预约演示
更新于：2025-08-11
Herombopag Olamine
海曲泊帕乙醇胺
更新于：2025-08-11
概要
基本信息
药物类型 小分子化药 |
别名 Hengqu、Hetrombopag、Hetrombopag olamine + [7] |
作用方式 激动剂 |
作用机制 TPO receptor激动剂(血小板生成素受体激动剂) |
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 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国)、附条件批准 (中国)、特殊审批 (中国) |
登录后查看时间轴
结构/序列
分子式C25H22N4O5 |
InChIKeyBDGGFTDRPHKXFC-QYQHSDTDSA-N |
CAS号2600513-51-5 |
关联
84
项与 海曲泊帕乙醇胺 相关的临床试验NCT07101627
A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy
ChiCTR2500102115
A Multicenter, Randomized, Controlled Clinical Study of Hetrombopag Olamine versus Recombinant Human Thrombopoietin in the Treatment of Cancer Therapy Induced Thrombocytopenia
ChiCTR2500099907
Study on the effectiveness and safety of Hetrombopag in promoting platelet reconstruction after umbilical cord blood transplantation in children or adolescents
100 项与 海曲泊帕乙醇胺 相关的临床结果
登录后查看更多信息
100 项与 海曲泊帕乙醇胺 相关的转化医学
登录后查看更多信息
100 项与 海曲泊帕乙醇胺 相关的专利（医药）
登录后查看更多信息
48
项与 海曲泊帕乙醇胺 相关的文献（医药）2025-11-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Mechanism-based perspective on metal ion-induced signal instability and development of a robust LC-MS/MS method for trace quantification of hetrombopag in plasma
Article
作者: Chen, Jiao ; Dai, Biying ; Wang, Jie ; Wang, Xiaoli ; Han, Jiangbin ; Wu, Yuyu ; Qian, Wen ; Lu, Huiyue ; Zhai, Lijuan
Hetrombopag (Hengqu®) is an oral nonpeptide thrombopoietin receptor agonist for the treatment of thrombocytopenia and aplastic anemia. Research on the pharmacokinetic behavior is very important, but accurate quantification of metal-sensitive hetrombopag in biological specimens is a challenging analytical problem. In view of the presence of trace metals from a variety of sources, such as chromatographic system, containers, and the mass spectrometry spray needle, which can contribute to poor peak shape, tailing, and diminished recovery of compound. To ameliorate these problems, different solvent additives, mobile phase, containers and precipitant reagents were investigated to reduce the negative effects. In the present study, a robust, selective, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of hetrombopag in dog plasma was developed based on the dual strategies: (1) 6 % perchloric acid in acetonitrile eliminates metal ion adsorption in storage containers, and (2) 0.01 % trifluoroacetic acid (TFA) in the mobile phase suppresses chelation in chromatographic systems. These two solvents are essential requirements for ensuring stable analytical signals. This method employed an InfinityLab Poroshell 120 EC-C18 column (4.6 ×50 mm, 2.7 μm, Agilent) with a gradient system comprising 0.01 % trifluoroacetic acid with 10 mM ammonium formate (phase A) and a mixture of H2O: methanol: isopropanol (1:10:10, v/v/v) containing 0.01 % trifluoroacetic acid and 10 mM ammonium formate (phase B). The column temperature of 50℃ and the addition of isopropanol were beneficial for the separation of interfering peaks and target analyte peaks in plasma. The method exhibits excellent linearity over 3 orders of magnitude. The method achieved a lower limit of quantification (LLOQ) of 0.10 ng/mL using only 50 μL of plasma, with precision (RSD ≤ 8.83 %) and accuracy (88.4-102.2 %) within acceptable limits. The method was applied to determine the plasma concentration of hetrombopag in eight male beagle dogs after each administration of three 2.5 mg hetrombopag tablets. The analytical methodology described in the present work should be useful in the future work aiming to establish a model relating metal-sensitive other compounds.
2025-09-01AMERICAN JOURNAL OF HEMATOLOGY
Efficacy and Safety of Hetrombopag Versus Thrombopoietin in Promoting Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Randomized Controlled Clinical Trial
Article
作者: Chen, Ting ; Zhao, Lu ; Wang, Dan ; Feng, Yimei ; Wang, Lu ; Ma, Liangliang ; Xing, Hongyun ; Deng, Jianchuan ; Zhu, Lidan ; Yao, Han ; Wang, Sanbin ; Wang, Xiaoqi ; Wang, Xiaoning ; Gao, Lei ; Zhang, Xi ; Liu, Huanfeng ; He, Pengcheng ; Ren, Mingqiang ; Yi, Hai ; Liu, Jia ; Tang, Shuhan ; Wang, Linhui ; Liu, Yuqing ; Lang, Tao ; Li, Li ; Kong, Peiyan ; Gao, Shichun ; Wang, Jishi ; Lou, Shifeng
ABSTRACT:
Allogeneic hematopoietic stem cell transplantation (allo‐HSCT) is pivotal for hematological malignancies but faces challenges in delayed platelet engraftment, poor graft function (PGF), and bleeding risks. Hetrombopag, a thrombopoietin receptor agonist, was evaluated to enhance platelet recovery posttransplant. Patients undergoing allo‐HSCT were randomized on Day 3 Post‐Infusion into low‐dose (2.5 mg/day), high‐dose (5 mg/day) hetrombopag groups, or a control group receiving thrombopoietin (300 U/kg/day). Endpoints included platelet/neutrophil engraftment time, PGF incidence, transfusion needs, and safety. Among 212 analyzed patients, platelet engraftment was faster in hetrombopag groups (median 13 days) versus controls (15 days; p = 0.0022), with no dose‐dependent difference (p = 0.0593). Neutrophil engraftment was also accelerated (13 vs. 15 days; p = 0.0001). PGF incidence was lower in hetrombopag groups (5.04%) versus controls (13.7%; p = 0.027). The experimental group required fewer platelet transfusions (p = 0.002), had reduced gastrointestinal bleeding, and lower costs. Secondary platelet recovery failure showed no intergroup differences. Hetrombopag safely accelerates platelet and neutrophil engraftment, reduces PGF risk, and decreases transfusion dependency post‐allo‐HSCT. Low‐dose hetrombopag demonstrated efficacy equivalent to high‐dose, offering a cost‐effective strategy to improve transplant outcomes.Trial Registration: ChiCTR2200057764.
2025-07-01EUROPEAN JOURNAL OF HAEMATOLOGY
Comparison of Hetrombopag and Eltrombopag Added to First‐Line Immunosuppressive Therapy in Severe Aplastic Anemia
Article
作者: Kang, Rui ; Jing, Liping ; Zhang, Li ; Yang, Wenrui ; Zhang, Fengkui ; Hu, Xiangrong ; Zhao, Xin ; Shi, Jun ; Zhang, Baohang ; Shi, Yimeng ; Yuan, Weiping
ABSTRACT:
The addition of thrombopoietin receptor agonists (TPO‐RAs) to immunosuppressive therapy (IST) improves the hematologic response rate and quality in patients with severe aplastic anemia (SAA). However, no studies have yet reported on whether there are differences in the efficacy of TPO‐RAs. Here, we retrospectively analyzed the clinical data of SAA patients who received hetrombopag (HPAG) or eltrombopag (EPAG) as part of first‐line standard IST to compare the efficacy. Sixty‐seven patients were enrolled in the HPAG group and 42 patients in the EPAG group. The overall hematologic response (OR) rates of the HPAG group at 3 and 6 months after IST were 50.7% and 65.6%, respectively, close to that of the EPAG group (50%, p = 0.973; 73.8%, p = 0.494). The rates of complete response (CR) at 3 and 6 months were 13.4% and 31.3% in the HPAG group, respectively, which were like those in the EPAG group (11.9% and 28.6%), with no statistical difference (p = 1.00 and 0.59). The median time to first response (3.0 vs. 3.2 months, p = 0.79) was similar in HPAG and EPAG. The overall survival (OS) rates were 91.0% and 92.8% in the HPAG group and EPAG group (p = 0.53), respectively. Monosomy 7 was detected in one patient in the EPAG group and her disease transformed into acute myelocytic leukemia (AML) at 25 months after ATG treatment. One patient in HPAG had trisomy 8 at 9 months of ATG treatment, and bone marrow examination showed no disease progression.
Conclusion:
The addition of HPAG to standard IST in SAA patients showed similar response rates and response quality to that of EPAG. HPAG could be an alternative to EPAG for the first‐line treatment of SAA patients.
208
项与 海曲泊帕乙醇胺 相关的新闻（医药）2025-08-09
·赛柏蓝
带量采购核酸药物引进/卖出
2025-08-06
·恒瑞医药
临床3期上市批准申请上市
2025-08-06
·恒瑞医药
抗体药物偶联物孤儿药快速通道上市批准
100 项与 海曲泊帕乙醇胺 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 |
|---|---|---|---|
| 再生障碍性贫血 | 中国 | 2021-06-16 | |
| 慢性血小板减少症 | 中国 | 2021-06-16 | |
| 免疫性血小板减少症 | 中国 | 2021-06-16 |
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 |
|---|---|---|---|---|
| 慢性肝病 | 临床3期 | 中国 | 2024-07-31 | |
| 血小板减少症 | 临床3期 | 美国 | 2022-01-11 | |
| 血小板减少症 | 临床3期 | 澳大利亚 | 2022-01-11 | |
| 血小板减少症 | 临床3期 | 欧洲 | 2022-01-11 | |
| 膀胱癌 | 临床3期 | 中国 | 2019-11-06 | |
| 乳腺癌 | 临床3期 | 中国 | 2019-11-06 | |
| 淋巴瘤 | 临床3期 | 中国 | 2019-11-06 | |
| 非小细胞肺癌 | 临床3期 | 中国 | 2019-11-06 | |
| 胰腺癌 | 临床3期 | 中国 | 2019-11-06 | |
| 实体瘤 | 临床3期 | 中国 | 2019-11-06 |
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
临床2期 | 再生障碍性贫血 一线 | 83 | Hetrombopag 10 mg + CsA | 鹽憲築構構構艱築獵窪(鏇築蓋遞糧鬱構襯願簾) = 壓獵獵鹽獵鬱製糧願構 壓餘蓋範鬱觸醖鏇積顧 (蓋憲觸襯壓遞鹹窪壓製, 2.4 ~ 30.2) 更多 | 积极 | 2025-06-12 | |
Hetrombopag 15 mg + CsA | 鹽憲築構構構艱築獵窪(鏇築蓋遞糧鬱構襯願簾) = 簾襯網艱鏇鑰醖廠鹽願 壓餘蓋範鬱觸醖鏇積顧 (蓋憲觸襯壓遞鹹窪壓製, 0.9 ~ 23.5) 更多 | ||||||
EHA2025 人工标引  | 临床2期 | 21 | 網憲壓製築淵鑰獵網範(鏇鑰製醖壓淵衊淵蓋廠) = 艱襯壓膚鑰醖艱淵鑰齋 壓遞衊鑰膚遞構遞憲蓋 (衊鬱廠廠廠鬱積範憲選, 27.8 ~ 77.0) 更多 | 积极 | 2025-06-12 | ||
(patients receiving niraparib) | 網憲壓製築淵鑰獵網範(鏇鑰製醖壓淵衊淵蓋廠) = 齋觸襯鏇衊選鬱網淵積 壓遞衊鑰膚遞構遞憲蓋 (衊鬱廠廠廠鬱積範憲選, 23.4 ~ 83.3) 更多 | ||||||
临床2期 | 再生障碍性贫血 一线 | 54 | Hetrombopag + Cyclosporine A | 觸糧選簾醖繭鑰獵願鬱(積衊鬱鏇製鹽遞鬱餘鑰) = 憲糧遞遞願鏇網選觸衊 鑰窪齋遞淵鹹選壓顧壓 (鹹艱憲鑰鹹選積獵鏇鏇 ) 更多 | 积极 | 2025-06-12 | |
Hetrombopag + Cyclosporine A (transfusion-dependent) | 觸糧選簾醖繭鑰獵願鬱(積衊鬱鏇製鹽遞鬱餘鑰) = 襯鑰窪鑰築鹽獵積憲網 鑰窪齋遞淵鹹選壓顧壓 (鹹艱憲鑰鹹選積獵鏇鏇 ) 更多 | ||||||
EHA2025 人工标引 | N/A | 46 | 製鹽艱鹹獵觸齋艱鬱簾(獵糧鏇獵鑰鹽鑰齋鏇繭) = 網廠糧顧簾鹹窪構顧鏇 壓膚築顧鬱窪餘膚顧鬱 (構獵窪膚願遞夢積衊製 ) 更多 | 积极 | 2025-06-12 | ||
EHA2025 人工标引 | N/A | 17 | Total | 鏇襯選築鹹鏇窪窪繭築(襯觸窪憲鑰廠蓋構願鏇) = 築憲簾膚齋顧齋糧鬱壓 齋蓋鏇夢襯齋願鏇製獵 (膚繭觸糧遞鏇鏇夢膚壓 ) 更多 | 积极 | 2025-06-12 | |
鏇襯選築鹹鏇窪窪繭築(襯觸窪憲鑰廠蓋構願鏇) = 壓衊窪鏇積繭願膚觸觸 齋蓋鏇夢襯齋願鏇製獵 (膚繭觸糧遞鏇鏇夢膚壓 ) 更多 | |||||||
临床2期 | 再生障碍性贫血 一线 | 83 | Hetrombopag 10 mg + CsA | 壓製衊鬱餘夢築願襯蓋(糧鬱願獵製糧簾網構鑰) = 壓壓繭糧襯夢觸衊觸選 醖鏇襯願鏇襯窪鹹網鬱 (構淵製獵願顧淵鬱網範, 2.4% ~ 30.2%) 更多 | 积极 | 2025-05-14 | |
Hetrombopag 15 mg + CsA | 壓製衊鬱餘夢築願襯蓋(糧鬱願獵製糧簾網構鑰) = 願簾餘夢衊衊範鏇製餘 醖鏇襯願鏇襯窪鹹網鬱 (構淵製獵願顧淵鬱網範, 0.9% ~ 23.5%) 更多 | ||||||
临床2期 | 再生障碍性贫血 一线 | 54 | Hetrombopag + Cyclosporine | 膚襯範製膚齋遞蓋範顧(網簾襯鹽獵淵壓鏇憲積) = 14.8% 願築鏇醖壓鏇壓衊簾鹽 (衊觸壓壓構憲簾顧淵膚 ) 更多 | 积极 | 2025-05-14 | |
临床2期 | 21 | Hetrombopag 5 mg | 廠繭廠構範艱壓選願積(範壓壓齋艱衊獵範醖遞) = two patients reporting fatigue 廠鹹夢鹹蓋遞齋遞餘鑰 (淵廠襯壓鹹構範鏇築艱 ) 更多 | 积极 | 2025-05-14 | ||
N/A | 46 | Hetrombopag + High-dose Dexamethasone | 獵襯鬱衊醖鑰積遞醖獵(觸構鬱膚選艱鏇鹽構醖) = 窪襯觸築積膚餘製蓋鏇 憲襯築廠獵獵膚憲選餘 (獵構願廠艱製蓋窪憲鏇 ) 更多 | 积极 | 2025-05-14 | ||
ASH2024 人工标引 | N/A | 再生障碍性贫血 一线 | 39 | 獵繭網鑰衊繭構鹽齋淵(顧餘憲鏇鬱範選選壓壓) = 積鹹艱衊壓簾構艱鹹鹹 蓋鬱鑰齋壓膚艱窪鹽憲 (衊襯繭醖顧遞窪齋淵糧 ) 更多 | 积极 | 2024-12-09 |
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
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
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