预约演示
更新于：2025-10-30
Romiplostim Biosimilar (Qilu Pharma)
罗米司亭生物类似药 (齐鲁制药)
更新于：2025-10-30
概要
基本信息
药物类型 Peptibody、生物类似药 |
别名 Recombinant human thrombopoietin mimetic-fusion protein(Qilu Pharma)、Romiplostim Biosimilar (Qilu Pharmaceutical Co., Ltd.)、注射用重组人血小板生成素拟肽-Fc融合蛋白 (齐鲁制药) + [5] |
作用方式 激动剂 |
作用机制 TPO receptor激动剂(血小板生成素受体激动剂) |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-04-02), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
Sequence Code 116979
当前序列信息引自: *****
关联
17
项与 罗米司亭生物类似药 (齐鲁制药) 相关的临床试验NCT07162519
A Prospective, Single-arm, Multicenter Clinical Study of Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients.
NCT07185893
A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors
NCT07206823
An Open-label, Single-arm, Single-center Study to Evaluate the Efficacy and Safety of Romiplostim N01 in Combination With Rituximab in Patients With Primary Immune Thrombocytopenia Refractory to Oral TPO-RAs
100 项与 罗米司亭生物类似药 (齐鲁制药) 相关的临床结果
登录后查看更多信息
100 项与 罗米司亭生物类似药 (齐鲁制药) 相关的转化医学
登录后查看更多信息
100 项与 罗米司亭生物类似药 (齐鲁制药) 相关的专利（医药）
登录后查看更多信息
2
项与 罗米司亭生物类似药 (齐鲁制药) 相关的文献（医药）2025-08-08MEDICINE
Successful treatment of refractory cancer therapy-induced thrombocytopenia in a breast cancer patient using romiplostim N01: A case report
Article
作者: Chen, Lin ; Jiang, Yiming ; Ling, Jiajun ; Dong, Enlai ; Xie, Bo ; Liu, Peng
Rationale::
Cancer therapy-induced thrombocytopenia (CTIT) is a frequent complication in cancer treatment, with severe cases posing risks of bleeding and hindering therapeutic progress.
Patient concerns::
A breast cancer patient developed refractory CTIT following multiple lines of chemotherapy. Despite treatment with various thrombopoietic agents, including recombinant human thrombopoietin, eltrombopag, avatrombopag, steroids, and platelet transfusions, platelet counts remained below 50 × 109/L, with a nadir of 6 × 109/L.
Diagnoses::
Bone marrow biopsies revealed an absence of megakaryocytes, supporting the diagnosis of CTIT.
Interventions::
The patient received 2 doses of romiplostim N01.
Outcomes::
The romiplostim N01 resulted in a rapid and sustained normalization of platelet counts. Platelet levels were maintained between 251 × 109/L and 304 × 109/L during follow-up, allowing uninterrupted anticancer therapy and achieving stable disease for the primary tumor.
Lessons::
Romiplostim N01 effectively managed refractory CTIT in this case, showing rapid and sustained platelet recovery. This case demonstrates the potential of romiplostim N01 as a potential effective treatment for refractory CTIT.
2023-12-20Journal 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.
100 项与 罗米司亭生物类似药 (齐鲁制药) 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
临床结果
临床结果
适应症
分期
评价
查看全部结果
NEWS 人工标引  | 临床2/3期 | 63 | 淵夢齋鹹簾淵鑰窪獵遞(醖網淵蓋膚壓獵憲簾廠) = 獵範積築衊廠選夢顧衊 襯願網鬱積積顧積膚餘 (鬱構餘夢餘糧願網艱鹽 ) 更多 | 积极 | 2025-09-14 | ||
安慰剂 | 淵夢齋鹹簾淵鑰窪獵遞(醖網淵蓋膚壓獵憲簾廠) = 觸鑰製積積鹹憲壓鑰顧 襯願網鬱積積顧積膚餘 (鬱構餘夢餘糧願網艱鹽 ) 更多 | ||||||
临床2/3期 | 113 | 蓋鏇簾蓋觸憲觸繭鬱鹹(壓繭網積範鏇鹽鏇鏇願) = 網獵憲餘醖簾觸選觸選 艱網醖齋範餘壓鹽網顧 (齋獵獵繭齋顧廠蓋築鹹 ) 更多 | 积极 | 2024-09-30 | |||
Placebo (PLT count 75~150×109/L) | 蓋鏇簾蓋觸憲觸繭鬱鹹(壓繭網積範鏇鹽鏇鏇願) = 糧糧夢網鏇齋艱淵築衊 艱網醖齋範餘壓鹽網顧 (齋獵獵繭齋顧廠蓋築鹹 ) 更多 | ||||||
临床3期 | 216 | 鹽齋糧觸觸壓遞積壓餘(築鹽顧淵夢艱構廠壓鏇) = 鬱糧廠艱積顧蓋網廠鏇 網艱網衊簾築鹽夢選蓋 (廠鏇鹽觸壓襯襯衊蓋鏇, 53.3 ~ 69.8) | 积极 | 2023-12-20 |
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
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
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
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
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