拜耳的sevabertinib在日本获批用于HER2突变非小细胞肺癌患者-动脉网

Bayer’s sevabertinib approved in Japan for patients with HER2-mutant non-small cell lung cancer

拜耳等信源发布 2026-08-24 14:33

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二十四

August

八月

2026

08:29 AM

上午 08:29

Europe/Amsterdam

欧洲/阿姆斯特丹

Bayer’s sevabertinib approved in Japan for patients with HER2-mutant non-small cell lung cancer

拜耳的sevabertinib在日本获批，用于治疗HER2突变的非小细胞肺癌患者

Not intended for U.S. and UK Media

非面向美国和英国媒体

Summary

摘要

First targeted therapy approved in Japan for this indication, with use across all lines of therapy, including first-line treatment / Approval is based on results from the ongoing Phase I/II SOHO-01 trial evaluating the efficacy and safety of sevabertinib in patients with advanced HER2-mutant NSCLC / HER2-mutant NSCLC typically has a poor prognosis and limited treatment options.

这是日本首个针对该适应症获批的靶向疗法，适用于所有治疗线数，包括一线治疗 / 该批准基于正在进行的I/II期SOHO-01试验的结果，该试验旨在评估塞瓦替尼在晚期HER2突变非小细胞肺癌患者中的疗效和安全性 / HER2突变非小细胞肺癌通常预后较差，且治疗选择有限。

Berlin, August 24, 2026

柏林，2026年8月24日

– The Ministry of Health, Labour, and Welfare (MHLW) in Japan has granted approval for Hyrnuo™ (sevabertinib) for the treatment of patients with

– 日本厚生劳动省（MHLW）已批准 Hyrnuo™（sevabertinib）用于治疗患者

HER2 (ERBB2)

mutation-positive unresectable advanced or recurrent non-small cell lung cancer (NSCLC). In Japan, Hyrnuo is the first approved targeted therapy for this indication that can be used regardless of line of therapy, including as a first-line treatment. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI)..

突变阳性、不可切除的晚期或复发性非小细胞肺癌（NSCLC）。在日本，Hyrnuo 是首个获批用于该适应症的靶向治疗药物，可在任何治疗线数中使用，包括作为一线治疗。Sevabertinib 是一种口服、可逆的小分子酪氨酸激酶抑制剂（TKI）。

“

HER2-

mutant

突变体

NSCLC remains an area of significant unmet medical need. Sevabertinib has demonstrated clinically meaningful efficacy together with a manageable safety profile and offers a promising new treatment option for these patients. The availability of sevabertinib in the first-line setting, without restriction by .

非小细胞肺癌（NSCLC）领域仍存在巨大的未满足医疗需求。Sevabertinib 已显示出具有临床意义的疗效，且安全性可控，为这些患者提供了一种前景广阔的新治疗选择。Sevabertinib 可在一线治疗中使用，不受限制。

HER2

mutation subtype, marks an important step forward in expanding treatment choices for both patients and healthcare professionals. We look forward to its potential as a new treatment option for patients,” said Dr Koichi Goto, PhD, Chief of the Department of Thoracic Oncology at the National Cancer Center Hospital East in Japan..

突变亚型，标志着在扩大患者和医疗专业人员治疗选择方面迈出了重要一步。我们期待其作为患者新治疗方案的潜力。”日本国立癌症中心东医院胸部肿瘤科主任后藤光一博士表示。

The MHLW approval is supported by data from the global Phase I/II SOHO-01 trial (NCT05099172). In patients with unresectable advanced or recurrent HER2-mutant NSCLC who had not received prior systemic therapy following diagnosis of advanced or recurrent disease, the primary endpoint of objective response rate (ORR) was 75.3% (95% CI: 63.9–84.7; N=73).

日本厚生劳动省（MHLW）的批准得到了全球性I/II期SOHO-01试验（NCT05099172）数据的支持。在确诊为晚期或复发性疾病后未接受过既往系统性治疗的不可切除晚期或复发性HER2突变非小细胞肺癌（NSCLC）患者中，客观缓解率（ORR）这一主要终点为75.3%（95%置信区间：63.9–84.7；N=73）。

Median duration of response (DOR) was 12.2 months (95% CI: 8.8–not estimable; N=73), and median progression-free survival (PFS) was 13.5 months (95% CI: 10.0–not estimable; N=73). The study also demonstrated a manageable safety profile, with the most frequently observed adverse events being diarrhea, rash, and paronychia.

中位缓解持续时间（DOR）为12.2个月（95% CI：8.8–无法估算；N=73），中位无进展生存期（PFS）为13.5个月（95% CI：10.0–无法估算；N=73）。该研究还显示出可控的安全性特征，最常见的不良事件为腹泻、皮疹和甲沟炎。

Adverse events leading to treatment discontinuation occurred in 3% of patients..

3%的患者发生了导致治疗中断的不良事件。

“The approval of sevabertinib by Japan’s MHLW marks an important advancement for patients with advanced HER2-mutant NSCLC, a patient population that has historically faced limited treatment options,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

拜耳公司全球产品战略与商业化执行副总裁、制药业务领导团队成员克里斯汀·罗斯表示：“日本厚生劳动省对塞瓦贝替尼的批准，标志着晚期HER2突变非小细胞肺癌患者治疗领域的重要进展，而该患者群体以往面临的治疗选择十分有限。”

“Supported by results from the ongoing SOHO‑01 study, this latest approval advances our precision oncology strategy and builds on earlier approvals in both the U.S. and China. We continue to work with clinicians and diagnostic partners to support timely .

“在正在进行的SOHO-01研究结果的支持下，这一最新批准推进了我们的精准肿瘤学战略，并在此基础上进一步巩固了此前在美国和中国获得的批准。我们继续与临床医生和诊断合作伙伴合作，以支持及时...”

HER2

testing and appropriate access in line with the approved indication, with the goal of improving outcomes for people living with this difficult‑to‑treat form of lung cancer.”

开展检测并确保按照获批适应症进行适当用药，旨在改善患有这种难治性肺癌患者的预后。

In November 2025, sevabertinib, under the brand name Hyrnuo™, received U.S. Food and Drug Administration (FDA) accelerated approval for patients with previously treated advanced

2025年11月，sevabertinib（商品名：Hyrnuo™）获得美国食品药品监督管理局（FDA）加速批准，用于治疗既往接受过治疗的晚期患者

HER2

-mutant NSCLC. Earlier this year, sevabertinib was also approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have

突变型非小细胞肺癌（NSCLC）。今年早些时候，塞瓦替尼也已获得中国国家药品监督管理局（NMPA）批准，作为单药疗法用于患有不可切除、局部晚期或转移性非小细胞肺癌且肿瘤具有

HER2

activating mutations, and who have received one prior systemic therapy. These approvals follow on from the U.S. FDA and the Center for Drug Evaluation (CDE) in China granting sevabertinib Breakthrough Therapy Designation for both first- and second-line use in patients with advanced

携带激活突变且既往接受过一种全身性治疗的患者。此前，美国食品药品监督管理局（FDA）和中国国家药品监督管理局药品审评中心（CDE）已授予塞瓦贝替尼用于晚期患者一线和二线治疗的突破性疗法认定。

HER2

-mutant NSCLC, highlighting its potential to provide substantial improvement over existing therapies. In May this year, the FDA granted sevabertinib Priority Review as a first-line treatment in this patient population recognizing its potential to address a critical unmet need.

突变型非小细胞肺癌（NSCLC），凸显了其在现有疗法基础上实现显著改善的潜力。今年5月，美国食品药品监督管理局（FDA）授予塞瓦贝替尼作为该患者人群一线治疗的优先审评资格，以认可其满足关键未竟医疗需求的潜力。

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），能有效抑制突变型人

HER2

, including

，包括

HER2

exon 20 insertions and

20号外显子插入突变和

HER2

point mutations. 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.

点突变。塞瓦替尼通过阻断称为酪氨酸激酶的某些酶来发挥作用，这些酶参与癌细胞的生长。可逆性酪氨酸激酶抑制剂（TKIs）可以暂时阻断其靶点，从而实现对治疗的更精确控制，并与不可逆性TKIs相比可能减少长期副作用。

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

Sevabertinib 源自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之间的战略研究联盟。

As part of its clinical development program, alongside the SOHO-01 trial, sevabertinib is also being studied in the Phase III SOHO-02 trial (NCT 06452277) evaluating sevabertinib in treatment naïve patients with

作为其临床开发计划的一部分，除SOHO-01试验外，塞瓦替尼也在III期SOHO-02试验（NCT 06452277）中接受研究，该试验旨在评估塞瓦替尼在初治患者中的疗效。

HER2

-mutant NSCLC and in the panSOHO study (NCT06760819) in patients with metastatic or unresectable solid tumors with

突变型非小细胞肺癌患者，以及在泛SOHO研究（NCT06760819）中患有转移性或不可切除实体瘤的患者

HER2

-activating mutations, excluding advanced NSCLC.

-激活突变，不包括晚期非小细胞肺癌（NSCLC）。

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主要原因。非小细胞肺癌（NSCLC）是最常见的肺癌类型，占所有病例的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

在晚期非小细胞肺癌（NSCLC）患者中，2%至4%可检测到基因突变。80%的非小细胞肺癌患者在确诊时已进展至晚期，这使得治疗更加困难。患有

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（NSCLC）患者目前面临的治疗选择有限，凸显出对更有效疗法的迫切需求。

About Oncology at Bayer

关于拜耳的肿瘤学

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疗法，以科学创造更美好的生活。公司满怀热情与决心，致力于开发新药，帮助改善癌症患者的生活并延长其生命。拜耳的肿瘤业务板块涵盖多个已上市产品，涉及多种适应症，并拥有处于不同临床开发阶段的多种化合物。

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..

我们在多个领域拥有丰富的专业知识，包括：肿瘤内在通路、靶向放射性核素疗法以及新一代免疫肿瘤学。我们正推动前列腺癌治疗从早期阶段发展至转移性阶段，旨在延长患者生存期并限制副作用。作为拜耳专注于创新精准肿瘤治疗的一部分，我们拥有一款已获批的TRK抑制剂，该药物专为携带NTRK基因融合的肿瘤而设计，此类基因融合是驱动肿瘤生长和扩散的致癌因素。

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.

拜耳是一家在医疗保健和营养等生命科学领域拥有核心能力的全球性企业。秉承“人人享有健康，无人遭受饥饿”的使命，公司的产品和服务旨在通过支持应对全球人口增长和老龄化所带来的重大挑战，帮助人类和地球繁荣发展。

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 2025, the Group employed around 88,000 people and had sales of 45.6 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升盈利能力并创造价值。拜耳品牌在全球范围内代表着信任、可靠和品质。在2025财年，集团员工人数约为88,000人，销售额达456亿欧元。

R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com..

研发费用为58亿欧元。更多信息请访问 www.bayer.com。

Reference:

参考文献：

1. Herbert H. Loong, SOHO-01: Updated safety and efficacy of sevabertinib in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC). ASCO Publications:

1. Herbert H. Loong，SOHO-01：塞瓦替尼在晚期HER2突变非小细胞肺癌（NSCLC）患者中的最新安全性和疗效。ASCO出版物：

https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8622

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Forward-Looking Statements

前瞻性陈述

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.

本次发布可能包含基于拜耳管理层当前假设和预测的前瞻性陈述。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未来的实际业绩、财务状况、发展或表现与本文给出的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments..

这些因素包括拜耳在其公开报告中讨论的因素，这些报告可在拜耳网站（www.bayer.com）上获取。公司不承担任何更新这些前瞻性陈述或使其与未来事件或发展保持一致的责任。

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

拜耳股份公司是一家在全球拥有运营子公司的控股公司。文中提及“拜耳”或“本公司”时，视上下文需要，可能指代一家或多家子公司。

Contacts

联系人

Silvia Grosso

西尔维娅·格罗索

Global Oncology Communications

全球肿瘤学传播

silvia.grosso@bayer.com

+1 973 270 6828

Contact for investor inquiries: Bayer Investor Relations Team

投资者问询联系人：拜耳投资者关系团队

ir@bayer.com