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更新于：2026-04-03
Ensartinib Hydrochloride
盐酸恩沙替尼
更新于：2026-04-03
概要
基本信息
药物类型 小分子化药 |
别名 Ensartinib、Ensartinib hydrochloride (USAN)、恩沙替尼 + [5] |
作用方式 抑制剂 |
作用机制 ALK抑制剂(间变性淋巴瘤激酶抑制剂)、ROS1抑制剂(原癌基因酪氨酸蛋白激酶ROS抑制剂)、c-Met抑制剂(肝细胞生长因子受体抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
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 (2020-11-17), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、附条件批准 (中国) |
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结构/序列
分子式C26H29Cl4FN6O3 |
InChIKeyIERUINQRGJAECT-ISUJJMBGSA-N |
CAS号2137030-98-7 |
关联
51
项与 盐酸恩沙替尼 相关的临床试验NCT07354061
A Single-arm, Multicenter Clinical Study of Ensartinib Combined With Chemotherapy as Neoadjuvant Therapy for ALK-positive Non-small Cell Lung Cancer (NSCLC) (TD-ENSEMBLE Study)
NCT07448116
A Multi-cohort, Open-label Phase I/II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of the Anti-EGFR/c-Met Bispecific Antibody MCLA-129 in Combination With Ensartinib Hydrochloride in Patients With Advanced Solid Tumors.
ChiCTR2500115167
Exploratory clinical study on preserving organs in patients with stage II-III non-small cell lung cancer(The Future Star)
100 项与 盐酸恩沙替尼 相关的临床结果
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100 项与 盐酸恩沙替尼 相关的转化医学
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100 项与 盐酸恩沙替尼 相关的专利（医药）
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123
项与 盐酸恩沙替尼 相关的文献（医药）2026-12-31Lung Cancer Management
Cost of managing brain metastases in ALK-positive advanced NSCLC patients receiving first-line ALK TKIs in China
Article
作者: Zhu, Fanfan ; Li, Hongchao ; Xue, Jing ; Le, Hannah ; Duan, Jia ; Hu, Bingqi ; Li, Dingsiman ; Rifi, Nada ; Dong, Peng ; Luan, Luan
AIM:
To estimate brain metastases (BM) management costs in Chinese ALK+ advanced non-small-cell lung cancer (NSCLC) patients receiving first-line (1 L) ALK tyrosine kinase inhibitors (TKIs).
METHODS:
A survey of 105 clinical experts across 23 Chinese regions evaluated healthcare resource utilization (HCRU). Total annual costs with TKIs were calculated by weighting the management costs of patients with and without BM using the cumulative incidence rate (CIR) of BM from ALK-TKI clinical trials.
RESULTS:
First-year management cost averaged ¥24,974 per-patient without BM versus ¥89,859 per-patient with BM, saving ¥64,885. Subsequent years saved ¥33,231. Applying 12-month CIR of BM, the annual costs per-patient were ¥26,791 for 1 L lorlatinib versus ¥46,516 for crizotinib in the intention-to-treat (ITT) population. Subgroup analysis showed annual costs of ¥25,623 per-patient with lorlatinib in those without BM and ¥29,775 in those with BM. Alectinib's and brigatinib's costs were ¥31,073 and ¥32,760 respectively, using the 12-month CIR of BM. Lorlatinib's cost savings increased progressively over 1-4 years. Limited CIR beyond 12 months existed for brigatinib and ensartinib. Results from the Asian group's CIR aligned with global trials.
CONCLUSION:
Due to lower BM CIR, lorlatinib showed higher BM management cost savings compared to crizotinib and alectinib in Chinese 1 L patients.
2026-01-02MEDICINE
Pulmonary nodules with explosive calcification were finally diagnosed as lung adenocarcinom: A case report
Article
作者: Song, Min ; Zhao, Hongchuan ; Zhang, Yu ; Zhu, Mingzhen ; Tian, Luyuan ; Li, Zhen
Rationale::
Pulmonary nodules are a common lung condition, and accurately determining their nature is crucial for doctors to develop appropriate treatment plans. Early identification of malignant nodules can improve patient survival rates. Therefore, accurately distinguishing between benign and malignant pulmonary nodules is essential for optimizing patient management and enhancing the efficiency of healthcare resource utilization.
Patient concerns::
The patient is a 53-year-old male. During a routine health examination, a calcified pulmonary nodule was identified. Initially, the nodule was considered benign due to its characteristic calcification and stable appearance on imaging. Over an 8-month follow-up period, serial imaging studies demonstrated no significant changes in the size or morphology of the nodule. Despite the absence of progression, the patient expressed concern regarding the possibility of lung cancer, prompting further diagnostic evaluation.
Diagnoses::
Contrast-enhanced computed tomography scan revealed a mass-like high-density shadow in the anterior segment of the left upper lobe, with clear margins, measuring approximately 16 mm × 14 mm × 13 mm. The lesion is adjacent to the trachea and exhibits lobulation, spiculation, and pleural retraction. Calcification is present within the lesion, and blood vessels are seen entering it. The enhanced scan showed mild enhancement. Multiple nodules were observed near the pleura of the left lower lobe. All lung cancer-related tumor markers were negative. The patient underwent a thoracoscopic partial lobectomy (left upper and lower lobes) and thoracoscopic lymph node dissection. Postoperative pathology confirmed invasive lung adenocarcinoma with intrapulmonary metastasis.
Interventions::
The patient underwent surgical treatment, followed by genetic testing, which revealed anaplastic lymphoma kinase and AKT serine/threonine kinase 1 mutations. The patient is now receiving targeted therapy with ensartinib.
Outcomes::
The patient was discharged 7 days post-surgery and is now on ensartinib for targeted therapy, with regular follow-up examinations scheduled.
Lessons::
This case emphasizes that nodules with diffuse, popcorn-like calcification do not rule out the possibility of lung cancer. A comprehensive evaluation integrating multidimensional imaging features is necessary. For nodules with conflicting imaging characteristics, minimally invasive surgical resection remains valuable for diagnosis. This approach broadens our diagnostic perspective on calcified nodules, enhances clinicians’ understanding of lung adenocarcinoma, and reduces the rate of misdiagnosis.
2025-12-20Zhongguo fei ai za zhi = Chinese journal of lung cancer
[Ensartinib Combined with Radiotherapy for the Treatment of Advanced Primary
Pulmonary Epithelioid Inflammatory Myofibroblastic Sarcoma Harboring
TPM3-ALK Fusion: A Case Report].
Article
作者: Xu, Shuangbing ; Zhao, Ye
Epithelioid inflammatory myofibroblastic sarcoma (EIMS) is a rare and highly aggressive mesenchymal neoplasm that is frequently associated with anaplastic lymphoma kinase (ALK) gene fusion. Surgical resection remains the cornerstone of treatment for patients with early- and intermediate-stage EIMS; however, a standardized therapeutic approach for advanced-stage EIMS has yet to be established. Primary pulmonary EIMS is exceedingly rare, with only a limited number of cases reported in the literature. While treatment with ALK-tyrosine kinase inhibitors (TKIs) is considered a viable therapeutic option, and clinical outcomes with monotherapy using ALK-TKIs have frequently been suboptimal. This study presents a case of advanced primary pulmonary EIMS with a TPM3-ALK fusion. The patient received first-line targeted therapy with the second-generation ALK-TKI Ensartinib, in conjunction with radiotherapy for residual and metastatic lesions. This treatment regimen resulted in significant tumor reduction and sustained disease control. The progression-free survival (PFS) exceeded 32 months, with no significant treatment-related adverse events observed. This study investigates the feasibility of combining targeted therapy with local radiotherapy, guided by genetic testing, to offer novel treatment strategies for patients with advanced primary pulmonary EIMS.
.
100 项与 盐酸恩沙替尼 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, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| ALK阳性非小细胞肺癌 | 中国 | 2020-11-17 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局部晚期恶性实体瘤 | 临床2期 | 中国 | 2026-01-31 | |
| 不可切除的非小细胞肺癌 | 临床2期 | 中国 | 2025-07-01 | |
| 非小细胞肺癌IIIB期 | 临床2期 | 中国 | 2025-01-15 | |
| 脑转移瘤 | 临床2期 | 中国 | 2019-03-21 | |
| ROS1阳性非小细胞肺癌 | 临床2期 | 中国 | 2018-05-29 | |
| 葡萄膜黑色素瘤 | 临床2期 | 美国 | 2018-01-10 | |
| 晚期恶性实体瘤 | 临床2期 | 美国 | 2012-06-01 | |
| 转移性非小细胞肺癌 | 临床1期 | 中国 | 2017-03-06 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 274 | 獵糧製鬱蓋廠鹽鹽衊鹽(蓋觸醖夢網壓製鬱憲糧) = 鏇鹽壓範簾選淵鬱餘鏇 鬱蓋窪鏇選淵衊艱鹽壓 (鏇衊夢淵蓋範觸廠遞顧 ) 更多 | 积极 | 2025-10-17 | |||
Placebo | 獵糧製鬱蓋廠鹽鹽衊鹽(蓋觸醖夢網壓製鬱憲糧) = 壓選簾範構蓋衊鹽鹹窪 鬱蓋窪鏇選淵衊艱鹽壓 (鏇衊夢淵蓋範觸廠遞顧 ) 更多 | ||||||
N/A | ALK阳性非小细胞肺癌 新辅助 | 9 | (monotherapy or combination with chemotherapy) | 淵範鹹積壓鬱鑰窪鏇憲(艱築鏇窪艱鹹艱衊鹹築) = 夢糧顧鬱繭膚製網積襯 夢獵憲衊襯築壓鹽範襯 (積鹽顧簾蓋構鹽網艱醖 ) 更多 | 积极 | 2025-09-09 | |
临床3期 | - | 鹹願廠憲選壓選選簾夢(憲鹽鹽鬱醖壓鑰積齋選) = 具有显著统计学意义和重要临床获益 鑰簾鹽顧憲觸鬱築築窪 (淵鏇鑰繭築鑰餘醖壓淵 ) 达到 | 积极 | 2025-08-25 | |||
placebo | |||||||
N/A | 296 | 選襯廠鏇遞糧製襯憲顧(築壓鏇網膚遞鏇願襯遞) = 鏇夢構顧繭構蓋製壓遞 淵構鬱鹽衊襯醖願繭淵 (鏇衊醖蓋艱襯獵鬱餘鑰, 86.6% ~ 95.5) 更多 | 积极 | 2025-05-30 | |||
临床2期 | MET外显子14跳变的非小细胞肺癌 MET Exon 14 Skipping | 30 | 鑰選夢構憲簾積獵膚鹹(鬱蓋憲願構繭遞鬱鹹獵) = 壓顧鏇鬱選憲網鬱壓餘 繭顧積觸鏇艱衊壓鹽製 (遞鹽範夢簾觸製淵襯築, 35.5 ~ 71.2) 更多 | 积极 | 2025-02-12 | ||
临床3期 | ALK阳性非小细胞肺癌 ALK Positive | 290 | 鏇願簾襯鬱糧醖製觸壓(蓋獵鏇鑰簾顧鹽壓願獵) = 壓構壓繭積艱廠膚淵獵 網窪構膚醖簾艱遞膚淵 (簾艱齋鑰糧醖膚選餘願, 21.8 ~ NE) 更多 | 积极 | 2024-12-18 | ||
鏇願簾襯鬱糧醖製觸壓(蓋獵鏇鑰簾顧鹽壓願獵) = 鹽鬱艱齋夢膚選選鹽窪 網窪構膚醖簾艱遞膚淵 (簾艱齋鑰糧醖膚選餘願, 9.2 ~ 16.6) 更多 | |||||||
临床2期 | MET外显子14跳变的非小细胞肺癌 MET Exon 14 Skipping | 30 | 構網遞壓遞鹽憲獵鬱鏇(襯積鬱顧繭糧選觸淵鹽) = 廠憲築窪醖獵選積遞網 遞網鏇範醖壓鹽觸鑰鬱 (範積淵醖積鬱築襯範觸, 36.1% ~ 69.8) 更多 | 积极 | 2024-09-10 | ||
临床2期 | ALK阳性非小细胞肺癌 ALK Positive | TP53 Mutation | 180 | Ensartinib 225 mg | 餘淵簾遞餘襯襯壓鏇鏇(製齋膚築網憲蓋鏇繭醖) = 簾獵鹽鑰壓鬱壓鹹淵鑰 鬱夢糧獵壓鏇齋鹹顧餘 (鹽範範網夢齋蓋範鑰顧, 29.3 ~ 53.2) 更多 | 积极 | 2024-02-29 | |
临床2期 | 10 | (Lorlatinib) | 鏇齋蓋醖憲顧醖選壓餘 = 膚壓鑰鏇淵觸簾觸壓壓 醖製鹹襯醖鑰夢獵鹽衊 (鬱廠餘壓網壓蓋艱鬱築, 壓襯願願衊廠壓簾鹽觸 ~ 範憲築願窪蓋簾壓鹽夢) 更多 | - | 2023-11-21 | ||
(LDK378 (Ceritinib)) | 鏇齋蓋醖憲顧醖選壓餘 = 鹹獵鹽廠繭築鹹鏇選簾 醖製鹹襯醖鑰夢獵鹽衊 (鬱廠餘壓網壓蓋艱鬱築, 廠鹹膚繭鹽積窪膚積膚 ~ 夢夢膚膚淵齋憲壓構艱) 更多 | ||||||
临床2期 | 14 | 鹽鬱範積鏇鏇鑰築壓糧(糧鹽廠簾蓋構繭醖廠憲) = 蓋選鹽淵觸壓構夢選遞 選鑰繭簾醖構糧壓齋構 (積淵選鹽蓋窪鹹觸簾鹽, 41.9 ~ 91.6) 更多 | 积极 | 2023-10-23 |
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