This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
Sevabertinib is an experimental drug being developed to treat certain types of cancers that have specific genetic changes called HER2 mutations. This includes lung cancer, tumors that have spread to other parts of the body (metastatic), and tumors that cannot be removed with surgery (unresectable). Before this medicine can be given to cancer patients with liver problems, researchers need to understand how liver disease might change the way the body handles the drug.
The study will include about 20 people divided into two groups: 10 people with moderate liver problems (called Child-Pugh B liver impairment) and 10 healthy people with normal liver function. The healthy volunteers will be matched to the liver patients by age, sex, and weight to make fair comparisons.
All participants will take a single 20 mg dose of sevabertinib by mouth and stay in the research clinic for 5 days. During this time, researchers will take blood samples at specific times to measure how much drug is in the blood and how long it stays in the body. They will also monitor participants closely for any side effects.
The main goal is to see if people with liver problems have different drug levels in their blood compared to healthy people. This information will help doctors determine if cancer patients with liver disease need different doses of sevabertinib to be safe and effective.
The study will also look at the safety and tolerability of sevabertinib in both groups. Participants will have follow-up visits to ensure their continued health and safety.
This research is important because many cancer patients also have liver problems, and understanding how liver disease affects this new cancer treatment will help ensure it can be used safely and effectively in all patients who might benefit from it.

开始日期2025-07-24

申办/合作机构

Bayer AG

NCT06760819

/ Recruiting临床2期

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.
In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).
Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.
The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.
The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.
During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.

开始日期2025-02-13

申办/合作机构

Bayer AG

NCT06452277

/ Recruiting临床3期

A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.
The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC.
The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations.
The study participants will receive one of the study treatments:
* BAY 2927088 twice every day as a tablet by mouth, or
* Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment.
During the study, the doctors and their study team will:
* take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer
* check the overall health of the participants by performing tests such as blood and urine tests, and checking
* heart health using an electrocardiogram (ECG)
* perform pregnancy tests for women
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

开始日期2024-08-28

申办/合作机构

Bayer AG

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100 项与赛伐替尼相关的转化医学

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100 项与赛伐替尼相关的专利（医药）

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项与赛伐替尼相关的文献（医药）

2026-01-12·Cancer Discovery

Sevabertinib, a Reversible HER2 Inhibitor with Activity in Lung Cancer

Article

作者: Grassi, Paolo ; Denney, Daniel ; Cherniack, Andrew D. ; Kaplan, Bethany ; Hillig, Roman C. ; Golfier, Sven ; Lewis, Timothy A. ; Kotýnková, Kristýna ; Berger, Markus ; Eis, Knut ; Goto, Koichi ; Korr, Daniel ; Siegel, Stephan ; Tomono, Haruna ; Petersen, Kirstin ; Loong, Herbert H. ; Boemer, Ulf ; Meyerson, Matthew ; Andersen, Sawyer ; Karsli Uzunbas, Gizem ; Mortier, Jérémie ; Greulich, Heidi ; Rüttinger, Dominik ; Schulze, Volker K. ; Siegel, Franziska ; Williams, Sybil

Abstract:

Exon 20 insertions of HER2, encoded by erb-b2 receptor tyrosine kinase 2 (ERBB2), and other activating HER2 mutations occur in 2% to 4% of lung adenocarcinomas, but there are only limited therapeutic options available for these patients. Sevabertinib (BAY 2927088) is a potent and reversible dual EGFR–HER2 inhibitor that is selective with respect to wild-type EGFR. In this study, we report the preclinical activity of sevabertinib in lung cancer models harboring alterations of HER2, including exon 20 insertions, point mutations, and amplification of wild-type ERBB2. We furthermore demonstrate the activity of sevabertinib in a cancer cell line dependent on a fusion of neuregulin-1, a ligand for the HER2 family member and heterodimerization partner, HER3. Finally, we report patient responses to sevabertinib from a phase 1/2 clinical trial, indicating potential benefit for patients with HER2-mutant lung cancer.

Significance::

Additional therapeutic options are needed for patients with lung cancer with HER2 activating mutations, including exon 20 insertions. Sevabertinib shows activity against ERBB2-encoded HER2 exon 20 insertions in preclinical models of lung cancer, corroborated by early data from a phase 1/2 clinical trial.

2025-11-06·NEW ENGLAND JOURNAL OF MEDICINE

Sevabertinib in Advanced HER2 -Mutant Non–Small-Cell Lung Cancer

Article

作者: Grassi, Paolo ; Fang, Yong ; Prelaj, Arsela ; Ruiter, Gerrina ; Kim, Hye Ryun ; Goh, Boon Cher ; Lu, Shun ; Yang, Tsung-Ying ; Miao, Liyun ; Novello, Silvia ; Brega, Nicoletta ; Goto, Koichi ; Loong, Herbert H. ; Bao, Weichao ; Descamps, Tine ; Zhao, Jun ; Jänne, Pasi A. ; Daniele, Gennaro ; Tan, Daniel Shao-Weng ; Kim, Tae Min ; Wu, Lin ; Le, Xiuning ; Rüttinger, Dominik ; Li, Rui ; Dong, Xiaorong ; Li, Lin ; Shinno, Yuki ; Brase, Jan Christoph ; Girard, Nicolas

BACKGROUND:

HER2 gene mutations occur in 2 to 4% of patients with non-small-cell lung cancer (NSCLC). Sevabertinib is an oral, reversible tyrosine kinase inhibitor that has shown anti-HER2 activity in preclinical models.

METHODS:

We conducted an open-label, multicenter, multicohort, phase 1-2 study to evaluate sevabertinib at a twice-daily dose of 20 mg in patients with locally advanced or metastatic HER2-mutant NSCLC. Three cohorts were defined according to previous therapy: cohort D comprised previously treated patients who had not received HER2-targeted therapy; cohort E, patients who had previously received HER2-directed antibody-drug conjugates; and cohort F, patients who had not previously received treatment. The primary end point was an objective response, as assessed by blinded independent central review. Secondary end points were duration of response and progression-free survival.

RESULTS:

A total of 209 patients received sevabertinib (as of June 27, 2025, the data-cutoff date); the median duration of follow-up was 13.8 months in cohort D, 11.7 months in cohort E, and 9.9 months in cohort F. Among 81 patients in cohort D, an objective response was observed in 64% (95% confidence interval [CI], 53 to 75); the median duration of response was 9.2 months (95% CI, 6.3 to 13.5), and the median progression-free survival was 8.3 months (95% CI, 6.9 to 12.3). Among 55 patients in cohort E, an objective response was observed in 38% (95% CI, 25 to 52); the median duration of response was 8.5 months, and the median progression-free survival was 5.5 months. Among 73 patients in cohort F, an objective response was observed in 71% (95% CI, 59 to 81), and the median duration of response was 11.0 months; data on progression-free survival were immature. Grade 3 or higher drug-related adverse events occurred in 31% of the patients. The most common adverse event was diarrhea (in 84 to 91%), with diarrhea of grade 3 or higher occurring in 5 to 23%. Treatment was discontinued by 3% of the patients owing to drug-related adverse events.

CONCLUSIONS:

Sevabertinib showed antitumor activity in patients with locally advanced or metastatic HER2-mutant NSCLC. Diarrhea was the most common adverse event. (Funded by Bayer; SOHO-01 ClinicalTrials.gov number, NCT05099172.).

Biomolecules

Recent Advances in the Development and Clinical Use of HER2 Inhibitors in Non-Small Cell Lung Cancer

Review

作者: Ekyalongo, Richy ; Yamaoka, Toshimitsu ; Tsurutani, Junji

Alterations in the human epidermal growth factor receptor 2 (HER2) gene are well-recognized oncogenic drivers and therapeutic targets in non-small cell lung cancer (NSCLC). The first anti-HER2 inhibitor, trastuzumab-deruxtecan, was approved for previously treated advanced NSCLC with HER2 mutations, which accounts for 2–4% of NSCLC. The first anti-HER2 antibody, trastuzumab, was approved for HER2-positive metastatic breast cancer in 1998, and a combination therapy comprising trastuzumab, pertuzumab, and docetaxel demonstrated efficacy in the first-line setting. Some EGFR-tyrosine kinase inhibitors (TKIs) have been evaluated as pan-HER TKIs but have shown limited benefits in HER2-altered NSCLC. However, HER2-specific TKIs, such as zongertinib and BAY2927088, have demonstrated encouraging results. Zongertinib was the first HER2-specific TKI to be approved by the FDA in 2025 for previously treated ERBB2-mutated advanced NSCLC. In this narrative review, we have summarized the latest research on the biology of HER2 signaling, HER2 alterations, HER2-targeting therapies, and challenges of treating HER2-overexpressing or -mutated NSCLC. Despite different targets of HER2 mutations in NSCLC and HER2 amplification/overexpression in breast cancer, the development of HER2-targeting agents has been more advanced in breast cancer than in NSCLC. Therefore, pivotal clinical studies in breast cancer may help in identifying more effective therapies for NSCLC.

227

项与赛伐替尼相关的新闻（医药）

2026-02-26

·EndPoints

Voucher holder Boehringer wins sped-up approval for first-line use of lung cancer drug

The FDA greenlit an expanded label for Boehringer Ingelheim’s lung cancer drug Hernexeos, marking the first use of the Commissioner’s National Priority Voucher for a new indication. Boehringer won an accelerated approval for use of Hernexeos in advanced non-small cell lung cancer patients with certain HER2 mutations who haven’t previously been treated. In August, the agency granted accelerated approval for use of the drug in patients who have been treated with other therapies. The decision gives Boehringer an advantage over its rival Bayer, which is studying its HER2-targeted pill Hyrnuo in first-line patients. Bayer has neither received the Commissioner’s voucher nor announced an FDA submission in the first-line indication. A spokesperson for Bayer didn’t immediately respond to a request for comment. The commissioner’s voucher is a pilot program meant to significantly speed the review of drugs from “companies supporting US national interests.” Health policy experts and some former FDA officials have raised concerns over whether the program is politicizing the drug approval process. “The FDA is on the hunt for game-changing therapies that can qualify for a priority review. In this case a final decision was rendered 44 days after the filling date,” FDA Commissioner Marty Makary said in a statement on Thursday. A Boehringer spokesperson told Endpoints News in early December that it anticipated “hearing news within the coming weeks” on the Hernexeos decision. On Dec. 16, the company told Endpoints that its supplemental application “is currently under review within the parameters of this pilot program.” Last October, both Boehringer and Bayer presented data at the biggest European cancer conference, ESMO, concerning the use of their rival drugs in first-line patients. Those data showed similar efficacy, though a smaller proportion of patients who received Boehringer’s drug experienced diarrhea. About 2% to 4% of non-small cell lung cancer cases bear HER2 mutations. Boehringer and Bayer contend their drugs can provide a potentially safer and more convenient targeted treatment option for those patients compared to other HER2 therapies, such as AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu. The first commissioner’s voucher recipient to get an approval was USAntibiotics in December for Augmentin XR, an extended-release form of the antibiotic amoxicillin. GSK’s version of the antibiotic initially won US approval in 2002, but it was later pulled from the market for commercial reasons. Boehringer was one of 17 drugmakers that the Trump administration called out in July as part of its “most favored nation” push around drug pricing.

上市批准优先审批加速审批

2026-02-26

·新浪看点

在肺癌靶向药这个大赛道，艾力斯未来面临的主要竞争对手是谁？

在肺癌靶向药这一千亿级赛道上，艾力斯作为国产三代EGFR-TKI（表皮生长因子受体酪氨酸激酶抑制剂）的代表企业，其核心产品伏美替尼虽已确立市场地位，但未来将面临来自跨国巨头、本土创新药企及新兴疗法开发者的多维竞争。一、国际巨头：联合疗法与广谱靶向药的碾压性优势强生：破解耐药难题的"深水炸弹"组合强生的第三代EGFR-TKI药物兰泽替尼（Lazertinib）与埃万妥单抗（Amivantamab）联用方案于2025年7月在中国获批。该组合直击奥希替尼耐药后的临床痛点——可同时抑制EGFR敏感突变、T790M及C797S三重突变，并对MET扩增等旁路激活耐药机制有效。临床前数据显示，其对奥希替尼耐药细胞的抑制率比单药高80%，显著延长无进展生存期。这一组合可能直接冲击艾力斯伏美替尼在EGFR一线治疗的市场份额。阿斯利康：巩固"药王"奥希替尼的统治地位奥希替尼（泰瑞莎）通过LAURA等临床试验持续拓展适应症边界。2024年ASCO数据显示，其在不可切除的Ⅲ期EGFR突变肺癌中，中位无进展生存期达39.1个月（对照组仅5.6个月）。奥希替尼已形成从晚期到早中期、从单药到联合的全周期治疗壁垒，并通过医保覆盖挤压国产三代药价格空间。勃林格殷格翰：抢占HER2等新兴靶点2025年8月，勃林格殷格翰全球首款HER2突变口服靶向药宗艾替尼（Zongertinib）获FDA批准。其Ib期数据显示客观缓解率77%，完全缓解率8%，疾病控制率96%。拜耳同类药物Sevabertinib亦快速跟进。此类布局对艾力斯构成跨靶点威胁，分流研发资源有限的药企注意力。二、本土创新势力：ADC与双抗技术的弯道超车科伦博泰：TROP2 ADC的全球化破局科伦博泰的芦康沙妥珠单抗（TROP2 ADC）在2025年ESMO大会公布关键数据：治疗EGFR-TKI耐药肺癌的中位无进展生存期达8.3个月（化疗组4.3个月），死亡风险降低40%。默沙东联合黑石注资7亿美元推动其全球开发，覆盖肺癌、乳腺癌等15项Ⅲ期临床。该药2025年上半年国内销售额3.01亿元，商业化团队已渗透2000余家医院，直接挑战艾力斯的核心市场。康方生物：双特异性抗体的治疗范式革新其PD-1/VEGF双抗依沃西单抗（Ivonescimab）Ⅲ期临床显示：对比PD-1单抗联合化疗，晚期非小细胞肺癌患者无进展生存期延长40%。该药瞄准EGFR突变肺癌二线治疗，计划2025年底提交美国上市申请。双抗技术有望绕过传统TKI耐药机制，重塑治疗标准。恒瑞医药/贝达药业：管线广度与研发效率碾压恒瑞凭借抗PD-1单抗、阿帕替尼等建立肺癌矩阵，贝达药业的恩沙替尼（ALK抑制剂）国内峰值销售预期超20亿元。此类企业通过多靶点布局（如KRAS、HER3）和快速仿创能力，对单一EGFR产品线的艾力斯形成降维竞争。三、未来挑战者：颠覆性技术与"不可成药"靶点突破KRAS抑制剂开发者劲方医药的KRAS G12D抑制剂VS-7375/GFH375在非小细胞肺癌中客观缓解率69%，获FDA快速通道资格。礼来第二代KRAS G12C抑制剂Olomorasib联用PD-1单抗的客观缓解率达77%。此类药物一旦落地，将分流EGFR耐药患者市场。第四代EGFR抑制剂研发企业针对奥希替尼耐药后C797S突变的第四代药物（如BLU-945）已进入临床。若艾力斯未能及时迭代产品，可能重演二代TKI被三代药取代的悲剧。四、艾力斯的突围路径加速迭代核心管线需快速推进伏美替尼联合疗法（如+MET抑制剂）以应对强生组合方案，并布局第四代EGFR抑制剂保持技术延续性。差异化靶点开发与复旦大学合作的PGAM1代谢靶点抑制剂是潜在突破口。该全球首创（First-in-Class）项目若成功，可避开EGFR红海竞争。探索国际化合作参考科伦博泰与默沙东模式，通过授权出海分摊研发成本，利用国际巨头渠道打开海外市场。风险提示：肺癌靶向治疗存在个体差异，药物选择需遵循临床指南并在专业医师指导下进行。企业竞争格局分析不构成投资建议。竞争格局演变核心结论：肺癌靶向药赛道已从单药迭代进入"联合疗法+广谱靶向"时代。艾力斯若仅固守EGFR单靶点，将被跨国药企的复合制剂和本土企业的ADC/双抗技术边缘化。未来胜负手在于：能否在PGAM1等原创靶点上实现突破，并构建涵盖小分子药、生物制剂的多元管线生态。内容由AI生成

临床3期ASCO会议抗体药物偶联物申请上市临床结果

2026-02-26

·拜耳中国

拜耳集团CEO比尔·安德森随德国总理访华

2月25日至26日，德国总理默茨对中国进行正式访问。拜耳集团首席执行官比尔·安德森（Bill Anderson）及数十位商业代表随同访华。中共中央政治局委员、国务院副总理何立峰25日下午在人民大会堂会见随德国总理默茨访华的德国经济代表团，双方就深化中德经贸合作等问题交换了意见。会见期间，比尔·安德森进行了发言。他表示，拜耳对在华长期以来的合作关系深表感谢。拜耳深深植根于中国这个充满活力的创新生态系统，致力于将创新成果推向市场，造福中国人民。中国在医学研究与现代科技领域展现出的全球领导力令人印象深刻，拜耳深表赞赏与敬佩。像拜耳这样的全球生命科学企业，与中国的发展机遇相辅相成、相互促进。拜耳拥有相应的基础设施与专业能力，愿成为中国创新者的优选合作伙伴，持续在华投资，不断拓展合作关系。何立峰会见德国经济代表团，比尔·安德森（右二）出席（图片来源：CCTV13《时政要闻》）作为深化在华投资的举措之一，25日，拜耳集团与中国银行举行了签约仪式，达成战略合作。双方将进一步在产业金融与绿色发展领域深化协同合作，共同推动实体经济高质量发展与可持续增长，打造具有长期价值的战略伙伴关系。拜耳集团与中国银行举行签约仪式近年来，比尔·安德森频繁到访中国，继去年三月随国际工商界代表受到中国国家主席的亲切接见后，今年二月再次访华。这彰显了拜耳始终坚定地践行“共享健康、消除饥饿”的企业使命，扎根中国，深化在华发展的信心与决心。恰逢全球产业链供应链协同发展的关键阶段，在中国十五五规划的蓝图下，拜耳在医疗健康和农业领域看到了巨大的技术机遇，包括数字化医疗、细胞基因疗法、人工智能驱动新药开发、现代育种技术、作物保护等。拜耳期待携手中国伙伴拓展合作边界、共享发展机遇。扎根百年，深度服务本土需求拜耳在华已144年，从最初的染料销售到如今的多业务领域发展，拜耳始终与中国经济社会的发展同频共振。随着研发、生产、销售、创新一体化本土发展体系的构建，拜耳业务全面覆盖处方药、健康消费品、作物科学三大核心领域，深度服务患者、消费者和种植者的需求。如今，中国已成为拜耳全球最重要的战略支柱之一。拜耳在中国拥有约7,000名员工，5个研发或创新中心，5个一流的供应中心。拜耳在华还拥有1家玉米种子合资公司——中种国际种子有限公司。此外，拜耳与清华大学和北京大学已累计开展超100个联合研究项目。在处方药领域，拜耳秉持百年拜阿司匹灵®的创新传承，持续洞察中国医生与患者的临床需求，聚焦心血管、肾病、肿瘤、眼科及女性健康等重点领域，加速全球创新药同步落地中国。去年，非奈利酮在中美同时递交心力衰竭适应症上市申请；塞伐艾替尼获中美双突破性治疗认定，用于HER2突变非小细胞肺癌一线治疗；艾力雅®8mg在中国获批用于年龄相关性黄斑变性（mAMD）患者，延长治疗间隔达4个月。今年，诺倍戈®刚于2月获批第三个适应症，用于转移性激素敏感性前列腺癌（mHSPC）。未来，拜耳将继续推动更多创新药物和新适应症在华上市，以更好满足中国患者健康需求。在健康消费品领域，拜耳致力于为消费者提供值得信赖的自我保健方案，帮助数十亿人拥有更健康的生活。拜耳在中国市场拥有众多深受消费者喜爱的品牌和丰富的自我保健产品，覆盖营养、消化道健康、皮肤健康、过敏、镇痛及感冒与咳嗽等方面的健康需求。近年来，拜耳精准回应消费者日益多元化、精细化的健康需求，推出了10余款创新产品，包括开瑞坦®糠酸莫米松鼻喷雾剂、达喜®复方消化酶、达喜®乳果糖口服溶液、贝乐欣®B5精华护臀膏等。中国不仅已成为消费市场、制造市场，更是创新市场，拜耳的创新体现在多元化商业模式、本土研发与供应链网络，以及产品与产品组合的持续进化。在作物科学领域，拜耳在中国的业务涵盖种子与作物保护产品，现有五大类近100款植保产品，7类100多个蔬菜品种，超70个玉米品种（合资公司中种国际）供应中国市场，为中国农户、客户及合作伙伴创造价值。2025年，拜耳作物科学在中国推出了作物健康品牌德来®、多款高产抗病的迪卡®玉米种子新品种、服务黄淮海地区玉米种植户的新品牌农倍乐®、全面守护作物根系健康的根域®守护品牌2.0等创新解决方案，满足中国农户日益变化的种植需求。持续深耕，共拓未来合作新空间中国市场的创新潜力持续释放、实力不断提升。中国正从创新的“跟随者”向“策源地”转变，吸引全球关注。拜耳期待继续携手中国的创新伙伴，共同构建“在中国、为中国、惠世界”的创新共同体。在细胞基因疗法、肿瘤治疗等领域，中国创新步伐加快，学术成果转化走在世界前列。拜耳在华不断推进拜耳·亦庄创新中心与拜耳Co.Lab中国的“创新双引擎”建设，致力于成为链接中国创新与全球医药产业的重要枢纽。过去几年，拜耳健康消费品在中国不断发展“产学研”一体化的创新合作体系，以科学为引擎、合作为桥梁，依托中国创新合作中心（CCIP）, 通过深入洞察消费者健康需求，推动科技赋能，加速前沿科学成果转化，提升健康可及性。在作物科学领域，通过“领丰计划”创新服务模式、“飞将军”飞防服务专业平台和“耘远农场”等项目，拜耳持续深化与本土伙伴的合作，将创新转化为符合中国农业需求的切实成果，并不断推动中国农业可持续发展。拜耳在中国的承诺是长远而坚定的，源自百年拜阿司匹灵®的创新精神将驱动我们一路向前。展望未来，拜耳将继续携手中国合作伙伴，为患者、消费者、种植者创造美好生活，为中国的可持续发展和国家战略目标贡献力量。关于拜耳拜耳作为一家跨国企业，在生命科学领域的医疗健康与农业方面具有核心竞争力。秉承“共享健康，消除饥饿”的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2024财年，拜耳的员工人数约为93,000名，销售额为466亿欧元。不计特殊项目的研究开发投入为62亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

100 项与赛伐替尼相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HER2突变型非小细胞肺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2025-11-19
HER2突变型非小细胞肺癌	美国	Bayer HealthCare	2025-11-19

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期非小细胞肺癌	临床3期	美国	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	中国	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	日本	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	阿根廷	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	澳大利亚	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	奥地利	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	比利时	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	巴西	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	保加利亚	Bayer AG	2024-08-28
晚期非小细胞肺癌	临床3期	加拿大	Bayer AG	2024-08-28

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05099172 (SOHO-01, ESMO_ASIA2025)	临床1/2期	HER2突变型非小细胞肺癌一线 HER2-activating mutations	140	Sevabertinib 20 mg (naïve to HER2-targeted therapy)	淵蓋鹽簾獵鑰夢窪繭鹽(鏇顧鑰網獵構襯齋簾製) = 遞壓選願襯糧網願鬱觸夢獵鹽衊構鬱鑰獵選製 (鹹範選餘選淵鏇鹹襯網, 47.6 ~ 74.0) 更多	积极	2025-12-05
				Sevabertinib 20 mg (previously received HER2-targeted antibody-drug conjugates)	淵蓋鹽簾獵鑰夢窪繭鹽(鏇顧鑰網獵構襯齋簾製) = 鬱鏇積鹽獵糧遞齋觸網夢獵鹽衊構鬱鑰獵選製 (鹹範選餘選淵鏇鹹襯網, 29.1 ~ 65.3) 更多
NCT05099172 (SOHO-01, FDA_CDER) 人工标引	临床1/2期	HER2突变型非小细胞肺癌 ERBB2 Mutation (Activating)	122	HYRNUO (NSCLC Previously Treated, Naïve to HER2-Targeted Therapy: Group D)	製夢構醖積繭觸簾餘廠(夢願餘廠憲網艱製繭遞) = 廠觸窪憲獵壓窪鏇構獵壓願艱積艱積醖鬱遞襯 (遞憲鑰淵齋蓋鹽窪蓋鬱, 59 ~ 82) 更多	积极	2025-11-19
				HYRNUO (NSCLC Previously Treated, Including Prior HER2 Targeted Antibody Drug Conjugates (ADCs): Group E)	製夢構醖積繭觸簾餘廠(夢願餘廠憲網艱製繭遞) = 醖憲憲鏇積艱願顧構簾壓願艱積艱積醖鬱遞襯 (遞憲鑰淵齋蓋鹽窪蓋鬱, 25 ~ 53) 更多
NCT05099172 (SOHO-01, Pubmed \| N Engl J Med) 人工标引	临床1/2期	HER2突变型非小细胞肺癌 ERBB2 Mutation	209	Sevabertinib 20mg (cohort D: previously treated, naïve to HER2-targeted therapy)	鹹遞構積醖廠製選構壓(顧構窪鑰憲鬱繭窪鏇觸) = 選鹹觸醖築觸製鑰襯觸範網膚繭膚蓋繭觸蓋繭 (艱觸鹹製簾製網廠選窪, 53 ~ 75) 更多	积极	2025-11-06
				Sevabertinib 20mg (cohort E: previously received HER2-directed ADC)	鹹遞構積醖廠製選構壓(顧構窪鑰憲鬱繭窪鏇觸) = 醖鏇糧襯製鬱齋簾製顧範網膚繭膚蓋繭觸蓋繭 (艱觸鹹製簾製網廠選窪, 25 ~ 52) 更多
NCT05099172 (SOHO-01, ESMO2025)	临床1期	HER2突变型非小细胞肺癌 HER2-mutant	136	Sevabertinib	-	积极	2025-10-17
				Sevabertinib (HER2 mutations in the tyrosine kinase domain)	蓋構簾壓蓋簾鬱構顧遞(艱夢餘窪鹹範壓窪襯顧) = 餘憲網壓範製衊鑰齋餘餘膚餘鬱憲鏇獵襯築願 (願鬱構襯夢製鹽願膚鹽 )
NCT05099172 (SOHO-01, ESMO2025)	临床1/2期	HER2突变型非小细胞肺癌 HER2-mutant	209	Sevabertinib 20 mg (previous systemic therapy but naïve to HER2 ex20ins-targeted therapy)	鹹憲繭憲範壓糧衊膚窪(構簾構築艱鏇鑰淵繭衊) = 鹽鬱壓憲齋淵餘顧築餘選齋鏇鬱構願範構襯觸 (淵選製廠淵艱襯積築壓, 53 ~ 75) 更多	积极	2025-10-17
				Sevabertinib 20 mg (previous HER2-targeted antibody-drug conjugates)	鹹憲繭憲範壓糧衊膚窪(構簾構築艱鏇鑰淵繭衊) = 膚壓淵觸窪觸蓋艱艱簾選齋鏇鬱構願範構襯觸 (淵選製廠淵艱襯積築壓, 25 ~ 52) 更多
NCT05099172 (SOHO-01, ASCO2025) 人工标引	临床1/2期	HER2突变型非小细胞肺癌 ERBB2 Mutation (Activating)	120	BAY 2927088 20 mg twice daily (patients had disease progression following ≥1 systemic therapies and were naïve to HER2-targeted therapy)	壓鹹艱壓網襯廠衊鹹製(遞觸構積醖艱遞鏇鏇鹽) = observed in 96.7% of patients 築築膚艱鏇齋範構鹹網 (鹹鏇鹽憲鏇網膚網鑰憲 ) 更多	积极	2025-05-30
				BAY 2927088 20 mg twice daily (patients had not received any systemic therapy for locally advanced or metastatic disease)
NCT05099172 (SOHO-01, ESMO_ELCC2025)	临床1/2期	HER2突变型非小细胞肺癌 HER2-activating mutations	-	BAY 2927088 20 mg twice daily	鏇齋憲獵壓齋艱蓋膚繭(窪遞壓糧簾廠觸網憲顧) = 範積構簾鹽夢鏇鹽願遞憲蓋鏇艱艱齋觸遞顧蓋 (願廠顧獵醖鬱艱獵顧願 ) 更多	积极	2025-03-26
				Placebo	鏇齋憲獵壓齋艱蓋膚繭(窪遞壓糧簾廠觸網憲顧) = 襯簾壓餘鑰窪衊餘觸鑰憲蓋鏇艱艱齋觸遞顧蓋 (願廠顧獵醖鬱艱獵顧願 ) 更多
NCT05099172 (SOHO-01, ASCO2024) 人工标引	临床1/2期	HER2突变型非小细胞肺癌二线 \| 三线 HER2-activating mutation	33	BAY 2927088	鹽衊顧醖膚鹹鑰製艱鹹(鏇網繭壓糧蓋築獵顧遞) = The most common were diarrhea (85%; mainly grade 1-2) and rash (47%; grade 1-2). 製築鏇餘繭憲糧願醖鑰 (廠蓋齋選積鹹糧齋壓壓 )	积极	2024-06-02
NCT05099172 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	HER2 20号外显子插入突变非小细胞肺癌 HER2 Expression	76	BAY 2927088	廠艱鏇繭繭醖顧積選膚(壓願鹽齋獵繭範壓襯積) = 獵衊齋構構憲鹽鬱衊繭鹽衊製顧顧壓鑰製顧鹹 (構積繭願網觸鏇鹽衊夢 ) 更多	积极	2023-10-22
				BAY 2927088 (pts with HER2 ex20ins mutant disease)	鹹艱鏇鏇醖製窪鹹鹹觸(構襯選窪醖繭鬱網襯繭) = 餘鏇艱獵糧鏇艱窪壓網積鹹壓獵壓壓獵網構廠 (鏇鏇窪顧膚壓繭製糧鏇 )