Efficacy and Safety of a Long-acting Thrombopoietin Receptor Agonist for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing Umbilical Cord Blood Transplantation

To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies.

开始日期2024-12-01

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）

NCT06613880 / Not yet recruiting临床2期IIT

A Prospective, Single Center, Single-arm Study on the Efficacy and Safety of Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia

This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA.

开始日期2024-10-01

申办/合作机构

中国医学科学院血液病医院

[+1]

NCT06456528 / Not yet recruiting临床2/3期

Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.

To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.

开始日期2024-07-01

申办/合作机构

齐鲁制药有限公司

100 项与罗米司亭生物类似药 (齐鲁制药) 相关的临床结果

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100 项与罗米司亭生物类似药 (齐鲁制药) 相关的转化医学

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100 项与罗米司亭生物类似药 (齐鲁制药) 相关的专利（医药）

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项与罗米司亭生物类似药 (齐鲁制药) 相关的文献（医药）

2023-12-20·Journal of Translational Internal Medicine

Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial

Article

作者: Zheng, Changcheng ; Li, Yujie ; Han, Shouqing ; Jin, Jie ; Zuo, Xuelan ; Ge, Zheng ; Zhang, Feng ; Ran, Xuehong ; Han, Ying ; Huang, Meijuan ; Wang, Xin ; Zhou, Hu ; Shi, Yan ; Guo, Xinhong ; Wang, Binghua ; Wang, Wei ; Shen, Xuliang ; Huang, Ruibin ; Yao, Hongxia ; Kang, Xiaoyan ; Fu, Rong ; Gao, Da ; Hou, Ming ; Yang, Tonghua ; Du, Xin

AbstractObjectiveQL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein, is a romiplostim (Nplate®) biosimilar used to treat primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with chronic primary ITP over a 24-week treatment period.MethodsWe conducted a double-blind, placebo-controlled, phase III study in patients diagnosed with primary ITP for at least 12 months who had received at least one first-line ITP treatment with no response or recurrence after treatment, or who relapsed after splenectomy at 44 sites in China. Patients were randomly allocated (2:1 ratio) to QL0911 or placebo injection subcutaneously once weekly at an initial dose of 1 μg/kg for 24 weeks. The doses were adjusted to maintain the target platelet counts from 50 × 109/L to 200 × 109/L. Patients and investigators were blinded to the assignment. The primary endpoints were the proportion of patients who achieved a durable platelet response at week 24 (platelet count, ≥ 50 × 109/L during 6 of the last 8 weeks of treatment) and safety. The study was registered at ClinicalTrials.gov (NCT05621330).ResultsBetween October 2019 and December 2021, 216 patients were randomly assigned (QL0911,144; placebo,72). A durable platelet response was achieved by significantly more patients in the QL0911 group (61.8%, 95% CI: 53.3-69.8; P < 0.0001) than in the placebo group (0%). The mean duration of platelet responses was 15.9 (SE: 0.43) weeks with QL0911, and 1.9 (SE:0.26) week with placebo. Consistent results were achieved in subgroup analyses categorized by baseline splenectomy status (yes/no), concomitant ITP treatment (yes/no), and baseline platelet count (≤ 10 × 109/L, > 10 × 109/L, ≤ 20 × 109/L, > 20 × 109/L, and < 30 × 109/L). The incidence of TEAEs was comparable between the QL0911 and the placebo groups (91.7% and 88.9%, respectively). The most common adverse events overall were ecchymosis (28.5% for QL0911 vs. 37.5% for placebo), upper respiratory tract infections respiratory tract infections (31.9% for QL0911 vs. 27.8% for placebo), and gingival bleeding (17.4% for QL0911 vs. 26.4% for placebo).ConclusionQL0911 was well-tolerated and increased and maintained platelet counts in adults with ITP. QL0911, a biosimilar to romiplostim (Nplate®), may be a novel treatment option for patients with ITP who have failed or relapsed from first-line treatment in China. Ongoing studies will provide further data on long-term efficacy and safety in such patient populations.

2023-11-01·International journal of radiation oncology, biology, physics

Survival and Hematologic Benefits of Romiplostim After Acute Radiation Exposure Supported FDA Approval Under the Animal Rule.

Article

作者: Lane, Joan H ; Bakke, James ; Bunin, Deborah I ; Chang, Polly Y ; Javitz, Harold S ; Andrews, Dina A ; Gahagen, Janet

PURPOSEPatients exposed to acute high doses of ionizing radiation are susceptible to dose-dependent bone marrow depression with resultant pancytopenia. Romiplostim (RP; Nplate) is a recombinant thrombopoietin receptor agonist protein that promotes progenitor megakaryocyte proliferation and platelet production and is an approved treatment for patients with chronic immune thrombocytopenia. The goal of our study was to evaluate the postirradiation survival and hematologic benefits of a single dose of RP with or without pegfilgrastim (PF; Neulasta, granulocyte colony stimulating factor) by conducting a well-controlled, treatment-concealed, good laboratory practice-compliant study in rhesus macaques that was compliant with the United States Food and Drug Administration Animal Rule regulatory approval pathway.METHODS AND MATERIALSIrradiated male and female rhesus macaques (20/sex in each of 3 groups: control, RP, and RP + PF) were subcutaneously administered vehicle or RP (5 mg/kg, 10 mL/kg) on day 1 in the presence or absence of 2 doses of PF (0.3 mg/kg, 0.03 mL/kg, days 1 and 8). Total body radiation (680 cGy, 50 cGy/min from cobalt-60 gamma ray source) occurred 24 ± 2 hours previously at a dose targeting 70% lethality for the control cohort over 60 days. The study examined 60-day survival postirradiation as the primary endpoint. Secondary endpoints included incidence, severity, and duration of thrombocytopenia and neutropenia, other hematology parameters, coagulation parameters, and body weight change to provide insights into potential mechanisms of action.RESULTSCompared with sham-treated controls, treated animals demonstrated a 40% to 55% survival benefit compared with controls, less severe clinical signs, reduced incidence of thrombocytopenia and/or neutropenia, earlier hematologic recovery, and reduced morbidity from bacterial infection.CONCLUSIONSThese results were pivotal in obtaining Food and Drug Administration approval in January 2021 for RP's new indication as a single administration therapy to increase survival in adults and pediatric patients acutely exposed to myelosuppressive doses of radiation.

2005-01-01·Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi

[A preliminary study on the expression and biological function of recombinant human SCF-TPO fusion protein].

Article

作者: Cui, Jian-wu ; Liang, Fei ; Guo, Si-qi ; Sun, Yu-ying ; Yuan, Zhi-hong ; Xi, Yong-zhi ; Kong, Fan-hua ; Xi, Cai-xia ; Liu, Nan

OBJECTIVETo study the expression of recombinant human SCF-TPO fusion protein and its biological function.METHODSFour primers were designed according to known sequences of TPO and SCF. The functional amino acid domains of TPO and SCF were amplified by RT-PCR from fetus hepatocytes, respectively. The expression plasmid pET32a/SCF-TPO was constructed by VOE gene fusion technique and expressed in E. coli BL21(DE3) plysS as inclusion body after isopropyl-beta-D-1-thiogalactopyranoside (IPTG) induction. The fusion protein was tested by SDS-PAGE and Western blot. The biological functions of SCF-TPO fusion protein in MO7e cells was investigated by MTT method after purification with metal chelating chromatography.RESULTSThe high expression SCF-TPO fusion protein was obtained, reaching up to 30% of the total cellular protein. Western blot verified the correct fusion expression and MTT results showed the growth promoting effect of the SCF-TPO fusion protein on MO7e cells, with a higher promoting activity at 100 ng/ml.CONCLUSIONSExpressed SCF-TPO fusion protein after renaturation has biological activity in promoting the proliferation of MO7e cells.

项与罗米司亭生物类似药 (齐鲁制药) 相关的新闻（医药）

2024-11-07

·米内网

【重磅】齐鲁1类新药亮相！猛攻2200亿市场

精彩内容 11月7日，CDE官网显示，齐鲁制药提交1类新药QLS1304片临床申请获受理。今年以来，公司已有7款1类新药申报IND，其中6款已获批临床。齐鲁制药在研1类新药集中在抗肿瘤和免疫调节剂，米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）抗肿瘤和免疫调节剂（化药+生物药）销售额超过2200亿元。 QLS1304片是齐鲁制药今年以来第7款申报IND的1类新药。此前申报的6款1类新药均已获批临床，其中有5款为抗肿瘤和免疫调节剂，QLC1101胶囊、注射用QLS4131为首次获批临床，且目前均处于I期临床，分别用于治疗晚期实体瘤、多发性骨髓瘤。非首次获批的艾帕洛利托沃瑞利单抗注射液、注射用QLF31907、注射用QLS31905均为新型双特异性抗体，分别靶向PD-1/CTLA-4、PD-L1/4-1BB、CLDN18.2/CD3。目前全球已有16款双抗药物获批上市，2024年全球销售额大概率突破百亿美元。今年以来齐鲁制药申报临床的1类新药来源：米内网中国申报进度（MED）数据库近年来，齐鲁制药持续推进“创新驱动”战略，加大研发投入力度支持药品研发创新。今年以来，公司创新研发管线持续推进：1类新药艾帕洛利托沃瑞利单抗注射液附条件批准上市，为全球首款获批的PD-1/CTLA-4组合抗体；伊鲁阿克片新适应症获批，3.4类新药注射用罗普司亭、3.3类新药注射用曲妥珠单抗、地舒单抗注射液及雷珠单抗注射液获批生产；2.2类新药布瑞哌唑口溶膜及司美格鲁肽注射液、3.4类新药帕妥木单抗注射液申报上市；8款1类新药、2款改良型新药、2款生物类似药获批临床（含非首次获批）。截至目前，齐鲁制药有30余款1类新药处于获批临床及以上阶段（不含已上市新药及开展新适应症），其中抗肿瘤和免疫调节剂占比超八成。米内网数据显示，随着越来越多的创新药获批上市并实现销售，叠加临床刚需属性拉动，近年来中国三大终端六大市场抗肿瘤和免疫调节剂（化药+生物药）销售额逐年上涨，2023年超过2200亿元，2024上半年以约7.5%的增速继续攀升。近年来中国三大终端六大市场抗肿瘤和免疫调节剂（化药+生物药）销售情况（单位：万元）来源：米内网格局数据库齐鲁制药在研1类新药中，抗肿瘤药艾帕洛利单抗注射液（PD-1单抗）已于2023年提交NDA，最快有望于2024年内获批上市；注射用重组人血小板生成素拟肽-Fc融合蛋白、注射用美罗培南普莱巴坦均处于III期临床，分别用于治疗肿瘤化疗相关性血小板减少症、碳青霉烯耐药肠杆菌科细菌感染。资料来源：米内网数据库、CDE官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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7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

临床申请上市批准临床3期申请上市

2024-10-23

·米内网

【瞩目】年年暴涨的明星药，齐鲁制药拿下国产第二家

精彩内容近日，齐鲁制药的克立硼罗软膏顺利获批，成为国产第二家。克立硼罗软膏是皮肤病用药潜力产品，上市以来年年暴涨，在中国三大终端六大市场（统计范围见文末）的销售额已累计超过3亿元。近两年，齐鲁制药的皮肤病用药快速增长，潜力可期。图1：齐鲁制药最新获批的产品来源：国家药监局官网据悉，克立硼罗软膏适用于2岁及以上轻度至中度特应性皮炎患者的局部外用治疗，米内网数据显示，原研企业Anacor在2020年获批进入中国市场，2021年首次进入医保谈判目录，2024年9月南京万融健诚医药科技拿下该产品的国内首仿，齐鲁制药为该产品国产第二家获批企业。图2：已上市的克立硼罗软膏来源：米内网中国上市药品（MID）数据库图3：克立硼罗软膏的销售情况（单位：万元）来源：米内网格局数据库在中国三大终端六大市场，原研的克立硼罗软膏销售额快速攀升，2021-2024上半年分别增长了1989.09%、261.52%、82.20%、19.31%，截至今年上半年该产品的销售额累计超过3亿元。表1：齐鲁制药部分已上市的皮肤病用药销售增长情况来源：米内网格局数据库在中国三大终端六大市场，齐鲁制药多个皮肤病用药近两年保持快速增长态势，盐酸特比萘芬乳膏、盐酸特比萘芬喷雾剂、盐酸特比萘芬片、他克莫司软膏2023年合计销售额已接近1.7亿元。表2：齐鲁制药今年以来获批的新产品来源：米内网中国上市药品（MID）数据库克立硼罗软膏是齐鲁制药今年第37个获批的新品，战绩在业内名列前茅。整体来看，全身用抗感染药物占了10个，抗肿瘤和免疫调节剂占了9个，其中艾帕洛利托沃瑞利单抗注射液是1类新药、注射用曲妥珠单抗是3.3类新药，消化系统及代谢药占了4个，心脑血管系统药物、血液和造血系统药物各占了3个，其中注射用罗普司亭N01是3.4类新药，全身用激素类制剂(不含性激素和胰岛素)、皮肤病用药各占了2个，感觉系统药物、肌肉-骨骼系统、神经系统药物、生殖泌尿系统和性激素类药物各占1个，其中雷珠单抗注射液和地舒单抗注射液均为3.3类新药。资料来源：米内网数据库、国家药监局官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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10月22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 【分享、点赞、在看】点一点不失联哦

上市批准

2024-10-08

·齐鲁制药集团

罗普司亭临床合理应用专家共识（2024年版）重磅发布

近日，《罗普司亭临床合理应用专家共识（2024年版）》（以下简称为“共识”）在中华医学会旗下《白血病·淋巴瘤》杂志全文发布。作为全球首个罗普司亭合理应用《共识》，它将为罗普司亭临床合理应用提供权威指导意见。《共识》由哈尔滨血液病肿瘤研究所马军教授牵头，全国50余家医院的67位血液病、血液肿瘤、实体肿瘤领域权威专家共同参与，中国临床肿瘤学会（CSCO）淋巴瘤专家委员会、中国临床肿瘤学会（CSCO）白血病专家委员会共同编写。《共识》从罗普司亭的作用机制、药代动力学、药效动力学、有效性、安全性、临床应用注意事项等方面对罗普司亭进行了全面阐述。《共识》同时汇总整理了罗普司亭在成人原发免疫性血小板减少症（ITP）、儿童 ITP、再生障碍性贫血（AA）、肿瘤治疗所致血小板减少症（CTIT）、移植（HSCT）后血小板减少、骨髓增生异常综合征（MDS）、计划/择期手术的血小板减少、慢性肝病的血小板减少症（CLDT）、遗传性血小板减少症（HT）和急性放射综合征（ARS）等疾病领域的研究证据，为罗普司亭在多种原因导致的血小板减少症患者的临床应用提供了参考。目前，罗普司亭在全球范围内已获批用于成人和儿童ITP、AA、ARS等疾病领域，并被CSCO《CTIT诊疗指南（2024版）》推荐用于CTIT的预防和治疗，同时罗普司亭也是唯一被NCCN指南推荐用于CTIT管理的TPO-RA类药物。 2024年4月，齐鲁制药注射用罗普司亭N01（瑞立升®）获批上市，为国内首个获批上市的罗普司亭生物类似药，用于对其他治疗（例如皮质类固醇、免疫球蛋白）反应不佳的成人（≥18周岁）慢性ITP患者，极大改善了罗普司亭在国内的可及性。目前，国内临床专家正在积极探索瑞立升®治疗重症ITP、儿童ITP、ITP一线、难治性CTIT、AA、HSCT后血小板减少等多个疾病领域的临床疗效，同时瑞立升®用于CTIT治疗的随机对照研究也正在进行，有望为CTIT的治疗提供新的治疗选择。撰稿：阿立翔、王蒙点击下方关键词获取更多资讯 ↓↓ | 李燕总裁 | 全国人大代表 | | 中国医药百强 | 伊鲁阿克 | | 雷珠单抗 | 1类新药 | 患者招募 | | 董事长的二十万个蛋糕 | 社会责任企业 |

CSCO会议上市批准

100 项与罗米司亭生物类似药 (齐鲁制药) 相关的药物交易

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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性特发性血小板减少性紫癜	中国	齐鲁制药有限公司	2024-04-02

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床3期	-	齐鲁制药有限公司	2024-07-01
血小板减少症	临床3期	-	齐鲁制药有限公司	2024-07-01
再生障碍性贫血	临床2期	中国	齐鲁制药有限公司	2024-10-01
疼痛	临床2期	中国	齐鲁制药有限公司	2024-10-01

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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


NCT05554913 \| NCT05851027 (ASCO_QCS2024) 人工标引	临床2/3期	实体瘤 \| 血小板减少症 \| 淋巴瘤	113	Romiplostim N01	(鏇膚鑰鏇膚夢窪襯願糧) = 鹹衊製範鹽鏇廠鑰構艱獵襯憲衊鹽鏇壓廠鏇廠 (遞願齋鑰憲鑰齋繭顧鏇 ) 更多	积极	2024-09-30
NCT05554913 \| NCT05851027 (ASCO_QCS2024) 人工标引	临床2/3期	实体瘤 \| 血小板减少症 \| 淋巴瘤	113	Placebo (PLT count 75~150×109/L)	(鏇膚鑰鏇膚夢窪襯願糧) = 鬱繭繭鏇襯構齋觸範衊獵襯憲衊鹽鏇壓廠鏇廠 (遞願齋鑰憲鑰齋繭顧鏇 ) 更多	积极	2024-09-30
NCT05621330 (phase III, Pubmed \| J Transl Int Med)	临床3期	慢性特发性血小板减少性紫癜一线	216	QL0911	積製壓顧鬱膚積糧鬱鹹(簾窪遞網齋築顧獵構繭) = 廠鑰廠艱鹽廠鹽夢糧艱齋網糧艱選糧衊窪憲齋 (壓積艱製簾獵醖願積襯, 53.3 ~ 69.8)	积极	2023-12-20
NCT05621330 (EHA2023)	临床3期	免疫性血小板减少症二线	216	QL0911	鏇鑰鑰築艱糧願觸簾築(蓋簾願憲範鹹顧廠簾鏇) = 窪範餘鏇鹹夢繭顧衊鹽選製積膚膚願窪夢糧繭 (選網蓋構衊齋獵艱夢鏇, 53.3 ~ 69.8)	积极	2023-06-08