<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>该疗法为危及生命的肺部疾病提供了一种新的替代方案。图片来源：pada smith stockphoto/Shutterstock.com。</p>
<p>中国国家药品监督管理局（NMPA）已批准勃林格殷格翰的 Jascayd（nerandomilast）用于治疗进行性肺纤维化（PPF）。</p>
<p>该批准标志着五年来首个针对成人 PPF 的新治疗方案，为患有这种危及生命的肺部疾病的人们提供了新的选择。</p>
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<p>该疗法是唯一获得批准的优先磷酸二酯酶 4B（PDE4B）抑制剂，具有血管、免疫调节和抗纤维化特性。</p>
<p>该批准得到了关键的 III 期 FIBRONEER-ILD 试验结果的支持，该试验表明 nerandomilast 达到了其主要目标：在第 52 周与安慰剂相比，强制肺活量（FVC）[mL] 的绝对变化。</p>
<p>FVC 是评估肺功能的关键指标，试验结果表明 nerandomilast 能够减缓 PPF 患者的肺功能下降。</p>
<p>该疗法还显示出良好的安全性和耐受性，低停药率消除了对肝脏监测的需求。</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>
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<h1>美国关税正在变化 - 你会反应还是预见？</h1>
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<p>FIBRONEER-ILD 研究表明，该疗法改善了生存率，显著降低了死亡风险。</p>
<p>勃林格殷格翰人类制药部门负责人及董事会主席 Shashank Deshpande 表示：“对于生活在 PPF 中的人们来说，首次将有机会获得这种渐进性和危及生命的疾病的新治疗选择，这是一个重大的进展，在这个创新稀缺的领域中尤为重要。</p>
<p>“虽然在中国的首次批准代表了 PPF 社区的一个重要里程碑，但我们正在不懈努力，确保全球患者能够尽快受益于 Jascayd。”</p>
<p>中国对 PPF 的批准是在其对特发性肺纤维化（IPF）批准几周后做出的。</p>
<p>美国食品药品监督管理局也已批准 nerandomilast 用于 IPF，并授予其优先审查和突破性疗法状态。</p>
<p>目前正在对该疗法在成人 PPF 中的使用进行优先审查。</p>
<p>该疗法在 PPF 和 IPF 的监管申请正在欧盟、日本、英国及其他国家审查，预计将在 2026 年获得进一步批准。</p>
<p>在 2025 年 11 月，勃林格殷格翰与 CDR-Life 宣布了一项全球许可协议，用于开发针对自身免疫疾病的抗体分子 CDR111。</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 获得了精准肿瘤学创新奖，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，看看 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>

<p>中国国家药品监督管理局已批准勃林格殷格翰的 Jascayd（nerandomilast）用于治疗进行性肺纤维化（PPF）。这是五年来 PPF 的首个新治疗方案。该批准基于成功的 III 期 FIBRONEER-ILD 试验，结果显示 nerandomilast 能够减缓肺功能下降并改善生存率。这种疗法是唯一获批用于 PPF 的 PDE4B 抑制剂，具有良好的安全性和耐受性。美国、欧盟、日本及其他国家的监管申请也正在审查中</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>该疗法为危及生命的肺部疾病提供了一种新的替代方案。图片来源：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>中国国家药品监督管理局（NMPA）已批准勃林格殷格翰的 Jascayd（nerandomilast）用于治疗进行性肺纤维化（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>该批准标志着五年来首个针对成人 PPF 的新治疗方案，为患有这种危及生命的肺部疾病的人们提供了新的选择。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入了解 GlobalData</h3>
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</div><h4>LOA and PTSR Model - Zilurgisertib Fumarate in Fibrodysplasia Ossif...</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Zilurgisertib Fumarate 在纤维发育不良中的应用...</h4>
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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 在头颈癌鳞状细胞...</h4>
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<div class="lb-trans"><p>商业智能的黄金标准。</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>该疗法是唯一获得批准的优先磷酸二酯酶 4B（PDE4B）抑制剂，具有血管、免疫调节和抗纤维化特性。</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>该批准得到了关键的 III 期 FIBRONEER-ILD 试验结果的支持，该试验表明 nerandomilast 达到了其主要目标：在第 52 周与安慰剂相比，强制肺活量（FVC）[mL] 的绝对变化。</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 是评估肺功能的关键指标，试验结果表明 nerandomilast 能够减缓 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>该疗法还显示出良好的安全性和耐受性，低停药率消除了对肝脏监测的需求。</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 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 - 你会反应还是预见？</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>
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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，该疗法改善了生存率，显著降低了死亡风险。</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>勃林格殷格翰人类制药部门负责人及董事会主席 Shashank Deshpande 表示：“对于生活在 PPF 中的人们来说，首次将有机会获得这种渐进性和危及生命的疾病的新治疗选择，这是一个重大的进展，在这个创新稀缺的领域中尤为重要。</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>“虽然在中国的首次批准代表了 PPF 社区的一个重要里程碑，但我们正在不懈努力，确保全球患者能够尽快受益于 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>中国对 PPF 的批准是在其对特发性肺纤维化（IPF）批准几周后做出的。</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>美国食品药品监督管理局也已批准 nerandomilast 用于 IPF，并授予其优先审查和突破性疗法状态。</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>目前正在对该疗法在成人 PPF 中的使用进行优先审查。</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>该疗法在 PPF 和 IPF 的监管申请正在欧盟、日本、英国及其他国家审查，预计将在 2026 年获得进一步批准。</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，勃林格殷格翰与 CDR-Life 宣布了一项全球许可协议，用于开发针对自身免疫疾病的抗体分子 CDR111。</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 获得了精准肿瘤学创新奖，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，看看 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>

勃林格的 Jascayd 获得中国国家药品监督管理局对 PPF 的批准