The clinical comparative study met its primary endpoint and showed similar efficacy and comparable safety profile in patients with moderate to severe plaque psoriasis

临床比较研究符合其主要终点，并且在中度至重度斑块状银屑病患者中显示出相似的功效和相当的安全性

GUANGZHOU, China, Nov. 29, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced results from the Phase 3 study of BAT2206, a proposed biosimilar referencing Stelara® (ustekinumab).

中国广州，2023年11月29日/PRNewswire/-Bio-Thera Solutions，Ltd。（688177:SH），一家开发生物仿制药和创新资产管道的商业阶段生物制药公司，今天宣布了第3阶段的结果研究BAT2206，一种拟议的生物仿制药参考Stelara®（ustekinumab）。

The primary endpoint of this study was improvement from baseline in Psoriasis Area and Severity Index (PASI) score to Week 12, demonstrating BAT2206 is highly similar with Stelara® in patients with moderate to severe plaque psoriasis..

本研究的主要终点是银屑病面积和严重程度指数（PASI）评分从基线改善至第12周，表明BAT2206与中重度斑块状银屑病患者的Stelara®高度相似。。

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In the US, Stelara® is currently approved for the treatment of patients 6 years or older with active psoriatic arthritis (PsA), the treatment of patients 6 years or older with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn's disease (CD) in adults, and the treatment of moderately to severely active ulcerative colitis (UC) in adults..

在美国，Stelara®目前被批准用于治疗6岁或以上患有活动性银屑病关节炎（PsA）的患者，治疗6岁或以上患有中度至重度斑块状银屑病（Ps）的患者，这些患者可用于光疗或全身治疗，成人中度至重度活动性克罗恩病（CD）的治疗，以及成人中重度活动性溃疡性结肠炎（UC）的治疗。。

Bio-Thera Solutions Announces Positive Results from Phase 3 Study of BAT2206, a Proposed Biosimilar Referencing Stelara®

Bio-Thera Solutions宣布BAT2206第3阶段研究取得积极成果，BAT2206是一项拟议的生物仿制药参考Stelara®

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The BAT2206 clinical trial was a global, multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare the efficacy, safety, immunogenicity and PK of BAT2206 with Stelara® in 556 patients with moderate to severe plaque psoriasis. More information regarding the BAT2206 Phase 3 clinical trial, including inclusion and exclusion criteria and primary and secondary outcome measures, can be found here: https://clinicaltrials.gov/study/NCT04728360  Results of the study will be presented in a future medical meeting or publication..

BAT2206临床试验是一项全球性，多中心，随机，双盲，平行臂3期研究，旨在比较BAT2206与Stelara®在556例中重度斑块状银屑病患者中的疗效，安全性，免疫原性和PK。有关BAT2206 3期临床试验的更多信息，包括纳入和排除标准以及主要和次要结局指标，请参见：https://clinicaltrials.gov/study/NCT04728360研究结果将在未来的医学会议或出版物中公布。。

'We are pleased to report on our fourth proposed biosimilar with positive Phase 3 study results. These results demonstrate the potential of our proposed ustekinumab biosimilar to be a safe and effective treatment,' said Shengfeng Li, Ph.D., chief executive officer at Bio-Thera Solutions. 'Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars.''I'm very pleased to have participated in the successful global Phase 3 study of BAT2206,' commented professor Min Zheng, leading investigator for global phase 3 study of BAT2206.  'BAT2206 will provide a new affordable treatment option for global patients in need.

'我们很高兴报告我们的第四个提出的具有积极的3期研究结果的生物仿制药。这些结果证明了我们提出的ustekinumab生物仿制药是一种安全有效的治疗方法的潜力，“Bio-Thera Solutions首席执行官李胜峰博士说。”Bio-Thera致力于通过开发高质量的生物仿制药来增加患者获得创新药物的机会BAT2206全球3期研究的首席研究员Min Zheng教授评论说，我很高兴参加了BAT2206成功的全球3期研究。BAT2206将为有需要的全球患者提供一种新的负担得起的治疗方案。

Congratulations to Bio-Thera Solutions.'Bio-Thera entered into a commercialization and license agreement with Hikma for BAT2206 in August 2021. Developed by Bio-Thera, BAT2206 will be commercialized by Hikma in the United States of America. About BAT2206 (ustekinumab)BAT2206 is a proposed biosimilar to Janssen's Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells.

祝贺Bio-Thera解决方案。”Bio-Thera于2021年8月与Hikma就BAT2206签订了商业化和许可协议。由Bio-Thera开发，BAT2206将由Hikma在美利坚合众国商业化。关于BAT2206（ustekinumab）BAT2206是Janssen'sStelara®的拟议生物仿制药，Janssen's Stelara®是一种人单克隆抗体，通过阻止共享p40与表达的IL-12Rβ1受体蛋白结合来抑制人IL-12和IL-23的生物活性。免疫细胞表面。

IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases. About Bio-Thera SolutionsBio-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, cardiovascu.

IL-12和IL-23参与炎症和免疫反应，例如自然杀伤细胞活化和CD4+T细胞分化和活化。IL-12和IL-23被认为是慢性炎症的重要贡献者，慢性炎症是克罗恩病和溃疡性结肠炎以及许多其他自身免疫疾病的标志。关于Bio-Thera Solutions Bio-Thera Solutions，Ltd。是中国广州领先的创新型全球生物制药公司，致力于研究和开发治疗癌症，自身免疫，心血管疾病的新疗法。

Stelara® is a registered trademark of Johnson & Johnson Corporation

Stelara®是强生公司的注册商标

QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.

QLETLI®是Bio-Thera Solutions，Ltd。的注册商标。

POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.

POBEVCY®是Bio-Thera Solutions，Ltd。的注册商标。

TOFIDENCETM is a trademark of Biogen, Inc.

TOFIDENCETM是Biogen，Inc。的商标。

SOURCE Bio-Thera Solutions, Ltd

SOURCE Bio-Thera Solutions，Ltd