<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/PT-19-12-2025-9361151-RYBREVANT-FASPRO-Manufacturing-Image1-430x241.jpeg?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/PT-19-12-2025-9361151-RYBREVANT-FASPRO-Manufacturing-Image1-430x241.jpeg"/></p>
<p>研究表明，Rybrevant Faspro 已满足共同主要药代动力学终点。来源：强生 / PRNewswire。</p>
<p>强生（J&amp;J）已获得美国食品药品监督管理局（FDA）对 Rybrevant Faspro（阿米万单抗和透明质酸酶-lpuj）的批准，这是一种皮下（SC）给药的疗法，用于治疗表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者。</p>
<p>该批准涵盖了 Rybrevant 的所有现有适应症。</p>
<h3>深入了解 GlobalData</h3>
<ul>
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<p>报告</p>
<h4>LOA 和 PTSR 模型 - AMC-303 在鳞状非小细胞肺癌中的应用</h4>
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<p>报告</p>
<h4>LOA 和 PTSR 模型 - COM-701 在非小细胞肺癌中的应用</h4>
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<p>与静脉（IV）给药相比，SC 制剂将给药时间从数小时缩短至五分钟，提高了患者的便利性，并减少了医疗资源的使用。</p>
<p>Rybrevant 的批准得到了 III 期 PALOMA-3 研究结果的支持，该研究表明该疗法满足了两个共同主要药代动力学终点。</p>
<p>这些发现最初在 2024 年美国临床肿瘤学会（ASCO）年会上提出，并发表在《临床肿瘤学杂志》上。</p>
<p>进一步的 PALOMA-3 数据显示，SC 组与 Lazcluze（拉泽替尼）联合使用时，整体生存期（OS）更长，反应持续时间更长，且无进展生存期改善，相较于 IV 组，SC 组在 12 个月时有 65% 的患者存活，而 IV 组为 51%。</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>
<p>强生创新药物实体肿瘤总裁 Biljana Naumovic 表示：“Rybrevant Faspro 的批准是向前迈出的重要一步，因为 EGFR+ NSCLC 患者之前面临有限的治疗选择。</p>
<p>“现在，患者获得了更大的机会接触这种变革性治疗，以及主动管理常见皮肤反应所需的工具。”</p>
<p>Rybrevant Faspro 与 Lazcluze 联合使用的安全性特征与 IV 给药基本一致。</p>
<p>联合用药的常见不良反应（≥ 20%）包括肌肉骨骼疼痛、出血、食欲减退和周围神经病。</p>
<p>上个月，强生与 Halda Therapeutics（Halda）签署了一项最终协议，以 30.5 亿美元的现金交易收购该公司。</p>
<h2>制药技术卓越奖 - 提名已结束</h2>
<p>提名现已结束，感谢所有参与的组织 - 你们的响应非常出色，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>Upperton Pharma Solutions 因在 综合制造 方面的业务扩展获得 2025 年制药技术卓越奖，Upperton 正在迅速扩展其在英国的 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转向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>

强生

<p>强生（Johnson & Johnson，J&J）已获得美国 FDA 对 Rybrevant Faspro 的批准，这是一种用于治疗 EGFR 突变的非小细胞肺癌（NSCLC）患者的皮下给药疗法。该批准基于 III 期 PALOMA-3 研究，该研究显示与静脉给药相比，整体生存率和无进展生存期有所改善。皮下制剂将给药时间缩短至五分钟，提高了患者的便利性。其安全性特征与静脉给药一致。此项批准为 EGFR+ NSCLC 患者提供了更大的治疗机会</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/PT-19-12-2025-9361151-RYBREVANT-FASPRO-Manufacturing-Image1-430x241.jpeg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/PT-19-12-2025-9361151-RYBREVANT-FASPRO-Manufacturing-Image1-430x241.jpeg"/></p>
<p>The study demonstrated that Rybrevant Faspro has met co-primary pharmacokinetic endpoints. Credit: Johnson &amp; Johnson / PRNewswire.</p>
<div class="lb-trans"><p>研究表明，Rybrevant Faspro 已满足共同主要药代动力学终点。来源：强生 / PRNewswire。</p>
</div><p>Johnson &amp; Johnson (J&amp;J) has received the US Food and Drug Administration (FDA) approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), a subcutaneously (SC) administered therapy to treat patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).</p>
<div class="lb-trans"><p>强生（J&amp;J）已获得美国食品药品监督管理局（FDA）对 Rybrevant Faspro（阿米万单抗和透明质酸酶-lpuj）的批准，这是一种皮下（SC）给药的疗法，用于治疗表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者。</p>
</div><p>The approval covers all existing indications for Rybrevant.</p>
<div class="lb-trans"><p>该批准涵盖了 Rybrevant 的所有现有适应症。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入了解 GlobalData</h3>
</div><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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</ul>
</div><p>Reports</p>
<div class="lb-trans"><p>报告</p>
</div><h4>LOA and PTSR Model - AMC-303 in Squamous Non-Small Cell Lung Carcinoma</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - AMC-303 在鳞状非小细胞肺癌中的应用</h4>
</div><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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</div><p>Reports</p>
<div class="lb-trans"><p>报告</p>
</div><h4>LOA and PTSR Model - COM-701 in Non-Small Cell Lung Cancer</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - COM-701 在非小细胞肺癌中的应用</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>
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<div class="lb-trans"><h4>发现高效的 B2B 营销</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>
</div><p>Find out more</p>
<div class="lb-trans"><p>了解更多</p>
</div><p>The SC formulation reduces administration time from several hours to five minutes, compared to intravenous (IV) delivery, offering increased patient convenience and decreasing healthcare resource use.</p>
<div class="lb-trans"><p>与静脉（IV）给药相比，SC 制剂将给药时间从数小时缩短至五分钟，提高了患者的便利性，并减少了医疗资源的使用。</p>
</div><p>Rybrevant’s approval is supported by results from the Phase III PALOMA-3 study, which demonstrated that the therapy met both co-primary pharmacokinetic endpoints.</p>
<div class="lb-trans"><p>Rybrevant 的批准得到了 III 期 PALOMA-3 研究结果的支持，该研究表明该疗法满足了两个共同主要药代动力学终点。</p>
</div><p>These findings were initially presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology.</p>
<div class="lb-trans"><p>这些发现最初在 2024 年美国临床肿瘤学会（ASCO）年会上提出，并发表在《临床肿瘤学杂志》上。</p>
</div><p>Further PALOMA-3 data showed that the SC arm, in combination with Lazcluze (lazertinib), had longer overall survival (OS), longer duration of response, and improved progression-free survival compared to the IV arm. At 12 months, 65% of patients in the SC group were alive, against 51% in the IV group.</p>
<div class="lb-trans"><p>进一步的 PALOMA-3 数据显示，SC 组与 Lazcluze（拉泽替尼）联合使用时，整体生存期（OS）更长，反应持续时间更长，且无进展生存期改善，相较于 IV 组，SC 组在 12 个月时有 65% 的患者存活，而 IV 组为 51%。</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>
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<div class="lb-trans"><p>了解更多关于战略情报</p>
</div><p>J&amp;J’s innovative medicine solid tumour president Biljana Naumovic said: “The approval of Rybrevant Faspro is a pivotal step forward, as EGFR+ NSCLC patients have previously faced limited treatment options.</p>
<div class="lb-trans"><p>强生创新药物实体肿瘤总裁 Biljana Naumovic 表示：“Rybrevant Faspro 的批准是向前迈出的重要一步，因为 EGFR+ NSCLC 患者之前面临有限的治疗选择。</p>
</div><p>“Now, patients are gaining greater access to this transformative treatment, as well as the tools needed to proactively manage common dermatological effects.”</p>
<div class="lb-trans"><p>“现在，患者获得了更大的机会接触这种变革性治疗，以及主动管理常见皮肤反应所需的工具。”</p>
</div><p>The safety profile of Rybrevant Faspro in combination with Lazcluze was found to be largely consistent with IV administration.</p>
<div class="lb-trans"><p>Rybrevant Faspro 与 Lazcluze 联合使用的安全性特征与 IV 给药基本一致。</p>
</div><p>Common adverse reactions (≥ 20%) of the combination included musculoskeletal pain, haemorrhage, decreased appetite, and peripheral neuropathy.</p>
<div class="lb-trans"><p>联合用药的常见不良反应（≥ 20%）包括肌肉骨骼疼痛、出血、食欲减退和周围神经病。</p>
</div><p>Last month, J&amp;J signed a definitive agreement to acquire Halda Therapeutics (Halda) in a $3.05bn cash deal.</p>
<div class="lb-trans"><p>上个月，强生与 Halda Therapeutics（Halda）签署了一项最终协议，以 30.5 亿美元的现金交易收购该公司。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - Nominations Closed</h2>
<div class="lb-trans"><h2>制药技术卓越奖 - 提名已结束</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>提名现已结束，感谢所有参与的组织 - 你们的响应非常出色，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>Upperton Pharma Solutions 因在 综合制造 方面的业务扩展获得 2025 年制药技术卓越奖，Upperton 正在迅速扩展其在英国的 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转向临床和小众商业供应，减少交接和加快时间表。</p>
</div><p>Discover the Impact</p>
<div class="lb-trans"><p>发现影响</p>
</div>

强生公司获得 FDA 批准其肺癌治疗方案