查看“DB-1303”的源代码

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            <strong>[[DB-1303]]</strong>（<strong>[[Zituvitax单抗]]</strong>）是一种基于[[Duality双抗平台]]开发的第三代靶向[[人表皮生长因子受体2]]（<strong>[[HER2]]</strong>）的[[抗体偶联药物]]（<strong>[[ADC]]</strong>）。该药物由抗[[HER2]][[单克隆抗体]]（[[曲妥珠单抗]]生物类似物）、[[可切割链接子]]以及新型[[拓扑异构酶I抑制剂]]载药<strong>[[P1021]]</strong>（[[喜树碱]]衍生物）偶联而成。[[DB-1303]]具有高[[药物抗体比]]（[[DAR]]约8）及显著的<strong>[[旁观者效应]]</strong>，旨在解决[[HER2]]过表达及[[HER2低表达]]实性肿瘤的耐药问题。目前，该药物已获得[[美国食品药品监督管理局]]（[[FDA]]）授予的[[快速通道]]资格，用于治疗[[晚期子宫内膜癌]]。
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            <div style="font-size: 1.2em; font-weight: bold; letter-spacing: 1.2px;">[[DB-1303]]</div>
            <div style="font-size: 0.7em; opacity: 0.85; margin-top: 4px;">[[HER2]]-靶向[[ADC]] · 点击展开详情</div>
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                <div style="font-size: 0.8em; color: #64748b; margin-top: 12px; font-weight: 600;">核心靶标：[[ERBB2]]</div>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0; width: 40%;">[[Entrez]]ID</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">2064([[ERBB2]])</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">载药([[Payload]])</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #b91c1c;">[[P1021]]</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[DAR]]值</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">平均约8</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[抗体]]成分</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">[[曲妥珠单抗]]类似物</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">研发状态</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #1e40af;">[[临床III期]]</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569;">开发厂商</th>
                    <td style="padding: 12px; color: #0f172a;">[[映恩生物]](DualityBio)</td>
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    <h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #0f172a; font-weight: bold;">分子机制：DITAC平台与双重杀伤</h2>
    
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        [[DB-1303]]利用其专有的<strong>[[DITAC]]</strong>平台设计，通过多重路径实现对[[肿瘤]]的精准清除：
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        <li style="margin-bottom: 12px;"><strong>[[HER2]]高效靶向：</strong>抗体部分精准识别并结合癌细胞表面的[[HER2]]受体，不仅涵盖[[IHC]]3+的高表达人群，对[[IHC]]1+或2+的[[HER2低表达]]细胞也具有高亲和力。</li>
        <li style="margin-bottom: 12px;"><strong>受体介导的[[内吞]]：</strong>药物被细胞吞噬并运输至[[溶酶体]]。在[[组织蛋白酶]]的作用下，[[链接子]]被剪切，释放出高活性的[[P1021]]。</li>
        <li style="margin-bottom: 12px;"><strong>抑制[[DNA复制]]：</strong>[[P1021]]作为[[拓扑异构酶I抑制剂]]，能阻断DNA单链修复并诱导[[DNA双链断裂]]，导致[[肿瘤细胞]]发生[[程序性死亡]]。</li>
        <li style="margin-bottom: 12px;"><strong>高效[[旁观者效应]]：</strong>释放的载药具有优异的细胞膜渗透性，能杀伤邻近不表达[[HER2]]的“冷”肿瘤细胞，有效对抗[[肿瘤异质性]]。</li>
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    <h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #0f172a; font-weight: bold;">核心临床研究矩阵</h2>

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                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #0f172a; width: 25%;">适应症领域</th>
                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #475569;">研究人群/分层</th>
                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #1e40af;">关键客观数据</th>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">[[乳腺癌]] (BC)</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">[[HER2]]过表达及[[低表达]]人群</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">[[客观缓解率]]([[ORR]])在多线治疗失败后仍展现强劲的缓解潜力。</td>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">[[子宫内膜癌]] (EC)</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">[[HER2]]阳性晚期[[EC]]患者</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">获[[FDA]]认证，在[[IHC]]3+亚组中[[疾病控制率]]极高。</td>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">其他[[实性肿瘤]]</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">[[胃癌]]、[[非小细胞肺癌]]等</td>
                <td style="padding: 8px; border: 1px solid #3b82f6;">全球[[篮子研究]]正在评估其在泛癌种中的通用活性。</td>
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    <h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #0f172a; font-weight: bold;">诊疗策略：序贯治疗与安全性均衡</h2>
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        [[DB-1303]]的应用代表了[[ADC]]领域“[[减毒增效]]”的新趋势：
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        <li style="margin-bottom: 12px;"><strong>[[HER2检测]]全覆盖：</strong>不再仅限于[[HER2阳性]]，[[HER2低表达]]（[[IHC]]1+/2+）亦为重点获益人群。</li>
        <li style="margin-bottom: 12px;"><strong>[[肺部毒性]]监测：</strong>作为[[拓扑异构酶抑制剂]]类[[ADC]]，需警惕[[间质性肺病]]（[[ILD]]）。临床建议定期进行[[胸部CT]]扫描及[[血氧饱和度]]监测。</li>
        <li style="margin-bottom: 12px;"><strong>[[血液学]]管理：</strong>常见的[[副反应]]包括[[中性粒细胞减少]]。用药期间需常规复查[[血常规]]。</li>
        <li style="margin-bottom: 12px;"><strong>[[生物类似药]]竞争背景：</strong>在[[德曲妥珠单抗]]（[[DS-8201]]）已确立标准的情况下，[[DB-1303]]通过优化[[稳定性]]，旨在提供更优的[[药代动力学]]窗口。</li>
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    <h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #0f172a; font-weight: bold;">关键相关概念</h2>
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            <li style="margin-bottom: 8px;"><strong>[[HER2]]：</strong>肿瘤驱动[[原癌基因]]，是[[ADC]]最成熟的“导航地址”。</li>
            <li style="margin-bottom: 8px;"><strong>[[P1021]]：</strong>[[映恩生物]]特有的[[喜树碱]]类载药，具有极高的细胞杀伤力。</li>
            <li style="margin-bottom: 8px;"><strong>[[旁观者效应]]：</strong>药物穿透细胞膜影响邻近细胞的能力。</li>
            <li style="margin-bottom: 8px;"><strong>[[DITAC平台]]：</strong>[[映恩生物]]自主研发的[[抗体偶联药物]]技术平台。</li>
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        <span style="color: #0f172a; font-weight: bold; font-size: 1.05em; display: inline-block; margin-bottom: 15px;">学术参考文献与权威点评</span>
        
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            [1] <strong>Moore KN, et al. (2023).</strong> <em>DB-1303 in patients with advanced/metastatic solid tumors: Updated results from a phase 1/2 study.</em> <strong>[[ASCO Annual Meeting]]</strong>.[Academic Review]<br>
            <span style="color: #475569;">[权威点评]：临床研究初步证实了DB-1303在子宫内膜癌及乳腺癌中的突破性活性。</span>
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            [2] <strong>Duality Biologics. (2023).</strong> <em>FDA grants Fast Track Designation to DB-1303 for Endometrial Cancer.</em> <strong>[[BioSpace]]</strong>.<br>
            <span style="color: #475569;">[研究进展]：标志着该款ADC在妇科肿瘤领域的全球领先地位。</span>
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            [[DB-1303]] ([[Zituvitax单抗]]) 诊疗生态 · 知识图谱
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                <td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">关联靶点</td>
                <td style="padding: 10px 15px; color: #334155;">[[HER2]]•[[ERBB2]]•[[Topoisomerase I]]•[[组织蛋白酶]]</td>
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                <td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">竞争药物</td>
                <td style="padding: 10px 15px; color: #334155;">[[德曲妥珠单抗]]•[[维迪西妥单抗]]•[[恩美曲妥珠单抗]]•[[A166]]</td>
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                <td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">战略实体</td>
                <td style="padding: 10px 15px; color: #334155;">[[映恩生物]]•[[BioNTech]] (全球合作)•[[FDA]]•[[NMPA]]</td>
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                <td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">研究前沿</td>
                <td style="padding: 10px 15px; color: #334155;">[[针对HER2低表达乳腺癌的III期试验]]•[[与PD-1联用探索]]•[[子宫内膜癌首线应用评估]]</td>
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