预约演示
更新于：2026-02-27
Tocilizumab-bavi
托珠单抗生物类似药 (百奥泰生物)
更新于：2026-02-27
概要
基本信息
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 (2023-01-16), |
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 12264H
当前序列信息引自: *****
Sequence Code 12270L
当前序列信息引自: *****
关联
7
项与 托珠单抗生物类似药 (百奥泰生物) 相关的临床试验NCT06262477
A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. Compared to Actemra® in Healthy Male Participants
ChiCTR2300075487
A randomised, double-blind, single dose, parallel two-arm study of the pharmacokinetics and safety of BAT1806 subcutaneous injection versus ACTEMRA® in healthy male subjects in China
NCT05968508
A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects
100 项与 托珠单抗生物类似药 (百奥泰生物) 相关的临床结果
登录后查看更多信息
100 项与 托珠单抗生物类似药 (百奥泰生物) 相关的转化医学
登录后查看更多信息
100 项与 托珠单抗生物类似药 (百奥泰生物) 相关的专利（医药）
登录后查看更多信息
9
项与 托珠单抗生物类似药 (百奥泰生物) 相关的文献（医药）2025-10-03EXPERT OPINION ON BIOLOGICAL THERAPY
A randomized, double-blind, single-dose, parallel two-group study comparing the pharmacokinetics, safety, and immunogenicity of BAT1806 SC with tocilizumab in healthy Chinese male subjects
Article
作者: Dong, Qingfeng ; Zhang, Qian ; Jiang, Yan ; Hu, Wei ; Yang, Qin ; Liu, Zhijie ; Wu, Juan ; Liu, Yueran ; Zhang, Qin ; Qin, Huiling
BACKGROUND:
This study compared the pharmacokinetics (PK), safety, and immunogenicity of the Tocilizumab biosimilar, BAT1806 SC (Tocilizumab biosimilar, Subcutaneous Injection), with Tocilizumab (RoActemra®) in healthy Chinese male subjects.
RESEARCH DESIGN AND METHODS:
In this randomized, double-blind, parallel-group phase I clinical study, healthy Chinese male subjects (Number (N) = 300) were randomized 1:1 to receive 162 mg/0.9 mL either BAT1806 SC or Tocilizumab subcutaneously.
RESULTS:
The mean drug concentration-time curve trend and PK parameters were similar between BAT1806 SC and Tocilizumab. The 90% CIs (Confidence Interval), of the GMRs (Geometric Mean Ratio) of AUC0-inf (area under the curve from zero to infinity) (97.07%), and AUC0-t (area under the curve from time 0 to the last measured) (97.18%) and Cmax (95.72%) were all within the bioequivalence limits [80.00%-125.00%]. The TEAE was very similar between the BAT1806 SC group (89.4%) and the Tocilizumab group (91.3%). No serious adverse events such as TEAEs (Treatment-related adverse events) leading to early discontinuation or deaths were reported. The ADA (anti-drug antibodies) incidence was 67 (44.4%) and 49 (32.9%) in the BAT1806 SC group and Tocilizumab group. This study revealed that immunogenicity had no significant effect on the PK or safety of the Tocilizumab.
CONCLUSION:
This study demonstrated bioequivalent PK, comparable safety, and immunogenicity profiles of BAT1806 SC and Tocilizumab in healthy subjects.
TRIAL REGISTRATION:
The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05968508).
2025-06-01Rheumatology and Therapy
A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product
Article
作者: Zhou, Yinbo ; Taylor, Peter C ; Yang, Xiaolei ; Ebbers, Hans C ; Leng, Xiaomei ; Chamberlain, Paul ; Kinsella, Niamh M ; Wei, Wei
INTRODUCTION:
Biosimilars need to demonstrate similarity in terms of quality, pharmacokinetics (PK), efficacy, safety, and immunogenicity. Here, we report the outcome of a comprehensive evaluation of the immunogenicity of the biosimilar BAT1806 compared with the tocilizumab reference product (TCZ).
METHODS:
We conducted a post hoc analysis of study BAT1806-001-CR, a comparative PK study in healthy male volunteers (n = 129), and BAT1806-002-CR, a phase III, 52-week trial in patients with rheumatoid arthritis (n = 621). Anti-drug antibodies (ADA), ADA titers, and neutralizing ADA were measured, and their impact on PK, safety, and efficacy parameters were assessed.
RESULTS:
In BAT1806-001-CR, treatment-induced ADA were observed in 37.8% of participants for the BAT1806 group, 28.6% for the EU-sourced TCZ group, and 31.0% for the US-sourced TCZ group, without an impact on PK and safety. In BAT1806-002-CR after 52 weeks, 28.2% of participants in the BAT1806 group developed treatment-induced ADA, compared with 24.0% in the TCZ group and 19.7% of participants who initiated TCZ and switched to BAT1806 at week 24. ADA-positive participants reported lower geometric mean serum tocilizumab trough concentrations than ADA-negative participants in all treatment groups. ADA-positive participants achieved similar efficacy outcomes to ADA-negative participants in all treatment groups. ADA were not associated with an incremental risk of treatment-emergent adverse events or hypersensitivity in any of the treatment groups.
CONCLUSIONS:
The results of these post hoc analyses did not indicate any clinically relevant differences in the immunogenicity profile of intravenously administered BAT1806 compared with TCZ.
TRIAL REGISTRATION:
ClinicalTrials.gov identifiers, NCT03606876, NCT03830203.
2025-03-01BIODRUGS
Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Article
作者: Ebbers, Hans C ; Liu, Cuihua ; Liu, Suli ; Li, Shengfeng ; Mei, Xiong ; Liu, Yujie ; Xie, Jianhua ; Cao, Di ; Li, Zhuxiang ; Engle, Linda
BACKGROUND:
BAT1806/BIIB800 (Tofidence™/tocilizumab-bavi), a biosimilar of tocilizumab, demonstrated a high degree of analytical and functional similarity to reference tocilizumab (TCZ) in a comprehensive comparative analytical assessment. Minor differences with respect to TCZ were observed for some attributes and this study assessed the potential impact of these differences through structure activity relationship characterization.
METHODS:
Structure activity relationship studies were conducted to assess glycation, glycosylation, charge variants, hydrophobicity, oxidation, and deamidation differences, using a range of investigative techniques. Structure activity relationship studies were performed on one lot each of BAT1806/BIIB800 and TCZ (European Union sourced only) except for glycation, where additional lots sourced from China and the USA were used.
RESULTS:
Average total glycated protein content of BAT1806/BIIB800 was higher than TCZ (10.08% vs 1.19%); however, biological activity, including target binding and functional potency, was unaffected. Stress-induced glycation of BAT1806/BIIB800 and TCZ also did not affect the biological activity of the products despite up to 60% total glycation content. Minor differences were observed between BAT1806/BIIB800 and TCZ in glycosylation, charge variants, hydrophobicity, oxidation, and deamidation without a relevant impact on interleukin-6 receptor binding, Fc-receptor binding, and effector functions. In forced degradation studies, oxidation and deamidation trends were comparable between the two products.
CONCLUSIONS:
Comparative structure activity relationship characterization of BAT1806/BIIB800 and TCZ indicated that there are no relevant differences in quality attributes between BAT1806/BIIB800 and reference TCZ. Observed differences between BAT1806/BIIB800 and TCZ had no functional impact on BAT1806/BIIB800. The results support the conclusion that BAT1806/BIIB800 is similar to TCZ.
100 项与 托珠单抗生物类似药 (百奥泰生物) 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
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 幼年特发性关节炎 | 加拿大 | 2025-10-01 | |
| 新型冠状病毒感染 | 欧盟 | 2024-06-20 | |
| 新型冠状病毒感染 | 冰岛 | 2024-06-20 | |
| 新型冠状病毒感染 | 列支敦士登 | 2024-06-20 | |
| 新型冠状病毒感染 | 挪威 | 2024-06-20 | |
| 少关节关节炎 | 欧盟 | 2024-06-20 | |
| 少关节关节炎 | 冰岛 | 2024-06-20 | |
| 少关节关节炎 | 列支敦士登 | 2024-06-20 | |
| 少关节关节炎 | 挪威 | 2024-06-20 | |
| 多关节型幼年特发性关节炎 | 美国 | 2023-09-29 | |
| 细胞因子释放综合征 | 中国 | 2023-01-16 | |
| 类风湿关节炎 | 中国 | 2023-01-16 | |
| 全身型幼年特发性关节炎 | 中国 | 2023-01-16 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | - | 300 | (BIIB800) | 壓襯願鹽膚襯鏇築廠壓(齋齋顧鏇餘憲夢鏇窪顧) = 觸壓鏇廠鹽網鏇網齋餘 鏇繭製築壓鬱夢選鏇廠 (憲選淵繭壓願齋觸鑰簾, 43.3) 更多 | - | 2025-10-06 | |
(Actemra) | 壓襯願鹽膚襯鏇築廠壓(齋齋顧鏇餘憲夢鏇窪顧) = 夢壓糧夢鏇網壓膚範選 鏇繭製築壓鬱夢選鏇廠 (憲選淵繭壓願齋觸鑰簾, 41.3) 更多 | ||||||
临床3期 | 类风湿关节炎 Anti-drug antibodies (ADA) | neutralizing ADA | - | 蓋繭築觸觸網蓋築艱艱(窪製網衊餘襯鬱構餘製) = 觸糧鏇餘鑰顧糧壓構壓 鏇憲範網繭壓憲蓋蓋齋 (製餘醖襯觸選獵夢鬱淵 ) | 积极 | 2025-04-08 | ||
TCZ | 蓋繭築觸觸網蓋築艱艱(窪製網衊餘襯鬱構餘製) = 遞壓鬱襯窪觸襯觸願構 鏇憲範網繭壓憲蓋蓋齋 (製餘醖襯觸選獵夢鬱淵 ) | ||||||
临床3期 | 621 | TCZ | 糧繭憲廠繭願襯糧衊觸(鹹衊壓憲襯鑰鏇鹽製襯) = 夢鹽鹹醖選願顧顧窪鏇 窪繭廠顧鬱範製觸醖艱 (鑰夢淵鏇衊範憲鬱遞窪 ) | 积极 | 2024-09-07 | ||
糧繭憲廠繭願襯糧衊觸(鹹衊壓憲襯鑰鏇鹽製襯) = 鏇膚艱廠艱齋顧窪壓鹽 窪繭廠顧鬱範製觸醖艱 (鑰夢淵鏇衊範憲鬱遞窪 ) | |||||||
临床3期 | 621 | 壓憲願顧網鹽繭鬱鹹夢(憲襯餘鑰衊醖鏇憲膚憲) = 窪衊壓醖遞廠膚壓壓製 積願鬱構艱齋襯遞鑰獵 (餘餘襯鏇鬱鏇築糧簾膚 ) 更多 | 相似 | 2024-01-01 | |||
壓憲願顧網鹽繭鬱鹹夢(憲襯餘鑰衊醖鏇憲膚憲) = 範鹽窪獵製糧製遞網餘 積願鬱構艱齋襯遞鑰獵 (餘餘襯鏇鬱鏇築糧簾膚 ) 更多 | |||||||
临床3期 | 621 | (BAT1806 up to Week 48) | 淵廠範糧淵壓選鬱憲鏇(築齋糧蓋遞鬱願鑰繭製) = 襯構願簾齋齋選夢蓋膚 製襯觸選鹽簾獵積構鑰 (壓憲遞襯襯遞鏇廠網憲 ) 更多 | 相似 | 2022-09-12 | ||
(TCZ up to Week 24 followed by BAT1806 from Week 24 to Week 48) | 淵廠範糧淵壓選鬱憲鏇(築齋糧蓋遞鬱願鑰繭製) = 網積簾艱鹽鹽糧遞積顧 製襯觸選鹽簾獵積構鑰 (壓憲遞襯襯遞鏇廠網憲 ) 更多 | ||||||
临床1期 | - | 138 | 構範遞鬱獵餘襯襯醖淵(衊積醖觸淵襯鑰壓簾廠) = similar in all three groups: BAT1806 (n = 45), RoActemra-EU (n = 42), and Actemra-US (n = 42). The 90% confidence intervals (CIs) for the ratios of C max , AUC0-t and AUC0-∞ were 86.90-104.41% for BAT1806 vs. RoActemra-EU, 91.70-106.15% for BAT1806 vs Actemra-US, and 90.04-105.53% for Actemra-US vs RoActemra-EU. For all comparisons, the 90% CIs for the C max , AUC0-t , and AUC0-∞ were within the predefined bioequivalence limit of 80.00-125.00%. 選構餘窪遞製網齋鏇鏇 (簾廠襯願範鏇積壓窪積 ) | 相似 | 2020-01-01 | ||
RoActemra-EU |
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