更新于：2024-06-23
Recombinant human thrombopoietin biosimilar(Biolotus Biotech Ltda.)
重组人血小板生成素生物类似药(Biolotus Biotech Ltda.)
更新于：2024-06-23
概要
基本信息
药物类型 生物类似药、集落刺激因子 |
别名 Recombinant human thrombopoietin、rhTPO、TPO + [1] |
作用机制 TPO receptor激动剂(血小板生成素受体激动剂) |
治疗领域 |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 巴西 (2015-01-01), |
最高研发阶段(中国)- |
特殊审评- |
登录后查看首次获批时间轴
关联
4
项与 重组人血小板生成素生物类似药(Biolotus Biotech Ltda.) 相关的临床试验A prospective, multicentre, self-paired,cross-over design study of secondary prevention or treatment with rhTPO for CIT improvement in patients with AML who received high-dose cytarabine consolidation therapy
Exploration of optimal timing of administration of rhTPO for secondary prevention of CIT in Mid/High-dose cytarabine consolidation therapy in AML patients: a prospective, randomized, self-controlled trial
Recombinant human thrombopoietin promotes platelet recovery in DCAG-treated patients with intermediate-high-risk MDS
100 项与 重组人血小板生成素生物类似药(Biolotus Biotech Ltda.) 相关的临床结果
登录后查看更多信息
100 项与 重组人血小板生成素生物类似药(Biolotus Biotech Ltda.) 相关的转化医学
登录后查看更多信息
100 项与 重组人血小板生成素生物类似药(Biolotus Biotech Ltda.) 相关的专利（医药）
登录后查看更多信息
283
项与 重组人血小板生成素生物类似药(Biolotus Biotech Ltda.) 相关的文献（医药）2023-12-31Platelets
Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study
Article
作者: Qin, Ling ; Ye, Xu ; Zhang, Qing ; Xia, Ruixiang ; Qian, Shenxian ; Yang, Renchi ; Wang, Tao ; Ma, Jun ; Cao, Sunqiong ; Song, Yanping ; Lu, Quanyi ; Sun, Feng ; Li, Yan ; Liu, Xiaofan ; Guo, Xinhong ; Guo, Zhiqiang ; Zhu, Feiyue ; Bai, Yusheng ; Li, Linjie ; Cheng, Shuqin ; Zhan, Xinrong ; Chen, Youhua
Recombinant human TPO (rhTPO) is effective for refractory/relapsed primary immune thrombocytopenia (ITP), but optimal dosing regimen remains elusive. In this multicenter, randomized, controlled trial, a total of 282 adult ITP patients (mean age 47.3 years; 82 men) with a platelet count ≤30 × 109/L or >30 × 109/L with active bleeding randomly received a once daily (QD) subcutaneous injection of 7500 U (n = 64) or 15000 U rhTPO for 14 injections, or 15000 U or 30000 U rhTPO once every other day (QOD) for 7 injections. The primary outcomes included change from baseline in platelet count and total response rate (TRR) on day 14. On day 14, the median increase of platelet count from baseline was the highest in the 15000-U QD group (167.5 × 109/L, interquartile range [IQR] 23.0-295.0 × 109/L), followed by the 30000-U QOD group (57.5 × 109/L, IQR 9.0-190.0 × 109/L) (ANCOVA P < .001; P = .266 with baseline count as a covariate). The TRR on day 14 was also the highest in the 15000-U QD group (63.2%), followed by the 30000-U QOD group (59.7%). The rate of grade 3 and above adverse events did not differ among the four groups. There were no new safety concerns. All 4 regimens are safe and well-tolerated. The 30000-U QOD regimen is practically indistinguishable in efficacy to the 15000-U QD regimen.
2023-09-01Waste management (New York, N.Y.)
Adjusting effects of pyrolytic volatiles interaction in char to upgrade oil by swelling waste nylon-tire.
Article
作者: Jiang, Long ; Zhang, Jialin ; Ren, Qiangqiang ; He, Limo ; Hu, Song ; Xu, Jun ; Xiang, Jun ; Su, Sheng ; Huang, Rui ; Wang, Yi
Waste nylon-tire (WNT) is a typical solid municipal waste, pyrolysis efficiently disposes WNT to produce oil containing high-value chemicals. Upgrading the quality of oil is the key to improve WNT pyrolysis economy. Herein, swelling was applied to pretreat WNT, and swelled waste nylon-tire (SWNT) was pyrolyzed at different temperatures (400 °C-600 °C). Lower than 500 °C, swelling pretreatment realized the number of compounds in oil by GC-MS decreased 59.57% at 400 °C (60.78% at 450 °C, 67.97% at 500 °C) compared to Waste nylon-tire pyrolytic oil (TPO). Over 500 °C, this phenomenon weakened, decreased 47.67% at 550 °C (11.48% at 600 °C). At 400 °C and 450 °C, long chain methyl esters yield was over 30 A.% instead of short chain alkanes in TPO. D-limonene yield was over 20 A.% in oil of swelled waste nylon-tire (STPO). From 500 °C to 600 °C, swelling pretreatment affected the relative content of BTX and PAHs. At 500 °C and 550 °C, the relative content of BTX in STPO was more than twice of TPO, and BTX reached 28.75 A.% at 600 °C. PAHs in STPO appeared at 500 °C higher than TPO (450 °C), and PAHs was 0.73 A.% at 500 °C. Swelling pretreatment could produce more larger pores in particle during pyrolysis, which sharply inhibited the interaction of volatiles inside tire, so the number of compounds in oil sharply decreased at lower temperatures. Over 550 °C, temperature became the dominant role for generating oil, and components tended to be similar for STPO and TPO. CS2 with high-volatility released quickly from WNT during pyrolysis, it could be recycled to reduce final cost and environment impacts.
2023-08-01PharmacoEconomics
Cost-Effectiveness of Thrombopoietin Mimetics in Patients with Thrombocytopenia: A Systematic Review
Review
作者: Nahirniak, Susan ; Georgsen, Jørgen ; Scheers, Hans ; Avau, Bert ; Compernolle, Veerle ; Shehata, Nadine ; Vandekerckhove, Philippe ; Stanworth, Simon J ; De Buck, Emmy ; Van Remoortel, Hans
OBJECTIVES:
Thrombopoietin (TPO) mimetics are a potential alternative to platelet transfusion to minimize blood loss in patients with thrombocytopenia. This systematic review aimed to evaluate the cost-effectiveness of TPO mimetics, compared with not using TPO mimetics, in adult patients with thrombocytopenia.
METHODS:
Eight databases and registries were searched for full economic evaluations (EEs) and randomized controlled trials (RCTs). Incremental cost-effectiveness ratios (ICERs) were synthesized as cost per quality-adjusted life year gained (QALY) or as cost per health outcome (e.g. bleeding event avoided). Included studies were critically appraised using the Philips reporting checklist.
RESULTS:
Eighteen evaluations from nine different countries were included, evaluating the cost-effectiveness of TPO mimetics compared with no TPO, watch-and-rescue therapy, the standard of care, rituximab, splenectomy or platelet transfusion. ICERs varied from a dominant strategy (i.e. cost-saving and more effective), to an incremental cost per QALY/health outcome of EUR 25,000-50,000, EUR 75,000-750,000 and EUR > 1 million, to a dominated strategy (cost-increasing and less effective). Few evaluations (n = 2, 10%) addressed the four principal types of uncertainty (methodological, structural, heterogeneity and parameter). Parameter uncertainty was most frequently reported (80%), followed by heterogeneity (45%), structural uncertainty (43%) and methodological uncertainty (28%).
CONCLUSIONS:
Cost-effectiveness of TPO mimetics in adult patients with thrombocytopenia ranged from a dominant strategy to a significant incremental cost per QALY/health outcome or a strategy that is clinically inferior and has increased costs. Future validation and tackling the uncertainty of these models with country-specific cost data and up-to-date efficacy and safety data are needed to increase the generalizability.
45
项与 重组人血小板生成素生物类似药(Biolotus Biotech Ltda.) 相关的新闻（医药）2024-06-17
·药渡
优先审批临床3期申请上市
2024-06-17
·医药观澜
临床3期优先审批临床结果申请上市
2024-05-17
·精准药物
优先审批申请上市临床3期临床结果
100 项与 重组人血小板生成素生物类似药(Biolotus Biotech Ltda.) 相关的药物交易
登录后查看更多信息
研发状态
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 |
|---|---|---|---|
| 血小板减少症 | 巴西 | 2015-01-01 |
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
N/A | - | Group A (15,000U) | 選衊選憲積窪齋廠齋製(構範艱廠夢糧廠簾鏇廠) = Treatment-related adverse events were reported in 6 (9.8%) and 6 (13.6%) patients in the group A and group B, respectively, all being mild and transient in nature 壓鏇鹽鬱選顧衊廠鹽鏇 (觸齋簾選遞積製顧遞選 ) 更多 | - | 2022-07-09 | ||
Group B (30,000U) |
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
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