<ul>
<li>欧洲委员会批准了 Gotenfia®，这是一种由 Bio-Thera 开发的与 Simponi®相似的 golimumab 生物仿制药，将由 STADA 进行市场推广</li>
<li>启动准备工作正在进行中，预计将在未来几周和几个月内将第二种获批的 golimumab 生物仿制药带给欧洲患者</li>
<li>Bio-Thera 负责开发、生产和供应；STADA 负责在欧盟、英国、瑞士及其他部分国家的商业化</li>
</ul>
<p>, /PRNewswire/ -- 全球专业、仿制药和消费者医疗保健药品公司 STADA 与 Bio-Thera Solutions（688177:SH），一家开发创新疗法和生物仿制药的商业阶段生物制药公司，已获得欧洲委员会的市场授权 [1]，用于其 Gotenfia®（golimumab）生物仿制药，参考 Simponi®。</p>
<p>Gotenfia®的授权适用于多种慢性炎症性自身免疫疾病 [2]，涵盖整个欧盟（EU）和欧洲经济区（EEA），该授权是在 2025 年 12 月由欧洲药品管理局（EMA）下属的人用药品委员会（CHMP）推荐的基础上获得的。启动准备工作正在进行中，预计将在未来几周和几个月内将这一治疗选择带给欧洲患者。作为欧盟中第二种获批的与 Simponi®相似的生物仿制药，Gotenfia® ̵ 由 Bio-Thera 开发，产品代码为 BAT2506 ̵ 将显著促进市场竞争，预计将以更低的单位成本增加更多患者的治疗机会。</p>
<p>&#34;获得欧洲市场授权后，这是我们第 11 个生物仿制药的授权，我们期待在这一成熟的抗 TNF 疗法上增加竞争，&#34; STADA 全球专业负责人 Bryan Kim 评论道。&#34;我们从多年来供应 adalimumab 和 ustekinumab 生物仿制药的经验中了解到，获得生物治疗的机会对慢性自身免疫和炎症性疾病患者的生活质量有着显著影响。&#34;</p>
<p>&#34;将这一便捷的每月一次的治疗选择带给风湿病学家、胃肠病学家及其服务的患者，标志着 Bio-Thera 致力于成为全球顶尖生物仿制药开发和生产商之一的重要里程碑，&#34; Bio-Thera Solutions 首席执行官李胜峰表示。&#34;在我们之前在美国和欧盟的批准和上市基础上，这一欧洲授权进一步确立了 Bio-Thera 作为全球主要生物仿制药开发和生产商的地位。&#34;</p>
<p>Gotenfia®的市场授权和 CHMP 的积极意见是基于全面的分析、非临床和临床数据包的整体证据，证明 Gotenfia®与其参考产品相似。Gotenfia® 50mg/0.5mL 和 100mg/mL 注射用溶液的市场授权适用于 27 个欧盟成员国，以及挪威、冰岛和列支敦士登。</p>
<p>Bio-Thera 与 STADA 于 2024 年 5 月签署了 BAT2506 的许可和商业化协议 [3]。根据协议条款，Bio-Thera 负责开发、生产和商业供应。STADA 拥有在欧盟（EU）、英国、瑞士及其他部分国家商业化该产品的独占权。2025 年，两位合作伙伴宣布扩展其联盟，以涵盖免疫抑制单克隆抗体 tocilizumab[4]，该产品的启动准备工作也在进行中。</p>
<p><strong>关于 Gotenfia</strong> ® <strong>/</strong> <strong>BAT2506</strong> Gotenfia®/BAT2506 是与 Simponi®相似的生物仿制药，Simponi®是一种针对肿瘤坏死因子α（TNF-α）的抗人 IgG1 单克隆抗体，这是一种促炎分子。golimumab 与 TNF-α结合可减少 C 反应蛋白（CRP）、白介素 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），这些都是炎症标志物。Gotenfia®已在欧洲获得多种适应症的批准，包括类风湿关节炎、银屑病关节炎、强直性脊柱炎和溃疡性结肠炎。</p>
<p><strong>商标使用</strong> Simponi®是强生公司的注册商标。Gotenfia®是 STADA 的注册商标。</p>
<p><strong>关于 STADA Arzneimittel AG</strong> STADA Arzneimittel AG 总部位于德国巴德维尔贝尔。该公司专注于由消费者医疗保健产品、仿制药和专业药品组成的三大支柱战略。STADA Arzneimittel AG 的产品在全球 100 多个国家销售。在 2024 财年，STADA 实现集团销售额 40.59 亿欧元，调整后的恒定货币息税折旧摊销前利润（adj. cc EBITDA）为 8.86 亿欧元。截至 2024 年 12 月 31 日，STADA 在全球雇佣了 11649 名员工。</p>
<p><strong>关于 Bio-Thera Solutions</strong> Bio-Thera Solutions, Ltd.是一家位于中国广州的领先创新全球生物制药公司，致力于研究和开发用于癌症、自身免疫、心血管、眼科疾病及其他严重未满足医疗需求的创新疗法，以及用于治疗多种癌症和自身免疫疾病的现有品牌生物制剂的生物仿制药。作为下一代抗体发现和工程的领导者，该公司已将多个候选药物推进至后期开发阶段，包括五种已获批准的产品：QLETLI®（adalimumab）和 BETAGRIN®（贝非巴肽）注射剂在中国，STARJEMZA®（ustekinumab）在美国和 USYMRO®（ustekinumab）在欧盟，以及 TOFIDENCE®/BAT1806（tocilizumab）和 AVZIVI®（贝伐单抗-tnjn）在美国和欧盟，亦称为 POBEVCY®在中国。此外，该公司在临床试验中有超过 20 个有前景的候选药物，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。有关更多信息，请访问 www.bio-thera.com/en/或在 X 平台上关注我们（@bio_thera_sol）和微信（Bio-Thera）。</p>
<p><strong>Bio-Thera 关于前瞻性声明的警示说明</strong> 本新闻稿包含与 Gotenfia®（BAT2506）或 Bio-Thera Solutions 的一般产品管线相关的某些前瞻性声明。读者被强烈警告，依赖任何前瞻性声明涉及已知和未知的风险和不确定性。前瞻性声明包括但不限于那些包含 “可能”、“或许”、“应该”、“将”、“会”、“预期”、“相信”、“计划”、“有前景”、“潜在” 等类似表达的内容。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在 Bio-Thera Solutions 当前可获得的信息下合理的假设，并不保证未来的表现或发展。实际结果和事件可能因多种因素而与前瞻性声明中包含的信息有实质性差异，包括但不限于制药研究和开发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。其他风险和不确定性包括获得监管批准、制造、市场营销、竞争、知识产权、产品有效性或安全性、全球医疗状况变化、公司财务状况变化以及适用法律法规的变化等方面的挑战。此处包含的前瞻性声明仅在其首次发布之日有效。除非法律或法规要求，Bio-Thera Solutions 不承担公开更新任何前瞻性声明的义务，无论是由于新信息、未来事件、公司观点的变化还是其他原因。</p>
<p><strong>STADA 的媒体信息</strong> STADA Arzneimittel AG - 媒体关系</p>
<p>Stadastrasse 2-18, 61118 Bad Vilbel - 德国</p>
<p>电话：+49 (0) 6101 603-165</p>
<p>电子邮件：[email protected]</p>
<p>或通过我们的网站访问 https://www.stada.com/media/newsroom</p>
<p>在 LinkedIn 上关注 @STADAGroup</p>
<p><strong>STADA 的资本市场参与者信息</strong> STADA Arzneimittel AG - 投资者与债权人关系</p>
<p>Stadastrasse 2-18, 61118 Bad Vilbel – 德国</p>
<p>电话：+49 (0) 6101 603-4689</p>
<p>传真：+49 (0) 6101 603-215</p>
<p>电子邮件：[email protected]</p>
<p>或访问我们的网站 https://www.stada.com/investor-relations</p>
<p><strong>Bio-Thera 联系方式</strong> Bio-Thera Solutions, Ltd</p>
<p>Bert E. Thomas IV</p>
<p>+1.410.627.1734</p>
<p>[email protected]</p>
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<td>1 欧盟委员会药品注册公共健康联合注册</td>
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<td>2 STADA 和 Bio-Thera 对 Golimumab 的积极 CHMP 意见 | STADA</td>
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<td>3 Bio-Thera 与 STADA 达成 BAT2506 的独家协议 | STADA</td>
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<td>4 Bio-Thera 与 STADA 将生物仿制药联盟扩展至 Tocilizumab | STADA</td>
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<p>来源：Bio-Thera Solutions, Ltd</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjEzJk5ld3NJdGVtSWQ9TEE4NzgwMSZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMTMwNjA4UFJfTkVXU19VU1BSX19fX19MQTg3ODAx?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjEzJk5ld3NJdGVtSWQ9TEE4NzgwMSZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMTMwNjA4UFJfTkVXU19VU1BSX19fX19MQTg3ODAx"/></p>

<p>STADA 和 Bio-Thera Solutions 已获得欧洲市场授权，推出 Gotenfia®，这是一种与 Simponi®相似的生物仿制药。该批准允许 Gotenfia®在欧盟、英国及部分国家销售，用于治疗慢性炎症性自身免疫疾病。上市准备工作正在进行中，Bio-Thera 负责开发，STADA 负责商业化。Gotenfia®预计将增强市场竞争，并改善患者的治疗获取。这标志着 STADA 获得的第 11 个生物仿制药授权，进一步巩固了其在生物仿制药市场的地位</p>

<ul>
<li>European Commission grants approval for Gotenfia®, a golimumab biosimilar to Simponi® that was developed by Bio-Thera and will be marketed by STADA</li>
<li>Launch preparations are underway to bring the second approved golimumab biosimilar to patients across Europe in the coming weeks and months</li>
<li>Bio-Thera is responsible for development, manufacture and supply; STADA for commercialization in the EU, the UK, Switzerland and selected other countries</li>
</ul>
<div class="lb-trans"><ul>
<li>欧洲委员会批准了 Gotenfia®，这是一种由 Bio-Thera 开发的与 Simponi®相似的 golimumab 生物仿制药，将由 STADA 进行市场推广</li>
<li>启动准备工作正在进行中，预计将在未来几周和几个月内将第二种获批的 golimumab 生物仿制药带给欧洲患者</li>
<li>Bio-Thera 负责开发、生产和供应；STADA 负责在欧盟、英国、瑞士及其他部分国家的商业化</li>
</ul>
</div><p>, /PRNewswire/ -- Global specialty, generic and consumer healthcare medicines company STADA and Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, have received a marketing authorization from the European Commission[1] for their Gotenfia® (golimumab) biosimilar referencing Simponi®.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- 全球专业、仿制药和消费者医疗保健药品公司 STADA 与 Bio-Thera Solutions（688177:SH），一家开发创新疗法和生物仿制药的商业阶段生物制药公司，已获得欧洲委员会的市场授权 [1]，用于其 Gotenfia®（golimumab）生物仿制药，参考 Simponi®。</p>
</div><p>The authorization of Gotenfia® for several chronic inflammatory autoimmune diseases[2], which applies across the European Union (EU and European Economic Area (EEA), follows a recommendation in December 2025 from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA). Launch preparations are underway to bring this therapeutic option to patients across Europe in the coming weeks and months. Being the second biosimilar to Simponi® approved in the EU, Gotenfia® ̵ developed by Bio-Thera under the product code BAT2506 ̵ will significantly spur market competition, which is expected to increase treatment access for many more patients at lower unit costs.</p>
<div class="lb-trans"><p>Gotenfia®的授权适用于多种慢性炎症性自身免疫疾病 [2]，涵盖整个欧盟（EU）和欧洲经济区（EEA），该授权是在 2025 年 12 月由欧洲药品管理局（EMA）下属的人用药品委员会（CHMP）推荐的基础上获得的。启动准备工作正在进行中，预计将在未来几周和几个月内将这一治疗选择带给欧洲患者。作为欧盟中第二种获批的与 Simponi®相似的生物仿制药，Gotenfia® ̵ 由 Bio-Thera 开发，产品代码为 BAT2506 ̵ 将显著促进市场竞争，预计将以更低的单位成本增加更多患者的治疗机会。</p>
</div><p>&#34;Having received the European marketing authorization, our 11th for a biosimilar in total, we look forward to increasing competition on this well-established anti-TNF therapy,&#34; commented STADA's Global Specialty Head, Bryan Kim. &#34;We know from our years of experience supplying adalimumab and ustekinumab biosimilars the considerable impact that access to biological treatments for chronic autoimmune and inflammatory conditions can have on patients' quality of life.&#34;</p>
<div class="lb-trans"><p>&#34;获得欧洲市场授权后，这是我们第 11 个生物仿制药的授权，我们期待在这一成熟的抗 TNF 疗法上增加竞争，&#34; STADA 全球专业负责人 Bryan Kim 评论道。&#34;我们从多年来供应 adalimumab 和 ustekinumab 生物仿制药的经验中了解到，获得生物治疗的机会对慢性自身免疫和炎症性疾病患者的生活质量有着显著影响。&#34;</p>
</div><p>&#34;Bringing this convenient, once-monthly treatment option to rheumatologists, gastroenterologists and the patients they serve marks a major milestone in Bio-Thera's commitment to being one of the premier biosimilar developers and manufacturers in the world,&#34; said Shengfeng Li, CEO of Bio-Thera Solutions. &#34;Building on our prior approvals and launches in the US and EU, this European authorization further establishes Bio-Thera as a major global biosimilar developer and manufacturer.&#34;</p>
<div class="lb-trans"><p>&#34;将这一便捷的每月一次的治疗选择带给风湿病学家、胃肠病学家及其服务的患者，标志着 Bio-Thera 致力于成为全球顶尖生物仿制药开发和生产商之一的重要里程碑，&#34; Bio-Thera Solutions 首席执行官李胜峰表示。&#34;在我们之前在美国和欧盟的批准和上市基础上，这一欧洲授权进一步确立了 Bio-Thera 作为全球主要生物仿制药开发和生产商的地位。&#34;</p>
</div><p>The marketing authorization and positive CHMP opinion on Gotenfia® were based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package demonstrating that Gotenfia® is biosimilar to its reference product. The marketing authorization for Gotenfia® 50mg/0.5mL and 100mg/mL solution for injection in pre-filled syringes with passive needle safety guards applies across the 27 EU member states, in addition to Norway, Iceland and Lichtenstein.</p>
<div class="lb-trans"><p>Gotenfia®的市场授权和 CHMP 的积极意见是基于全面的分析、非临床和临床数据包的整体证据，证明 Gotenfia®与其参考产品相似。Gotenfia® 50mg/0.5mL 和 100mg/mL 注射用溶液的市场授权适用于 27 个欧盟成员国，以及挪威、冰岛和列支敦士登。</p>
</div><p>Bio-Thera and STADA entered into a license and commercialization agreement for BAT2506 in May 2024[3]. Under the terms of the agreement, Bio-Thera is responsible for development, manufacture and commercial supply. STADA holds exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries. In 2025, the two partners announced an extension of their alliance to cover the immunosuppressant monoclonal antibody tocilizumab[4] for which launch preparations are also underway.</p>
<div class="lb-trans"><p>Bio-Thera 与 STADA 于 2024 年 5 月签署了 BAT2506 的许可和商业化协议 [3]。根据协议条款，Bio-Thera 负责开发、生产和商业供应。STADA 拥有在欧盟（EU）、英国、瑞士及其他部分国家商业化该产品的独占权。2025 年，两位合作伙伴宣布扩展其联盟，以涵盖免疫抑制单克隆抗体 tocilizumab[4]，该产品的启动准备工作也在进行中。</p>
</div><p><strong>About Gotenfia</strong> ® <strong>/</strong> <strong>BAT2506</strong> Gotenfia®/BAT2506 is a biosimilar to Simponi® which is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. Binding of golimumab to TNF-α 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. Gotenfia® has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.</p>
<div class="lb-trans"><p><strong>关于 Gotenfia</strong> ® <strong>/</strong> <strong>BAT2506</strong> Gotenfia®/BAT2506 是与 Simponi®相似的生物仿制药，Simponi®是一种针对肿瘤坏死因子α（TNF-α）的抗人 IgG1 单克隆抗体，这是一种促炎分子。golimumab 与 TNF-α结合可减少 C 反应蛋白（CRP）、白介素 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），这些都是炎症标志物。Gotenfia®已在欧洲获得多种适应症的批准，包括类风湿关节炎、银屑病关节炎、强直性脊柱炎和溃疡性结肠炎。</p>
</div><p><strong>Use of Trademarks</strong> Simponi® is a registered trademark of Johnson &amp; Johnson. Gotenfia® is a registered trademark of STADA.</p>
<div class="lb-trans"><p><strong>商标使用</strong> Simponi®是强生公司的注册商标。Gotenfia®是 STADA 的注册商标。</p>
</div><p><strong>About STADA Arzneimittel AG</strong> STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in over 100 countries. In financial year 2024, STADA achieved group sales of € 4,059 million and adjusted constant-currency earnings before interest, taxes, depreciation and amortization (adj. cc EBITDA) of € 886 million. As of 31 December 2024, STADA employed 11,649 people worldwide.</p>
<div class="lb-trans"><p><strong>关于 STADA Arzneimittel AG</strong> STADA Arzneimittel AG 总部位于德国巴德维尔贝尔。该公司专注于由消费者医疗保健产品、仿制药和专业药品组成的三大支柱战略。STADA Arzneimittel AG 的产品在全球 100 多个国家销售。在 2024 财年，STADA 实现集团销售额 40.59 亿欧元，调整后的恒定货币息税折旧摊销前利润（adj. cc EBITDA）为 8.86 亿欧元。截至 2024 年 12 月 31 日，STADA 在全球雇佣了 11649 名员工。</p>
</div><p><strong>About Bio-Thera Solutions</strong> 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 five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and USYMRO® (ustekinumab) in EU, and TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY® in 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 www.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).</p>
<div class="lb-trans"><p><strong>关于 Bio-Thera Solutions</strong> Bio-Thera Solutions, Ltd.是一家位于中国广州的领先创新全球生物制药公司，致力于研究和开发用于癌症、自身免疫、心血管、眼科疾病及其他严重未满足医疗需求的创新疗法，以及用于治疗多种癌症和自身免疫疾病的现有品牌生物制剂的生物仿制药。作为下一代抗体发现和工程的领导者，该公司已将多个候选药物推进至后期开发阶段，包括五种已获批准的产品：QLETLI®（adalimumab）和 BETAGRIN®（贝非巴肽）注射剂在中国，STARJEMZA®（ustekinumab）在美国和 USYMRO®（ustekinumab）在欧盟，以及 TOFIDENCE®/BAT1806（tocilizumab）和 AVZIVI®（贝伐单抗-tnjn）在美国和欧盟，亦称为 POBEVCY®在中国。此外，该公司在临床试验中有超过 20 个有前景的候选药物，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。有关更多信息，请访问 www.bio-thera.com/en/或在 X 平台上关注我们（@bio_thera_sol）和微信（Bio-Thera）。</p>
</div><p><strong>Bio-Thera Cautionary Note Regarding Forward-Looking Statements</strong> This news release contains certain forward-looking statements relating to Gotenfia® (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 &#34;could,&#34; &#34;may,&#34; &#34;should,&#34; &#34;will,&#34; &#34;would,&#34; &#34;anticipate,&#34; &#34;believe,&#34; &#34;plan,&#34; &#34;promising,&#34; &#34;potentially,&#34; 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.</p>
<div class="lb-trans"><p><strong>Bio-Thera 关于前瞻性声明的警示说明</strong> 本新闻稿包含与 Gotenfia®（BAT2506）或 Bio-Thera Solutions 的一般产品管线相关的某些前瞻性声明。读者被强烈警告，依赖任何前瞻性声明涉及已知和未知的风险和不确定性。前瞻性声明包括但不限于那些包含 “可能”、“或许”、“应该”、“将”、“会”、“预期”、“相信”、“计划”、“有前景”、“潜在” 等类似表达的内容。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在 Bio-Thera Solutions 当前可获得的信息下合理的假设，并不保证未来的表现或发展。实际结果和事件可能因多种因素而与前瞻性声明中包含的信息有实质性差异，包括但不限于制药研究和开发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。其他风险和不确定性包括获得监管批准、制造、市场营销、竞争、知识产权、产品有效性或安全性、全球医疗状况变化、公司财务状况变化以及适用法律法规的变化等方面的挑战。此处包含的前瞻性声明仅在其首次发布之日有效。除非法律或法规要求，Bio-Thera Solutions 不承担公开更新任何前瞻性声明的义务，无论是由于新信息、未来事件、公司观点的变化还是其他原因。</p>
</div><p><strong>STADA information for journalists</strong> STADA Arzneimittel AG - Media Relations</p>
<div class="lb-trans"><p><strong>STADA 的媒体信息</strong> STADA Arzneimittel AG - 媒体关系</p>
</div><p>Stadastrasse 2-18, 61118 Bad Vilbel - Germany</p>
<div class="lb-trans"><p>Stadastrasse 2-18, 61118 Bad Vilbel - 德国</p>
</div><p>Phone: +49 (0) 6101 603-165</p>
<div class="lb-trans"><p>电话：+49 (0) 6101 603-165</p>
</div><p>E-Mail: [email protected]</p>
<div class="lb-trans"><p>电子邮件：[email protected]</p>
</div><p>Or visit us via our website at https://www.stada.com/media/newsroom</p>
<div class="lb-trans"><p>或通过我们的网站访问 https://www.stada.com/media/newsroom</p>
</div><p>Follow @STADAGroup on LinkedIn</p>
<div class="lb-trans"><p>在 LinkedIn 上关注 @STADAGroup</p>
</div><p><strong>STADA information for capital market participants</strong> STADA Arzneimittel AG - Investor &amp; Creditor Relations</p>
<div class="lb-trans"><p><strong>STADA 的资本市场参与者信息</strong> STADA Arzneimittel AG - 投资者与债权人关系</p>
</div><p>Stadastrasse 2-18, 61118 Bad Vilbel – Germany</p>
<div class="lb-trans"><p>Stadastrasse 2-18, 61118 Bad Vilbel – 德国</p>
</div><p>Phone: +49 (0) 6101 603-4689</p>
<div class="lb-trans"><p>电话：+49 (0) 6101 603-4689</p>
</div><p>Fax: +49 (0) 6101 603-215</p>
<div class="lb-trans"><p>传真：+49 (0) 6101 603-215</p>
</div><p>E-mail: [email protected]</p>
<div class="lb-trans"><p>电子邮件：[email protected]</p>
</div><p>Or visit our website at https://www.stada.com/investor-relations</p>
<div class="lb-trans"><p>或访问我们的网站 https://www.stada.com/investor-relations</p>
</div><p><strong>Bio-Thera Contacts</strong> Bio-Thera Solutions, Ltd</p>
<div class="lb-trans"><p><strong>Bio-Thera 联系方式</strong> Bio-Thera Solutions, Ltd</p>
</div><p>Bert E. Thomas IV</p>
<div class="lb-trans"><p>Bert E. Thomas IV</p>
</div><p>+1.410.627.1734</p>
<div class="lb-trans"><p>+1.410.627.1734</p>
</div><p>[email protected]</p>
<div class="lb-trans"><p>[email protected]</p>
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<td>1 Union Register of medicinal products - Public health - European Commission</td>
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<td>2 Positive CHMP opinion for Golimumab from STADA and Bio-Thera | STADA</td>
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<td>3 Bio-Thera and STADA Reach Exclusive Agreement for BAT2506 | STADA</td>
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<td>4 Bio-Thera &amp; STADA Extend Biosimilars Alliance to Tocilizumab | STADA</td>
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<td>1 欧盟委员会药品注册公共健康联合注册</td>
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<td>2 STADA 和 Bio-Thera 对 Golimumab 的积极 CHMP 意见 | STADA</td>
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<td>3 Bio-Thera 与 STADA 达成 BAT2506 的独家协议 | STADA</td>
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<td>4 Bio-Thera 与 STADA 将生物仿制药联盟扩展至 Tocilizumab | STADA</td>
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</div><p>SOURCE Bio-Thera Solutions, Ltd</p>
<div class="lb-trans"><p>来源：Bio-Thera Solutions, Ltd</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjEzJk5ld3NJdGVtSWQ9TEE4NzgwMSZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMTMwNjA4UFJfTkVXU19VU1BSX19fX19MQTg3ODAx" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=LA87801&amp;Transmission_Id=202602130608PR_NEWS_USPR_____LA87801&amp;DateId=20260213"/></p>

06:08 ETSTADA 和 Bio-Thera 获得了 Gotenfia 的欧洲市场授权，这是一种 Simponi 的生物类似药