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

开始日期2021-04-06

申办/合作机构-

ChiCTR2100044414 / Recruiting早期临床1期IIT

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

开始日期2021-01-01

申办/合作机构-

ChiCTR2000038982 / Completed临床4期

Recombinant human thrombopoietin promotes platelet recovery in DCAG-treated patients with intermediate-high-risk MDS

开始日期2018-05-15

申办/合作机构

The Third People'S Hospital of Henan Province

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

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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

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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）

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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）

2024-07-01·Dental materials : official publication of the Academy of Dental Materials

The influence of filler load in 3D printing resin-based composites.

Article

作者: Morganti, Francisco Amaro ; Zattera, Ana Cristina Andrioli ; Collares, Fabricio Mezzomo ; de Souza Balbinot, Gabriela ; Della Bona, Alvaro

OBJECTIVETo evaluate the influence of the barium glass (BG) filler in 3D printing resin-based composites for restorative structures.METHODSExperimental 3D printing resin-based composites were formulated with UDMA 70%wt, Bis-EMA 20%wt, and TEGDMA 10%wt. Photoinitiators TPO and DFI (2%wt) were used. BG was incorporated at 40%wt and 50%wt. 0%wt BG was used as negative control and the VarseoSmile Crown^plus (Bego) was used as a commercial control. Specimens were printed using a 3D printer. Subsequently, specimens were washed and submitted to post-curing with 405 nm at 60ºC for 2 × 20 min at FormCure (FormLabs). 3D printing resin-based composites were evaluated by flexural strength, degree of conversion, softening in solvent, radiopacity, and cytotoxicity against gingival fibroblasts. Data were statistically analyzed using one-way ANOVA (α = 0.05).RESULTSNo significant differences in flexural strength were showed between BG40% (90.5 ± 5,4 MPa), BG50% (102.0 ± 11.7 MPa) and VA (105.2 ± 11.7 MPa). Addition of 40% and 50% of BG showed no influence in the degree of conversion compared to VA (p > 0.05). All groups showed softening in solvent after immersion in ethanol (p < 0.05). All groups showed more than 1mmAl of radiopacity. BG50% showed significantly higher radiopacity (2.8 ± 0.3 mmAl) than other groups (p < 0,05). Cytotoxicity evaluation showed gingival cell viability higher than 80% for all groups.SIGNIFICANCEAddition of up to 50%wt of barium glass in experimental 3D printing resin-based composites showed promising results for long-term restorative structures.

2024-05-01·Transplantation and Cellular Therapy

Recombinant Human Thrombopoietin Promotes Platelet Engraftment in Severe Aplastic Anemia Patients Following Treatment With Haploid Hematopoietic Stem Cell Transplantation using Modified Post-Transplantation Cyclophosphamide

Article

作者: Huang, Lifang ; Xu, Jinhuan ; Wang, Na ; Cheng, Ping ; Wang, Jue ; Yang, Yang ; Peng, Yizhou ; Cheng, Hui ; Fu, Andie ; Wei, Jia ; Cao, Yang ; Zhang, Yicheng ; Xiao, Yi ; Wan, Yuling ; Wu, Jiaying ; Zhu, Xiaojian ; Meng, Fankai ; Zhang, Donghua

BACKGROUNDRecombinant human TPO (rhTPO) promotes platelet engraftment in patients after allogeneic HSCT (allo-HSCT). However, the effects of rhTPO on platelet recovery after Haplo-HSCT in patients with severe aplastic anemia (SAA) have not been intensively studied.OBJECTIVEWe aimed to evaluate the efficacy of rhTPO on platelet engraftment in patients with SAA who were treated with Haplo-HSCT using post-transplantation cyclophosphamide (PTCy).STUDY DESIGNSAA patients who received Haplo-HSCT plus PTCy regimen were divided into the rhTPO group (with subcutaneous injection of rhTPO, n = 28) and Control group (no rhTPO administration, n = 27). The engraftment of platelet/neutrophil, platelet infusion amount, and transplant-related complications between the 2 groups were compared.RESULTSAll 55 patients showed successful hematopoietic reconstitution. The median time of platelet engraftment was 11 (9 to 29) days in the rhTPO group and 14 (9 to 28) days in the Control group (P = .003). The rhTPO group had a significantly reduced amount of infused platelets compared to the Control group (2 (1 to 11.5) versus 3 (1 to 14) therapeutic doses; P = .004). There was no significant difference between the 2 groups regarding median time of neutrophil engraftment, incidence of acute graft-versus-host disease (aGVHD) and chronic GVHD (cGVHD), incidence of cytomegalovirus or Epstein-Barr virus reactivation, 3-yr overall survival rate, and failure-free-survival rate. No obvious adverse reactions were observed in the rhTPO group.CONCLUSIONrhTPO promoted platelet engraftment, reduced the amount of transfused platelets, and demonstrated good safety profiles without evidence of adverse reactions in patients with SAA who received Haplo-HSCT using PTCy regimen.

2024-02-01·Zhonghua wei zhong bing ji jiu yi xue

[Effect of recombinant human thrombopoietin on platelets in rats with D-galactosamine salt-induced acute liver failure].

Article

作者: Jing, Li ; Wang, Fengmei ; Tang, Fei ; Liu, Gang ; Liang, Jing

OBJECTIVETo evaluate the effects of recombinant human thrombopoietin (rhTPO) on platelet count (PLT) and liver function in acute liver failure (ALF) rats by observing the dynamic changes of PLT, thrombopoietin (TPO) and liver function during ALF.METHODSTwenty-four male Sprague-Dawley (SD) rats were divided into model group, TPO group and interleukin-11 (IL-11) group using a random number table method, with eight rats in each group. All rats were intraperitoneally injected with D-galactosamine (D-GalN, 1 500 mg/kg, dosed within 72 hours) to induce the ALF model. After modeling, rats in TPO group was received subcutaneous injection of 15 μg/kg of rhTPO for 5 days, and rats in IL-11 group was received subcutaneous injection of 0.45 mg/kg of IL-11 for 5 days. Venous blood samples were collected before and at 1, 3, 5, 7 and 12 days after molding for whole blood cell detection. The level of TPO in serum was detected by enzyme-linked immunosorbent assay (ELISA). Liver function indexes including serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil) and albumin (ALB) were measured before and at 1, 3 and 5 days after modeling. The rats were sacrificed 12 days after the modeling, and the pathological changes of liver tissue were observed by hematoxylin-eosin (HE) staining.RESULTSTwo rats in each group died within 24-48 hours after modeling. HE staining showed that all three groups of ALF rats showed large flake necrosis of hepatocytes, disorder of hepatic lobular structure, mesh scaffold collapse, hepatic sinus congestion and hemorrhage, and flake infiltration of inflammatory cells on day 12 after modeling. The levels of serum ALT, AST and TBil of rats in each group were significantly increased 1 day after modeling and then decreased. The level of ALB decreased significantly on the first day after modeling and then increased, but there was no significant difference in the trend of liver function indexes among the three groups. PLT in the three groups decreased rapidly on day 1 after modeling, and then recovered gradually with the improvement of liver function. The PLT of the TPO group rose to the peak value 7 days after molding and was significantly higher than that of the model group [PLT (×10⁹/L): 1 673.3±347.5 vs. 855.3±447.0, P < 0.05], while there was no significant difference between the IL-11 group and the model group [PLT (×10⁹/L): 1 350.3±386.6 vs. 855.3±447.0, P > 0.05]. The level of serum TPO of the three groups increased significantly on day 1 after modeling, then decreased, and dropped to the lowest value on day 5, but there was no significant difference in the trend of serum TPO level among the three groups.CONCLUSIONSPLT in ALF rats decreased rapidly in the early stage and recovered gradually with the improvement of liver function, and the serum TPO level increased first and then decreased. Injection of rhTPO can significantly increase PLT in ALF rats, but has no significant effect on liver function and survival rate.

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

和黄医药Syk抑制剂中国III期研究结果于《柳叶刀·血液病学》发表

6月17日，和黄医药公司宣布其研发的索乐匹尼布（HMPL-523）在治疗成人原发性免疫性血小板减少症的中国III期研究结果已发表在国际知名医学期刊《柳叶刀·血液病学》上。同时，在欧洲血液协会2024年年会上，该研究的更多细节和亚组结果也以口头报告和海报展示的形式向全球同行分享。中国国家药监局（NMPA）正式受理索乐匹尼布针对成人原发免疫性血小板减少症的上市申请，并将其列入优先评审。索乐匹尼布是一种开发用于治疗血液恶性肿瘤和自身免疫性疾病的新型、高选择性靶向口服脾酪氨酸激酶（Syk）抑制剂。Syk作为B细胞受体和Fc受体信号传导通路中的一个关键蛋白，是多种亚型的B细胞淋巴瘤及自身免疫疾病的成熟治疗靶点。索乐匹尼布知识图谱（来源：药渡数据）最新发表在《柳叶刀·血液病学》上的ESLIM-01研究结果，针对188名曾历经至少一线标准治疗的成人原发免疫性血小板减少症患者。结果显示：索乐匹尼布在原发免疫性血小板减少症患者中展现出具有临床意义的快速且持久的持续血小板计数应答，具有可耐受的安全性特征，并改善了患者的生活质量。索乐匹尼布组展现出高达48.4%的持续应答率，远超安慰剂组的零应答。这一优势在多数预设子群体中均得到验证。更令人振奋的是，索乐匹尼布在治疗初期便展现出强劲疗效，0-12周整体应答率达68.3%，0-24周更是提升至70.6%。相比之下，安慰剂组应答率仅为14.5%和16.1%。索乐匹尼布治疗组患者出现应答的平均时间仅为8天，相较于安慰剂组的30天，疗效更为迅速。该研究进一步的事后亚组分析显示，无论既往的治疗线数或者既往TPO/TPO-RA治疗情况（包括TPO/TPO-RA治疗类型或治疗方案的数量）如何，索乐匹尼布在免疫性血小板减少症患者中均带来一致的临床获益。在最新的研究中，我们发现绝大多数参与研究的患者在之前已经历过多轮治疗，平均接受过四次免疫性血小板减少症的治疗。在那些至少接受过四轮治疗的患者群体中，使用索乐匹尼布的患者中有高达47.7%展现出了持续的疗效反应，相比之下，安慰剂组的这一比例为零。此外，大多数患者在过去曾经接受过TPO或TPO-RA类药物的治疗。索乐匹尼布组中有74.6%的患者曾接受过TPO/TPO-RA治疗，并且在这个亚组中，索乐匹尼布的持续疗效反应率为46.8%，而安慰剂组依旧为零。在安全性方面，ESLIM-01研究中索乐匹尼布的表现与之前的临床研究相吻合。在治疗期间，大多数不良事件（TEAE）的严重程度被评为轻度或中度（即1级或2级）。接受索乐匹尼布治疗的患者中有25.4%出现了3级或更高级别的TEAE，而安慰剂组的这一比例为24.2%。索乐匹尼布在显著提升患者的生活质量方面发挥了积极作用，特别是在改善患者的躯体功能以及精力和疲劳状况方面。这些发现进一步证实了索乐匹尼布在治疗免疫性血小板减少症方面的潜力和有效性。目前，和黄医药拥有索乐匹尼布在全球范围内的全部权益。除了免疫性血小板减少症外，索乐匹尼布用于治疗温抗体性自身免疫性溶血性贫血 (NCT05535933)和惰性非霍奇金淋巴瘤(NCT03779113)的研究亦在进行中。编者按：作为一款新型高选择性脾酪氨酸激酶抑制剂，索乐匹尼布为经治的免疫性血小板减少症患者带来快速且持久的血小板计数改善，显著改善患者生活质量，同时保持良好的安全性。展望未来，和黄医药将进一步拓展索乐匹尼布的应用领域，探索其治疗潜力。点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！

优先审批临床3期申请上市

2024-06-17

·医药观澜

和黄医药Syk抑制剂中国3期临床数据获《柳叶刀》子刊发表

▎药明康德内容团队编辑 6月17日，和黄医药宣布索乐匹尼布（HMPL-523）用于成人原发免疫性血小板减少症患者的ESLIM-01中国3期研究结果已于《柳叶刀·血液病学》(The Lancet Haematology）发表。此外，该研究的额外详情和亚组结果已于日前在欧洲血液协会（EHA）2024年年会上以一项口头报告及两项海报展示的形式公布。值得一提的是，中国国家药监局（NMPA）已受理索乐匹尼布用于成人原发免疫性血小板减少症患者的上市申请，并将其纳入了优先审评。索乐匹尼布是一种用于治疗血液恶性肿瘤和免疫性疾病的新型、高选择性的脾酪氨酸激酶（Syk）口服抑制剂。Syk是Fc受体和B细胞受体信号传导通路的重要组成部分。免疫性血小板减少症是一种复杂的自身免疫性出血性疾病，导致患者外周血中的血小板水平降低。由于造成疲劳、活动限制和焦虑，免疫性血小板减少症也可能对患者的生活质量造成影响。此次在《柳叶刀·血液病学》发表的是ESLIM-01研究结果。ESLIM-01研究是一项在中国188名既往接受过至少一线标准治疗的成人原发免疫性血小板减少症患者中开展的按2:1比例随机、双盲的3期临床试验。研究结果显示，索乐匹尼布在原发免疫性血小板减少症患者中展现出具有临床意义的快速且持久的持续血小板计数应答，具有可耐受的安全性特征，并改善了患者的生活质量。研究的主要终点已达到，索乐匹尼布组的持续应答率（DRR）为48.4% (61/126)，而安慰剂组则为零，且在大部分预设的分组中保持一致。此外，索乐匹尼布组在0-12周时的整体应答率（ORR）为68.3%，在0-24周时的整体应答率为70.6%，而安慰剂组的整体应答率则分别为14.5%和16.1%。接受索乐匹尼布治疗的患者出现应答的中位时间为8天，而安慰剂组则为30天。该研究进一步的事后亚组分析显示，无论既往的治疗线数或者既往TPO/TPO-RA治疗情况（包括TPO/TPO-RA治疗类型或治疗方案的数量）如何，索乐匹尼布在免疫性血小板减少症患者中均带来一致的临床获益。研究中大部分患者既往都接受过大量治疗，中位既往免疫性血小板减少症治疗线数为四线。在既往接受过四线或以上治疗的患者中，索乐匹尼布组的持续应答率为47.7%，而安慰剂组则为0%。此外，大部分患者既往曾接受过TPO/TPO-RA治疗。索乐匹尼布组的患者中74.6%的患者曾接受过TPO/TPO-RA治疗，对该亚组的分析显示，索乐匹尼布组的持续应答率为46.8%，而安慰剂组则为零。 ESLIM-01研究中索乐匹尼布的安全性与既往临床研究保持一致。大多数治疗期间不良事件（TEAE）的程度为轻度或中度（1级或2级）。在接受索乐匹尼布治疗的患者中，25.4%出现3级或以上TEAE，而安慰剂组则为24.2%。索乐匹尼布亦显着改善了患者躯体功能和精力/疲劳方面的生活质量。和黄医药目前拥有索乐匹尼布在全球范围内的所有权利。除了免疫性血小板减少症外，索乐匹尼布用于治疗温抗体性自身免疫性溶血性贫血和惰性非霍奇金淋巴瘤的研究亦在进行中。2024年3月，和黄医药已在中国启动索乐匹尼布用于治疗温抗体型自身免疫性溶血性贫血（wAIHA）成人患者的2/3期研究。参考资料：[1]和黄医药宣布ESLIM-01 III期研究的结果于《柳叶刀·血液病学》发表. Retrieved June 17 , 2024, from https://mp.weixin.qq.com/s/sQHdwNLNT8eg5_bDzFT-xA 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期优先审批临床结果申请上市

2024-05-17

·精准药物

2023/2024年！业绩最强的小分子肿瘤药物

01药融云数据（www.pharnexcloud.com）监测显示：2024年2月16日，阿斯利康（AZ）泰瑞沙（奥希替尼，AZD9291）联合化疗在美国获批，用于治疗局部晚期或转移性表皮生长因子受体突变 (EGFRm) 非小细胞肺癌 (NSCLC) 患者。此次在美国食品和药物管理局（FDA）优先审评的基础上获批是基于发表在《新英格兰医学杂志》的 FLAURA2 III 期研究结果。与全球一线标准治疗方案奥希替尼单药治疗相比，奥希替尼联合化疗将疾病进展或死亡风险降低了38%（风险比[HR]：0.62; 95%置信区间[CI] 0.49-0.79; p<0.0001）。由研究者评估的结果显示，与奥希替尼单药治疗相比，奥希替尼联合化疗使得患者的中位无进展生存期（PFS）达25.5个月，相较于奥希替尼单药治疗（中位PFS为16.7个月），延长了8.8个月。研究者评估和BICR评估的PFS;FLAURA2研究以及中国队列数据这与由盲态独立中央审查组（BICR）评估的PFS结果一致：奥希替尼联合化疗使得患者的中位无进展生存期（PFS）达29.4个月，相较于奥希替尼单药治疗（中位PFS为19.9个月），将患者的中位PFS延长了9.5个月（HR：0.62; 95% CI 0.48-0.80; p=0.0002）。FLAURA2研究的中国队列数据显示，与奥希替尼单药相比，INV评估的中位PFS分别为27.4和22.3个月（HR=0.56，95% CI：0.34-0.92）；BICR评估的中位PFS分别为33.2和22.0个月（HR=0.58，95% CI：0.34-1.01）（图1）；无论是INV PFS还是BICR PFS，结果高度一致，HR分别是0.56和0.58；奥希替尼单药治疗的mPFS均达到22个月，与单药治疗相比，奥希替尼联合化疗获益更显著。02在美国，每年被诊断为肺癌的人数超过20万，其中 80%-85%为非小细胞肺癌，这是最常见的肺癌类型。约有70%的非小细胞肺癌在确诊时已是晚期。此外，美国约有15%的非小细胞肺癌患者伴有EGFR突变。2023年12月，基于FLAURA2研究，奥希替尼联合化疗作为1类推荐中"其他推荐方案"，被纳入《NCCN临床实践指南》（NCCN Guidelines®），用于治疗伴有EGFR Exon 19 Del/Exon 21 L858R突变的非小细胞肺癌患者。美国注册申请文件正处于Orbis项目的审查中，该项目旨在为监管机构提供一个针对肿瘤药物的共同提交和审批的协作框架。作为项目中的一部分，奥希替尼联合化疗也正在接受澳大利亚、加拿大和瑞士监管机构的审查。与此同时，基于FLAURA2研究结果的注册申请也正在接受其他几个国家的评审。03奥希替尼已在包括美国、欧盟、中国和日本在内的100多个国家被批准用作单药治疗，包括局部晚期或转移性EGFR突变非小细胞肺癌患者的一线治疗、局部晚期或转移性EGFR T790M突变非小细胞肺癌患者的治疗以及早期EGFR突变非小细胞肺癌患者的辅助治疗。2023年，本品成为业绩最强的小分子肿瘤药物之一57.99亿美元，仅次于BMS来那度胺的60.97亿美元(top1)。2024年4月25日，阿斯利康披露2024年第一季度业绩，营收126.79亿美元，按CER计算同比增长19%。其中，2024 Q1奥希替尼增长 15% ，销售收入为15.95 亿美元。此外Enhertu（HER2 ADC）在第一季度全球总销售额8.79亿美元。值得关注的是，其他国产新药在2023年度业绩接近或超过20亿人民币的有：翰森制药/豪森药业的阿美替尼、艾力斯的伏美替尼、百济神州泽布替尼、正大天晴的安罗替尼、信达生物的PD-1、恒瑞医药的PD-1、石药集团的丁苯酞、强生/传奇生物的BCMA CAR-T、百济神州的PD-1、三生制药的TPO等等。附，分享：此前，阿斯利康在2024年发布的2023财年报告以及2024 Q1报告公开。发送AZ2024（请正确复制）至药融圈微信公众号（点击下方发送）后台可获得原文件。仅供学习交流分享！参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；https://www.astrazeneca.com;https://www.astrazeneca.com/investor-relations/q1-2024-results-event.html;https://www.businesswire.com/news/home/20240216171764/en/TAGRISSO%C2%AE-osimertinib-with-the-addition-of-chemotherapy-approved-in-the-US-for-patients-with-EGFR-mutated-advanced-lung-cancer；NCCN, National Comprehensive Cancer Network® (NCCN®). Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer Version 1.2024.© National Comprehensive Cancer Network, Inc. [2024]. All rights reserved. Accessed [February 14, 2024]. To view the most recent and complete version of the guideline, go online to NCCN.org；Planchard D, Planchard D, Cheng Y, et al. Osimertinib With/Without Platinum-Based Chemotherapy as First-line Treatment in Patients with EGFRm Advanced NSCLC (FLAURA2). 2023 WCLC. Abstract PL03.13；等等。声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

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

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AC02	DB16364

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
血小板减少症	巴西	Biolotus Biotech Ltda.	2015-01-01

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临床结果

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分期

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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


EHA2019	N/A	-	59	rhTPO treated group	襯鏇壓淵蓋範餘選觸鬱(觸構選淵淵鹹構壓繭鬱) = 鹽觸餘蓋網鬱製遞淵鬱獵範壓築鬱獵憲衊繭壓 (鹹壓齋選顧醖鬱襯壓觸, (10 ~ 12)) 更多	-	2019-05-16
				Recombinant human thrombopoietin (untreated group)	襯鏇壓淵蓋範餘選觸鬱(觸構選淵淵鹹構壓繭鬱) = 窪憲艱鏇鑰鹹憲膚願網獵範壓築鬱獵憲衊繭壓 (鹹壓齋選顧醖鬱襯壓觸, (9 ~ 11)) 更多