盐酸阿思尼布(Asciminib Hydrochloride) - 药物靶点：Bcr-Abl x STAMP_在研适应症：慢性期费城染色体阳性慢性粒细胞白血病，T315I 突变的慢性期费城染色体阳性慢性粒细胞白血病，慢性粒细胞性白血病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Asciminib、阿思尼布、阿西米尼

+ [7]

靶点

Bcr-Abl x STAMP

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)、STAMP inhibitors(tubulin tyrosine ligase like 5 inhibitors)

治疗领域

肿瘤血液及淋巴系统疾病免疫系统疾病+ [1]

在研适应症

慢性期费城染色体阳性慢性粒细胞白血病T315I 突变的慢性期费城染色体阳性慢性粒细胞白血病慢性粒细胞性白血病+ [10]

非在研适应症

慢性肾病肾功能不全

原研机构

Novartis AG

在研机构

Novartis Pharma AG诺华（中国）生物医学研究有限公司Novartis Pharma Stein AG

+ [10]

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),

费城染色体阳性慢性粒细胞白血病

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、快速通道 (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)、加速批准 (美国)、突破性疗法 (美国)

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结构/序列

分子式C20H19Cl2F2N5O3

InChIKeyHGCOOPLEWPBLOY-PFEQFJNWSA-N

CAS号2119669-71-3

关联

36

项与盐酸阿思尼布相关的临床试验

NCT06409936

/ Not yet recruiting临床2期IIT

Asciminib as Single Agent or in Combination With Nilotinib in the 1st-line Treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a Randomized GIMEMA-GELMC Phase II Study PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML

A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B).
All patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued.
During the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily.
The patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.

开始日期2025-06-01

申办/合作机构

Gruppo Italiano Malattie EMatologiche dell'Adulto

NCT06514534

/ Recruiting临床2期

A Phase II, Multi-center, Prospective, Open-label Study of Asciminib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) or Accelerated Phase (CML-AP) With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.

The objective of this Phase II study is to assess the potential of asciminib in managing CML-CP or CML-AP in patient carrying the T315I mutation. The presence of this mutation introduces treatment difficulties due to the limited available options. The study seeks to collect additional data on the effectiveness and safety of asciminib for these patients. By determining the drug's capacity to manage the disease and enhance patients outcomes, the study is designed to fill the unmet medical need and potentially offer a new therapeutic path for patients at a treatment deadlock.

开始日期2025-02-18

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06629584

/ Recruiting临床2期

Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia

This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.

开始日期2025-02-14

申办/合作机构

Novartis AG

100 项与盐酸阿思尼布相关的临床结果

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100 项与盐酸阿思尼布相关的转化医学

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100 项与盐酸阿思尼布相关的专利（医药）

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319

项与盐酸阿思尼布相关的文献（医药）

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Population pharmacokinetic modeling of asciminib in support of exposure-response and ethnic sensitivity analyses in patients with chronic myeloid leukemia

Article

作者: Darstein, Christelle ; Sy, Sherwin K B ; Kawakita, Yasunori ; Wu, Shengyuan ; Yoon, Deokyong ; Grosch, Kai ; Yang, Yiqun ; Dasgupta, Kohinoor ; Kapoor, Shruti ; Hoch, Matthias

BACKGROUND:

The original population pharmacokinetics (popPK) model for asciminib in patients with chronic myeloid leukemia in chronic phase (CML-CP) was refined to address drug development needs in support of drug submission, namely, attainment of target drug exposure in specific patient populations, populating individual daily exposures for exposure-response analyses of key efficacy and safety endpoints, confirmation of comparability in exposure between 40 mg b.i.d. and 80 mg q.d., and assessment of ethnic insensitivity.

METHODS:

Participants from two organ dysfunction studies, patients with CML in blast and acute phases and acute lymphoblastic leukemia and patients from a phase III efficacy study in newly diagnosed Ph + CML-CP, and data from a dedicated phase II study in the Chinese patients previously treated with at least two prior tyrosine kinase inhibitors, and a phase IIIb study comparing two dose regimens of asciminib (40 mg b.i.d. and 80 mg q.d.) were included in the revised popPK model. Covariates evaluated were line of therapy, baseline renal and hepatic functions, Chinese or Japanese ethnicity.

RESULTS:

The apparent clearance and steady-state volume of distribution of asciminib were 6.84 L/h and 110 L, respectively, for a typical individual of 70 kg weight and 90 mL/min absolute glomerular filtration rate. Both the 40 mg b.i.d. and 80 mg q.d. resulted in a steady-state daily AUC of 12,600 ng.h/mL, and there was no difference between lines of therapy. Effects of renal or hepatic impairment on clearance were not clinically relevant. Chinese and Japanese exhibited similar PK as that of the global population.

CONCLUSIONS:

The 40 mg b.i.d. and 80 mg q.d. regimens are comparable in their daily exposure, supporting the use of the two dosing regimens in newly diagnosed and previously treated CML-CP patients. The PK of asciminib is insensitive to ethnic differences and no dose adjustment is required for severe renal and hepatic impaired patients.

2025-06-01·Clinical Lymphoma Myeloma & Leukemia

SOHO State of the Art Updates and Next Questions: Combination Therapy in Chronic Myeloid Leukemia in Chronic Phase

Review

作者: Costa, Alessandro ; Breccia, Massimo

Therapeutic strategies for chronic myeloid leukemia (CML) are rapidly evolving, with novel agents emerging to address the limitations of current treatments. Goals of CML management are disease control and achieve a deep and sustained molecular response for a possible successful treatment-free remission (TFR). However, a significant proportion of patients fail to reach adequate molecular response and require sequential therapies. A crucial aspect of treatment resistance lies in the persistence of leukemic stem cells (LSCs), which serve as a reservoir for disease recurrence. Increasing focus is placed on combination strategies to overcome the constraints of TKI monotherapy. Various strategies have been explored, starting with the combination of interferon (IFN) and TKIs. The investigation of alternative administration methods, dosing regimens, or extended treatment durations in clinical trials involving IFN represents potential avenues to address current conflicting results. Additionally, the combination of ATP-competitive TKIs with asciminib has shown encouraging preclinical and clinical results, with further data needed for a comprehensive safety profile. Recently, efforts to inhibit other signaling pathways have been explored but with contrasting results. Despite ongoing advancements, TKIs remain the cornerstone of both current and future combination therapies. Their integration with personalized approaches is crucial to overcome complex biological challenges and ensure long-term, effective and safe treatment for CML patients.

2025-06-01·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Which Is the Best Tyrosine Kinase Inhibitor for Newly Diagnosed Chronic Myelogenous Leukemia?

Review

作者: Hughes, Timothy P. ; Osborn, Michael ; Shanmuganathan, Naranie

The choice of frontline therapy for a patient with chronic phase chronic myeloid leukemia (CP-CML) can have a profound effect on the long-term clinical outcome. Currently, five tyrosine kinase inhibitors (TKIs—imatinib, dasatinib, nilotinib, bosutinib, and asciminib) are available for frontline therapy, but no single TKI is optimal for all patients. EUTOS long-term survival (ELTS) risk score, comorbidities, and treatment-free remission (TFR) priority are the key determinants of frontline TKI selection. Higher ELTS score, low age and comorbidity score, and a high priority for achievement of TFR would all favor the frontline use of a more potent TKI than imatinib. However, no TKI has improved survival compared with imatinib. In children with CP-CML, imatinib, dasatinib, and nilotinib have similar long-term efficacy, with ease of administration and impact of toxicities on quality of life being key considerations. Recent adult trials of reduced-dose dasatinib frontline showed that efficacy may be equivalent to standard-dose dasatinib with a better tolerability and safety profile, but experience is limited in patients with high-risk ELTS scores. The ASC4FIRST trial has confirmed that tolerability and molecular response with asciminib are superior to those with both imatinib and the second-generation (2G)-TKIs. While the overall treatment failure rate was lower with asciminib, the rate of BCR::ABL1 mutations that emerged with asciminib appeared to be higher. The risk of emergent mutations appears to be highly associated with the presence of ASXL1 mutations in the CML cells at diagnosis, but more work is needed to understand the implications of this finding.

267

项与盐酸阿思尼布相关的新闻（医药）

2025-05-27

·FiercePharma

Novartis expands strategic collaboration with Shanghai Pharma in China to cover eye drugs

China has been one of Novartis’ priority geographies, alongside the U.S., Germany and Japan. With the goal to become a top 3 pharma company in China, Novartis has been busy tapping into the expertise of local drugmakers.In its latest collaboration, Novartis has signed a strategic agreement with Shanghai Pharma to help sell the Swiss company’s mature ophthalmic products in China, Shanghai Pharma said (Chinese) Monday.Novartis will leverage Shanghai Pharma’s omni-channel integrated marketing services and broad market coverage capabilities to accelerate the reach of some Novartis drugs for ocular infections and glaucoma in smaller territories not currently targeted by Novartis, according to the Chinese company.The two companies did not disclose the specific products covered by the deal. Ophthalmology is not a Novartis focus area. The company is now focused on four core therapeutic areas: cardiovascular-renal-metabolic, immunology, neuroscience and oncology.The new partnership builds on a longstanding relationship between Novartis and Shanghai Pharma.Also on Monday, the two firms unveiled (Chinese) the opening of a cardiovascular health management platform to offer patients continuous support before and after diagnosis. The platform includes a cloud-based service to offer medication guidance, test results tracking and follow-up visits.The partners labeled the platform as a part of a “specialty pharmacy” that now covers treatments for skin disease, breast cancer, high cholesterol and high blood pressure. In November 2024, Novartis China signed on (Chinese) Shanghai Pharma and C.Q. Pharmaceutical to build a supply chain for its radioligand therapies. The deal came after Novartis in July broke ground on a 600 million Chinese yuan ($83 million) on a radioligand therapy manufacturing facility in the province of Zhejiang, near Shanghai. The company expects the facility to be operational by the end of 2026.China has been one of Novartis’ priority geographies, alongside the U.S., Germany and Japan. In China, Novartis’ goal is to become a top-three multinational pharma company by sales, and CEO Vas Narasimhan recently said the company may achieve that goal this year. To contribute toward that goal, Novartis earlier this month won Chinese approvals for Kisqali as an adjuvant treatment for early-stage HR-positive, HER2-negative breast cancer and for Scemblix in newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.In 2024, Novartis saw sales from China grow 21% at constant exchange rates year-over-year to $3.9 billion. Novartis likely won’t be able to pull it off all by itself in China. Shanghai Pharma is one of the country’s largest pharma distributors and contract sales organizations (CSO). In 2024, Shanghai Pharma’s CSO business managed 65 drugs, contributing to 8 billion Chinese yuan ($1.1 billion) of those products’ annual revenue, up 177% year-over-year, according to the company’s annual report. Alongside Novartis’ radioligand therapy pact, Shanghai Pharma in November inked (Chinese) a group of commercialization deals, including with Pfizer on vaccines and with Gilead Sciences on long-acting HIV therapy, among others.Besides Shanghai Pharma, Novartis has also been working with China’s state-owned behemoth Sinopharma, which markets Novartis’ Gleevec (also known as Glivec) in the country since 2023. In January, the two signed (Chinese) a strategic collaboration to focus on oncology drugs in the future.

上市批准

2025-05-26

·echemi

Novartis Breakthrough Drug Asciminib Gains China Approval Bringing Hope to Over 75 Countries

On May 14, Novartis achieved a major regulatory milestone as asciminib tablets were officially approved by China’s NMPA for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This decision adds China to the growing list of over 75 countries, including the United States, Japan, and EU nations, where the therapy has already received market authorization. What sets asciminib apart is its revolutionary STAMP (Specifically Targeting the ABL Myristoyl Pocket) mechanism, a first-in-class and only-in-class approach that enables high specificity and reduces unwanted side effects. Instead of binding to the ATP pocket like traditional TKIs, asciminib interacts with a distinct allosteric site on the BCR-ABL protein, altering its conformation and enhancing patient tolerability. Approved initially in October 2021 by the U.S. FDA under an accelerated pathway, asciminib has rapidly expanded its reach across major global markets. In October 2024, the FDA further extended its approval to include first-line use, solidifying its role as a frontline therapy. China’s greenlight for this drug marks a significant advancement for patients with TKI resistance or intolerance. With six existing BCR-ABL inhibitors already approved in China, asciminib enters a crowded but critical landscape, offering a novel and more tolerable option. This approval strengthens Novartis’ position in oncology innovation and provides new hope for thousands of patients who previously had limited options.

上市批准加速审批CSCO会议临床研究

2025-05-25

·信狐药迅

轩竹生物乳腺癌新药吡罗西尼、海思科镇痛药HSK21542和北海康成罕见病用药维拉苷酶β获批上市| 新获批(5.19-5.25）

每周药品注册获批数据，分门别类呈现，一目了然。(5.19-5.25）新药上市申请药品名称企业注册分类受理号HSK21542注射液辽宁海思科制药有限公司1CXHS2300094吡罗西尼片轩竹生物科技股份有限公司1CXHS2300093吡罗西尼片轩竹生物科技股份有限公司1CXHS2300075盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400069盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400068盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2400067注射用维拉苷酶β北海康成(上海)生物科技有限公司1CXSS2400119贝莫苏拜单抗注射液正大天晴药业集团南京顺欣制药有限公司2.2CXSS2400082注射用卡瑞利珠单抗苏州盛迪亚生物医药有限公司2.2CXSS2300091新药临床申请药品名称企业注册分类受理号PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500257PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500256PRT-064040鼻喷雾剂四川普锐特药业有限公司1CXHL2500255HS-10510片江苏豪森药业集团有限公司1CXHL2500244HS-10510片江苏豪森药业集团有限公司1CXHL2500243SGB-3383注射液苏州圣因生物医药有限公司1CXHL2500238KEM2418缓释直服颗粒深圳珐玛易药品科技有限公司2.2CXHL2500252利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500250利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500249利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500248利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500247利奥西呱胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2500246TAP-1503 乳膏上海泽德曼医药科技有限公司2.4CXHL2500231BPR-102胶囊成都倍特益康恩生物医药科技有限公司1CXSL2500210BPR-102胶囊成都倍特益康恩生物医药科技有限公司1CXSL2500209FB1002重组人源化单克隆抗体注射液福贝生物医药科技(北京)有限公司1CXSL2500192皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500195皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500194皮炎诊断贴剂02贴浙江我武生物科技股份有限公司1CXSL2500193仿制药申请药品名称企业注册分类受理号维生素B6注射液上海禾丰制药有限公司3CYHS2501112氨溴特罗口服溶液湖北欣泽霏药业有限公司3CYHS2400652硫酸镁注射液河北一品制药股份有限公司3CYHS2400554美索巴莫注射液广州合和医药有限公司3CYHS2400448氯化钾颗粒福州基石医药科技有限公司3CYHS2400193氯化钾颗粒福州基石医药科技有限公司3CYHS2400192二羟丙茶碱注射液湖南柏齐鹤药物研发有限公司3CYHS2400173美索巴莫注射液海南普利制药股份有限公司3CYHS2400129醋酸葡萄糖维持液山东科伦药业有限公司3CYHS2400053醋酸葡萄糖维持液山东科伦药业有限公司3CYHS2400054重酒石酸间羟胺注射液武汉久安药业有限公司3CYHS2303676美索巴莫注射液北京沃邦医药科技有限公司3CYHS2303661注射用甲磺酸加贝酯石家庄四药有限公司3CYHS2303631复方电解质醋酸钠注射液山东科伦药业有限公司3CYHS2303623注射用比阿培南/氯化钠注射液湖南科伦制药有限公司3CYHS2303536异烟肼注射液广州绿十字制药股份有限公司3CYHS2303510二羟丙茶碱注射液华夏生生药业(北京)有限公司3CYHS2303378硫酸沙丁胺醇注射液山东华鲁制药有限公司3CYHS2303298二羟丙茶碱注射液武汉华尔生物科技有限公司3CYHS2303282硫酸镁注射液江西博泰药业有限公司3CYHS2303278氟马西尼注射液上海旭东海普药业有限公司3CYHS2303241氟马西尼注射液上海旭东海普药业有限公司3CYHS2303240注射用尼可地尔成都地奥九泓制药厂3CYHS2303209硫酸镁注射液焦作市民康药业有限公司3CYHS2303181甲硫酸新斯的明注射液云南先施药业有限公司3CYHS2303137甲硫酸新斯的明注射液云南先施药业有限公司3CYHS2303136生理氯化钠溶液华夏生生药业(北京)有限公司3CYHS2303121甲硫酸新斯的明注射液杭州民生药业股份有限公司3CYHS2303109甲硫酸新斯的明注射液杭州民生药业股份有限公司3CYHS2303108甲硫酸新斯的明注射液杭州民生药业股份有限公司3CYHS2303107重酒石酸去甲肾上腺素注射液中润药业有限公司3CYHS2303046重酒石酸去甲肾上腺素注射液中润药业有限公司3CYHS2303045地奈德软膏杭州领业医药科技有限公司3CYHS2303027复合磷酸氢钾注射液成都米子生物医药科技有限公司3CYHS2303010复合磷酸氢钾注射液成都欣捷高新技术开发股份有限公司3CYHS2303008酮咯酸氨丁三醇注射液广州一品红制药有限公司3CYHS2303001盐酸丙卡特罗颗粒江苏正大清江制药有限公司3CYHS2302905醋酸钠林格葡萄糖注射液成都赛诺联创生物科技有限公司3CYHS2302812复方电解质醋酸钠葡萄糖注射液仁合益康集团有限公司3CYHS2302807复方电解质醋酸钠葡萄糖注射液仁合益康集团有限公司3CYHS2302806醋酸钙口服溶液河北华晨药业集团有限公司3CYHS2302797盐酸去氧肾上腺素注射液安徽长江药业有限公司3CYHS2302659水合氯醛灌肠剂成都硕德药业有限公司3CYHS2302523利伐沙班颗粒南京海纳制药有限公司3CYHS2302484氯化钙注射液广州合和医药有限公司3CYHS2302480钠钾镁钙注射用浓溶液山东豪瑞恩制药有限公司3CYHS2302447盐酸利多卡因注射液云南药科院生物医药股份有限公司3CYHS2302400注射用阿莫西林钠广州艾奇西新药研究有限公司3CYHS2302386注射用阿莫西林钠广州艾奇西新药研究有限公司3CYHS2302385硫代硫酸钠注射液成都倍特药业股份有限公司3CYHS2302223富马酸酮替芬口服溶液海口天行健药物研究有限公司3CYHS2302211甲硫酸新斯的明注射液宝利化(南京)制药有限公司3CYHS2301868米诺地尔外用溶液浙江高跖医药科技股份有限公司3CYHS2301380卡络磺钠注射液海口天行健药物研究有限公司3CYHS2301262卡络磺钠注射液海口天行健药物研究有限公司3CYHS2301261米诺膦酸片安徽博诺美科生物医药有限公司3CYHS2301180利多卡因凝胶贴膏湖南九典制药股份有限公司3CYHS2300719卡络磺钠注射液四川汇宇海玥医药科技有限公司3CYHS2300666卡络磺钠注射液四川汇宇海玥医药科技有限公司3CYHS2300665依巴斯汀口服溶液南京海纳医药科技股份有限公司3CYHS2300635布洛氢可酮片宜昌人福药业有限责任公司3CYHS2201954国;CYHS2201954布洛氢可酮片宜昌人福药业有限责任公司3CYHS2201953国;CYHS2201953多潘立酮片温州海鹤药业有限公司4CYHS2402862甲泼尼龙片武汉九珑人福药业有限责任公司4CYHS2402356氧(液态)侨源气体(眉山)有限公司4CYHS2402288普拉洛芬滴眼液山东辰欣佛都药业股份有限公司4CYHS2401017沙格列汀二甲双胍缓释片江苏万高药业股份有限公司4CYHS2400993沙格列汀二甲双胍缓释片江苏万高药业股份有限公司4CYHS2400992盐酸伐地那非片江苏万高药业股份有限公司4CYHS2400984盐酸伐地那非片江苏万高药业股份有限公司4CYHS2400982吸入用乙酰半胱氨酸溶液海南皇隆制药股份有限公司4CYHS2400970孟鲁司特钠咀嚼片牡丹江恒远药业股份有限公司4CYHS2400855孟鲁司特钠咀嚼片牡丹江恒远药业股份有限公司4CYHS2400854妥布霉素滴眼液浙江赛默制药有限公司4CYHS2400761马来酸氟伏沙明片合肥英太制药有限公司4CYHS2400736马来酸氟伏沙明片合肥英太制药有限公司4CYHS2400735马来酸氟伏沙明片苏州第三制药厂有限责任公司4CYHS2400617马来酸氟伏沙明片苏州第三制药厂有限责任公司4CYHS2400616硫酸氨基葡萄糖胶囊江苏润邦药业有限公司4CYHS2400579马来酸氟伏沙明片江苏诺泰澳赛诺生物制药股份有限公司4CYHS2400595乙酰半胱氨酸泡腾片浙江赛默制药有限公司4CYHS2400520双氯芬酸钠缓释片锦州奥鸿药业有限责任公司4CYHS2400513双氯芬酸钠缓释片锦州奥鸿药业有限责任公司4CYHS2400512丙戊酸钠口服溶液山东达因海洋生物制药股份有限公司4CYHS2400465盐酸决奈达隆片石家庄四药有限公司4CYHS2400464盐酸奥洛他定滴眼液石家庄格瑞药业有限公司4CYHS2400399溴莫尼定噻吗洛尔滴眼液石家庄格瑞药业有限公司4CYHS2400335盐酸伐地那非片广州绿十字制药股份有限公司4CYHS2400334地夸磷索钠滴眼液深圳市华生元基因工程发展有限公司4CYHS2400318间苯三酚注射液常州四药制药有限公司4CYHS2400234吸入用丙酸倍氯米松混悬液河北创健药业有限公司4CYHS2400231盐酸伊立替康脂质体注射液无锡济煜山禾药业股份有限公司4CYHS2400207盐酸奥洛他定滴眼液乐信乐美(海南)生物科技有限公司4CYHS2400163硫酸氨基葡萄糖胶囊武汉维奥制药有限公司4CYHS2400157地夸磷索钠滴眼液郑州卓峰制药有限公司4CYHS2400151奥美沙坦酯氨氯地平片珠海润都制药股份有限公司4CYHS2400029曲伏噻吗滴眼液山东辰欣佛都药业股份有限公司4CYHS2400034注射用头孢唑肟钠安徽省先锋制药有限公司4CYHS2303664注射用头孢唑肟钠安徽省先锋制药有限公司4CYHS2303663利托那韦片福建广生中霖生物科技有限公司4CYHS2303569左氧氟沙星滴眼液山东辰欣佛都药业股份有限公司4CYHS2303542奥美沙坦酯氨氯地平片宁波大红鹰药业股份有限公司4CYHS2303522注射用盐酸美法仑凯信远达医药(无锡)有限公司4CYHS2303513注射用头孢他啶/氯化钠注射液湖南科伦制药有限公司4CYHS2303472注射用氯诺昔康天津梅花生物医药科技有限公司4CYHS2303416布洛芬混悬滴剂山东新华制药股份有限公司4CYHS2303315布洛芬混悬滴剂山东新华制药股份有限公司4CYHS2303314二甲双胍恩格列净片(I)浙江易泽达医药科技有限公司4CYHS2303310罗沙司他胶囊重庆圣华曦药业股份有限公司4CYHS2303284罗沙司他胶囊重庆圣华曦药业股份有限公司4CYHS2303283苯磺酸左氨氯地平片山东鲁抗医药股份有限公司4CYHS2303187苯磺酸左氨氯地平片山东鲁抗医药股份有限公司4CYHS2303186盐酸贝尼地平片上海安必生制药技术有限公司4CYHS2303185利奈唑胺葡萄糖注射液北京吉洛华制药有限公司4CYHS2303183枸橼酸托法替布片国药集团容生制药有限公司4CYHS2303134盐酸乌拉地尔注射液江苏迪赛诺制药有限公司4CYHS2303114达格列净二甲双胍缓释片(IV)浙江华海药业股份有限公司4CYHS2303039达格列净二甲双胍缓释片(III)浙江华海药业股份有限公司4CYHS2303038达格列净二甲双胍缓释片(I)浙江华海药业股份有限公司4CYHS2303037达格列净二甲双胍缓释片(I)浙江华海药业股份有限公司4CYHS2303036黄体酮软胶囊浙江仙琚制药股份有限公司4CYHS2302889黄体酮软胶囊浙江仙琚制药股份有限公司4CYHS2302888碘普罗胺注射液博瑞制药(苏州)有限公司4CYHS2302630碘普罗胺注射液博瑞制药(苏州)有限公司4CYHS2302629注射用硼替佐米瑞阳制药股份有限公司4CYHS2302231莫匹罗星软膏海南紫程众投生物科技有限公司4CYHS2302106注射用头孢哌酮钠舒巴坦钠浙江惠迪森药业有限公司4CYHS2302052盐酸度洛西汀肠溶胶囊北京四环制药有限公司4CYHS2300590盐酸度洛西汀肠溶胶囊北京四环制药有限公司4CYHS2300589盐酸度洛西汀肠溶胶囊北京四环制药有限公司4CYHS2300588多种油脂肪乳注射液(C6-24)四川科伦药业股份有限公司4CYHL2500048多种油脂肪乳注射液(C6-24)四川科伦药业股份有限公司4CYHL2500047进口申请药品名称企业注册分类受理号盐酸阿思尼布片Novartis Pharma Schweiz AG2.4JXHS2400043琥珀酸瑞波西利片Novartis Pharma Schweiz AG2.4JXHS2300126乙酰半胱氨酸注射液Zambon Switzerland Ltd.5.1JXHS2200025国;JXHS2200025注射用替奈普酶Boehringer Ingelheim International GmbH2.2JXSS2400001注射用坦昔妥单抗Incyte Biosciences Distribution B.V.3.1JXSS2400050MK-7240注射液Merck Sharp & Dohme LLC1JXSL2500037中药相关申请药品名称企业注册分类受理号开心散上海和黄药业有限公司3.1CXZS2400024注：橙色字体部分结论为不批准或收到通知件；

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100 项与盐酸阿思尼布相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11403 D11404	-	-	DB12597

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性期费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2024-10-29
T315I 突变的慢性期费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2024-10-29
慢性粒细胞性白血病	日本	Novartis Pharmaceuticals KK	2022-03-28
费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2021-10-29

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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	Novartis Pharma AG	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	Novartis Pharma AG	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	Novartis Pharma AG	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	Novartis Pharma AG	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	Novartis Pharma AG	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	Novartis Pharma AG	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	Novartis Pharma AG	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	Novartis Pharma AG	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	Novartis Pharma AG	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	Novartis Pharma AG	2022-08-30

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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


NCT03595917 (Phase I study, ASCO2025)	临床1期	ABL1 T315I \| p190 \| p210 ... 更多	15	Asciminib 80 mg/d	鬱糧構獵鬱鬱艱鑰鹹繭(網膚範網願鬱餘夢製觸) = 鑰鹹築遞顧範壓餘簾醖衊獵築鏇餘鹹襯築鹹廠 (蓋顧壓鏇築網遞願鹹夢 ) 更多	积极	2025-05-30
				Dasatinib 140 mg/d	製觸膚獵製顧膚襯襯願(壓鹹憲憲構齋網構構網) = 簾蓋繭齋網淵觸淵廠鬱餘糧獵醖鬱鏇築襯膚願 (艱選夢願遞築淵願淵繭 )
NCT04971226 (ASC4FIRST, CTgov)	临床3期	费城染色体阳性慢性粒细胞白血病	406	Asciminib (Asciminib (All Asciminib ))	廠顧鏇範窪壓醖築顧繭 = 構蓋鹹願鏇夢餘鏇顧選製襯鑰鏇鑰窪簾簾憲淵 (簾鹹選鏇衊餘鑰糧觸餘, 糧鏇顧膚壓繭糧壓構網 ~ 製網顧廠築遞壓鏇觸簾) 更多	-	2025-03-10
				dasatinib+nilotinib+imatinib+bosutinib (Investigator Selected TKI (All Comparators))	廠顧鏇範窪壓醖築顧繭 = 簾夢獵鬱積觸夢築憲築製襯鑰鏇鑰窪簾簾憲淵 (簾鹹選鏇衊餘鑰糧觸餘, 簾壓鏇鏇築鏇繭衊網餘 ~ 膚構壓積窪壓蓋膚積構) 更多
NCT03578367 (ASC4MORE, CTgov)	临床2期	慢性期慢性髓性白血病 \| 慢性期费城染色体阳性慢性粒细胞白血病	104	Asciminib add-on+Imatinib (Asciminib 40mg QD + Imatinib 400mg QD)	構觸製範遞選遞壓鏇願 = 願艱餘淵鑰醖鑰襯衊獵範築膚繭顧鹽鏇壓鏇選 (膚鑰廠範鹹鹽範觸衊蓋, 積窪膚鬱簾鏇鏇蓋製製 ~ 齋構夢鬱糧餘鬱衊顧齋) 更多	-	2025-02-14
				Asciminib add-on+Imatinib (Asciminib 60mg QD + Imatinib 400mg QD)	構觸製範遞選遞壓鏇願 = 淵製顧夢窪繭糧夢範衊範築膚繭顧鹽鏇壓鏇選 (膚鑰廠範鹹鹽範觸衊蓋, 鏇窪選積憲鏇選鑰鹹蓋 ~ 艱願築鑰淵繭鹹網觸淵) 更多
NCT04971226 (ASC4FIRST, NEWS) 人工标引	临床3期	慢性期慢性髓性白血病一线	405	Scemblix® 80mg	構鬱衊鬱顧壓醖壓襯糧(齋選夢鏇鏇遞遞選網夢) = 鹽顧齋壓膚艱齋鏇鹹築繭簾糧餘願蓋鏇觸遞網 (構顧簾餘獵繭構窪夢積 ) 更多	积极	2025-01-10
				Standard of Care TKIs	構鬱衊鬱顧壓醖壓襯糧(齋選夢鏇鏇遞遞選網夢) = 糧選齋遞鹹繭願繭蓋壓繭簾糧餘願蓋鏇觸遞網 (構顧簾餘獵繭構窪夢積 ) 更多
NCT03578367 (ASC4MORE, Pubmed \| J Hematol Oncol)	临床2期	慢性期慢性髓性白血病 \| 慢性期费城染色体阳性慢性粒细胞白血病追加	84	Asciminib 40 mg QD add-on to Imatinib 400 mg QD	築範艱膚憲網壓窪鹽壓(艱獵鏇膚廠簾遞願廠獵) = 鹽蓋糧憲糧餘齋鏇襯鹽構鹽遞願網顧製襯鏇顧 (製網範夢製選觸積醖願 ) 更多	积极	2024-12-18
				Asciminib 60 mg QD add-on to Imatinib 400 mg QD	築範艱膚憲網壓窪鹽壓(艱獵鏇膚廠簾遞願廠獵) = 顧製鏇簾鏇鹽艱繭蓋遞構鹽遞願網顧製襯鏇顧 (製網範夢製選觸積醖願 ) 更多
ASH2024	N/A	慢性期慢性髓性白血病	-	Asciminib	壓築餘夢鹽憲觸餘齋淵(獵襯襯選窪顧獵鑰膚淵) = less frequent in the RW settings 醖襯糧網簾獵襯選鑰觸 (築憲繭廠鬱艱鏇觸鑰築 ) 更多	-	2024-12-09
				Placebo
ASH2024	N/A	慢性期慢性髓性白血病	-	Asciminib 80 mg once daily	觸蓋夢艱艱襯選範淵醖(艱襯鹹壓鏇選願製餘壓) = NIL, 2.0% 獵獵艱觸範餘膚衊夢憲 (積艱願願顧獵積製夢遞 ) 更多	-	2024-12-08
				Imatinib (IMA)
ASH2024	N/A	慢性粒细胞性白血病	-	Asciminib 200 mg BID	製鬱構醖繭膚製壓願餘(糧鹽遞簾選醖窪鏇鏇糧) = 4 [8.3%] 膚繭選鹽築築蓋網衊鹹 (艱襯衊遞夢網網簾範艱 ) 更多	-	2024-12-07
				Ponatinib
NCT03106779 (ASCEMBL, FDA_CDER) 人工标引	临床3期	慢性期费城染色体阳性慢性粒细胞白血病	233	SCEMBLIX 40 mg twice daily	鹹壓憲願憲襯繭衊壓淵(遞衊顧襯繭願築淵網構) = 鹽齋積構壓獵淵願積醖簾範獵醖簾齋製廠鬱憲 (壓窪醖獵鹹壓齋窪遞衊, 19 ~ 33) 更多	积极	2024-10-29
				Bosutinib 500 mg once daily	鹹壓憲願憲襯繭衊壓淵(遞衊顧襯繭願築淵網構) = 襯艱觸願鏇觸淵醖窪襯簾範獵醖簾齋製廠鬱憲 (壓窪醖獵鹹壓齋窪遞衊, 6.5 ~ 23) 更多
NCT04971226 (ASC4FIRST, FDA_CDER) 人工标引	临床3期	慢性期费城染色体阳性慢性粒细胞白血病一线	405	SCEMBLIX 80 mg once daily (All patients)	願淵築願範夢蓋選範齋(顧糧獵廠襯艱淵艱衊衊) = 構壓鹽夢窪壓積齋壓網網鏇醖糧觸製鏇淵糧壓 (夢網簾蓋夢襯廠蓋齋憲, 61 ~ 74) 更多	积极	2024-10-29
				SCEMBLIX 80 mg once daily (Imatinib stratum)	願淵築願範夢蓋選範齋(顧糧獵廠襯艱淵艱衊衊) = 範鹹糧繭鬱鑰艱鹹願築網鏇醖糧觸製鏇淵糧壓 (夢網簾蓋夢襯廠蓋齋憲, 59 ~ 78)