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

NCT05554913 / Completed临床2/3期

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Thrombopoietin Mimetic Peptide-Fc Fusion Protein for Injection (QL0911) in the Prevention of Chemotherapy- Induced Thrombocytopenia

To evaluate the efficacy and safety of QL0911 to prevention chemotherapy-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.

开始日期2022-11-08

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

Abstract:

Objective:

QL0911, 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.

Methods:

We 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).

Results:

Between 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).

Conclusion:

QL0911 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: Bakke, James ; Gahagen, Janet ; Javitz, Harold S ; Andrews, Dina A ; Chang, Polly Y ; Lane, Joan H ; Bunin, Deborah I

PURPOSE:

Patients 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 MATERIALS:

Irradiated 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.

RESULTS:

Compared 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.

CONCLUSIONS:

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

OBJECTIVE:

To study the expression of recombinant human SCF-TPO fusion protein and its biological function.

METHODS:

Four 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.

RESULTS:

The 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.

CONCLUSIONS:

Expressed 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）

2024-10-23

·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

2024-09-29

·齐鲁制药集团

齐鲁制药注射用罗普司亭N01最新临床数据在ASCO QCS大会发布

9月27-28日，2024年美国临床肿瘤学会优质护理专题研讨会（ASCO QCS）召开，齐鲁制药注射用罗普司亭N01（瑞立升®）用于肿瘤化疗相关性血小板减少症（CIT）的2/3期临床试验最新数据在会上发布。罗普司亭是第二代血小板生成素（TPO）受体激动剂，用于治疗原发慢性免疫性血小板减少症（ITP）。今年4月，齐鲁制药瑞立升®获得国家药监局上市批准，适用于对其他治疗（例如皮质类固醇、免疫球蛋白）反应不佳的成人（≥18周岁）慢性免疫性血小板减少症患者。本研究招募发生CIT的实体瘤或淋巴瘤患者，牵头研究者为同济大学附属东方医院的李进教授。研究的A部分为开放标签临床试验，根据不同基线血小板计数水平（100~200×10^9/L或<100×10^9/L）和罗普司亭N01起始剂量（1μg/kg或2μg/kg）将受试者分为3组，探索罗普司亭N01在CIT患者中的最佳给药方案。其主要终点为化疗周期最后一天的有效反应率。研究的B部分为双盲、随机、安慰剂对照临床试验，评价罗普司亭N01用于预防CIT发生的疗效和安全性。其主要终点为双盲期产生有效性反应的患者比例。 A部分共纳入50例受试者，第1组（基线血小板计数100~200×10^9/L；起始剂量1μg/kg）、第2组（基线血小板计数100~200×10^9/L；起始剂量2μg/kg）、第3组（基线血小板计数<100×10^9/L；起始剂量2μg/kg）分别为15、15、20例。三组的有效反应率分别为66.7%、53.3%和90.0%。仅1例患者（第3组）发生化疗延迟≥4天或化疗剂量降低≥20%。三组的治疗相关不良事件（TRAE）的发生率分别为26.7%、20.0%、20.0%。未发生治疗相关的严重不良事件。无治疗相关出血或死亡事件发生。 B部分共计63例受试者被随机分配到罗普司亭N01组（41例）或安慰剂组（22例）。两组产生有效性反应的患者比例分别为68.3%和40.9%，校正后率差为27.6%。罗普司亭N01组和安慰剂组中分别有75.6%和40.9%的患者未发生因血小板减少导致的化疗延迟或剂量降低或停药。无需挽救治疗的患者比例在罗普司亭N01组和安慰剂组中分别为78.0%和63.6%。任何等级的TRAE在罗普司亭N01组和安慰剂组中的发生率分别为41.5%和54.4%，其中罗普司亭N01组中有1例（2.4%）≥3级TRAE。无治疗相关出血或死亡事件发生。此外，汇总A、B研究部分患者的疗效数据结果显示，罗普司亭N01组和安慰剂组中的产生有效性反应的患者比例分别为73.3%（55/75）和40.9%（9/22），校正后率差为37.7%。综上，罗普司亭N01能有效升高CIT患者的血小板计数水平，降低化疗延迟或化疗剂量减少的发生率，整体的给药安全性和耐受性良好。撰稿：韩颖、吴苏嘉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 |

临床结果ASCO会议

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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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	積範網淵觸醖廠繭襯艱(壓糧鹹製製遞遞繭網廠) = 糧鬱衊鑰鏇膚壓願衊鏇鹹築廠憲齋鬱簾鏇網鏇 (構簾繭繭蓋築簾襯鏇餘 ) 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)	積範網淵觸醖廠繭襯艱(壓糧鹹製製遞遞繭網廠) = 觸壓衊夢淵鹹簾願鏇鬱鹹築廠憲齋鬱簾鏇網鏇 (構簾繭繭蓋築簾襯鏇餘 ) 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	壓鹽願齋顧鹽鏇鏇鹽繭(鑰鏇鹽衊艱廠觸構顧範) = 遞願選夢獵鬱積夢獵遞鹹廠鹹願鑰鑰築淵壓蓋 (繭齋構鬱網淵選淵願顧, 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	鏇獵膚鹽鹹選衊選膚繭(簾願願願艱鏇窪網鏇窪) = 齋製齋齋網網積獵網範憲範膚願鹽顧鹽鬱網構 (獵構觸憲構願夢廠窪齋, 53.3 ~ 69.8)	积极	2023-06-08