宗格替尼(Zongertinib) - 药物靶点：HER2_在研适应症：HER2阳性非鳞状非小细胞肺癌，HER2突变型非小细胞肺癌，晚期癌症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

佐博替尼、宗艾替尼、BI 1810631

+ [2]

靶点

HER2

作用方式

拮抗剂

作用机制

HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)

治疗领域

肿瘤呼吸系统疾病消化系统疾病+ [2]

在研适应症

HER2阳性非鳞状非小细胞肺癌HER2突变型非小细胞肺癌晚期癌症+ [13]

非在研适应症-

原研机构

Boehringer Ingelheim Pharmaceuticals, Inc.

在研机构

Boehringer Ingelheim GmbHBoehringer Ingelheim International GmbHBoehringer Ingelheim Pharma GmbH & Co., KG

+ [3]

非在研机构-

权益机构

Boehringer Ingelheim GmbH

中國生物製藥有限公司

最高研发阶段批准上市

首次获批日期

美国 (2025-08-08),

HER2阳性非鳞状非小细胞肺癌

最高研发阶段(中国)申请上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、优先审评 (中国)、突破性疗法 (中国)、孤儿药 (日本)、优先审评 (美国)、加速批准 (美国)

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结构/序列

分子式C29H29N9O2

InChIKeyYSGNGFPNTLERCR-UHFFFAOYSA-N

CAS号2728667-27-2

关联

17

项与宗格替尼相关的临床试验

NCT06692322

/ Completed临床1期

Pharmacokinetics, Safety and Tolerability of Zongertinib Following Oral Administration in Male and Female Participants of Non-childbearing Potential With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants of Non-childbearing Potential With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)

This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m^2 can take part. Women can only participate if they cannot get pregnant. This study includes people with mild liver problems, people with moderate liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild and moderate liver problems affect how the body handles a medicine called zongertinib.
Participants take zongertinib once as tablets. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study.
Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times. This also includes an overnight stay for 6 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the study staff regularly takes blood samples.

开始日期2025-01-15

申办/合作机构

Boehringer Ingelheim GmbH

CTR20242277

/ Recruiting临床1/2期

Beamion BCGC-1：一项评价口服zongertinib（BI 1810631）单药或联合其他药物用于治疗晚期HER2+转移性乳腺癌（mBC）和转移性胃癌、食管胃结合部癌或食管腺癌（mGEAC）患者的Ib期剂量递增和II期剂量优化、随机、开放性、多中心临床研究

本研究的目的是确定zongertinib与德曲妥珠单抗、恩美曲妥珠单抗或曲妥珠单抗（联合或不联合卡培他滨）联合治疗时对已扩散的不同类型HER2+癌症患者的最佳耐受剂量。另一个目的是检查zongertinib单药治疗或与其他治疗联合使用是否可以使肿瘤缩小。Zongertinib 能抑制HER2，而HER2 能促进癌细胞生长。

开始日期2024-10-25

申办/合作机构

勃林格殷格翰（中国）投资有限公司

[+5]

NCT06581432

/ Recruiting临床2期

Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours

This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.
Participants are put into 13 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.
Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.

开始日期2024-10-11

申办/合作机构

C.H. Boehringer Sohn AG & Co. KG

100 项与宗格替尼相关的临床结果

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100 项与宗格替尼相关的转化医学

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100 项与宗格替尼相关的专利（医药）

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12

项与宗格替尼相关的文献（医药）

2025-11-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

The development of Zongertinib for HER2-mutant NSCLC

Review

作者: Park, Cathleen J ; Brazel, Danielle ; Nagasaka, Misako

Human epidermal growth factor receptor 2 (HER2) mutations are rare in NSCLC and the only FDA approved agent until recently, was trastuzumab deruxtecan in the second line setting. HER2 mutated NSCLC has historically shown worse prognosis compared to other NSCLC and represent an unmet clinical need. Almost 50 % of patients with HER2-mutated non-small cell lung cancer (NSCLC) have brain metastases at diagnosis. Thus, developing an efficacious agent with good blood brain penetration is key. Zongertinib is a HER2 selective tyrosine kinase inhibitor that covalently binds to HER2 receptors, including exon20ins mutations. Zongertinib is safe and effective for patients with HER2-mutated NSCLC based on initial results from preclinical studies and the phase I Beamion LUNG-1 trial showing promising response rates and safety profile ultimately leading to the FDA accelerated approval on August 8, 2025.

2025-07-28·Cureus Journal of Medical Science

Targeted Therapy in HER2 Exon 20-Mutant Non-small Cell Lung Cancer With Leptomeningeal Disease: A Case-Based Approach to Treatment Decision-Making

Article

作者: Elzaafarany, Osama

A rare and clinically challenging case of leptomeningeal disease (LMD) secondary to HER2-mutated non-small cell lung cancer (NSCLC), marked by both exon 20 insertion and gene amplification, is presented. In the absence of LMD-specific therapeutic guidelines for HER2-driven NSCLC, treatment was initiated with trastuzumab deruxtecan (Enhertu), based on extrapolated evidence from clinical trials in systemic NSCLC and HER2-positive breast cancer with central nervous system involvement. The patient, a 69-year-old woman with good performance status, developed LMD following prior systemic therapy and local CNS treatments. MRI and CSF cytology confirmed the diagnosis. Given the lack of approved therapies for HER2-mutant NSCLC with LMD, the treatment strategy was informed by available clinical data and supporting literature on the CNS activity of Enhertu. Other options such as poziotinib and zongertinib were considered but not pursued. This case underscores the urgent need for inclusive clinical trials addressing CNS complications in molecularly defined NSCLC and demonstrates the real-world application of precision oncology beyond trial populations.

2025-06-19·NEW ENGLAND JOURNAL OF MEDICINE

Zongertinib in Previously Treated HER2 -Mutant Non–Small-Cell Lung Cancer

Article

作者: Yoh, Kiyotaka ; Zugazagoitia, Jon ; Sabari, Joshua K. ; Nadal, Ernest ; Eigenbrod-Giese, Sabina ; Wu, Yi-Long ; Heymach, John V. ; Smit, Egbert F. ; Sadrolhefazi, Behbood ; Cho, Byoung Chul ; Ahn, Myung-Ju ; von Wangenheim, Ute ; Planchard, David ; Girard, Nicolas ; Ruiter, Gerrina ; Zhao, Yanqiu ; Tu, Hai-Yan ; Rohrbacher, Maren ; Yamamoto, Noboru

BACKGROUND:

Innovative oral targeted therapies are warranted for patients with human epidermal growth factor receptor 2 (HER2)-mutant non-small-cell lung cancer (NSCLC). Zongertinib is an oral, irreversible, HER2-selective tyrosine kinase inhibitor that has been shown to have efficacy in persons with advanced or metastatic solid tumors with HER2 alterations in a phase 1 study.

METHODS:

We evaluated zongertinib in a multicohort, phase 1a-1b trial involving patients with advanced or metastatic HER2-mutant NSCLC. Here we report the primary analysis of zongertinib in previously treated patients: those with tumors harboring a mutation in the tyrosine kinase domain (cohort 1), those with tumors harboring a mutation in the tyrosine kinase domain previously treated with a HER2-directed antibody-drug conjugate (cohort 5), and those with tumors harboring a non-tyrosine kinase domain mutation (cohort 3). In cohort 1, patients were initially randomly assigned to receive zongertinib at a dose of 120 mg or 240 mg once daily. Patients in cohorts 5 and 3 initially received 240 mg daily. After an interim analysis of data from cohort 1, subsequently recruited patients across all cohorts received zongertinib at a dose of 120 mg. The primary end point was an objective response assessed by blinded independent central review (cohorts 1 and 5) or by investigator review (cohort 3). Secondary end points included the duration of response and progression-free survival.

RESULTS:

In cohort 1, a total of 75 patients received zongertinib at a dose of 120 mg. At the data cutoff (November 29, 2024), 71% of these patients (95% confidence interval [CI], 60 to 80; P<0.001 against a ≤30% benchmark) had a confirmed objective response; the median duration of response was 14.1 months (95% CI, 6.9 to not evaluable), and the median progression-free survival was 12.4 months (95% CI, 8.2 to not evaluable). Grade 3 or higher drug-related adverse events occurred in 13 patients (17%). In cohort 5 (31 patients), 48% of the patients (95% CI, 32 to 65) had a confirmed objective response. Grade 3 or higher drug-related adverse events occurred in 1 patient (3%). In cohort 3 (20 patients), 30% of the patients (95% CI, 15 to 52) had a confirmed objective response. Grade 3 or higher drug-related adverse events occurred in 5 patients (25%). Across all three cohorts, no cases of drug-related interstitial lung disease occurred.

CONCLUSIONS:

Zongertinib showed clinical benefit with mainly low-grade adverse events in patients with previously treated HER2-mutant NSCLC. (Funded by Boehringer Ingelheim; Beamion LUNG-1 ClinicalTrials.gov number, NCT04886804.).

182

项与宗格替尼相关的新闻（医药）

2025-08-27

·勃林格殷格翰中国

重磅！全球首个HER2突变晚期非小细胞肺癌口服靶向药圣赫途®在华获批

勃林格殷格翰与中国生物制药今日共同宣布，双方联合推广的圣赫途®（中文通用名：宗艾替尼片，英文通用名：zongertinib）获得中国国家药品监督管理局正式批准，适用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。圣赫途®是全球首个且目前唯一获批的口服HER2酪氨酸激酶抑制剂，此次在华获得附条件批准是基于Beamion-LUNG 1研究的积极结果，该试验评估了宗艾替尼在HER2（ERBB2）突变晚期非小细胞肺癌（NSCLC）患者中的疗效安全性。数据显示，在接受治疗的队列1经治患者（N=75）中，客观缓解率（ORR）达71%（95% CI：60-80），其中7%为完全缓解，疾病控制率（DCR）高达96%。中位缓解持续时间（DoR）达14.1个月，中位无进展生存期（PFS）达12.4个月。该数据已在2025年美国癌症研究协会（AACR）年会上公布，并同步刊发于《新英格兰医学杂志》。1此外，宗艾替尼的安全性可控，研究中治疗中断率仅2.9%。2 吴一龙教授中国胸部肿瘤研究协作组（CTONG）主席、广东省人民医院在非小细胞肺癌治疗中长期面临一项关键挑战，一直没有一款针对HER2靶点且耐受性良好的口服药物。宗艾替尼的获批将改变这一局面，为HER2突变晚期非小细胞肺癌建立新的治疗标杆。这一创新药物为这个预后极差且治疗选择十分有限的患者群体，提供了一种高效、靶向、口服的治疗新选择。此外，凭借其高选择性设计，宗艾替尼有效地避免了传统治疗中因抑制EGFR而导致的严重皮肤或胃肠道不良反应，显著提升了患者的治疗耐受性和生活质量。陈文汉勃林格殷格翰大中华区人药业务总经理宗艾替尼连续获得了'突破性治疗认定'和'优先审评'资格，并实现加速批准，这充分体现了国家药品监管部门对该创新药物临床价值的高度认可。作为全球首个针对HER2突变非小细胞肺癌患者的口服靶向治疗药物，圣赫途®的上市将填补该领域治疗空白，为患者带来突破性的治疗新选择和新希望。秉承'以患者为中心'的理念，未来，勃林格将持续聚焦肿瘤领域高度未满足的临床需求，加速引进全球领先的治疗方案，让更多中国患者能够及早获益于前沿医学成果。谢承润中国生物制药首席执行长肺癌不论在全球还是中国范围都是第一大癌种，临床中仍面临巨大的未满足治疗需求。圣赫途®在中国获批，将为国内众多HER2突变非小细胞肺癌患者带来更高效、依从性更佳的治疗选择，也将进一步丰富中国生物制药在肿瘤特别是肺癌治疗领域的药物管线，争取为更多患者带来治疗获益，用‘健康科技，温暖更多生命’。关于非小细胞肺癌（NSCLC）肺癌是全球致死率最高的一类恶性肿瘤，3预计到2040年全球发病数将突破300万例。4其中，非小细胞肺癌（NSCLC）是最常见的病理类型。5该疾病确诊时通常已届晚期，6患者5年生存率不足30%。7晚期非小细胞肺癌（NSCLC）患者往往承受着身体机能衰退、心理创伤和情绪困扰等多重打击，生活质量因而大打折扣。现阶段，晚期非小细胞肺癌（NSCLC）患者仍存在巨大的未满足需求。HER2基因突变会导致过度表达与过度激活，进而引发细胞增殖失控、抑制细胞死亡，最终诱导肿瘤生长、癌细胞扩散。关于勃林格殷格翰在肿瘤学领域勃林格殷格翰致力于推动具有深远意义的科学进步，为癌症患者生活带来变革，最终实现治愈各类癌症。公司世世代代推动科学创新的承诺，在稳健的癌细胞靶向与免疫肿瘤学在研疗法产品线，以及巧妙的联合疗法策略中得到生动体现。在肿瘤学领域，勃林格殷格翰矢志不渝地构建广泛合作研究网络，积极寻求多元化的创新思路，这对于攻克极具挑战且影响巨大的癌症研究领域至关重要。简而言之，对于勃林格殷格翰，攻克癌症关乎当前和未来的世世代代。关于勃林格殷格翰与中国生物制药的战略合作勃林格殷格翰与中国生物制药建立战略合作伙伴关系，致力于为中国大陆市场带来创新的肿瘤疗法。此次合作将凭借双方的互补优势，为中国的癌症患者提供更多更好的治疗方案。双方将合作勃林格殷格翰多个处于临床开发晚期阶段的创新肿瘤产品。宗艾替尼是勃林格殷格翰和中国生物制药在中国大陆的战略合作产品之一。参考文献 [1] Heymach, J. et al. Zongertinib in previously treated HER2-mutant non-small cell lung cancer. N Engl J Med. 2025;01-13. [2] HERNEXEOS Prescribing Information [3] World Health Organization Cancer Factsheet. https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/cancer (Accessed April 2025). [4] International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: https://gco.iarc.fr/tomorrow/en (Accessed August 2024). [5] Zappa C & Mousa Non-small cell lung cancer: current treatment and future advances, Transl Lung Cancer Res. 2016 Jun; 5(3): 288–300. [6] Polanco D et al. Prognostic value of symptoms at lung cancer diagnosis: a three-year observational study. J Thorac Dis 2021;13:1485–1494 [7] National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). 医学审批号：MPR-CN-101997

优先审批AACR会议突破性疗法临床结果申请上市

2025-08-22

·PMLiVE

Boehringer’s Hernexeos granted FDA accelerated approval for lung cancer patients

Boehringer Ingelheim’s Hernexeos (zongertinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat a subset of non-small cell lung cancer (NSCLC) patients. The kinase inhibitor has been authorised to treat unresectable or metastatic NSCLC in adults whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations and who have previously received systemic therapy. Approximately 226,650 people are expected to be diagnosed with lung cancer in the US this year, with NSCLC accounting for around 87% of cases. HER2 (ERBB2) mutations affect up to 4% of NSCLC patients and are associated with a poor prognosis and higher incidence of brain metastases. Boehringer’s Hernexeos is designed to selectively inhibit HER2 (ERBB2) and is now the first orally administered targeted therapy approved by the FDA for this patient population, the company said. The US regulator’s decision was supported by results from the phase 1b Beamion-LUNG 1 trial, in which Hernexeos demonstrated an objective response rate (ORR) of 75% in patients who had received prior platinum-based chemotherapy but not a HER2-targeted tyrosine kinase inhibitor or antibody-drug conjugate (ADC), with 58% experiencing a duration of response (DOR) of at least six months. Among a smaller cohort of patients previously treated with platinum-based chemotherapy and a HER2-targeted ADC, ORR was 44% and 27% had a DOR of at least six months. Coordinating investigator for Beamion-LUNG 1, John Heymach, said: “With the approval of [Hernexeos], we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant NSCLC in the US that not only elicits a durable response but, importantly, has a manageable safety profile. “In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care.” In line with the FDA’s accelerated approval pathway, continued approval for Hernexeos in this indication may be contingent on the verification of clinical benefit in a confirmatory trial. Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim, added: “We are grateful to be able to bring forward Hernexeos, which has the potential to reset the benchmark for those living with HER2-mutant advanced NSCLC, a condition associated with a particularly poor prognosis.”

临床结果上市批准临床1期加速审批

2025-08-21

·正大天晴药业集团

战略升维，品牌跃迁，正大天晴引领院外渠道增量新圈层

8月16日至21日，2025健康产业（国际）生态大会（简称西普会）在海南博鳌举行。正大天晴聚焦“战略升维，品牌跃迁，引领院外渠道增量新圈层”这一核心方向，通过营销资源整合、推广渠道升级、服务模式创新、深度赋能零售客户等举措，在稳固现有存量的同时，不断开拓新的增长空间。本次西普会以“快蜕变，穿越新周期——增长元动力重构与产业生态进化” 为主题，吸引了来自各级政府、行业协会、医药工业、零售企业、国内外资本机构、医疗及健康服务机构等8万余名业界精英参会，通过主题论坛、展览展示、圆桌对话等多元形式，深入探讨产业变革中的痛点与机遇，促进跨领域的创新合作与生态融合，为健康产业的高质量发展注入新动能。正大天晴携多款重点明星产品亮相西普会，涵盖肝病、呼吸、内分泌、疼痛疾病治疗管理等核心领域，充分展现了在细分治疗领域的产品实力。会上，润众®、得百安®泽普思®凭借其显著的临床效果和卓越品质，荣登“2025健康中国·品牌榜”，这一荣誉不仅是对两款产品在各自领域卓越表现的高度肯定，更是对公司多年来深耕肝病治疗与外用镇痛贴膏领域实力的认可。从研发投入到生产质控，从临床研究到患者服务，公司始终以患者需求为核心，推动产品迭代升级。会上，公司零售事业部总经理王坤参与西普会DTP药房新发展峰会，并围绕“DTP药房盈利：如今有何新思路”主题发表讲话。他表示，DTP药房发展需从数智化、专业化慢病服务、精细化运营以及和制药企业、保险机构生态协同等方面寻求突破。此外，公司在本次大会布局了全方位的品牌展示矩阵：设计新颖的展台集中呈现产品核心优势与企业发展理念，多元化宣传资料系统传递产品临床价值及患者获益信息；得百安®泽普思®吉祥物“泰哥”则以亲切可爱的形象拉近与参会者的距离。此外，展台区域创新打造了“疼痛无忧馆”体验专区，聚焦办公室久坐肩颈痛、运动后肌肉酸痛等真实生活场景，让参会者亲身体验得百安®泽普思®的镇痛表现。沉浸式的场景化体验，切实强化了用户对产品的认知和感受。展望未来，正大天晴将始终以“全面创新”为核心战略，以创新驱动发展，在肿瘤、肝病、呼吸、外科/镇痛等领域持续深耕：一方面加大研发投入，探索新的治疗靶点与制剂技术，丰富产品线矩阵；另一方面精益求精，通过优化生产工艺、强化全流程质量管控提升产品品质；同时积极拓展国际市场，推动优质产品惠及全球患者，为人类健康事业贡献更多力量。声明： 1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2.本公司不对任何药品和/或适应症作推荐。 3.本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。来源：2025西普会 ● 中国生物制药上半年业绩报捷：净利润翻倍增长创新驱动营收175.7亿元创新高 ● 中国生物制药与无锡市签署战略合作协议 ● 聚焦核心素养创新跨企协同 | Q-Shine中生计划二期全新启航 ● 宗艾替尼新适应症再获CDE突破性治疗资格认定

100 项与宗格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阳性非鳞状非小细胞肺癌	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2025-08-08

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
HER2突变型非小细胞肺癌	申请上市	中国	Boehringer Ingelheim International GmbH	2025-01-15
晚期癌症	临床2期	美国	C.H. Boehringer Sohn AG & Co. KG	2024-10-11
晚期癌症	临床2期	中国	C.H. Boehringer Sohn AG & Co. KG	2024-10-11
晚期癌症	临床2期	日本	C.H. Boehringer Sohn AG & Co. KG	2024-10-11
晚期癌症	临床2期	澳大利亚	C.H. Boehringer Sohn AG & Co. KG	2024-10-11
晚期癌症	临床2期	比利时	C.H. Boehringer Sohn AG & Co. KG	2024-10-11
晚期癌症	临床2期	加拿大	C.H. Boehringer Sohn AG & Co. KG	2024-10-11
晚期癌症	临床2期	法国	C.H. Boehringer Sohn AG & Co. KG	2024-10-11
晚期癌症	临床2期	德国	C.H. Boehringer Sohn AG & Co. KG	2024-10-11
晚期癌症	临床2期	意大利	C.H. Boehringer Sohn AG & Co. KG	2024-10-11

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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


NCT04886804 (Beamion LUNG-1, WCLC2025)	临床1期	HER2突变型非小细胞肺癌 HER2-mutant	75	Zongertinib 120 mg	膚餘淵願鏇遞範鏇鬱鹹(觸糧製壓鹹窪願鏇蓋壓) = 選選廠壓鑰製鹽鏇築觸觸網醖糧艱窪夢鬱襯廠 (顧製膚觸積衊窪壓積積, 4.2 ~ 14.1)	积极	2025-09-09
NCT04886804 (Beamion LUNG-1, FDA_CDER) 人工标引	临床1期	HER2阳性非鳞状非小细胞肺癌 ERBB2 Mutation (Activating)	71	HERNEXEOS	廠鑰餘鬱鑰鑰範鏇夢憲(積繭觸築糧積獵襯積膚) = 構鏇願衊夢醖廠遞簾鬱齋夢選構繭鏇鏇選網顧 (齋淵艱壓齋夢淵遞窪糧, 63 ~ 83) 更多	积极	2025-08-08
				HERNEXEOS (previous treatment with platinum-based chemotherapy and a HER2-targeted ADC)	廠鑰餘鬱鑰鑰範鏇夢憲(積繭觸築糧積獵襯積膚) = 窪築製蓋膚積窪蓋網製齋夢選構繭鏇鏇選網顧 (齋淵艱壓齋夢淵遞窪糧, 29 ~ 61) 更多
NCT04886804 (Phase Ia dose escalation/expansion trial, ASCO2025)	临床1期	HER2 阴性乳腺癌 HER2	121	Zongertinib	夢膚夢繭選鏇餘鏇顧鹹(襯繭範廠衊鏇網鏇選淵) = The MTD was not reached 齋廠網鬱夢淵遞簾糧糧 (繭窪鏇鬱膚製淵艱鹽醖 )	积极	2025-05-30
				Tucatinib
Phase I study (AACR2025)	临床1期	HER2 mutations	-	Zongertinib 60 mg (C-14)-zongertinib solution	繭醖壓壓簾繭繭鏇簾繭(鏇襯膚艱觸簾鏇遞鏇齋) = 窪艱顧衊衊膚齋築鏇襯構淵衊鑰積鑰窪選網選 (廠獵製製餘積範壓範淵 ) 更多	积极	2025-04-29
				Zongertinib 60 mg film-coated tablet	糧網範淵淵糧獵壓築襯(衊糧選壓鏇願蓋觸壓獵) = 糧蓋齋鬱築選網憲選壓鹽繭觸夢獵觸醖簾觸網 (觸範鑰淵廠艱構鑰衊簾 )
NCT04886804 (Beamion LUNG-1, GlobeNewswire \| Pubmed \| AACR2025) 人工标引	临床1期	HER2突变型非小细胞肺癌 ERBB2 Mutation (Activating)	126	Zongertinib (cohort 1; pretreated HER2-mutant NSCLC within the TKD)	鏇觸構繭齋廠鹽繭遞艱(繭膚鹹醖鏇願獵構繭鬱) = 網鏇艱餘窪醖顧糧壓築構壓鑰鏇築襯蓋艱鏇顧 (簾膚淵觸淵構廠鬱構遞, 60 ~ 80) 更多	积极	2025-04-28
				Zongertinib (cohort 3; pretreated HER2-mutant NSCLC with TKD or non-TKD mutations)	鏇觸構繭齋廠鹽繭遞艱(繭膚鹹醖鏇願獵構繭鬱) = 繭衊齋壓簾網壓獵繭鹹構壓鑰鏇築襯蓋艱鏇顧 (簾膚淵觸淵構廠鬱構遞, 15 ~ 52) 更多
NCT04886804 (Beamion Lung 1, NEWS \| Pubmed) 人工标引	临床1期	实体瘤 \| 非小细胞肺癌 ERBB2 Mutation (Activating)	105	宗格替尼	廠艱築選鏇製淵遞膚衊(構艱餘夢鬱築衊顧壓選) = Two DLTs occurred during the MTD evaluation period. 積築膚願構獵壓鏇鹽構 (獵網鹽網製糧糧顧淵鏇 ) 更多	积极	2025-03-11
				宗格替尼 (NSCLC)
NCT04886804 (BEAMION LUNG-1, PRNewswire) 人工标引	临床1期	HER2突变型非小细胞肺癌 HER2	-	zongertinib (每日120毫克，单次服用)	蓋醖網膚壓餘襯觸觸選(鑰衊衊觸簾觸襯繭艱選) = 糧窪醖鑰鹽顧醖鹽壓網鑰膚積艱淵蓋願鏇鏇鹽 (築醖壓鹽糧蓋窪醖觸醖 ) 更多	积极	2024-12-10
NCT04886804 (Beamion LUNG-1, ESMO_ASIA2024) 人工标引	临床1期	HER2阳性实体瘤 HER2 Positive	105	Zongertinib	窪蓋膚觸鬱簾積襯遞遞(願淵鑰壓獵憲衊繭製遞) = MTD was not reached for BID or QD schedules. 鏇製齋鏇鬱襯願製觸壓 (壓選遞觸鑰鏇積顧觸憲 ) 更多	积极	2024-12-07
				Zongertinib (Asian pts)
NCT04886804 (Beamion LUNG-1, WCLC2024) 人工标引	临床1期	HER2阳性实体瘤 HER2 Positive	83	Zongertinib BID	鏇積餘願願獵築鑰廠餘(襯選壓壓鬱憲衊艱淵憲) = 壓壓壓糧廠製艱醖獵築醖鹽築遞遞範遞鬱鑰廠 (築壓衊築鏇構憲築壓醖 ) 更多	积极	2024-09-10
				Zongertinib QD	選窪艱鏇憲築壓鑰築憲(餘簾齋範鹹窪構鬱選鹹) = 廠網選簾遞鑰網艱製鑰獵鬱夢窪製憲衊鏇壓糧 (築構願蓋餘壓願鬱觸膚 ) 更多
NCT04886804 (Beamion LUNG-1, ASCO2024) 人工标引	临床1期	HER2阳性实体瘤	61	Zongertinib 15/30/60/100/150 mg BID	襯網夢廠簾鏇齋憲膚艱(範齋鹹憲艱選糧積鑰網) = 網觸膚夢醖壓範獵壓餘窪製築鹽淵獵餘築醖壓 (襯積製淵壓繭簾餘網夢 ) 更多	积极	2024-05-24
				Zongertinib 60/120/180/240/300/360 mg QD	襯網夢廠簾鏇齋憲膚艱(範齋鹹憲艱選糧積鑰網) = 醖網構襯醖膚簾糧遞簾窪製築鹽淵獵餘築醖壓 (襯積製淵壓繭簾餘網夢 ) 更多