Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive Surgery: a Prospective, Multicentre, Single-arm Clinical Study

To assess the efficacy and safety of lusutrombopag combined with recombinant human thrombopoietin for the treatment of thrombocytopenia in patients with chronic liver disease destined to undergo elective invasive surgery.

开始日期2024-11-10

申办/合作机构

安徽省立医院（中国科学技术大学附属第一医院）

ChiCTR2400090506 / Suspended临床1/2期IIT

the efficacy and safety of hytrebopag combined with rhTPO treating severe thrombocytopenia after chemotherapy in patients with solid tumors

开始日期2024-10-08

申办/合作机构-

NCT06630494 / Recruiting临床1期

A Single-center, Single-arm, Open-label, Single-dose Phase I Clinical Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of rhTPO in Healthy Caucasian Participants. Approximately 22 Subjects Will be Enrolled.

This is a single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in healthy Caucasian participants. Approximately 22 healthy Caucasian participants will be enrolled for this study.
One dose level is planned in this study, and participants will receive a single abdominal subcutaneous injection at a dose of 300 U/kg after entering the study.
Participants will undergo screening, admission (baseline), administration and follow-up observation period. Participants will sign an informed consent form before any study procedures are performed. During screening, all participants will be screened for study eligibility within 28 days prior to administration. Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing (D-1). Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing. Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1
D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and ADA will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study.

开始日期2024-10-03

申办/合作机构

沈阳三生制药有限责任公司

100 项与重组人血小板生成素(rhTPO) (三生制药) 相关的临床结果

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100 项与重组人血小板生成素(rhTPO) (三生制药) 相关的转化医学

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100 项与重组人血小板生成素(rhTPO) (三生制药) 相关的专利（医药）

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项与重组人血小板生成素(rhTPO) (三生制药) 相关的文献（医药）

2025-01-01·Current Research in Translational Medicine

Effect and safety of recombinant human thrombopoietin on haematopoietic reconstitution after allogeneic haematopoietic cell transplantation

Article

作者: Ma, Le ; Chen, Jieping ; Tian, Meilin ; Gong, Qiang

Delayed platelet engraftment (DPE) and thrombocytopenia are common complications following myeloablative conditioning in the advanced stage of allogeneic haematopoietic cell transplantation (allo-HCT), and they are associated with transplantation-related mortality and poor prognosis. Therefore, promoting haematopoietic reconstitution after allo-HCT plays a key role in improving patient outcomes. The aim of this retrospective study was to assess the effectiveness and safety of recombinant human thrombopoietin (rhTPO) in promoting haematopoietic reconstruction after allo-HCT. The study included 210 patients who underwent transplantation, with 158 in the rhTPO group and 52 in the control group. Of the total patient population, 120 were males and 90 were females, with a median age of 31 years (range=6 to 59 years). The results showed that the rhTPO group had a median platelet engraftment time that was 14.1 days shorter than that of the control group (14.1 days vs. 21.9 days; P < 0.001). The time for platelet count recovery to 50 × 10^9/L was also shorter in the rhTPO group than in the control group (21.7 days vs. 30.3 days; P < 0.001). Additionally, the granulocyte engraftment time was shorter in the rhTPO group (14.3 days vs. 18.2 days; P < 0.001). There was no significant difference in overall survival (OS) between the rhTPO group and the control group at 2 years after transplantation (77.2% vs. 65.4 %; P = 0.08). Furthermore, there were no significant differences in the amount of platelet transfusions, the rate of platelet engraftment, the rate of DPE, or the incidence of Grade 4 haemorrhage between the groups. Moreover, no adverse reactions were found in the rhTPO group. This study demonstrated that rhTPO administration after allo-HCT effectively reduced the time required for platelet and granulocyte engraftment and was safe.

2024-12-31·Hematology (Amsterdam, Netherlands)

High- vs regular-dose recombinant human thrombopoietin plus cyclosporine A in patients with newly diagnosed non-severe aplastic anemia: a retrospective cohort study

Article

作者: Yang, Yuan ; Yang, Chen ; Chen, Miao ; Hu, Qinglin ; Han, Bing

BACKGROUND:

Cyclosporine A (CsA) and regular doses of recombinant human thrombopoietin (rhTPO) can accelerate platelet recovery in patients with non-severe aplastic anemia (NSAA). However, it is unclear whether CsA plus rhTPO at a higher dose can further increase the efficacy.

METHODS:

Data from patients with newly diagnosed NSAA, who had been treated with CsA in combination with different doses of rhTPO between February 2021 and August 2021 at Peking Union Medical College Hospital, were reviewed. All the enrolled patients had been treated with CsA at 3-5 mg/(kg/d), and patients were further classified into high-dose (with rhTPO 30000U qd × 14 days for 2 months) group or regular-dose (with rhTPO 15000U qd × 7days for 3 months) group. The treatment response and therapy-related adverse events were compared.

RESULTS:

36 patients including 16 (44.4%) in the high-dose and 20 (55.6%) in the regular-dose group were enrolled. The baseline characteristics were compatible between the two groups. The platelet counts were significantly higher at 1/3/6 months in the high-dose group (p = 0.028, 0.0063 and p = 0.040, respectively). The high-dose group had a significantly shorter time to platelet transfusion independence ([1 (0.5-6) months vs 2.5 (1-12) months, p = 0.040]). There was no significant difference in overall response and complete response rate between the two groups at 1/3/6/12 months (p > 0.05). Treatment-related morbidities were similar between the two groups (p > 0.05).

CONCLUSIONS:

Adding a higher dose of rhTPO can further accelerate platelet recovery and platelet transfusion independence in patients with newly diagnosed NSAA.

2024-11-01·INTERNATIONAL JOURNAL OF HEMATOLOGY

Expansion effect of romiplostim on hematopoietic stem and progenitor cells versus thrombopoietin and eltrombopag

Article

作者: Sumitomo, Yoshiki ; Onoda, Naoki ; Morishima, Tatsuya ; Takizawa, Hitoshi ; Kai, Masayuki ; Tezuka, Yuta ; Nishii, Keigo

Abstract:

Romiplostim, a thrombopoietin (TPO) receptor agonist, is a clinically approved drug that is clearly effective in reconstituting hematopoiesis in refractory aplastic anemia and　idiopathic thrombocytopenic purpura. However, the mechanism underlying its biological effect is unknown, and its differences from other TPO receptor agonists remain unclear. Therefore, we determined the in vitro expansion effect of romiplostim on human CD34 + hematopoietic stem and progenitor cells (HSPCs) versus recombinant human TPO (rhTPO) and another clinically available drug, eltrombopag. We also performed single-cell RNA-seq to determine effects of romiplostim on CD34 + HSPCs at the molecular level. The maximum expansion effect of romiplostim on total CD34 + cells, CD34 + CD38 + progenitor cells, and CD34 + CD38 − immature cells was comparable to that of rhTPO, but higher than that of eltrombopag, particularly on CD34 + CD38 − immature cells. Single-cell RNA-seq analysis revealed that both romiplostim and eltrombopag induced signatures driven by rhTPO, but romiplostim induced molecular changes related to RHOA signaling in the most primitive HSPC subsets that were partially driven or not driven by eltrombopag. Additionally, romiplostim did not induce TFRC expression as was observed with eltrombopag. In conclusion, romiplostim expands and affects human HSPCs similar to rhTPO, but partially different from eltrombopag in terms of induction of gene expression.

项与重组人血小板生成素(rhTPO) (三生制药) 相关的新闻（医药）

2024-11-28

·三生制药

rhTPO获中华医学会《肝硬化血小板减少症临床管理实用指南》推荐治疗肝硬化血小板减少症

近日，由中华医学会肝病学分会肝纤维化、肝硬化及门静脉高压学组组织指定的国内首部《肝硬化血小板减少症临床管理使用指南》（以下称《指南》）发表在中华肝脏病杂志，为肝硬化血小板减少症的临床管理提供了规范治疗的建议。中国肝硬化患者群体庞大，接近700万，患者往往长期伴随血小板减少症。血小板减少症导致患者出血风险增加，限制有创操作、抗肿瘤药物治疗、介入及手术的进行，对肝硬化患者的诊疗产生负面影响，给临床工作造成困扰。《指南》针对肝硬化血小板减少症患者有创操作的阈值、药物治疗、抗凝与升板、特殊人群的管理进行了详细阐述。《指南》详细建议了针对行有创操作的肝硬化血小板减少症患者，应当根据血小板计数进行分层管理：血小板计数50~100x109/L时，合并消化道溃疡的患者；血小板计数20~50x109/L时，针对高出血风险操作（出血风险≥1.5%，或轻微出血也可造成永久损伤或死亡的操作）患者，可根据具体情况以升血小板药物治疗为主。《指南》指出，治疗时根据需要的血小板阈值，可使用重组人血小板生成素（rhTPO），减少出血风险。若治疗效果不佳时，可适当延长药物疗程，rhTPO 可延长1～6 个月。此外，《指南》还首次明确提出了肝硬化合并肿瘤患者抗肿瘤治疗时及合并严重感染时血小板减少症的管理建议，提示临床关注这两类特殊情况的治疗，并推荐rhTPO用于以上两类特殊情况的升血小板治疗。参考文献：中华医学会肝病学分会肝纤维化、肝硬化及门静脉高压学组 . 肝硬化血小板减少症临床管理实用指南[J]. 中华肝脏病杂志, 2024, 32(10): 865-871. 关于三生制药三生制药是一家集研发、生产和销售为一体的生物制药领军企业，致力于以高品质的药品提高患者生存质量，为人类健康造福。目前，公司拥有100余项国家发明专利授权，40余种上市产品，覆盖肾科、肿瘤科、自身免疫性疾病、眼科及皮肤科等多种治疗领域。公司拥有抗体药物国家工程研究中心以及生物药和化药双平台的4大研发中心，共有28种在研产品，其中25种为国家新药，并拥有符合GMP标准的5大生产基地。未来，三生制药将继续秉持“珍爱生命、关注生存、创造生活”的理念，全力打造全球领先的中国生物制药企业。请访问www.3sbio.com获取更多信息。 About 3SBio 警示说明及前瞻性陈述本新闻稿包含前瞻性陈述，例如涉及业务和产品前景,或公司的意图、计划、认知、预期及策略。该等前瞻性陈述是根据本公司现有的资料，并按本新闻稿发布时的展望陈述。该等前瞻性陈述基于若干预测、假设及前提，其中一些是主观性的或不受我们控制。该等前瞻性陈述可能被证明是不正确的，或将来可能无法实现。就任何新产品或产品的新适应症, 我们无法确保其将能成功开发或最终上市销售。该等前瞻性陈述受各种风险及不明朗因素影响。我们的其他公开披露文件可能提供该等风险及不明朗因素的更多信息。所涉及之科学信息可能只是初步的和研究性的。本公司股东及潜在投资者在买卖本公司股份时，请务必谨慎行事。

临床结果临床研究

2024-11-22

·ioncology

乳腺癌ADC治疗相关的血液毒性管理

点击上方蓝字关注我们编者按：抗体偶联药物（ADC）是有特异性靶点的单克隆抗体通过连接子与高效的小分子毒素载药构成的化合物，为乳腺癌治疗带来了许多突破性进展，目前已有众多针对不同靶点的ADC已经进入临床或者正在开展研究中。血液学毒性是大多数ADC常见的不良事件，临床实践中应该如何进行科学的评估、监测和管理？国内发布的《中国乳腺癌抗体药物偶联物安全性管理专家共识》可为此提供参考。一、不良反应机制目前大多数ADC的有效载荷为微管蛋白抑制剂和DNA损伤剂，包括美坦辛衍生物［如emtansine（DM1）和ravtansine（DM4）］或澳瑞他汀［如澳瑞他汀E（monomethyl auristatin E, MMAE）和澳瑞他汀F（MMAF）］等强效毒素，半数最大抑制浓度（IC50）可达皮摩尔水平。大多数ADC治疗过程中可以观察导与载荷特征相似的不良反应。例如，MMAE常诱导周围神经病变和中性粒细胞减少，MMAF与血小板减少和眼部不良反应有关，DM1可引起胃肠道反应、血小板减少以及中性粒细胞减少，卡利卡霉素会导致血小板减少和肝功能不全，SN-38（伊立替康活性代谢物）早期研究常报告中性粒细胞减少。由此可见，在许多不同载荷的ADC中，血液学毒性事件是较为常见的不良反应。血小板减少为接受T-DM1治疗患者中最常见的药物不良反应，其发生率及严重程度在亚裔患者中更高。T-DM1可能通过两种机制引起血小板减少，即经由Fcγ受体介导或非Fcγ受体途径。T-DM1与Fcγ受体ⅡA结合后，驱动内化以及后续的偶联物降解与DM1释放，进而影响血小板前驱细胞的增殖与分化。化疗药物诱导中性粒细胞减少的机制与直接抑制骨髓前体细胞以及免疫介导相关。大多数ADC均可发生中性粒细胞减少，目前临床研究报道中，戈沙妥珠单抗的中性粒细胞发生率较高，其载荷为伊立替康活性代谢物SN-38，经由UGT1A1代谢，而UGT1A1低活性可导致SN-38血浆清除率降低，进一步诱导中性粒细胞减少。贫血也是ADC常见的不良反应，为化药直接破坏包括红细胞前体细胞合成在内的造血功能所导致。红细胞计数下降常出现在中性粒细胞减少和血小板减少之后，因为白细胞和血小板寿命更短。表1. 常见血液学毒性事件分级分级血小板减少（x109/L）中性粒细胞减少（x109/L）贫血（g/L） 1级 75.0~

抗体药物偶联物临床结果临床研究

2024-11-17

·米内网

【火热】30个品种拟进院，独家品种“霸屏”

精彩内容近日，汉源县人民医院发布公告称，拟遴选引进30款新药以满足临床用药需求，“中化生”领域均有涉及。其中，独家品种（含剂型独家，下同）占比达五成，不乏重组人血小板生成素注射液、依达拉奉右莰醇注射用浓溶液等2023年在中国公立医疗机构终端销售规模超20亿元的重磅药，以及注射用甲磺酸萘莫司他、环硅酸锆钠散等销售额增速达三位数的潜力品种。来源：汉源县人民医院官网从治疗大类上看，此次汉源县人民医院拟引进的新药以血液和造血系统药物、心脑血管系统药物为主，各占据6个席位；消化系统及代谢药、神经系统药物、全身用抗感染药物分别以5个、4个和2个产品位居其后；抗肿瘤和免疫调节剂、神经系统疾病用药、感觉系统药物等七个品类均有1个产品在列。30个拟新增进院的新药中，独家品种有15个，占比达五成，其中，化学药有9个，中成药和生物药各有3个。拟进院新药名单注：带*为独家品种来源：汉源县人民医院官网，米内网整理重组人血小板生成素注射液用于治疗实体瘤化疗后所致的血小板减少症、原发免疫性血小板减少症（ITP）等，是三生制药的1类独家创新药，目前已纳入全国医保乙类药目录。米内网数据显示，在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端，重组人血小板生成素注射液近年来销售额稳步提升，2023年拿下创新高的超47亿元，同比增长17.29%；2024上半年收获约25亿元，高居止血药产品TOP1之位。中国公立医疗机构终端重组人血小板生成素注射液销售趋势（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局依达拉奉右莰醇注射用浓溶液为先声药业的1类创新药，用于改善急性缺血性脑卒中所致的神经症状、日常生活活动能力和功能障碍等。2020年该药首次获批上市后便通过谈判进入全国医保目录，2021年在中国公立医疗机构终端销售额突破14亿元，2022年以73.75%的增速增长至25亿元以上；2023年销售额虽略有回落，但仍有超20亿元进账，是神经系统药物注射剂TOP6产品。2023年中国公立医疗机构终端神经系统药物注射剂产品TOP10来源：米内网中国公立医疗机构药品终端竞争格局注：增长率为负数用*表示此外，拟进院的独家品种还包括：人福医药的盐酸氢吗啡酮注射液、正大制药的平消胶囊、桂林三金集团的眩晕宁片、远大健康的脑安滴丸、长春高新的聚乙二醇重组人生长激素注射液等，涵盖神经系统药物、肿瘤疾病用药、心脑血管疾病用药、全身用激素类制剂(不含性激素和胰岛素)等治疗领域，以满足不同患者的临床用药需求。来源：米内网数据库、汉源县人民医院官网注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至11月15日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

上市批准医药出海

100 项与重组人血小板生成素(rhTPO) (三生制药) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	重组人血小板生成素(rhTPO) (三生制药)	L03AA	DB16364

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
免疫性血小板减少症	中国	沈阳三生制药有限责任公司	2010-01-01
血小板减少症	中国	沈阳三生制药有限责任公司	2005-05-10

未上市

10 条进展最快的记录,

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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	沈阳三生制药有限责任公司	2023-05-18
肝硬化	临床1期	中国	沈阳三生制药有限责任公司	2018-06-28
肝功能衰竭	临床1期	中国	沈阳三生制药有限责任公司	2018-06-28

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


PRNewswire 人工标引	临床3期	血小板减少症	-	特比澳	膚選鬱鹹網餘獵糧醖鹽(蓋鏇餘鏇醖蓋壓膚艱襯) = 壓選鹹鏇鬱獵壓願鑰遞衊衊鏇選鏇鹹簾醖襯範 (淵窪淵餘餘構壓繭顧膚, 75.26，92.00) 达到	积极	2024-07-26
				Placebo	膚選鬱鹹網餘獵糧醖鹽(蓋鏇餘鏇醖蓋壓膚艱襯) = 廠顧築觸醖範鑰積選鏇衊衊鏇選鏇鹹簾醖襯範 (淵窪淵餘餘構壓繭顧膚, 4.19，26.80) 达到
ASCO2024	N/A	淋巴瘤	-	recombinant human thrombopoietin (Group 1 (platelet counts fell below 50×10^9/L but remained above 25×10^9/L))	壓鑰製鹹衊網顧蓋觸淵(獵窪範簾製積簾鬱襯鹽) = 觸憲齋醖網襯鹹醖鬱鏇願衊醖簾積構衊獵獵積 (膚餘繭鏇範襯憲襯簾鹹, 10.19)	积极	2024-05-24
				recombinant human thrombopoietin (Group 2 (platelet counts ≥ 50×10^9/L and < 75×10^9/L))	壓鑰製鹹衊網顧蓋觸淵(獵窪範簾製積簾鬱襯鹽) = 廠鏇餘顧窪鑰廠範廠鏇願衊醖簾積構衊獵獵積 (膚餘繭鏇範襯憲襯簾鹹, 14.97)
EHA2024	N/A	再生障碍性贫血	17	rhTPO+HETROM+CsA	窪衊鹹廠淵壓範淵夢願(壓簾艱顧顧築顧醖製衊) = 鹹願蓋壓蓋糧範鏇網夢齋夢衊醖衊積積衊觸廠 (遞衊糧選襯網鹹膚選繭 )	积极	2024-05-14
				HETROM+CsA	窪衊鹹廠淵壓範淵夢願(壓簾艱顧顧築顧醖製衊) = 壓齋膚積壓壓鏇鏇繭繭齋夢衊醖衊積積衊觸廠 (遞衊糧選襯網鹹膚選繭 )
ISTH2021	N/A	免疫性血小板减少症二线	96	rhTPO	範範選簾構遞構顧壓膚(醖膚淵鏇齋憲簾簾觸壓) = 廠鑰衊構築願製壓觸膚顧鬱網願鬱網淵糧衊築 (齋艱鬱廠簾繭繭齋鏇艱 )	-	2021-07-17
				eltrombopag	範範選簾構遞構顧壓膚(醖膚淵鏇齋憲簾簾觸壓) = 簾網糧壓遞衊鑰鏇願鹹顧鬱網願鬱網淵糧衊築 (齋艱鬱廠簾繭繭齋鏇艱 )
ASCO2004	N/A	复发性实体肿瘤	-	rhTPO	艱鹽齋鏇壓廠觸繭憲餘(壓範獵繭淵鬱窪壓鹽網) = 顧醖製餘憲膚網醖艱餘襯蓋獵簾獵鹽壓衊鬱廠 (廠艱顧膚醖襯齋製醖鹽 ) 更多	-	2004-07-15
				rhIL-11 + G-SCF	艱鹽齋鏇壓廠觸繭憲餘(壓範獵繭淵鬱窪壓鹽網) = 獵蓋壓艱衊繭願齋窪鹹襯蓋獵簾獵鹽壓衊鬱廠 (廠艱顧膚醖襯齋製醖鹽 ) 更多