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

The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.

开始日期2024-01-02

申办/合作机构

Biogen, Inc.

ChiCTR2300075487

/ Suspended临床1期IIT

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

开始日期2023-09-28

申办/合作机构

安徽医科大学第二附属医院

[+1]

NCT05968508

/ Completed临床1期

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

This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.

开始日期2023-08-29

申办/合作机构

百奥泰生物制药股份有限公司

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

项与托珠单抗生物类似药 (百奥泰生物) 相关的文献（医药）

2025-10-03·EXPERT 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 AUC_0-inf (area under the curve from zero to infinity) (97.07%), and AUC_0-t (area under the curve from time 0 to the last measured) (97.18%) and C_max (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).

2025-06-01·Rheumatology 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.

2025-03-01·BIODRUGS

Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

Article

作者: Liu, Cuihua ; Ebbers, Hans C ; 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.

535

项与托珠单抗生物类似药 (百奥泰生物) 相关的新闻（医药）

22 小时之前

·研发客

百奥泰优卓美®获国家药监局上市批准

百奥泰生物制药股份有限公司（股票代码：688177）是一家位于中国广州，基于科学而创新的全球性生物制药企业，以下简称“百奥泰”或“公司”。公司10月22日宣布，国家药品监督管理局（NMPA）已正式批准其递交的司库奇尤单抗注射液优卓美®（BAT2306）上市申请，该产品为全球首个司库奇尤单抗生物类似药。优卓美®获批适应症为：银屑病、强直性脊柱炎、银屑病关节炎。银屑病、强直性脊柱炎等自身免疫性疾病在国内患者基数庞大，中重度患者对可负担生物制剂的需求尤为突出。优卓美®获批上市将填补国内司库奇尤单抗生物类似药的空白，为患者带来全新、可负担的治疗选择，有助于提升生物制剂的临床可及性。在海外布局方面，百奥泰已就BAT2306与多家合作伙伴达成授权协议，覆盖中东北非、拉丁美洲、东南亚、俄罗斯及独联体等国家和地区，进一步完善了公司生物类似药的全球化管线布局。百奥泰创始人及总经理李胜峰博士表示：“优卓美®的成功获批，是公司发展史上的重要里程碑。它将进一步丰富百奥泰自身免疫领域的产品矩阵，巩固公司在全球生物类似药赛道的竞争力。公司将快速推进优卓美®的生产、准入与商业化落地，持续以高品质生物药满足全球自身免疫疾病患者尚未被满足的临床需求。” 关于优卓美优卓美®（BAT2306）作为司库奇尤单抗（商品名：Cosentyx®；可善挺®）的生物类似药，是一款抗人白细胞介素-17A（IL-17A）单克隆抗体（IgG1κ），可通过与IL-17A的选择性结合以抑制其与IL-17受体的相互作用，抑制促炎症细胞因子和趋化因子的释放。IL-17A 是人体炎症和免疫应答过程中形成的细胞因子，在多种自身免疫性疾病的发病机制中具有重要作用。在银屑病、银屑病关节炎和强直性脊柱炎患者的血液中发现分泌 IL-17A 的淋巴细胞数目增加以及 IL-17A 水平升高。关于百奥泰百奥泰是一家立足于广州、放眼于全球、基于科学而创新的生物制药企业。公司聚焦肿瘤、自身免疫、心血管、眼科等重大疾病，深耕创新药与生物类似药研发、产业化与全球商业化布局。公司多款产品落地海内外，托珠单抗 TOFIDENCE®是首个由中国药企研发、生产且获得美国FDA批准上市的单克隆抗体药物、IMMGOLIS™是全球首个获FDA批准上市的戈利木单抗生物类似药、格乐立®是首个国产的阿达木单抗生物类似药、优卓美®为全球首个获批上市的司库奇尤单抗生物类似药。乌司奴单抗及贝伐珠单抗生物类似药等核心品种已先后在中国、美国、欧盟、英国、巴西、瑞士等多地获批上市。公司另有多款候选药物进入后期临床试验，其中肿瘤领域主要聚焦PD-1后时代的肿瘤免疫治疗和抗体药物偶联体（ADC）靶向药物开发。百奥泰始终以患者的福祉作为首要核心价值，通过创新研发，为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。

生物类似药上市批准

2026-10-23

·药通社

超级大药，全球首仿获批！

10月22日，国家药监局官网显示，百奥泰的BAT2306（司库奇尤单抗生物类似药）获批上市。这是全球首款获批的司库奇尤单抗生物类似药。原研司库奇尤单抗由诺华开发，是一款全人源IgG1单克隆抗体，可选择性结合白细胞介素17A（IL-17A），阻断其与受体相互作用，从而发挥抗炎作用。 2014年12月，司库奇尤单抗首次在海外获批上市，商品名为Cosentyx；2019年3月，该药在中国获批，商品名为可善挺。目前，司库奇尤单抗已覆盖银屑病、银屑病关节炎、强直性脊柱炎等多种免疫介导的炎症性疾病。 2025年，其全球销售额达到66.68亿美元，是诺华的最重要产品之一。不过，随着核心专利到期，司库奇尤单抗也进入生物类似药竞争阶段。中国市场的核心序列专利已于2025年8月到期。截至目前，全球已有3款司库奇尤单抗生物类似药递交上市申请，分别为百奥泰BAT2306、石药集团SYS6012和Celltrion的CT-P55。百奥泰率先获批，抢下了这一品种的首个上市席位。而看向百奥泰，明显发现这家企业定位和产品布局很具有差异化，上市起专攻生物类似药，先后拿下了第一个国产阿达木单抗生物类似药（格乐立，2019年获批）；中国药企研发生产、第一个拿到美国FDA上市批准的单克隆抗体（托珠单抗类似药TOFIDENCE，2023年9月）；以及 potentially 全球第一个戈利木单抗生物类似药（IMMGOLIS，2026年5月获FDA批准）。接连几款重磅生物类似药获批，百奥泰自此在行业内名声大噪，此番又拿下全球首个司库奇尤单抗生物类似药，再下一城。百奥泰自然也有创新药管线，但目前都还处于烧钱阶段，眼下营收仍主要依靠生物类似药。从名不见经传到国内生仿药龙头，百奥泰这些年的发展无疑是成功的，当然百奥泰的路径并非孤例，国内生物类似药市场经过多年发展，早已形成一批具有代表性的企业： 1、齐鲁制药：规模化生产与成本优势本土工业龙头跨界大分子，主打 “首仿 + 复杂制剂 + 性价比国产替代”。国内首家推出贝伐珠单抗生物类似药安可达，快速放量，国内年销售额超60亿，市场断层领先；后续在眼科抗 VEGF 赛道形成差异化，雷珠单抗实现国内首仿并率先出海欧盟。依托成熟化药渠道、规模化产能与成本控制能力，管线覆盖肿瘤、眼科、骨病等，是国内生仿药放量最快、供给能力最强的企业之一，至今累计12款生物类似药在国内获批，是生物类似药上市最多的企业。 2、信达生物：创新药与生物类似药协同创新药底盘之上布局生仿，主打 “创新 + 类似药管线协同、医保快速上量”。商业化三款核心单抗类似药：贝伐珠单抗（达攸同）、阿达木单抗（苏立信）、利妥昔单抗（达伯华），全部纳入医保。依托 PD-1（信迪利单抗）建立的肿瘤学术推广体系，生仿产品与自研创新药互相导流，临床证据、商业化团队共享，以协同打法抢占院内市场，生仿是其商业化底盘的稳定压舱石，进而为创新管线提供现金流支撑。 3、复宏汉霖：以全球化拓展市场国内生物类似药的标杆型企业，锚定全球化同步开发。汉利康（利妥昔单抗）是国内首款按新规获批的生物类似药，拉开行业序幕；曲妥珠单抗汉曲优实现中国、欧盟、美国三地获批，也是首个真正进入欧美主流市场的国产单抗生仿药。产品在剂型规格上做本土化优化，如双规格无防腐剂配方降低给药损耗，管线以肿瘤核心单抗为主，海外授权覆盖上百个国家，是国产生仿出海的样板企业。 4、正大天晴：依托产业化与商业化能力依托肝病、血液肿瘤渠道优势切入，核心亮点在于大规模产业化能力。利妥昔单抗、贝伐珠单抗、曲妥珠单抗陆续获批，建成国内较早获批的万升级不锈钢生物反应器产线，放大工艺稳定、适合大规模供应。擅长院内学术与渠道渗透，同时同步推进海外授权，将部分在研生仿品种对外授权欧洲药企，兼顾国内放量与海外权益变现，重产能、重商业化落地。 5、博锐生物：深耕自身免疫领域赛道高度聚焦自身免疫炎症，是国内自免领域生仿的核心玩家。以阿达木单抗（安健宁）、英夫利昔单抗（安佰诺）、托珠单抗等 TNF-α/IL-6 通路产品为主，临床样本量大、适应症铺得全，适配类风湿关节炎、银屑病、炎症性肠病等慢病长期用药场景，深耕风湿免疫科学术体系，差异化避开拥挤的肿瘤单抗红海，在自免细分赛道形成稳固壁垒。 6、三生国健：积累自免领域基础国内老牌大分子生物企业，国内最早布局重组抗体、深耕自免赛道的先行者。益赛普（依那西普）是国内上市最早的 TNF-α 融合蛋白生物制剂，长期教育自免市场；后续持续推进多款自免类生物类似药。优势在于多年的风湿免疫科室沉淀、真实世界数据积累，品牌在风湿领域认知度高，是国内自免生物药市场的拓荒者，管线节奏偏稳健。 7、甘李药业：从胰岛素向单抗拓展赛道完全差异化，专注胰岛素类似物这一特殊生物类似药赛道，是国产三代胰岛素龙头。甘精、赖脯、门冬胰岛素相继在欧盟获批，成为首个多款三代胰岛素登陆欧洲的中国企业。区别于单抗赛道玩家，扎根内分泌、糖尿病专科，工艺、制剂、给药装置一体化开发，近年才向外拓展度普利尤单抗等单抗类生物类似药，核心基本盘牢牢锁定代谢慢病领域 *上述盘点不完全。综上，国内生物类似药市场正在从单品竞争走向综合实力竞争，但上市只是第一步，真正的商业化竞争才刚刚开始。随着热门靶点布局增多、同类产品陆续上市，价格、产能、医院准入和商业化能力将直接影响企业的市场表现。未来，单纯依靠产品获批已不够，成本控制、规模化生产和海外市场拓展，将成为企业建立长期竞争力的关键。 ↓⭐关注药通社，洞见行业趋势↓

2026-10-22

·PRNewswire

Bio-Thera to Present Phase 2 Clinical Data for BAT8008 in Combination with BAT1308 at ESMO 2026

GUANGZHOU, China, Oct. 22, 2026 /PRNewswire/ -- Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, today announced that clinical data from a Phase 2 study of BAT8008, a TROP2-targeted antibody-drug conjugate (ADC), in combination with BAT1308, an anti-PD-1 monoclonal antibody in First Line NSCLC, will be presented at the 2026 European Society for Medical Oncology (ESMO) Congress. The presentation will highlight findings from the combination regimen in patients with first-line non-small cell lung cancer (NSCLC), including an evaluation of its antitumor activity and safety profile. The study reflects Bio-Thera's continued commitment to advancing innovative antibody-based therapies for patients with significant unmet medical needs. Lung cancer remains a leading cause of cancer-related mortality worldwide, and NSCLC accounts for the majority of lung cancer cases. Despite advances in immunotherapy and combination treatment approaches, new therapeutic strategies remain an important area of research for patients with advanced NSCLC. BAT8008 is a TROP2-targeted ADC designed to deliver an exatecan payload, a cytotoxic TOP1 inhibitor, to tumor cells expressing TROP2. BAT1308 is a monoclonal antibody targeting programmed cell death protein 1 (PD-1), an immune checkpoint involved in regulating antitumor immune responses. The combination is being investigated for its potential to integrate targeted cytotoxic activity with immune checkpoint inhibition. Presentation Details Congress: 2026 European Society for Medical Oncology (ESMO) Congress Presentation: First-line BAT8008 (TROP2-ADC) plus BAT1308 (anti-PD-1) for advanced NSCLC: Results from a multicenter Phase 2 study Presentation format: Rapid Oral 1: NSCLC, metastatic Abstract number: 2631RO Date: Saturday, October 24, 2026 Time: 8:30–10:00 a.m. CEST (session window) Location: Almeria Auditorium, Hall 9 The presentation will provide further insight into the clinical development of this investigational combination. The full data will be presented at the ESMO 2026 Congress. For more information, please visit Bio-Thera Solutions' official website. About Bio-Thera Solutions: Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including six approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and USYMRO® (ustekinumab) in the EU, TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in the EU, a/k/a POBEVCY® in China, and GOTENFIA® (golimumab) in the EU and IMMGOLIS™ (golimumab-sldi) in the US. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera). Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT8008, BAT1308 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. Bio-Thera Contact: Bert E. Thomas IV Phone: +1.410.627.1734 Email: [email protected] SOURCE Bio-Thera Solutions, Ltd 21% more press release views with Request a Demo

临床2期免疫疗法抗体药物偶联物

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
-	-	L04AC07	-

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
幼年特发性关节炎	加拿大	Biogen, Inc.	2025-10-01
巨细胞动脉炎	美国	Biogen MA, Inc.	2024-07-22
新型冠状病毒感染	欧盟	BIOGEN NETHERLANDS BV	2024-06-24
新型冠状病毒感染	冰岛	BIOGEN NETHERLANDS BV	2024-06-24
新型冠状病毒感染	列支敦士登	BIOGEN NETHERLANDS BV	2024-06-24
新型冠状病毒感染	挪威	BIOGEN NETHERLANDS BV	2024-06-24
多关节型幼年特发性关节炎	美国	Biogen MA, Inc.	2023-09-29
细胞因子释放综合征	中国	百奥泰生物制药股份有限公司	2023-01-16
类风湿关节炎	中国	百奥泰生物制药股份有限公司	2023-01-16
全身型幼年特发性关节炎	中国	百奥泰生物制药股份有限公司	2023-01-16

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06262477 (CTgov)	临床1期	-	300	BIIB800 (BIIB800)	鏇網鑰鏇淵鬱壓鑰壓鹹(糧選鹽糧繭鹹選範顧築) = 膚夢廠鑰淵願艱築鹹膚鏇範淵構膚顧餘壓範積 (鬱壓艱糧艱廠夢醖襯襯, 43.3) 更多	-	2025-10-06
				Actemra (Actemra)	鏇網鑰鏇淵鬱壓鑰壓鹹(糧選鹽糧繭鹹選範顧築) = 顧製淵憲鹽繭膚選獵憲鏇範淵構膚顧餘壓範積 (鬱壓艱糧艱廠夢醖襯襯, 41.3) 更多
NCT03830203 \| NCT03606876 (BAT1806-001-CR;BAT1806-002-CR, Pubmed \| Rheumatol Ther)	临床3期	类风湿关节炎 Anti-drug antibodies (ADA) \| neutralizing ADA	-	BAT1806	鬱鹹鑰鬱憲廠網廠衊遞(襯觸簾觸膚齋窪憲衊餘) = 鬱蓋鏇廠鏇積構艱遞製鹹淵願齋繭壓蓋願鑰蓋 (積壓衊襯壓遞壓醖鏇壓 )	积极	2025-04-08
				TCZ	鬱鹹鑰鬱憲廠網廠衊遞(襯觸簾觸膚齋窪憲衊餘) = 醖願鑰糧網廠醖構艱製鹹淵願齋繭壓蓋願鑰蓋 (積壓衊襯壓遞壓醖鏇壓 )
NCT03830203 \| EUCTR2018-002202-31-BG (Pubmed \| Arthritis Res Ther)	临床3期	类风湿关节炎	621	TCZ	鑰顧選積淵繭製製繭繭(範選鏇餘鑰窪繭構願餘) = 鑰遞簾膚網蓋餘齋網築積鏇壓鏇願廠鑰願淵齋 (觸鹹壓願襯顧範襯網鏇 )	积极	2024-09-07
				TCZ to BAT1806/BIIB800	鑰顧選積淵繭製製繭繭(範選鏇餘鑰窪繭構願餘) = 鑰簾憲鬱鹽鬱膚鬱窪觸積鏇壓鏇願廠鑰願淵齋 (觸鹹壓願襯顧範襯網鏇 )
NCT03830203 (Pubmed 1 \| Pubmed 2 \| Lancet Rheumatol) 人工标引	临床3期	类风湿关节炎	621	BAT1806	選糧鑰鏇鏇鏇鬱繭簾憲(夢膚構糧遞膚醖顧獵願) = 範繭簾壓廠選齋遞顧觸鬱範範齋糧簾糧鹹網壓 (遞範鹹鏇蓋夢憲積觸顧 ) 更多	相似	2024-01-01
				tocilizumab	選糧鑰鏇鏇鏇鬱繭簾憲(夢膚構糧遞膚醖顧獵願) = 淵選醖鬱築蓋壓鑰憲襯鬱範範齋糧簾糧鹹網壓 (遞範鹹鏇蓋夢憲積觸顧 ) 更多
NCT03830203 (ACR2022) 人工标引	临床3期	类风湿关节炎	621	BAT1806 (BAT1806 up to Week 48)	鬱築簾膚築築觸蓋鏇製(窪選糧鏇願憲鏇醖簾範) = 鹽簾醖艱築壓製網齋範齋範觸鬱願鬱鹹遞糧鬱 (膚網願淵遞願鏇襯選觸 ) 更多	相似	2022-09-12
				BAT1806 (TCZ up to Week 24 followed by BAT1806 from Week 24 to Week 48)	鬱築簾膚築築觸蓋鏇製(窪選糧鏇願憲鏇醖簾範) = 蓋鑰選齋繭壓糧衊範餘齋範觸鬱願鬱鹹遞糧鬱 (膚網願淵遞願鏇襯選觸 ) 更多
CTR20180039 \| NCT03606876 (Pubmed \| Front Pharmacol) 人工标引	临床1期	-	138	BAT1806	齋選膚窪憲築夢獵鑰顧(襯膚鹹觸蓋築艱遞鏇願) = 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%. 構餘鹽壓觸艱鬱鏇鑰淵 (夢壓壓廠艱襯觸構餘選 )	相似	2020-01-01
				RoActemra-EU