美国食品药品监督管理局（FDA）加速批准了拜耳公司的HYRNUO™（sevabertinib），用于治疗先前接受过治疗的晚期HER2突变非小细胞肺癌患者-动脉网

U.S. FDA grants accelerated approval to Bayer’s HYRNUO™ (sevabertinib) for patients with previously treated advanced HER2-mutant non-small cell lung cancer

拜耳等信源发布 2025-11-20 15:32

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November

十一月

2025

08:29 AM

早上08:29

Europe/Amsterdam

欧洲/阿姆斯特丹

U.S. FDA grants accelerated approval to Bayer’s HYRNUO™ (sevabertinib) for patients with previously treated advanced HER2-mutant non-small cell lung cancer

美国食品药品监督管理局（FDA）加速批准了拜耳公司的HYRNUO™（sevabertinib），用于治疗先前接受过治疗的晚期HER2突变非小细胞肺癌患者。

Not intended for U.S. and UK Media

不适用于美国和英国媒体

Berlin, November 20, 2025

柏林，2025年11月20日

– Following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for HYRNUO™ (sevabertinib), for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (.

– 在获得优先审查和突破性疗法认定后，美国食品药品监督管理局 (FDA) 已加速批准 HYRNUO™（sevabertinib），用于治疗局部晚期或转移性非鳞状非小细胞肺癌 (NSCLC) 的成年患者，其肿瘤具有人类表皮生长因子受体 2 (HER2)。

HER2

) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI).

酪氨酸激酶结构域激活突变，通过FDA批准的检测方法检测到，并且曾接受过先前的系统治疗。Sevabertinib是一种口服、可逆的小分子酪氨酸激酶抑制剂（TKI）。

“The FDA’s approval of sevabertinib elevates the standard of care and provides a new treatment option for patients living with

“FDA对sevabertinib的批准提升了治疗标准，并为患有该疾病的患者提供了新的治疗选择。

HER2

-mutant NSCLC, which is a challenging disease with limited therapies available,” said SOHO-01 lead trialist, Xiuning Le, MD, PhD, The University of Texas MD Anderson Cancer Center, Houston, Texas. “Clinical results from the SOHO-01 trial showed that sevabertinib is effective with a manageable safety profile.”.

“突变型非小细胞肺癌是一种具有挑战性的疾病，可用的治疗方法有限，”SOHO-01 首席试验负责人、德克萨斯大学 MD 安德森癌症中心（休斯顿，德克萨斯州）的乐秀宁博士表示，“SOHO-01 试验的临床结果表明，sevabertinib 具有良好的疗效和可控的安全性。”

The FDA approved this indication for sevabertinib under accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the ongoing Phase I/II SOHO-01 trial (NCT05099172) in patients with advanced NSCLC harboring a

基于正在进行的I/II期SOHO-01试验（NCT05099172）中客观缓解率（ORR）和缓解持续时间（DOR）的数据，FDA根据加速批准途径批准了sevabertinib用于治疗携带特定基因变异的晚期非小细胞肺癌（NSCLC）患者的适应症。

HER2

-activating mutation, with disease progression after ≥1 systemic therapies for advanced disease. Continued approval of sevabertinib for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

-激活突变，在接受≥1种针对晚期疾病的系统治疗后疾病进展。sevabertinib 对该适应症的持续批准可能取决于在确证性试验中对临床获益的验证和描述。

Results from the Phase I/II SOHO-01 trial demonstrated for patients naïve to

I/II 期 SOHO-01 试验的结果显示，对于初治患者

HER2

targeted therapy an ORR of 71% (95% CI: 59%-82%, N=70); 2.9% of patients had a complete response and 69% of patients had a partial response. Median DOR was 9.2 months (95% CI, 6.3–15.0, N=50). Sevabertinib demonstrated a manageable safety profile with a 3.7% discontinuation rate. In the pooled safety population, the most common (> 20%) adverse reactions were diarrhea (87%), rash (66%), paronychia (33%), stomatitis (29%) and nausea (21%)..

靶向治疗的客观缓解率（ORR）为71%（95% CI：59%-82%，N=70）；2.9%的患者完全缓解，69%的患者部分缓解。中位缓解持续时间（DOR）为9.2个月（95% CI，6.3–15.0，N=50）。塞瓦伯替尼显示出可控的安全性，停药率为3.7%。在汇总的安全性人群中，最常见的（>20%）不良反应为腹泻（87%）、皮疹（66%）、甲沟炎（33%）、口腔炎（29%）和恶心（21%）。

Positive results from the Phase I/II SOHO-01 trial were presented at the European Society for Medical Oncology (ESMO) Congress 2025 and simultaneously published in the

SOHO-01 I/II 期试验的积极结果在 2025 年欧洲医学肿瘤学会 (ESMO) 大会上公布，并同时发表在

New England Journal of Medicine.

新英格兰医学杂志。

[1]

“Globally, it is estimated that up to 84,000 people are diagnosed with NSCLC harboring a

“在全球范围内，据估计，多达84,000人被诊断出患有NSCLC（非小细胞肺癌），其中包含一种”

HER2

mutation each year,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “At Bayer our oncology R&D strategy is centered on precision drug development which is designed to help us address critical unmet medical needs through the advancement of innovative therapies.

“每年的突变，”拜耳制药部门研发主管克里斯蒂安·罗梅尔博士说，“在拜耳，我们的肿瘤学研发战略以精准药物开发为中心，旨在通过推进创新疗法来帮助我们解决关键的未满足医疗需求。”

Today's FDA approval of sevabertinib exemplifies this approach, delivering a targeted treatment specifically for patients with advanced .

今天FDA对sevabertinib的批准就是这种方法的例证，专门为晚期患者提供靶向治疗。

HER2

-mutant NSCLC. This significant milestone underscores our unwavering commitment to transforming cancer care by delivering meaningful therapies that have the potential to improve outcomes and extend survival for people living with cancer.”

“-突变型非小细胞肺癌。这一重要的里程碑彰显了我们通过提供有意义的疗法来改善癌症患者的生活和延长生存期，从而改变癌症治疗的坚定承诺。”

In 2024, both the U.S. FDA and the CDE in China granted sevabertinib Breakthrough Therapy designation indicating that the compound has the potential to provide substantial improvement over existing therapies in NSCLC with

2024年，美国FDA和中国CDE均授予sevabertinib突破性疗法认定，表明该化合物有潜力为非小细胞肺癌（NSCLC）现有疗法带来显著改进。

HER2

-activating mutations. China accepted a new drug application (NDA) for sevabertinib in July 2025.

-激活突变。中国于2025年7月接受了sevabertinib的新药申请（NDA）。

About HYRNUO™ (sevabertinib)

关于HYRNUO™（sevabertinib）

Sevabertinib is a new, oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that potently inhibits mutant human

塞瓦伯替尼是一种新型、口服、可逆的小分子酪氨酸激酶抑制剂（TKI），能够有效抑制突变的人类

HER2

, including

，包括

HER2

exon 20 insertions and

第20号外显子插入和

HER2

point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type

点突变，以及表皮生长因子受体（EGFR），对突变型与野生型具有高选择性。

EGFR

表皮生长因子受体

. Sevabertinib works by blocking certain enzymes called tyrosine kinases, which are involved in the growth of cancer cells. Reversible TKIs can temporarily block their targets, allowing for more precise control over treatment and potentially reducing long-term side effects compared to irreversible TKIs..

Sevabertinib通过阻断某些称为酪氨酸激酶的酶来发挥作用，这些酶参与癌细胞的生长。可逆TKI可以暂时阻断其目标，从而实现对治疗更精确的控制，并可能比不可逆TKI减少长期副作用。

Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

塞瓦贝替尼源于拜耳与美国马萨诸塞州剑桥市麻省理工学院和哈佛大学博德研究所的战略研究联盟。

The ongoing Phase III SOHO-02 trial (NCT06452277) is evaluating sevabertinib as a first-line treatment option for patients with advanced NSCLC whose tumors have

正在进行的 III 期 SOHO-02 试验（NCT06452277）正在评估 sevabertinib 作为肿瘤具有特定特征的晚期非小细胞肺癌患者的一线治疗选择。

HER2

mutations. Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring

突变。Sevabertinib 也正在研究用于携带转移性或不可切除的实体瘤的患者，

HER2

-activating mutations, excluding advanced NSCLC, in the panSOHO study (NCT06760819).

-激活突变，排除晚期非小细胞肺癌，在panSOHO研究中（NCT06760819）。

About Non-Small Cell Lung Cancer (NSCLC)

关于非小细胞肺癌（NSCLC）

Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating

肺癌是全球癌症相关死亡的首要原因。非小细胞肺癌是最常见的肺癌类型，占病例的85%以上。激活

HER2

mutations are found in 2% to 4% of patients with advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with

在2%到4%的晚期非小细胞肺癌患者中发现了突变。80%的被诊断为非小细胞肺癌的人已经进展到晚期阶段，这使得治疗更加困难。患者

HER2

-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies.

-突变型非小细胞肺癌目前面临有限的治疗选择，凸显出对更有效疗法的迫切需求。

About Oncology at Bayer

拜耳肿瘤学相关

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development.

拜耳致力于通过推进一系列创新治疗方案来为更美好的生活提供科学支持。该公司充满热情和决心，开发能够帮助改善和延长癌症患者生命的新药。拜耳的肿瘤学产品组合包括多种已上市的产品，涵盖不同的适应症，同时还有多个化合物处于临床开发的不同阶段。

We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread..

我们在肿瘤内在通路、靶向放射性核素治疗和下一代免疫肿瘤学等领域拥有丰富的专业知识。我们正在推进前列腺癌治疗从早期到转移阶段的发展，目标是延长生存期同时限制副作用。拜耳专注于创新精准肿瘤治疗的一部分，包括一种获批的TRK抑制剂，该抑制剂专门设计用于治疗具有NTRK基因融合的肿瘤，这种基因融合是肿瘤生长和扩散的致癌驱动因素。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在全球范围内具有核心竞争力的企业，专注于医疗保健和营养等生命科学领域。秉承“人人健康，无饥饿”的使命，公司通过产品和服务支持全球人口增长和老龄化带来的重大挑战，助力人类与地球共同繁荣。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于推动可持续发展，并通过其业务产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，该集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用达62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

Find more information at

更多信息请访问

https://pharma.bayer.com

在Facebook上关注我们：

http://www.facebook.com/bayer

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司的实际未来结果、财务状况、发展或业绩与这里提供的估计值存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，该报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担任何更新这些前瞻性声明或使其符合的法律责任。

them to future events or developments.

将它们应用于未来的事件或发展。

[1]

X Le, M.D., Ph.D., TM Kim, M.D., Ph.D. H.H.Loong, M.B., B.S. et al. Sevabertinib in Advanced

X Le, 医学博士，哲学博士，TM Kim，医学博士，哲学博士，H.H.Loong，内外全科医学士等。Sevabertinib 在晚期

HER2

-Mutant Non–Small-Cell Lung Cancer. New England Journal of Medicine. 2025/10/21. Available at:

-突变型非小细胞肺癌。《新英格兰医学杂志》。2025年10月21日。可用地址：

https://www.nejm.org/doi/abs/10.1056/NEJMoa2511065

. Last accessed November 2025.

最后访问时间：2025年11月。

Summary

摘要

Accelerated approval is based on an objective response rate of 71% (N=70) for patients naïve to HER2 targeted therapy, as demonstrated in the Phase I/II SOHO-01 trial / In SOHO-01, sevabertinib demonstrated robust and durable anti-tumor responses and a manageable safety profile / HER2-mutant NSCLC typically has a poor prognosis and limited treatment options.

加速批准是基于I/II期SOHO-01试验中对HER2靶向治疗初治患者（N=70）的71%客观缓解率 / 在SOHO-01中，sevabertinib显示出强大且持久的抗肿瘤反应和可控的安全性 / HER2突变型非小细胞肺癌通常预后较差且治疗选择有限。

Contacts

联系人

Silvia Grosso

西尔维娅·格罗索

Global Oncology Communications

全球肿瘤学通讯

silvia.grosso@bayer.com

+1 973 270 6828

Contact for investor inquiries: Bayer Investor Relations Team

投资者咨询请联系：拜耳投资者关系团队

ir@bayer.com