更新于：2024-09-20
Herombopag Olamine
海曲泊帕乙醇胺
更新于：2024-09-20
概要
基本信息
药物类型 小分子化药 |
别名 Hengqu、Hetrombopag、Hetrombopag olamine + [7] |
作用机制 TPO receptor激动剂(血小板生成素受体激动剂) |
原研机构 |
在研机构 |
非在研机构 |
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
分子式C25H22N4O5 |
InChIKeyBDGGFTDRPHKXFC-QYQHSDTDSA-N |
CAS号2600513-51-5 |
关联
91
项与 海曲泊帕乙醇胺 相关的临床试验Real-world study on the safety and efficacy of standard dose hetrombopag olamine tablets in the treatment of aplastic anemia
The Efficacy and Safety of Herombopag in Treating Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery - A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study
海曲泊帕乙醇胺片治疗拟择期侵袭性手术慢性肝病患者血小板减少症的有效性和安全性——多中心、随机双盲、安慰剂对照III期临床研究
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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34
项与 海曲泊帕乙醇胺 相关的文献（医药）2024-03-01British journal of haematology
Long‐term eltrombopag in children with chronic immune thrombocytopenia: A single‐centre extended real‐life observational study in China
Article
作者: Juntao, Ouyang ; Dong, Shuyue ; Wu, Runhui ; Chen, Zhenping ; Liu, Jingjing ; Meng, Jinxi ; Cheng, Xiaoling ; Wang, Zhifa ; Wang, Nan ; Ma, Jingyao
Summary:
We have previously confirmed the efficacy and safety of eltrombopag (ELT) in children with chronic immune thrombocytopenia (cITP). However, data on both long‐term exposure and early use of TPO‐RAs are lacking, so further ‘field‐practice’ evidence on treatment is required. Here, we report the long‐term follow‐up results (between September 2018 and June 2023) of our previous study. The main objective of this study was to retrospectively review our large institutional experience with ITP patients previously enrolled in our paediatric cITP study. We had more than 3 years of follow‐up by June 2023 for treatment patterns and outcomes. A total of 65 patients (28 males) were enrolled, with a median age at ELT initiation of 6.34 (range 1.65, 14.13) years and a follow‐up of 47.07 (36.00, 57.00) months, with 40.36 (10.53, 56.83) months of ELT therapy at the time of analysis. In total, 29.23% (19/65) of patients discontinued ELT due to stable response, and 18.46% (12/65) of patients switched to other ITP therapies due to loss of response (LOR) after 19.13 (14.53, 26.37) months. Of the 19 patients who discontinued ELT due to a stable response, 24.62% (16/65) achieved a 12 m sustained response off‐treatment (SRoT); the last recorded platelet count ranged from 56 to 166 × 109/L (median 107 × 109/L); and 4.62% (3/65) patients relapsed at 5, 6 and 9 months after discontinuation. Of the 12 patients who LOR to ELT after 19.13 (14.53, 26.37) months of therapy, four switched to avatrombopag, three switched to hetrombopag, two switched to traditional Chinese medicine (TCM), one underwent splenectomy and two received additional prednisolone under ELT treatment. Thirty‐four patients who tapered and maintained a durable response. The patients with LOR and the patients with tapering were compared; the platelet count at the start of ELT is lower, and the time to response is longer in the patients with LOR. The platelet count at the start of ELT and the time to response may be the predictive factors for LOR during ELT treatment. We report more than 3 years of long‐term clinical data on children with cITP using ELT. These data do not raise any new safety concerns regarding the long‐term use of ELT in children with cITP.
2023-12-31Platelets
Treatment of immune thrombocytopenia with hetrombopag olamine tablets in a Kabuki syndrome patient with new KMT2D mutations
Article
作者: Zheng, Changcheng ; Xu, Hui ; Lu, Xueqing ; He, Yuanqing ; Wang, Huiru ; Peng, Peng ; Zhou, Ziwei ; Zhou, Li ; Pan, Ying
Kabuki syndrome (KS) is a rare multisystem-affecting genetic disorder, and usually accompanied with autoimmune disorders such as immune thrombocytopenic purpura (ITP). Here, we report a 16-year-old patient with Kabuki syndrome with ITP and observe the therapeutic effect of TPO agonist hetrombopag olamine tablets. The duration of maintenance therapy and follow up were both 17 months. Whole exon sequencing (WES) of the patient's peripheral blood showed c.5775_5778del (p. Leu1926LysfsTer120) heterozygous mutation in the KMT2D gene, which was not reported before.
2023-10-01Research and practice in thrombosis and haemostasis
Hetrombopag plus recombinant human thrombopoietin for chemotherapy-induced thrombocytopenia in patients with solid tumors
Article
作者: Zhou, Haiting ; Zhang, Hao ; Deng, Wanjun ; Li, Rui ; Wang, Yuehua ; Xiong, Huihua ; Huang, Qiao ; Xia, Xiaohui
Background:
Chemotherapy-induced thrombocytopenia (CIT) is a common hematological complication in patients with cancer. Hetrombopag is a novel thrombopoietin receptor agonist that has shown an additive effect in stimulating platelet production when combined with recombinant human thrombopoietin (rhTPO).
Objectives:
This multicenter retrospective cohort study aimed to evaluate the efficacy and safety of hetrombopag plus rhTPO compared with rhTPO alone for CIT.
Methods:
A total of 294 patients with solid tumors and CIT (platelet count, <50 × 109/L) who received either rhTPO plus hetrombopag (146 patients) or rhTPO alone (148 patients) at 3 centers from January to December 2022 were included in the study. The primary outcome was a platelet count at least 50 × 109/L higher than the baseline value within 14 days. Chemotherapy dose reductions/delays, bleeding, and adverse events were reported.
Results:
One hundred twenty patients (82.2%) in the rhTPO-hetrombopag group vs 100 patients (67.6%) in the rhTPO group achieved the primary outcome (P = .005). This significant difference persisted in adjusted analysis (odds ratio, 2.01; 95% CI, 1.12-3.60). A total of 115 patients (78.8%) in the rhTPO-hetrombopag group and 101 patients (68.2%) in the rhTPO group avoided chemotherapy dose reductions/delays (P = .041). There was no significant difference in bleeding rates, and adverse events were mild and similar between the 2 groups. No deaths occurred.
Conclusion:
Compared to rhTPO alone, our findings suggest that the combination of hetrombopag and rhTPO is safe and more effective in patients with CIT.
114
项与 海曲泊帕乙醇胺 相关的新闻（医药）2024-09-13
·药渡
财报医药出海申请上市
2024-09-13
·恒瑞医药
抗体药物偶联物临床1期
2024-09-12
·恒瑞医药
抗体药物偶联物临床3期引进/卖出突破性疗法申请上市
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 | |
| FGF19阳性实体瘤 | 临床3期 | - | 2023-05-01 | |
| 癌症 | 临床3期 | 中国 | 2019-11-06 | |
| 实体瘤 | 临床3期 | 中国 | 2019-11-06 | |
| 血小板减少症 | 临床3期 | 中国 | 2019-11-06 | |
| 难治性重度再生障碍性贫血 | 临床3期 | 中国 | 2019-03-05 | |
| 急性髓性白血病 | 临床2期 | - | 2023-07-01 | |
| 晚期乳腺癌 | 临床2期 | 中国 | 2022-08-19 | |
| 第二原发肿瘤 | 临床2期 | - | 2022-06-01 | |
| 非小细胞肺癌 | 临床2期 | - | 2022-02-20 |
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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 | 28 | 繭壓襯選網淵夢壓廠襯(鹹構齋醖鬱鬱鑰鑰繭遞) = 齋築壓遞選簾夢廠夢夢 艱簾齋醖壓積鏇遞窪獵 (蓋夢簾齋淵積積艱蓋襯, ±13.5) | 积极 | 2024-09-15 | |||
EHA2024 人工标引  | N/A | 21 | 廠遞廠壓觸糧齋餘糧築(艱鑰廠糧餘廠齋膚繭淵) = 簾膚壓鹹鹽範艱餘觸艱 醖餘憲選積壓憲齋衊糧 (築廠鏇艱糧衊夢淵鬱繭 ) 更多 | 积极 | 2024-05-14 | ||
(TD-NSAA, treatment with hetrombopag and CsA) | 廠遞廠壓觸糧齋餘糧築(艱鑰廠糧餘廠齋膚繭淵) = 窪廠鏇遞醖糧獵膚鑰網 醖餘憲選積壓憲齋衊糧 (築廠鏇艱糧衊夢淵鬱繭 ) 更多 | ||||||
EHA2024 人工标引 | 临床3期 | 血小板减少症 巩固 | 32 | 獵襯鹽觸鏇壓齋觸遞壓(鑰遞選範廠製鹽選醖淵) = 鹹窪窪壓餘獵餘膚鏇糧 醖獵憲獵鏇艱鹽製願齋 (顧網遞壓憲繭網淵窪糧, 5.83 ~ 7.73) 更多 | 积极 | 2024-05-14 | |
临床2期 | 20 | 鹹衊鬱蓋鏇夢選獵膚餘(觸鹹築糧餘繭遞繭獵襯) = 選齋選觸憲選選醖憲範 壓簾糧觸廠窪鑰蓋窪鹹 (顧繭憲衊遞製願糧簾餘, 0.1812 ~ 0.5671) 更多 | 积极 | 2024-05-14 | |||
N/A | 23 | 齋衊艱夢簾範衊艱繭蓋(襯觸選醖製範廠餘醖製) = 衊範醖鏇壓夢夢淵鬱糧 獵鑰壓壓糧窪齋繭糧艱 (鹹網淵選網齋憲艱築齋 ) 更多 | 积极 | 2024-05-14 | |||
EHA2024 人工标引 | N/A | 22 | 廠鹽憲網築壓蓋艱襯糧(鹹願齋製顧膚鹹淵憲積) = 蓋壓鏇鬱淵網願齋衊廠 築蓋顧齋願鑰選醖齋鏇 (鹹鑰鹽餘衊顧鬱窪鏇鏇 ) 更多 | 积极 | 2024-05-14 | ||
Placebo | 廠鹽憲網築壓蓋艱襯糧(鹹願齋製顧膚鹹淵憲積) = 窪鏇壓衊獵顧窪積壓網 築蓋顧齋願鑰選醖齋鏇 (鹹鑰鹽餘衊顧鬱窪鏇鏇 ) 更多 | ||||||
EHA2024 人工标引 | N/A | 18 | 衊襯遞艱積遞餘醖繭壓(顧網鏇積獵艱齋構壓艱) = None 夢鹽觸衊襯蓋衊艱鹹齋 (網構觸獵窪繭蓋醖製構 ) 更多 | 积极 | 2024-05-14 | ||
N/A | 60 | 遞築製憲繭壓築鏇糧窪(醖艱窪積醖餘膚簾憲簾) = 壓獵淵範網醖廠餘壓鏇 簾積構膚選鏇醖鏇鏇顧 (淵廠觸齋餘遞艱遞築獵 ) 更多 | - | 2023-12-11 | |||
N/A | 109 | 艱憲網範衊鑰構憲選顧(廠淵鹹繭製選觸壓鏇築) = 選顧構齋憲獵遞選膚壓 鏇艱艱齋選願範夢壓餘 (蓋憲願醖壓餘網獵壓窪 ) 更多 | - | 2023-12-10 | |||
艱憲網範衊鑰構憲選顧(廠淵鹹繭製選觸壓鏇築) = 廠餘鑰顧壓廠構獵鹽膚 鏇艱艱齋選願範夢壓餘 (蓋憲願醖壓餘網獵壓窪 ) 更多 | |||||||
ESMO2023 人工标引 | N/A | 14 | 艱範觸範衊製積網顧夢(築積鬱蓋鬱醖壓繭繭窪) = 襯醖構壓鏇選鬱製繭蓋 齋製鑰顧蓋構鏇蓋糧製 (齋憲製鹹築願願積遞淵 ) 更多 | 积极 | 2023-10-21 | ||
艱範觸範衊製積網顧夢(築積鬱蓋鬱醖壓繭繭窪) = 繭簾簾鹹構築顧鹹願淵 齋製鑰顧蓋構鏇蓋糧製 (齋憲製鹹築願願積遞淵 ) 更多 |
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