<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>阿斯利康在美國市場撤回了緊急凝血劑 Andexxa，因應 FDA 的要求。圖片來源：andreaaaaaaaaa via ShutterStock.com。</p>
<p>阿斯利康因患者死亡事件，從美國市場撤回了其抗凝治療藥物 Andexxa（重組凝血因子 Xa）。</p>
<p>這源於美國食品藥品監督管理局（FDA）對 Andexxa 的效益風險特徵日益關注，後期市場研究顯示該凝血劑可能使患者面臨嚴重或致命的血栓栓塞事件風險。</p>
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<h4>NPVM: 阿斯利康的 AZD-8205</h4>
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<h4>NPVM: 阿斯利康的 Datopotamab deruxtecan</h4>
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<p>在確認性 III 期 ANNEXA-I 研究（NCT03661528）中，該研究在 Andexxa 獲得加速批准後進行，治療組的血栓發生率為 14.6%，而常規護理對照組為 6.9%。在 Andexxa 組中，30 天后與血栓事件相關的死亡人數為六人，而對照組有兩名患者死亡。</p>
<p>在 FDA 細胞、組織和基因治療顧問委員會成員討論這些結果後，該機構在 2024 年 12 月將 Andexxa 在美國市場的未來置於懸而未決的狀態，拒絕完全批准該藥物。阿斯利康現已自願撤回 Andexxa 的生物製品許可申請（BLA），並將在 2025 年 12 月 22 日後不再在美國銷售或生產 Andexxa。</p>
<p>阿斯利康最初在 2021 年以 390 億美元收購 Alexion Pharmaceuticals 後獲得了 Andexxa 的權利。Alexion 此前在 2020 年以 14 億美元收購了該藥物的原開發商 Portola Pharmaceuticals。</p>
<p>該凝血劑於 2018 年獲得加速批准，用於逆轉由抗凝藥物 Eliquis（阿哌沙班）和 Xarelto（利伐沙班）引發的危及生命或無法控制的出血。在美國市場時，要求附帶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 戰略情報</p>
<h1>美國關税正在變化 - 你會反應還是預見？</h1>
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<p>目前，Andexxa 仍在歐洲藥品管理局（EMA）和英國藥品和健康產品監管局（MHRA）獲得有條件使用批准。</p>
<p>雖然目前尚不清楚其他全球監管機構將對 Andexxa 的效益風險特徵採取何種立場，但不利的後期市場安全數據可能導致該療法未能獲得完全批准。</p>
<p>Andexxa 在 2024 年全球銷售額為 2.19 億美元，其中 8100 萬美元來自美國。</p>
<h2>製藥技術卓越獎 - 提名已關閉</h2>
<p>製藥技術卓越獎 的提名現已關閉。感謝所有參與的組織 - 你們的反應非常出色，展示了卓越的創新、領導力和影響力。</p>
<p><strong>行動中的卓越</strong></p>
<p>因在 綜合製造 方面的業務擴展而獲得 2025 年製藥技術卓越獎的 Upperton Pharma Solutions，正在迅速擴大其在英國的 GMP 和無菌製造能力。瞭解 Upperton 的綜合 CDMO 模型如何幫助製藥公司從早期開發到臨牀和小眾商業供應，減少交接和加快時間表。</p>
<p>發現影響</p>

阿斯利康

阿斯利康制藥

<p>阿斯利康已從美國市場撤回其抗凝治療藥物 Andexxa，此舉是由於 FDA 對該藥物相關的嚴重血栓栓塞事件表示擔憂。該決定是在市場後研究顯示風險增加並導致死亡後做出的。阿斯利康自願撤回 Andexxa 的生物製劑許可申請，並將在 2025 年 12 月之前停止在美國的銷售和生產。該藥物在歐洲和英國仍然有條件獲批，但由於安全數據不利，其未來的批准情況不確定</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>阿斯利康在美國市場撤回了緊急凝血劑 Andexxa，因應 FDA 的要求。圖片來源：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，從美國市場撤回了其抗凝治療藥物 Andexxa（重組凝血因子 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>這源於美國食品藥品監督管理局（FDA）對 Andexxa 的效益風險特徵日益關注，後期市場研究顯示該凝血劑可能使患者面臨嚴重或致命的血栓栓塞事件風險。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入瞭解 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 class="lb-trans"><p>報告</p>
</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><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>在確認性 III 期 ANNEXA-I 研究（NCT03661528）中，該研究在 Andexxa 獲得加速批准後進行，治療組的血栓發生率為 14.6%，而常規護理對照組為 6.9%。在 Andexxa 組中，30 天后與血栓事件相關的死亡人數為六人，而對照組有兩名患者死亡。</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 細胞、組織和基因治療顧問委員會成員討論這些結果後，該機構在 2024 年 12 月將 Andexxa 在美國市場的未來置於懸而未決的狀態，拒絕完全批准該藥物。阿斯利康現已自願撤回 Andexxa 的生物製品許可申請（BLA），並將在 2025 年 12 月 22 日後不再在美國銷售或生產 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 億美元收購 Alexion Pharmaceuticals 後獲得了 Andexxa 的權利。Alexion 此前在 2020 年以 14 億美元收購了該藥物的原開發商 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>該凝血劑於 2018 年獲得加速批准，用於逆轉由抗凝藥物 Eliquis（阿哌沙班）和 Xarelto（利伐沙班）引發的危及生命或無法控制的出血。在美國市場時，要求附帶血栓栓塞事件的警告。</p>
</div><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 Strategic Intelligence</p>
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<div class="lb-trans"><h1>美國關税正在變化 - 你會反應還是預見？</h1>
</div><p>Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.</p>
<div class="lb-trans"><p>不要讓政策變化讓你措手不及。通過實時數據和專家分析保持主動。</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 仍在歐洲藥品管理局（EMA）和英國藥品和健康產品監管局（MHRA）獲得有條件使用批准。</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>雖然目前尚不清楚其他全球監管機構將對 Andexxa 的效益風險特徵採取何種立場，但不利的後期市場安全數據可能導致該療法未能獲得完全批准。</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 年全球銷售額為 2.19 億美元，其中 8100 萬美元來自美國。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - Nominations Closed</h2>
<div class="lb-trans"><h2>製藥技術卓越獎 - 提名已關閉</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>製藥技術卓越獎 的提名現已關閉。感謝所有參與的組織 - 你們的反應非常出色，展示了卓越的創新、領導力和影響力。</p>
</div><p><strong>Excellence in Action</strong></p>
<div class="lb-trans"><p><strong>行動中的卓越</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 綜合製造 方面的業務擴展而獲得 2025 年製藥技術卓越獎的 Upperton Pharma Solutions，正在迅速擴大其在英國的 GMP 和無菌製造能力。瞭解 Upperton 的綜合 CDMO 模型如何幫助製藥公司從早期開發到臨牀和小眾商業供應，減少交接和加快時間表。</p>
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<div class="lb-trans"><p>發現影響</p>
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阿斯利康因上市後出現死亡事件，從美國市場撤回 Andexxa