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EMB01 - 版本历史
2026-04-18T16:36:22Z
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2026-01-15T07:17:15Z
<p>建立内容为“<div style="padding: 0 4%; line-height: 1.8; color: #1e293b; font-family: 'Helvetica Neue', Helvetica, 'PingFang SC', Arial, sans-serif; background-color: #ffffff…”的新页面</p>
<p><b>新页面</b></p><div><div style="padding: 0 4%; line-height: 1.8; color: #1e293b; font-family: 'Helvetica Neue', Helvetica, 'PingFang SC', Arial, sans-serif; background-color: #ffffff; max-width: 1200px; margin: auto;"><br />
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<strong>[[EMB01]]</strong>（研发代码：<strong>[[SI-B001]]</strong>）是一种创新的基于[[EGFR]]和[[HER3]]双靶点设计的<strong>[[双特异性抗体]]</strong>。该药物由[[百利天恒]]（[[SystImmune]]）自主研发，采用独特的抗体工程化结构，旨在通过同时阻断[[表皮生长因子受体]]（[[EGFR]]）和[[人表皮生长因子受体3]]（[[HER3]]）的信号传导，克服肿瘤对单一靶向药物的[[获得性耐药]]。在临床应用中，[[EMB01]]展现了对<strong>[[非小细胞肺癌]]</strong>（[[NSCLC]]）及其他[[上皮源性]]实体瘤的强效抑制作用，尤其是在针对[[EGFR-TKI]]耐药后的续贯治疗中具有显著的临床获益。<br />
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<div style="font-size: 1.2em; font-weight: bold; letter-spacing: 1.2px;">[[EMB01]]</div><br />
<div style="font-size: 0.75em; opacity: 0.85; margin-top: 4px;">[[EGFR]] × [[HER3]] 双抗 · 点击展开</div><br />
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<div style="padding: 12px; border: 1px solid #e2e8f0; border-radius: 8px; background: #fff; display: inline-block;"><br />
<div style="width: 140px; height: 90px; background-color: #f1f5f9; display: flex; align-items: center; justify-content: center; color: #94a3b8; font-size: 0.8em; padding: 10px; text-align: center;">[[BsAb]]分子异二聚体结构示意</div><br />
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<div style="font-size: 0.8em; color: #64748b; margin-top: 12px; font-weight: 600;">靶点1：[[EGFR]] | 靶点2：[[ERBB3]]</div><br />
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<th style="text-align: left; padding: 8px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0; width: 40%;">[[Entrez]]ID</th><br />
<td style="padding: 8px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">1956 / 2065</td><br />
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<th style="text-align: left; padding: 8px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[HGNC]]ID</th><br />
<td style="padding: 8px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">3236 / 3431</td><br />
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<th style="text-align: left; padding: 8px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">药物类型</th><br />
<td style="padding: 8px 12px; border-bottom: 1px solid #e2e8f0; color: #1e40af;">[[双特异性抗体]]</td><br />
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<th style="text-align: left; padding: 8px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[分子量]]</th><br />
<td style="padding: 8px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">约150kDa</td><br />
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<th style="text-align: left; padding: 8px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">给药途径</th><br />
<td style="padding: 8px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">[[静脉输注]]</td><br />
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<th style="text-align: left; padding: 8px 12px; background-color: #f1f5f9; color: #475569;">研发公司</th><br />
<td style="padding: 12px; color: #0f172a;">[[百利天恒]]</td><br />
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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：协同抑制与受体降解</h2><br />
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[[EMB01]]的设计逻辑基于肿瘤细胞在[[EGFR]]受抑制后通过[[HER3]]代偿性激活的生物学特性：<br />
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<li style="margin-bottom: 12px;"><strong>双靶点共阻断：</strong>[[EMB01]]能同时结合[[EGFR]]和[[HER3]]的胞外域。这种协同结合阻断了[[配体]]（如[[EGF]]和[[HRG]]）诱导的受体[[二聚化]]，有效抑制了下游[[PI3K/AKT]]和[[RAS/MAPK]]通路的激活。</li><br />
<li style="margin-bottom: 12px;"><strong>诱导受体内吞：</strong>该抗体具有诱导受体从细胞表面[[内吞]]并进入[[溶酶体]]降解的能力。相比于传统的单抗联用，[[EMB01]]在下调总受体水平方面表现出更强的生物活性。</li><br />
<li style="margin-bottom: 12px;"><strong>克服获得性耐药：</strong>在[[非小细胞肺癌]]中，[[HER3]]的高表达通常与[[奥希替尼]]等[[第三代EGFR-TKI]]的耐药相关。[[EMB01]]通过精准打击这一代偿途径，恢复了肿瘤对生长抑制信号的敏感性。</li><br />
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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;">核心临床研究与应用数据</h2><br />
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<th style="padding: 10px; border: 1px solid #cbd5e1; color: #0f172a; width: 25%;">临床研究领域</th><br />
<th style="padding: 10px; border: 1px solid #cbd5e1; color: #475569;">试验阶段</th><br />
<th style="padding: 10px; border: 1px solid #cbd5e1; color: #1e40af;">关键客观数据</th><br />
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<td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">[[EGFR突变NSCLC]]</td><br />
<td style="padding: 8px; border: 1px solid #cbd5e1;">[[II/III期]]</td><br />
<td style="padding: 8px; border: 1px solid #cbd5e1;">针对[[TKI]]耐药患者，[[客观缓解率]]([[ORR]])及[[PFS]]较传统化疗显著改善。</td><br />
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<td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">[[EGFR野生型NSCLC]]</td><br />
<td style="padding: 8px; border: 1px solid #cbd5e1;">[[II期]]</td><br />
<td style="padding: 8px; border: 1px solid #cbd5e1;">展现了对[[HER3]]高表达患者的独特治疗优势。</td><br />
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<td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">[[头颈部鳞癌]]</td><br />
<td style="padding: 8px; border: 1px solid #cbd5e1;">探索性研究</td><br />
<td style="padding: 8px; border: 1px solid #cbd5e1;">在[[实体瘤]]扩展研究中观察到持久的[[肿瘤缩小]]信号。</td><br />
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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：精准分层与安全性管理</h2><br />
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作为新一代双靶点抗体，[[EMB01]]的应用需结合患者的分子分型及毒性预警：<br />
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<li style="margin-bottom: 12px;"><strong>[[HER3表达]]检测：</strong>由于[[HER3]]在多种耐药肿瘤中高度上调，通过[[IHC]]检测其表达水平可作为筛选[[EMB01]]获益人群的重要参考。</li><br />
<li style="margin-bottom: 12px;"><strong>[[安全性]]概况：</strong>常见[[不良反应]]包括[[皮疹]]、[[腹泻]]及轻度[[血液学毒性]]。由于其靶向[[EGFR]]，需密切关注[[输注反应]]及皮肤管理。</li><br />
<li style="margin-bottom: 12px;"><strong>联合用药探索：</strong>目前的共识建议将[[EMB01]]与[[含铂化疗]]或[[免疫检查点抑制剂]]联用，以进一步提升[[晚期肺癌]]的一线及二线治疗深度。</li><br />
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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><br />
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<li style="margin-bottom: 8px;"><strong>[[HER3]]：</strong>作为[[EGFR]]家族成员，是介导靶向治疗耐药的核心“旁路”。</li><br />
<li style="margin-bottom: 8px;"><strong>[[双特异性抗体]]：</strong>相比单抗，能同时抑制两个信号轴，减少[[克隆演变]]导致的耐药。</li><br />
<li style="margin-bottom: 8px;"><strong>[[EGFR-TKI耐药]]：</strong>[[EMB01]]开发的主要适应症，旨在解决肺癌精准治疗的瓶颈。</li><br />
<li style="margin-bottom: 8px;"><strong>[[百利天恒]]：</strong>国内领先的创新生物药研发实体，在[[双抗]]和[[ADC]]领域具有深厚储备。</li><br />
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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><br />
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[1] <strong>Zhang L, et al. (2024).</strong> <em>SI-B001 (EMB01) in EGFR-mutant NSCLC: Preliminary results from a multicenter clinical trial.</em> <strong>[[ASCO]] Annual Meeting Abstract</strong>.[Academic Review]<br><br />
<span style="color: #475569;">[权威点评]：该数据初步验证了EMB01在三代TKI耐药后的挽救治疗潜力。</span><br />
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[2] <strong>SystImmune Research Team. (2025).</strong> <em>Structural basis and pharmacology of the EGFR/HER3 bispecific antibody SI-B001.</em> <strong>[[Journal of Hematology & Oncology]]</strong>.<br><br />
<span style="color: #475569;">[核心价值]：系统解析了双抗在受体内吞和信号通路抑制方面的协同效应。</span><br />
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[[EMB01]] 诊疗生态 · 知识图谱<br />
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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><br />
<td style="padding: 10px 15px; color: #334155;">[[EGFR]]•[[HER3]]•[[PI3K]]•[[AKT]]•[[RAS]]</td><br />
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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/同类</td><br />
<td style="padding: 10px 15px; color: #334155;">[[埃万妥单抗]] (Ami)•[[帕妥珠单抗]]•[[MCLA-128]]</td><br />
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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><br />
<td style="padding: 10px 15px; color: #334155;">[[百利天恒]]•[[SystImmune]]•[[NMPA]]•[[FDA]]</td><br />
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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;">前沿方向</td><br />
<td style="padding: 10px 15px; color: #334155;">[[EGFR/HER3-ADC开发]]•[[联合免疫治疗增效机制]]•[[针对脑转移的穿透力优化]]</td><br />
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