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.

NCT05968508 / Active, not recruiting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

CTR20232409 / Active, not recruiting临床1期

一项随机、双盲、单次给药、平行两组BAT1806皮下注射液与雅美罗®在中国健康男性受试者的药代动力学和安全性比对研究

主要研究目的：比较在中国健康男性受试者中单次皮下注射BAT1806皮下注射液或雅美罗®（欧盟），两药之间药代动力学的相似性。次要研究目的：评价BAT1806皮下注射液、雅美罗®（欧盟）在中国健康男性受试者的临床安全性、耐受性及免疫原性。

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）

2024-01-01·The Lancet. Rheumatology

Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial

Article

作者: Mitroiu, Marian ; Dong, Qingfeng ; Yang, Xiaolei ; Leszczynski, Piotr ; Gu, Jieruo ; Rezk, Mourad ; Miakisz, Malgorzata ; Jeka, Slawomir ; Zhou, Yinbo ; Addison, Janet ; Stanislavchuk, Mykola ; Liu, Sheng-Yun ; Zeng, Xiaofeng ; Liu, Huaxiang ; Kilasonia, Lali ; Leng, Xiaomei

BACKGROUND:

Biosimilars provide an opportunity to address unmet medical need by expanding access to biological treatments. This study aimed to show equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles of a proposed tocilizumab biosimilar BAT1806/BIIB800, to reference tocilizumab, in participants with rheumatoid arthritis with an inadequate response to methotrexate.

METHODS:

This phase 3, multicentre, randomised, double-blind, active-controlled, equivalence study comprised a 24-week initial treatment period (results reported here) and a 24-week secondary treatment period. Participants were recruited at 54 centres across five countries (China, Ukraine, Poland, Georgia, and Bulgaria). Patients with active rheumatoid arthritis with an inadequate response to methotrexate were randomly assigned (1:1:2) to receive reference tocilizumab up to week 48, or reference tocilizumab up to week 24 followed by BAT1806/BIIB800 up to week 48 (the two reference tocilizumab groups were analysed as a single group in this analysis), or BAT1806/BIIB800 up to week 48 (the BAT1806/BIIB800 group), administered by intravenous infusion once every 4 weeks at a starting dose of 8 mg/kg. The primary endpoint was the proportion of participants who had a 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 (for the European Medicines Agency [EMA]) or week 24 (for the US Food and Drug Administration [FDA] and China National Medical Products Administration [NMPA]) using prespecified equivalence margins (95% CI -14·5 to +14·5 [EMA], 90% CI -12·0 to +15·0 [FDA], and 95% CI -13·6 to +13·6 [NMPA]). The International Council for Harmonisation E9(R1) estimand framework, with strategies for addressing intercurrent events, was implemented for the efficacy evaluations with expected differences as per the predefined equivalence margins. This trial is registered at ClinicalTrials.gov (NCT03830203) and EudraCT (2018-002202-31), and is closed to new participants.

FINDINGS:

Between Dec 19, 2018, and Jan 5, 2021, we randomly assigned 621 participants: 309 to the reference tocilizumab group and 312 to the BAT1806/BIIB800 group. The mean age was 50·5 years (SD 12·0), 534 (86%) were women, 87 (14%) were men, and 368 (59%) were White. For the primary estimands, estimated ACR20 response rates were 64·8% in the reference tocilizumab group and 69·0% in the BAT1806/BIIB800 group (treatment difference 4·1% [95% CI -3·6 to 11·9]) at week 12, and 67·9% in the reference tocilizumab group and 69·9% in the BAT1806/BIIB800 group (treatment difference 1·9% [90% CI -4·0 to 7·9; 95% CI -5·2 to 9·1]) at week 24. All confidence intervals were contained within the predefined equivalence margins. Comparable pharmacokinetic and immunogenicity profiles were observed for the reference tocilizumab and BAT1806/BIIB800 groups. Adverse events were reported by 201 (65%) participants in the reference tocilizumab group and 206 (66%) in the BAT1806/BIIB800 group; 196 (63%) participants in the reference tocilizumab group and 201 (64%) participants in the BAT1806/BIIB800 group reported a treatment-emergent adverse event. Five participants had a fatal event (reference tocilizumab n=1; BAT1806/BIIB800 n=4).

INTERPRETATION:

BAT1806/BIIB800 showed equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles as reference tocilizumab.

FUNDING:

Bio-Thera Solutions and Biogen.

2021-01-01·Annals of medicine3区 · 医学

A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra ^® ) in Chinese healthy subjects

3区 · 医学

Article

作者: Liu, Jingrui ; Zhu, Xiaoxue ; Zhang, Hong ; Wu, Min ; Li, Xiaojiao ; Fang, Min ; Ding, Yanhua ; Li, Cuiyun ; Sun, Jixuan

PURPOSE:

QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects.

DESIGN:

A randomised, double-blind, two-arm, parallel study was performed to examine the bioequivalence of QX003S (8 mg/kg) with that of Actemra® as a reference drug.

RESULTS:

QX003S (N = 40) and Actemra® (N = 40) groups exhibited similar PK properties. The inter-subject variability ranged from 14.95% to 18.78%. The 90% confidence intervals of the ratios for C_max, AUC_0-t andAUC_0-∞ in both groups were within the range of 80-125%. After administration, the number of subjects who tested positive for anti-drug antibodies (ADA) in the QX003S group and Actemra® groups was 6 (14.3%) and 14 (34.1%), respectively. Adverse reactions occurred in 100% and 97.6% subjects in the QX003S and Actemra® groups, respectively. The most common adverse reactions were decrease in fibrinogen level and neutrophil and leukocyte counts.

CONCLUSION:

The PK characteristics and immunogenicity exhibited by QX003S were similar to that of the reference product, Actemra®. The safety profile was similar in the two treatment groups with mild-moderate adverse effects.Trial RegistrationThe trial is registered at Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html#CTR20190002)Key pointsThis was the first clinical report of a new proposed tocilizumab biosimilar, QX003S.This phase-I randomized, controlled study compared pharmacokinetics, variability,immunogenicity, and safety of QX003S vs. the approved tocilizumab product (Actemra@).The results demonstrate bioequivalence between BAT1806 and the reference products (Actemra@), as well as comparable immunogenicity, safety and tolerability profiles.

Frontiers in pharmacology2区 · 医学

A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men

2区 · 医学

ArticleOA

作者: Yang, Xiaolei ; Wang, Zhaohe ; Liu, Jingrui ; Wu, Min ; Wei, Haijing ; Zhou, Yinbo ; Ding, Yanhua ; Li, Xiaojiao ; Zhu, Xiaoxue ; Zhang, Hong ; Chen, Hong ; Li, Cuiyun ; Wang, Hong ; Yu, Jinchen

Objective: The study aimed to explore the bioequivalence of a proposed biosimilar BAT1806 to its reference products marketed in the EU and US (RoActemra-EU and Actemra-US) among healthy Chinese men. The tolerance, immunogenicity, and pharmacokinetics (PK) of the three drugs were also investigated.Methods: In this randomized, double-blind, single-dose, three-arm, parallel study, a single-dose of 4 mg/kg of the reference products, or the biosimilar was administered to the participants. The participants were followed up for 57 days, and PK, immunogenicity, and tolerance evaluations were completed during this period.Results: The PK parameters were 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 Cmax, 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 Cmax, AUC0–t, and AUC0–∞ were within the predefined bioequivalence limit of 80.00–125.00%. The intersubject variability ranged from 14.5% to 21.5%, which was considerably low. Among the participants, 19 (42.2%), 10 (23.8%), and 12 (28.6%) from the BAT1806, RoActemra-EU, and Actemra-US groups were, respectively, found to be positive for anti-drug antibodies, while 14 (31.1%), nine (21.4%), and 12 (28.6%) were positive for neutralizing antibodies. Nevertheless, these antibodies did not affect the drug concentrations, and the outcomes in the bioequivalence tests were similar after sensitivity analysis. Treatment-related and treatment-emergent adverse events (TEAEs) were recorded in 27, 34, and 32 participants in the BAT1806, RoActemra-EU, and Actemra-US groups, respectively. The most common treatment-related adverse events observed were a decrease in neutrophil, and white blood cell counts.Conclusion: The PK characteristics of BAT1806 were similar to those of the reference products, RoActemra-EU and Actemra-US. Both BAT1806 and the reference products exhibited low intersubject variability and similar safety profiles.Clinical trial registration number:http://www.chinadrugtrials.org.cn/index.html, CTR20180039; https://clinicaltrials.gov/NCT03606876

150

项与托珠单抗生物类似药 (百奥泰生物) 相关的新闻（医药）

2024-09-11

·百奥泰

百奥泰与渤健在《关节炎研究与治疗》期刊中发表TOFIDENCE(一款参照雅美罗®托珠单抗开发的生物类似药)的III期临床数据

百奥泰生物制药股份有限公司（证券代码：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”。公司今日宣布，与渤健共同撰写的文章《评估BAT1806/BIIB800在第2治疗期期间（TP2，第24-48周）的3期临床研究》已发表于《关节炎研究与治疗》Arthritis Research & Therapy期刊中，BAT1806/BIIB800是一款由百奥泰参照雅美罗® (托珠单抗)开发的生物类似药，目前已在欧美地区上市，商品名为TOFIDENCE™。在3期临床研究中，对甲氨蝶呤应答不足的类风湿性关节炎患者按1:1:2的比例随机分配至3个治疗组：（1）使用原研药每4周静脉注射8mg/kg，直至第48周；（2）使用原研药治疗至第24周，随后转换为使用BAT1806/BIIB800至第48周；（3）使用BAT1806/BIIB800治疗至第48周。TP2（第24-48周）的疗效评估标准包括ACR20/50/70反应率以及DAS28距基线的变化。此外还评估比较了药代动力学、安全性和免疫原性。TP2期间也评估了第24周后从原研药（雅美罗®）转换为使用BAT1806/BIIB800治疗可能产生的影响，从而反映在临床实践中药物的互换使用情况。在3期临床TP2的研究结果表明，对甲氨蝶呤应答不足的类风湿性关节炎患者使用原研药（雅美罗®）后转换为使用BAT1806/BIIB800，其临床疗效、安全性、免疫原性和药代动力学都仍与原研药治疗组可比。百奥泰风湿免疫学医学总监杨晓蕾表示：“我们很高兴能在Arthritis Research & Therapy期刊中发表TOFIDENCE™(BAT1806/BIIB800)与原研药转换使用的研究结果，研究结果也证明了TOFIDENCE™(BAT1806/BIIB800)与原研药的高度相似性。我们希望这一研究结果能打消可能存在的对既往使用原研药的患者转为使用TOFIDENCE™(BAT1806/BIIB800)的安全性和疗效的担忧。” 2021年4月，渤健和百奥泰就BAT1806/BIIB800的开发、生产和商业化活动签署商业化及授权许可协议。渤健拥有BAT1806/BIIB800 除在中国（包括香港、澳门和台湾）以外所有国家的注册、生产和商业化相关的独占权利。关于百奥泰百奥泰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。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的疾病。作为新一代抗体药物研发的领导者，百奥泰已推动多款候选药物进入后期临床试验，其中格乐立®（阿达木单抗）、普贝希®（贝伐珠单抗）、施瑞立®（托珠单抗）、贝塔宁®（枸橼酸倍维巴肽）已在中国获批上市。TOFIDENCE™（托珠单抗）和Avzivi®（贝伐珠单抗）已实现中美欧三地获批上市。公司现有20多款在研产品处于不同临床研究阶段，其中肿瘤领域主要聚焦后PD-1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。欲了解更多信息，请访问www.bio-thera.com，或关注我们的推特（@bio_thera_sol）和微信公众号（百奥泰）。 1. 格乐立®是百奥泰的注册商标 2. 普贝希®是百奥泰的注册商标 3. 施瑞立®是百奥泰的注册商标 4. 贝塔宁®是百奥泰的注册商标 5. TOFIDENCETM是渤健的注册商标 6. Avzivi®是山德士的注册商标 7. 雅美罗®是基因泰克公司的注册商标百奥泰前瞻性声明本新闻稿包含了BAT1806/BIIB800或百奥泰及其产品线相关的前瞻性声明。由于某些重要因素可能会影响公司的实际结果，特此提醒读者注意不要过分依赖该前瞻性声明。这些前瞻性语句包括但不限于包含意愿、将要、可能、潜在性、预测、计划、估计、预期等类似陈述。它们都应被视为百奥泰基于截至本新闻稿发布之日可获得的信息的合理假设，并不保证未来的表现或发展。由于多种因素，实际结果和事件可能与前瞻性声明中包含的信息存在重大差异，这些因素包括但不限于本产品可能不会获得受理或批准，以及药物研究、开发和商业化中固有的风险和不确定性，例如临床前和临床研究的风险和不确定性以及能否获得药政部门的批准。其他风险因素包括生产、分销、营销、竞争、知识产权、药物功效和安全性方面的风险和不确定性，国家及全球财务与医疗状况的变化，公司财务状况的变化以及适用法律法规的变化等。本新闻稿中包含的任何前瞻性声明仅针对截止于作出声明之日的情况。除非法律要求，否则百奥泰没有义务更新本新闻稿中包含的任何前瞻性声明，以反映本新闻稿发布之日以后的新信息和事件，公司观点的改变或其他情况。

临床3期生物类似药临床结果临床1期上市批准

2024-09-11

·PRNewswire

Bio-Thera Solutions and Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE™ (BAT1806/BIIB800), an approved Biosimilar referencing tocilizumab in Arthritis Research & Therapy

Comparable clinical efficacy and safety in Treatment Period 2 (TP2, Week 24-48) is maintained after switch from reference tocilizumab to TOFIDENCE (BAT1806/BIIB800) Phase 3 clinical data in totality demonstrates biosimilarity between TOFIDENCE (BAT1806/BIIB800) and reference tocilizumab before and after switching.1,2 GUANGZHOU, China, Sept. 11, 2024 /PRNewswire/ -- Bio-Thera Solutions, Ltd. today announced, in collaboration with Biogen, the publication in the journal Arthritis Research & Therapy of results from Treatment Period 2 (TP2; study weeks 24-48) of a Phase 3 clinical study evaluating BAT1806/BIIB800, an approved biosimilar to Actemra®/RoActemra®3 (tocilizumab). BAT1806/BIIB800 is currently commercialized under the brand name TOFIDENCE™4. In the Phase 3, multicenter, multiregional, double-blind, active-controlled, clinical equivalence study, participants with active rheumatoid arthritis (RA) despite treatment with methotrexate were randomized (1:1:2) to intravenous (iv) administration of 8 mg/kg reference tocilizumab (TCZ) every 4 weeks to week 48 (TCZ group), or TCZ to week 24 followed by BAT1806/BIIB800 to week 48 (TCZ to BAT1806/BIIB800 group), or BAT1806/BIIB800 to week 48 (BAT1806/BIIB800 group)1,2. Efficacy in TP2 of the study was evaluated using American College of Rheumatology (ACR) response criteria (ACR20/50/70) and change from baseline in Disease Activity Score on 28 joints (DAS28)2. Pharmacokinetics, safety, and immunogenicity were also evaluated. TP2 analysis also assessed the possible impact of a single treatment switch from TCZ to BAT1806/BIIB800 after week 24, reflecting clinical practice where multiple treatment switches occur. Results from TP2 of the Phase 3 study demonstrated maintenance of comparable clinical efficacy, safety, immunogenicity and PK following switch to BAT1806/BIIB800 from TCZ, in patients with Rheumatoid Arthritis and an inadequate response to methotrexate. "We are pleased to publish the switching data of TOFIDENCE (BAT1806/BIIB800) from reference tocilizumab that strongly supports its biosimilarity to tocilizumab for a long-term period in treating patients with active rheumatoid arthritis and an inadequate response to MTX," said Dr Xiaolei Yang, Executive Medical Director for Rheumatology and Immunology at Bio-Thera. "We hope the study results help allay any concerns over safety and efficacy of TOFIDENCE (BAT1806/BIIB800) for use in patients who were previously treated with reference product." Bio-Thera Solutions, Ltd. and Biogen entered into a commercialization and license agreement to develop, manufacture and commercialize TOFIDENCE (BAT1806/BIIB800) on April 8th, 2021. Biogen has exclusive regulatory, manufacturing and commercial rights to TOFIDENCE (BAT1806/BIIB800) in all countries excluding China (including Hong Kong, Macau and Taiwan). BAT1806/BIIB800 TP2 Analysis Of 621 randomized participants, 577 (92.9%) completed Treatment Period 1 (TP1, Week 0-24) and entered TP2 (TCZ: N = 145 [93.5%]; TCZ to BAT1806/BIIB800: N = 142 [92.2%]; BAT1806/BIIB800: N = 290 [92.9%])1,2. Proportions of ACR20 responders were similar between treatment groups throughout TP2 (87.8%, 90.3%, and 90.4%, respectively, at week 48), as were proportions of ACR50 and ACR70 responders, and reduction in DAS28. Drug trough levels and antidrug antibody incidences were comparable between the treatment groups. Adverse events were balanced across the treatment groups and no fatal events were reported. In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups. These longer-term findings reinforce the results reported for TP1 and further support biosimilarity. 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 four approved products: QLETLI®5 and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE/ BAT1806 and Avzivi®6 / Pobevcy®7 in the US, EU and China. 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 ADCs. For more information, please visit or follow us on Twitter (@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 BAT1806 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, 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. 1. Leng X, Leszczynski P, Jeka S, et al. Comparing tocilizumab biosimilar BAT1806/ BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. Lancet Rheumatol. 2024;6(1):e40-50 2. Leng X, Leszczynski P, Jeka S, et al. A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a proposed tocilizumab biosimilar, with a tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 and week 48). Manuscript in review 3. Actemra® / RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp, a member of the Roche Group 4. TOFIDENCE™ is a trademark of Biogen 5. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 6. Avzivi® is a registered trademark of Sandoz AG 7. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. MEDIA CONTACT – BIO-THERA SOLUTIONS, LTD. Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床结果引进/卖出上市批准

2024-08-30

·百奥泰

百奥泰BAT2406（IL-4Rα）（一款参照达必妥®度普利尤单抗开发的生物类似药）获批临床

百奥泰生物制药股份有限公司（证券代码：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”。公司今日收到国家药品监督管理局核准签发的关于公司在研药品度普利尤单抗注射液（BAT2406）的《药物临床试验批准通知书》。 BAT2406是百奥泰根据中国国家药品监督管理局（NMPA）、美国食品药品监督管理局（FDA）、欧洲药品管理局（EMA）生物类似药相关指导原则开发的度普利尤单抗注射液，拟用于治疗特应性皮炎、哮喘、结节性痒疹、慢性鼻实炎伴鼻息肉病和嗜酸性食管炎等。BAT2406（度普利尤单抗注射液）是一种全人单克隆抗体（IgG4型），可通过与白介素-4（IL-4）和白介素-13（IL-13）受体复合物共享的IL-4Rα亚单位特异性结合而抑制IL-4和IL-13的信号传导。度普利尤单抗通过 I型受体抑制IL-4信号传导，并通过II型受体抑制IL-4和IL-13信号传导。目前，国内已获批上市的度普利尤单抗药物为赛诺菲生物科技股份有限公司的Dupixent®（商品名：达必妥®），百奥泰为首家在中国获得度普利尤单抗生物类似药临床试验批准的公司。关于百奥泰百奥泰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。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的疾病。作为新一代抗体药物研发的领导者，百奥泰已推动多款候选药物进入后期临床试验，其中格乐立®（阿达木单抗）、普贝希®（贝伐珠单抗）、施瑞立®（托珠单抗）、贝塔宁®（枸橼酸倍维巴肽）已在中国获批上市。TOFIDENCE™（托珠单抗）和Avzivi®（贝伐珠单抗）已实现中美欧三地获批上市。公司现有20多款在研产品处于不同临床研究阶段，其中肿瘤领域主要聚焦后PD-1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。欲了解更多信息，请访问www.bio-thera.com，或关注我们的推特（@bio_thera_sol）和微信公众号（百奥泰）。 1. 格乐立®是百奥泰的注册商标 2. 普贝希®是百奥泰的注册商标 3. 施瑞立®是百奥泰的注册商标 4. 贝塔宁®是百奥泰的注册商标 5. TOFIDENCETM是渤健的注册商标 6. Avzivi®是山德士的注册商标 7. 达必妥®是赛诺菲的注册商标 8. Dupixent®是赛诺菲的注册商标百奥泰前瞻性声明本新闻稿包含了BAT2406或百奥泰及其产品线相关的前瞻性声明。由于某些重要因素可能会影响公司的实际结果，特此提醒读者注意不要过分依赖该前瞻性声明。这些前瞻性语句包括但不限于包含意愿、将要、可能、潜在性、预测、计划、估计、预期等类似陈述。它们都应被视为百奥泰基于截至本新闻稿发布之日可获得的信息的合理假设，并不保证未来的表现或发展。由于多种因素，实际结果和事件可能与前瞻性声明中包含的信息存在重大差异，这些因素包括但不限于本产品可能不会获得受理或批准，以及药物研究、开发和商业化中固有的风险和不确定性，例如临床前和临床研究的风险和不确定性以及能否获得药政部门的批准。其他风险因素包括生产、分销、营销、竞争、知识产权、药物功效和安全性方面的风险和不确定性，国家及全球财务与医疗状况的变化，公司财务状况的变化以及适用法律法规的变化等。本新闻稿中包含的任何前瞻性声明仅针对截止于作出声明之日的情况。除非法律要求，否则百奥泰没有义务更新本新闻稿中包含的任何前瞻性声明，以反映本新闻稿发布之日以后的新信息和事件，公司观点的改变或其他情况。

上市批准生物类似药抗体药物偶联物

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

批准上市

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
新型冠状病毒感染	欧盟	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	冰岛	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	列支敦士登	Biogen Netherlands BV	2024-06-20
新型冠状病毒感染	挪威	Biogen Netherlands BV	2024-06-20
少关节关节炎	欧盟	Biogen Netherlands BV	2024-06-20
少关节关节炎	冰岛	Biogen Netherlands BV	2024-06-20
少关节关节炎	列支敦士登	Biogen Netherlands BV	2024-06-20
少关节关节炎	挪威	Biogen Netherlands BV	2024-06-20
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

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	申请上市	美国	百奥泰生物制药股份有限公司	2022-12-09

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


NCT03830203 (EudraCT 2018-002202-31, Pubmed \| Arthritis Res Ther)	临床3期	-	621	TCZ	膚廠壓範鹹鑰艱蓋壓窪(構觸鏇鬱衊築範醖廠鬱) = 衊願窪艱糧醖衊選積獵繭簾簾壓鹽淵鏇夢鬱簾 (顧積鏇簾壓範鏇繭膚憲 )	积极	2024-09-07
				TCZ to BAT1806/BIIB800	膚廠壓範鹹鑰艱蓋壓窪(構觸鏇鬱衊築範醖廠鬱) = 鹹窪顧積廠製夢蓋繭餘繭簾簾壓鹽淵鏇夢鬱簾 (顧積鏇簾壓範鏇繭膚憲 )
NCT03830203 \| EUCTR2018-002202-31-BG (Pubmed) 人工标引	临床3期	类风湿关节炎	621	BAT1806	憲觸鏇憲顧艱簾壓獵觸(遞選網壓積鹹餘網壓築) = 艱網遞膚鬱淵選壓繭鹹窪襯築壓構鑰鑰網艱襯 (遞鑰網獵繭鹹顧築餘憲 ) 更多	相似	2024-01-01
				tocilizumab	憲觸鏇憲顧艱簾壓獵觸(遞選網壓積鹹餘網壓築) = 製鬱醖構鹽網網繭獵鹹窪襯築壓構鑰鑰網艱襯 (遞鑰網獵繭鹹顧築餘憲 ) 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)	壓簾鬱餘蓋蓋繭選憲餘(鑰鑰繭遞蓋製簾鹽鹽鹽) = 築積齋鑰顧鹽顧遞膚淵窪遞醖獵顧觸夢簾繭範 (鏇網糧衊觸繭築遞齋衊 ) 更多	相似	2022-09-12
				BAT1806 (TCZ up to Week 24 followed by BAT1806 from Week 24 to Week 48)	壓簾鬱餘蓋蓋繭選憲餘(鑰鑰繭遞蓋製簾鹽鹽鹽) = 選衊獵艱構夢蓋範鑰憲窪遞醖獵顧觸夢簾繭範 (鏇網糧衊觸繭築遞齋衊 ) 更多
CTR20180039 \| NCT03606876 (Pubmed \| Front Pharmacol) 人工标引	临床1期	-	138	BAT1806	廠獵餘壓願範膚淵齋顧(壓廠餘襯鏇蓋廠鏇鹽窪) = 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%. 艱壓鑰淵餘簾鹹製構衊 (淵餘艱壓願鬱膚壓壓構 )	相似	2020-01-01
				RoActemra-EU