重组人血小板生成因子 (上海三生国健)(Recombinant human thrombopoietin(Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.))

概要

基本信息

药物类型

集落刺激因子

别名-

靶点

TPO receptor

作用机制

TPO receptor激动剂(血小板生成素受体激动剂)

治疗领域

消化系统疾病血液及淋巴系统疾病

在研适应症-

非在研适应症

慢性肝病血小板减少症

原研机构

三生国健药业（上海）股份有限公司

在研机构-

非在研机构

沈阳三生制药有限责任公司

三生国健药业（上海）股份有限公司

最高研发阶段无进展临床1期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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关联

9

项与重组人血小板生成因子 (上海三生国健) 相关的临床试验

ChiCTR2400081344 / Suspended临床4期IIT

Clinical study on the efficacy and safety of recombinant human thrombopoietin in the prevention and treatment of thrombocytopenia after chemotherapy for lymphoma

开始日期2024-03-01

申办/合作机构

Shanxi Province Cancer Hospital

NCT05193201 / Unknown status临床1期

A Multicenter Phase Ib Clinical Study for Recombinant Human Thrombopoietin Injection in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease

The purpose of this study is to explore the multiple-dose regimen of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease.

开始日期2022-01-16

申办/合作机构

沈阳三生制药有限责任公司

ChiCTR2100049137 / Suspended临床3期IIT

A single-center, prospective, self-controlled study of recombinat human thrombopoietin in the treatment of thrombocytopenia following high dose cytarabine consolidation chemotherapy in acute myeloid leukemia

开始日期2021-07-23

申办/合作机构-

100 项与重组人血小板生成因子 (上海三生国健) 相关的临床结果

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100 项与重组人血小板生成因子 (上海三生国健) 相关的转化医学

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100 项与重组人血小板生成因子 (上海三生国健) 相关的专利（医药）

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143

项与重组人血小板生成因子 (上海三生国健) 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: Tian, Meilin ; Chen, Jieping ; Gong, Qiang ; Ma, Le

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

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 ; Han, Bing ; Chen, Miao ; Yang, Chen ; Hu, Qinglin

BACKGROUNDCyclosporine 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.METHODSData 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.RESULTS36 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).CONCLUSIONSAdding a higher dose of rhTPO can further accelerate platelet recovery and platelet transfusion independence in patients with newly diagnosed NSAA.

2024-10-01·Transfusion and Apheresis Science

Recombinant human thrombopoietin improves platelet engraftment after autologous hematopoietic stem cell transplantation in patients with aggressive lymphoma

Article

作者: Huang, Liansheng ; Xu, Yang ; Qiu, Xi ; Xiao, Xibin ; Jiang, Huawei

BACKGROUNDTo explore the efficiency and safety of recombinant human thrombopoietin (TPO) on the platelet engraftment after autologous stem cell transplantation (ASCT) in patients with aggressive lymphoma.PATIENTS AND METHODSForty patients were enrolled in a single-center, retrospective clinical trial from July 2019 with rhTPO administration when the platelet count ≤ 75 × 10⁹/L after the reinfusion of stem cells. The hematopoietic reconstitution, platelet transfusion dependence, the cost and length of hospitalization, side effects and survival benefit were compared between the rhTPO group and the control group of 25 historic patients without rhTPO.RESULTSThe cumulative incidence of platelet engraftment in the rhTPO group was significantly higher since d+ 13 post-transplantation. But no difference of neutrophil engraftment was found. rhTPO was considered to influence the platelet engraftment independently by multivariate analysis. Subgroup analysis demonstrated that when the patients were older than 45 years old, male, at stage-IV as diagnosed and obtained PR after previous treatment, rhTPO was more recommended to facilitate platelet early engraftment after ASCT. Although rhTPO didn't relieve the dependency of platelet transfusion, patients had the shorter length of hospitalization. And better OS was shown in the rhTPO group.CONCLUSIONrhTPO improved platelet engraftment after ASCT with aggressive lymphoma, especially the ones older than 45 years old, male, at stage-IV as diagnosed and obtained PR after previous treatment. Although rhTPO didn't lessen platelet transfusion dependence, the length and medical cost of hospitalization were reduced when rhTPO was involved. rhTPO was efficacy and safety which could be recommended after ASCT.

100 项与重组人血小板生成因子 (上海三生国健) 相关的药物交易

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研发状态

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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1期	中国	沈阳三生制药有限责任公司	2022-01-16
血小板减少症	临床1期	中国	三生国健药业（上海）股份有限公司	2017-08-24

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临床结果

适应症

分期

评价

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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


EHA2023	N/A	慢性血小板减少症	20	Recombinant human thrombopoietin (rhTPO) + Eltrombopag (EPAG)	(壓築築觸觸繭餘鏇艱鑰) = 衊鹹壓壓鹽鑰築蓋窪壓膚繭鑰憲夢鬱遞顧鏇顧 (網窪獵選鏇壓網鹽鬱醖 )	-	2023-06-08
EBMT2022	N/A	-	29	recombinant human thrombopoietin	(顧襯壓範襯獵襯窪襯醖) = rhTPO was well tolerated in all patients without side effects urging withdrawal and clinical intervention 網範簾構衊繭蓋膚蓋構 (範齋製鑰簾膚選簾範膚 )	-	2022-03-19
EHA2020	N/A	多发性骨髓瘤	255	recombinant human thrombopoietin (Low CD34+ stem cells without rhTPO)	憲廠鹹艱憲網願夢壓齋(顧網築簾夢鹽壓築願餘) = 鹹廠選糧壓願廠遞糧艱製觸醖築蓋糧窪獵廠鹽 (壓淵築壓艱構鬱鹹衊淵 ) 更多	积极	2020-05-14
				recombinant human thrombopoietin (Normal CD34+ stem cells without rhTPO)	憲廠鹹艱憲網願夢壓齋(顧網築簾夢鹽壓築願餘) = 網鑰鑰觸鬱築襯鹹鹽窪製觸醖築蓋糧窪獵廠鹽 (壓淵築壓艱構鬱鹹衊淵 )
EHA2019	N/A	-	59	rhTPO treated group	壓膚繭夢艱壓繭壓壓窪(廠淵範憲顧衊艱蓋製積) = 壓觸醖餘糧願窪鑰夢糧繭顧鑰網鏇鏇遞鏇積膚 (積遞鬱窪遞壓鹹顧顧鬱, (10 ~ 12)) 更多	-	2019-05-16
				Recombinant human thrombopoietin (untreated group)	壓膚繭夢艱壓繭壓壓窪(廠淵範憲顧衊艱蓋製積) = 簾鏇顧鑰齋範襯鑰鏇膚繭顧鑰網鏇鏇遞鏇積膚 (積遞鬱窪遞壓鹹顧顧鬱, (9 ~ 11)) 更多
ASCO2010	N/A	晚期非小细胞肺癌	24	recombinant human thrombopoietin (Prophylactic treated cycle)	(蓋範鹹繭遞製觸構廠壓) = 築蓋選艱醖窪醖壓築鑰憲艱繭壓糧憲構襯鹹選 (繭繭範鑰廠繭膚夢衊鹽, ± 2) 更多	-	2010-05-20
				recombinant human thrombopoietin (Control cycle)	(蓋範鹹繭遞製觸構廠壓) = 餘艱糧蓋糧鹹襯淵鹹鏇憲艱繭壓糧憲構襯鹹選 (繭繭範鑰廠繭膚夢衊鹽, ± 3) 更多