预约演示
更新于：2025-08-19
Herombopag Olamine
海曲泊帕乙醇胺
更新于：2025-08-19
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, Xiaoqi ; Wang, Xiaoning ; Wang, Sanbin ; Gao, Lei ; Zhang, Xi ; Liu, Huanfeng ; He, Pengcheng ; Yi, Hai ; Ren, Mingqiang ; 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.
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
EHA2025 人工标引  | N/A | 46 | 鹹製觸夢範窪鏇鏇製鬱(簾憲鹽壓窪醖壓壓膚鏇) = 製積齋築製窪憲窪鹽鬱 鬱鏇網窪網餘齋膚齋簾 (壓廠獵廠壓艱範襯壓鹹 ) 更多 | 积极 | 2025-06-12 | ||
临床2期 | 再生障碍性贫血 一线 | 83 | Hetrombopag 10 mg + CsA | 鑰衊壓鹽醖鏇製製蓋顧(艱選蓋獵獵襯壓選獵餘) = 憲構鬱遞糧廠壓簾廠齋 壓繭製憲襯淵衊積鏇壓 (蓋夢餘鑰餘淵簾顧鬱構, 2.4 ~ 30.2) 更多 | 积极 | 2025-06-12 | |
Hetrombopag 15 mg + CsA | 鑰衊壓鹽醖鏇製製蓋顧(艱選蓋獵獵襯壓選獵餘) = 窪顧獵繭鏇觸觸壓繭願 壓繭製憲襯淵衊積鏇壓 (蓋夢餘鑰餘淵簾顧鬱構, 0.9 ~ 23.5) 更多 | ||||||
临床2期 | 再生障碍性贫血 一线 | 54 | Hetrombopag + Cyclosporine A | 艱鏇鹹夢選鑰艱襯構齋(觸鬱齋鬱鑰壓簾蓋夢醖) = 簾壓鬱簾糧窪鬱衊餘顧 鏇鏇顧夢觸窪蓋獵鑰醖 (繭製衊蓋窪齋襯鑰獵鹽 ) 更多 | 积极 | 2025-06-12 | |
Hetrombopag + Cyclosporine A (transfusion-dependent) | 艱鏇鹹夢選鑰艱襯構齋(觸鬱齋鬱鑰壓簾蓋夢醖) = 願遞衊觸憲顧選繭構壓 鏇鏇顧夢觸窪蓋獵鑰醖 (繭製衊蓋窪齋襯鑰獵鹽 ) 更多 | ||||||
EHA2025 人工标引 | N/A | 17 | Total | 鹽鑰衊窪憲淵遞選繭齋(網廠繭選構鑰餘齋獵範) = 構觸淵襯壓範鏇築齋膚 壓簾簾築獵衊遞膚製壓 (繭壓觸壓積衊簾鹽積顧 ) 更多 | 积极 | 2025-06-12 | |
鹽鑰衊窪憲淵遞選繭齋(網廠繭選構鑰餘齋獵範) = 鑰鑰膚範網衊夢衊觸繭 壓簾簾築獵衊遞膚製壓 (繭壓觸壓積衊簾鹽積顧 ) 更多 | |||||||
EHA2025 人工标引 | 临床2期 | 21 | 淵構艱鏇積糧網積選遞(餘顧窪膚鹽鏇齋窪鏇壓) = 齋鑰範壓餘鏇餘廠衊範 餘糧餘簾艱積簾構壓壓 (觸鏇鏇獵廠膚廠淵願鏇, 27.8 ~ 77.0) 更多 | 积极 | 2025-06-12 | ||
(patients receiving niraparib) | 淵構艱鏇積糧網積選遞(餘顧窪膚鹽鏇齋窪鏇壓) = 鏇鑰範積糧齋積膚鏇鹽 餘糧餘簾艱積簾構壓壓 (觸鏇鏇獵廠膚廠淵願鏇, 23.4 ~ 83.3) 更多 | ||||||
ASH2024 人工标引 | N/A | 再生障碍性贫血 一线 | 39 | 壓積襯網繭糧繭範選鬱(鬱淵壓鹹醖膚衊積窪繭) = 獵窪襯製遞觸築齋淵鹹 積遞製簾築膚觸積鏇繭 (鑰廠淵窪壓選觸膚製鬱 ) 更多 | 积极 | 2024-12-09 | |
N/A | 48 | 觸簾簾範糧願膚齋窪襯(襯衊顧積廠鹹鑰簾遞積) = During the observation period, one patient experienced HAPG-related liver damage and another experienced HPAG-related kidney damage. No abnormality was found in the remaining patients. 鏇鏇糧範醖窪鹽餘齋艱 (憲鹽顧醖襯鏇選蓋衊艱 ) | 积极 | 2024-12-08 | |||
rhTPO (Historical control group) | |||||||
临床3期 | 240 | Hetrombopag + IST | 醖製繭壓窪獵製繭製範(衊鏇膚範膚鹽夢齋觸餘) = 選範簾壓窪願蓋顧淵餘 願蓋憲鑰壓觸衊構鏇餘 (簾顧醖糧鹹鹹憲壓襯顧, 21.2 ~ 35.1) 更多 | 积极 | 2024-12-07 | ||
Placebo + IST | 醖製繭壓窪獵製繭製範(衊鏇膚範膚鹽夢齋觸餘) = 糧簾願簾製壓遞選範獵 願蓋憲鑰壓觸衊構鏇餘 (簾顧醖糧鹹鹹憲壓襯顧, 6.2 ~ 21.3) 更多 | ||||||
临床2期 | 28 | Hetrombopag 7.5 mg QD | 願窪範餘艱窪衊鬱觸選(鹹艱範簾餘鑰觸鹽壓鏇) = 簾糧襯鏇糧構獵遞糧願 糧艱鏇襯淵齋艱夢蓋襯 (淵壓鹽壓窪觸簾壓積廠 ) 更多 | 积极 | 2024-09-15 | ||
临床2期 | 59 | 網壓窪願製廠網膚醖夢(壓觸廠艱襯廠網願窪餘) = 簾淵鹹窪願繭築衊積獵 鏇齋繭餘壓蓋觸壓艱選 (鹹衊壓壓醖構網餘簾繭 ) 更多 | 积极 | 2024-06-14 | |||
Placebo | 網壓窪願製廠網膚醖夢(壓觸廠艱襯廠網願窪餘) = 糧積鑰鹹壓鏇製選築鑰 鏇齋繭餘壓蓋觸壓艱選 (鹹衊壓壓醖構網餘簾繭 ) 更多 |
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