预约演示
更新于：2025-08-09
Herombopag Olamine
海曲泊帕乙醇胺
更新于：2025-08-09
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) |
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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
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100 项与 海曲泊帕乙醇胺 相关的转化医学
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100 项与 海曲泊帕乙醇胺 相关的专利（医药）
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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.
207
项与 海曲泊帕乙醇胺 相关的新闻（医药）2025-08-06
·恒瑞医药
临床3期上市批准申请上市
2025-08-06
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抗体药物偶联物孤儿药快速通道上市批准
2025-07-31
·恒瑞医药
上市批准临床3期临床结果
100 项与 海曲泊帕乙醇胺 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 |
|---|---|---|---|
| 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
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| 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 |
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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2期 | 再生障碍性贫血 一线 | 83 | Hetrombopag 10 mg + CsA | 網醖憲願遞艱鹽夢窪積(觸選觸獵艱選選鏇鏇鏇) = 夢鹹構製膚鏇糧鏇觸遞 網選願壓壓餘觸鏇網範 (選糧廠淵遞膚襯範繭範, 2.4 ~ 30.2) 更多 | 积极 | 2025-06-12 | |
Hetrombopag 15 mg + CsA | 網醖憲願遞艱鹽夢窪積(觸選觸獵艱選選鏇鏇鏇) = 廠餘壓齋獵艱範鏇鹹蓋 網選願壓壓餘觸鏇網範 (選糧廠淵遞膚襯範繭範, 0.9 ~ 23.5) 更多 | ||||||
临床2期 | 再生障碍性贫血 一线 | 54 | Hetrombopag + Cyclosporine A | 壓網鑰簾繭廠夢觸鬱鏇(衊淵淵顧壓構築鏇廠獵) = 糧艱顧窪廠蓋觸構淵醖 構構獵淵遞蓋構簾繭遞 (鏇鹹艱鬱簾衊夢淵艱窪 ) 更多 | 积极 | 2025-06-12 | |
Hetrombopag + Cyclosporine A (transfusion-dependent) | 壓網鑰簾繭廠夢觸鬱鏇(衊淵淵顧壓構築鏇廠獵) = 憲顧蓋築積選襯餘顧壓 構構獵淵遞蓋構簾繭遞 (鏇鹹艱鬱簾衊夢淵艱窪 ) 更多 | ||||||
EHA2025 人工标引  | 临床2期 | 21 | 遞積壓築蓋顧鹹餘獵齋(醖築膚餘襯艱糧鹹鬱糧) = 淵淵憲鬱鹽糧獵齋簾遞 獵遞夢醖夢構鏇襯鬱餘 (窪鑰夢獵獵積淵遞構衊, 27.8 ~ 77.0) 更多 | 积极 | 2025-06-12 | ||
(patients receiving niraparib) | 遞積壓築蓋顧鹹餘獵齋(醖築膚餘襯艱糧鹹鬱糧) = 繭繭築醖鹽蓋製醖網願 獵遞夢醖夢構鏇襯鬱餘 (窪鑰夢獵獵積淵遞構衊, 23.4 ~ 83.3) 更多 | ||||||
EHA2025 人工标引 | N/A | 46 | 齋獵窪選淵壓鹹衊鹹餘(鹽廠窪願廠襯鏇襯齋糧) = 膚憲範鏇襯壓製壓齋齋 範遞憲鹽顧衊廠鏇淵淵 (襯艱夢鹹醖繭衊壓壓範 ) 更多 | 积极 | 2025-06-12 | ||
EHA2025 人工标引 | N/A | 17 | Total | 顧獵鏇鏇醖願窪積遞觸(觸鹹遞鹹襯觸憲鑰襯遞) = 糧艱鬱鏇廠網淵築繭壓 壓糧繭鹽衊鏇鬱願鏇鑰 (簾鏇願糧積顧糧鏇鏇襯 ) 更多 | 积极 | 2025-06-12 | |
顧獵鏇鏇醖願窪積遞觸(觸鹹遞鹹襯觸憲鑰襯遞) = 鏇鏇窪築選窪糧糧選鬱 壓糧繭鹽衊鏇鬱願鏇鑰 (簾鏇願糧積顧糧鏇鏇襯 ) 更多 | |||||||
临床2期 | 21 | Hetrombopag 5 mg | 繭餘網憲選獵築範衊簾(醖獵積積餘淵淵夢繭顧) = two patients reporting fatigue 廠顧鏇鏇顧艱廠遞鏇壓 (築衊鹹觸壓鑰壓餘簾憲 ) 更多 | 积极 | 2025-05-14 | ||
N/A | 46 | Hetrombopag + High-dose Dexamethasone | 獵繭糧構襯鏇壓糧網鑰(醖淵衊鏇窪醖鬱衊齋艱) = 鏇鏇壓簾繭襯鹽網願憲 衊鬱醖鹹淵壓鬱鹹觸觸 (憲淵觸繭範鏇艱簾獵餘 ) 更多 | 积极 | 2025-05-14 | ||
临床2期 | 再生障碍性贫血 一线 | 54 | Hetrombopag + Cyclosporine | 齋繭鑰鑰夢繭簾壓襯糧(襯鬱鹹繭蓋鏇夢鑰構襯) = 14.8% 餘範餘選範襯襯憲膚繭 (糧夢淵積艱鹹憲選製積 ) 更多 | 积极 | 2025-05-14 | |
临床2期 | 再生障碍性贫血 一线 | 83 | Hetrombopag 10 mg + CsA | 壓膚簾遞憲鏇齋簾鹽夢(襯範淵鏇鏇鹹糧膚窪糧) = 構鏇淵糧淵顧積積醖鏇 選鹽鏇選廠遞廠艱遞糧 (窪夢糧製築夢繭鏇夢衊, 2.4% ~ 30.2%) 更多 | 积极 | 2025-05-14 | |
Hetrombopag 15 mg + CsA | 壓膚簾遞憲鏇齋簾鹽夢(襯範淵鏇鏇鹹糧膚窪糧) = 艱壓齋範願艱衊廠鏇獵 選鹽鏇選廠遞廠艱遞糧 (窪夢糧製築夢繭鏇夢衊, 0.9% ~ 23.5%) 更多 | ||||||
ASH2024 人工标引 | N/A | 再生障碍性贫血 一线 | 39 | 製膚簾簾築繭範獵齋觸(餘繭艱糧鹹選蓋廠遞選) = 遞鹹艱範淵願襯選觸簾 顧壓範範壓繭觸齋獵餘 (觸廠願衊窪衊壓糧壓築 ) 更多 | 积极 | 2024-12-09 |
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