<p>/PRNewswire/ -- 邁威生物（688062.SH），一家擁有完整產業鏈的創新生物製藥公司，宣佈國家藥品監督管理局（NMPA）已接受其全資子公司 T-mab 開發的 MAIWEIJIAN（地諾單抗注射液，研發代碼：9MW0321）的補充生物製劑許可申請，該產品用於預防多發性骨髓瘤患者及固體腫瘤骨轉移患者的骨相關事件。</p>
<p>MAIWEIJIAN 是中國首個獲批上市的地諾單抗生物類似藥（120mg）。該產品於 2024 年 3 月首次獲批，用於治療不可切除的骨鉅細胞瘤成人及骨骼成熟青少年（定義為至少有一根成熟長骨且體重≥45kg）。在 2025 年 8 月，該產品獲得巴基斯坦藥品監管局的批准，成為該國首個地諾單抗生物類似藥（120mg），並已開始供應。邁威生物已在包括巴西、沙特阿拉伯和印度尼西亞在內的 33 個國家簽署了該產品的正式合作協議，並在 8 個國家提交了註冊申請。</p>
<p>由於地諾單抗顯示出良好的治療效果，已被多個專家共識或治療指南推薦。作為中國首個上市的地諾單抗生物類似藥（120mg），MAIWEIJIAN 具有先發優勢。與臨牀治療中常用的雙膦酸鹽相比，地諾單抗具有以下優勢：</p>
<ol>
<li><strong>靶向作用</strong> – 它特異性結合 RANKL，阻斷 RANKL/RANK/OPG 信號通路，從而預防和治療由骨轉移引起的骨相關事件（SREs）。</li>
<li><strong>優越的臨牀療效</strong> – 它的臨牀療效顯著優於雙膦酸鹽，並且在雙膦酸鹽治療失敗的患者中仍然有效。</li>
<li><strong>良好的安全性</strong> – 它不通過腎臟排泄，接受地諾單抗治療的患者經歷的腎毒性副作用較少。</li>
</ol>
<p>此前，邁威生物在《國際免疫藥理學》和頂級國際期刊《JAMA Oncology》上分別發佈了該產品的 I 期和 III 期臨牀研究結果。通過對骨轉移患者進行的頭對頭藥代動力學比較和臨牀療效研究，該產品在藥代動力學、藥效學、臨牀療效和安全性方面已係統全面地證明與參考產品相似。</p>
<p>關於邁威生物</p>
<p>邁威生物（688062.SH）是一家創新驅動的生物製藥公司，具備覆蓋整個製藥價值鏈的能力。公司致力於提供更有效和可及的治療方案，以滿足全球醫療需求，重點關注腫瘤學和與老齡化相關的疾病。邁威生物的使命是 “探索生命，造福健康”，願景是 “創新，從想法到現實”。欲瞭解更多信息，請訪問 www.mabwell.com/en。</p>
<p>前瞻性聲明</p>
<p>本新聞稿包含前瞻性聲明，包括但不限於我們產品候選者的潛在安全性、有效性、監管審查或批准及商業成功，以及與公司產品開發、臨牀研究、臨牀和監管里程碑及時間表、市場機會、競爭地位、可能或假設的未來運營結果、商業策略、潛在增長機會及其他預測性陳述相關的內容。“前瞻性聲明” 是指非歷史事實的陳述，涉及多種風險和不確定性，可能導致實際結果與前瞻性聲明中表達或暗示的未來結果存在重大差異。這些聲明可能通過使用前瞻性表達來識別，包括但不限於 “期望”、“預期”、“打算”、“計劃”、“相信”、“估計”、“潛在”、“預測”、“項目”、“應該”、“會” 等類似表達及其否定形式。</p>
<p>前瞻性聲明基於公司的當前預期和假設。前瞻性聲明受到多種風險、不確定性和其他因素的影響，其中許多超出公司的控制，包括但不限於：環境；政治；經濟；社會；立法；我們對產品候選者的依賴，其中大多數仍處於臨牀前或不同階段的臨牀開發中；我們對第三方供應商的依賴，如合同研究組織和合同製造組織；臨牀測試中固有的不確定性；我們完成產品候選者所需臨牀試驗並獲得監管機構批准的能力；我們保護知識產權的能力；任何高管或關鍵人員的離職。如果這些風險或不確定性之一或多個惡化，或任何假設不正確，實際結果可能與所述結果嚴重不一致。</p>
<p>公司提醒所有人不要對任何此類前瞻性聲明過度依賴，這些聲明僅在本新聞稿日期有效。公司不承擔任何義務，除非法律和適用證券監管機構的規則明確要求，公開更新或修訂任何此類聲明，以反映任何期望或事件、條件或情況的變化，或可能影響實際結果與前瞻性聲明中所述結果的可能性。所有前瞻性描述、數字和假設在本新聞稿中均適用於本聲明。</p>
<p>來源：邁威生物</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>

邁威生物-U

<p>邁威生物宣佈，國家藥品監督管理局（NMPA）已接受其補充生物製品許可證申請，針對 MAIWEIJIAN（地舒單抗注射液），旨在預防多發性骨髓瘤患者及骨轉移患者的骨骼相關事件。這標誌着 MAIWEIJIAN 成為中國首個地舒單抗生物類似藥。該產品在臨牀療效上優於雙膦酸鹽，並且具有良好的安全性。邁威生物已在 33 個國家達成合作協議，並在 8 個國家提交了註冊申請，進一步鞏固了其對創新生物製藥解決方案的承諾</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/ -- 邁威生物（688062.SH），一家擁有完整產業鏈的創新生物製藥公司，宣佈國家藥品監督管理局（NMPA）已接受其全資子公司 T-mab 開發的 MAIWEIJIAN（地諾單抗注射液，研發代碼：9MW0321）的補充生物製劑許可申請，該產品用於預防多發性骨髓瘤患者及固體腫瘤骨轉移患者的骨相關事件。</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 是中國首個獲批上市的地諾單抗生物類似藥（120mg）。該產品於 2024 年 3 月首次獲批，用於治療不可切除的骨鉅細胞瘤成人及骨骼成熟青少年（定義為至少有一根成熟長骨且體重≥45kg）。在 2025 年 8 月，該產品獲得巴基斯坦藥品監管局的批准，成為該國首個地諾單抗生物類似藥（120mg），並已開始供應。邁威生物已在包括巴西、沙特阿拉伯和印度尼西亞在內的 33 個國家簽署了該產品的正式合作協議，並在 8 個國家提交了註冊申請。</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>由於地諾單抗顯示出良好的治療效果，已被多個專家共識或治療指南推薦。作為中國首個上市的地諾單抗生物類似藥（120mg），MAIWEIJIAN 具有先發優勢。與臨牀治療中常用的雙膦酸鹽相比，地諾單抗具有以下優勢：</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> – 它特異性結合 RANKL，阻斷 RANKL/RANK/OPG 信號通路，從而預防和治療由骨轉移引起的骨相關事件（SREs）。</li>
<li><strong>優越的臨牀療效</strong> – 它的臨牀療效顯著優於雙膦酸鹽，並且在雙膦酸鹽治療失敗的患者中仍然有效。</li>
<li><strong>良好的安全性</strong> – 它不通過腎臟排泄，接受地諾單抗治療的患者經歷的腎毒性副作用較少。</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，邁威生物在《國際免疫藥理學》和頂級國際期刊《JAMA Oncology》上分別發佈了該產品的 I 期和 III 期臨牀研究結果。通過對骨轉移患者進行的頭對頭藥代動力學比較和臨牀療效研究，該產品在藥代動力學、藥效學、臨牀療效和安全性方面已係統全面地證明與參考產品相似。</p>
</div><p>About Mabwell</p>
<div class="lb-trans"><p>關於邁威生物</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>邁威生物（688062.SH）是一家創新驅動的生物製藥公司，具備覆蓋整個製藥價值鏈的能力。公司致力於提供更有效和可及的治療方案，以滿足全球醫療需求，重點關注腫瘤學和與老齡化相關的疾病。邁威生物的使命是 “探索生命，造福健康”，願景是 “創新，從想法到現實”。欲瞭解更多信息，請訪問 www.mabwell.com/en。</p>
</div><p>Forward-Looking Statements</p>
<div class="lb-trans"><p>前瞻性聲明</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>本新聞稿包含前瞻性聲明，包括但不限於我們產品候選者的潛在安全性、有效性、監管審查或批准及商業成功，以及與公司產品開發、臨牀研究、臨牀和監管里程碑及時間表、市場機會、競爭地位、可能或假設的未來運營結果、商業策略、潛在增長機會及其他預測性陳述相關的內容。“前瞻性聲明” 是指非歷史事實的陳述，涉及多種風險和不確定性，可能導致實際結果與前瞻性聲明中表達或暗示的未來結果存在重大差異。這些聲明可能通過使用前瞻性表達來識別，包括但不限於 “期望”、“預期”、“打算”、“計劃”、“相信”、“估計”、“潛在”、“預測”、“項目”、“應該”、“會” 等類似表達及其否定形式。</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>前瞻性聲明基於公司的當前預期和假設。前瞻性聲明受到多種風險、不確定性和其他因素的影響，其中許多超出公司的控制，包括但不限於：環境；政治；經濟；社會；立法；我們對產品候選者的依賴，其中大多數仍處於臨牀前或不同階段的臨牀開發中；我們對第三方供應商的依賴，如合同研究組織和合同製造組織；臨牀測試中固有的不確定性；我們完成產品候選者所需臨牀試驗並獲得監管機構批准的能力；我們保護知識產權的能力；任何高管或關鍵人員的離職。如果這些風險或不確定性之一或多個惡化，或任何假設不正確，實際結果可能與所述結果嚴重不一致。</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對任何此類前瞻性聲明過度依賴，這些聲明僅在本新聞稿日期有效。公司不承擔任何義務，除非法律和適用證券監管機構的規則明確要求，公開更新或修訂任何此類聲明，以反映任何期望或事件、條件或情況的變化，或可能影響實際結果與前瞻性聲明中所述結果的可能性。所有前瞻性描述、數字和假設在本新聞稿中均適用於本聲明。</p>
</div><p>SOURCE Mabwell</p>
<div class="lb-trans"><p>來源：邁威生物</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 邁威生物-U 宣佈其 MAIWEIJIAN（地諾單抗）的補充生物製品許可申請已被國家藥品監督管理局接受