查看“菲泽妥单抗”的源代码

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            <strong>[[菲泽妥单抗]]([[Felzartamab]])</strong>，研发代码为<strong>[[MOR202]]</strong>，是一种高亲和力、全人源化单克隆抗体，特异性靶向细胞表面抗原<strong>[[CD38]]</strong>。该药物最初由[[MorphoSys]]开发，现归属于<strong>[[勃健]]([[Biogen]])</strong>旗下（通过收购[[HI-Bio]]获得）。与传统的[[CD38]]单抗主要用于血液肿瘤不同，[[Felzartamab]]在2026年的临床定位核心在于**[[免疫介导性肾病]]**。它通过精准耗竭产生致病抗体的<strong>[[浆细胞]]</strong>及<strong>[[浆母细胞]]</strong>，从源头上阻断自身免疫损伤。在2026年的治疗规范中，[[Felzartamab]]已被视为治疗<strong>[[IgA肾病]]</strong>及<strong>[[膜性肾病]]</strong>最具前景的“疾病修饰疗法”之一。
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            <div style="font-size: 1.2em; font-weight: bold; letter-spacing: 1.2px;">菲泽妥单抗</div>
            <div style="font-size: 0.7em; opacity: 0.85; margin-top: 4px; white-space: nowrap;">Felzartamab (MOR202)·点击展开</div>
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                <div style="font-size: 0.8em; color: #64748b; margin-top: 12px; font-weight: 600;">作用靶点：[[CD38]]</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;">952</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[UniProt]]</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">P28074</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">药物类型</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">人源化IgG1κ单抗</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">分子量</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">约147kDa</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">给药途径</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">静脉输注([[IV]])</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">主要药企</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #1e40af;">勃健([[Biogen]])</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569;">2026状态</th>
                    <td style="padding: 12px; color: #1e40af;">肾病领域突破性药物</td>
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        [[Felzartamab]]通过识别浆细胞表面高度表达的[[CD38]]分子，启动多重免疫杀伤机制。
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        <li style="margin-bottom: 12px;"><strong>免疫介导杀伤：</strong>
            通过结合[[CD38]]，[[Felzartamab]]激活<strong>[[抗体依赖性细胞介导的细胞毒性]]([[ADCC]])</strong>及<strong>[[抗体依赖性细胞吞噬作用]]([[ADCP]])</strong>，通过NK细胞和巨噬细胞高效清除目标浆细胞。</li>
        <li style="margin-bottom: 12px;"><strong>清除抗体工厂：</strong>
            与靶向B细胞的CD20单抗不同，[[Felzartamab]]能打击B细胞发育的终末阶段——<strong>[[浆细胞]]</strong>。这些细胞正是产生<strong>[[抗PLA2R抗体]]</strong>（膜性肾病）或<strong>[[Gd-IgA1]]</strong>（IgA肾病）的源头。</li>
        <li style="margin-bottom: 12px;"><strong>2026 深度发现：</strong>
            研究证实[[Felzartamab]]能显著降低骨髓中的<strong>[[长寿浆细胞]]</strong>库，这一效应在实现慢性自身免疫性肾病的长期缓解中起到决定性作用。</li>
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                <th style="padding: 12px; border: 1px solid #cbd5e1; color: #0f172a; width: 25%;">适应症</th>
                <th style="padding: 12px; border: 1px solid #cbd5e1; color: #475569;">2026核心证据(研究名称)</th>
                <th style="padding: 12px; border: 1px solid #cbd5e1; color: #1e40af;">临床意义</th>
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                <td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">[[原发性膜性肾病]]</td>
                <td style="padding: 10px; border: 1px solid #cbd5e1;">M-PROVE研究：显著提高蛋白尿完全缓解率及抗体转阴速度。</td>
                <td style="padding: 10px; border: 1px solid #cbd5e1;"><strong>快速起效</strong>。优于传统利妥昔单抗。</td>
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                <td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">[[IgA肾病]]</td>
                <td style="padding: 10px; border: 1px solid #cbd5e1;">IGNAZ研究：治疗5个月后显著降低[[uPCR]]，保护肾功能。</td>
                <td style="padding: 10px; border: 1px solid #cbd5e1;"><strong>精准打击</strong>。靶向致病性半乳糖缺失型IgA1产生。</td>
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                <td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">[[抗体介导的排斥]]</td>
                <td style="padding: 10px; border: 1px solid #cbd5e1;">针对肾移植术后慢性[[AMR]]，展现了改善移植物存活的潜力。</td>
                <td style="padding: 10px; border: 1px solid #cbd5e1;">填补移植领域难治性排斥的治疗空白。</td>
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        [[Felzartamab]]在临床应用中强调“平衡耗竭”策略，以最大限度减少免疫缺陷风险：
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        <li style="margin-bottom: 12px;"><strong>阶段化给药方案：</strong>2026年专家共识推荐先进行为期9周的强化诱导，随后转入每4-8周一次的维持治疗，旨在确保持续清空病理性浆细胞。</li>
        <li style="margin-bottom: 12px;"><strong>[[输注相关反应]]管理：</strong>首次给药建议配合预防性使用地塞米松及抗组胺药，以降低[[IRR]]发生率。</li>
        <li style="margin-bottom: 12px;"><strong>免疫球蛋白监测：</strong>治疗期间需定期检测血清<strong>[[总IgG]]</strong>水平。2026指南明确，若IgG水平持续过低，需考虑预防性补充[[IVIG]]或延长给药间隔。</li>
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            <li style="margin-bottom: 8px;"><strong>[[CD38]]：</strong>一种在浆细胞上高度表达的外酶，[[Felzartamab]]的核心攻击位点。</li>
            <li style="margin-bottom: 8px;"><strong>[[长寿浆细胞]]([[LLPCs]])：</strong>存活于骨髓中的致病抗体“种子”，是普通免疫抑制剂无法触及的靶区。</li>
            <li style="margin-bottom: 8px;"><strong>[[达雷妥尤单抗]]：</strong>全球首款上市的[[CD38]]单抗，为[[Felzartamab]]在肾病领域的开发提供了理论先行。</li>
            <li style="margin-bottom: 8px;"><strong>[[Mezagitamab]]：</strong>武田研发的同类竞争药物，目前正与[[Felzartamab]]展开头对头研究。</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>Dahan K,et al.(2024/2025Revision).</strong> <em>Felzartamab in antibody-mediated renal diseases:Long-term follow-up of the M-PROVE trial.</em> <strong>[[The New England Journal of Medicine]]</strong>.<br>
            <span style="color: #475569;">[权威点评]：该项具有里程碑意义的研究展示了[[CD38]]靶向策略在实现膜性肾病深度缓解方面的代际优势。</span>
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            [2] <strong>[[Biogen]]Inc.(2026Update).</strong> <em>Integrating plasma cell depletion into the treatment paradigm of IgA Nephropathy:2026 Consensus Statement.</em> [Academic Review]<br>
            <span style="color: #475569;">[学术点评]：2026年最新综述论证了[[Felzartamab]]作为IgA肾病一线高危患者联合用药的必要性。</span>
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            菲泽妥单抗 (Felzartamab) · 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;">[[CD38]]•[[BCMA]]•[[BlyS]]•[[APRIL]]•[[FcRn]]</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;">治疗领域</td>
                <td style="padding: 10px 15px; color: #334155;">[[膜性肾病]]•[[IgA肾病]]•[[多发性骨髓瘤]]•[[SLE]]</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;">核心临床</td>
                <td style="padding: 10px 15px; color: #334155;">[[IGNAZ研究]]•[[M-PROVE研究]]•[[ROCKY试验]]</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;">监测指标</td>
                <td style="padding: 10px 15px; color: #334155;">[[抗PLA2R滴度]]•[[24h尿蛋白]]•[[eGFR]]•[[IgG水平]]</td>
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