<p>美国食品和药物管理局（FDA）周一批准了 <strong>阿斯利康</strong>（AstraZeneca Plc）和 <strong>第一三共</strong>（Daiichi Sankyo）的_Enhertu_（trastuzumab deruxtecan）与 pertuzumab 联合用于某种类型乳腺癌患者的治疗。</p>
<p>该批准涵盖了对不可切除或转移性 HER2 阳性乳腺癌成年患者的首选治疗。</p>
<p>该批准是在 FDA 的优先审查和突破性疗法认定之后，基于 DESTINY-Breast09 三期试验的结果。</p>
<p>在试验中，_Enhertu_与 pertuzumab 联合使用相比于紫杉烷、trastuzumab 和 pertuzumab（THP），降低了疾病进展或死亡的风险 44%。</p>
<p>_Enhertu_加 pertuzumab 的中位无进展生存期（PFS）为 40.7 个月，而 THP 为 26.9 个月。</p>
<p>_Enhertu_加 pertuzumab 与 THP 相比的 PFS 获益在各亚组中是一致的。</p>
<p><strong>财务考虑</strong></p>
<p>在美国获得该批准后，阿斯利康需向第一三共支付 1.5 亿美元作为不可切除或转移性 HER2 阳性乳腺癌适应症的里程碑付款。</p>
<p>第一三共确认在美国的_Enhertu_销售。</p>
<p>周二，欧洲委员会批准了阿斯利康的_Saphnelo_（anifrolumab）用于系统性红斑狼疮（SLE）成年患者的皮下自我给药，作为一种预填充笔，适用于标准治疗之上。</p>
<p>该批准基于人用药品委员会（CHMP）的积极意见，并基于三期 TULIP-SC 试验的结果。</p>
<p>在试验中，_Saphnelo_的皮下给药与安慰剂相比，在接受标准治疗的中度至重度、活动性、自身抗体阳性 SLE 参与者中，显著且临床意义上降低了疾病活动性。</p>
<p><strong>财务考虑</strong></p>
<p>阿斯利康通过与 Medarex, Inc.于 2004 年签署的独家许可和合作协议获得了_Saphnelo_的全球权利。</p>
<p>Medarex 共同推广该产品的选项在其于 2009 年被 <strong>百时美施贵宝</strong>（Bristol-Myers Squibb &amp; Co）收购时到期。</p>
<p>根据协议，阿斯利康将根据地区向百时美施贵宝支付销售额的低至中等十几的特许权使用费。</p>
<p><strong>AZN 价格动态：</strong> 根据 Benzinga Pro 的数据，阿斯利康的股价在周二发布时下跌 1.03%，报 90.62 美元。</p>
<p><strong>下一步阅读：</strong></p>
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<li><strong>AI 芯片制造商 Nvidia 刚刚发布了 AI 代理的开源模型</strong></li>
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<p><em>图片来源：Piotr Swat via Shutterstock</em></p>

阿斯利康

<p>阿斯利康获得 FDA 批准，将 Enhertu 与 pertuzumab 联合用于 HER2 阳性乳腺癌的一线治疗，降低疾病进展风险 44%。此外，欧盟批准 Saphnelo 用于狼疮自我注射。阿斯利康因 Enhertu 的批准需向大冢制药支付 1.5 亿美元。阿斯利康将向百时美施贵宝支付 Saphnelo 销售的版税。阿斯利康股价下跌 1.03%，至 90.62 美元</p>

<p>The U.S. Food and Drug Administration (FDA) on Monday approved <strong>AstraZeneca Plc</strong> (NASDAQ: AZN) and <strong>Daiichi Sankyo's</strong> <em>Enhertu</em> (trastuzumab deruxtecan) in combination with pertuzumab for patients with a certain type of breast cancer.</p>
<div class="lb-trans"><p>美国食品和药物管理局（FDA）周一批准了 <strong>阿斯利康</strong>（AstraZeneca Plc）和 <strong>第一三共</strong>（Daiichi Sankyo）的_Enhertu_（trastuzumab deruxtecan）与 pertuzumab 联合用于某种类型乳腺癌患者的治疗。</p>
</div><p>The approval covers the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.</p>
<div class="lb-trans"><p>该批准涵盖了对不可切除或转移性 HER2 阳性乳腺癌成年患者的首选治疗。</p>
</div><p>The approval follows Priority Review and Breakthrough Therapy Designation by the FDA and is based on the results of the DESTINY-Breast09 Phase 3 trial.</p>
<div class="lb-trans"><p>该批准是在 FDA 的优先审查和突破性疗法认定之后，基于 DESTINY-Breast09 三期试验的结果。</p>
</div><p>In the trial, <em>Enhertu</em> in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab, and pertuzumab (THP).</p>
<div class="lb-trans"><p>在试验中，_Enhertu_与 pertuzumab 联合使用相比于紫杉烷、trastuzumab 和 pertuzumab（THP），降低了疾病进展或死亡的风险 44%。</p>
</div><p>Median progression-free survival (PFS) was 40.7 months with <em>Enhertu</em> plus pertuzumab compared to 26.9 months for THP.</p>
<div class="lb-trans"><p>_Enhertu_加 pertuzumab 的中位无进展生存期（PFS）为 40.7 个月，而 THP 为 26.9 个月。</p>
</div><p>The PFS benefit for <em>Enhertu</em> plus pertuzumab versus THP was consistent across subgroups.</p>
<div class="lb-trans"><p>_Enhertu_加 pertuzumab 与 THP 相比的 PFS 获益在各亚组中是一致的。</p>
</div><p><strong>Financial considerations</strong></p>
<div class="lb-trans"><p><strong>财务考虑</strong></p>
</div><p>Following this approvalin the U.S., an amount of $150 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the first-line unresectable or metastatic HER2-positive breast cancer indication.</p>
<div class="lb-trans"><p>在美国获得该批准后，阿斯利康需向第一三共支付 1.5 亿美元作为不可切除或转移性 HER2 阳性乳腺癌适应症的里程碑付款。</p>
</div><p>Daiichi Sankyo recognises sales of Enhertu in the U.S.</p>
<div class="lb-trans"><p>第一三共确认在美国的_Enhertu_销售。</p>
</div><p>On Tuesday, the European Commission approved AstraZeneca's <em>Saphnelo</em> (anifrolumab) for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.</p>
<div class="lb-trans"><p>周二，欧洲委员会批准了阿斯利康的_Saphnelo_（anifrolumab）用于系统性红斑狼疮（SLE）成年患者的皮下自我给药，作为一种预填充笔，适用于标准治疗之上。</p>
</div><p>The approval follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion and is based on the Phase 3 TULIP-SC trial results.</p>
<div class="lb-trans"><p>该批准基于人用药品委员会（CHMP）的积极意见，并基于三期 TULIP-SC 试验的结果。</p>
</div><p>In the trial, subcutaneous administration of <em>Saphnelo</em> led to a statistically significant and clinically meaningful reduction in disease activity compared with placebo in participants with moderate-to-severe, active, autoantibody-positive SLE while receiving standard therapy.</p>
<div class="lb-trans"><p>在试验中，_Saphnelo_的皮下给药与安慰剂相比，在接受标准治疗的中度至重度、活动性、自身抗体阳性 SLE 参与者中，显著且临床意义上降低了疾病活动性。</p>
</div><p><strong>Financial considerations</strong></p>
<div class="lb-trans"><p><strong>财务考虑</strong></p>
</div><p>AstraZeneca acquired global rights to <em>Saphnelo</em> through an exclusive license and collaboration agreement with Medarex, Inc. in 2004.</p>
<div class="lb-trans"><p>阿斯利康通过与 Medarex, Inc.于 2004 年签署的独家许可和合作协议获得了_Saphnelo_的全球权利。</p>
</div><p>The option for Medarex to co-promote the product expired on its acquisition by <strong>Bristol-Myers Squibb &amp; Co</strong> (NYSE: BMY) in 2009.</p>
<div class="lb-trans"><p>Medarex 共同推广该产品的选项在其于 2009 年被 <strong>百时美施贵宝</strong>（Bristol-Myers Squibb &amp; Co）收购时到期。</p>
</div><p>Under the agreement, AstraZeneca will pay Bristol-Myers a low- to mid-teens royalty on sales, depending on geography.</p>
<div class="lb-trans"><p>根据协议，阿斯利康将根据地区向百时美施贵宝支付销售额的低至中等十几的特许权使用费。</p>
</div><p><strong>AZN Price Action:</strong> AstraZeneca shares were down 1.03% at $90.62 at the time of publication on Tuesday, according to Benzinga Pro data.</p>
<div class="lb-trans"><p><strong>AZN 价格动态：</strong> 根据 Benzinga Pro 的数据，阿斯利康的股价在周二发布时下跌 1.03%，报 90.62 美元。</p>
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</div><p><em>Photo by Piotr Swat via Shutterstock</em></p>
<div class="lb-trans"><p><em>图片来源：Piotr Swat via Shutterstock</em></p>
</div>

阿斯利康的乳腺癌药物获得了 FDA 的批准，同时其狼疮笔也获得了欧盟的许可