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更新于：2026-10-03
Rituximab biosimilar (Henlius Biotech)
利妥昔单抗生物类似药（复宏汉霖）
更新于：2026-10-03
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Han Li Kang、Recombinant Human/Murine Chimeric Anti-CD20 Monoclonal Antibody、利妥昔单抗 (复宏汉霖) + [5] |
靶点 |
作用方式 抑制剂 |
作用机制 CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、补体依赖的细胞毒性作用 |
在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2019-02-22), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
9
项与 利妥昔单抗生物类似药（复宏汉霖） 相关的临床试验NCT05253495
Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure From Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults With Lymphoma
NCT04671420
A Phase 3 Multi-Centre, Randomised, Double-Blind, Parallel-Arm Study to Evaluate the Efficacy and Safety of HLX01 Versus Rituximab (Mabthera®) as First Line Treatment in Patients With Low Tumour Burden Follicular Lymphoma.
NCT03522415
A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
100 项与 利妥昔单抗生物类似药（复宏汉霖） 相关的临床结果
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100 项与 利妥昔单抗生物类似药（复宏汉霖） 相关的转化医学
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100 项与 利妥昔单抗生物类似药（复宏汉霖） 相关的专利（医药）
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8
项与 利妥昔单抗生物类似药（复宏汉霖） 相关的文献（医药）2026-02-01Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
Rituximab biosimilar HLX01 versus reference rituximab in the treatment of diffuse large B-cell lymphoma: Real-world clinical experience
Article
作者: Wu, Hanbiao ; Yang, Sensen ; Huang, Guoning ; Chen, Jisheng ; Chen, Haitao ; Yang, Changyuan ; Deng, Weishang
Introduction:
HLX01 is the first rituximab biosimilar produced in China and the first monoclonal antibody biosimilar marketed in China. The purpose of this study was to comprehensively evaluate whether HLX01 is clinically consistent with the original drug based on real-world data to provide evidence for the clinical substitution of biosimilars in China.
Methods:
A single-center retrospective study was conducted to select patients with diffuse large B-cell lymphoma who met the inclusion criteria and were treated with HLX01 or reference rituximab. Baseline characteristics, efficacy and safety results were recorded, and the corresponding statistical analysis was performed for various indicators.
Results:
Thirty-three patients diagnosed with diffuse large B-cell lymphoma were included and divided into two groups that received HLX01 or reference rituximab. The results showed no significant difference in the overall response rate (86.7% vs. 88.9%; p = 1.000) or complete response rate (46.7% vs. 55.6%; p = 0.889) between the two groups. Kaplan–Meier survival curves also showed no significant difference in time-to-event variables between the two groups (log-rank = 0.244). Safety was also comparable in both groups.
Conclusions:
HLX01 is a suitable replacement for reference rituximab in the treatment of diffuse large B-cell lymphoma and is relatively inexpensive, thereby reducing the economic burden of patients. Nevertheless, the conclusion of this study still needs to be further validated by large-sample real-world data and explored for HLX01 in other indications, such as follicular lymphoma.
Clinical trial registration:
Not applicable.
2022-12-01Arthritis research & therapy
Efficacy and safety of HLX01 in patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy: a phase 3 study
Article
作者: Pingting Yang ; Zhuoli Zhang ; Xiaoxia Yu ; Linjie Chen ; Lingyun Sun ; Hongsheng Sun ; Jiankang Hu ; Hua Wei ; Jun Zhu ; Huaxiang Liu ; Jian Wu ; Jian Xu ; Jianhong Zhao ; Ju Liu ; Xiaomei Li ; Qingyu Wang ; Lijun Wu ; Zhenyu Jiang ; Qinghua Zou ; Wufang Qi ; Xiaofeng Zeng ; Meimei Wang ; Xiumei Liu ; Xin Lu ; Fu-ai Lu ; Ying Li ; Yang Li ; Rongbin Li ; Hao Zhang ; Hua Zhang ; Liqi Bi ; Baijie Xu ; Cibo Huang ; Lan He ; Xiangping Liao ; Yi Liu ; Huaxiang Wu ; Jianzhao Cheng ; Xiaoxia Li ; Hongwei Du ; Fengju Li ; Jingchun Jin ; Zongwen Shuai
Abstract:
Background:
To evaluate the efficacy and safety of HLX01, a rituximab biosimilar, as combination therapy with methotrexate in Chinese patients with active rheumatoid arthritis who had inadequate responses to methotrexate.
Methods:
In this double-blind, placebo-controlled phase 3 trial, biologic-naïve patients with moderate-to-severe active rheumatoid arthritis and inadequate responses to methotrexate were randomized 2:1 to receive 1000 mg HLX01 or placebo intravenously on days 1 and 15. On the first day of weeks 24 and 26, patients in both groups received 1000 mg HLX01 via intravenous infusion. The primary endpoint was the American College of Rheumatology (ACR) 20 response rate at week 24. Secondary endpoints including efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics were assessed up to week 48.
Results:
Between 28 May 2018 and 11 September 2020, 275 patients were randomized to the HLX01 group (n = 183) or the placebo group (n = 92). At week 24, the proportion of patients achieving ACR20 response was significantly greater in the HLX01 group compared with the placebo group in the intention-to-treat population (60.7% vs 35.9%; P < 0.001) and per-protocol set (60.3% vs 37.1%; P < 0.001). Most secondary efficacy endpoints favoured HLX01 when assessed at weeks 12, 24, 36 and 48. Incidences of treatment-emergent adverse events were similar between groups. Infusion-related reactions occurred more frequently following the initial two doses of HLX01 than the subsequent doses.
Conclusions:
HLX01 plus methotrexate improved clinical outcomes compared with placebo in Chinese patients with rheumatoid arthritis who had inadequate responses to methotrexate. This treatment regimen was well tolerated, showing comparable safety profiles to placebo.
Trial registration:
ClinicalTrials.gov, NCT03522415. Registered on 11 May 2018.
2020-12-01Journal of hematology & oncology
A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma
Letter
作者: Han, Xiaohong ; Jin, Zhengming ; Chen, Guo'an ; Wang, Huaqing ; Shi, Yuankai ; Ke, Xiaoyan ; Zhang, Yang ; Cheng, Jiancheng ; Luk, Alvin ; Yi, Pingyong ; Fu, Weijun ; Sun, Tao ; Zhang, Xin ; Yang, Haiyan ; Wang, Xiuli ; Su, Hang ; Du, Xin ; Zhang, Huilai ; Yu, Ding ; Zhao, Xielan ; Song, Yongping ; Qin, Yan ; Li, Wei ; Zhang, Mingzhi ; Liu, Eugene ; Jin, Chuan ; Cheng, Ying ; Yang, Jianmin ; Hong, Xiaonan ; Wang, Zhao ; Liu, Li ; Chen, Yun ; Yang, Yu ; Wang, Dong ; Zhang, Qingyuan ; Feng, Jifeng ; Ma, Chaoming ; Chai, Katherine ; Zhang, Xiaohong ; Jin, Jie ; Hu, Jianda
Abstract:
Rituximab in combination with chemotherapy has shown efficacy in patients with diffuse large B-cell lymphoma (DLBCL) for more than 15 years. HLX01 was developed as the rituximab biosimilar following a stepwise approach to demonstrate biosimilarity in analytical, pre-clinical, and clinical investigations to reference rituximab. With demonstrated pharmacokinetic similarity, a phase 3 multi-center, randomized, parallel, double-blind study (HLX01-NHL03) was subsequently conducted to compare efficacy and safety between HLX01 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (H-CHOP) and reference rituximab plus CHOP (R-CHOP) in a total of 407 treatment-naïve, CD20-positive DLBCL patients aged 18–80 years. The primary efficacy endpoint was best overall response rate (ORR) within six cycles of treatment in the per-protocol set (PPS). Secondary endpoints included 1-year efficacy outcomes, safety, and immunogenicity profile. The results showed difference in ORRs [H-CHOP 94.1%; R-CHOP 92.8%] between two treatment groups was 1.4% (95% confidence interval [CI], − 3.59 to 6.32, p = 0.608) which falls within the pre-defined equivalence margin of ± 12%. The safety profile was comparable between the treatment groups, with a similar overall incidence of treatment-emergent adverse events (H-CHOP 99.5%, R-CHOP 99.0%, p = 1.000) and serious adverse events (H-CHOP 34.0%, R-CHOP 32.5%, p = 0.752). This study established bioequivalence in efficacy and safety between HLX01 and reference rituximab. The trial was registered at http://www.chinadrugtrials.org.cn on 26 August 2015 [#CTR20150583].
100 项与 利妥昔单抗生物类似药（复宏汉霖） 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 类风湿关节炎 | 中国 | 2022-02-23 | |
| 类风湿关节炎 | 中国 | 2022-02-23 | |
| 淋巴细胞白血病 | 中国 | 2020-07-14 | |
| 弥漫性大B细胞淋巴瘤 | 中国 | 2019-02-22 | |
| 滤泡性淋巴瘤 | 中国 | 2019-02-22 | |
| 非霍奇金淋巴瘤 | 中国 | 2019-02-22 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| CD20阳性滤泡性淋巴瘤 | 临床3期 | - | 2020-10-01 | |
| 复发性滤泡性淋巴瘤 | 临床3期 | - | 2020-10-01 | |
| CD20阳性弥漫性大B细胞淋巴瘤 | 临床3期 | 中国 | 2015-10-01 | |
| CD20阳性B细胞淋巴瘤 | 临床2期 | - | 2014-10-01 | |
| CD20阳性的B细胞非霍奇金淋巴瘤 | 临床1期 | 中国 | 2015-06-25 |
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临床结果
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适应症
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Pubmed 人工标引  | N/A | 33 | 選襯網簾鬱遞醖製蓋範(積襯獵觸築衊廠鑰壓齋) = 簾蓋鬱鬱廠壓壓糧積構 醖窪鏇餘廠鑰齋淵範艱 (鬱繭願鹹齋鹽顧齋鏇簾 ) 更多 | 相似 | 2022-07-03 | ||
選襯網簾鬱遞醖製蓋範(積襯獵觸築衊廠鑰壓齋) = 淵鑰餘膚選淵齋憲選衊 醖窪鏇餘廠鑰齋淵範艱 (鬱繭願鹹齋鹽顧齋鏇簾 ) 更多 | |||||||
临床3期 | 275 | methotrexate+HLX01 | 觸構齋網衊齋襯範憲築(膚醖蓋窪窪繭選糧製餘) = 鹽蓋觸積鏇遞齋鏇窪膚 鏇餘窪製顧願構觸窪選 (顧鏇衊窪廠觸膚艱鹽製 ) 更多 | 积极 | 2022-06-10 | ||
methotrexate+Placebo | 觸構齋網衊齋襯範憲築(膚醖蓋窪窪繭選糧製餘) = 鹹構繭製衊獵製範糧齋 鏇餘窪製顧願構觸窪選 (顧鏇衊窪廠觸膚艱鹽製 ) 更多 | ||||||
临床3期 | 407 | CHOP+HLX01 | 築網齋齋鹹鏇網艱衊選(簾範繭範壓鹹鏇積衊夢) = 廠築簾顧襯網積範窪鏇 鏇衊顧築蓋簾廠鏇齋膚 (廠齋醖範齋襯壓鬱膚鬱 ) 更多 | 相似 | 2020-04-16 | ||
CHOP+Rituximab | 築網齋齋鹹鏇網艱衊選(簾範繭範壓鹹鏇積衊夢) = 鑰餘壓憲範鏇膚餘鹽蓋 鏇衊顧築蓋簾廠鏇齋膚 (廠齋醖範齋襯壓鬱膚鬱 ) 更多 | ||||||
临床1/2期 | 196 | 憲遞餘襯構齋簾顧艱蓋(鑰蓋築壓選醖繭醖觸築) = 積夢淵齋製蓋鏇齋鹽範 膚鑰願蓋觸餘顧構顧構 (餘網蓋遞夢膚憲鹹鹽餘 ) 更多 | - | 2019-11-24 |
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