This study is open to adults who participated in a previous clinical study with brigimadlin.
The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer.
Participants are grouped in cohorts depending on their treatment in the previous study:
* Cohort 1a got brigimadlin and continues treatment with brigimadlin
* Cohort 1b got brigimadlin for 4 or less treatment cycles; each cycle was 3 weeks long
* Cohort 2 received a comparator and gets brigimadlin for the first time
All participants take brigimadlin as tablets once every 3 weeks at the study site. Participants in the Cohorts 1b and 2 visit the sites more frequently. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body.
Participants are in the study as long as they benefit from treatment and can tolerate it.

开始日期2024-12-30

申办/合作机构

Boehringer Ingelheim GmbH

NCT06370871

/ Withdrawn临床3期

Brightline-3: A Phase III, Randomized, Open-label, Multi-center Trial of Brigimadlin + Ezabenlimab Compared to Gemcitabine + Docetaxel for Second-line Treatment of Patients With Advanced TP53 Wild-type Soft Tissue Sarcoma Subtypes

This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse.
The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy. Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer.
Participants are put into 3 groups by chance:
* Ezabenlimab group: Participants receive ezabenlimab as an infusion into a vein every 3 weeks
* Brigimadlin + ezabenlimab group: Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks
* Chemotherapy group: Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks. Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma.
There are twice as many participants in the brigimadlin + ezabenlimab group and in the chemotherapy group, compared to those in the ezabenlimab group.
Participants can continue treatment in the study as long as they benefit from it and can tolerate it.
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing.

开始日期2024-06-27

申办/合作机构

Boehringer Ingelheim GmbH

NCT06084689

/ Not yet recruiting临床2期IIT

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.

开始日期2024-01-01

申办/合作机构

Institut Bergonié

[+1]

100 项与 Brigimadlin 相关的临床结果

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100 项与 Brigimadlin 相关的转化医学

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100 项与 Brigimadlin 相关的专利（医药）

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项与 Brigimadlin 相关的文献（医药）

2025-12-01·MOLECULAR BIOLOGY REPORTS

Brigimadlin (BI-907828) and napabucasin (BBI608) cooperatively trigger apoptosis in chronic lymphocytic leukemia cells by simultaneous inhibition of MDM2 and STAT3

Article

作者: Aptullahoglu, Erhan

BACKGROUND:

Chronic lymphocytic leukemia (CLL) remains largely incurable, particularly in elderly or treatment-resistant patients. Although MDM2 inhibitors restore p53-mediated apoptosis in p53-functional CLL, single-agent activity is limited by resistance mechanisms. Signal transducer and activator of transcription 3 (STAT3) signaling also promotes CLL survival and immune evasion, suggesting that concurrent blockade of both pathways may enhance cell death.

METHODS AND RESULTS:

Here, the synergistic potential of the oral MDM2 antagonist BI-907828 (brigimadlin) and the STAT3 inhibitor BBI608 (napabucasin) was evaluated in two CLL cell lines with distinct TP53 (Tumor Protein p53, the gene encoding p53 protein) status: p53-wild-type EHEB and p53-mutant/17p-deleted MEC-1. Monotherapy with BI-907828 induced marked p53 stabilization, upregulation of p21^WAF1, PARP cleavage, and caspase-3/7 activation in EHEB cells, whereas MEC-1 cells remained unresponsive. BBI608 alone reduced cell viability in both lines in a dose-dependent manner, with its effect in MEC-1 cells suggesting a p53-independent mechanism. When combined, BI-907828 and BBI608 synergistically enhanced apoptotic markers in EHEB cells (δ synergy score > 17) but elicited no synergy in MEC-1, underlining the requirement for intact p53.

CONCLUSION:

These findings establish a mechanistic rationale for the concurrent targeting of the MDM2 and STAT3 axes and provide preclinical evidence for a promising, non-genotoxic therapeutic strategy in p53-functional CLL. A limitation of this study is the lack of in vivo validation and clinical data, which are necessary to further assess the safety, optimal dosing, and efficacy, particularly in elderly or unfit patients with limited treatment options.

2025-07-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Exposure‐tumour growth inhibition modelling of brigimadlin using phase I solid tumour data to support phase II dose selection

Article

作者: Jayadeva, Girish ; Pérez‐Pitarch, Alejandro ; Busse, David ; Friberg, Lena E. ; Lahmar, Mehdi ; Gausi, Kamunkhwala ; Sarr, Céline ; Neldemo, Ida ; Schmid, Ulrike ; Sailer, Reinhard

Abstract:

Aims:

Brigimadlin (BI 907828) is a potent, oral MDM2‐p53 antagonist under clinical investigation for the treatment of advanced solid tumours. A brigimadlin exposure–tumour growth inhibition (E‐TGI) model was developed to support the recommended phase II dose (RP2D) selection of brigimadlin in future clinical trials.

Methods:

Population modelling was applied to analyse longitudinal tumour size (sum of longest diameters, SLD) data of 151 patients from a phase I trial treated with 5–80 mg brigimadlin every third or fourth week (q3w/q4w). The impact of brigimadlin exposure on tumour shrinkage was assessed and the effects of patient‐ and tumour‐related covariates on model parameters were explored. The final E‐TGI model was used to simulate the effect of brigimadlin treatment on longitudinal SLD. The probability of dropout from tumour assessments were characterized via logistic regression and included in simulations to allow for realistic predictions of tumour shrinkage over time.

Results:

The E‐TGI model adequately characterized the observed SLD data over time. Simulations demonstrated a substantially stronger tumour shrinkage with higher dose, based on the identified exposure–response relationship. For patients with the most common tumour (dedifferentiated liposarcoma) and standard body weight (70 kg) and remaining in the study for 1 year, the median relative change from baseline in tumour size was 0.141%, −4.48%, −10.8% and −17.4%, for treatment with 20, 30, 45 and 60 mg brigimadlin q3w doses, respectively.

Conclusions:

The developed E‐TGI model predicted that higher doses of brigimadlin resulted in a substantially stronger tumour shrinkage. These results contributed to selecting 45 mg brigimadlin q3w dose as RP2D in subsequent clinical trials.

2024-06-23·Future Oncology

Treatment options for biliary tract cancer: unmet needs, new targets and opportunities from both physicians' and patients' perspectives

Review

作者: Shroff, Rachna T ; Bachini, Melinda

Biliary tract cancer (BTC) is a rare cancer with poor prognosis, characterized by considerable pathophysiological and molecular heterogeneity. While this makes it difficult to treat, it also provides targeted therapy opportunities. Current standard-of-care is chemotherapy ± immunotherapy, but several targeted agents have recently been approved. The current investigational landscape in BTC emphasizes the importance of biomarker testing at diagnosis. MDM2/MDMX are important negative regulators of the tumor suppressor p53 and provide an additional target in BTC (∼5-8% of tumors are MDM2-amplified). Brigimadlin (BI 907828) is a highly potent MDM2-p53 antagonist that has shown antitumor activity in preclinical studies and promising results in early clinical trials; enrollment is ongoing in a potential registrational trial for patients with BTC.

项与 Brigimadlin 相关的新闻（医药）

2025-06-25

·CPHI制药在线

六箭齐发！中国药企首占全球TOP50六席

关注并星标CPHI制药在线2025年美国《制药经理人》最新榜单揭晓，云南白药、中国生物制药、百济神州等六家中国企业首次集体跻身全球TOP50，创下中国药企入围数量之最。这一突破远非规模扩张的简单注脚——从GLP-1赛道黑马到ADC技术破局，从百亿级海外授权到AI研发革命，中国药企正以“创新质变”重塑全球竞争版图。 01创新药“破壁”三大路径在全球医药创新的浪潮中，中国药企正凭借独特的战略与创新实践，逐步打破传统格局，开辟出属于自己的发展路径。从前沿靶点的突破，到国际化步伐的加速，再到技术融合的创新驱动，中国药企正全方位展示着在创新药领域的崛起之势。靶点突围：聚焦前沿，剑指高端在创新药研发的征程中，靶点选择至关重要，它犹如开启成功之门的钥匙。中国生物制药在这一领域积极布局，展现出强大的研发实力与前瞻性眼光。其押注的HER2双抗ADC（TQB2102）备受瞩目，在多个瘤种的临床试验中表现出色。如在HER2低表达晚期乳腺癌患者中，TQB2102展现出与DS-8201相当甚至更优的疗效，客观缓解率（ORR）达到53.4%，疾病控制率（DCR）为86.3%，特别是在HR+亚组中ORR更是高达66.7%；在HER2阳性乳腺癌新辅助治疗中，TQB2102单药治疗（8周期组）的病理完全缓解率（tpCR）高达76.9%，显著超过传统化疗联合双靶向治疗的60%-65%。同时，中国生物制药还布局了PROTAC降解剂（TQB3019）等前沿管线，PROTAC技术作为一种新兴的药物研发手段，能够通过诱导靶蛋白降解来实现疾病治疗，为解决传统药物难以攻克的靶点提供了新的思路。中国生物制药通过这些前沿管线的布局，计划在2027年实现创新药收入占比60%，这一目标的设定彰显了其向创新药转型的坚定决心与信心。华东医药同样在靶点突破上取得了重要进展。其自主研发的口服GLP-1小分子HDM1002已杀入III期临床，这一成果意义非凡。GLP-1受体激动剂类产品在糖尿病和肥胖治疗领域具有重要地位，兼具减肥、降糖和心血管获益的功效，是相对成熟稳定和安全的靶点。然而，此前全球尚无口服小分子GLP-1受体激动剂药物上市，HDM1002的研发成功有望打破这一局面，为患者提供更加便捷的治疗选择，同时也将打破国际巨头在该领域的垄断，提升华东医药在全球GLP-1市场的竞争力。围绕GLP-1受体靶点，华东医药已构筑了包括口服、注射剂在内的长效及多靶点全球创新药和生物类似药相结合的全方位和差异化的产品管线，进一步巩固了其在该领域的研发优势。出海加速度：国际合作，全球拓展国际化是创新药发展的重要方向，中国药企在这一道路上不断探索前行，百济神州和中国生物制药成为了出海的先锋企业。百济神州的泽布替尼在海外市场取得了显著成绩，成为其增长的强劲引擎。泽布替尼2024年全球销售额突破14.3亿美元，同比增长136%，其中美国市场贡献9.6亿美元，成为首个在美年销售额超5亿美元的中国抗癌药。泽布替尼在美国获批多个适应症，如慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）成人患者等，在更新版的美国国家癌症综合网络（NCCN）B细胞淋巴瘤指南中，已被列为治疗CLL/SLL最高级别的推荐方案。这些成绩的取得，不仅证明了泽布替尼的药物疗效和安全性，也展示了百济神州在国际市场的商业化能力和全球化布局的成功。中国生物制药则通过与勃林格殷格翰联手开发肿瘤药，积极推进对外授权（out-licensing）模式，加速国际化进程。其中Brigimadlin是一种鼠双微体同源基因2（MDM2）-p53拮抗剂，可抑制TP53与其负调控物MDM2之间的相互作用，从而导致具有TP53野生型状态的肿瘤细胞发生细胞周期停滞或凋亡。通过与国际药企的合作，中国生物制药能够充分利用双方的优势资源，加速创新药物的研发和商业化进程，提升其在国际市场的知名度和影响力。技术超车：跨界融合，创新驱动在科技飞速发展的时代，技术融合成为创新药研发的新趋势。中国生物制药与华为、阿里合作探索AI辅助药物研发，开启了数字化创新的新篇章。华为的盘古药物分子大模型由华为云联合中国科学院上海药物研究所共同训练而成，可以实现针对小分子药物全流程的人工智能辅助药物设计，将药物设计的效率提升33%，优化后的分子结合能提升40%以上，实现早研阶段的全流程加速。通过与华为的合作，中国生物制药有望借助盘古大模型的强大算力和算法，加速药物研发进程，提高研发效率，降低研发成本。同时，中国生物制药与阿里的合作也在基因测序、甲状腺结节识别、肺结节识别、数字化模拟临床实验等领域展开，进一步拓展了AI在医药研发中的应用场景。华东医药则通过入股德国HeidelbergPharma强化ADC技术生态。HeidelbergPharma在ADC技术领域拥有独特的技术优势和研发经验，华东医药的入股将有助于其获取先进的ADC技术，加强自身在ADC药物研发方面的能力。ADC药物是近年来肿瘤治疗领域的热点，通过将细胞毒性药物与单克隆抗体连接，能够实现对肿瘤细胞的精准杀伤，具有高效、低毒的特点。华东医药在ADC技术上的布局，将进一步丰富其肿瘤药物研发管线，提升其在肿瘤治疗领域的竞争力。 02TOP10榜单背后的中国信号随着中国药企在创新药领域的不断突破和国际化进程的加速，其在全球医药市场中的地位日益凸显。在全球市值竞争、处方药销售结构以及研发费率策略等方面，中国药企都展现出了独特的发展态势和积极的变化信号，这些信号不仅反映了中国药企当前的发展水平，也预示着其未来在全球医药格局中的重要角色。全球市值暗战：潜力凸显，价值攀升在全球医药市场的市值竞争中，中国药企虽然在整体排名上与国际巨头仍存在一定差距，但部分企业已展现出强劲的增长势头和巨大的发展潜力。截至6月24日美股盘前，全球市值TOP10药企中，礼来以7303.63亿美元的市值位居榜首，诺和诺德以3094.91亿美元紧随其后。相比之下，中国药企的市值虽未进入前十，但云南白药和百济神州等企业的估值却在持续攀升。云南白药作为中国传统中药企业的代表，凭借其在中药全产业链的深厚布局和品牌影响力，在全球医药市场中占据了一席之地。其业务覆盖了40个品类、416个品种，产品涵盖了云南白药系列、三七系列等多个知名品牌，不仅在国内市场拥有广泛的用户基础，还逐渐拓展至日本、欧美等发达国家市场。2023年，云南白药交出了靓丽的成绩单，总营收、归母净利润分别实现391.11亿元、40.94亿元，同比增长7.19%、36.41%；扣非归母净利润为37.64亿元，同比增长16.45%，创同期历史新高。2024年，公司继续保持良好的发展态势，全年实现营业收入400.33亿元，同比增长2.36%；归属净利润47.49亿元，同比增长16.02%；扣非净利润45.23亿元，同比增长20.18%。这些优异的业绩表现使得云南白药的市值稳步提升，成为中国药企在全球市值竞争中的重要力量。百济神州则以其国际化的研发和重磅肿瘤药物布局，在全球医药市场中迅速崛起。作为国内“创新药一哥”，百济神州2024年前三季度实现营业总收入191.36亿元，同比增长48.6%，超过2023年全年营收，第三季度营收首次突破十亿美元大关。其核心产品泽布替尼在全球市场表现出色，2024年上半年贡献的营业收入为80.18亿元，占比约为66.84%，第三季度全球销售额达49.14亿元，同比增长91.1%。泽布替尼已在包括美国、中国、欧盟、英国、加拿大、澳大利亚、韩国和瑞士在内的超过70个市场获批多项适应证，其海外收入远超中国，全球商业化版图已拓展至超过65个市场。此外，百济神州的研发管线不断丰富，从单一肿瘤免疫产品拓展至肺癌、消化道肿瘤、乳腺癌及自免领域，有多款产品有望达到销售峰值超20亿美元。处方药销售质变：创新驱动，结构优化 2024年处方药收入榜单中，中国入榜企业呈现出从“仿制输血”转向“创新造血”的显著变化，这一转变在肿瘤与代谢疾病领域尤为突出。肿瘤和代谢疾病已成为全球医药市场的重要治疗领域，市场需求巨大，同时也是创新药研发的热点方向。中国药企在这两个领域积极布局创新药研发，取得了一系列重要成果，推动了处方药销售结构的优化和升级。中国生物制药在肿瘤领域的创新成果显著，其核心产品安罗替尼在非小细胞肺癌、软组织肉瘤等多个瘤种的治疗中发挥了重要作用。2024年，安罗替尼有9项研究入选ASCO2025口头报告，进一步证明了其在肿瘤治疗领域的有效性和创新性。此外，中国生物制药还积极布局HER2双抗ADC（TQB2102）、PROTAC降解剂（TQB3019）等前沿管线，为肿瘤治疗提供了更多的创新选择。在代谢疾病领域，华东医药凭借其在GLP-1领域的差异化布局，取得了重要进展。华东医药糖尿病药物HDM1002（口服GLP-1）进入III期临床，其减肥适应症由HDM1005承担，目前已完成II期入组。这些创新产品的研发和上市，不仅丰富了中国药企在代谢疾病领域的产品线，也提升了其在全球GLP-1市场的竞争力。这种从仿制到创新的转型，对于中国药企具有重要意义。一方面，创新药具有更高的技术壁垒和附加值，能够为企业带来更高的利润和市场份额；另一方面，创新药的研发和上市能够提升企业的品牌形象和核心竞争力，增强企业在全球医药市场中的话语权。随着中国药企在创新药领域的不断突破，其在处方药销售榜单中的排名有望进一步提升，对全球医药市场的影响力也将不断扩大。研发费率博弈：战略聚焦，效率提升在研发费率方面，中国药企与国际药企在战略聚焦和效率提升上已逐渐同频。以默沙东和辉瑞为例，默沙东将31%的研发费用聚焦于K药的拓展，通过不断开展临床试验，探索K药在更多瘤种和治疗阶段的应用，使得K药在2024年的销售额持续增长，为默沙东的营收做出了重要贡献。辉瑞则通过砍掉B7-H4ADC非核心管线，优化研发资源配置，提高研发效率。中国药企在研发投入和战略聚焦上也做出了积极调整。恒瑞医药在2024年累计研发投入82.28亿元，创历史新高，研发投入占销售收入比重达到29.40%。在研发战略上，恒瑞医药聚焦于肿瘤、自身免疫等重大疾病领域，加大创新药研发力度，取得了一系列重要成果。其自主研发的PD-1抑制剂卡瑞利珠单抗在多个瘤种的治疗中展现出良好的疗效，已获批多项适应症。中国生物制药同样注重研发投入和战略聚焦，2023年研发投入达44亿元，占比达到16.8%，其中创新药投入占总研发费用的77%。通过聚焦肿瘤、肝病、呼吸、免疫等治疗领域，中国生物制药不断推进创新药研发，多个创新产品获批上市，进入创新产品的密集收获期。这种在研发费率上的战略聚焦和效率提升，有助于中国药企提高研发成功率，降低研发成本，加快创新药的研发和上市进程。随着中国药企在研发能力和创新水平上的不断提升，其在全球医药市场中的竞争力将进一步增强，有望在未来的全球医药格局中占据更加重要的地位。 03最后六家中国企业登榜全球制药50强，恰似中国医药产业“成人礼”的宣言——量变积累终迎质变喷发。当华东医药的GLP-1药物撼动诺和诺德霸主地位，当百济神州的海外授权协议覆盖130国，中国药企已从技术追随者蜕变为规则参与者。未来十年，随着肿瘤靶向疗法、代谢疾病突破性技术持续输出，叠加AI研发降本增效，中国药企必将以更凌厉的姿态，在全球医药版图刻下“中国坐标”。这场始于2025年的历史性跨越，仅仅是个开始。END来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

临床3期抗体药物偶联物蛋白降解靶向嵌合体生物类似药临床1期

2025-05-14

·Firstwordpharma

Boehringer Ingelheim expands oncology pipeline with real-world data from Tempus AI

Boehringer Ingelheim has entered a multi-year partnership with Tempus AI to leverage its real-world data and AI platform in support of Boehringer's expanding oncology pipeline. Through the partnership, Boehringer will gain access to Tempus' de-identified data and its advanced data analytics platform, Lens."Leveraging real-world patient data is crucial for strengthening our data foundation and harnessing advanced AI methodologies, ultimately accelerating drug development," said Jan Nygaard Jensen, head of computational innovation at Boehringer Ingelheim. "Integrating these comprehensive datasets with our internal data and techniques not only drives innovation but also enhances the precision and efficiency of pharmaceutical research, paving the way for groundbreaking medical advancements."Tempus' database comprises over eight million research records. Its AI-enabled Lens platform allows researchers to define patient cohorts using molecular and clinical filters, or to automatically build cohorts using Tempus One, an AI-enabled assistant that applies inclusion and exclusion criteria. Researchers can visualise or download datasets for in-depth analysis. These insights can support biomarker discovery, patient stratification, novel target identification, hypotheses for combination therapies and patient education. Boehringer currently markets three oncology drugs — Gilotrif (afatinib) and Ofev (nintedanib) for non-small-cell-lung cancer (NSCLC) and Tevimbra (tislelizumab) for oesophageal and gastric cancers. Its oncology pipeline includes a broad portfolio of investigational agents, such as anti-DLL3 T-cell engager BI 764532 in phase II trials for small cell lung cancer and neuroendocrine cancers; HER2 exon 20 inhibitor zongertinib in phase III trials for NSCLC and MDM2-p53 antagonist brigimadlin in phase III trials for de-differentiated liposarcoma and soft tissue sarcoma, and phase II trials for NSCLC and bile duct cancer. Additional early-stage assets target a variety of solid tumours."By combining internal, pre-clinical experimental data, with real-world data from Tempus on its AI-powered platform, we can profoundly deepen our understanding of cancer biology and accelerate our drug discovery and development efforts," said Mark Paul Petronczki, head of oncology research at Boehringer Ingelheim.

临床2期临床3期ASCO会议

2025-04-23

·Pharmaceutical Technology

Boehringer to expand oncology presence with $572m Tessellate Bio deal

Boehringer expands oncology pipeline with Tessellate deal. Credit: Sundry Photography via Getty Images. Boehringer Ingelheim has signed a €500m ($572m) agreement with UK-based biotech Tessellate Bio to co-develop targeted cancer therapies for tumours that rely on the alternative lengthening of telomeres (ALT) mechanism – a lesser-known telomere maintenance process that supports the survival of certain hard to treat cancers. Under the terms of the deal, Tessellate Bio will receive an upfront licensing fee, research funding, and technical milestone payments, along with additional success-based development and commercial milestones. The total potential value of the agreement is more than $572m. Tessellate has developed small molecule inhibitors against an undisclosed target that plays a central role in enabling the replication and survival of ALT-positive cancer cells. According to the company, preclinical data shows that blocking this target leads to DNA damage and replication stress, selectively killing tumour cells dependent on the ALT mechanism while sparing healthy cells that do not use this pathway. The collaboration builds on Tessellate’s ongoing work to characterise ALT activity across tumour types, following a research initiative launched in September 2024 with Australian research institutes CMRI and Omico. Tessellate secured €8m in seed funding from BioGeneration Ventures and Forbion when it launched publicly in October 2023. This deal with Boehringer marks Tessellate’s first partnership with a biopharma company. For Boehringer, this deal aligns with its strategic expansion in oncology. Over the last few years, the German pharma company has pursued a series of R&D and licensing agreements to strengthen its cancer portfolio. In October 2024, it partnered with Circle Pharma to co-develop a first-in-class cyclin inhibitor, in a deal worth up to $607m in upfront and milestone payments. That same month, it opened a €60m ($66.8m) research building in Vienna, Austria , focused on advancing novel cancer therapies. Boehringer’s marketed oncology products include Giotrif (afatinib) for EGFR-mutated non-small cell lung cancer (NSCLC) and Vargatef (nintedanib) for specific types of lung cancer. The company is also advancing late-stage assets such as brigimadlin, an MDM2-p53 antagonist in a pivotal clinical trial for rare cancer dedifferentiated liposarcoma (DDLPS). Boehringer is also advancing zongertinib , a tyrosine kinase inhibitor being evaluated as a potential treatment for HER2-mutated NSCLC. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence In January 2025, Boehringer signed two further licensing agreements to deepen its pipeline. The first, with Synaffix, grants access to the company’s antibody-drug conjugate (ADC) platform in a deal worth up to $1.3bn , covering multiple undisclosed targets. The second was an extension of a long-standing partnership with Oxford BioTherapeutics, under which Boehringer exercised an option for a fourth novel target. Oxford BioTherapeutics will receive development milestones and royalties, while Boehringer takes over full development and commercial responsibilities.

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100 项与 Brigimadlin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期软组织肉瘤	临床3期	-	Boehringer Ingelheim GmbH	2024-06-27
粘液样MFH	临床3期	-	Boehringer Ingelheim GmbH	2024-06-27
去分化脂肪肉瘤	临床3期	中国	Boehringer Ingelheim GmbH	2022-03-31
去分化脂肪肉瘤	临床3期	丹麦	Boehringer Ingelheim GmbH	2022-03-31
去分化脂肪肉瘤	临床3期	法国	Boehringer Ingelheim GmbH	2022-03-31
去分化脂肪肉瘤	临床3期	德国	Boehringer Ingelheim GmbH	2022-03-31
去分化脂肪肉瘤	临床3期	意大利	Boehringer Ingelheim GmbH	2022-03-31
去分化脂肪肉瘤	临床3期	荷兰	Boehringer Ingelheim GmbH	2022-03-31
去分化脂肪肉瘤	临床3期	西班牙	Boehringer Ingelheim GmbH	2022-03-31
去分化脂肪肉瘤	临床3期	瑞典	Boehringer Ingelheim GmbH	2022-03-31

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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


NCT05218499 (CTgov)	临床2/3期	去分化脂肪肉瘤	400	Brigimadlin (Brigimadlin 30 mg q3w)	鏇鬱獵廠積襯網醖淵範(範醖鑰顧鏇鏇構齋繭積) = 糧選選構遞鹽糧膚夢壓壓餘壓艱構夢遞窪壓積 (淵鏇繭製觸鹹鏇淵願構, 構鏇醖糧餘獵膚壓簾鏇 ~ 鹽顧蓋餘餘遞淵夢遞廠) 更多	-	2025-07-04
				Brigimadlin (Brigimadlin 45 mg q3w)	鏇鬱獵廠積襯網醖淵範(範醖鑰顧鏇鏇構齋繭積) = 窪構願鹹窪鏇艱鑰壓鹽壓餘壓艱構夢遞窪壓積 (淵鏇繭製觸鹹鏇淵願構, 餘構糧糧膚顧遞積繭簾 ~ 蓋壓鬱廠鑰齋壓襯網鹹) 更多
NCT03449381 \| NCT05512377 \| NCT03964233 (WCLC2024) 人工标引	临床1/2期	晚期肺腺癌 MDM2 Amplification	16	Brigimadlin 45 mg q3w	淵製醖鹽鑰簾繭餘窪顧(鬱壓獵範製網衊糧衊製) = In patients who received brigimadlin 45 mg q3w in the Phase Ia/Ib monotherapy (n=140)/combination trials (n=74), the most common any-grade treatment-related adverse events (TRAEs) were nausea (67.9%/70.3%) and fatigue (53.6%/39.2%), respectively. 夢遞糧鏇窪網網築餘蓋 (衊艱網襯鏇廠顧範製鹹 ) 更多	积极	2024-09-09
				brigimadlin + ezabenlimab (Phase Ia/Ib)
NCT03449381 (ESMO_SRC2024) 人工标引	临床1期	脂肪肉瘤 MDM2 Amplification	190	Brigimadlin (BI 907828) 45 mg q3w	選衊夢醖顧願衊積淵廠(簾鏇鹽顧顧鬱糧齋顧網) = 構鏇選顧顧餘醖網襯憲觸簾夢積遞壓簾觸衊觸 (範廠壓鏇夢鹹蓋襯齋繭 ) 更多	积极	2024-03-15
NCT03449381 (ESMO_SRC2024) 人工标引	临床1期	去分化脂肪肉瘤	90	Brigimadlin	襯窪願醖鬱鹹鬱衊鏇膚(積獵網齋餘襯繭積糧醖) = 廠築壓觸築選顧鑰築淵廠繭餘構鹹遞憲製觸觸 (餘範蓋憲壓廠製顧廠網 ) 更多	积极	2024-03-14
NCT05512377 (ESMO2023)	临床1期	肺癌 \| 实体瘤 \| 胰腺导管腺癌 ... 更多	-	BI 907828	膚齋鑰築鏇鏇蓋選獵構(窪積醖願遞襯鹽窪遞繭) = 淵廠範遞餘膚觸獵艱範遞製積鬱觸膚壓鏇壓廠 (窪醖觸簾夢艱壓鏇醖淵 ) 更多	-	2023-10-23
NCT03449381 (ASCO2023) 人工标引	临床1期	去分化脂肪肉瘤	73	BI 907828 45 mg	願範淵簾糧鏇醖齋壓顧(積鏇選網範蓋廠範窪餘) = 鏇壓鹽襯選齋夢製遞築觸壓獵淵鹽鑰製繭衊壓 (鏇鬱簾艱艱醖淵鹽糧鹹 ) 更多	积极	2023-05-31
NCT03449381 \| NCT03964233 (ASCO_GI2023) 人工标引	临床1期	晚期胆管癌 MDM2 Expression	8	BI 907828	夢鹽願顧觸窪窪範觸艱(淵鏇鏇遞製廠獵淵鏇壓) = 網構鏇顧襯艱淵製範窪鏇醖憲窪餘簾艱鏇醖艱 (餘淵衊願壓選觸築壓艱 ) 更多	积极	2023-01-24
				BI 907828+Ezabenlimab 240 mg±BI 754111	獵蓋蓋鏇糧製糧網觸網(壓齋鹽淵鹽窪簾廠願蓋) = 衊製糧遞壓鑰鬱觸網壓顧鑰鹹鑰淵窪醖遞鬱顧 (繭鏇窪淵餘鏇願網鑰構 ) 更多
NCT03449381 (ESMO2022) 人工标引	临床1期	肿瘤 MDM2 Amplification \| TP53 Wild-type	94	BI 907828 45 mg	顧製網選壓範蓋構衊觸(廠鬱網餘願製遞鑰壓範) = 築窪壓願顧製夢範鹹齋範醖鹽觸衊網糧範鹹醖 (膚鹹製製夢築簾積簾鬱 ) 更多	积极	2022-09-10
				BI 907828 45 mg (DDLPS)	鹽願築廠網範網遞蓋醖(鑰艱鏇夢廠繭鏇膚願觸) = 淵積網範壓窪艱製觸醖襯衊顧衊艱網遞齋壓膚 (繭選願齋顧糧簾廠鹽選 ) 更多
NCT03964233 (ASCO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	26	BI 907828+ezabenlimab+BI 754111	壓憲夢顧鑰繭積廠廠構(醖觸鑰選齋衊簾廠餘觸) = 膚蓋窪鏇顧構齋選壓鏇觸廠獵觸蓋艱壓憲製淵 (築夢齋淵艱顧齋獵遞膚 ) 更多	积极	2022-06-02
				BI 907828+ezabenlimab	壓憲夢顧鑰繭積廠廠構(醖觸鑰選齋衊簾廠餘觸) = 繭壓醖鏇鬱餘廠範構網觸廠獵觸蓋艱壓憲製淵 (築夢齋淵艱顧齋獵遞膚 ) 更多
NCT03449381 (ASCO2022) 人工标引	临床1期	实体瘤 \| 晚期脂肪肉瘤	90	BI 907828	願艱顧願築網廠觸鹹構(鬱鬱繭窪膚構積築餘簾) = 網簾鹽網築鹽餘積齋鏇鏇構網衊鏇憲獵鏇夢繭 (顧膚選鏇繭築窪襯窪構 ) 更多	积极	2022-06-02
				BI 907828 (DDLPS)	簾網網壓醖糧選獵遞獵(遞構蓋壓鏇衊獵鏇壓範) = 廠鑰選醖鹹鑰衊鹽糧衊顧餘夢積鬱鬱鏇築鏇構 (網鹽顧獵網築齋襯築膚 ) 更多