百奥泰生物制药宣布FDA接受BAT2506（一种拟议的Simponi®生物类似药）的生物制品许可申请-动脉网

Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT2506, a Proposed Biosimilar to Simponi®

CISION 等信源发布 2025-07-16 19:59

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GUANGZHOU, China

中国广州

，

July 16, 2025

2025年7月16日

/PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi.

/PRNewswire/ -- 百奥泰生物制药股份有限公司（688177:SH），一家处于商业化阶段的生物制药公司，致力于开发创新疗法和生物类似药的管线，今日宣布美国食品药品监督管理局（FDA）已接受其关于BAT2506的生物制品许可申请（BLA），该药物为Simponi的拟议生物类似药。

(golimumab). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 16

（戈利木单抗）。根据生物类似药用户费用法案（BsUFA）设定的FDA目标日期是16日。

泰国语

May 2026

2026年5月

。

The BLA was submitted by Bio-Thera's US commercialization partner Accord BioPharma, who will be the MA holder if BAT2506 is approved by FDA. Accord BioPharma filed the BLA with FDA on 16

生物类似药申请由百奥泰的美国商业化合作伙伴Accord BioPharma提交，如果BAT2506获得FDA批准，Accord BioPharma将成为上市许可持有人。Accord BioPharma于16日向FDA递交了生物类似药申请。

May 2025. The BLA requests approval for all approved presentations and all currently approved indications for Simponi, including 1) moderately to severely active rheumatoid arthritis (RA) in adults, used with methotrexate, 2) active psoriatic arthritis (PsA) in adults, used alone or with methotrexate, 3) active ankylosing spondylitis (AS) in adults and 4) moderately to severely active ulcerative colitis (UC) in adults who depend on corticosteroids or haven't responded well to or tolerated other treatments.

2025年5月。BLA请求批准Simponi的所有已批准的报告和所有当前获批的适应症，包括1）中度至重度活动性类风湿关节炎（RA）成年患者，与甲氨蝶呤联合使用；2）活动性银屑病关节炎（PsA）成年患者，单独使用或与甲氨蝶呤联合使用；3）活动性强直性脊柱炎（AS）成年患者；4）依赖皮质类固醇或对其他治疗无良好反应或无法耐受的中度至重度活动性溃疡性结肠炎（UC）成年患者。

The BLA also requests BAT2506 be declared interchangeable with Simponi..

生物制品许可申请还请求将BAT2506声明为与Simponi可互换。

Bio-Thera and Intas entered into a license and commercialization agreement for BAT2506 in

百奥泰和Intas就BAT2506签订了许可和商业化协议

February 2025

2025年2月

. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Accord BioPharma, the U.S. specialty division of Intas is responsible for the commercialization of BAT2506 in

根据协议条款，百奥泰负责产品的开发和生产。Intas的美国专业部门Accord BioPharma负责BAT2506的商业化。

the United States

美国

。

'The FDA's acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing autoimmune patients in the

“FDA对我们BLA的接受是一项重大成就，使百奥泰更接近于为美国的自身免疫性疾病患者提供治疗方案

USA

美国

with a high-quality, low-cost treatment option,' said Dr.

随着一种高质量、低成本的治疗选择，'博士说。

Shengfeng Li

李盛峰

, Founder and CEO of Bio-Thera Solutions. 'Bio-Thera is committed to developing, manufacturing and commercializing biosimilars in the US and this marks the fourth FDA BLA that Bio-Thera has filed for a biosimilar.'

百奥泰创始人兼首席执行官。“百奥泰致力于在美国开发、生产和商业化生物类似药，这是百奥泰提交的第四份生物类似药的FDA生物制品许可申请（BLA）。”

The BLA submission is based on a comprehensive analytical, non-clinical, and clinical data package submitted to the FDA. Extensive analytical characterization between BAT2506 and US and EU Simponi

生物制品许可申请（BLA）的提交基于向美国食品药品监督管理局（FDA）提交的全面的分析、非临床和临床数据包。BAT2506与美国和欧盟的Simponi之间进行了广泛的分析表征。

was conducted on structural, physicochemical, and biological properties to support bio-similarity of BAT2506. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT2506

对BAT2506的结构、理化和生物学特性进行了研究，以支持其生物相似性。一项随机双盲、单剂量、三臂平行的I期研究比较了BAT2506的药代动力学、安全性和免疫原性。

with both the US and EU Simponi

同时在美国和欧盟使用Simponi

in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared BAT2506 with EU Simponi

在健康志愿者中。一项多中心、随机、双盲、平行组的III期研究比较了BAT2506与欧盟版Simponi的效果。

for efficacy, safety, and immunogenicity in patients with active psoriatic arthritis. The totality of the evidence demonstrated that BAT2506 has similar efficacy, safety, immunogenicity, and quality as the reference product golimumab.

用于评估活动性银屑病关节炎患者中的疗效、安全性和免疫原性。所有证据表明，BAT2506与参比产品戈利木单抗在疗效、安全性、免疫原性和质量方面相似。

About BAT2506

关于BAT2506

BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- a), a pro-inflammatory molecule. Binding of golimumab to TNF-a results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in .

BAT2506 是由百奥泰开发的一种拟议的戈利木单抗生物类似药。戈利木单抗是一种人源化的 IgG1 单克隆抗体，靶向肿瘤坏死因子α（TNF-α），一种促炎分子。戈利木单抗与 TNF-α 的结合可降低 C 反应蛋白（CRP）、白细胞介素 6（IL-6）、细胞间粘附分子 1（ICAM-1）、基质金属蛋白酶 3（MMP-3）和血管内皮生长因子（VEGF）等所有炎症标志物的水平。参照药物戈利木单抗已在。

the United States

美国

and

和

Europe

欧洲

for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

适用于多种病症，包括类风湿性关节炎、银屑病关节炎、强直性脊柱炎和溃疡性结肠炎。

About Bio-Thera Solutions

关于百奥泰生物制药

Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou,

百奥泰生物制药股份有限公司，一家位于广州的领先的创新型全球生物制药公司，

China

中国

, 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 five approved products: QLETLI.

，致力于研究和开发用于治疗癌症、自身免疫疾病、心血管疾病、眼科疾病以及其他严重未满足医疗需求的新型疗法，同时也在开发生物类似药以替代现有的品牌生物制品，用于治疗多种癌症和自身免疫疾病。作为下一代抗体发现与工程领域的领导者，该公司已将多个候选药物推进到后期开发阶段，其中包括五款已获批产品：QLETLI。

(adalimumab) and BETAGRIN

（阿达木单抗）和贝他格琳

(bevifibatide citrate) Injection in China, STARJEMZA

（贝维法巴肽柠檬酸盐）注射液在中国，STARJEMZA

in the US, and BAT1806/TOFIDENCE

在美国，以及BAT1806/TOFIDENCE

商标

(tocilizumab) and AVZIVI

（托珠单抗）和 AVZIVI

(bevacizumab-tnjn) in the US, a/k/a POBEVCY

（贝伐单抗-tnjn）在美国，又称为 POBEVCY

in 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 antibody-drug conjugates (ADCs). For more information, please visit

在欧盟和中国。此外，该公司还有20多个有前景的候选药物正在进行临床试验，专注于后PD-1时代的免疫肿瘤学和抗体药物偶联物（ADCs）等靶向疗法。欲了解更多信息，请访问

www.bio-thera.com/en/

www.bio-thera.com/zh/

or follow us on X (

或在X上关注我们 (

@bio_thera_sol

) and WeChat (Bio-Thera).

）以及微信（百奥泰）。

About Intas Pharmaceuticals

关于英特思制药公司

Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in

印度英特赛斯制药公司是生物仿制药的先驱，已经开发并推出了数量最多的本土生物仿制药之一。

India

印度

. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies.

Intas Pharmaceuticals有着让大众获得优质生物仿制药的丰富历史。作为最实惠的治疗选择，Intas的产品如Neukine（非格司亭）、Pegasta（培非格司亭）、Mabtas（利妥昔单抗）、Razumab（雷珠单抗）和Bevatas（贝伐单抗）已经改变了各自疗法的管理方式。

Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas' biosimilars are manufactured at Intas Pharmaceuticals' state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat.

Eleftha 是 Intas「为数十亿人提供生物类似药」理念的最新例证，履行了其为大众提供优质癌症治疗的承诺。Intas 的生物类似药在位于古吉拉特邦艾哈迈达巴德附近、符合欧盟良好生产规范 (EU-GMP) 认证的先进生物技术工厂生产。

For more information, visit us at .

欲了解更多信息，请访问我们。

www.intaspharma.com

。

About Accord BioPharma, Inc

关于Accord BioPharma公司

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives.

Accord BioPharma, Inc. 是 Intas Pharmaceuticals 的美国专业部门，致力于在肿瘤学、免疫学和重症护理领域提供经济实惠、易于获取且以患者为中心的治疗方案。通过关注患者体验，Accord BioPharma 不仅超越了药物的生物学范畴，更从患者的角度看待疾病，并开发能够真正影响患者生活的高质量疗法。

Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com..

Accord BioPharma相信生物类似药能够增加多种生物药物的可及性，过去由于高昂的成本，这些药物可能未被考虑用于患者。Accord BioPharma期待提供业内最丰富的生物类似药产品组合之一。欲了解更多信息，请访问AccordBioPharma.com。

Bio-Thera Cautionary Note Regarding Forward-Looking Statements

百奥泰前瞻性声明警示性说明

This news release contains certain forward-looking statements relating to BAT2506, 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.

本新闻稿包含某些与BAT2506或百奥泰解决方案的产品管线相关的前瞻性声明。读者被强烈警告，依赖任何前瞻性陈述涉及已知和未知的风险和不确定性。这些前瞻性声明包括但不限于含有“可能”、“或许”、“应该”、“将会”、“预期”、“相信”、“计划”、“有前景”、“潜在”或类似表述的声明。

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.

它们反映了公司对未来事件的当前看法，这些看法基于公司认为合理的假设，并且是根据百奥泰目前可获得的信息制定的，但并不保证未来的业绩或发展。实际结果和事件可能与前瞻性陈述中包含的信息存在重大差异，这是由于多种因素造成的，包括但不限于药物研发过程中固有的风险和不确定性，例如临床前和临床研究的不确定性。

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.

其他风险和不确定性包括：获得监管批准、生产、营销、竞争、知识产权、产品功效或安全性、全球医疗状况变化、公司财务状况变化以及适用法律法规变化等方面的挑战等。

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..

本文中包含的前瞻性陈述仅于其首次发布之日作出。除非法律或法规要求，百奥泰生物制药公司不承担任何公开更新前瞻性陈述的义务，无论是否由于新信息、未来事件、公司观点的变化或其他原因。

Contact

联系

Bert E. Thomas IV

伯特·E·托马斯四世

Phone: +1.410.627.1734

电话：+1.410.627.1734

Email:

电子邮件：

bethomas@bio-thera.com

贝托马斯@生物泰拉.com

SOURCE Bio-Thera Solutions, Ltd