<p>/PRNewswire/ -- 迈威生物（688062.SH，02493.HK）是一家创新驱动的生物制药公司，拥有完整的产业链，宣布其自主研发的新型抗体 9MW5211 的临床试验新药（IND）申请已获得美国食品药品监督管理局（FDA）的批准，可以开展针对炎症性肠病（IBD）的临床研究。针对包括 IBD 和多发性硬化症（MS）在内的多种适应症的临床试验申请已被中国国家药品监督管理局（NMPA）接受审查。9MW5211 是全球首个针对其靶点的临床阶段药物候选者。</p>
<p>9MW5211 是一种由迈威生物自主研发的高特异性、去除型创新抗体，旨在精确干预自身免疫疾病中由异常免疫细胞介导的关键病理机制。免疫细胞的异常激活和组织浸润是各种自身免疫疾病发生和发展的核心驱动因素。9MW5211 的靶分子在致病性免疫细胞表面特异性表达，作为其异常激活的重要生物标志物。通过选择性识别和去除这一类致病细胞，9MW5211 能够有效阻断免疫级联反应，从而延缓疾病进展，改善临床症状。</p>
<p>经过多轮分子工程优化，9MW5211 展现出卓越的靶向选择性。在实现高效阻断的同时，显著降低了非特异性结合的风险，确保对高表达靶蛋白的致病细胞进行深度去除。这种独特的作用机制预计不仅能带来更深的疾病缓解，还可能支持延长给药间隔，从而提高患者的依从性和生活质量。</p>
<p>前临床研究结果表明，9MW5211 在多种小鼠自身免疫疾病模型中展现出显著的治疗潜力，暗示其未来的临床应用可能涵盖多种主要适应症。在猕猴模型中进行的安全性评估显示出良好的安全性特征。其他适应症的临床试验申请也在积极推进中。</p>
<p><strong>关于炎症性肠病（IBD）</strong></p>
<p>炎症性肠病是一种慢性、复发性、免疫介导的胃肠道疾病，主要包括溃疡性结肠炎和克罗恩病。全球 IBD 病例数量持续增加。流行病学研究表明，全球新诊断的 IBD 患者数量从 2019 年的 590 万上升至 2023 年的 700 万，年复合增长率（CAGR）为 4.4%。预计到 2032 年，全球新诊断的 IBD 患者数量将达到 1150 万，从 2023 年到 2032 年的年复合增长率为 5.6%。</p>
<p><strong>关于多发性硬化症（MS）</strong></p>
<p>多发性硬化症是一种慢性自身免疫疾病，其特征是对大脑和脊髓神经的保护性髓鞘的炎症损伤。全球 MS 患者数量从 2020 年的 280 万增加到 2024 年的 300 万，预计到 2035 年将达到约 350 万。在中国，MS 患者数量从 2020 年的 32800 例增加到 2024 年的 33900 例，预计到 2035 年将达到 35500 例。</p>
<p><strong>关于迈威生物</strong></p>
<p>迈威生物（688062.SH，02493.HK）是一家创新驱动的生物制药公司，具备覆盖整个制药价值链的能力。公司致力于提供更有效和可及的治疗方案，以满足全球医疗需求，重点关注肿瘤学和与衰老相关的疾病。迈威生物的使命是 “探索生命，造福健康”，愿景是 “创新，从想法到现实”。欲了解更多信息，请访问 www.mabwell.com/en。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含前瞻性声明，包括但不限于我们产品候选者的潜在安全性、有效性、监管审查或批准及商业成功，以及与公司产品开发、临床研究、临床和监管里程碑及时间表、市场机会、竞争地位、可能或假定的未来运营结果、商业策略、潜在增长机会及其他预测性陈述相关的内容。“前瞻性声明” 是指那些不是历史事实的陈述，涉及多种风险和不确定性，可能导致实际结果与前瞻性声明中表达或暗示的任何未来结果存在重大差异。这些声明可能通过使用前瞻性表达来识别，包括但不限于 “期望”、“预期”、“打算”、“计划”、“相信”、“估计”、“潜在”、“预测”、“项目”、“应该”、“会” 等类似表达及这些术语的否定形式。</p>
<p>前瞻性声明基于公司的当前预期和假设。前瞻性声明受到多种风险、不确定性和其他因素的影响，其中许多因素超出了公司的控制范围，包括但不限于：环境；政治；经济；社会；立法；我们对产品候选者的依赖，其中大多数仍处于临床前或不同阶段的临床开发中；我们对第三方供应商的依赖，例如合同研究组织和合同制造组织；临床测试中固有的不确定性；我们完成产品候选者所需临床试验并获得监管机构批准的能力；我们保护知识产权的能力；任何高管或关键人员的离职。如果这些风险或不确定性之一或多个恶化，或任何假设不正确，实际结果可能与所述结果严重不一致。</p>
<p>公司提醒所有人不要对任何此类前瞻性声明过度依赖，这些声明仅在本新闻稿发布之日有效。公司不承担任何义务，除非法律和适用证券机构的规则明确要求，公开更新或修订任何此类声明，以反映任何预期或事件、条件或情况的变化，或可能影响实际结果与前瞻性声明中所列结果之间差异的可能性。本新闻稿中的所有前瞻性描述、数字和假设均适用于本声明。</p>
<p>来源：Mabwell</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA4Jk5ld3NJdGVtSWQ9Q041NTAxMiZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDgyMDAwUFJfTkVXU19VU1BSX19fX19DTjU1MDEy?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-RGF0ZUlkPTIwMjYwNTA4Jk5ld3NJdGVtSWQ9Q041NTAxMiZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDgyMDAwUFJfTkVXU19VU1BSX19fX19DTjU1MDEy"/></p>

迈威生物-B

迈威生物-U

<p>迈威生物已获得 FDA 对其 9MW5211 的 IND 申请的批准，这是一种旨在治疗炎症性肠病（IBD）的新型抗体。这标志着全球首个针对该疾病的临床阶段药物候选者。该抗体选择性地消耗致病性免疫细胞，可能改善患者的治疗效果。针对包括 IBD 和多发性硬化症在内的多种适应症的临床试验申请正在中国审核中。前临床研究表明其具有显著的治疗潜力，安全性评估显示出良好的特征。迈威生物旨在提高自身免疫疾病的治疗可及性和有效性</p>

<p>, /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the Investigational New Drug (IND) application for 9MW5211, its independently developed novel antibody, has received clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical studies for the treatment of inflammatory bowel disease (IBD). Clinical trial applications for multiple indications including IBD and multiple sclerosis (MS) have been accepted for review by the National Medical Products Administration (NMPA) of China. 9MW5211 is the world's first clinical-stage drug candidate for its target.</p>
<div class="lb-trans"><p>/PRNewswire/ -- 迈威生物（688062.SH，02493.HK）是一家创新驱动的生物制药公司，拥有完整的产业链，宣布其自主研发的新型抗体 9MW5211 的临床试验新药（IND）申请已获得美国食品药品监督管理局（FDA）的批准，可以开展针对炎症性肠病（IBD）的临床研究。针对包括 IBD 和多发性硬化症（MS）在内的多种适应症的临床试验申请已被中国国家药品监督管理局（NMPA）接受审查。9MW5211 是全球首个针对其靶点的临床阶段药物候选者。</p>
</div><p>9MW5211 is a highly specific, depleting, and innovative antibody independently developed by Mabwell, designed to precisely intervene in the key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases. The abnormal activation and tissue infiltration of immune cells act as the core driving factors in the occurrence and development of various autoimmune diseases. The target molecule of 9MW5211 is specifically expressed on the surface of pathogenic immune cells and serves as a vital biological marker of their abnormal activation. By selectively recognizing and depleting this population of pathogenic cells, 9MW5211 can effectively block the immune cascade, thereby delaying disease progression and ameliorating clinical symptoms.</p>
<div class="lb-trans"><p>9MW5211 是一种由迈威生物自主研发的高特异性、去除型创新抗体，旨在精确干预自身免疫疾病中由异常免疫细胞介导的关键病理机制。免疫细胞的异常激活和组织浸润是各种自身免疫疾病发生和发展的核心驱动因素。9MW5211 的靶分子在致病性免疫细胞表面特异性表达，作为其异常激活的重要生物标志物。通过选择性识别和去除这一类致病细胞，9MW5211 能够有效阻断免疫级联反应，从而延缓疾病进展，改善临床症状。</p>
</div><p>Through multiple rounds of molecular engineering optimization, 9MW5211 has demonstrated excellent target selectivity. While achieving efficient blockade, it significantly mitigates the risk of non-specific binding, ensuring deep depletion of pathogenic cells highly expressing the target protein. Such a unique mechanism of action is expected to not only bring deeper disease remission but also potentially support an extended dosing interval, thereby enhancing patient compliance and quality of life.</p>
<div class="lb-trans"><p>经过多轮分子工程优化，9MW5211 展现出卓越的靶向选择性。在实现高效阻断的同时，显著降低了非特异性结合的风险，确保对高表达靶蛋白的致病细胞进行深度去除。这种独特的作用机制预计不仅能带来更深的疾病缓解，还可能支持延长给药间隔，从而提高患者的依从性和生活质量。</p>
</div><p>Preclinical study results have demonstrated that 9MW5211 exhibits significant therapeutic potential in various mouse models of autoimmune diseases, suggesting its future clinical application may cover multiple major indications. Safety evaluations conducted in cynomolgus monkey models have shown a favorable safety profile. Clinical trial applications for other indications are also being actively advanced.</p>
<div class="lb-trans"><p>前临床研究结果表明，9MW5211 在多种小鼠自身免疫疾病模型中展现出显著的治疗潜力，暗示其未来的临床应用可能涵盖多种主要适应症。在猕猴模型中进行的安全性评估显示出良好的安全性特征。其他适应症的临床试验申请也在积极推进中。</p>
</div><p><strong>About Inflammatory Bowel Disease (IBD)</strong></p>
<div class="lb-trans"><p><strong>关于炎症性肠病（IBD）</strong></p>
</div><p>Inflammatory bowel disease is a chronic, relapsing, immune-mediated disorder of the gastrointestinal tract, which primarily includes ulcerative colitis and Crohn's disease. The number of IBD cases globally has been steadily increasing. Epidemiological studies indicate that the number of newly diagnosed IBD patients worldwide rose from 5.90 million in 2019 to 7.00 million in 2023, representing a compound annual growth rate (CAGR) of 4.4%. The number of newly diagnosed IBD patients globally is projected to reach 11.50 million by 2032, with a CAGR of 5.6% from 2023 to 2032</p>
<div class="lb-trans"><p>炎症性肠病是一种慢性、复发性、免疫介导的胃肠道疾病，主要包括溃疡性结肠炎和克罗恩病。全球 IBD 病例数量持续增加。流行病学研究表明，全球新诊断的 IBD 患者数量从 2019 年的 590 万上升至 2023 年的 700 万，年复合增长率（CAGR）为 4.4%。预计到 2032 年，全球新诊断的 IBD 患者数量将达到 1150 万，从 2023 年到 2032 年的年复合增长率为 5.6%。</p>
</div><p><strong>About Multiple Sclerosis (MS)</strong></p>
<div class="lb-trans"><p><strong>关于多发性硬化症（MS）</strong></p>
</div><p>Multiple sclerosis is a chronic autoimmune disease characterized by inflammatory damage to the protective myelin sheaths surrounding the nerves of the brain and spinal cord. The number of MS patients globally increased from 2.80 million cases in 2020 to 3.00 million cases in 2024, and is projected to reach approximately 3.50 million cases by 2035. In China, the number of MS patients increased from 32,800 cases in 2020 to 33,900 cases in 2024, and is expected to reach 35,500 cases by 2035.</p>
<div class="lb-trans"><p>多发性硬化症是一种慢性自身免疫疾病，其特征是对大脑和脊髓神经的保护性髓鞘的炎症损伤。全球 MS 患者数量从 2020 年的 280 万增加到 2024 年的 300 万，预计到 2035 年将达到约 350 万。在中国，MS 患者数量从 2020 年的 32800 例增加到 2024 年的 33900 例，预计到 2035 年将达到 35500 例。</p>
</div><p><strong>About Mabwell</strong></p>
<div class="lb-trans"><p><strong>关于迈威生物</strong></p>
</div><p>Mabwell (688062.SH, 02493.HK) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company is committed to providing more effective and accessible therapies to meet global medical needs, with a focus on oncology and aging-related diseases. Mabwell's mission is &#34;Explore Life, Benefit Health&#34; and its vision is &#34;Innovation, from Ideas to Reality.&#34; For more information, please visit www.mabwell.com/en.</p>
<div class="lb-trans"><p>迈威生物（688062.SH，02493.HK）是一家创新驱动的生物制药公司，具备覆盖整个制药价值链的能力。公司致力于提供更有效和可及的治疗方案，以满足全球医疗需求，重点关注肿瘤学和与衰老相关的疾病。迈威生物的使命是 “探索生命，造福健康”，愿景是 “创新，从想法到现实”。欲了解更多信息，请访问 www.mabwell.com/en。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. &#34;Forward-looking statements&#34; are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, &#34;expect,&#34; &#34;anticipate,&#34; &#34;intend,&#34; &#34;plan,&#34; &#34;believe,&#34; &#34;estimate,&#34; &#34;potential,&#34; &#34;predict,&#34; &#34;project,&#34; &#34;should,&#34; &#34;would,&#34; and similar expressions and the negatives of those terms.</p>
<div class="lb-trans"><p>本新闻稿包含前瞻性声明，包括但不限于我们产品候选者的潜在安全性、有效性、监管审查或批准及商业成功，以及与公司产品开发、临床研究、临床和监管里程碑及时间表、市场机会、竞争地位、可能或假定的未来运营结果、商业策略、潜在增长机会及其他预测性陈述相关的内容。“前瞻性声明” 是指那些不是历史事实的陈述，涉及多种风险和不确定性，可能导致实际结果与前瞻性声明中表达或暗示的任何未来结果存在重大差异。这些声明可能通过使用前瞻性表达来识别，包括但不限于 “期望”、“预期”、“打算”、“计划”、“相信”、“估计”、“潜在”、“预测”、“项目”、“应该”、“会” 等类似表达及这些术语的否定形式。</p>
</div><p>Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politics; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results.</p>
<div class="lb-trans"><p>前瞻性声明基于公司的当前预期和假设。前瞻性声明受到多种风险、不确定性和其他因素的影响，其中许多因素超出了公司的控制范围，包括但不限于：环境；政治；经济；社会；立法；我们对产品候选者的依赖，其中大多数仍处于临床前或不同阶段的临床开发中；我们对第三方供应商的依赖，例如合同研究组织和合同制造组织；临床测试中固有的不确定性；我们完成产品候选者所需临床试验并获得监管机构批准的能力；我们保护知识产权的能力；任何高管或关键人员的离职。如果这些风险或不确定性之一或多个恶化，或任何假设不正确，实际结果可能与所述结果严重不一致。</p>
</div><p>The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement.</p>
<div class="lb-trans"><p>公司提醒所有人不要对任何此类前瞻性声明过度依赖，这些声明仅在本新闻稿发布之日有效。公司不承担任何义务，除非法律和适用证券机构的规则明确要求，公开更新或修订任何此类声明，以反映任何预期或事件、条件或情况的变化，或可能影响实际结果与前瞻性声明中所列结果之间差异的可能性。本新闻稿中的所有前瞻性描述、数字和假设均适用于本声明。</p>
</div><p>SOURCE Mabwell</p>
<div class="lb-trans"><p>来源：Mabwell</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA4Jk5ld3NJdGVtSWQ9Q041NTAxMiZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDgyMDAwUFJfTkVXU19VU1BSX19fX19DTjU1MDEy" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN55012&amp;Transmission_Id=202605082000PR_NEWS_USPR_____CN55012&amp;DateId=20260508"/></p>

全球首例 | 迈威生物的 9MW5211 获得 FDA 临床试验申请批准