瑞康曲妥珠单抗(Trastuzumab Rezetecan) - 药物靶点：HER2 x Top I_在研适应症：HER2阳性结直肠癌，HER2阳性乳腺癌，HER2突变型非小细胞肺癌_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阳性结直肠癌HER2阳性乳腺癌HER2突变型非小细胞肺癌+ [38]

非在研适应症

晚期宫颈癌子宫内膜癌HER2阳性癌症+ [3]

原研机构

在研机构

+ [1]

非在研机构-

权益机构

Glenmark Specialty SA

江苏恒瑞医药股份有限公司

最高研发阶段批准上市

首次获批日期

中国 (2025-05-27),

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

144

项与瑞康曲妥珠单抗相关的临床试验

NCT07896005

/ Not yet recruiting临床3期

A Randomized, Controlled, Open-label, Multicenter Phase III Study of SHR-A1811 Combined With Adebrelimab for the First-line Treatment of Patients With HER2-overexpressing Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

This is a randomized, open-label, multicenter, phase 3 clinical study comparing the efficacy and safety of SHR-A1811 in combination with Adebrelimab versus platinum-based doublet chemotherapy in combination with Tislelizumab as first-line treatment in patients with HER2-overexpressing locally advanced or metastatic non-squamous non-small cell lung cancer.

开始日期2026-12-01

申办/合作机构

苏州盛迪亚生物医药有限公司

ChiCTR2600134798

/ Not yet recruiting临床2期IIT

Efficacy and Safety of Trastuzumab Rezetecan Plus Adebrelimab and Capecitabine for Locally Advanced Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: A Single-Arm, Multicenter Tria

开始日期2026-11-02

申办/合作机构

青岛大学附属医院

NCT07912957

/ Not yet recruiting临床2期IIT

A Dual-Cohort, Exploratory Study of Trastuzumab Rezetecan (SHR-A1811) With or Without Adebrelimab as Neoadjuvant Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

This single-center, dual-cohort, exploratory phase II trial evaluates the efficacy and safety of trastuzumab rezetecan (SHR-A1811), an anti-HER2 antibody-drug conjugate (ADC), with or without the anti-PD-L1 antibody adebrelimab as neoadjuvant therapy in patients with locally advanced, resectable esophageal, gastric, or gastroesophageal junction (GEJ) adenocarcinoma. Approximately 62 patients aged ≥18 years with pathologically confirmed resectable disease (cT1b-2N+M0 or cT3-4NanyM0, American Joint Committee on Cancer [AJCC] 8th edition), HER2 intermediate-to-high expression (immunohistochemistry [IHC] 2+ or 3+), no prior systemic antitumor therapy for esophageal or gastric adenocarcinoma, and Eastern Cooperative Oncology Group (ECOG) performance status 0-1 are planned for enrollment. Eligible participants will be randomly assigned to receive either trastuzumab rezetecan monotherapy or trastuzumab rezetecan plus adebrelimab for 3 cycles (each cycle 21 days), followed by radical surgery. The primary endpoint is pathological complete response (pCR). Secondary endpoints include major pathological response (MPR), R0 resection rate, objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety. Exploratory objectives include biomarker analysis to identify predictors of response to HER2 ADC therapy with or without PD-L1 blockade.

开始日期2026-11-01

申办/合作机构

复旦大学

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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35

项与瑞康曲妥珠单抗相关的文献（医药）

2026-10-20·JOURNAL OF CLINICAL ONCOLOGY

Erratum: Biomarker-Stratified Phase II Trial of Trastuzumab Rezetecan in Advanced Salivary Gland Carcinoma Across Cohorts With High and Low Human Epidermal Growth Factor Receptor 2 Expression

Article

作者: Sang, Youzhou ; Yang, Ya'nan ; Dong, Shu ; Zhang, Yan ; Liu, Xin ; Hu, Chaosu ; Wang, Jiachen ; Sun, Si ; Chen, Tong-Zhen ; Ji, Dongmei ; Wen, Duo ; Chen, Guang-Liang ; Guo, Yanjing ; Ji, Qinghai ; Zhang, Lu ; Wang, Yulong ; Lu, Xueguan ; Niu, Xiao-Shuang ; Qu, Ning ; Shi, Xiao ; Wang, Yu

2026-10-01·LANCET

Ruzaltatug rezetecan versus chemotherapy for EGFR-mutated advanced non-small-cell lung cancer progressing after EGFR tyrosine kinase inhibitor therapy (HERON-Lung01): interim analysis of a randomised, open-label, phase 3 trial in China

Article

作者: He, Zhiyi ; Ji, Yuanyuan ; Dong, Xiaorong ; Xue, Feng ; Shi, Wei ; Sun, Longhua ; Wang, Haiyong ; Xu, Chong-Rui ; Zhang, Jingyu ; Qiu, Fei ; Wang, Qiming ; Wan, Lixin ; Wu, Yi-Long ; Han, Xinghua ; Duan, Jianchun ; Liu, Hongxu ; Su, Haichuan ; Luo, Yongzhong ; Yu, Yan ; Zhou, Jin ; Wu, Lin ; He, Sisi ; Guo, Sanxing ; Liu, Lingxiang ; Huang, Dingzhi ; Liu, Haifeng ; Yang, Bin ; Zhang, Peng ; Chen, Bi ; Lin, Guinan ; Chu, Qian ; Zhong, Jia ; Zhong, Hua ; Yang, Lulu ; Yu, Xinmin ; Zhang, Yan ; Yang, Runxiang

BACKGROUND:

Ruzaltatug rezetecan is a novel HER3-directed antibody-drug conjugate that has shown promising antitumour activity and manageable safety in pretreated EGFR-.mutated non-small-cell lung cancer (NSCLC) in a phase 1 trial. We aimed to compare the efficacy and safety of ruzaltatug rezetecan with chemotherapy in patients with EGFR-mutated advanced NSCLC that had progressed after EGFR tyrosine kinase inhibitor (TKI) therapy.

METHODS:

HERON-Lung01 is a randomised, open-label, phase 3 trial conducted at 62 sites in China. Eligible patients were aged 18-75 years, with locally advanced or metastatic non-squamous NSCLC harbouring an EGFR activating mutation (exon 19 deletion or L858R mutation), and had progressed during or after EGFR-TKI therapy. Patients were randomly assigned (1:1) to receive ruzaltatug rezetecan 8·0 mg/kg or chemotherapy comprising pemetrexed 500 mg/m² plus carboplatin (area under the curve 5) or cisplatin 75 mg/m² for four cycles, followed by maintenance pemetrexed. All treatments were administered intravenously on day 1 of each 3-week cycle. Block randomisation was stratified by presence of brain metastases, EGFR mutation subtype, and use of a first-line third-generation EGFR-TKI. The primary endpoint was progression-free survival (PFS), as assessed by blinded independent central review (BICR), in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT06671379). Recruitment is complete, with the trial ongoing.

FINDINGS:

Between Nov 29, 2024, and Jan 29, 2026, 498 patients were randomly assigned to receive ruzaltatug rezetecan (n=250) or chemotherapy (n=248). The median age was 60·0 years (IQR 54·0-68·0); 276 (55%) patients were female and 222 (45%) male. At the prespecified interim PFS analysis, median follow-up was 7·7 months (95% CI 7·1-8·3). BICR-assessed PFS was significantly longer with ruzaltatug rezetecan than with chemotherapy (median 8·3 months vs 5·4 months; hazard ratio 0·47 [95% CI 0·36-0·60]; one-sided p<0·0001). Grade 3 or worse treatment-related adverse events (TRAEs) occurred in 101 (41%) of 248 patients receiving ruzaltatug rezetecan and 93 (39%) of 239 patients receiving chemotherapy, most commonly decreased neutrophil count (64 [26%] of 248 patients vs 46 [19%] of 239 patients), decreased white blood cell count (29 [12%] vs 29 [12%]), and anaemia (15 [6%] vs 26 [11%]). TRAEs led to treatment discontinuation in three (1%) patients in the ruzaltatug rezetecan group and three (1%) in the chemotherapy group. One death (unknown cause) in the ruzaltatug rezetecan group was considered by the investigator to be possibly treatment related.

INTERPRETATION:

Ruzaltatug rezetecan significantly prolonged PFS compared with chemotherapy, with a manageable safety profile, in EGFR-TKI-resistant, EGFR-mutated advanced NSCLC. These data support ruzaltatug rezetecan as a potential treatment option in this setting.

FUNDING:

Jiangsu Hengrui Pharmaceuticals.

2026-09-20·JOURNAL OF CLINICAL ONCOLOGY

Biomarker-Stratified Phase II Trial of Trastuzumab Rezetecan in Advanced Salivary Gland Carcinoma Across Cohorts With High and Low Human Epidermal Growth Factor Receptor 2 Expression

Article

作者: Sang, Youzhou ; Zhang, Yan ; Yang, Ya'nan ; Dong, Shu ; Liu, Xin ; Hu, Chaosu ; Wang, Jiachen ; Chen, Tong-Zhen ; Sun, Si ; Ji, Dongmei ; Wen, Duo ; Chen, Guang-Liang ; Guo, Yanjing ; Ji, Qinghai ; Zhang, Lu ; Lu, Xueguan ; Wang, Yulong ; Niu, Xiao-Shuang ; Wang, Yu ; Shi, Xiao ; Qu, Ning

PURPOSE:

Systemic treatment options for advanced salivary gland carcinoma (SGC) are limited, and prospective data for human epidermal growth factor receptor 2 (HER2)–directed therapy remain sparse, particularly in HER2-low disease. We evaluated trastuzumab rezetecan (SHR-A1811), a HER2-directed antibody-drug conjugate, in prospectively defined HER2-high and HER2-low cohorts.

PATIENTS AND METHODS:

In this phase II trial, patients with unresectable locally advanced or recurrent/metastatic SGC were enrolled in separate HER2-high (immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+) and HER2-low (IHC 1+ or IHC 2+/ISH–) cohorts. Each cohort was independently evaluated using Simon's optimal two-stage design. SHR-A1811 was administered intravenously once every 3 weeks at a recommended starting dose of 4.8 mg/kg. The primary end point was confirmed objective response rate (ORR) per RECIST version 1.1.

RESULTS:

Forty-six patients were enrolled and treated, including 24 in the HER2-high cohort and 22 in the HER2-low cohort. The median follow-up was 21.9 months (95% CI, 16.9 to 26.9) and 11.3 months (95% CI, 6.9 to 15.7), respectively. The confirmed ORR was 91.7% (95% CI, 73.0 to 99.0), including four complete responses, in the HER2-high cohort and 45.5% (95% CI, 24.4 to 67.8) in the HER2-low cohort. Median progression-free survival (PFS) and overall survival (OS) were not reached in the HER2-high cohort. In the HER2-low cohort, the median PFS was 12.7 months and the median OS was 21.3 months. Grade 3 or higher treatment-related adverse events occurred in 41.3% of patients, most commonly neutrophil count decreased (32.6%). Interstitial lung disease occurred in 6.5% of patients, all grade 1. No treatment-related deaths occurred.

CONCLUSION:

SHR-A1811 showed high antitumor activity in HER2-high SGC and promising activity in HER2-low SGC, with a manageable safety profile.

3,811

项与瑞康曲妥珠单抗相关的新闻（医药）

2026-11-05

·癌度

11月5日：肿瘤圈的24小时发生了哪些事？

✅ 1. 拜耳塞伐艾替尼在中国获批一线治疗HER2突变肺癌 NMPA已批准塞伐艾替尼片单药用于存在HER2（ERBB2）激活突变的不可切除局部晚期或转移性非小细胞肺癌成人患者的一线治疗。该药此前已在日本和美国获批一线，此次中国获批进一步扩大了其全球商业化范围。 ✅ 2. 奥赛康CLDN18.2单抗上市申请获受理，胃癌一线III期已达主要终点奥美妥塔单抗注射液联合替雷利珠单抗及化疗，用于CLDN18.2阳性晚期胃/胃食管交界处腺癌一线治疗的上市许可申请已获NMPA受理。其关键III期研究中，IRC评估的PFS已达到主要终点，OS也观察到一致的获益趋势。 ✅ 3. 恒瑞两款抗肿瘤新药获临床试验批准，聚焦肺癌围手术期瑞康曲妥珠单抗联合PD-1/PD-L1抑制剂，用于伴有HER2异常的可切除非鳞NSCLC围手术期治疗的临床试验申请已获NMPA批准。瑞康曲妥珠单抗此前已获批肺癌、乳腺癌、结直肠癌三项适应症。 ✅ 4. 恒瑞卡瑞利珠单抗+阿帕替尼肝癌BLA获FDA受理，目标审评日期2027年4月卡瑞利珠单抗联合阿帕替尼用于不可切除或转移性肝细胞癌一线治疗的BLA重新提交后获FDA受理，PDUFA目标审评日期为2027年4月9日。该联合方案的III期研究此前已达到PFS和OS的双主要终点。 ✅ 5. 齐鲁制药QLS5133启动Ib/II期临床，晚期实体瘤，国内目标558人 QLS5133注射液针对晚期实体瘤的Ib/II期临床试验已启动，试验状态为“进行中（尚未招募）”，目标入组人数国内558人。 ✅ 6. 多禧生物c-Met ADC启动中国I期临床 DXC-016（靶向c-Met的ADC）于11月4日在中国启动针对实体瘤的I期临床试验，登记号CTR20264176。 ✅ 7. 百济神州GPC3/4-1BB双抗启动肝癌II期临床 BGB-B2033于11月3日启动针对肝细胞癌的II期临床试验，登记号NCT07911683。 ✅ 8. 迈威生物CD3/LILRB4双抗启动血液肿瘤I期临床 2MW7061于11月3日启动针对急性髓系白血病、多发性骨髓瘤等血液系统肿瘤的中国I期临床试验。 ✅ 9. 石药集团ATM抑制剂SYH2051启动实体瘤I/II期临床 SYH2051于11月3日在中国启动针对实体瘤的I/II期临床试验，登记号NCT07911579。 ✅ ⭐️📢：基因检测报告解读，申请临床试验，欢迎联系癌度咨询！以上信息来自公开渠道，仅供速览参考。具体用药、临床试验入组及援助申请条件，请以官方公示和医生评估为准。

2026-11-05

·戊戌数据

【医药早报】2026年11月5日

中生制药70亿美元授权出海，恒瑞"双艾"再闯FDA，医保耗材编码12月起大换血。今日必看 1. 中国生物制药牵手勃林格殷格翰，6个项目最高70亿美元中国生物制药把 6 个肿瘤创新药临床前项目授权给勃林格殷格翰，覆盖 ADC 和 T 细胞衔接器（TCE）两大技术方向。中国生物制药先拿 3.58 亿美元首付款及近期付款，后续里程碑全部走完，交易总额最高可达 70 亿美元，外加最高两位数比例的分级销售分成。早期研发由中生制药负责，到约定临床节点后，勃林格殷格翰可行使独家开发、生产和商业化的选择权。值得注意的是，6 个项目里有 5 个出自中生制药去年并购的礼新医药；双方 2024 年已就肿瘤管线在中国内地合作，首个产品宗艾替尼已拿下两项肺癌适应证。收购礼新的弹药开始兑现，70 亿美元总额创今年国产创新药出海纪录之一，M&A 的价值链路跑通了。 2. 恒瑞"双艾"组合重新递交后获FDA受理，目标审评日期2027年4月恒瑞医药重新提交的卡瑞利珠单抗联合甲磺酸阿帕替尼片（"双艾"组合）一线治疗不可切除或转移性肝细胞癌的 BLA，已获 FDA 受理，目标审评日期定在 2027 年 4 月 9 日。出海路上最磨人的一步重新落定，若获批将是"双艾"国际化的关键一役，2027 年二季度见分晓。 3. 奥赛康奥美妥塔单抗胃癌一线上市申请获受理奥赛康子公司收到国家药监局《受理通知书》，奥美妥塔单抗注射液联合替雷利珠单抗及化疗，用于 CLDN18.2 阳性胃或胃食管交界处腺癌一线治疗的上市许可申请获受理。关键 III 期试验已达到独立评审委员会评估的 PFS 主要终点，与对照组相比改善具有统计学显著性和临床意义。CLDN18.2 赛道又添国产选手，后续审评、现场检查节奏值得关注。新药 / 研发恒瑞两款新药获临床试验批准恒瑞子公司苏州盛迪亚、上海盛迪收到国家药监局核准签发的《药物临床试验批准通知书》，涉及注射用瑞康曲妥珠单抗、阿得贝利单抗注射液，将于近期开展临床试验。ADC 加免疫的组合拳继续加码，恒瑞管线推进速度依然在线。单日注册审批 40 条，38 条新受理本期数据库收录注册审批记录 40 条，其中新受理 38 条：邦顺制药贝泽昔替尼片、诺和诺德卡瑞林肽司美格鲁肽注射液、安进 AMG 562、爱科诺 AC-401 片、科瑞德盐酸美金刚多奈哌齐缓释胶囊等均在列。诺和诺德司美格鲁肽新品种进口受理，减肥药市场下一波供给已在路上。临床研发 47 条：默许 23 条、登记 22 条临床默示许可 23 条，包括翰森/恒邦注射用 HS-20122、再鼎医药注射用 ZL-1310、百济神州 BG-92505 片、英百瑞 IBR854 细胞注射液等。临床试验登记 22 条，奥罗生物 ARC01 注射液、甘李药业 GLR2053 片等完成登记。ADC、细胞治疗扎堆默许，创新管线的早期供给依然密集。政策动态 1. 医保局调整 7 类耗材分类代码，12 月 1 日起旧编码停用国家医保局印发《神经介入与神经外科植入材料等 7 类医保医用耗材分类与代码及医保通用名》，对相关分类与代码、材质特征及医保通用名进行调整。2026 年 12 月 1 日起，调整范围内产品的旧医保编码将全部停用。相关耗材企业需登录国家医保信息业务编码标准数据库动态维护平台，按调整后的分类维护产品信息；各省级医保部门负责指导辖区内企业和定点医疗机构正确维护、使用编码。留给企业换码的窗口不到一个月，神经介入、神外耗材厂商要抓紧维护信息，否则直接影响挂网和结算。 2. 医保局发布第二十二批智能监管"两库"规则本次公开的是"诊断与患者性别不符"规则中"泌尿生殖系统疾病"章对应的知识点明细。各省级医保部门需根据最新知识点明细及代码，对省级医保信息平台智能监管子系统的"两库"进行动态更新。《国家医保基金智能监管知识库、规则库（2025 年版）》近日已出版发行。 3. FDA 启动罕见病框架倡议，为孤儿药建评估方法 FDA 于 10 月 14 日宣布启动罕见病框架倡议，为罕见病（孤儿病）药物建立评估方法，重点关注可收集的证据，将纳入疾病特征、患者需求、患者人群规模和孤儿药特征等考量，但倡议本身不设立新的批准标准。配套的个体化人类基因组编辑产品指南草案也已发布，涉及单一 BLA 中纳入多个产品变异体及获批后新增变异体的情形。罕见病证据要求的口子在松，做孤儿药出海的国内企业值得研究这套评估框架。本期重点品种品种出现次数企业卡瑞利珠单抗 ×2 恒瑞医药阿帕替尼 ×2 恒瑞医药奥美妥塔单抗 ×1 奥赛康替雷利珠单抗 ×1 奥赛康（联合方案）司美格鲁肽 ×1 诺和诺德 AMG 562 ×1 安进贝泽昔替尼片 ×1 邦顺制药注射用 ZL-1310 ×1 再鼎医药想查更多？药达·isearch 免费体验文末「阅读原文」直达戊戌数据 · 医药早报数据来源：药达isearch（https://isearch.wuxuwang.com）戊戌数据（www.wuxuwang.com）内容仅供参考，不构成投资或用药建议 END ★ 点击下方卡片，发现更多精彩

2026-11-04

·新时空

恒瑞医药(01276.HK)：两药获临床试验批准，涉非鳞非小细胞肺癌

2026年11月4日，恒瑞医药(01276.HK)公告，子公司苏州盛迪亚、上海盛迪收到国家药监局《药物临床试验批准通知书》，涉及注射用瑞康曲妥珠单抗及阿得贝利单抗注射液，同意前者联合PD-1/PD-L1抑制剂用于可切除非鳞非小细胞肺癌围手术期患者。核心摘要：注射用瑞康曲妥珠单抗已在国内获批三项适应症，累计研发投入约236,070万元（未经审计）。阿得贝利单抗注射液已获批两项适应症，累计研发投入约137,030万元（未经审计）。核心摘要：注射用瑞康曲妥珠单抗已在国内获批三项适应症，累计研发投入约236,070万元（未经审计）。阿得贝利单抗注射液已获批两项适应症，累计研发投入约137,030万元（未经审计）。核心摘要：新时空讯：2026年11月4日，江苏恒瑞医药股份有限公司（股份代号：01276）根据上市规则第13.10B条刊发海外监管公告，公司子公司苏州盛迪亚生物医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，涉及注射用瑞康曲妥珠单抗及阿得贝利单抗注射液，将于近期开展临床试验。公告显示，2026年8月3日受理的临床试验申请符合药品注册的有关要求，同意注射用瑞康曲妥珠单抗联合PD-1/PD-L1抑制剂在伴有HER2异常的可切除非鳞非小细胞肺癌围手术期患者开展临床试验。瑞康曲妥珠单抗为自主研发的HER2靶点抗体偶联药物，已在国内获批三项适应症，相关项目累计研发投入约236,070万元；阿得贝利单抗为自主研发的人源化抗PD-L1单克隆抗体，已获批两项适应症，累计研发投入约137,030万元（均未经审计）。

申请上市临床申请

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

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适应症	国家/地区	公司	日期
HER2阳性结直肠癌	中国	苏州盛迪亚生物医药有限公司	2026-08-04
HER2阳性乳腺癌	中国	苏州盛迪亚生物医药有限公司	2026-03-17
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	2025-05-27

未上市

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适应症	最高研发状态	国家/地区	公司	日期
HER2低表达乳腺癌	申请上市	中国	江苏恒瑞医药股份有限公司	2026-06-29
HER2阳性非鳞状非小细胞肺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-12-01
转移性非鳞状非小细胞肺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-12-01
卵巢上皮癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-09-04
晚期结直肠腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-08-28
大肠腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-08-05
PD-L1阳性三阴性乳腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-08-20
转移性胃食管结合部腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-08-18
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
铂耐药性输卵管癌	临床3期	中国	江苏恒瑞医药股份有限公司	2025-03-13

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06649331 (SWITCH, ESMO2026)	临床2期	转移性乳腺癌 HER2-negative	54	SHR-A1921	鑰餘鹹製齋廠餘淵繭醖(簾簾鬱膚獵淵築構醖醖) = 積淵製鬱鹽鏇壓觸淵鏇願觸餘窪簾蓋遞淵鏇遞 (醖築積觸繭顧鏇遞範齋 )	不佳	2026-10-23
				SHR-A2102	鑰餘鹹製齋廠餘淵繭醖(簾簾鬱膚獵淵築構醖醖) = 壓壓醖廠製蓋顧繭糧蓋願觸餘窪簾蓋遞淵鏇遞 (醖築積觸繭顧鏇遞範齋 )
NCT05911958 (HELEN-015, Pubmed \| Nat Commun)	临床2期	HER2低表达乳腺癌新辅助 HR positive \| HER2 low	65	SHR-A1811 6.4 mg/kg	鏇齋遞鬱鏇選餘範餘鬱(繭鑰窪網願夢廠築夢餘) = 鏇願鏇糧鑰鑰艱遞淵襯製簾鏇廠網憲艱齋積獵 (積繭襯繭壓選鏇餘鏇構, 3.5 ~ 19.6) 更多	积极	2026-08-31
NCT05424835 (HORIZON-Breast01, Pubmed \| Lancet Oncol)	临床3期	HER2阳性转移性乳腺癌 HER2-positive	287	Trastuzumab rezetecan	網膚膚夢憲鏇醖醖夢鹹(憲餘遞簾鏇願窪獵艱鹽) = decreased neutrophil count (77 [54%] with trastuzumab rezetecan vs 13 [9%] with the control), decreased white blood cell count (29 [20%] vs four [3%]), and decreased platelet count (15 [11%] vs two [1%]); 簾網餘艱鑰醖壓製積膚 (繭範糧鑰築構蓋窪蓋鑰 )	积极	2026-08-01
				Pyrotinib plus capecitabine
NCT04446260 (HORIZON-X, Signal Transduct Target Ther) 人工标引	临床1期	HER2阳性实体瘤 HER2-expressing \| HER2 mutated	396	SHR-A1811	獵築齋膚遞獵鑰顧糧鑰(積顧網憲簾窪鑰壓製衊) = 窪觸艱夢遞選夢衊獵夢淵製憲製壓願築鏇製選 (壓遞觸網顧願壓繭願簾 ) 更多	积极	2026-03-19
				SHR-A1811 (patients with HER2-positive breast cancer)	鬱夢餘願膚糧廠積繭選(簾窪餘繭壓獵選齋鏇築) = 淵鹽鑰糧膚齋憲選廠窪齋醖選糧範廠醖繭鏇艱 (淵廠窪鏇選選艱夢顧繭, 17.2 ~ 33.6)
NCT05424835 (SHR-A1811-Ⅲ-301 \| HORIZON-Breast01, NEWS) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	287	SHR-A1811	醖襯繭餘鬱築餘顧顧繭(鬱餘鏇顧網鏇鹹觸繭膚) = 繭遞鏇簾醖膚獵蓋繭鹹遞鏇簾艱觸築膚淵選範 (製窪鬱選膚膚鹽遞觸簾, 16.8 ~ NR) 达到更多	积极	2025-10-22
				Pyrotinib+Capecitabine	醖襯繭餘鬱築餘顧顧繭(鬱餘鏇顧網鏇鹹觸繭膚) = 繭製製願艱淵蓋築簾顧遞鏇簾艱觸築膚淵選範 (製窪鬱選膚膚鹽遞觸簾, 6.9 ~ 11.0) 达到更多
NCT05424835 (HORIZON-Breast01, ESMO2025)	临床3期	晚期 HER2 阳性乳腺癌二线 HER2+	287	SHR-A1811	糧鹹鹽壓願鹹蓋齋壓鬱(選蓋鏇鏇鏇簾製淵壓壓) = 鹹淵觸網襯襯願襯選窪鹽製鏇鬱醖網遞網襯鏇 (觸遞鹽襯醖餘蓋淵顧選 ) 更多	积极	2025-10-17
				CapecitabinePyrotinib + CapecitabinePyrotinibine	糧鹹鹽壓願鹹蓋齋壓鬱(選蓋鏇鏇鏇簾製淵壓壓) = 夢選範夢築獵鑰夢襯蓋鹽製鏇鬱醖網遞網襯鏇 (觸遞鹽襯醖餘蓋淵顧選 ) 更多
NCT05635487 (MUKDEN 07, ESMO2025)	临床2期	HER2阳性乳腺癌新辅助 HER2-positive	64	SHR-A1811 monotherapy	觸醖夢獵廠襯齋遞鑰觸(製選鏇衊膚糧鬱衊製醖) = 艱衊願繭壓簾窪構醖觸鏇鑰醖鬱遞鏇餘憲壓簾 (觸網鏇醖壓構範網築壓 ) 更多	积极	2025-10-17
				SHR-A1811 plus pyrotinib combination therapy	觸醖夢獵廠襯齋遞鑰觸(製選鏇衊膚糧鬱衊製醖) = 鹹壓襯膚艱構憲鑰淵願鏇鑰醖鬱遞鏇餘憲壓簾 (觸網鏇醖壓構範網築壓 ) 更多
NCT05353361 (ESMO2025)	临床1/2期	HER2阳性转移性乳腺癌 HER2+	75	SHR-A1811 3.2 mg/kg	襯襯積積觸顧齋膚繭顧(壓鏇顧顧醖夢艱網觸壓) = Not observed in phase 1b cohorts 築淵顧襯糧鏇餘鏇齋繭 (壓獵壓夢衊糧鏇遞築構 ) 更多	积极	2025-10-17
				SHR-A1811 4.8 mg/kg
NCT06411457 (ESMO2025)	临床2期	HR阴性/HER2低表达乳腺癌 HER2-low \| HR- or low HR expression	24	SHR-A1811Adebrelimab + SHR-A1811Adebrelimab (HR-negative/HR-low, HER2-low metastatic breast cancer)	齋鏇夢構窪選觸繭願鏇(願獵膚觸鹹膚廠顧鏇獵) = 簾鏇簾網艱製衊鹹膚選艱鹹夢壓觸鏇獵鏇膚醖 (築壓簾蓋構觸夢範鬱鑰 ) 更多	积极	2025-10-17
NCT05424835 (SHR-A1811-Ⅲ-301, Corporate Publications) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	325	SHR-A1811 + 吡咯替尼 + 卡培他滨	選壓簾淵簾簾齋簾糧壓(獵鹹艱觸製糧艱積築遞) = 达到预设的优效标准壓鏇範鏇顧鏇積構鏇簾 (糧艱簾顧憲鹹憲構夢廠 ) 达到更多	积极	2025-09-17