<p>/PRNewswire/ -- 迈威生物（688062.SH），一家拥有完整产业链的创新生物制药公司，宣布国家药品监督管理局（NMPA）已接受其全资子公司 T-mab 开发的 MAIWEIJIAN（地诺单抗注射液，研发代码：9MW0321）的补充生物制剂许可申请，该产品用于预防多发性骨髓瘤患者及固体肿瘤骨转移患者的骨相关事件。</p>
<p>MAIWEIJIAN 是中国首个获批上市的地诺单抗生物类似药（120mg）。该产品于 2024 年 3 月首次获批，用于治疗不可切除的骨巨细胞瘤成人及骨骼成熟青少年（定义为至少有一根成熟长骨且体重≥45kg）。在 2025 年 8 月，该产品获得巴基斯坦药品监管局的批准，成为该国首个地诺单抗生物类似药（120mg），并已开始供应。迈威生物已在包括巴西、沙特阿拉伯和印度尼西亚在内的 33 个国家签署了该产品的正式合作协议，并在 8 个国家提交了注册申请。</p>
<p>由于地诺单抗显示出良好的治疗效果，已被多个专家共识或治疗指南推荐。作为中国首个上市的地诺单抗生物类似药（120mg），MAIWEIJIAN 具有先发优势。与临床治疗中常用的双膦酸盐相比，地诺单抗具有以下优势：</p>
<ol>
<li><strong>靶向作用</strong> – 它特异性结合 RANKL，阻断 RANKL/RANK/OPG 信号通路，从而预防和治疗由骨转移引起的骨相关事件（SREs）。</li>
<li><strong>优越的临床疗效</strong> – 它的临床疗效显著优于双膦酸盐，并且在双膦酸盐治疗失败的患者中仍然有效。</li>
<li><strong>良好的安全性</strong> – 它不通过肾脏排泄，接受地诺单抗治疗的患者经历的肾毒性副作用较少。</li>
</ol>
<p>此前，迈威生物在《国际免疫药理学》和顶级国际期刊《JAMA Oncology》上分别发布了该产品的 I 期和 III 期临床研究结果。通过对骨转移患者进行的头对头药代动力学比较和临床疗效研究，该产品在药代动力学、药效学、临床疗效和安全性方面已系统全面地证明与参考产品相似。</p>
<p>关于迈威生物</p>
<p>迈威生物（688062.SH）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老龄化相关的疾病。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>前瞻性声明</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、可能或假设的未来运营结果、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” 是指非历史事实的陈述，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” 等类似表达及其否定形式。</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，其中许多超出公司的控制，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，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日期有效。公司不承担任何义务，除非法律和适用证券监管机构的规则明确要求，公开更新或修订任何此类声明，以反映任何期望或事件、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述结果的可能性。所有前瞻性描述、数字和假设在本新闻稿中均适用于本声明。</p>
<p>来源：迈威生物</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNDE1Jk5ld3NJdGVtSWQ9Q04zNDk4MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MTUyMDAwUFJfTkVXU19VU1BSX19fX19DTjM0OTgz?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-RGF0ZUlkPTIwMjYwNDE1Jk5ld3NJdGVtSWQ9Q04zNDk4MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MTUyMDAwUFJfTkVXU19VU1BSX19fX19DTjM0OTgz"/></p>

迈威生物-U

<p>迈威生物宣布，国家药品监督管理局（NMPA）已接受其补充生物制品许可证申请，针对 MAIWEIJIAN（地舒单抗注射液），旨在预防多发性骨髓瘤患者及骨转移患者的骨骼相关事件。这标志着 MAIWEIJIAN 成为中国首个地舒单抗生物类似药。该产品在临床疗效上优于双膦酸盐，并且具有良好的安全性。迈威生物已在 33 个国家达成合作协议，并在 8 个国家提交了注册申请，进一步巩固了其对创新生物制药解决方案的承诺</p>

<p>, /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with a full industry chain, announced that the National Medical Products Administration (NMPA) has accepted supplemental Biologics License Application for MAIWEIJIAN (denosumab injection, R&amp;D code: 9MW0321), a product developed by its wholly-owned subsidiary T-mab, for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.</p>
<div class="lb-trans"><p>/PRNewswire/ -- 迈威生物（688062.SH），一家拥有完整产业链的创新生物制药公司，宣布国家药品监督管理局（NMPA）已接受其全资子公司 T-mab 开发的 MAIWEIJIAN（地诺单抗注射液，研发代码：9MW0321）的补充生物制剂许可申请，该产品用于预防多发性骨髓瘤患者及固体肿瘤骨转移患者的骨相关事件。</p>
</div><p>MAIWEIJIAN is the first denosumab biosimilar (120mg) approved to market in China. It was initially approved in March 2024 for the treatment of adults and skeletally mature adolescents (defined as at least 1 mature long bone and weighing ≥ 45 kg) with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. In August 2025, the product received approval from the Drug Regulatory Authority of Pakistan as the country's first denosumab biosimilar (120mg), and supply has now commenced. Mabwell has signed formal cooperation agreements for this product in 33 countries, including Brazil, Saudi Arabia, and Indonesia, and has submitted registration applications in 8 countries.</p>
<div class="lb-trans"><p>MAIWEIJIAN 是中国首个获批上市的地诺单抗生物类似药（120mg）。该产品于 2024 年 3 月首次获批，用于治疗不可切除的骨巨细胞瘤成人及骨骼成熟青少年（定义为至少有一根成熟长骨且体重≥45kg）。在 2025 年 8 月，该产品获得巴基斯坦药品监管局的批准，成为该国首个地诺单抗生物类似药（120mg），并已开始供应。迈威生物已在包括巴西、沙特阿拉伯和印度尼西亚在内的 33 个国家签署了该产品的正式合作协议，并在 8 个国家提交了注册申请。</p>
</div><p>Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines. As the first denosumab biosimilar (120mg) launched in China, MAIWEIJIAN possesses early-mover advantages. Compared with bisphosphonates commonly used in clinical treatment, denosumab has the following advantages:</p>
<div class="lb-trans"><p>由于地诺单抗显示出良好的治疗效果，已被多个专家共识或治疗指南推荐。作为中国首个上市的地诺单抗生物类似药（120mg），MAIWEIJIAN 具有先发优势。与临床治疗中常用的双膦酸盐相比，地诺单抗具有以下优势：</p>
</div><ol>
<li><strong>Targeted action</strong> – It specifically binds to RANKL, blocking the RANKL/RANK/OPG signaling pathway, thereby preventing and treating SREs caused by bone metastases.</li>
<li><strong>Superior clinical efficacy</strong> – It demonstrates significantly better clinical efficacy than bisphosphonates and remains effective in patients who have failed bisphosphonate therapy.</li>
<li><strong>Favorable safety profile</strong> – It is not cleared by the kidneys, and patients receiving denosumab experience fewer renal toxicity side effects.</li>
</ol>
<div class="lb-trans"><ol>
<li><strong>靶向作用</strong> – 它特异性结合 RANKL，阻断 RANKL/RANK/OPG 信号通路，从而预防和治疗由骨转移引起的骨相关事件（SREs）。</li>
<li><strong>优越的临床疗效</strong> – 它的临床疗效显著优于双膦酸盐，并且在双膦酸盐治疗失败的患者中仍然有效。</li>
<li><strong>良好的安全性</strong> – 它不通过肾脏排泄，接受地诺单抗治疗的患者经历的肾毒性副作用较少。</li>
</ol>
</div><p>Previously, Mabwell published the Phase I and Phase III clinical study results of this product in <em>International Immunopharmacology</em> and the top-tier international journal <em>JAMA Oncology</em>, respectively. Through head-to-head pharmacokinetic comparisons and clinical efficacy studies in patients with bone metastases from solid tumors, the product has been systematically and comprehensively demonstrated to be similar to the reference product in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety.</p>
<div class="lb-trans"><p>此前，迈威生物在《国际免疫药理学》和顶级国际期刊《JAMA Oncology》上分别发布了该产品的 I 期和 III 期临床研究结果。通过对骨转移患者进行的头对头药代动力学比较和临床疗效研究，该产品在药代动力学、药效学、临床疗效和安全性方面已系统全面地证明与参考产品相似。</p>
</div><p>About Mabwell</p>
<div class="lb-trans"><p>关于迈威生物</p>
</div><p>Mabwell (688062.SH) 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）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老龄化相关的疾病。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>Forward-Looking Statements</p>
<div class="lb-trans"><p>前瞻性声明</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、可能或假设的未来运营结果、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” 是指非历史事实的陈述，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” 等类似表达及其否定形式。</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; politic; 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，其中许多超出公司的控制，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，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日期有效。公司不承担任何义务，除非法律和适用证券监管机构的规则明确要求，公开更新或修订任何此类声明，以反映任何期望或事件、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述结果的可能性。所有前瞻性描述、数字和假设在本新闻稿中均适用于本声明。</p>
</div><p>SOURCE Mabwell</p>
<div class="lb-trans"><p>来源：迈威生物</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNDE1Jk5ld3NJdGVtSWQ9Q04zNDk4MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MTUyMDAwUFJfTkVXU19VU1BSX19fX19DTjM0OTgz" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN34983&amp;Transmission_Id=202604152000PR_NEWS_USPR_____CN34983&amp;DateId=20260415"/></p>

20:00 ET 迈威生物-U 宣布其 MAIWEIJIAN（地诺单抗）的补充生物制品许可申请已被国家药品监督管理局接受