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, sevabertinib, 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 sevabertinib 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:
* Sevabertinib twice every day as a tablet by mouth, or
* Standard treatment in cycles of 21 days via infusion ("drip") into the vein.
* Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant receiving the standard treatment has their disease get worse (this is called "disease progression"), they may have the opportunity to switch ("cross over") to receive sevabertinib.
* Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop 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

100 项与赛伐替尼相关的临床结果

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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）

2026-04-01·Journal of Thoracic Oncology

ERBB2 activating mutations and co-occurring genomic alterations contribute to disease heterogeneity in patients with ERBB2-mutant lung cancer

Article

作者: Stockhammer, Paul ; Li, Fangyong ; Politi, Katerina ; Schillo, Jacob L ; Goldberg, Sarah B ; El Zarif, Talal ; Grant, Michael J

BACKGROUND:

ERBB2 mutations occur in 1-4% of all non-small cell lung cancers (NSCLCs). Trastuzumab-deruxtecan and the novel ERBB2 tyrosine kinase inhibitors zongertinib and sevabertinib are FDA-approved for the treatment of metastatic ERBB2-mutant NSCLC based on data from tumors harboring tyrosine kinase domain (TKD) mutations. The clinico-genomic characteristics of NSCLC tumors with ERBB2 mutations beyond the TKD remain largely unexplored.

METHODS:

Patients with NSCLC with oncogenic ERBB2 mutations included in two independent cohorts [AACR Project GENIE database and the US-based deidentified Flatiron Health-Foundation Medicine advanced NSCLC Clinico-Genomic Database (FH)] were studied. The clinico-genomic characteristics of patients with tumors harboring TKD, extracellular (ECD), or transmembrane (TMD)/juxtamembrane domain (JMD) ERBB2 mutations were compared and clinical outcomes with chemoimmunotherapy were evaluated.

RESULTS:

483 patients (GENIE cohort) and 286 patients (FH cohort) with ERBB2-mutant NSCLC were included. In both cohorts, most patients had tumors harboring TKD (75 and 71%), followed by ECD (18 and 24%) and TMD/JMD mutations (7 and 5%). In both cohorts, male patients (p<0.05), patients with squamous NSCLC tumors (p=0.0001 and p=0.0002), and patients with a smoking history (p=0.01 and p<0.0001) were more likely to have ECD-mutant tumors. In the GENIE cohort with detailed genomic information available, ECD- vs. TKD-mutant tumors had a higher median TMB (p<0.0001) and higher rates of co-mutations in EGFR (p<0.0001), KRAS (p<0.0001), STK11 (p<0.0001), KEAP1 (p<0.0001), and SMARCA4 (p<0.0001). TMD/JMD-mutant tumors had high rates of PIK3CA (24%) and RBM10 (18%) co-mutations. In the FH cohort with detailed outcome data available, among patients with advanced ERBB2-mutant NSCLC treated with first-line chemoimmunotherapy, those with ECD-mutant tumors had longer 12-month PFS compared to those with TKD mutations (35 vs. 18%, HR 0.72, CI: 0.54-0.94, p=0.026). This difference persisted in a multivariate Cox regression model accounting for other variables.

CONCLUSION:

NSCLCs harboring ECD-ERBB2 mutations are associated with a unique clinico-genomic phenotype and improved outcomes with first-line chemoimmunotherapy. These findings have implications for optimizing treatment strategies in this disease.

2026-03-01·JTO clinical and research reports

Acquired ERBB2 Amplification and Overexpression as On-Target Resistance Mechanisms to Zongertinib With Subsequent Response to Trastuzumab-Deruxtecan: A Case Report

Article

作者: Yousaf, Nadia ; John, Alexius ; Popat, Sanjay ; Robertus, JanLukas ; MacMahon, Suzanne ; Vick, Joanna ; Amin, Nawa ; Sarker, Sarah ; Tokaca, Nadza ; Kalofonou, Foteini ; McMahon, David John

A number of drugs are in development for the treatment of ERBB2(HER2)-mutated NSCLC, including antibody-drug conjugates such as trastuzumab-deruxtecan and tyrosine kinase inhibitors such as zongertinib and sevabertinib. Herein, we report a case of relapsed advanced ERBB2-mutant NSCLC with acquired resistance to zongertinib potentially mediated through ERBB2 amplification and HER2 3+ immunohistochemistry overexpression with subsequent durable response to fifth-line trastuzumab-deruxtecan. We propose this as a mechanism for zongertinib resistance, one that may underpin a biological rationale for future ERBB2 tyrosine kinase inhibitor-antibody-drug conjugate combination therapy.

2026-03-01·CANCER

Oral TKI sevabertinib approved for advanced HER2 ‐mutant NSCLC

作者: Lawrence, Leah

332

项与赛伐替尼相关的新闻（医药）

22 小时之前

·药博士说健康

这款肺癌口服新药正式获批上市，誓要打破HER2突变的“僵局”！

点击蓝字关注我们温馨提示：点上方“蓝字”订阅我们，以免走失在浩浩荡荡的肺癌靶向治疗大军中，有这样一群人，他们曾觉得自己像是被遗忘在荒岛上的弃儿。当EGFR、ALK基因突变的病友们有着琳琅满目的靶向药可以挑选时，他们手里却空空如也。这群人，就是携带HER2突变的非小细胞肺癌患者。长期以来，HER2突变犹如一道难以逾越的壁垒。它不仅驱动肿瘤细胞疯狂生长，还天然具备着一种“狡黠”的耐药性，使得传统的化疗或免疫治疗效果大打折扣。很多患者在经历了数次化疗的身心俱疲后，依然面临着疾病进展的绝望。他们渴求一粒能精准制导的靶向药，哪怕只是能让肿瘤稍微停滞一下，也好过在无休止的输液椅上消耗生命。但今天，这道坚冰终于被砸碎了。2026年4月15日，一则重磅喜讯在肺癌圈刷屏：由拜耳研发的1类创新药——塞伐艾替尼片（商品名：赫新诺），正式获得中国国家药品监督管理局（NMPA）的优先审评批准上市！它的使命极其明确：单药治疗存在HER2激活突变且既往接受过至少一种系统治疗的不可切除局部晚期或转移性非小细胞肺癌成人患者。这不仅是全球首个基于随机对照数据、在中国率先获批的口服HER2小分子TKI，更是千万HER2突变患者苦苦等待的“破局者”。 01 斩断癌变信号的“智能剪刀” 要理解塞伐艾替尼为何能在这场抗癌战役中脱颖而出，我们需要潜入微观的细胞世界，看看它究竟是如何施展魔法的。在携带HER2突变的肺癌细胞中，HER2基因就像是一个被破坏了的“开关”，它持续不断地向细胞发出疯狂分裂和增殖的指令。传统的化疗药物像是大面积喷洒的农药，在杀伤癌细胞的同时，也误伤了大量正常的组织细胞。而塞伐艾替尼则完全不同，它属于一种可逆性的小分子酪氨酸激酶抑制剂（TKI），具备极其精准的“狙击”能力。我们可以把它想象成一把量身定制的“智能剪刀”。它能够高效地识别出癌细胞表面的HER2受体（无论是外显子20插入突变还是点突变），并与之紧密结合，从而物理性地阻断了下游致癌信号的传导。更有意思的是，它对野生型的一种在正常组织中广泛存在的蛋白具有高度选择性。这意味着，它在剪断癌细胞信号的同时，并不会去干扰正常细胞的运转。这种巧妙的“区分敌我”的能力，从根本上避免了传统靶向药常常带来的严重皮疹或腹泻等“脱靶”毒性，实现了疗效与安全性的绝佳平衡。 02 从绝望到重生：惊艳临床数据背后的意义一款抗癌药好不好，终究要靠硬核的临床数据来背书。塞伐艾替尼的获批，依托于一项在医学界引起轰动的开放标签、多中心I/II期SOHO-01试验，其结果甚至登上了权威医学期刊《新英格兰医学杂志》。这项研究专门招募了那些既往接受过至少一次系统治疗、且未用过HER2靶向TKI的晚期患者。最终的结果，可以用“震撼”二字来形容。我们先来看看那些已经历过至少一种系统治疗、正陷入无药可用困境的患者队列。在接受塞伐艾替尼治疗后，他们的客观缓解率（ORR）竟然高达64%。这是一个什么概念？意味着超过六成的患者在接受治疗后，肿瘤体积实现了显著萎缩（部分甚至完全消失）。不仅如此，他们从中位缓解持续时间（DoR）中获得的收益长达9.2个月，中位无进展生存期（PFS）也达到了8.3个月。这彻底打破了以往经治患者“无药可救”的僵局，为他们强行按下了一条充满希望的“生命延长线”。而对于那些尚未接受过任何系统治疗的初治患者，塞伐艾替尼的表现则更加惊艳。其客观缓解率飙升至71%，疾病控制率（DCR）更是逼近90%。更让人鼓舞的是，这部分患者的中位缓解持续时间达到了11.0个月。这些数据强有力地证明了它作为一线疗法巨大的潜力，未来甚至可能直接改写HER2突变肺癌的初始化疗格局。 03 把尊严还给生活：口服便捷性与安全耐受性的双重护航对于晚期肺癌患者而言，治疗的终极目标不仅仅是“活下去”，更是要“有尊严、有质量地活下去”。塞伐艾替尼作为一款口服靶向药物，首先就把生活的自主权还给了患者。不再需要频繁地跑医院住院输液，只需要在家按时吞服药片，就能实现对肿瘤的持续压制。这种便捷的给药方式，极大地减轻了患者的心理负担，也让家属的照护压力骤减。当然，任何具有抗癌效力的药物都伴随着一定的副作用，这是无法完全避免的生理博弈。但塞伐艾替尼在安全性方面的表现同样可圈可点，其不良事件谱与同类药物高度一致，且临床管理路径十分成熟。研究显示，虽然腹泻的发生率较高（各队列在84%-91%之间），但这主要是药物作用于胃肠道黏膜的正常生理反应，绝大多数患者能够通过饮食调整或常规止泻药轻松应对。真正严重的3级以上腹泻占比仅为5%-23%，且仅有3%的患者会因为无法耐受副作用而被迫停药。至于3级及以上的药物相关不良事件，总体发生率被控制在约31%，这在肿瘤靶向治疗中属于完全可以接受且易于管控的范围。患者无需时刻提心吊胆，只需在医嘱下进行简单的对症处理，就能稳稳地推进治疗进程。 04 总结回望过去，HER2突变的肺癌患者确实走过了一段过于艰难的岁月。他们试错了太多的化疗方案，承受了太多的无效治疗。但医学的进步从来不是一蹴而就的奇迹，而是无数个日夜里科研人员对分子结构的反复推敲与临床试验的严苛验证。塞伐艾替尼的问世，不仅是肺癌精准治疗领域的一个重要里程碑，更是中国罕见靶点药物研发“加速度”的缩影。黑夜无论多么漫长，朝阳总会升起。这款凝聚着尖端科技与人性关怀的口服新药，正在向所有身处绝境的战士发出邀请：别放弃，属于你们的曙光，已经冲破云层。 END

22 小时之前

·生物经纬

药企药品周讯 | 特立妥单抗新适应症上市申请获受理，多发性骨髓瘤治疗再迎新希望

01 4月17日，CDE官网显示，强生的特立妥单抗在国内递交新适应症上市申请，并获得受理。根据该药的研究进展和国内注册进度推测，本次申报的适应症可能为用于复发或难治性多发性骨髓瘤成人患者二线治疗。 02 4月15日，拜耳（Bayer）宣布，中国国家药品监督管理局（NMPA）批准肺癌新型靶向治疗药物塞伐艾替尼片单药用于治疗存在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。塞伐艾替尼片是一种口服小分子酪氨酸激酶抑制剂（TKI），此前已获得NMPA药品审评中心（CDE）纳入突破性治疗品种，且其上市申请被纳入优先审评。 03 4月17日，NMPA官网公示，正大天晴的「贝莫苏拜单抗+安罗替尼」联合疗法一项新适应症获批上市，用于治疗晚期或不可切除腺泡状软组织肉瘤（ASPS）。该联合方案曾被CDE纳入突破性治疗、优先审评。 04 4月21日，CDE官网显示，艾伯维的乌帕替尼申报新适应症。根据注册进展，推测此次申报的适应症为非节段性白癜风。该适应症已在今年3月被CDE纳入优先审评。 05 4月21日，罗氏宣布美国FDA已受理该公司奥妥珠单抗（Gazyva®/Gazyvaro®）的补充生物制品许可申请 (sBLA)，用于治疗系统性红斑狼疮 (SLE)。FDA预计将于2026年12月前做出批准决定。 06 4月21日，CDE官网显示，翰森制药的注射用HS-20093又有一项申请被纳入突破性治疗公示名单，适应症为既往接受过新型内分泌治疗和紫杉类化疗的晚期去势抵抗性前列腺癌。HS-20093是进度最快的国产 B7-H3 ADC，已在Ⅲ期临床阶段。 01 4月21日，神基制药与梯瓦医药共同宣布，双方正式达成关于AJOVY(夫瑞奈珠单抗注射液)的战略合作及许可协议。神基制药将获得AJOVY在中国大陆商业化的独家权益及产品所涉专利与商标的独占许可，并根据协议约定，获得该产品中国大陆地区上市许可持有人(MAH)资格。双方将充分发挥各自在全球创新药物开发和本土市场深耕的优势，协同推进AJOVY在中国市场的广泛可及，为偏头痛患者提供更具可持续性的治疗选择，更好服务患者的长期管理需求。 02 4月20日，礼来宣布与Kelonia达成收购协议。Kelonia Therapeutics为一家体内CAR-T生物技术公司，核心管线靶向BCMA的体内CAR-T疗法KLN-1010目前处于一期临床阶段。2025年ASH会议上，Kelonia Therapeutics披露了KLN-101令人振奋的初步临床数据，飙戏拿出优异的疗效和安全性。此次收购对价为70亿美元，包括32.5亿美元现金以及后续里程碑金额。 03 4月20日，天境生物宣布与Biogen达成合作协议，将CD38抗体菲泽妥单抗的大中华区权益授权给Biogen，后者支付1亿美元预付款，7.5亿美元里程碑金额，以及中个位数至低两位数比例的销售分成。根据协议，Biogen将继续主导菲泽妥单抗免疫领域适应症的开发，并将在大中华区主导该产品的生产和商业化。天境生物已于2024年12月向NMPA成功递交菲泽妥单抗治疗多发性骨髓瘤的上市申请，目前正在审评中。该适应症获批后，Biogen将主导商业化工作，天境生物将作为生产方，依托其位于杭州的GMP生产基地，负责产品的商业化供药。2024年7月，Biogen以18亿美元的价格收购HI-Bio，获得菲泽妥单抗大中华区外全球权益，此次进一步与天境生物合作引进菲泽妥单抗的大中华区权益，完成菲泽妥单抗全球权益的布局。 04 4月17日，比利时生物制药龙头UCB官宣重磅并购交易：以6.5亿美元现金首付款及最高5亿美元里程碑付款，收购临床阶段细胞疗法公司Neurona Therapeutics，交易总金额最高达11.5亿美元，预计于2026年第二季度末完成交割。UCB在癫痫领域拥有数十年深耕积淀，本次收购的核心资产为Neurona的领先候选药物NRTX-1001——一款用于耐药性内侧颞叶癫痫（mTLE）的神经细胞疗法，目前正处于1/2期临床阶段。该药物为多能干细胞来源疗法，采用单次脑内局部给药，通过定向递送可分泌γ-氨基丁酸（GABA）的细胞，修复并平衡癫痫患者大脑中过度活跃的神经环路，从而实现减少癫痫发作的治疗目标。UCB方面表示，NRTX-1001具备单次给药、实现神经系统持久靶向修复的潜力，有望为耐药性内侧颞叶癫痫患者带来突破性治疗选择。 05 4月16日，迈威生物宣布，就两款地舒单抗注射液迈利舒®（Prolia®生物类似药）和迈卫健®（Xgeva®生物类似药）与马来西亚战略合作伙伴签署授权许可及商业化协议。根据协议，合作伙伴负责两款产品在马来西亚的注册和销售，迈威生物负责产品的开发、生产及商业化供货。往期回顾药企药品周讯 | 首款EGFR×HER3双抗ADC“iza-bren”在华申报上市药企药品周讯 | 1分钟完成注射！罗氏莫妥珠单抗皮下注射制剂获批上市药企药品周讯 | 重磅！血液新药卡拉西珠单抗国内获批药企药品周讯 | 重要突破！国产HIV1类新药首次获批临床药企药品周讯 | 疾病控制率达100%！康方生物双抗新药治疗三阴性乳腺癌拟纳入突破性治疗品种综合整理 | 王超，贺银慧（NO.812期）图文编辑 | 王小雨商务合作丨马经理 15850522742 新闻投稿/访谈邀约彭经理 18012921198

2026-04-22

·今日头条

国产创新药再传捷报！4月两款新药获批上市，从跟跑到领跑，

进入2026年二季度，国产创新药领域喜讯不断。就在刚刚过去的4月，国家药监局接连批准两款具有里程碑意义的国产1类新药上市，一款精准攻克肺癌罕见靶点难题，一款实现核医学诊断领域全球首创。从研发立项到获批上市，两款药物均耗时超十年，凝聚无数科研人员心血，也印证着中国医药创新正稳步迈入高质量发展新阶段，越来越多患者在家门口就能用上国际领先的国产好药。一、4月两款新药齐落地，覆盖诊断与治疗，填补临床空白此次获批的两款新药，均为我国企业自主研发、拥有完全自主知识产权的1类创新药，分别聚焦肿瘤精准诊断与肺癌靶向治疗两大关键领域，直接解决长期存在的临床痛点。首款新药为锝[99mTc]佩昔瑞特加肽注射液，于4月2日正式获批，是全球首个针对整合素αvβ3靶点的放射性诊断显像剂。这款创新核药主要用于可疑肺癌患者区域淋巴结转移的辅助检查，能在分子层面精准识别肿瘤细胞，比传统CT、核磁更早发现毫米级微小转移灶，假阳性率更低、诊断更精准。与传统诊断技术不同，该药可随血液循环精准聚集在肿瘤区域，通过特殊成像技术清晰显示病灶位置，不仅适用于肺癌，未来还将逐步拓展至胃癌、肝癌等多种实体瘤，为肿瘤早筛、术后复发监测提供全新工具。第二款新药为塞伐艾替尼片（商品名：赫新诺），4月15日通过优先审评程序获批，是国内针对HER2突变非小细胞肺癌的重要口服靶向药。在肺癌患者中，约4%-5%存在HER2基因突变，这类患者对传统化疗、免疫治疗效果不佳，长期缺乏专属有效药物。塞伐艾替尼能精准作用于HER2靶点，强效抑制肿瘤细胞增殖与转移，临床试验数据显示，未接受过相关治疗的患者客观缓解率达64%，中位缓解持续时间超9个月，即便接受过其他治疗的患者，缓解率仍可达38%，且口服给药、安全性可控，大幅提升患者治疗便利性与生活质量。两款新药均严格遵循国际临床试验标准，所有数据经国家药监局全面核查，疗效与安全性均达到国际先进水平，无任何夸大表述，完全基于真实临床数据获批上市。二、十年磨一剑：从实验室到患者，国产创新药的突围之路一款创新药从靶点发现到获批上市，平均需要10-15年、投入超10亿元资金，过程漫长且充满挑战。这两款新药的诞生，正是中国医药创新厚积薄发的真实缩影。锝[99mTc]佩昔瑞特加肽注射液的研发始于2012年，研发团队先后攻克靶点筛选、分子结构设计、放射性标记稳定性等多项技术难题。早期研发阶段，团队每天工作超12小时，筛选上百种分子结构，经历数百次失败才确定最优候选分子。进入临床试验后，联合全国20多家三甲医院，招募上千名肺癌患者，历经5年多临床试验，最终以优异数据通过审评。塞伐艾替尼的研发同样不易。针对HER2突变肺癌这一罕见靶点，国内此前无任何研发先例，团队从零搭建靶点验证、化合物筛选体系，克服靶点结合难、易耐药等技术瓶颈。临床试验期间，团队全程跟踪患者数据，不断优化给药方案，凭借显著疗效获得优先审评资格，从提交上市申请到获批仅用7个月，创下同类药物审批速度新纪录。过去十年，我国创新药研发环境发生翻天覆地变化。研发投入持续增长，2025年国内药企研发总投入超2000亿元，年均增速超20%；大批海外高端人才回国组建成熟研发团队，核心技术不断突破；优先审评、突破性治疗等制度落地，让临床急需新药加快上市。正是政策、人才、资本的三重合力，推动国产抗癌药实现从"仿制"到"原研"、从"跟随"到"首创"的质变。三、从量变到质变：中国创新药跻身全球第一梯队两款新药获批，只是2026年国产创新药爆发的一个缩影。最新数据显示，截至4月20日，2026年国内已批准14款创新药上市，其中7款为全球首创新药，数量创历史同期新高。在抗癌领域，今年已有8款国产新药获批，覆盖肺癌、胃癌、淋巴瘤等多个癌种，多款为全球或国内首创。从全球格局看，中国创新药已稳居世界第二。目前国内在研创新药管线达4751个，占全球33.7%；临床试验数量每年超3000项，位居全球前列。2025年，我国有73项抗癌新药研究入选全球顶级肿瘤学术会议ASCO，数量仅次于国际领先水平，多款药物研究结果改写国际治疗指南。更可喜的是，国产创新药正加速走向世界。2026年一季度，我国创新药对外授权交易总额突破600亿美元，接近2025年全年的一半，平均单笔交易额超11亿美元。此次获批的锝[99mTc]佩昔瑞特加肽注射液，已同步向欧美、日韩提交上市申请，有望成为中国首款全球同步上市的创新核药。越来越多国产抗癌药实现海外授权，国际认可度持续提升。四、好药用得上、用得起：医保加持，创新药可及性大幅提升创新药的最终价值，是让患者用得上、用得起。近年来，随着医保谈判、集中采购等政策推进，国产创新药可及性大幅提升。 2026年1月1日，新版国家医保药品目录正式实施，新增114种药品，其中50种为1类新药，肿瘤用药占比超三成。新增36种抗肿瘤靶向药、免疫治疗药，医保目录内抗癌药总数突破230种，覆盖肺癌、乳腺癌等20余种高发恶性肿瘤。经医保谈判，新增抗癌药平均降价超63%，部分药物降价超70%。以此前上市的国产抗癌药为例，医保报销后患者月自付费用从数万元降至数千元，有效减轻家庭负担。此次获批的两款新药，企业均表示将积极参与后续医保谈判，争取尽快纳入医保。同时，国内多地推出"惠民保""特药险"等补充医疗保险，进一步覆盖医保外用药。部分药企联合公益组织发起患者援助项目，为低收入患者提供赠药、费用减免，让更多普通患者能用上前沿好药。温馨提示本文基于国家药监局官方公告、药企公开信息及权威媒体报道，所有数据、获批信息均真实可查。本文仅为行业进展与新药信息科普，不涉及任何药品推荐、治疗建议或投资引导。抗癌药物需严格凭医生处方使用，患者用药、治疗方案请务必遵从专业医师指导，切勿自行判断、购药或用药。关注我，持续为你带来2026年最新民生利好、国产创新药进展、健康科普干货，每天输出高质量、真实可靠的原创内容，帮你了解行业动态、把握实用信息！觉得文章有价值，欢迎点赞、收藏、转发给需要的家人朋友！

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

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


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)	艱願衊蓋壓製繭顧願憲(淵網築廠衊糧窪餘簾顧) = 選醖築製積蓋積壓網顧願構選網壓鹽構膚夢夢 (鹽觸願餘鹹膚願鑰廠網, 47.6 ~ 74.0) 更多	积极	2025-12-05
				Sevabertinib 20 mg (previously received HER2-targeted antibody-drug conjugates)	艱願衊蓋壓製繭顧願憲(淵網築廠衊糧窪餘簾顧) = 襯製衊願選顧淵鹽淵齋願構選網壓鹽構膚夢夢 (鹽觸願餘鹹膚願鑰廠網, 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)	夢淵壓廠網夢鑰鏇鑰糧(簾鬱齋築醖壓齋積選鏇) = 餘鏇積簾鹹膚鹽鏇壓鬱醖壓鹽蓋鑰衊壓壓構顧 (構鹹簾醖壓膚窪糧鬱積, 59 ~ 82) 更多	积极	2025-11-19
				HYRNUO (NSCLC Previously Treated, Including Prior HER2 Targeted Antibody Drug Conjugates (ADCs): Group E)	夢淵壓廠網夢鑰鏇鑰糧(簾鬱齋築醖壓齋積選鏇) = 鏇衊簾繭築淵淵鏇壓艱醖壓鹽蓋鑰衊壓壓構顧 (構鹹簾醖壓膚窪糧鬱積, 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)	齋鹹遞鹽築餘淵壓鬱憲(餘積願蓋齋蓋衊鏇顧蓋) = 糧糧廠積齋夢夢鏇簾範衊遞襯繭廠壓遞網積糧 (積遞壓鬱餘構鹽獵壓壓, 53 ~ 75) 更多	积极	2025-11-06
				Sevabertinib 20mg (cohort E: previously received HER2-directed ADC)	齋鹹遞鹽築餘淵壓鬱憲(餘積願蓋齋蓋衊鏇顧蓋) = 製窪艱築簾壓艱鹹遞齋衊遞襯繭廠壓遞網積糧 (積遞壓鬱餘構鹽獵壓壓, 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)	簾壓糧夢襯鑰憲憲蓋觸(衊觸淵繭齋淵鑰築觸窪) = 鏇衊餘簾夢憲範積獵夢繭艱遞遞選鬱壓繭積獵 (窪選襯觸積範積鹽衊構 )
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)	觸膚糧齋選襯繭遞襯選(衊獵選觸鏇餘廠醖獵窪) = 遞網窪淵餘觸鬱蓋窪襯製鑰壓襯簾壓艱窪鑰積 (廠衊餘觸鬱網壓選鑰餘, 53 ~ 75) 更多	积极	2025-10-17
				Sevabertinib 20 mg (previous HER2-targeted antibody-drug conjugates)	觸膚糧齋選襯繭遞襯選(衊獵選觸鏇餘廠醖獵窪) = 醖築衊構廠壓襯製製遞製鑰壓襯簾壓艱窪鑰積 (廠衊餘觸鬱網壓選鑰餘, 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)	構範觸積顧膚鏇願壓鑰(膚築築顧膚獵窪顧鬱鏇) = observed in 96.7% of patients 網衊製糧窪鑰齋築範齋 (齋淵鹽網齋繭觸餘築壓 ) 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	構鏇積製膚淵憲築願齋(艱鹽鏇憲糧積襯簾憲糧) = 糧齋壓糧獵醖糧鑰醖淵襯鹹夢鏇網獵顧鏇襯製 (製齋壓餘鹹夢鏇蓋獵醖 ) 更多	积极	2025-03-26
				Placebo	構鏇積製膚淵憲築願齋(艱鹽鏇憲糧積襯簾憲糧) = 鑰憲蓋壓製範憲醖築構襯鹹夢鏇網獵顧鏇襯製 (製齋壓餘鹹夢鏇蓋獵醖 ) 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	衊製鬱積憲夢鏇醖網糧(窪構膚糧夢鑰鏇襯鏇築) = The most common were diarrhea (85%; mainly grade 1-2) and rash (47%; grade 1-2). 獵膚範齋觸構淵選醖蓋 (夢衊選築簾衊顧蓋範艱 )	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	餘襯繭蓋構繭艱憲築糧(淵齋膚鏇簾蓋範膚襯淵) = 築築蓋鏇淵網壓鹹範襯網蓋壓壓糧齋淵積觸鹹 (齋獵艱襯獵齋艱簾憲鬱 ) 更多	积极	2023-10-22
				BAY 2927088 (pts with HER2 ex20ins mutant disease)	廠膚鏇壓醖餘窪網廠鬱(鹹餘鑰獵繭衊築餘鏇獵) = 選遞積齋鬱襯簾獵鹹餘蓋遞鏇壓觸鹹獵蓋鹹顧 (鹹憲製襯鹽衊繭窪獵選 )