瑞康曲妥珠单抗(Trastuzumab Rezetecan) - 药物靶点：HER2 x Top I_在研适应症：HER2突变型非小细胞肺癌，输卵管癌，卵巢癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Trastuzumab-rezetecan、SHR A1811、SHR-A1811

+ [2]

靶点

HER2 x Top I

作用方式

拮抗剂、抑制剂

作用机制

HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、TOP1抑制剂(DNA拓扑异构酶I抑制剂)、ADCC(抗体依赖的细胞毒作用)

治疗领域

肿瘤呼吸系统疾病消化系统疾病+ [3]

在研适应症

HER2突变型非小细胞肺癌输卵管癌卵巢癌+ [35]

非在研适应症-

原研机构

江苏恒瑞医药股份有限公司

在研机构

苏州盛迪亚生物医药有限公司

江苏恒瑞医药股份有限公司Atridia Pty Ltd.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

中国 (2025-05-29),

HER2突变型非小细胞肺癌

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国)、特殊审批 (中国)

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结构/序列

使用我们的ADC技术数据为新药研发加速。

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Sequence Code 18481L

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Sequence Code 44772H

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关联

61

项与瑞康曲妥珠单抗相关的临床试验

NCT06990503

/ Not yet recruiting临床3期IIT

An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR - A1811 Versus Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer With HER2 Expression

This study is a randomized, open-label, active-controlled, multicenter phase III clinical trial.
It is planned to enroll 300 subjects with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with HER2 expression. The randomization will be stratified according to the following factors: 1) HER2 immunohistochemistry (IHC) expression status (HER2 IHC 1+ versus HER2 IHC 2+/3+); 2) whether the subject has previously received vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) inhibitors such as bevacizumab (yes versus no).
Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (SHR - A1811) or the control treatment group (chemotherapy chosen by the investigator, namely liposomal doxorubicin, paclitaxel, topotecan, or gemcitabine).

开始日期2025-06-01

申办/合作机构-

NCT06975462

/ Not yet recruiting临床2期IIT

SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases: a Prospective，Sigle-arm，Phase II Study

A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases

开始日期2025-06-01

申办/合作机构

华中科技大学同济医学院附属协和医院

NCT06990516

/ Not yet recruiting临床1/2期IIT

An Open-label, Multi-center Phase Ib/II Clinical Study of the Combination Regimen of SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer

This study is a multi - center, single - arm, open - label, phase Ib/II clinical trial for dose exploration and efficacy expansion. The aim is to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of the combination regimen of SHR - A1811 in the treatment of platinum - sensitive recurrent epithelial ovarian cancer, determine the recommended phase II dose (RP2D) of the combination therapy, and preliminarily assess its efficacy.

开始日期2025-06-01

申办/合作机构-

100 项与瑞康曲妥珠单抗相关的临床结果

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100 项与瑞康曲妥珠单抗相关的转化医学

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100 项与瑞康曲妥珠单抗相关的专利（医药）

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9

项与瑞康曲妥珠单抗相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-06-01·ANNALS OF ONCOLOGY

Efficacy and safety of neoadjuvant SHR-A1811 with or without pyrotinib in women with locally advanced or early HER2-positive breast cancer: a randomized, open-label, phase II trial

Article

作者: Hou, Y F ; Liang, Q N ; Jiang, S H ; Wu, J ; Yu, K D ; Shao, Z-M ; Li, J J ; Wang, Z H ; Jiang, Y Z ; Ma, L X X ; Fan, L ; Di, G H ; Chen, L ; Shen, Y ; Zhang, W J ; Liu, G Y

BACKGROUND:

Standard neoadjuvant regimens for human epidermal growth factor receptor 2 (HER2)-positive breast cancer include trastuzumab and pertuzumab combined with chemotherapy, and the efficacy and safety of third-generation HER2-directed antibody-drug conjugate (ADC) remain to be elucidated.

PATIENTS AND METHODS:

This open-label, randomized, phase II study enrolled patients aged ≥18 years with stage II-III HER2-positive breast cancer. Patients were randomly assigned (1 : 1 : 1) to receive neoadjuvant treatment either with SHR-A1811 monotherapy, SHR-A1811 with pyrotinib, or nab-paclitaxel combined with carboplatin, trastuzumab, and pertuzumab (PCbHP) for 24 weeks. The primary endpoint was pathological complete response (pCR). Safety was analysed in patients who received at least one dose of study medication.

RESULTS:

Between 27 December 2022 and 11 February 2024, 265 patients were randomly allocated to neoadjuvant, mono-SHR-A1811 (n = 87), SHR-A1811 plus pyrotinib (n = 88), or PCbHP (n = 90). The baseline characteristics were well balanced; ∼45% of the patients were hormone receptor (HR) positive, and 70% of the patients were stage III. The pCR rate was 63.2% for mono-SHR-A1811 (50% for HR positive and 74.5% for HR negative), 62.5% for SHR-A1811 plus pyrotinib (44.7% for HR positive and 76% for HR negative), and 64.4% for PCbHP (54.1% for HR positive and 71.7% for HR negative), with no significant difference between the groups. Grade ≥3 treatment-related adverse events occurred in 44.8% of patients with mono-SHR-A1811, 71.6% with SHR-A1811 plus pyrotinib, and 38.8% with PCbHP. One patient experienced grade 2 interstitial lung disease in SHR-A1811, 9.1% of patients experienced grade 3 diarrhoea in SHR-A1811 plus pyrotinib, and no treatment-related deaths occurred.

CONCLUSIONS:

This is the first study to report the efficacy and safety of third-generation HER2-directed ADC in the neoadjuvant setting for HER2-positive breast cancer. SHR-A1811 showed robust activity, with a tolerable safety profile.

2025-04-01·LANCET ONCOLOGY

Trastuzumab rezetecan, a HER2-directed antibody–drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study

Article

作者: Wang, Zhihui ; Liang, Wenhua ; Luo, Yongzhong ; Sun, Yuping ; Song, Zhengbo ; Wang, Yan ; Li, Xingya ; Yu, Yan ; Yang, Haiyan ; Lu, Shun ; Peng, Min ; Hong, Wei ; Fang, Jian ; He, Zhiyi ; Yang, Lulu ; Wang, Donglin ; Wang, Yong ; Wang, Yongsheng ; Li, Ziming ; Li, You ; Meng, Rui ; Sun, Longhua ; Hu, Sheng ; Wang, Linlin ; Xia, Guohao ; Shi, Wei ; Wang, Qiming ; Song, Ke ; Song, Yong

BACKGROUND:

Trastuzumab rezetecan (also known as SHR-A1811) is a novel antibody-drug conjugate consisting of a humanised HER2-directed monoclonal antibody, cleavable tetrapeptide-based linker, and DNA topoisomerase I inhibitor. In the phase 1 portion of this phase 1/2 study, trastuzumab rezetecan showed preliminary anti-tumour activity and a favourable safety profile in patients with HER2-mutant non-small-cell lung cancer (NSCLC). We present phase 2 results from the study, which aimed to further evaluate the activity and safety of trastuzumab rezetecan at the recommended dose.

METHODS:

In this multicentre, single-arm, phase 2 trial, conducted in 35 hospitals in China, we recruited patients aged 18-75 years, with locally advanced or metastatic NSCLC with an activating HER2 mutation and an Eastern Cooperative Oncology Group performance status score of 0-1, who had disease progression after or were intolerant to platinum-based chemotherapy and anti-PD-1 treatment or anti-PD-L1 treatment. Trastuzumab rezetecan was administered at 4·8 mg/kg intravenously once every 3 weeks. The primary endpoint was objective response rate assessed by an independent review committee in patients who received at least one cycle of study treatment. All patients who received at least one cycle of study treatment were included in safety analyses. This study is registered with ClinicalTrials.gov, NCT04818333, and is ongoing but not recruiting.

FINDINGS:

Between April 14, 2023, and Dec 14, 2023, 94 patients were enrolled and treated. 42 (45%) patients were male, 52 (55%) female, 92 (98%) were Han Chinese, and two (2%) were other ethnicity Chinese. At data cutoff (June 14, 2024), the median duration of follow-up was 8·7 months (IQR 7·0-10·4). 69 (73%; 95% CI 63·3-82·0) of 94 patients had a confirmed objective response, as assessed by independent review committee. The most common grade 3-4 treatment-related adverse events were decreased neutrophil count (38 [40%] patients), decreased white blood cell count (25 [27%]), anaemia (22 [23%]), decreased platelet count (10 [11%]), and decreased lymphocyte count (seven [7%]). Treatment-related serious adverse events occurred in 22 (23%) patients, which were decreased platelet count (six [6%]), decreased neutrophil count (six [6%]), interstitial lung disease (five [5%]), decreased white blood cell count (four [4%]), anaemia (four [4%]), vomiting (three [3%]), pneumonia (three [3%]), hyponatraemia (two [2%]), and pyrexia (one [1%]), small intestinal obstruction (one [1%]), nausea (one [1%]), and chronic obstructive pulmonary disease (one [1%]). There were no treatment-related deaths.

INTERPRETATION:

Trastuzumab rezetecan showed clinically meaningful activity and manageable safety in patients with previously treated HER2-mutant NSCLC. Further trials are justified.

FUNDING:

Jiangsu Hengrui Pharmaceuticals, National Multi-disciplinary Treatment Project for Major Diseases, Collaborative Innovation Center for Clinical and Translational Science by the Ministry of Education & Shanghai.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

400

项与瑞康曲妥珠单抗相关的新闻（医药）

17 小时之前

·恒瑞医药

国内首个获批用于HER2突变非小细胞肺癌、中国自主研发ADC艾维达®上市

近日，恒瑞医药子公司苏州盛迪亚生物医药有限公司收到国家药品监督管理局的通知，批准公司自主研发的HER2 ADC、1类新药注射用瑞康曲妥珠单抗（商品名：艾维达®）上市，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。这是国内首个获批用于HER2突变NSCLC患者的中国自主研发抗体偶联药物（ADC），为HER2突变NSCLC患者提供了新的治疗选择。此次获批是基于上海市胸科医院陆舜教授牵头开展的关键性HORIZON-Lung研究。该研究最新数据显示，瑞康曲妥珠单抗治疗既往经治的HER2突变晚期或转移性NSCLC中位随访时间已达14.2个月，独立评审委员会（IRC）评估的客观缓解率（ORR）则达74.5%，刷新了全球同类研究的纪录[1,2]。患者中位无进展生存期（mPFS）达11.5个月，12个月PFS率达48.6%。该研究于2025年2月成功发表于《柳叶刀·肿瘤学》（The Lancet Oncology）杂志[1]，且在2025年美国癌症研究学会（AACR）年会上凭其更新数据再次重磅亮相，引发领域内学者广泛关注[2]。陆舜教授：“HORIZON-Lung研究验证了瑞康曲妥珠单抗在HER2突变NSCLC中的临床价值，填补了中国HER2突变晚期NSCLC患者抗HER2治疗领域的空白。其基线特征更加符合中国临床实践，该成果不仅为患者提供了新的治疗选择，也标志着中国创新药物在全球肺癌ADC领域迈出了里程碑式的一步。”恒瑞医药总裁、首席运营官冯佶女士：“此次瑞康曲妥珠单抗获批，显著提升HER2突变NSCLC的临床可及，为广大中国患者带来新治疗选择的同时，助力推动中国肺癌精准靶向治疗新发展。未来恒瑞医药也将持续探索更多高质量创新疗法，造福全球更广泛的患者群体。”在NSCLC驱动基因变异谱系中，HER2突变亚型罕见且极具挑战，发生率仅占2%~4%。尽管HER2突变是明确的驱动基因，但传统二线治疗方案如化疗、免疫治疗及目前获批的泛HER TKI疗效有限，ORR普遍不足30%，mPFS仅约6个月[3-7]，患者长期面临治疗手段匮乏的困境。注射用瑞康曲妥珠单抗（研发代号：SHR-A1811）是恒瑞医药自主研发的、以HER2为靶点的抗体药物偶联物，可通过与HER2表达的肿瘤细胞结合并内吞，在肿瘤细胞溶酶体内通过蛋白酶剪切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细胞凋亡。释放的毒素具有高透膜性，可发挥旁观者杀伤效应，进一步提高抗肿瘤疗效。在抗HER2治疗领域，瑞康曲妥珠单抗正积极探索其在HER2突变NSCLC一线治疗人群及HER2扩增和HER2过表达人群中的治疗潜力。瑞康曲妥珠单抗目前在肺癌、乳腺癌、结直肠癌、胃癌或胃食管结合部腺癌、胆道癌以及上皮性卵巢癌、输卵管癌或原发性腹膜癌治疗领域的8项适应症均获国家药品监督管理局突破性疗法认定，未来有望造福更广泛的患者群体。作为创新型国际化制药企业，恒瑞医药多年来持续围绕临床急需进行创新研发，累计研发投入超460亿元，已在国内获批上市23款新分子实体药物（1类创新药）、4款其他创新药（2类新药），另有90多个自主创新产品正在临床开发，约400项临床试验在国内外开展。除了深耕传统优势的肿瘤领域，公司还在代谢和心血管疾病、免疫和呼吸系统疾病、神经科学等领域也进行了广泛布局。目前，基于十多年的经验，公司建立了专有的恒瑞迅捷模块化ADC创新平台(HRMAP)，研究ADC和其他生物偶联药物。截至目前，已将包括HER2 ADC瑞康曲妥珠单抗在内的超过10种具有恒瑞专门设计的DXh有效载荷的差异化ADC分子推进至临床阶段。关于HORIZON-Lung研究HORIZON-Lung研究聚焦HER2突变NSCLC人群，对恒瑞医药自主研发的HER2 ADC瑞康曲妥珠单抗的临床价值进行了深入探索。该研究纳入94例HER2突变NSCLC患者，患者基线情况较差且均接受过充分的前线治疗。其中ECOG PS评分（美国东部肿瘤协作组体能状态评分）1分患者占比达81%；23%的患者接受过HER2酪氨酸激酶抑制剂（TKI）治疗；100%的患者接受过化疗和免疫治疗；26%的患者基线存在脑转移。人群特征高度反映中国肺癌真实世界治疗困境。根据HORIZON-Lung研究最新数据，瑞康曲妥珠单抗治疗既往经治的HER2突变晚期或转移性NSCLC中位随访时间已达14.2个月，独立评审委员会（IRC）评估的客观缓解率（ORR）则达74.5%，刷新了全球同类研究的纪录[1,2]。患者中位无进展生存期（mPFS）达11.5个月，12个月PFS率达48.6%。亚组分析显示，基线脑转移患者客观缓解率（ORR）达87.5%，mPFS达11.3个月，提示HER2突变的脑转移NSCLC患者能从瑞康曲妥珠单抗治疗中获益。既往接受过HER2 TKI治疗的患者ORR达81.8%，mPFS达9.7个月，提示接受过HER2 TKI治疗的患者仍能从瑞康曲妥珠单抗治疗中获益[2]。与同类药物相比，瑞康曲妥珠单抗展现了持久的抗肿瘤活性，取得了亮眼的ORR和PFS获益[2,8]，并且随着随访时间的延长，不良反应发生谱和发生率没有明显变化，提示瑞康曲妥珠单抗安全性良好，长期用药安全性风险可控[2]。参考文献：1.Li Z, Wang Y, Sun YP, Si W, Lu S. The Lancet Oncology 2025.2.Lu S, et al. AACR 2025. 注：非头对头研究，不建议直接对比.3.Cooper AJ,et al. J Clin Oncol. 2022 Mar 1;40(7):693-697.4.Mazieres J, et al. Annals of Oncology 27: 281–286, 2016. 5.Shepherd FA, et al. J Clin Oncol18:2095-2103, 2000. 6.Ioannis A Vathiotis et al.Cancers (Basel). 2023 Feb 17;15(4):1286. 7.Chu X, Qiang H, Xie M, et al. Cancer Immunol Immunother. 2022;71(7):1625-1631.8.Ying Cheng, et al. 2024 AACR. CT248.声明：1.本新闻旨在分享研发注册进展，仅供医疗卫生专业人士参阅，非广告用途。2.恒瑞医药不对任何药品和/或适应症作推荐。3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。排版：程梦真责编：王玲往期精选| 研发创新 |恒瑞创新药、中国首个自主研发JAK1抑制剂硫酸艾玛昔替尼片获批上市| 国际化 |恒瑞医药再次与德国默克集团达成合作，推进辅助生殖领域口服GnRH拮抗剂商业化落地恒瑞医药与默沙东就Lp(a)抑制剂HRS-5346签订独家许可协议| 重磅奖项 |喜报！恒瑞医药荣获2023年度国家科技进步奖恒瑞医药连续六年入选全球制药企业50强榜单！| 社会公益 |“健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

AACR会议抗体药物偶联物申请上市临床结果

21 小时之前

·药筛

NMPA创新药大放送，11个新药同日获批

今天，NMPA创新药批文大放送，一口气发布11个创新药上市通知。附条件批准江苏恒瑞医药股份有限公司申报的1类创新药苹果酸法米替尼胶囊（商品名：艾比特），该药联合注射用卡瑞利珠单抗用于既往接受含铂化疗治疗失败但未接受过贝伐珠单抗治疗的复发或转移性宫颈癌患者批准海创药业股份有限公司申报的1类创新药氘恩扎鲁胺软胶囊（商品名：海纳安），该药适用于接受醋酸阿比特龙及化疗后出现疾病进展，且既往未接受新型雄激素受体抑制剂的转移性去势抵抗性前列腺癌（mCRPC）成人患者。批准锦州奥鸿药业有限责任公司申报的1类创新药枸橼酸伏维西利胶囊（商品名：复妥宁），该药联合氟维司群，适用于既往接受内分泌治疗后出现疾病进展的激素受体（HR）阳性、人表皮生长因子2 (HER2)阴性的复发或转移性成年乳腺癌患者。通过优先审评审批程序批准上海复星医药产业发展有限公司申报的1类创新药芦沃美替尼片（商品名：复迈宁），该药适用于朗格汉斯细胞组织细胞增生症（LCH）和组织细胞肿瘤成人患者；2岁及2岁以上伴有症状、无法手术的丛状神经纤维瘤（PN）的I型神经纤维瘤病（NF1）儿童及青少年患者。批准苏州泽璟生物制药股份有限公司申报的1类创新药盐酸吉卡昔替尼片（商品名：泽普平），该药用于中危或高危原发性骨髓纤维化（PMF）、真性红细胞增多症继发性骨髓纤维化（PPV-MF）和原发性血小板增多症继发性骨髓纤维化（PET-MF）的成人患者，治疗疾病相关脾肿大或疾病相关症状。批准Genor Biopharma(USA), Inc.申报的1类创新药盐酸来罗西利片（商品名：汝佳宁），该药适用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（HR+/HER2-）局部晚期或转移性乳腺癌成人患者：与芳香化酶抑制剂联合使用作为初始内分泌治疗；与氟维司群联合用于既往接受内分泌治疗后疾病进展的患者。批准福建盛迪医药有限公司申报的1类创新药注射用磷罗拉匹坦帕洛诺司琼（商品名：瑞坦宁），该药用于预防成人高度致吐性化疗（HEC）引起的急性和迟发性恶心和呕吐。通过优先审评审批程序附条件批准百济神州（苏州）生物科技有限公司申报的注射用泽尼达妥单抗（商品名：百赫安）上市，适用于既往接受过全身治疗的HER2高表达（IHC3+）的不可切除局部晚期或转移性胆道癌患者。批准厦门特宝生物工程股份有限公司申报的怡培生长激素注射液（商品名：益佩生）上市，适用于治疗 3岁及以上儿童的生长激素缺乏症所致的生长缓慢。批准江苏泰康生物医药有限公司申报的注射用阿格司亭α（商品名：迈粒生）上市，适用于成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症为表现的感染发生率。通过优先审评审批程序附条件批准苏州盛迪亚生物医药有限公司申报的注射用瑞康曲妥珠单抗（商品名：艾维达）上市，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。快速筛选药品，就用摩熵药筛小程序加客服小筛微信，进群获取第一手资讯数据

优先审批上市批准申请上市

22 小时之前

·PRNewswire

China's HER2-Targeted ADC Trastuzumab Rezetecan Gains NMPA Approval for HER2-Mutant NSCLC

SHANGHAI, May 29, 2025 /PRNewswire/ -- The National Medical Products Administration has recently granted approval for Trastuzumab rezetecan, China's first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations who have previously received at least one systemic therapy. The approval of Trastuzumab rezetecan was based on the pivotal HORIZON-Lung study led by Professor Lu Shun at Shanghai Chest Hospital, which demonstrated groundbreaking efficacy in HER2-mutant locally advanced or metastatic NSCLC patients who have received prior systemic therapy. The trial achieved a median follow-up of 14.2 months, an IRC-confirmed objective response rate (ORR) of 74.5%, and a median progression-free survival (mPFS) of 11.5 months—thereby doubling the efficacy of conventional treatments. In addition, Trastuzumab rezetecan significantly reduced the toxicity risks typically associated with conventional ADCs. These results have redefined global benchmarks for ADC research and garnered significant attention from the international scientific community. Trastuzumab rezetecan has achieved breakthroughs in both efficacy and safety through pioneering molecular design from the ground up, a milestone made possible by Hengrui Pharmaceuticals' decade-long development of its ADC R&D platform, the Hengrui Rapid Modular ADC Platform (HRMAP). HRMAP enables end-to-end capabilities spanning molecular design, preclinical optimization, and clinical translation. To date, Hengrui has advanced over 10 differentiated ADC candidates into clinical development, including Trastuzumab rezetecan, its flagship HER2-targeted ADC therapy. Shun Lu, MD, PhD, Director of oncology department (Shanghai Lung Tumor Clinical Medical Center)，China, and principal investigator of Horizon-Lung, said, "the HORIZON-Lung study validates Trastuzumab rezetecan as a transformative therapy for HER2-mutant NSCLC, addressing a critical unmet need for advanced HER2-driven NSCLC patients in China. Grounded in epidemiological data that accurately reflect China's NSCLC epidemiological landscape, this therapeutic advance not only provides a novel treatment option for patients, but also heralds China's emergence as a pioneering force in shaping the global ADC landscape for precision oncology. Beyond its established efficacy in lung cancer, Trastuzumab rezetecan has demonstrated significant clinical advances across multiple tumor types, with eight additional indications—including breast cancer, colorectal cancer, gastric cancer, biliary tract cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer—receiving Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA). SOURCE Hengrui Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床结果抗体药物偶联物突破性疗法优先审批

100 项与瑞康曲妥珠单抗相关的药物交易

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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	苏州盛迪亚生物医药有限公司	2025-05-29

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
输卵管癌	临床3期	中国	江苏恒瑞医药股份有限公司	2025-03-13
卵巢癌	临床3期	中国	江苏恒瑞医药股份有限公司	2025-03-13
铂耐药上皮性卵巢癌	临床3期	中国	江苏恒瑞医药股份有限公司	2025-03-13
复发性铂耐药性原发性腹膜癌	临床3期	中国	江苏恒瑞医药股份有限公司	2025-03-13
结直肠癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-03-01
RAS 野生型结直肠癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2024-03-01
HER2阳性胃癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-09
HER2阳性胃食管结合部腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2023-12-28
HER2阳性胃食管交界处癌	临床3期	中国	江苏恒瑞医药股份有限公司	2023-12-28
HER2低表达乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2023-06-05

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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


NCT04818333 (HORIZON-Lung, AACR2025) 人工标引	临床1/2期	HER2突变型非小细胞肺癌 ERBB2 Mutation (Activating)	94	SHR-A1811 (IRC)	夢選夢築餘繭製範廠願(夢糧糧醖願鑰齋網廠淵) = 顧衊鹹憲構鹹憲觸鬱醖醖鬱淵艱選範廠憲網餘 (選蓋鏇襯壓繭膚鏇襯顧, 64.4 ~ 82.9) 更多	积极	2025-04-27
				SHR-A1811 (INV)	夢選夢築餘繭製範廠願(夢糧糧醖願鑰齋網廠淵) = 壓積製壓簾選壓衊夢遞醖鬱淵艱選範廠憲網餘 (選蓋鏇襯壓繭膚鏇襯顧, 57.7 ~ 77.3) 更多
NCT05582499 (NEWS \| Pubmed) 人工标引	临床2期	HER2阳性乳腺癌新辅助 HER2 Positive	265	SHR-A1811单药组	顧製衊構選窪鹽齋願衊(鑰壓網齋製襯簾襯蓋醖) = 憲窪獵餘壓鏇壓願淵糧餘鬱構構糧廠鑰獵醖夢 (鑰鹹憲獵餘積艱鏇餘顧 ) 更多	积极	2025-03-24
				SHR-A1811联合吡咯替尼组	顧製衊構選窪鹽齋願衊(鑰壓網齋製襯簾襯蓋醖) = 齋範廠廠繭鏇壓願鹽構餘鬱構構糧廠鑰獵醖夢 (鑰鹹憲獵餘積艱鏇餘顧 ) 更多
NCT04818333 (HORIZON-Lung, NEWS \| Pubmed) 人工标引	临床1/2期	HER2突变型非小细胞肺癌二线 ERBB2 Mutation (Activating)	94	Trastuzumab Rezetecan	鬱廠醖鑰鑰糧遞憲膚壓(鏇糧淵鑰築糧顧襯選鏇) = 鹽積衊選膚膚襯壓鬱鹽繭憲觸窪衊膚齋範築壓 (齋醖壓鹹積鑰範膚餘鏇, 63.3 ~ 82.0) 更多	积极	2025-03-03
NCT05911958 (SABCS2024) 人工标引	临床2期	HR阳性/HER2低表达乳腺癌新辅助	35	SHR-A1811	齋鏇衊醖鏇築餘鑰襯夢(餘範範鏇鬱鹽鹹衊壓繭) = 構願襯艱鬱鹹窪糧選壓選構網艱網膚鏇製獵範 (壓艱衊艱遞夢壓窪糧餘 ) 达到更多	积极	2024-11-26
NCT05582499 (SABCS2024) 人工标引	临床2期	HER2阳性乳腺癌 HER2 Positive	265	PCbHP (nab-paclitaxel, carboplatin, trastuzumab, pertuzumab)	鬱觸夢積願選網餘襯齋(淵獵願窪醖夢衊窪遞齋) = 製鬱壓蓋餘衊鬱繭獵夢觸範積積簾膚廠餘憲鏇 (廠網遞衊蓋淵選窪製艱 ) 更多	积极	2024-11-26
				Mono-SHR-A1811	鬱觸夢積願選網餘襯齋(淵獵願窪醖夢衊窪遞齋) = 膚夢膚糧艱窪鏇糧積築觸範積積簾膚廠餘憲鏇 (廠網遞衊蓋淵選窪製艱 ) 更多
NCT04446260 (SABCS2024) 人工标引	临床1期	HER2阳性实体瘤 HER2 Positive	391	SHR-A1811 (HER2- positive breast cancer)	繭蓋襯餘觸鹽糧憲憲糧(範顧窪膚積繭繭簾憲廠) = 鏇淵鑰網鏇鬱簾鹽蓋廠糧構襯願齋淵醖餘餘蓋 (艱鹹蓋獵積製鹹範獵壓, 15.1 ~ NE) 更多	积极	2024-11-26
				SHR-A1811 (HER2-low breast cancer)	繭蓋襯餘觸鹽糧憲憲糧(範顧窪膚積繭繭簾憲廠) = 鹹築廠憲夢艱窪夢壓艱糧構襯願齋淵醖餘餘蓋 (艱鹹蓋獵積製鹹範獵壓, 8.2 ~ 13.7) 更多
NCT05635487 (MUKDEN 07, ESMO2024) 人工标引	临床2期	HER2阳性乳腺癌新辅助 HR+	29	SHR-A1811 + Pyrotinib	憲選製獵遞製膚憲鹹顧(範製淵獵簾獵構獵範遞) = 壓顧構製構膚齋窪餘衊範醖觸襯醖積積廠衊遞 (鏇鹹醖製憲衊淵窪壓窪, 59.1 ~ 91.7) 更多	积极	2024-09-16
				SHR-A1811SHR-A1811 4.8 mg/kg+ PyrotinibPyrotinib 240 mg/day	憲選製獵遞製膚憲鹹顧(範製淵獵簾獵構獵範遞) = 鏇構艱廠範壓膚構夢艱範醖觸襯醖積積廠衊遞 (鏇鹹醖製憲衊淵窪壓窪 ) 更多
NCT04818333 (Pubmed) 人工标引	临床1/2期	HER2突变型非小细胞肺癌二线 ERBB2 Mutation	63	SHR-A1811	築觸糧餘蓋網齋觸醖廠(製網醖顧構積壓艱遞鹽) = 願齋簾築餘範艱願襯鹽艱範窪鑰簾選壓選選餘 (顧遞觸鬱夢醖襯願醖齋, 27.0 ~ 57.9) 更多	积极	2024-07-15
NCT04446260 (Pubmed) 人工标引	临床1期	HER2阳性实体瘤 ERBB2 Mutation (Activating) \| HER2 Expression	307	SHR-A1811	鹽願糧鹽蓋範餘鑰獵繭(遞衊選淵餘壓觸醖積簾) = decreased neutrophil count (119 [38.8%]) and decreased WBC count (70 [22.8%]). Interstitial lung disease occurred in only eight (2.6%) patients. 鑰窪遞繭顧鹽築選膚鏇 (積繭齋鹹鹽壓艱繭範觸 ) 更多	积极	2024-06-20
				SHR-A1811 (HER2-positive breast cancer)
NCT05924256 (ASCO2024) 人工标引	临床2期	唾液腺肿瘤 HER2 Negative \| ERBB2 Amplification \| HER2 Overexpression \| ... 更多	21	SHR-A1811(anti-HER2) 4.8 mg/kg	壓糧齋鏇鑰蓋膚鹹淵鏇(窪窪觸鏇構網繭觸淵餘) = 糧艱淵鹽蓋遞獵遞遞夢齋獵齋繭遞壓艱築製襯 (網遞範餘糧膚繭鏇範製 ) 更多	积极	2024-05-24
				rezvilutamide 24leuprolided plus leuprolide 3.75mg s.c.	壓糧齋鏇鑰蓋膚鹹淵鏇(窪窪觸鏇構網繭觸淵餘) = 壓網夢齋願繭窪鑰願鬱齋獵齋繭遞壓艱築製襯 (網遞範餘糧膚繭鏇範製 ) 更多