<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/Boehringer11Dec25shutterstock_2381622677-3-430x241.jpg?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/uploads/sites/24/2025/12/Boehringer11Dec25shutterstock_2381622677-3-430x241.jpg"/></p>
<p>該療法為危及生命的肺部疾病提供了一種新的替代方案。圖片來源：pada smith stockphoto/Shutterstock.com。</p>
<p>中國國家藥品監督管理局（NMPA）已批准勃林格殷格翰的 Jascayd（nerandomilast）用於治療進行性肺纖維化（PPF）。</p>
<p>該批准標誌着五年來首個針對成人 PPF 的新治療方案，為患有這種危及生命的肺部疾病的人們提供了新的選擇。</p>
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<p>該療法是唯一獲得批准的優先磷酸二酯酶 4B（PDE4B）抑制劑，具有血管、免疫調節和抗纖維化特性。</p>
<p>該批准得到了關鍵的 III 期 FIBRONEER-ILD 試驗結果的支持，該試驗表明 nerandomilast 達到了其主要目標：在第 52 周與安慰劑相比，強制肺活量（FVC）[mL] 的絕對變化。</p>
<p>FVC 是評估肺功能的關鍵指標，試驗結果表明 nerandomilast 能夠減緩 PPF 患者的肺功能下降。</p>
<p>該療法還顯示出良好的安全性和耐受性，低停藥率消除了對肝臟監測的需求。</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>FIBRONEER-ILD 研究表明，該療法改善了生存率，顯著降低了死亡風險。</p>
<p>勃林格殷格翰人類製藥部門負責人及董事會主席 Shashank Deshpande 表示：“對於生活在 PPF 中的人們來説，首次將有機會獲得這種漸進性和危及生命的疾病的新治療選擇，這是一個重大的進展，在這個創新稀缺的領域中尤為重要。</p>
<p>“雖然在中國的首次批准代表了 PPF 社區的一個重要里程碑，但我們正在不懈努力，確保全球患者能夠儘快受益於 Jascayd。”</p>
<p>中國對 PPF 的批准是在其對特發性肺纖維化（IPF）批准幾周後做出的。</p>
<p>美國食品藥品監督管理局也已批准 nerandomilast 用於 IPF，並授予其優先審查和突破性療法狀態。</p>
<p>目前正在對該療法在成人 PPF 中的使用進行優先審查。</p>
<p>該療法在 PPF 和 IPF 的監管申請正在歐盟、日本、英國及其他國家審查，預計將在 2026 年獲得進一步批准。</p>
<p>在 2025 年 11 月，勃林格殷格翰與 CDR-Life 宣佈了一項全球許可協議，用於開發針對自身免疫疾病的抗體分子 CDR111。</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>Imagene 的 腫瘤智能（OI）套件 獲得了精準腫瘤學創新獎，改變了製藥公司設計和進行腫瘤試驗的方式。從 AI 驅動的生物標誌物發現到更智能的患者分層，看看 Imagene 如何在癌症藥物開發中縮短時間、降低成本和風險。</p>
<p>發現影響</p>

<p>中國國家藥品監督管理局已批准勃林格殷格翰的 Jascayd（nerandomilast）用於治療進行性肺纖維化（PPF）。這是五年來 PPF 的首個新治療方案。該批准基於成功的 III 期 FIBRONEER-ILD 試驗，結果顯示 nerandomilast 能夠減緩肺功能下降並改善生存率。這種療法是唯一獲批用於 PPF 的 PDE4B 抑制劑，具有良好的安全性和耐受性。美國、歐盟、日本及其他國家的監管申請也正在審查中</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/Boehringer11Dec25shutterstock_2381622677-3-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/Boehringer11Dec25shutterstock_2381622677-3-430x241.jpg"/></p>
<p>The therapy offers a new alternative for the life-threatening lung condition. Credit: pada smith stockphoto/Shutterstock.com.</p>
<div class="lb-trans"><p>該療法為危及生命的肺部疾病提供了一種新的替代方案。圖片來源：pada smith stockphoto/Shutterstock.com。</p>
</div><p>China’s National Medical Products Administration (NMPA) has granted approval for Boehringer Ingelheim’s Jascayd (nerandomilast) to treat progressive pulmonary fibrosis (PPF).</p>
<div class="lb-trans"><p>中國國家藥品監督管理局（NMPA）已批准勃林格殷格翰的 Jascayd（nerandomilast）用於治療進行性肺纖維化（PPF）。</p>
</div><p>The approval marks the first new treatment for the adult population with PPF in more than five years, offering a new alternative for those with this life-threatening lung condition.</p>
<div class="lb-trans"><p>該批准標誌着五年來首個針對成人 PPF 的新治療方案，為患有這種危及生命的肺部疾病的人們提供了新的選擇。</p>
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<div class="lb-trans"><h3>深入瞭解 GlobalData</h3>
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</div><h4>LOA and PTSR Model - CC-90001 in Head And Neck Cancer Squamous Cell...</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - CC-90001 在頭頸癌鱗狀細胞...</h4>
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<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>
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</div><p>The therapy is the sole preferential phosphodiesterase 4B (PDE4B) inhibitor with vascular, immunomodulatory and antifibrotic properties to be approved for this condition.</p>
<div class="lb-trans"><p>該療法是唯一獲得批准的優先磷酸二酯酶 4B（PDE4B）抑制劑，具有血管、免疫調節和抗纖維化特性。</p>
</div><p>The approval is supported by outcomes from the pivotal Phase III FIBRONEER-ILD trial, which demonstrated that nerandomilast met its main goal: the absolute change from baseline in forced vital capacity (FVC) [mL] at week 52 compared to placebo.</p>
<div class="lb-trans"><p>該批准得到了關鍵的 III 期 FIBRONEER-ILD 試驗結果的支持，該試驗表明 nerandomilast 達到了其主要目標：在第 52 周與安慰劑相比，強制肺活量（FVC）[mL] 的絕對變化。</p>
</div><p>FVC is a critical measure of the function of the lungs, and findings from the trial indicate that nerandomilast slows the lung function decline in patients with PPF.</p>
<div class="lb-trans"><p>FVC 是評估肺功能的關鍵指標，試驗結果表明 nerandomilast 能夠減緩 PPF 患者的肺功能下降。</p>
</div><p>The therapy also showed favourable safety and tolerability, with low rates of discontinuation eliminating the need for monitoring of the liver.</p>
<div class="lb-trans"><p>該療法還顯示出良好的安全性和耐受性，低停藥率消除了對肝臟監測的需求。</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>The FIBRONEER-ILD study showed that the therapy improved survival, with a significant decrease in mortality risk.</p>
<div class="lb-trans"><p>FIBRONEER-ILD 研究表明，該療法改善了生存率，顯著降低了死亡風險。</p>
</div><p>Boehringer Ingelheim human pharma head and managing directors’ board chairman Shashank Deshpande stated: “For the first time, people living with PPF will have access to a new treatment option for this progressive and life-threatening condition – a major advancement in a field where innovation has been scarce.</p>
<div class="lb-trans"><p>勃林格殷格翰人類製藥部門負責人及董事會主席 Shashank Deshpande 表示：“對於生活在 PPF 中的人們來説，首次將有機會獲得這種漸進性和危及生命的疾病的新治療選擇，這是一個重大的進展，在這個創新稀缺的領域中尤為重要。</p>
</div><p>“While this initial approval in China represents a pivotal milestone for the PPF community, we are working tirelessly to ensure patients around the world can benefit from Jascayd as quickly as possible.”</p>
<div class="lb-trans"><p>“雖然在中國的首次批准代表了 PPF 社區的一個重要里程碑，但我們正在不懈努力，確保全球患者能夠儘快受益於 Jascayd。”</p>
</div><p>The PPF approval in China comes weeks after its approval by the Chinese regulator for idiopathic pulmonary fibrosis (IPF).</p>
<div class="lb-trans"><p>中國對 PPF 的批准是在其對特發性肺纖維化（IPF）批准幾周後做出的。</p>
</div><p>The US Food and Drug Administration has also approved nerandomilast for IPF after granting it priority review and breakthrough therapy statuses.</p>
<div class="lb-trans"><p>美國食品藥品監督管理局也已批准 nerandomilast 用於 IPF，並授予其優先審查和突破性療法狀態。</p>
</div><p>It is currently conducting a priority review for the therapy’s use in adults with PPF.</p>
<div class="lb-trans"><p>目前正在對該療法在成人 PPF 中的使用進行優先審查。</p>
</div><p>Regulatory submissions for the therapy in PPF and IPF are being reviewed in the European Union, Japan, the UK and other nations, with further clearances expected in 2026.</p>
<div class="lb-trans"><p>該療法在 PPF 和 IPF 的監管申請正在歐盟、日本、英國及其他國家審查，預計將在 2026 年獲得進一步批准。</p>
</div><p>In November 2025, Boehringer and CDR-Life announced a global licensing agreement for the development of CDR111, an antibody-based molecule targeting autoimmune conditions.</p>
<div class="lb-trans"><p>在 2025 年 11 月，勃林格殷格翰與 CDR-Life 宣佈了一項全球許可協議，用於開發針對自身免疫疾病的抗體分子 CDR111。</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>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 腫瘤智能（OI）套件 獲得了精準腫瘤學創新獎，改變了製藥公司設計和進行腫瘤試驗的方式。從 AI 驅動的生物標誌物發現到更智能的患者分層，看看 Imagene 如何在癌症藥物開發中縮短時間、降低成本和風險。</p>
</div><p>Discover the Impact</p>
<div class="lb-trans"><p>發現影響</p>
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勃林格的 Jascayd 獲得中國國家藥品監督管理局對 PPF 的批准