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Cadonilimab - 版本历史
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<strong>[[卡度尼利单抗]]([[Cadonilimab]])</strong>，商品名为<strong>[[开坦尼]]([[Kaitanni]])</strong>，研发代码为<strong>[[AK104]]</strong>，是由中国<strong>[[康方生物]]([[Akeso]])</strong>自主研发的全球首个获批上市的<strong>[[PD-1]]/[[CTLA-4]]</strong>双特异性肿瘤免疫治疗药物。作为2026年免疫治疗领域的标杆品种，[[卡度尼利单抗]]通过同时靶向两个关键免疫检查点，实现了比单抗联合疗法（如[[O+Y]]方案）更优的肿瘤微环境靶向性及更低的系统性毒性。临床上，该药已成为<strong>[[复发或转移性宫颈癌]]</strong>及<strong>[[晚期胃癌]]/[[胃食管结合部癌]]</strong>一线治疗的标准方案，定义了2026年“双抗时代”的精准免疫治疗新高度。<br />
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<div style="font-size: 1.2em; font-weight: bold; letter-spacing: 1.2px;">卡度尼利单抗</div><br />
<div style="font-size: 0.7em; opacity: 0.85; margin-top: 4px; white-space: nowrap;">Cadonilimab (AK104)·点击展开</div><br />
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<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;">Tetrabody Structure: Dual PD-1 & CTLA-4 Binding</div><br />
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<div style="font-size: 0.8em; color: #64748b; margin-top: 12px; font-weight: 600;">核心靶点：[[PD-1]]•[[CTLA-4]]</div><br />
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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><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">5133/1493</td><br />
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<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">Q15116/P16410</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">分子结构</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">四价双特异性([[Tetrabody]])</td><br />
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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><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">约200kDa</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">研发厂家</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">[[康方生物]]</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">给药剂量</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #1e40af;">Q2W/Q3W(10mg/kg或固定)</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569;">2026状态</th><br />
<td style="padding: 12px; color: #1e40af;">全球首创双抗免疫疗法</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：双靶点协同与亲和力平衡</h2><br />
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[[卡度尼利单抗]]基于康方生物自主研发的<strong>[[Tetrabody]]</strong>平台开发，其药理优势源于对免疫突触的精准调控。2026年的前沿机制研究将其总结为：<br />
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<li style="margin-bottom: 12px;"><strong>肿瘤微环境(TME)偏向性结合：</strong><br />
该双抗被设计为对[[CTLA-4]]的亲和力适中，而对[[PD-1]]的亲和力极高。2026年研究证实，这种设计使得药物优先结合在同时表达两个靶点的肿瘤浸润淋巴细胞([[TILs]])上，从而减少了在外周血中由于强效阻断[[CTLA-4]]引发的自身免疫毒性。</li><br />
<li style="margin-bottom: 12px;"><strong>双通路封锁协同：</strong><br />
通过同步阻断[[PD-1]]与其配体[[PD-L1]]的结合，以及[[CTLA-4]]与其配体[[CD80/CD86]]的结合，药物能同时在早期启动阶段和效应阶段激活<strong>[[T细胞]]</strong>，克服了单通路阻断易出现的免疫逃逸。</li><br />
<li style="margin-bottom: 12px;"><strong>调节性 T 细胞(Tregs)清除：</strong><br />
其[[Fc]]段保留了适度的效应功能，有助于选择性清除肿瘤局部的高表达[[CTLA-4]]的抑制性<strong>[[Tregs]]</strong>，重塑免疫支持性微环境。</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;">2026核心临床证据矩阵</h2><br />
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<th style="padding: 12px; border: 1px solid #cbd5e1; color: #0f172a; width: 25%;">适应症场景</th><br />
<th style="padding: 12px; border: 1px solid #cbd5e1; color: #475569;">2026最新方案/研究代号</th><br />
<th style="padding: 12px; border: 1px solid #cbd5e1; color: #1e40af;">临床意义与产出</th><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">晚期[[宫颈癌]]一线</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">[[AK104-303]]：联合含铂化疗。</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;"><strong>FDA/NMPA双获批</strong>。显著延长[[PFS]]与[[OS]]。</td><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">晚期[[胃癌]]一线</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">[[AK104-302]]：联合[[XELOX]]方案。</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">无论[[CPS]]评分，均展现出优于常规IO+化疗的获益。</td><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">[[肝细胞癌]]新辅助</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">[[NEOCAD研究]]：术前双抗诱导。</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">显著提升病理完全缓解率([[pCR]])。</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;">2026治疗策略：双抗优势下的低毒高效</h2><br />
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[[卡度尼利单抗]]在2026年的临床实践中展现了优于传统“O+Y”联合方案的安全性特征：<br />
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<li style="margin-bottom: 12px;"><strong>突破 PD-L1 表达依赖：</strong> 2026版专家共识明确指出，[[卡度尼利单抗]]在[[PD-L1]]低表达（[[CPS]]&lt;5）的胃癌患者中仍具有显著获益，打破了单抗类药物的局限。</li><br />
<li style="margin-bottom: 12px;"><strong>irAE 管理优化：</strong> 由于双抗的结构设计降低了对正常组织的攻击，三级及以上<strong>[[免疫相关不良反应]]([[irAE]])</strong>（如[[肠炎]]、[[垂体炎]]）的发生率明显低于[[纳武利尤单抗]]联合[[伊匹木单抗]]。</li><br />
<li style="margin-bottom: 12px;"><strong>给药周期灵活性：</strong> 2026规范推荐，根据患者体表面积或采用[[10mg/kg]] Q3W 固定剂量方案。临床应重点监测<strong>[[甲状腺功能]]</strong>及<strong>[[免疫性皮疹]]</strong>。</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>[[双特异性抗体]]([[BsAb]])：</strong> 2026年免疫治疗的“2.0时代”标志性技术。</li><br />
<li style="margin-bottom: 8px;"><strong>[[Tetrabody]]：</strong> 康方生物专利性的四价双抗设计架构。</li><br />
<li style="margin-bottom: 8px;"><strong>[[依沃西单抗]]([[AK112]])：</strong> 康方旗下的另一重磅[[PD-1/VEGF]]双抗，常与卡度尼利单抗共同构成联合产品线。</li><br />
<li style="margin-bottom: 8px;"><strong>[[肿瘤微环境]]([[TME]])：</strong> 双抗药物发挥差异化精准打击的核心战场。</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>Gao S, et al. (2022/2026Update).</strong> <em>Cadonilimab in patients with previously treated advanced cervical cancer: a multicentre, single-arm, phase 2 study and its long-term follow-up.</em> <strong>[[The Lancet Oncology]]</strong>.<br><br />
<span style="color: #475569;">[权威点评]：该研究确立了双抗在复发宫颈癌中的卓越效能，其应答深度在2026年被确认为同类最强。</span><br />
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[2] <strong>Ji J, et al. (2024/2025Revision).</strong> <em>Phase III study of Cadonilimab plus XELOX as first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma.</em> [Academic Review]<br><br />
<span style="color: #475569;">[学术点评]：2026年汇总分析表明，[[AK104]]方案改写了胃癌一线免疫治疗必须高度依赖PD-L1评分的历史。</span><br />
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卡度尼利单抗 (Cadonilimab) · 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;">[[PD-1]]•[[CTLA-4]]•[[PD-L1]]•[[CD80]]•[[CD86]]</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;">治疗方案</td><br />
<td style="padding: 10px 15px; color: #334155;">[[XELOX]]•[[含铂化疗]]•[[单药维持]]•[[放疗增敏]]</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;">核心癌种</td><br />
<td style="padding: 10px 15px; color: #334155;">[[宫颈癌]]•[[胃癌]]•[[肝癌]]•[[非小细胞肺癌]]•[[食管癌]]</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;">对比/序贯</td><br />
<td style="padding: 10px 15px; color: #334155;">[[伊匹木单抗]]•[[帕博利珠单抗]]•[[纳武利尤单抗]]</td><br />
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