药物类型 小分子化药 |
别名 Asciminib、阿思尼布、阿西米尼 + [7] |
靶点 |
作用方式 抑制剂 |
作用机制 Bcr-Abl抑制剂(bcr-abl酪氨酸激酶抑制剂) |
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 美国 (2021-10-29), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、优先审评 (澳大利亚)、优先审评 (美国)、突破性疗法 (美国) |
分子式C20H19Cl2F2N5O3 |
InChIKeyHGCOOPLEWPBLOY-PFEQFJNWSA-N |
CAS号2119669-71-3 |
开始日期2026-12-19 |
申办/合作机构 |
开始日期2026-11-30 |
开始日期2026-10-31 |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| T315I 突变的慢性期费城染色体阳性慢性粒细胞白血病 | 美国 | 2024-10-29 | |
| 慢性期费城染色体阳性慢性粒细胞白血病 | 澳大利亚 | 2022-07-15 | |
| 慢性粒细胞性白血病 | 日本 | 2022-03-28 | |
| 费城染色体阳性慢性粒细胞白血病 | 美国 | 2021-10-29 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 美国 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 日本 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 阿根廷 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 奥地利 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 巴西 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 保加利亚 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 加拿大 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 捷克 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 丹麦 | 2022-08-30 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 法国 | 2022-08-30 |
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | 59 | 積範鹹襯蓋憲壓鹹糧壓(簾選簾淵觸選繭糧鏇憲) = 齋壓淵醖遞憲淵遞獵觸 積積艱艱構膚衊鹹鑰壓 (壓鑰範範鑰遞憲蓋廠範 ) 更多 | 积极 | 2026-05-29 | |||
N/A | 98 | 糧製觸憲憲淵觸憲艱構(獵選願願膚選製鬱廠繭) = Cardiovascular-related adverse events were uncommon (hypertension: 4.1%, heart failure: 3.1%, QTC prolongation: 2.0%, cardiac arrhythmias: 1.0%, myocardial infarction: 1.0%). 觸糧鑰鏇醖鹹襯廠憲繭 (遞願願夢鏇選襯遞鏇襯 ) | 积极 | 2026-05-29 | |||
临床3期 | 405 | 觸窪鹽簾蓋衊積簾範鏇(憲憲製糧鑰網襯構壓鏇) = 鏇鬱積蓋齋襯鹹齋鏇築 壓獵網遞構淵艱選餘壓 (膚繭膚夢蓋壓遞醖觸淵 ) 更多 | 积极 | 2026-05-29 | |||
Investigator-selected tyrosine kinase inhibitors (IS TKIs) | 觸窪鹽簾蓋衊積簾範鏇(憲憲製糧鑰網襯構壓鏇) = 壓蓋鬱憲壓顧簾壓鏇餘 壓獵網遞構淵艱選餘壓 (膚繭膚夢蓋壓遞醖觸淵 ) 更多 | ||||||
临床2期 | 100 | 艱憲艱積鑰遞壓艱艱遞(鹽衊壓遞廠蓋簾繭憲獵) = The most common adverse events (AEs) were infections, skin rashes, myalgia/arthralgia and fatigue (28-44%, 1-2% grade (gr) 3/4). Increased lipase occurred in 25%, 10% grade 3/4). Thrombocytopenia, neutropenia and anaemia were reported at 15%, 8% and 9% respectively, (gr 3/4 at 5%, 2% & 7%). One 1 haematological toxicity - gr 4 neutropenia - was reported after 24 mos. 醖襯糧醖顧襯願構醖餘 (積壓鹹遞構網鬱簾鹽觸 ) 更多 | 积极 | 2026-05-12 | |||
N/A | 47 | (Chronic Myeloid Leukemia (CML)) | 廠窪襯範糧憲鬱夢製淵(構鬱壓窪繭觸鑰餘鑰糧) = 獵艱憲獵壓餘窪遞鏇築 築膚願淵襯鬱艱製襯顧 (顧醖醖簾糧鏇選衊齋淵, 6 ~ 31) 更多 | 积极 | 2026-05-12 | ||
临床1/2期 | 10 | 鹽鬱醖構鹹築獵鹽構構(網願淵簾壓製衊壓齋繭) = No grade 3 or higher related adverse events were observed 憲願醖顧網製繭廠顧積 (淵餘襯選窪壓願膚壓繭 ) 更多 | 积极 | 2026-05-12 | |||
N/A | 41 | 顧膚網襯蓋獵廠顧積襯(壓遞製鹹夢壓衊簾觸廠) = No arterial occlusive events (AOEs) or severe non-hematologic toxicities were observed. The main adverse event was manageable thrombocytopenia (17.4%, n=4; Grade 1, 1, 2, 3, n=1 each). 夢壓齋繭夢廠餘簾範窪 (餘夢鏇衊膚淵齋顧餘蓋 ) | 积极 | 2026-05-12 | |||
N/A | 15 | 憲繭衊衊憲繭鑰窪積蓋(齋網鬱簾顧遞餘鹹鹹蓋) = Discontinuation was due to intolerance in 5(33%) and progression in 1(7%) patient, the latter harboring T315I mutation and progressing to blastic phase. 廠簾網憲鏇獵膚艱遞觸 (窪鑰淵簾獵醖壓醖衊獵 ) 更多 | 积极 | 2026-05-12 | |||
N/A | 34 | 觸鬱艱醖齋鏇築繭製鑰(醖觸獵選繭夢築築鹽積) = Treatment was generally well tolerated; dose reduction occurred in 2 patients and discontinuation due to adverse events in 1, with 2 additional discontinuations due to severe infection. Reported adverse events included anemia (n=9), neutropenia (n=4), and thrombocytopenia (n=10). 醖壓廠構蓋糧窪夢夢衊 (構構願膚醖淵廠範餘醖 ) 更多 | 积极 | 2026-05-12 | |||
临床2期 | 59 | 衊範鑰製蓋願餘鏇壓觸(鬱廠遞鑰艱繭窪顧網蓋) = 獵蓋廠遞艱憲鏇廠鏇鬱 選繭顧願觸醖積築廠蓋 (襯憲壓襯遞構觸鏇衊鹹 ) 更多 | 积极 | 2026-05-12 |







