<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2644496339-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="430" height="241" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2644496339-430x241.jpg"/></p>
<p>阿斯利康在美国市场撤回了紧急凝血剂 Andexxa，因应 FDA 的要求。图片来源：andreaaaaaaaaa via ShutterStock.com。</p>
<p>阿斯利康因患者死亡事件，从美国市场撤回了其抗凝治疗药物 Andexxa（重组凝血因子 Xa）。</p>
<p>这源于美国食品药品监督管理局（FDA）对 Andexxa 的效益风险特征日益关注，后期市场研究显示该凝血剂可能使患者面临严重或致命的血栓栓塞事件风险。</p>
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<p>在确认性 III 期 ANNEXA-I 研究（NCT03661528）中，该研究在 Andexxa 获得加速批准后进行，治疗组的血栓发生率为 14.6%，而常规护理对照组为 6.9%。在 Andexxa 组中，30 天后与血栓事件相关的死亡人数为六人，而对照组有两名患者死亡。</p>
<p>在 FDA 细胞、组织和基因治疗顾问委员会成员讨论这些结果后，该机构在 2024 年 12 月将 Andexxa 在美国市场的未来置于悬而未决的状态，拒绝完全批准该药物。阿斯利康现已自愿撤回 Andexxa 的生物制品许可申请（BLA），并将在 2025 年 12 月 22 日后不再在美国销售或生产 Andexxa。</p>
<p>阿斯利康最初在 2021 年以 390 亿美元收购 Alexion Pharmaceuticals 后获得了 Andexxa 的权利。Alexion 此前在 2020 年以 14 亿美元收购了该药物的原开发商 Portola Pharmaceuticals。</p>
<p>该凝血剂于 2018 年获得加速批准，用于逆转由抗凝药物 Eliquis（阿哌沙班）和 Xarelto（利伐沙班）引发的危及生命或无法控制的出血。在美国市场时，要求附带血栓栓塞事件的警告。</p>
<p><img src="/wp-content/themes/goodlife-wp-B2B/assets/images/strategic-int.png" alt="" original-src="/wp-content/themes/goodlife-wp-B2B/assets/images/strategic-int.png"/></p>
<p>GlobalData 战略情报</p>
<h1>美国关税正在变化 - 你会反应还是预见？</h1>
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<p>目前，Andexxa 仍在欧洲药品管理局（EMA）和英国药品和健康产品监管局（MHRA）获得有条件使用批准。</p>
<p>虽然目前尚不清楚其他全球监管机构将对 Andexxa 的效益风险特征采取何种立场，但不利的后期市场安全数据可能导致该疗法未能获得完全批准。</p>
<p>Andexxa 在 2024 年全球销售额为 2.19 亿美元，其中 8100 万美元来自美国。</p>
<h2>制药技术卓越奖 - 提名已关闭</h2>
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<p><strong>行动中的卓越</strong></p>
<p>因在 综合制造 方面的业务扩展而获得 2025 年制药技术卓越奖的 Upperton Pharma Solutions，正在迅速扩大其在英国的 GMP 和无菌制造能力。了解 Upperton 的综合 CDMO 模型如何帮助制药公司从早期开发到临床和小众商业供应，减少交接和加快时间表。</p>
<p>发现影响</p>

阿斯利康

阿斯利康制药

<p>阿斯利康已从美国市场撤回其抗凝治疗药物 Andexxa，此举是由于 FDA 对该药物相关的严重血栓栓塞事件表示担忧。该决定是在市场后研究显示风险增加并导致死亡后做出的。阿斯利康自愿撤回 Andexxa 的生物制剂许可申请，并将在 2025 年 12 月之前停止在美国的销售和生产。该药物在欧洲和英国仍然有条件获批，但由于安全数据不利，其未来的批准情况不确定</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2644496339-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2644496339-430x241.jpg"/></p>
<p>AstraZeneca has pulled Andexxa, an emergency coagulant, from the US market following the FDA’s request. Image credit: andreaaaaaaaaa via ShutterStock.com.</p>
<div class="lb-trans"><p>阿斯利康在美国市场撤回了紧急凝血剂 Andexxa，因应 FDA 的要求。图片来源：andreaaaaaaaaa via ShutterStock.com。</p>
</div><p>AstraZeneca has pulled its anticoagulant therapy, Andexxa (recombinant coagulation factor Xa), from the US market after patient fatalities.</p>
<div class="lb-trans"><p>阿斯利康因患者死亡事件，从美国市场撤回了其抗凝治疗药物 Andexxa（重组凝血因子 Xa）。</p>
</div><p>This follows rising concern from the US Food and Drug Administration (FDA) around Andexxa’s benefit-risk profile, as post-marketing studies have revealed that the coagulant can put patients at risk of serious or fatal thromboembolic events.</p>
<div class="lb-trans"><p>这源于美国食品药品监督管理局（FDA）对 Andexxa 的效益风险特征日益关注，后期市场研究显示该凝血剂可能使患者面临严重或致命的血栓栓塞事件风险。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入了解 GlobalData</h3>
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</div><h4>NPVM: AstraZeneca Plc's AZD-8205</h4>
<div class="lb-trans"><h4>NPVM: 阿斯利康的 AZD-8205</h4>
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</div><h4>NPVM: AstraZeneca Plc's Datopotamab deruxtecan</h4>
<div class="lb-trans"><h4>NPVM: 阿斯利康的 Datopotamab deruxtecan</h4>
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<div class="lb-trans"><p>结合商业智能和编辑卓越，覆盖 36 个领先媒体平台的专业人士。</p>
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<div class="lb-trans"><p>了解更多</p>
</div><p>During the confirmatory Phase III ANNEXA-I study (NCT03661528), which was conducted after Andexxa was granted accelerated approval, thrombosis incidence in the treatment group was 14.6% versus 6.9% in the usual care control arm. There were also six deaths linked to thrombotic events after 30 days in the Andexxa arm, while two patients died in the control cohort.</p>
<div class="lb-trans"><p>在确认性 III 期 ANNEXA-I 研究（NCT03661528）中，该研究在 Andexxa 获得加速批准后进行，治疗组的血栓发生率为 14.6%，而常规护理对照组为 6.9%。在 Andexxa 组中，30 天后与血栓事件相关的死亡人数为六人，而对照组有两名患者死亡。</p>
</div><p>Following a meeting between members of the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee to discuss these results, the agency left Andexxa’s US market future in limbo back in December 2024, as it refused to fully approve the drug. AstraZeneca has now voluntarily withdrawn Andexxa’s biologics license application (BLA) and will no longer sell or manufacture Andexxa in the US after 22 December 2025.</p>
<div class="lb-trans"><p>在 FDA 细胞、组织和基因治疗顾问委员会成员讨论这些结果后，该机构在 2024 年 12 月将 Andexxa 在美国市场的未来置于悬而未决的状态，拒绝完全批准该药物。阿斯利康现已自愿撤回 Andexxa 的生物制品许可申请（BLA），并将在 2025 年 12 月 22 日后不再在美国销售或生产 Andexxa。</p>
</div><p>AstraZeneca originally obtained the rights to Andexxa after its $39bn acquisition of Alexion Pharmaceuticals in 2021. Alexion has previously acquired the drug’s original developer, Portola Pharmaceuticals, in a $1.4bn buyout in 2020.</p>
<div class="lb-trans"><p>阿斯利康最初在 2021 年以 390 亿美元收购 Alexion Pharmaceuticals 后获得了 Andexxa 的权利。Alexion 此前在 2020 年以 14 亿美元收购了该药物的原开发商 Portola Pharmaceuticals。</p>
</div><p>The coagulant was previously approved on an accelerated basis for the reversal of life-threatening or uncontrolled bleeding triggered by anticoagulants Eliquis (apixaban) and Xarelto (rivaroxaban) back in 2018. When it was on the US market, a boxed warning for thromboembolic events was required.</p>
<div class="lb-trans"><p>该凝血剂于 2018 年获得加速批准，用于逆转由抗凝药物 Eliquis（阿哌沙班）和 Xarelto（利伐沙班）引发的危及生命或无法控制的出血。在美国市场时，要求附带血栓栓塞事件的警告。</p>
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<div class="lb-trans"><p>GlobalData 战略情报</p>
</div><h1>US Tariffs are shifting - will you react or anticipate?</h1>
<div class="lb-trans"><h1>美国关税正在变化 - 你会反应还是预见？</h1>
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<div class="lb-trans"><p>不要让政策变化让你措手不及。通过实时数据和专家分析保持主动。</p>
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</div><p>Currently, Andexxa is still approved for use by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Regulatory Agency (MHRA) on a conditional basis.</p>
<div class="lb-trans"><p>目前，Andexxa 仍在欧洲药品管理局（EMA）和英国药品和健康产品监管局（MHRA）获得有条件使用批准。</p>
</div><p>While it is currently unknown what stance other global regulators will take on Andexxa’s benefit-risk profile, the unfavourable post-marketing safety data could see the therapy fail to gain full approval.</p>
<div class="lb-trans"><p>虽然目前尚不清楚其他全球监管机构将对 Andexxa 的效益风险特征采取何种立场，但不利的后期市场安全数据可能导致该疗法未能获得完全批准。</p>
</div><p>Andexxa pulled in $219m in sales globally in 2024, with $81m of this profit coming from the US.</p>
<div class="lb-trans"><p>Andexxa 在 2024 年全球销售额为 2.19 亿美元，其中 8100 万美元来自美国。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - Nominations Closed</h2>
<div class="lb-trans"><h2>制药技术卓越奖 - 提名已关闭</h2>
</div><p>Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.</p>
<div class="lb-trans"><p>制药技术卓越奖 的提名现已关闭。感谢所有参与的组织 - 你们的反应非常出色，展示了卓越的创新、领导力和影响力。</p>
</div><p><strong>Excellence in Action</strong></p>
<div class="lb-trans"><p><strong>行动中的卓越</strong></p>
</div><p>Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing, Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines.</p>
<div class="lb-trans"><p>因在 综合制造 方面的业务扩展而获得 2025 年制药技术卓越奖的 Upperton Pharma Solutions，正在迅速扩大其在英国的 GMP 和无菌制造能力。了解 Upperton 的综合 CDMO 模型如何帮助制药公司从早期开发到临床和小众商业供应，减少交接和加快时间表。</p>
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<div class="lb-trans"><p>发现影响</p>
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阿斯利康因上市后出现死亡事件，从美国市场撤回 Andexxa