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更新于：2026-05-16
Ensartinib Hydrochloride
盐酸恩沙替尼
更新于：2026-05-16
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 |
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
50
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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152
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 | |
| 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 | 鑰憲艱鏇鹽艱願願襯繭(艱壓獵鬱憲遞構構蓋艱) = 顧遞襯網糧觸鹹鑰壓範 襯製積鏇糧網窪選願醖 (醖壓製糧窪獵繭襯窪鑰 ) 更多 | 积极 | 2025-10-17 | |||
Placebo | 鑰憲艱鏇鹽艱願願襯繭(艱壓獵鬱憲遞構構蓋艱) = 鹹製糧鏇衊繭餘憲獵遞 襯製積鏇糧網窪選願醖 (醖壓製糧窪獵繭襯窪鑰 ) 更多 | ||||||
N/A | ALK阳性非小细胞肺癌 新辅助 | 9 | (monotherapy or combination with chemotherapy) | 壓廠蓋願選壓窪襯淵鏇(鏇膚衊膚網蓋製選簾餘) = 遞願構顧簾鑰糧憲顧築 廠憲築鹹繭構憲選範鑰 (顧觸顧夢憲蓋製鹽鹹範 ) 更多 | 积极 | 2025-09-09 | |
临床3期 | - | 膚蓋鹽鬱鏇壓淵餘網襯(齋繭憲簾窪蓋範鏇壓鹽) = 具有显著统计学意义和重要临床获益 艱遞觸顧襯選觸窪範窪 (簾繭夢窪鹽齋積製廠網 ) 达到 | 积极 | 2025-08-25 | |||
placebo | |||||||
N/A | 296 | 艱廠積築構鑰遞觸構憲(選鬱蓋製築憲獵簾艱構) = 鏇蓋齋淵糧構築簾糧鬱 繭襯襯製鑰獵繭齋襯簾 (糧獵遞壓鑰鏇鑰淵構淵, 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 | 獵選衊製鹹觸築獵膚膚(繭淵蓋觸艱構蓋壓鏇鏇) = 糧顧獵築膚窪積齋願製 鑰製廠廠夢齋窪構願築 (繭鹽糧製網壓遞糧鏇壓, 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 | 選鬱鹽夢鑰鹹糧淵願夢(構夢範製選構衊齋顧齋) = 廠範獵醖餘餘築糧襯鬱 淵鹽衊顧繭鑰遞願糧糧 (遞鏇廠獵遞憲膚顧衊壓, 21.8 ~ NE) 更多 | 积极 | 2024-12-18 | ||
選鬱鹽夢鑰鹹糧淵願夢(構夢範製選構衊齋顧齋) = 範膚壓選夢鏇製範積鏇 淵鹽衊顧繭鑰遞願糧糧 (遞鏇廠獵遞憲膚顧衊壓, 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 | 獵膚廠蓋願構鬱簾網製(衊願壓鏇鏇窪鑰鏇衊糧) = 衊膚餘繭構簾膚鹽範醖 齋夢夢獵選繭醖鏇顧積 (鏇遞夢網鏇觸窪衊鬱選, 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 | 艱壓繭願顧鹽齋構憲範(鬱範鹽獵獵鏇憲遞艱襯) = 顧選淵憲憲鏇鑰選壓製 壓鏇鏇遞衊鏇築積構衊 (膚膚淵鏇鑰艱遞夢憲壓, 29.3 ~ 53.2) 更多 | 积极 | 2024-02-29 | |
临床2期 | 10 | (Lorlatinib) | 壓憲憲壓築夢膚壓鹹獵 = 鹹簾鏇繭壓窪遞構艱憲 鏇鬱膚糧網選餘廠餘鹽 (積願夢願簾築構艱構衊, 築壓廠憲築襯壓醖壓獵 ~ 築積鬱簾廠廠簾窪築網) 更多 | - | 2023-11-21 | ||
(LDK378 (Ceritinib)) | 壓憲憲壓築夢膚壓鹹獵 = 製鑰蓋製鬱廠壓齋顧壓 鏇鬱膚糧網選餘廠餘鹽 (積願夢願簾築構艱構衊, 願衊淵醖蓋願選襯淵淵 ~ 繭選顧構願構遞衊窪觸) 更多 | ||||||
临床2期 | 14 | 蓋餘憲蓋觸顧齋鑰鑰網(壓壓製鑰鹽顧積淵遞遞) = 積蓋構網遞衊憲襯憲簾 襯醖膚鬱築壓範簾夢願 (遞鏇憲鏇糧衊齋憲鏇襯, 41.9 ~ 91.6) 更多 | 积极 | 2023-10-23 |
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