Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations

This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow.
In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation).
Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits.
Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects.

开始日期2025-12-05

申办/合作机构

Boehringer Ingelheim GmbH

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

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100 项与宗艾替尼相关的临床结果

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100 项与宗艾替尼相关的转化医学

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100 项与宗艾替尼相关的专利（医药）

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项与宗艾替尼相关的文献（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.

2025-10-19·BRITISH JOURNAL OF CANCER

Enhanced HER2 internalization by clathrin-dependent endocytosis in non-small cell lung cancer positive for HER2 mutations

Article

作者: Shimauchi, Atsushi ; Shibahara, Daisuke ; Tsutsumi, Hirono ; Ibusuki, Ritsu ; Otsubo, Kohei ; Yoneshima, Yasuto ; Tanaka, Kentaro ; Okamoto, Isamu ; Iwama, Eiji

BACKGROUND:

HER2-targeted antibody-drug conjugates (ADCs) have shown marked efficacy for HER2 mutation-positive non-small cell lung cancer (NSCLC). The intracellular trafficking of mutant HER2 has remained to be fully elucidated, however.

METHODS:

HER2 dynamics were examined in cells expressing wild-type (WT) or mutant HER2 with the use of live cell imaging and an in situ proximity ligation assay. Proteins related to mutant HER2 trafficking were identified by liquid chromatography and tandem mass spectrometry.

RESULTS:

HER2 internalization was enhanced in NSCLC cells expressing mutant HER2 compared with those expressing HER2(WT). Homodimers of HER2(WT) were localized mainly at the cell surface, whereas those of mutant HER2 were present mostly in the cytoplasm. Knockdown of EGFR or HER3 suppressed internalization of HER2(WT) but not that of mutant HER2. The enhanced internalization of mutant HER2 was mediated by clathrin-dependent endocytosis, as was reflected by increased binding of the ubiquitin ligase c-Cbl to mutant HER2 and its consequent ubiquitination, and was attenuated by treatment with zongertinib, a HER2-specific tyrosine kinase inhibitor.

CONCLUSIONS:

Upregulation of HER2 phosphorylation promotes internalization of mutant HER2 mediated by clathrin-dependent endocytosis, likely contributing to the efficacy of HER2-targeted ADCs in NSCLC positive for HER2 mutations.

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.

224

项与宗艾替尼相关的新闻（医药）

2025-10-13

·蒲公英Ouryao

NMPA:又一新药获批上市！

来源：国家药监局编辑：清风 2025年10月13日，国家药监局批准了1类创新药莫米司特片上市，该药适用于治疗符合接受光疗或系统治疗指征的中度至重度斑块状银屑病。近日，国家药品监督管理局通过优先审评审批程序批准赣州和美药业股份有限公司申报的1类创新药莫米司特片上市，该药适用于治疗符合接受光疗或系统治疗指征的中度至重度斑块状银屑病的成人患者。该药品上市为患者提供了新的治疗选择。 2018年，国家药监局药品审评中心将作用于磷酸二酯酶4（PDE4）靶点的银屑病治疗药物纳入第一批临床急需境外新药名单，鼓励企业加大研发力度。公开资料显示，莫米司特片是我国首个自主研发并获批的PDE4抑制剂，也是全球首个具备磷酸二酯酶4B（PDE4B）蛋白表达阻断剂和PDE4抑制剂双重机制的小分子药物，标志着我国在银屑病治疗领域取得了又一重要突破，将为国内银屑病患者带来更有效、更安全的创新疗法。往期信息： 01 宗艾替尼片近日，国家药品监督管理局通过优先审评审批程序附条件批准Boehringer Ingelheim International GmbH申报的1类创新药宗艾替尼片（商品名：圣赫途），该药单药适用于治疗存在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。该药品上市为患者提供了新的治疗选择。 02 泽美妥司他片近日，国家药品监督管理局通过优先审评审批程序附条件批准江苏恒瑞医药股份有限公司申报的1类创新药泽美妥司他片（商品名：艾瑞璟）上市，该药品适用于既往接受过至少1线系统性治疗的复发或难治外周T细胞淋巴瘤成人患者。该药品上市为患者提供了新的治疗选择。声明：根据《中华人民共和国广告法》和《互联网药品信息服务管理办法》相关规定，本平台内容不属于药品广告范畴。所涉药品信息仅作客观陈述，不具备商业推广属性。本平台发布内容仅代表作者基于专业认知的学术观点，仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Ouryao

优先审批上市批准

2025-10-13

·肿瘤界

逾50项中国研究入选2025 ESMO Asia口头报告！大会摘要标题揭晓

点击蓝字关注我们 2025年欧洲肿瘤内科学会亚洲年会（ESMO Asia 2025）即将于12月5日至7日在新加坡隆重举行。ESMO亚洲年会是亚太地区肿瘤学领域的重要盛会，云集了亚太地区以及全球的肿瘤学专家学者，聚焦于引领亚太乃至全球肿瘤诊疗变革的突破性研究。日前，ESMO Asia官网披露了入选研究的标题（除LBA），本文整理了中国专家入选口头报告的研究成果，让我们一睹为快吧。发展与精准医学 1 摘要号：158O 标题：A phase 1 first-in-human study of BPB-101, a novel triple functional bispecific antibody targeting GARP/TGF-β complex and PD-L1, in patients with locally advanced or metastatic solid tumors【BPB-101（一种靶向GARP/TGF-β复合物和PD-L1的新型三重功能双特异性抗体）在局部晚期或转移性实体瘤患者中的首次人体I期研究】讲者：张力 | 中山大学肿瘤防治中心 2 摘要号：159O 标题：First-in-human study of ES014, a bispecific antibody targeting CD39 and TGF-β as monotherapy in patients with advanced solid tumors.【ES014（一种靶向CD39和TGF-β的双特异性抗体）单药治疗晚期实体瘤患者的首次人体研究】讲者：李子明 | 上海市胸科医院 3 摘要号：160MO 标题：BL-M07D1, a novel anti-HER2 antibody-drug conjugate (ADC), in subjects with metastatic HER2-mutant non-small cell lung cancer (NSCLC)【BL-M07D1，一种新型抗 HER2 抗体药物偶联物（ADC），用于转移性 HER2 突变非小细胞肺癌（NSCLC）患者】讲者：张力 | 中山大学肿瘤防治中心 4 摘要号：161MO 标题：Safety and tolerability of a novel PARP7 inhibitor QLS1103 in patients with advanced solid tumors: results from a phase 1 trial【一种新型PARP7抑制剂QLS1103在晚期实体瘤患者中的安全性和耐受性：一期临床试验结果】讲者：陈华军 | 广东省人民医院 5 摘要号：162MO 标题：A first-in-human (FIH), dose escalation study of HMPL-A83 (A83), an anti-CD47 monoclonal antibody (mAb) in patients (pts) with advanced solid tumors【抗CD47单克隆抗体HMPL-A83（A83）在晚期实体瘤患者中的的首次人体剂量递增研究】讲者：郭晔 | 上海市东方医院 6 摘要号：163MO 标题：First-in-human phase 1 study of the anti-TIGIT and PVRIG bispecific antibody as monotherapy or with sintilimab for advanced solid tumors【抗TIGIT和PVRIG双特异性抗体作为单药或联合信迪利单抗用于治疗晚期实体瘤的一期首次人体研究】讲者：张力 | 中山大学肿瘤防治中心胸部肿瘤 1 摘要号：928MO 标题：ARTEMIS-001: A Phase 1 Study of HS-20093 (GSK5764227) in Patients With Non-Small Cell Lung Cancer (NSCLC)【ARTEMIS-001：HS-20093（GSK5764227）在NSCLC患者中的I期研究】讲者：段建春 | 中国医学科学院肿瘤医院 2 摘要号：978MO 标题：Sintilimab Plus Platinum-Based Chemotherapy With vs Without Autologous CIK Cell Therapy in Metastatic NSCLC: A Multicenter Randomized Study【信迪利单抗联合铂类基础化疗加或不加自体CIK细胞疗法治疗转移性NSCLC：一项多中心随机研究】讲者：黄鼎智 | 天津医科大学肿瘤医院 3 摘要号：929MO 标题：Becotatug (JMT101, Beco) Combined with Docetaxel (Albumin-Bound, HB1801) for the Treatment of Patients (pts) with Locally Advanced Squamous Cell Non-Small Cell Lung Cancer (sqNSCLC) -A randomized control phase II study (BATTLE study)【Becotatug（JMT101, Beco）联合多西他赛（白蛋白结合型，HB1801）治疗局部晚期鳞状细胞非小细胞肺癌（sqNSCLC）患者——一项随机对照II期研究（BATTLE研究）】讲者：张力 | 中山大学肿瘤防治中心 4 摘要号：979MO 标题：Plinabulin/Docetaxel vs. Docetaxel in 2L/3L EGFRwt NSCLC after Platinum Regimens (DUBLIN-3): Asian Subgroup Analysis【普那布林/多西他赛对比多西他赛在铂类方案后二/三线（2L/3L）EGFR野生型NSCLC中的应用（DUBLIN-3）：亚洲亚组分析】讲者：韩宝惠 | 上海市胸科医院 5 摘要号：975MO 标题：Zongertinib in Asian patients with previously treated advanced HER2-mutant NSCLC【宗艾替尼在既往接受过治疗的晚期HER2突变NSCLC亚洲患者中的应用】讲者：吴一龙 | 广东省人民医院 6 摘要号：976MO 标题：Vebreltinib in MET amplification-driven advanced non-small-cell lung cancer (NSCLC): results from phase 2 KUNPENG study【伯瑞替尼治疗MET扩增驱动的晚期NSCLC：II期KUNPENG研究结果】讲者：吴一龙 | 广东省人民医院 7 摘要号：927MO 标题：Osimertinib (osi) before and after chemoradiotherapy (CRT) in patients (pts) with unresectable (UR) stage III EGFRm NSCLC: Phase 2 NEOLA study interim analysis (IA)【奥希替尼用于不可切除III期EGFR突变NSCLC患者放化疗（CRT）前后的治疗：II期NEOLA研究中期分析】讲者：陈明 | 中山大学肿瘤防治中心乳腺癌 1 摘要号：87MO 标题：Capivasertib (C) + paclitaxel (P) as first-line treatment of metastatic triple-negative breast cancer: The CAPItello-290 Phase III trial extended China cohort 【卡匹色替+紫杉醇作为转移性三阴性乳腺癌一线治疗：III期CAPItello-290试验扩展中国队列】讲者：王树森 | 中山大学肿瘤防治中心 2 摘要号：88MO 标题：Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of Asian patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC): a DESTINY-Breast09 analysis【德曲妥珠单抗（T-DXd）+帕妥珠单抗（P）对比紫杉类+曲妥珠单抗+帕妥珠单抗（THP）用于亚洲HER2阳性晚期/转移性乳腺癌患者一线治疗：DESTINY-Breast09分析】讲者：江泽飞 | 中国人民解放军总医院 3 摘要号：89MO 标题：Phase I/Ib data of SMP-656: a novel Eribulin-based HER2 ADC in solid tumor 【SMP-656（一种新型基于艾日布林的HER2 ADC）在实体瘤中的I/Ib期数据】讲者：张剑 | 复旦大学附属肿瘤医院 4 摘要号：90MO 标题：Preliminary efficacy and safety of FDA022-BB05 in advanced/metastatic HER2 low breast cancer: Results from a phase 2 study【FDA022-BB05在晚期/转移性HER2低表达乳腺癌中的初步疗效和安全性：一项II期研究结果】讲者：刘晓军 | 复旦大学附属肿瘤医院 5 摘要号：65MO 标题：Neoadjuvant HLX11 versus European Union (EU)-sourced pertuzumab in human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-negative early or locally advanced, breast cancer (BC): A double-blind, randomised phase 3 equivalence study【新辅助HLX11对比欧盟（EU）来源帕妥珠单抗治疗HER2阳性、HR阴性早期或局部晚期乳腺癌：一项双盲、随机III期等效性研究】讲者：刘强 | 中山大学孙逸仙纪念医院 6 摘要号：1MO 标题：Association of genetic risk, DEHP exposure, and their interaction with breast cancer and breast cancer-related mortality【遗传风险、DEHP暴露及其相互作用与乳腺癌及乳腺癌相关死亡率的关联】讲者：Lijuan Tang | 成都 7 摘要号：3MO 标题：Axillary Management Strategies in Breast Cancer Patients With ypN0 After Neoadjuvant Therapy【新辅助治疗后达到ypN0乳腺癌患者的腋窝处理策略】讲者：Qingyao Shang | 北京中国医学科学院北京协和医学院妇科肿瘤 1 摘要号：601O 标题：From Slides to Signals: A Multimodal Deep Learning Framework Decoding Platinum Resistance in Ovarian Cancer 【从切片到信号：解码卵巢癌铂类耐药的多模态深度学习框架】讲者：Enyu Tang | 北京 2 摘要号：602O 标题：Efficacy and Safety of HLX43 (an anti-PD-L1 ADC) in Recurrent/Metastatic Cervical Cancer (CC): a Randomised, Multicentre, Phase 2 Study【HLX43（一种抗PD-L1 ADC）在复发/转移性宫颈癌（CC）中的疗效和安全性：一项随机、多中心、II期研究】讲者：于金明 | 山东第一医科大学附属肿瘤医院 3 摘要号：603O 标题：DB-1311/BNT324 (a novel B7H3 ADC) in patients with advanced cervical cancer or platinum-resistant recurrent ovarian cancer【DB-1311/BNT324（一种新型B7H3抗体偶联药物）在晚期宫颈癌或铂类耐药复发性卵巢癌患者中的应用】讲者：Chih-Long Chang | 中国台湾 4 摘要号：606MO 标题：Efficacy of Neoadjuvant Anti-PD-1 Immunotherapy Plus Chemotherapy in Locally Advanced Cervical Cancer【新辅助抗PD-1免疫疗法联合化疗在局部晚期宫颈癌中的疗效】讲者：Liang Wen | 北京 5 摘要号：607MO 标题：Iparomlimab and tuvonralimab (QL1706) vs zimberelimab for previously treated recurrent/metastatic cervical cancer (r/mCC): An unanchored matching-adjusted indirect comparison (MAIC)【Iparomlimab和tuvonralimab（QL1706）对比zimberelimab用于既往治疗过的复发/转移性宫颈癌（r/mCC）：非锚定匹配调整间接比较（MAIC）】讲者：吕晓娟 | 浙江省肿瘤医院 6 摘要号：608MO 标题：Reduction of cell viability by immune-checkpoint inhibitor in co-cultured organoids derived from high-risk endometrial cancer patients pretreated with PARP inhibitor【免疫检查点抑制剂降低源自接受PARP抑制剂预处理的高危子宫内膜癌患者的共培养类器官的细胞活力】讲者：Wai Sun Chan | 中国香港 7 摘要号：609MO 标题：Tisotumab vedotin vs investigator’s choice of chemotherapy as second- or third-line (2L/3L) treatment for Chinese patients (pts) with recurrent or metastatic cervical cancer (r/mCC) in innovaTV 301【在 innovaTV 301 研究中，Tisotumab vedotin 与研究者选择的化疗作为中国复发或转移性宫颈癌（r/mCC）患者二线或三线（2L/3L）治疗】讲者：安菊生 | 中国医学科学院肿瘤医院 8 摘要号：610MO 标题：Optimal adjuvant radiotherapy strategy for cervical cancer: a multi-center database cohort study【宫颈癌的最佳辅助放疗策略：多中心数据库队列研究】讲者：Fang BAI | 上海头颈肿瘤 1 摘要号：666O 标题：Exploration of the efficacy of nimotuzumab combined with induction chemotherapy in locally advanced nasopharyngeal carcinoma: A multicenter, prospective phase 3 study【尼妥珠单抗联合诱导化疗在局部晚期鼻咽癌中的疗效探索：一项多中心、前瞻性III期研究】讲者：王孝深 | 复旦大学附属眼耳鼻喉科医院 2 摘要号：669MO 标题：Long Term Overall Survival Follow-up of Toripalimab versus Placebo in Combination with Gemcitabine and Cisplatin as First-line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma 【特瑞普利单抗对比安慰剂联合吉西他滨和顺铂作为复发或转移性鼻咽癌一线治疗的长期总生存随访】讲者：麦海强 | 中山大学肿瘤防治中心 3 摘要号：670MO 标题：Efficacy and Safety of Liposomal Irinotecan plus Nimotuzumab in Immune Checkpoint Inhibitor–Refractory Recurrent or Metastatic Nasopharyngeal Carcinoma: A Single-arm, Open-label, Phase 2 trial【脂质体伊立替康联合尼妥珠单抗在免疫检查点抑制剂耐药的复发或转移性鼻咽癌中的疗效和安全性：一项单臂、开放标签、II期试验】讲者：Shuiqing He | 广州 4 摘要号：671MO 标题：Long-Term Outcomes of Reduced-Dose Radiotherapy in Patients with Epstein-Barr Virus DNA-Selected Stage III Nasopharyngeal Carcinoma: A 5-Year Follow-Up Secondary Analysis of a Phase II Trial【Epstein-Barr病毒DNA选择的III期鼻咽癌患者减剂量放疗的长期结局：一项II期试验的5年随访二次分析】讲者：郭姗姗 | 中山大学肿瘤防治中心 5 摘要号：672MO 标题：Efficacy of Immunotherapy Rechallenge in Locoregionally Advanced Nasopharyngeal Carcinoma After Progression on Prior Immunotherapy: A Real-Word Analysis【既往免疫治疗进展后局部晚期鼻咽癌患者再次挑战免疫治疗的疗效：一项真实世界分析】讲者：Jiarui He | 广州 6 摘要号：673MO 标题：Optimizing Induction Chemotherapy Cycles in Locally Advanced Nasopharyngeal Carcinoma: A Recursive Partitioning Risk Stratification Analysis【优化局部晚期鼻咽癌诱导化疗周期数：一项基于递归分区的风险分层分析】讲者：Jie Yi Lin | 广州 7 摘要号：674MO 标题：Neoadjuvant application of Pembrolizumab and Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC): A Single-Arm, Single-Center Phase 2 Study【帕博利珠单抗和化疗在可切除局部晚期头颈部鳞状细胞癌（LA HNSCC）中的新辅助应用：一项单臂、单中心II期研究】讲者：Kai Wang | 北京 8 摘要号：675MO 标题：A prospective, multi-center phase II study: Evaluating the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in laryngeal/hypopharyngeal squamous cell carcinoma (L/HPSCC)【一项前瞻性、多中心II期研究：评估帕博利珠单抗联合化疗作为喉/下咽鳞状细胞癌（L/HPSCC）新辅助治疗的疗效和安全性】讲者：陈晓红 | 首都医科大学附属北京同仁医院 9 摘要号：676MO 标题：Neoadjuvant chemo-immunotherapy with camrelizumab plus chemotherapy in resectable or potentially resectable locally advanced head and neck squamous cell carcinoma: an open-label, single-arm, phase II trial【卡瑞利珠单抗联合化疗用于可切除或潜在可切除局部晚期头颈部鳞状细胞癌的新辅助化免治疗：一项开放标签、单臂、II期试验】讲者：苗素生 | 哈尔滨医科大学附属肿瘤医院胃肠道肿瘤 1 摘要号：271O 标题：Final Analysis and Biomarker Evaluation of JUPITER-06: A Phase 3 Trial of Toripalimab Plus Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma【JUPITER-06最终分析及生物标志物评估：特瑞普利单抗联合化疗治疗晚期或转移性食管鳞状细胞癌的III期试验】讲者：王峰 | 中山大学肿瘤防治中心 2 摘要号：198MO 标题：MK-1084 for KRAS G12C-mutated advanced colorectal cancer (CRC): Updated findings from KANDLELIT-001【MK-1084治疗KRAS G12C突变晚期结直肠癌（CRC）：KANDLELIT-001研究最新结果】讲者：薛俊丽 | 上海市东方医院 3 摘要号：274MO 标题：Pooled efficacy and safety with tremelimumab plus durvalumab in participants (pts) with unresectable hepatocellular carcinoma (uHCC) from China extension cohort, and Hong Kong (HK) and Taiwan (TW) subgroups from the global cohort in the Phase 3 HIMALAYA study【在III期HIMALAYA研究中，中国大陆扩展队列以及全球队列中中国香港（HK）和中国台湾（TW）亚组的不可切除肝细胞癌（uHCC）患者使用tremelimumab联合度伐利尤单抗的汇总疗效和安全性】讲者：George K. K. Lau | 中国香港 4 摘要号：275MO 标题：Overall efficacy outcomes of nivolumab plus ipilimumab by occurrence of immune-mediated adverse events (IMAEs) and additional safety from Asian patients in CheckMate 9DW 【纳武利尤单抗联合伊匹木单抗的总体疗效结局与免疫介导不良事件（IMAEs）发生率的关系及亚洲患者额外安全性数据（来自CheckMate 9DW研究）】讲者：Thomas Yau | 中国香港 5 摘要号：277MO 标题：Efficacy and safety of adebrelimab combined with S-1 plus oxaliplatin in neoadjuvant therapy for locally advanced gastric adenocarcinoma【阿得贝利单抗联合S-1加奥沙利铂用于局部晚期胃腺癌新辅助治疗的疗效和安全性】讲者：杨建军 | 空军军医大学西京医院泌尿肿瘤 1 摘要号：487O 标题：Capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): Phase 3 CAPItello-281 Chinese subgroup analysis【卡匹色替+阿比特龙对比安慰剂+阿比特龙治疗PTEN缺陷的初诊转移性激素敏感性前列腺癌（mHSPC）患者：III期CAPItello-281研究中国亚组分析】讲者：曾浩 | 四川大学华西医院 2 摘要号：488O 标题：MRI-targeted biopsy with index lesion ipsilateral or bilateral systematic biopsy in prostate cancer: a multicenter, paired, noninferiority, observational trial【前列腺癌中基于MRI靶向活检联合指数病灶同侧或双侧系统性活检：一项多中心、配对、非劣效性、观察性试验】讲者：Yongbing Cheng | 南京 3 摘要号：540O 标题：Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): results from phase 2 part of FRUSICA-2【呋喹替尼单药作为局部晚期或转移性肾细胞癌（RCC）二线治疗：FRUSICA-2研究II期部分结果】讲者：叶定伟 | 复旦大学附属肿瘤医院 4 摘要号：489MO 标题：A multicenter, single-arm, phase 2 trial of androgen deprivation therapy in combination with apalutamide in patients with high risk of recurrence after radical prostatectomy (ARES study)【多中心单臂II期试验：雄激素剥夺疗法联合阿帕他胺用于根治性前列腺切除术后高复发风险患者（ARES研究）】讲者：Qing Zhang | 南京 5 摘要号：490MO 标题：Niraparib (NIRA) and Abiraterone Acetate plus Prednisone (AAP) in Chinese Patients with breast cancer susceptibility gene (BRCA) altered metastatic castration-sensitive prostate cancer (mCSPC): Subgroup Analysis of the Phase 3 AMPLITUDE Trial【尼拉帕利（NIRA）联合醋酸阿比特龙+泼尼松（AAP）治疗中国乳腺癌易感基因（BRCA）突变的转移性去势敏感性前列腺癌（mCSPC）患者：III期AMPLITUDE试验亚组分析】讲者：叶定伟 | 复旦大学附属肿瘤医院 6 摘要号：541MO 标题：Efficacy and safety of disitamab vedotin combined with gemcitabine as neoadjuvant therapy for muscle-invasive bladder cancer: A multi-center, single-arm, phase II trial【维迪西妥单抗联合吉西他滨作为肌层浸润性膀胱癌新辅助治疗的疗效与安全性：多中心单臂II期试验】讲者：Chu Yang | 武汉 7 摘要号：542MO 标题：Efficacy and safety of disitamab vedotin (DV) combined with tislelizumab as adjuvant therapy after radical surgery for patients with HER2-expression upper tract urothelial carcinoma (UTUC): A single-arm, prospective, phase Ⅱ study【维迪西妥单抗联合替雷利珠单抗作为HER2表达上尿路尿路上皮癌（UTUC）根治术后辅助治疗的疗效与安全性：单臂前瞻性II期研究】讲者：顾良友 | 中国人民解放军总医院 8 摘要号：547MO 标题：Efficacy and Safety of Toripalimab Combined with Lenvatinib as First-Line Treatment for Unresectable/Advanced Non–Clear Cell Renal Cell Carcinoma: A Prospective, Single-arm, Phase II trial【特瑞普利单抗联合仑伐替尼一线治疗不可切除/晚期非透明细胞肾细胞癌的疗效与安全性：前瞻性单臂II期试验】讲者：顾良友 | 中国人民解放军总医院支持治疗和姑息治疗 1 摘要号：740MO 标题：Enhancing Community Palliative Care in Advanced Cancer Using SUPPORT+: A Randomized Trial Subgroup Analysis in Older Adults【使用SUPPORT+加强晚期癌症患者的社区姑息治疗：一项针对老年人的随机试验亚组分析】讲者：Wendy W. Chan | 中国香港声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通肿瘤科

临床1期抗体药物偶联物临床结果

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·勃林格殷格翰中国

欧唐宁®本地化生产计划启动，勃林格殷格翰深耕中国再提速

全球领先的生物制药企业勃林格殷格翰今日宣布旗下明星降糖药欧唐宁®（利格列汀）在华本地化生产计划正式启动。此举是勃林格深化在华战略布局的关键一步，标志着公司在中国市场实现了从商业运营向产业链纵深发展的新跨越。（从左至右：浦东新区科经委副主任凌刚、上海市药监局二级巡视员张清、上海勃林格殷格翰药业有限公司总经理殷雪林、勃林格殷格翰大中华区人药业务总经理陈文汉）勃林格殷格翰全球股东委员会主席冯保和(Hubertus von Baumbach)、大中华区总裁兼CEO高皓廷（Mohammed Tawil）、以及各方代表共同出席在上海张江人用药品生产基地举行的启动仪式，见证勃林格深耕中国市场三十年来的又一重要里程碑。该计划将显著提升欧唐宁®在中国市场的供应稳定性与韧性，进一步提高药物可及性，同时推动上海人用药品生产基地设备升级与产能优化，巩固其作为辐射亚太区域核心供应枢纽的战略地位。高皓廷勃林格殷格翰大中华区总裁兼CEO 在勃林格进入中国市场三十周年之际，欧唐宁®本地化生产计划落户上海具有特殊意义。三十年来，我们始终与中国发展同频共振，与上海、浦东共成长。如今，中国已成为勃林格全球的重要市场与创新高地。未来，我们将继续依托中国市场的速度、规模与影响力，深耕本土、服务全球，致力于成为中国高质量发展的实践者与全球创新合作的推动者，让创新成果更快惠及全球患者与动物健康。站在三十年的新起点，勃林格殷格翰将全面升级在华发展战略，加速研发成果落地，以更开放姿态融入中国医疗健康创新生态，于而立之年开启在华发展的新篇章。作为研发驱动的跨国药企，勃林格持续深化“中国关键”（China Key）战略，在跨国药企中率先将中国全面纳入全球早期研发当中，推动前沿创新疗法“零时差”带入中国。今年以来，公司新一代溶栓药物美通立®（注射用替奈普酶）与全球首个口服HER2酪氨酸激酶抑制剂圣赫途®（宗艾替尼片）相继在华获批，为卒中和肺癌患者带来新的治疗选择。此外，肺纤维化疗法nerandomilast是十年来首个递交注册申请的用于治疗成人特发性肺纤维化的新疗法，目前在中国优先审评中。在动物保健领域，勃林格今年在华推出犬用口服外驱新品福味恩®（阿福拉纳咀嚼片）、马用炎症及疼痛治疗药物美达佳®（美洛昔康内服混悬液（马用））等创新产品，引领行业创新。未来5年，公司计划在华研发投入超50亿元人民币，人用药品研发管线将聚焦于代谢、炎症、眼健康和肿瘤学领域，通过“中国关键”战略，这些新产品和新适应症有望在中国实现与全球同步甚至更早获批；动物保健业务也将加速动物疫苗的研发创新，引入全球领先的创新产品，覆盖经济动物和伴侣动物的关键物种。面对中国医疗健康产业蓬勃发展的机遇，勃林格殷格翰坚持开放式创新，携手各方伙伴合作构建创新生态。公司通过跨边界研究、业务拓展及许可和风险投资等方式，不断丰富研发管线，为生物医药创新者提供全方位支持。目前，公司已成功投资孵化4家亚洲地区生物医药初创企业。在动物保健领域，勃林格携手广州金苗动保加速动物疫苗研发，真正做到了动保研发合作“在中国，为全球”。三十年来，勃林格殷格翰持续加大对华投入，建立了涵盖早期研发、临床开发、生产制造、商业化和外部创新合作的全价值链布局。在服务本土市场的同时，公司在华的人用药品和动物保健生产基地已发展为辐射区域乃至全球的供应枢纽——人用药品生产基地的产品供应至澳大利亚、新西兰、新加坡等多个亚太国家和地区；动保南昌工厂也升级为全球化生产基地，目前已实现向包括巴西和阿根廷在内的多个国家稳定供货，未来每年将向30多个国家提供超50亿羽份疫苗。此外，勃林格殷格翰也将于金秋时节连续第七年亮相中国国际进口博览会，携多款全新上市的创新产品，全面展示公司在华加速管线研发、赋能新质发展的创新蓝图，践行“扎根中国、服务全球”的坚定承诺。关于勃林格殷格翰勃林格殷格翰是全球领先的生物制药企业，布局人用药品、动物保健两大业务领域。公司研发投入位居行业前列，致力于研究突破性疗法，解决巨大未满足的医疗需求，从而帮助改善或延长生命。自1885年成立以来，勃林格殷格翰一直是独立的家族企业，始终着眼长远发展，将可持续发展理念贯穿全价值链。公司在全球有近5.45万名员工，服务逾130个市场，致力于打造一个更健康、更可持续的未来。勃林格殷格翰于1994年进入中国，总部位于上海，业务遍布全国，拥有约3,200名员工。公司致力于人用药品、动物保健、生物制药合同开发与生产三大业务，实现研发、生产、商业运营、外部创新合作的全价值链布局。中国是勃林格殷格翰的重点市场和创新高地之一，公司将中国患者的需求纳入全球研发策略，致力于把更多更好的创新产品更早地带给中国的患者，助力中国健康产业的高质量发展，全面改善人与动物的健康。近年来，勃林格殷格翰在中国收获长足发展，并连续十二年荣获“中国杰出雇主”认证。更多详情，请访问：www.boehringer-ingelheim.cn， www.boehringer-ingelheim.com

优先审批

100 项与宗艾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	中国	Boehringer Ingelheim International GmbH	2025-08-26
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
非小细胞肺癌IIIB期	临床3期	美国	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	中国	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	日本	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	阿根廷	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	奥地利	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	比利时	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	巴西	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	加拿大	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	智利	Boehringer Ingelheim GmbH	2025-12-05
非小细胞肺癌IIIB期	临床3期	丹麦	Boehringer Ingelheim GmbH	2025-12-05

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临床结果

适应症

分期

评价

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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


NCT06075277 (CTgov)	临床1期	-	16	Zongertinib (Zongertinib iCF Fed (Test (T)))	窪醖窪淵蓋壓衊夢壓淵(醖窪艱廠範衊簾衊廠鬱) = 製鬱鹹淵糧製製鏇網構壓鑰範鏇醖淵餘餘糧網 (醖醖鹽襯獵鹹齋鹽願餘, NA) 更多	-	2025-09-22
				Zongertinib (Zongertinib iCF Fasted (Reference (R)))	窪醖窪淵蓋壓衊夢壓淵(醖窪艱廠範衊簾衊廠鬱) = 蓋繭廠壓艱糧鹽淵鏇鹹壓鑰範鏇醖淵餘餘糧網 (醖醖鹽襯獵鹹齋鹽願餘, NA) 更多
NCT06360081 (CTgov)	临床1期	-	56	Zongertinib (Zongertinib Test Treatment (T))	襯鹽醖窪窪襯選鹹鏇繭(鹽願積窪繭構糧積壓醖) = 鏇糧鑰簾顧膚願廠顧遞選窪憲襯齋糧選蓋積鬱 (獵鑰廠鬱簾顧遞構遞膚, NA) 更多	-	2025-09-22
				Zongertinib (Zongertinib Reference Treatment (R))	襯鹽醖窪窪襯選鹹鏇繭(鹽願積窪繭構糧積壓醖) = 齋廠選選範簾餘遞鹽築選窪憲襯齋糧選蓋積鬱 (獵鑰廠鬱簾顧遞構遞膚, NA) 更多
NCT05833139 (CTgov)	临床1期	-	16	Zongertinib (Zongertinib Alone)	獵範餘糧糧糧鏇壓鹽廠(衊繭淵醖積鹹膚壓顧簾) = 餘簾憲膚鹹鏇願壓壓醖壓糧遞鹽繭繭獵網選糧 (簾醖糧鏇蓋築憲獵廠窪, NA) 更多	-	2025-09-22
				Itraconazole+Zongertinib (Zongertinib + Itraconazole)	獵範餘糧糧糧鏇壓鹽廠(衊繭淵醖積鹹膚壓顧簾) = 簾積簾醖夢網範鏇窪醖壓糧遞鹽繭繭獵網選糧 (簾醖糧鏇蓋築憲獵廠窪, NA) 更多
NCT05879991 (CTgov)	临床1期	-	15	zongertinib (C-14) (Part A - Zongertinib (C-14) (T1))	鹹網築餘廠鏇築蓋夢築(鏇鬱壓膚築製齋鹹選鑰) = 鑰願衊艱選窪壓醖鬱鹽衊觸餘淵壓夢繭顧顧壓 (鹹艱夢築淵襯願獵網鏇, 16.8) 更多	-	2025-09-22
				zongertinib (C-14) (Part B - Zongertinib (T2), Then Zongertinib (C-14) (R))	顧齋鬱範衊壓簾鑰餘鑰(醖憲鏇窪醖鏇糧繭獵製) = 餘築構蓋顧膚築構積網願夢觸願獵廠窪願築網 (醖齋積選蓋窪鏇鹹願壓, NA) 更多
NCT04886804 (Beamion LUNG-1, WCLC2025) 人工标引	临床1期	HER2突变型非小细胞肺癌二线 \| 末线 \| 三线 HER2-mutant	75	Zongertinib 120 mg (stable/asymptomatic BMs at baseline)	顧獵願繭醖蓋觸觸蓋鏇(構願蓋網齋願壓構願積) = 遞憲餘醖範範願獵積膚範鹹願蓋鏇壓鬱網觸獵 (淵獵憲鑰膚簾醖願糧鬱, 46 ~ 79) 更多	积极	2025-09-09
				Zongertinib 120 mg (without BMs at baseline)	顧獵願繭醖蓋觸觸蓋鏇(構願蓋網齋願壓構願積) = 艱獵艱範淵衊廠膚襯鹹範鹹願蓋鏇壓鬱網觸獵 (淵獵憲鑰膚簾醖願糧鬱, 61 ~ 85) 更多
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	繭夢鬱鹽網衊鬱鑰鑰製(醖艱膚獵憲網簾積遞鹹) = 醖選窪糧獵鏇醖構製衊衊糧積積齋網壓窪餘膚 (範鹽夢選構齋鬱鏇簾淵, 63 ~ 83) 更多	积极	2025-08-08
				HERNEXEOS (previous treatment with platinum-based chemotherapy and a HER2-targeted ADC)	繭夢鬱鹽網衊鬱鑰鑰製(醖艱膚獵憲網簾積遞鹹) = 鹽鑰遞醖範醖窪艱餘觸衊糧積積齋網壓窪餘膚 (範鹽夢選構齋鬱鏇簾淵, 29 ~ 61) 更多
NCT04886804 (Beamion LUNG-1, Pubmed \| N Engl J Med)	临床1期	肝转移 \| 转移性肿瘤 \| 转移性实体瘤 ... HER2 更多	-	Zongertinib 120 mg	願衊鬱壓觸夢廠鹹獵構(淵積觸窪選餘窪鑰鏇襯) = 衊鑰憲憲夢築襯鑰夢淵醖鏇鏇壓窪鹹鏇餘範鑰 (壓願積夢餘範製觸選繭, 60 ~ 80) 更多	积极	2025-06-19
				HER2-directed antibody-drug conjugate	願衊鬱壓觸夢廠鹹獵構(淵積觸窪選餘窪鑰鏇襯) = 繭蓋淵鑰壓衊製鬱鹹夢醖鏇鏇壓窪鹹鏇餘範鑰 (壓願積夢餘範製觸選繭, 32 ~ 65)
NCT04886804 (Phase Ia dose escalation/expansion trial, ASCO2025)	临床1期	HER2 阴性乳腺癌 HER2	121	Zongertinib	夢襯襯糧窪膚願鑰廠構(齋廠壓鹹鬱夢糧獵願齋) = The MTD was not reached 構積觸糧遞蓋齋齋繭觸 (憲範糧窪簾選獵膚夢範 )	积极	2025-05-30
				Tucatinib
Phase I study (AACR2025)	临床1期	HER2 mutations	-	Zongertinib 60 mg (C-14)-zongertinib solution	夢繭糧餘積淵鏇鹽遞憲(廠築餘鹹觸膚衊範膚齋) = 觸夢觸齋觸遞鏇蓋網蓋顧繭積顧觸醖鑰願壓簾 (願餘範廠夢艱壓獵鹽齋 ) 更多	积极	2025-04-29
				Zongertinib 60 mg film-coated tablet	積壓願夢餘鹹願鹹鬱鬱(積願網簾鹽積願願衊淵) = 鬱鏇製襯遞築積積艱鹽積網鬱襯觸構觸醖淵積 (範觸憲鹽憲襯繭壓糧獵 )
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)	繭製艱醖顧壓網鏇醖築(鬱繭壓顧繭積鬱選衊範) = 觸遞鹽繭憲鏇鏇齋衊憲窪遞窪製餘膚襯築蓋獵 (獵膚鬱鬱膚獵糧糧觸鏇, 60 ~ 80) 更多	积极	2025-04-28
				Zongertinib (cohort 3; pretreated HER2-mutant NSCLC with TKD or non-TKD mutations)	繭製艱醖顧壓網鏇醖築(鬱繭壓顧繭積鬱選衊範) = 顧夢鏇鑰積遞繭網蓋襯窪遞窪製餘膚襯築蓋獵 (獵膚鬱鬱膚獵糧糧觸鏇, 15 ~ 52) 更多