<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 已滿足共同主要藥代動力學終點。來源：強生 / PRNewswire。</p>
<p>強生（J&amp;J）已獲得美國食品藥品監督管理局（FDA）對 Rybrevant Faspro（阿米萬單抗和透明質酸酶-lpuj）的批准，這是一種皮下（SC）給藥的療法，用於治療表皮生長因子受體（EGFR）突變的非小細胞肺癌（NSCLC）患者。</p>
<p>該批准涵蓋了 Rybrevant 的所有現有適應症。</p>
<h3>深入瞭解 GlobalData</h3>
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<p>報告</p>
<h4>LOA 和 PTSR 模型 - AMC-303 在鱗狀非小細胞肺癌中的應用</h4>
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<p>報告</p>
<h4>LOA 和 PTSR 模型 - COM-701 在非小細胞肺癌中的應用</h4>
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<p>與靜脈（IV）給藥相比，SC 製劑將給藥時間從數小時縮短至五分鐘，提高了患者的便利性，並減少了醫療資源的使用。</p>
<p>Rybrevant 的批准得到了 III 期 PALOMA-3 研究結果的支持，該研究表明該療法滿足了兩個共同主要藥代動力學終點。</p>
<p>這些發現最初在 2024 年美國臨牀腫瘤學會（ASCO）年會上提出，並發表在《臨牀腫瘤學雜誌》上。</p>
<p>進一步的 PALOMA-3 數據顯示，SC 組與 Lazcluze（拉澤替尼）聯合使用時，整體生存期（OS）更長，反應持續時間更長，且無進展生存期改善，相較於 IV 組，SC 組在 12 個月時有 65% 的患者存活，而 IV 組為 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 戰略情報</p>
<h1>美國關税正在變化 - 你會反應還是預測？</h1>
<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>
<p>來自 GlobalData</p>
<p>瞭解更多關於戰略情報</p>
<p>強生創新藥物實體腫瘤總裁 Biljana Naumovic 表示：“Rybrevant Faspro 的批准是向前邁出的重要一步，因為 EGFR+ NSCLC 患者之前面臨有限的治療選擇。</p>
<p>“現在，患者獲得了更大的機會接觸這種變革性治療，以及主動管理常見皮膚反應所需的工具。”</p>
<p>Rybrevant Faspro 與 Lazcluze 聯合使用的安全性特徵與 IV 給藥基本一致。</p>
<p>聯合用藥的常見不良反應（≥ 20%）包括肌肉骨骼疼痛、出血、食慾減退和周圍神經病。</p>
<p>上個月，強生與 Halda Therapeutics（Halda）簽署了一項最終協議，以 30.5 億美元的現金交易收購該公司。</p>
<h2>製藥技術卓越獎 - 提名已結束</h2>
<p>提名現已結束，感謝所有參與的組織 - 你們的響應非常出色，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>Upperton Pharma Solutions 因在 綜合製造 方面的業務擴展獲得 2025 年製藥技術卓越獎，Upperton 正在迅速擴展其在英國的 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轉向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>

強生

<p>強生（Johnson & Johnson，J&J）已獲得美國 FDA 對 Rybrevant Faspro 的批准，這是一種用於治療 EGFR 突變的非小細胞肺癌（NSCLC）患者的皮下給藥療法。該批准基於 III 期 PALOMA-3 研究，該研究顯示與靜脈給藥相比，整體生存率和無進展生存期有所改善。皮下製劑將給藥時間縮短至五分鐘，提高了患者的便利性。其安全性特徵與靜脈給藥一致。此項批准為 EGFR+ NSCLC 患者提供了更大的治療機會</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 已滿足共同主要藥代動力學終點。來源：強生 / 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>強生（J&amp;J）已獲得美國食品藥品監督管理局（FDA）對 Rybrevant Faspro（阿米萬單抗和透明質酸酶-lpuj）的批准，這是一種皮下（SC）給藥的療法，用於治療表皮生長因子受體（EGFR）突變的非小細胞肺癌（NSCLC）患者。</p>
</div><p>The approval covers all existing indications for Rybrevant.</p>
<div class="lb-trans"><p>該批准涵蓋了 Rybrevant 的所有現有適應症。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入瞭解 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>報告</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 在鱗狀非小細胞肺癌中的應用</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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</ul>
</div><p>Reports</p>
<div class="lb-trans"><p>報告</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 在非小細胞肺癌中的應用</h4>
</div><h5>Go deeper with GlobalData</h5>
<div class="lb-trans"><h5>深入瞭解 GlobalData</h5>
</div><p>The gold standard of business intelligence.</p>
<div class="lb-trans"><p>商業智能的黃金標準。</p>
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<div class="lb-trans"><h4>發現高效的 B2B 營銷</h4>
</div><p>Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.</p>
<div class="lb-trans"><p>結合商業智能和編輯卓越，覆蓋 36 個領先媒體平台的專業人士。</p>
</div><p>Find out more</p>
<div class="lb-trans"><p>瞭解更多</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>與靜脈（IV）給藥相比，SC 製劑將給藥時間從數小時縮短至五分鐘，提高了患者的便利性，並減少了醫療資源的使用。</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 研究結果的支持，該研究表明該療法滿足了兩個共同主要藥代動力學終點。</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>這些發現最初在 2024 年美國臨牀腫瘤學會（ASCO）年會上提出，並發表在《臨牀腫瘤學雜誌》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>進一步的 PALOMA-3 數據顯示，SC 組與 Lazcluze（拉澤替尼）聯合使用時，整體生存期（OS）更長，反應持續時間更長，且無進展生存期改善，相較於 IV 組，SC 組在 12 個月時有 65% 的患者存活，而 IV 組為 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 戰略情報</p>
</div><h1>US Tariffs are shifting - will you react or anticipate?</h1>
<div class="lb-trans"><h1>美國關税正在變化 - 你會反應還是預測？</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>
</div><p>By GlobalData</p>
<div class="lb-trans"><p>來自 GlobalData</p>
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<div class="lb-trans"><p>瞭解更多關於戰略情報</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>強生創新藥物實體腫瘤總裁 Biljana Naumovic 表示：“Rybrevant Faspro 的批准是向前邁出的重要一步，因為 EGFR+ NSCLC 患者之前面臨有限的治療選擇。</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>“現在，患者獲得了更大的機會接觸這種變革性治療，以及主動管理常見皮膚反應所需的工具。”</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 與 Lazcluze 聯合使用的安全性特徵與 IV 給藥基本一致。</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>聯合用藥的常見不良反應（≥ 20%）包括肌肉骨骼疼痛、出血、食慾減退和周圍神經病。</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>上個月，強生與 Halda Therapeutics（Halda）簽署了一項最終協議，以 30.5 億美元的現金交易收購該公司。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - Nominations Closed</h2>
<div class="lb-trans"><h2>製藥技術卓越獎 - 提名已結束</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>提名現已結束，感謝所有參與的組織 - 你們的響應非常出色，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>Upperton Pharma Solutions 因在 綜合製造 方面的業務擴展獲得 2025 年製藥技術卓越獎，Upperton 正在迅速擴展其在英國的 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轉向臨牀和小眾商業供應，減少交接和加快時間表。</p>
</div><p>Discover the Impact</p>
<div class="lb-trans"><p>發現影響</p>
</div>

強生公司獲得 FDA 批准其肺癌治療方案