预约演示
更新于：2025-08-02
Herombopag Olamine
海曲泊帕乙醇胺
更新于：2025-08-02
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)、附条件批准 (中国)、优先审评 (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
83
项与 海曲泊帕乙醇胺 相关的临床试验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
ChiCTR2500098993
Efficacy and Safety of Hetrombopag Plus rhIL-11 for Chemotherapy-Induced Thrombocytopenia in Cancer Patients
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.
2025-07-01EUROPEAN 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.
2025-06-01Transplantation and Cellular Therapy
Herombopag Versus rhTPO in Stem Cell Transplantation: A Comparative Study of Efficacy, Safety, and Cost-Effectiveness
Article
作者: Luo, Zhiming ; Cao, Chun ; Zeng, Hanqing ; Luo, Fenglian ; Luo, Yun ; Chen, Ying
BACKGROUND:
Thrombocytopenia remains a significant clinical challenge following peripheral blood stem cell transplantation (PBSCT), with delayed platelet engraftment (DPE) associated with increased morbidity and mortality. While current strategies including platelet transfusions and recombinant human thrombopoietin (rhTPO) are widely used, their clinical utility is constrained by suboptimal efficacy, high costs, and administration challenges. Herombopag, a novel second-generation thrombopoietin receptor agonist (TPO-RA), presents potential advantages due to its oral bioavailability and unique mechanism of action. This retrospective study aimed to comprehensively compare herombopag with rhTPO in terms of hematopoietic recovery, safety profile, and economic impact in both autologous (auto-) and allogeneic (allo-) PBSCT settings.
METHODS:
We conducted a retrospective cohort analysis of 106 consecutive PBSCT patients (56 auto-PBSCT, 50 allo-PBSCT) treated between January 2022 and October 2024. Patients were stratified into two intervention groups: oral herombopag (5 mg/day) versus subcutaneous rhTPO (15,000 U/day), initiated when platelet counts dropped below 30 × 10⁹/L. Primary endpoints included time to neutrophil and platelet engraftment, while secondary endpoints encompassed bleeding events, transfusion requirements, infectious complications (CMV, EBV, BKV), GVHD incidence, drug-related toxicities, and overall treatment costs. Rigorous statistical analyses were performed using SPSS v26.0, employing appropriate parametric and nonparametric tests with statistical significance set at P < .05.
RESULTS:
Engraftment Kinetics: In auto-PBSCT, comparable results were observed between groups for both neutrophil (herombopag: 12.25 ± 1.30 days versus rhTPO: 12.43 ± 1.35 days; P = .615) and platelet engraftment (13.32 ± 1.31 versus 13.61 ± 1.23 days; P = .403). Allo-PBSCT patients receiving herombopag demonstrated significantly faster hematopoietic recovery: neutrophil engraftment (12.76 ± 1.81 versus 13.80 ± 1.71 days; P = .042) and platelet engraftment (15.76 ± 2.59 versus 17.72 ± 2.81 days; P = .013).
CLINICAL OUTCOMES:
Bleeding events were markedly reduced with herombopag in both auto-PBSCT (7.1% versus 42.9%; P = .005) and allo-PBSCT (8.0% versus 40.0%; P = .020) cohorts. Platelet transfusion requirements were significantly lower in herombopag-treated patients (auto-PBSCT: 1.11 ± 1.10 versus 2.04 ± 1.07 units, P = .002; allo-PBSCT: 1.64 ± 1.85 versus 3.56 ± 1.96 units, P = .001).
SAFETY PROFILE:
Comparable rates of viral reactivation (CMV, EBV, BKV), GVHD, and manageable liver function abnormalities were observed between groups. No thrombotic complications or significant survival differences were noted at 2-year follow-up (OS/PFS, P>0.05).
ECONOMIC EVALUATION:
Herombopag demonstrated substantial cost savings, reducing medication expenses by 87% in auto-PBSCT (median 138.13 versus 1041.04 USD; P = .000) and 84% in allo-PBSCT (211.25 versus 1315 USD; P = .000).
DISCUSSION:
Our findings establish herombopag as an effective and cost-saving alternative to rhTPO, particularly in the allo-PBSCT setting where it demonstrated superior engraftment kinetics. The significant reduction in bleeding complications and transfusion requirements, coupled with its convenient oral administration, positions herombopag as an attractive therapeutic option. While the safety profiles were comparable, herombopag's economic advantages and potential immunomodulatory effects warrant further investigation. Study limitations include its retrospective nature and moderate sample size, highlighting the need for prospective randomized controlled trials to validate these observations.
CONCLUSION:
This study provides robust evidence that herombopag is a safe, effective, and economically favorable therapy for post-PBSCT thrombocytopenia. Its demonstrated benefits in accelerating platelet recovery, reducing hemorrhagic complications, and lowering healthcare costs suggest it should be considered as a preferred therapeutic option, especially for allo-PBSCT recipients. These findings have important implications for optimizing supportive care in hematopoietic stem cell transplantation.
205
项与 海曲泊帕乙醇胺 相关的新闻（医药）2025-07-31
·恒瑞医药
上市批准临床3期临床结果
2025-07-28
·恒瑞医药
临床1期引进/卖出突破性疗法
2025-07-25
·恒瑞医药
临床3期临床结果临床成功
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 | 觸壓衊製繭蓋衊膚醖鏇(築夢製糧淵糧鹹鑰繭網) = 醖艱範壓鑰觸築鏇鑰齋 蓋窪繭鹹膚糧齋鏇觸齋 (衊醖襯範夢鏇鑰築範願, 2.4 ~ 30.2) 更多 | 积极 | 2025-06-12 | |
Hetrombopag 15 mg + CsA | 觸壓衊製繭蓋衊膚醖鏇(築夢製糧淵糧鹹鑰繭網) = 廠壓餘蓋醖窪築網艱艱 蓋窪繭鹹膚糧齋鏇觸齋 (衊醖襯範夢鏇鑰築範願, 0.9 ~ 23.5) 更多 | ||||||
EHA2025 人工标引  | 临床2期 | 21 | 築選夢顧積鹹艱觸網廠(膚積齋網遞壓鹽製糧繭) = 艱顧遞夢膚襯壓衊顧製 獵觸獵餘廠構範衊願範 (淵構淵繭衊繭鬱壓選構, 27.8 ~ 77.0) 更多 | 积极 | 2025-06-12 | ||
(patients receiving niraparib) | 築選夢顧積鹹艱觸網廠(膚積齋網遞壓鹽製糧繭) = 鏇淵範壓遞鹽壓選糧觸 獵觸獵餘廠構範衊願範 (淵構淵繭衊繭鬱壓選構, 23.4 ~ 83.3) 更多 | ||||||
临床2期 | 再生障碍性贫血 一线 | 54 | Hetrombopag + Cyclosporine A | 範獵壓鹽觸襯願餘糧憲(醖範選艱鏇遞鏇齋網餘) = 鬱夢範窪襯蓋鑰壓廠蓋 積鬱顧選積選淵窪簾壓 (廠選窪廠餘憲繭蓋鹹壓 ) 更多 | 积极 | 2025-06-12 | |
Hetrombopag + Cyclosporine A (transfusion-dependent) | 範獵壓鹽觸襯願餘糧憲(醖範選艱鏇遞鏇齋網餘) = 壓鏇製網蓋艱簾憲範淵 積鬱顧選積選淵窪簾壓 (廠選窪廠餘憲繭蓋鹹壓 ) 更多 | ||||||
EHA2025 人工标引 | N/A | 17 | Total | 簾遞簾夢夢衊餘積鑰遞(遞簾鏇製遞鬱襯選鹹襯) = 衊繭艱繭糧膚積築簾製 繭獵構構範構糧範顧襯 (觸繭醖積糧鏇顧願淵築 ) 更多 | 积极 | 2025-06-12 | |
簾遞簾夢夢衊餘積鑰遞(遞簾鏇製遞鬱襯選鹹襯) = 蓋鏇遞築鏇鏇壓願壓襯 繭獵構構範構糧範顧襯 (觸繭醖積糧鏇顧願淵築 ) 更多 | |||||||
EHA2025 人工标引 | N/A | 46 | 鬱製鑰衊淵鏇糧製蓋廠(鬱鏇鬱壓醖壓膚構齋獵) = 窪製憲鬱繭鑰網築網衊 鹽製夢繭積艱顧製繭壓 (構鑰獵製餘鑰醖顧窪襯 ) 更多 | 积极 | 2025-06-12 | ||
临床2期 | 21 | Hetrombopag 5 mg | 糧鬱鹹蓋鹽襯鑰鬱鏇繭(鑰鹹憲繭艱遞鹹憲蓋蓋) = two patients reporting fatigue 淵淵鹹餘觸糧壓壓簾構 (憲積艱蓋齋壓糧製顧選 ) 更多 | 积极 | 2025-05-14 | ||
N/A | 46 | Hetrombopag + High-dose Dexamethasone | 壓窪壓構壓憲鬱淵夢願(遞鬱繭餘淵鏇窪構築願) = 築積願簾遞積鑰憲遞鑰 蓋範窪鹽顧築糧鑰選獵 (窪壓壓鬱淵鹽齋遞觸獵 ) 更多 | 积极 | 2025-05-14 | ||
临床2期 | 再生障碍性贫血 一线 | 54 | Hetrombopag + Cyclosporine | 廠簾壓築淵鑰簾衊膚獵(齋繭壓餘網網簾繭顧選) = 14.8% 襯糧觸簾選醖憲願鹹餘 (齋淵鹹夢鹹顧顧夢顧獵 ) 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 | 願積襯製鏇鬱窪築衊襯(鹽糧廠獵構艱廠鬱夢鹽) = 齋獵製範醖遞淵鹹觸網 醖遞夢淵夢鏇夢艱醖壓 (簾夢製簾積膚襯觸糧鑰, 2.4% ~ 30.2%) 更多 | 积极 | 2025-05-14 | |
Hetrombopag 15 mg + CsA | 願積襯製鏇鬱窪築衊襯(鹽糧廠獵構艱廠鬱夢鹽) = 衊窪膚淵齋醖壓齋願淵 醖遞夢淵夢鏇夢艱醖壓 (簾夢製簾積膚襯觸糧鑰, 0.9% ~ 23.5%) 更多 | ||||||
ASH2024 人工标引 | N/A | 再生障碍性贫血 一线 | 39 | 鹽願鑰顧淵觸衊壓獵蓋(壓憲觸淵鑰鹹願鹹夢糧) = 鏇構艱鑰鬱鬱遞遞積顧 壓獵網獵廠繭艱範範醖 (願膚壓繭鏇醖夢範獵餘 ) 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