<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2637269043-430x241.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_2637269043-430x241.jpg"/></p>
<p>强生的 Akeega 已获得 FDA 在 BRCA2 突变的转移性去势抵抗性前列腺癌 (mCRPC) 中的批准，标志着该疗法获得的第二个前列腺癌适应症。图片来源：PixelBiss via Shutterstock.com。</p>
<p>强生 (J&amp;J) 已获得其下一代肿瘤学组合 Akeega 在乳腺癌基因 2(BRCA-2) 突变的转移性去势敏感性前列腺癌 (mCSPC) 中的美国标签扩展。</p>
<p>Akeega 与强生的雄激素抑制剂 Zytiga（阿比特龙）以药丸形式结合使用，基于 III 期 AMPLITUDE 研究 (NCT04497844) 的积极结果，Akeega 获得了在 mCSPC 中的 FDA 批准，该研究发现 Akeega 加上泼尼松和雄激素剥夺治疗 (ADT) 相比标准治疗 (SoC) 将疾病进展或死亡的风险降低了 54%。</p>
<h3>深入了解 GlobalData</h3>
<ul>
<li><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></li>
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<p>报告</p>
<h4>LOA 和 PTSR 模型 - (阿比特龙乙酸盐 + 尼拉帕利) 在转移性...</h4>
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<p>报告</p>
<h4>LOA 和 PTSR 模型 - ACM-001 在癌症厌食 - 消瘦综合症中的应用</h4>
<h5>深入了解 GlobalData</h5>
<p>商业智能的黄金标准。</p>
<p>了解更多</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/images/GMS-logo.svg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/images/GMS-logo.svg"/></p>
<h4>发现有效的 B2B 营销</h4>
<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>
<p>了解更多</p>
<p>强生获得了调查和商业化 Zejula 在 前列腺癌 的权利，该药物的创造者 Tesaro 于 2018 年被 GSK 收购。</p>
<p>目前 mCSPC 的标准治疗围绕使用雄激素受体信号抑制剂，如 Zytiga，加上泼尼松和 ADT。</p>
<p>强生表示，此次批准使 Akeega 加泼尼松成为 FDA 批准的首个针对 BRCA2 突变 mCSPC 患者的精准医学组合治疗。</p>
<p>通过超越当前的标准治疗，Akeega 也可能成为与 ADT 和泼尼松并行的治疗标准，标志着标准治疗的潜在变化。</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 - 你会反应还是预测？</h1>
<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>
<p>来自 GlobalData</p>
<p>了解更多关于战略情报</p>
<h2>Akeega 在前列腺癌市场的潜力</h2>
<p>Akeega 的批准进一步巩固了强生在 mCSPC 市场的地位，因为该公司最初开发并销售 Zytiga。在 2018 年该疗法失去专利保护之前，它曾是一个畅销药物，在其年度销售高峰时为强生带来了 25 亿美元的收入。</p>
<p>Akeega 于 2023 年首次在美国获得批准，用于 BRCA 阳性转移性去势抵抗性前列腺癌 (mCRPC) 患者。这次标签扩展进一步扩大了强生在前列腺癌领域的影响力，该领域在 PARP 抑制剂获得批准后变得竞争激烈。这些包括 Pharmaand 的 Rubraca（鲁卡帕利）和 MSD 与阿斯利康的 Lynparza（奥拉帕利）针对 mCRPC 患者。</p>
<p>辉瑞的 PARP 抑制剂 Talzenna（塔拉佐帕利）也获得了 FDA 批准 与雄激素受体抑制剂辉瑞和 Astellas 的 Xtandi（恩杂鲁胺）联合使用。</p>
<p>根据 GlobalData 的制药智能中心，Xtandi 是 2024 年销售额最高的 mCRPC 药物，为辉瑞和 Astellas 带来了 59 亿美元的收入。</p>
<p>GlobalData 的患者基础预测显示，Akeega 将在 2030 年达到 6.76 亿美元的峰值销售，而与该药物相关的利润将在次年降至 2.05 亿美元。</p>
<p>GlobalData 是《制药技术》的母公司。</p>
<h2>制药技术卓越奖 - 提名已关闭</h2>
<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>
<p><strong>行动中的卓越</strong></p>
<p>Imagene 的 肿瘤智能 (OI) 套件 荣获精准肿瘤学创新奖，改变了制药公司设计和进行肿瘤试验的方式。从 AI 驱动的生物标志物发现到更智能的患者分层，了解 Imagene 如何在癌症药物开发中缩短时间、降低成本和风险。</p>
<p>发现影响</p>

强生

<p>强生的 Akeega 已获得 FDA 批准，扩展用于 BRCA2 突变的转移性去势敏感前列腺癌（mCSPC）的适应症。该批准基于 III 期 AMPLITUDE 研究，使 Akeega 成为首个获得 FDA 批准的针对 BRCA2 突变的 mCSPC 的精准医学联合治疗，可能改变治疗标准。Akeega 是 GSK 的 Zejula 和强生的 Zytiga 的组合，之前已获批准用于 mCRPC，增强了强生在竞争激烈的前列腺癌市场中的地位</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2637269043-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2637269043-430x241.jpg"/></p>
<p>Johnson &amp; Johnson’s Akeega has gained approval from the FDA in BRCA2-mutated mCRPC, marking the second prostate cancer indication in which the therapy has been approved. Image credit: PixelBiss via Shutterstock.com.</p>
<div class="lb-trans"><p>强生的 Akeega 已获得 FDA 在 BRCA2 突变的转移性去势抵抗性前列腺癌 (mCRPC) 中的批准，标志着该疗法获得的第二个前列腺癌适应症。图片来源：PixelBiss via Shutterstock.com。</p>
</div><p>Johnson &amp; Johnson (J&amp;J) has secured a US label expansion for its next-generation oncology combination, Akeega, in breast cancer gene 2 (BRCA-2)-mutated, metastatic, castration-sensitive prostate cancer (mCSPC).</p>
<div class="lb-trans"><p>强生 (J&amp;J) 已获得其下一代肿瘤学组合 Akeega 在乳腺癌基因 2(BRCA-2) 突变的转移性去势敏感性前列腺癌 (mCSPC) 中的美国标签扩展。</p>
</div><p>A combination of GSK’s Zejula (niraparib) and J&amp;J’s androgen inhibitor, Zytiga (abiraterone) in a pill format, J&amp;J’s therapy received FDA approval in mCSPC based on positive results of the Phase III AMPLITUDE study (NCT04497844), which found that Akeega plus prednisone and androgen deprivation therapy (ADT) cut the risk of disease progression or death by 54% compared with standard of care (SoC).</p>
<div class="lb-trans"><p>Akeega 与强生的雄激素抑制剂 Zytiga（阿比特龙）以药丸形式结合使用，基于 III 期 AMPLITUDE 研究 (NCT04497844) 的积极结果，Akeega 获得了在 mCSPC 中的 FDA 批准，该研究发现 Akeega 加上泼尼松和雄激素剥夺治疗 (ADT) 相比标准治疗 (SoC) 将疾病进展或死亡的风险降低了 54%。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入了解 GlobalData</h3>
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<li><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></li>
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</div><p>Reports</p>
<div class="lb-trans"><p>报告</p>
</div><h4>LOA and PTSR Model - (Abiraterone Acetate + Niraparib) in Metastati...</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - (阿比特龙乙酸盐 + 尼拉帕利) 在转移性...</h4>
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</div><p>Reports</p>
<div class="lb-trans"><p>报告</p>
</div><h4>LOA and PTSR Model - ACM-001 in Cancer Anorexia-Cachexia Syndrome</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - ACM-001 在癌症厌食 - 消瘦综合症中的应用</h4>
</div><h5>Go deeper with GlobalData</h5>
<div class="lb-trans"><h5>深入了解 GlobalData</h5>
</div><p>The gold standard of business intelligence.</p>
<div class="lb-trans"><p>商业智能的黄金标准。</p>
</div><p>Find out more</p>
<div class="lb-trans"><p>了解更多</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/images/GMS-logo.svg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/images/GMS-logo.svg"/></p>
<h4>Discover B2B Marketing That Performs</h4>
<div class="lb-trans"><h4>发现有效的 B2B 营销</h4>
</div><p>Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.</p>
<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>
</div><p>Find out more</p>
<div class="lb-trans"><p>了解更多</p>
</div><p>J&amp;J gained the rights to investigate and commercialise Zejula in prostate cancer from the drug’s creator, Tesaro, which was later acquired by GSK in 2018.</p>
<div class="lb-trans"><p>强生获得了调查和商业化 Zejula 在 前列腺癌 的权利，该药物的创造者 Tesaro 于 2018 年被 GSK 收购。</p>
</div><p>The current SoC for mCSPC revolves around the use of an androgen receptor signalling inhibitor such as Zytiga, plus prednisone and ADT.</p>
<div class="lb-trans"><p>目前 mCSPC 的标准治疗围绕使用雄激素受体信号抑制剂，如 Zytiga，加上泼尼松和 ADT。</p>
</div><p>J&amp;J said that this approval makes Akeega plus prednisone the first FDA-approved precision medicine combination treatment for patients with BRCA2-mutated mCSPC.</p>
<div class="lb-trans"><p>强生表示，此次批准使 Akeega 加泼尼松成为 FDA 批准的首个针对 BRCA2 突变 mCSPC 患者的精准医学组合治疗。</p>
</div><p>By besting the current SoC, Akeega could also be poised to become the treatment standard alongside ADT and prednisone, marking a potential change to SoC.</p>
<div class="lb-trans"><p>通过超越当前的标准治疗，Akeega 也可能成为与 ADT 和泼尼松并行的治疗标准，标志着标准治疗的潜在变化。</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>
<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 - 你会反应还是预测？</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>
</div><p>By GlobalData</p>
<div class="lb-trans"><p>来自 GlobalData</p>
</div><p>Learn more about Strategic Intelligence</p>
<div class="lb-trans"><p>了解更多关于战略情报</p>
</div><h2>Akeega’s prostate cancer market potential</h2>
<div class="lb-trans"><h2>Akeega 在前列腺癌市场的潜力</h2>
</div><p>Akeega’s approval furthers J&amp;J’s legacy in the mCSPC market, as the company originally developed and marketed Zytiga. Before the therapy lost exclusivity in 2018, it was a blockbuster seller, making $2.5bn for J&amp;J at the peak of its annual sales.</p>
<div class="lb-trans"><p>Akeega 的批准进一步巩固了强生在 mCSPC 市场的地位，因为该公司最初开发并销售 Zytiga。在 2018 年该疗法失去专利保护之前，它曾是一个畅销药物，在其年度销售高峰时为强生带来了 25 亿美元的收入。</p>
</div><p>Akeega was first approved in the US for use in patients with BRCA-positive, metastatic castration-resistant prostate cancer (mCRPC) in 2023. This label expansion furthers J&amp;J’s reach in the prostate cancer space, which has become highly competitive following the approval of PARP inhibitors. These include Pharmaand’s Rubraca (rucaparib) and MSD and AstraZeneca’s Lynparza (olaparib) for mCRPC patients.</p>
<div class="lb-trans"><p>Akeega 于 2023 年首次在美国获得批准，用于 BRCA 阳性转移性去势抵抗性前列腺癌 (mCRPC) 患者。这次标签扩展进一步扩大了强生在前列腺癌领域的影响力，该领域在 PARP 抑制剂获得批准后变得竞争激烈。这些包括 Pharmaand 的 Rubraca（鲁卡帕利）和 MSD 与阿斯利康的 Lynparza（奥拉帕利）针对 mCRPC 患者。</p>
</div><p>Pfizer’s PARP inhibitor, Talzenna (talazoparib), also gained FDA approval for use alongside androgen receptor inhibitor Pfizer and Astellas’ Xtandi (enzalutamide) in this patient group.</p>
<div class="lb-trans"><p>辉瑞的 PARP 抑制剂 Talzenna（塔拉佐帕利）也获得了 FDA 批准 与雄激素受体抑制剂辉瑞和 Astellas 的 Xtandi（恩杂鲁胺）联合使用。</p>
</div><p>According to GlobalData’s Pharma Intelligence Center, Xtandi was the best-selling mCRPC drug of 2024, bringing in $5.9bn for Pfizer and Astellas.</p>
<div class="lb-trans"><p>根据 GlobalData 的制药智能中心，Xtandi 是 2024 年销售额最高的 mCRPC 药物，为辉瑞和 Astellas 带来了 59 亿美元的收入。</p>
</div><p>A patient-based forecast from GlobalData predicts that Akeega will reach peak sales of $676m in 2030 while profits associated with the drug will drop to $205m the following year.</p>
<div class="lb-trans"><p>GlobalData 的患者基础预测显示，Akeega 将在 2030 年达到 6.76 亿美元的峰值销售，而与该药物相关的利润将在次年降至 2.05 亿美元。</p>
</div><p>GlobalData is the parent company of <em>Pharmaceutical Technology</em>.</p>
<div class="lb-trans"><p>GlobalData 是《制药技术》的母公司。</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>Imagene’s Oncology Intelligence (OI) Suite has won the Innovation Award for Precision Oncology, for transforming how pharma designs and runs oncology trials. From AI-driven biomarker discovery to smarter patient stratification, see how Imagene is cutting time, cost and risk in cancer drug development.</p>
<div class="lb-trans"><p>Imagene 的 肿瘤智能 (OI) 套件 荣获精准肿瘤学创新奖，改变了制药公司设计和进行肿瘤试验的方式。从 AI 驱动的生物标志物发现到更智能的患者分层，了解 Imagene 如何在癌症药物开发中缩短时间、降低成本和风险。</p>
</div><p>Discover the Impact</p>
<div class="lb-trans"><p>发现影响</p>
</div>

强生公司获得了 Akeega 用于转移性去势敏感性前列腺癌（mCSPC）的标签扩展批准