预约演示
更新于：2025-12-19
Trastuzumab
曲妥珠单抗
更新于：2025-12-19
概要
基本信息
药物类型 单克隆抗体 |
别名 Anti-HER2/neu-MAb、trastuzumab、Trastuzumab (Genetical Recombination) + [17] |
靶点 |
作用方式 拮抗剂 |
作用机制 HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、ADCC(抗体依赖的细胞毒作用) |
在研适应症 |
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (1998-09-25), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)、优先审评 (美国) |
登录后查看时间轴
结构/序列
Sequence Code 18481L
来源: *****
Sequence Code 44772H
来源: *****
关联
1,180
项与 曲妥珠单抗 相关的临床试验NCT07246317
A Multicenter, Prospective, Randomized Phase II Trial Evaluating Trastuzumab, Pertuzumab, Docetaxel Combined With QL1706 Versus Combined With Carboplatin as Neoadjuvant Therapy for Early or Locally Advanced HER2+ Breast Cancer
NCT07245797
the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC
ChiCTR2500113994
A Multicenter, Prospective, Randomized Phase II Trial Evaluating Trastuzumab, Pertuzumab, Docetaxel Combined With QL1706 Versus Combined With Carboplatin as Neoadjuvant Therapy for Early or Locally Advanced HER2+ Breast Cancer
100 项与 曲妥珠单抗 相关的临床结果
登录后查看更多信息
100 项与 曲妥珠单抗 相关的转化医学
登录后查看更多信息
100 项与 曲妥珠单抗 相关的专利（医药）
登录后查看更多信息
12,631
项与 曲妥珠单抗 相关的文献（医药）2026-12-01MOLECULAR BIOLOGY REPORTS
HER2 as a molecular trojan horse in prostate cancer: mechanistic insights and therapeutic unlocks
Review
作者: Mukherjee, Anirban Goutam ; Gopalakrishnan, Abilash Valsala
Human epidermal growth factor receptor 2 (HER2/ERBB2) is a well-established therapeutic target in breast and gastric cancers, but its relevance in prostate cancer (PC) remains unresolved. Although HER2 gene amplification is relatively uncommon in PC, heterogeneous overexpression has been observed, particularly in advanced and castration-resistant PC (CRPC), where it is frequently associated with aggressive clinicopathological features. Experimental studies portray HER2 as a signaling hub, mediating crosstalk with androgen receptor (AR) signaling to sustain tumor growth under androgen-deprived conditions. Concurrent activation of the HER2-PI3K-AKT axis further promotes cell survival, proliferation, and therapeutic adaptation. Moreover, HER2 cooperates with epidermal growth factor receptor (EGFR) and NF-κB pathways, reinforcing tumor plasticity and resistance mechanisms. Despite these compelling biological insights, clinical translation has been disappointing. Early trials with Trastuzumab, Lapatinib, and Pertuzumab yielded minimal benefit, underscoring patient heterogeneity, pathway redundancy, and the lack of biomarker-guided stratification. Lessons from these failures highlight the need for precision oncology approaches that integrate molecular profiling and rational therapeutic combinations. Recent advances, including next-generation HER2-targeted antibody-drug conjugates, bispecific antibodies, and CAR-T cell therapies, as well as strategies combining HER2 inhibition with AR signaling blockade, PI3K/AKT inhibitors, or immunotherapy, offer renewed promise. HER2 in PC thus represents a paradox: biologically significant but clinically underexploited. Reframing HER2 within the AR-PI3K signaling network and leveraging biomarker-driven strategies may finally unlock its therapeutic potential. This review critically examines HER2 in PC, analyzing its mechanistic roles, therapeutic potential, and the challenges that shape its value as both a prognostic biomarker and actionable target.
2026-05-01Value in Health Regional Issues
Economic Evaluation and Budget Impact of Biosimilar Trastuzumab for HER2-Positive Metastatic Breast Cancer in Thailand: Policy Implications for Access and Affordability
Article
作者: Lochid-Amnuay, Surasit ; Kongsakon, Ronnachai
OBJECTIVES:
To evaluate the cost-utility and budget impact of biosimilar trastuzumab plus paclitaxel versus paclitaxel monotherapy for HER2-positive metastatic breast cancer in Thailand and to explore policy implications for access and affordability.
METHODS:
A Markov model was developed from a societal perspective over a lifetime horizon, simulating 3 health states: stable disease, progressive disease, and death, in 3-week cycles. Two trastuzumab-based strategies were evaluated: (1) fixed-duration treatment for 1 year and (2) continuous treatment until disease progression. All costs were updated to 2024 values using local data. Clinical effectiveness was measured in quality-adjusted life-years (QALYs). A probabilistic sensitivity analysis and a 5-year budget impact analysis were performed.
RESULTS:
Compared with paclitaxel monotherapy, trastuzumab plus paclitaxel increased life-years by 0.31 and QALYs by 0.27. The incremental cost-effectiveness ratios were Thai Baht (THB) 195 541/QALY for the 1-year regimen and THB 231 119/QALY for the continuous regimen, both exceeding Thailand's cost-effectiveness threshold of THB 160 000/QALY. The 5-year budget impact was estimated at THB 166.3 million and THB 199.3 million, respectively. Price reductions would be required for trastuzumab to achieve cost-effectiveness under the Thai threshold.
CONCLUSIONS:
Although biosimilar trastuzumab has improved affordability, it remains not cost-effective at current prices. However, the relatively modest budget impact supports the feasibility of expanding access through targeted price negotiation and policy interventions. Threshold analysis indicated that price reductions to approximately THB 3700 per vial (1-year regimen) and THB 2950 per vial (until-progression regimen) would be required for trastuzumab to achieve cost-effectiveness under the Thai threshold.
2026-02-01CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
HER2 in gynecological malignancies: Bridging the gap between standardized pathological assessment and precision therapy
Review
作者: Buza, Natalia ; Matias-Guiu, Xavier ; D'Amati, Antonio ; Angelico, Giuseppe ; Zannoni, Gian Franco ; Santoro, Angela ; Scaglione, Giulia
HER2 is a transmembrane tyrosine kinase receptor involved in cell proliferation, survival, and differentiation. While its role in breast and gastric cancers is well established, increasing attention is being paid to HER2 expression in gynecologic malignancies. In endometrial cancer, HER2 overexpression is most commonly associated with serous endometrial carcinoma (SEC), where it occurs in approximately 30 % of cases and correlates with poor prognosis, platinum resistance, and TP53 mutations. HER2-low expression, defined by IHC scores of 1 + or 2 + without gene amplification, has also emerged as a potential therapeutic target. Trastuzumab-based therapy has shown survival benefit in HER2-positive SEC, leading to its inclusion in current treatment guidelines. In ovarian cancer, HER2 amplification is most frequent in mucinous subtypes but also appears in clear cell and endometrioid carcinomas. The prognostic value remains debated, though recent trials of antibody-drug conjugates (e.g., T-DXd) show promise. In cervical cancer, HER2 is more commonly expressed in adenocarcinomas, particularly gastric-type variants, with gene amplification linked to adverse features. HER2 positivity is rare in vulvar and vaginal cancers but is notably present in extramammary Paget disease. Accurate HER2 testing relies on IHC with ISH confirmation and may be complemented by NGS or PCR in select cases. Diagnostic challenges include variable scoring systems, intratumoral heterogeneity, and HER2-low classification. Standardization of testing criteria and further clinical validation of HER2-targeted strategies across gynecologic tumors are essential to guide personalized therapy and improve outcomes.
100 项与 曲妥珠单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| HER2阳性结直肠癌 | 日本 | 2022-03-28 | |
| HER2阳性唾液腺癌 | 日本 | 2021-11-25 | |
| HER2阳性胃癌 | 日本 | 2011-03-10 | |
| 胃癌 | 美国 | 2010-10-20 | |
| 乳腺癌 | 日本 | 2001-04-04 | |
| 早期乳腺癌 | 欧盟 | 2000-08-28 | |
| 早期乳腺癌 | 冰岛 | 2000-08-28 | |
| 早期乳腺癌 | 列支敦士登 | 2000-08-28 | |
| 早期乳腺癌 | 挪威 | 2000-08-28 | |
| HER2阳性乳腺癌 | 欧盟 | 2000-08-28 | |
| HER2阳性乳腺癌 | 冰岛 | 2000-08-28 | |
| HER2阳性乳腺癌 | 列支敦士登 | 2000-08-28 | |
| HER2阳性乳腺癌 | 挪威 | 2000-08-28 | |
| HER2阳性胃食管结合部腺癌 | 欧盟 | 2000-08-28 | |
| HER2阳性胃食管结合部腺癌 | 冰岛 | 2000-08-28 | |
| HER2阳性胃食管结合部腺癌 | 列支敦士登 | 2000-08-28 | |
| HER2阳性胃食管结合部腺癌 | 挪威 | 2000-08-28 | |
| HR阳性乳腺癌 | 欧盟 | 2000-08-28 | |
| HR阳性乳腺癌 | 冰岛 | 2000-08-28 | |
| HR阳性乳腺癌 | 列支敦士登 | 2000-08-28 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 膀胱癌 | 临床3期 | 英国 | - | 2023-03-07 |
| 结直肠癌 | 临床3期 | 英国 | - | 2023-03-07 |
| 胆囊肿瘤 | 临床3期 | 英国 | - | 2023-03-07 |
| 血液肿瘤 | 临床3期 | 英国 | - | 2023-03-07 |
| 肺癌 | 临床3期 | 英国 | - | 2023-03-07 |
| 卵巢癌 | 临床3期 | 英国 | - | 2023-03-07 |
| 胰腺癌 | 临床3期 | 英国 | - | 2023-03-07 |
| 前列腺癌 | 临床3期 | 英国 | - | 2023-03-07 |
| 唾液腺肿瘤 | 临床3期 | 英国 | - | 2023-03-07 |
| 皮肤肿瘤 | 临床3期 | 英国 | - | 2023-03-07 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 411 | 顧憲齋餘窪積遞壓築製(範襯鏇繭壓憲廠鏇糧膚) = 鏇膚網繭鏇觸積築膚糧 網壓獵襯遞構製鬱製襯 (遞壓鑰範糧觸鑰範鑰醖, 21.2 ~ 30.4) 更多 | 积极 | 2025-12-05 | |||
顧憲齋餘窪積遞壓築製(範襯鏇繭壓憲廠鏇糧膚) = 製顧範獵鹹構鹽顧鬱簾 網壓獵襯遞構製鬱製襯 (遞壓鑰範糧觸鑰範鑰醖, 13.2 ~ 23.3) 更多 | |||||||
N/A | 2,260 | 築鏇餘襯糧鬱製糧齋窪(積膚繭夢醖鑰鑰鹽鹹襯): RR = 1.14 (95.0% CI, 0.72 ~ 1.83), P-Value = 0.57 更多 | 不佳 | 2025-12-05 | |||
N/A | 1,120 | Small molecule targeted agents (SMs) | 齋築廠醖選範憲齋糧蓋(窪壓膚鏇憲選觸鹽積餘) = 製窪築蓋鹽膚顧鹽鏇願 鏇構醖網夢襯鹹窪積衊 (網觸膚遞製蓋鏇衊觸顧, 0.52 ~ 3.71) 更多 | 积极 | 2025-10-17 | ||
Immune checkpoint inhibitors (ICIs) | 襯構選糧憲觸積膚繭窪(夢鹽窪窪鹹齋糧衊廠襯) = 選衊鑰壓獵艱膚憲蓋願 築鹹壓壓醖壓淵膚遞鑰 (選窪淵繭餘夢蓋餘觸築, 12 ~ 23) | ||||||
临床1期 | - | 45 | 鹹醖簾繭夢築鹽淵鏇築(廠鏇廠淵餘夢壓獵製構) = Only three IRRs grade 1 occurred, of which one during 30-minute infusion of durvalumab, and two IRRs grade 1 during accelerated trastuzumab infusions 餘齋製膚夢願衊選衊繭 (構網獵網蓋願鑰憲壓遞 ) | 积极 | 2025-10-17 | ||
N/A | HER2-positive | 237 | TKI plus anti-HER2 antibody | 選繭衊製構艱範醖簾遞(餘鬱築餘網構築壓鹽醖) = 襯選遞齋壓襯衊醖糧鬱 憲糧願築顧築蓋網醖襯 (獵衊淵製壓廠醖壓築襯 ) 更多 | 不佳 | 2025-10-17 | |
TKI | 選繭衊製構艱範醖簾遞(餘鬱築餘網構築壓鹽醖) = 淵鏇鏇範壓蓋壓鬱觸網 憲糧願築顧築蓋網醖襯 (獵衊淵製壓廠醖壓築襯 ) 更多 | ||||||
临床2期 | HER2阳性转移性乳腺癌 HER2-positive | 80 | 鏇糧願壓遞繭簾餘餘壓(膚襯餘獵鑰襯壓餘廠鬱) = 餘網鹽繭製鹹範網製遞 壓齋網淵範遞夢選糧網 (範鬱鹽憲蓋遞鹽獵廠鹽 ) | 积极 | 2025-10-17 | ||
N/A | 12,820 | 衊鬱築簾鏇構鑰窪遞夢(獵膚廠構餘繭鬱獵鹹窪) = 繭鹽鏇觸鏇衊簾簾繭範 選艱夢窪膚壓夢憲鹹鑰 (鏇顧膚鹹繭構壓鑰窪鏇, 0.7 ~ 1.4) 更多 | 积极 | 2025-10-17 | |||
衊鬱築簾鏇構鑰窪遞夢(獵膚廠構餘繭鬱獵鹹窪) = 淵顧範鹽繭選壓範鹽齋 選艱夢窪膚壓夢憲鹹鑰 (鏇顧膚鹹繭構壓鑰窪鏇, 0.2 ~ 0.6) 更多 | |||||||
临床2期 | HER2阳性结直肠癌 HER2-positive | 70 | (RAS wt pts with prior EGFRi) | 窪淵夢鑰醖築顧網網衊(網鹽齋鬱鏇選襯構淵觸) = 夢鬱構衊醖簾築遞構構 鬱構範積鑰糧選鏇壓蓋 (憲鹹窪網範襯壓構網艱 ) 更多 | 不佳 | 2025-10-17 | |
(RAS wt pts without prior EGFRi) | 窪淵夢鑰醖築顧網網衊(網鹽齋鬱鏇選襯構淵觸) = 鹹壓築獵夢廠醖網醖鏇 鬱構範積鑰糧選鏇壓蓋 (憲鹹窪網範襯壓構網艱 ) 更多 | ||||||
N/A | 127 | 鹹餘齋窪糧顧艱壓醖鏇(餘構鹹壓繭顧製簾築壓) = 鹽顧遞繭顧鏇淵醖鹽鬱 製鑰網選淵醖膚顧鏇鏇 (憲壓鬱積選觸淵獵願淵 ) 更多 | 积极 | 2025-10-17 | |||
(SUVmax >10) | 鹹餘齋窪糧顧艱壓醖鏇(餘構鹹壓繭顧製簾築壓) = 憲衊夢齋蓋齋選鹽淵夢 製鑰網選淵醖膚顧鏇鏇 (憲壓鬱積選觸淵獵願淵 ) 更多 | ||||||
临床2期 | 37 | 憲醖製蓋繭襯顧鑰齋築(簾膚願獵遞築選願鬱鏇) = 淵廠襯鏇選夢壓艱顧繭 獵鏇製積蓋衊壓憲網淵 (鬱壓憲製鬱齋衊鹹範膚 ) | 积极 | 2025-10-17 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用