全球首个！“成都造”重磅抗癌新药获批上市
<section data-role="paragraph" style="visibility: visible;"><section data-tools="135编辑器" data-id="151607" style="-webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; outline: 0px; max-width: 100%; color: rgba(0, 0, 0, 0.9); font-size: 17px; letter-spacing: 1.5px; text-align: justify; background-color: rgb(255, 255, 255); visibility: visible; font-family: 微软雅黑; box-sizing: border-box !important; overflow-wrap: break-word !important;"><section style="-webkit-tap-highlight-color: transparent;margin: 10px auto;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible;"><section style="-webkit-tap-highlight-color: transparent;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible;"><section style="-webkit-tap-highlight-color: transparent;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;transform-style: preserve-3d;visibility: visible;"><section style="-webkit-tap-highlight-color: transparent;margin: -21px 0px;padding: 0px 4px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible;transform: translateZ(12px);-webkit-transform: translateZ(12px);-moz-transform: translateZ(12px);-o-transform: translateZ(12px);"><section style="-webkit-tap-highlight-color: transparent;margin: 0px;padding: 15px 10px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;background-color: #fafafa;visibility: visible;"><section style="-webkit-tap-highlight-color: transparent;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;line-height: 1.75em;font-size: 14px;color: #333333;background: transparent;visibility: visible;"><section data-autoskip="1" style="-webkit-tap-highlight-color: transparent;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible;"><p style="-webkit-tap-highlight-color: transparent;margin: 0px 5px;padding: 0px;outline: 0px;max-width: 100%;clear: both;min-height: 1em;visibility: visible;line-height: 2;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="font-size: 17px; caret-color: rgb(255, 0, 0); font-family: 微软雅黑, Microsoft YaHei; visibility: visible;"><span leaf="" style="visibility: visible;">6月22日，据国家药品监督管理局官网消息，</span><span style="color: rgb(10, 120, 230); visibility: visible;"><strong style="visibility: visible;"><span leaf="" style="visibility: visible;">由成都药企百利天恒自主研发的EGFR×HER3双抗ADC药物伦康依隆妥单抗（iza-bren，宜泽康）正式获批上市</span></strong></span><span leaf="" style="visibility: visible;">，用于治疗既往经至少二线系统化疗和PD-1/PD-L1抑制剂治疗失败的复发/转移性鼻咽癌的成人患者。</span></span></p></section></section></section></section><section style="-webkit-tap-highlight-color: transparent;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;display: flex;justify-content: flex-end;visibility: visible;transform: translateZ(10px);-webkit-transform: translateZ(10px);-moz-transform: translateZ(10px);-o-transform: translateZ(10px);"><section style="-webkit-tap-highlight-color: transparent;margin: 0px;padding: 0px;outline: 0px;max-width: 100%;overflow-wrap: break-word !important;width: 25px;height: 25px;background-color: #0a78e6;overflow: hidden;visibility: visible;box-sizing:border-box;"><p style="-webkit-tap-highlight-color: transparent; margin-top: 0px; margin-bottom: 0px; padding: 0px; outline: 0px; max-width: 100%; visibility: visible; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span leaf="" style="visibility: visible;"><br style="visibility: visible;"/></span></p></section></section></section></section></section></section><p style="visibility: visible;"><span leaf="" style="visibility: visible;"><br style="visibility: visible;"/></span></p><section style="text-align: center; visibility: visible;" nodeleaf=""></section></section><p style="text-align: center; visibility: visible;"><span style="color: rgb(127, 127, 127); font-size: 15px; visibility: visible;">图片来源：国家药品监督管理局官网</span></p><p style="visibility: visible;"><span leaf="" style="visibility: visible;"><br style="visibility: visible;"/></span></p><p style="visibility: visible;"><span leaf="" style="visibility: visible;">据了解，伦康依隆妥单抗是全球首创（First-in-class）、新概念（New concept）且首个进入III期注册临床研究的EGFR×HER3双抗ADC（双特异性抗体偶联药物）。作为全球首个获批上市的双抗ADC，临床结果显示，伦康依隆妥单抗具备精准、强效、低毒的治疗优势，</span><strong>其创新机制突破了传统化疗与单靶点药物的局限，为肿瘤精准治疗开辟全新路径。</strong></p><p><span leaf=""><br/></span></p><p><span leaf="">中国科学院院士、国际鼻咽癌Gordon大会候任主席、中山大学肿瘤防治中心常务副院长马骏院士表示：“</span><strong>伦康依隆妥单抗的获批，标志着针对复发及转移鼻咽癌的后线治疗正迈入双抗ADC治疗的新时代。</strong><span leaf="">以往多线治疗失败的患者常陷入无药可用的困境，而伦康依隆妥单抗凭借疗效与生存获益的翻倍突破性提升，已被NCCN、CSCO两大权威指南列为首选方案。</span><strong>这款药物不仅改写了临床指南，更树立起晚期鼻咽癌后线治疗的全新标准，为患者带来了生存获益。”</strong></p><p><span leaf=""><br/></span></p><p><span leaf="">据悉，</span><strong>伦康依隆妥单抗是首款成功出海的国产双抗ADC新药。</strong><span leaf="">2023年12月，百利天恒就伦康依隆妥单抗与跨国药企百时美施贵宝（BMS）达成合作，交易总金额最高达84亿美元，当年创下全球ADC单药对外授权纪录，成为“成都造”创新药“借船出海”的典范，也是国产创新药出海的里程碑式突破。</span></p><p><span leaf=""><br/></span></p><p><strong>此次伦康依隆妥单抗的全球首个适应症在国内率先获批，标志着我国肿瘤治疗率先迈入双抗ADC全新时代，</strong><span leaf="">实现全球领跑，证明了中国原研药已具备全球第一梯队的创新研发与转化能力。</span></p><p><span leaf=""><br/></span></p><p><span leaf=""></span></p><p><span leaf=""><br/></span></p><p><span leaf="">伦康依隆妥单抗的获批，无疑给成都生物医药发展注入了一剂“强心针”。近年来，成都大力发展生物医药产业，已形成成都天府国际生物城、成都医学城等产业聚集地，“成都力量”正不断刷新着速度与高度。</span></p><p><span leaf=""><br/></span></p><p><span leaf="">截至2025年底，成都生物医药产业规模突破4000亿元，先后获批国家先进制造业集群、国家战略性新兴产业集群、国家中医药传承创新发展试验区，是国家重要的生物医药产业基地。</span></p><p><span leaf=""><br/></span></p><p><span leaf="">去年，《成都市促进生物医药产业高质量发展若干政策措施》发布，从支持药械研发创新、提高临床研究质效、支持产品临床应用、支持企业发展壮大、构建完善产业生态五个方面，提出了25条政策措施，推动产业发展。截至2025年底，成都已有超100个药械单品年度销售额突破亿元大关。</span></p><p><span leaf=""><br/></span></p><p></p><section data-role="outer" label="edit by 135editor" data-pm-slice="0 0 []" style="-webkit-tap-highlight-color: rgba(0, 0, 0, 0); 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