，为HER2突变型晚期非小细胞肺癌设立新的治疗基准，”广东省人民医院吴一龙教授、中国胸部肿瘤研究协作组（CTONG）主席表示。

“This innovative drug provides a highly effective, targeted, oral treatment option for this patient population, which has an extremely poor prognosis and very limited treatment choices.'.

“这种创新药物为这类患者群体提供了一种高效、靶向的口服治疗选择，该患者群体预后极差且治疗选择非常有限。”

The conditional approval has been granted based on data from the Phase Ib Beamion-LUNG 1 trial, which demonstrated an objective response rate (ORR) of 71% (N=75). Data showed 7% of patients had a complete response (CR), with almost all patients (96%) achieving disease control. The median duration of response (mDoR) was 14.1 months, and the median progression-free survival (PFS) was 12.4 months.

基于Ib期Beamion-LUNG 1试验的数据，已授予有条件批准，该试验显示客观缓解率（ORR）为71%（N=75）。数据显示，7%的患者达到完全缓解（CR），几乎所有患者（96%）实现了疾病控制。中位缓解持续时间（mDoR）为14.1个月，中位无进展生存期（PFS）为12.4个月。

These results were previously presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine.2.

这些结果此前曾在2025年美国癌症研究协会（AACR）年会上公布，同时发表在《新英格兰医学杂志》上。2.

HERNEXEOS® demonstrated a manageable safety profile with a low discontinuation rate of 2.9%.

HERNEXEOS® 展现了可控的安全性，停药率低至2.9%。

Breakthrough Designation for first-line use

一线使用的突破性指定

The therapy was recently granted Breakthrough Therapy Designation by China’s Center for Drug Evaluation (CDE) for the first-line treatment of adult patients with unresectable or metastatic NSCLC harboring activating mutations in the HER2 tyrosine kinase domain (TKD). Zongertinib is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby limiting associated toxicities..

该疗法最近被中国药品审评中心（CDE）授予突破性疗法认定，用于一线治疗携带HER2酪氨酸激酶域（TKD）激活突变的不可切除或转移性非小细胞肺癌（NSCLC）成年患者。Zongertinib是一种不可逆的酪氨酸激酶抑制剂（TKI），可选择性抑制HER2，同时保留野生型EGFR，从而限制相关毒性。

“It is encouraging to see the NMPA’s continued recognition of zongertinib’s potential. Breakthrough Therapy Designation for first-line use of zongertinib in China illustrates the urgent need in this patient population. It is a critical next step to making this therapy available to more patients in need,” said Shashank Deshpande, Chairman of the Board of Managing Directors at Boehringer Ingelheim.

“看到中国国家药品监督管理局（NMPA）对佐格替尼潜力的持续认可，令人备受鼓舞。佐格替尼在中国获得一线治疗的突破性疗法认定，体现了这一患者群体的迫切需求。这是让这一疗法惠及更多有需要患者的关键下一步，”勃林格殷格翰董事会主席沙尚克·德什潘德表示。

“Given the robust clinical evidence, regulatory approvals and breakthrough designation, we are confident that zongertinib has the potential to redefine the standard for treating HER2-driven cancers. Therefore, we have initiated clinical studies to evaluate this therapy in other cancers, including breast cancer and the tumor-agnostic setting.”.

“鉴于强大的临床证据、监管批准和突破性认定，我们相信zongertinib有潜力重新定义HER2驱动癌症的治疗标准。因此，我们已经启动了临床研究，以评估该疗法在其他癌症中的应用，包括乳腺癌和泛肿瘤环境。”

Targeting lung cancer through HER2 mutation-directed treatment

通过HER2突变导向治疗靶向肺癌

Lung cancer is the leading cause of cancer death in China and the incidence and mortality rates of lung cancer have significantly increased in recent years.3 NSCLC is the most common type of lung cancer, accounting for approximately 85% of all cases.4 HER2 mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.5,6,7 Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.5,7 .

肺癌是中国癌症死亡的首要原因，近年来肺癌的发病率和死亡率显著增加。非小细胞肺癌（NSCLC）是最常见的肺癌类型，约占所有病例的85%。HER2突变发生在约2-4%的非小细胞肺癌病例中，与预后不良及更高的脑转移发生率相关。HER2（ERBB2）基因的改变，包括突变、扩增和过表达，会触发不受控制的细胞增殖，抑制细胞死亡，并促进肿瘤的生长和扩散。

About non-small cell lung cancer (NSCLC)

关于非小细胞肺癌（NSCLC）

Lung cancer claims more lives than any other cancer type and the incidence is set to increase to over 3 million cases worldwide by 2040.7,8 NSCLC is the most common type of lung cancer.4 Due to a lack of symptoms and misdiagnoses,9 most patients with NSCLC present at stage III or IV, where the disease has metastasized locally or to other organs.10 The estimated 5-year survival rate historically has been less than 10% for metastatic disease.11,12,13 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.14,15,16.

肺癌导致的死亡人数超过其他任何类型的癌症，预计到2040年，其全球发病数将增加到超过300万例。非小细胞肺癌（NSCLC）是最常见的肺癌类型。由于缺乏症状和误诊，大多数非小细胞肺癌患者在III期或IV期才被诊断出来，这时疾病已经局部转移或扩散到其他器官。对于转移性疾病的5年生存率历史上一直低于10%。患有晚期非小细胞肺癌的人可能会对其日常生活造成身体、心理和情感上的严重负面影响。

About zongertinib

关于佐格替尼

Zongertinib has been approved by the U.S. FDA (as HERNEXEOS®) and China’s NMPA (as HERNEXEOS®). It is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby limiting associated toxicities. This orally administered, targeted therapy has also been granted Orphan Drug Designation in Japan. .

宗格替尼已获美国FDA（作为HERNEXEOS®）和中国NMPA（作为HERNEXEOS®）批准。它是一种不可逆的酪氨酸激酶抑制剂（TKI），可选择性抑制HER2，同时保留野生型EGFR，从而限制相关毒性。这种口服的靶向治疗药物还获得了日本的孤儿药认定。

Zongertinib received Breakthrough Therapy Designation by China’s Center for Drug Evaluation (CDE) for the first line treatment of adult patients with unresectable or metastatic NSCLC harboring activating mutations in the HER2 tyrosine kinase domain (TKD).

宗格替尼获得中国药品审评中心（CDE）的突破性疗法认定，用于一线治疗携带HER2酪氨酸激酶结构域（TKD）激活突变的不可切除或转移性非小细胞肺癌（NSCLC）成年患者。

About the Beamion clinical trial program

关于Beamion临床试验计划

Beamion LUNG-1 (NCT04886804): 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 alterations. The study has 2 parts. The first part is open to adults with different types of advanced cancer with HER2 alterations that include mutations, amplifications, over-expression and fusions for whom previous treatment was not successful.

Beamion LUNG-1 (NCT04886804)：一项开放标签、I期剂量递增试验，通过剂量确认和扩展，评估zongertinib单药治疗不可切除或转移性HER2变异实体瘤患者的效果。研究分为两部分。第一部分面向携带包括突变、扩增、过表达和融合等HER2变异的不同类型晚期癌症成年患者，这些患者之前的治疗未获成功。

The second part is open to people with HER2-mutant non-small cell lung cancer..

第二部分对患有HER2突变型非小细胞肺癌的人开放。

Beamion LUNG-2 is a phase III, open label, randomized, active-controlled study that will enroll 416 patients with unresectable, or metastatic non-squamous NSCLC harboring HER2 tyrosine kinase domain mutations to evaluate zongertinib compared with standard of care.

Beamion LUNG-2是一项III期、开放标签、随机、阳性对照研究，将招募416名携带HER2酪氨酸激酶结构域突变的不可切除或转移性非鳞状非小细胞肺癌（NSCLC）患者，以评估宗格替尼与标准治疗的比较。

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 ultimate goal 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.

我们有一个明确的愿望——通过提供有意义的进展来改变癌症患者的生活，最终目标是治愈一系列癌症。勃林格殷格翰致力于推动科学创新的世代承诺，体现在公司强大的癌细胞导向和免疫肿瘤学研究治疗管线，以及这些方法的智能组合上。

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

勃林格殷格翰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，这对于应对一些最具挑战性但可能最有影响力的癌症研究领域至关重要。简而言之，对勃林格殷格翰而言，癌症护理既是个人的使命，也是世代的承诺。

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 that can improve and extend lives 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，勃林格专注于开发创新疗法，以改善和延长在高度未满足医疗需求领域中的生命。自1885年成立以来，勃林格始终保持独立，并以长远视角将可持续发展融入整个价值链。

Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. .

我们约有 54,500 名员工，服务于 130 多个市场，共同构建一个更健康、更可持续的明天。

References

参考文献

Source: boehringer-ingelheim.com

来源：boehringer-ingelheim.com