<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2514407931-430x241.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_2514407931-430x241.jpg"/></p>
<p>Brelovitug 通过与表面抗原结合来中和乙型肝炎和丁型肝炎病毒。图片来源：Vink Fan via Shutterstock.com。</p>
<p>Mirum Pharmaceuticals 已同意以高达 8.2 亿美元的交易收购 Bluejay Therapeutics，为其投资组合增加一项 III 期肝病候选药物。</p>
<p>根据协议，总部位于美国的 Mirum 将支付 2.5 亿美元现金和 3.7 亿美元的自有股票作为收购这家私人生物技术公司的预付款。Bluejay 还将有机会获得额外的 2 亿美元基于销售的里程碑付款。</p>
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<p>该交易使 Mirum 获得了 brelovitug，Bluejay 的单克隆抗体（mAb），目前正在进行 III 期试验，针对慢性丁型肝炎，这是一种罕见且严重的肝脏感染，目前没有美国食品和药物管理局（FDA）批准的治疗方案。吉利德的 Hepcludex（bulevirtide）已在欧盟获得批准作为丁型肝炎的治疗。</p>
<p>慢性丁型肝炎仅发生在已经感染乙型肝炎的人群中，因为病毒复制所需的表面蛋白，慢性丁型肝炎被认为是最严重的慢性病毒性肝炎类型，导致肝硬化、肝衰竭和肝癌。</p>
<p>Brelovitug 通过与表面抗原结合来中和丁型肝炎和乙型肝炎病毒，清除含有乙型肝炎表面抗原（HBsAg）的颗粒，并激活特异性抗原的 T 细胞。</p>
<p>2025 年 11 月，Bluejay 报告了在慢性丁型肝炎患者中评估 brelovitug 的 II 期研究的积极数据。该药物实现了 100% 的病毒学反应，并对肝脏炎症和病毒载量减少产生了有益效果。</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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<p>正在进行的全球 AZURE III 期项目目前正在招募患者，预计在 2026 年下半年公布初步数据。Mirum 预计将在 2027 年向 FDA 提交申请，并在同年推出。</p>
<p>Mirum 表示，它还通过与新老医疗投资者的私募融资获得了 2 亿美元，以帮助资助该药物的开发和商业化。</p>
<p>Mirum 的商业产品组合包括用于阿拉吉尔综合症引起的慢性瘙痒的 Livmarli（maralixibat）、用于胆汁酸合成障碍的 Cholbam（胆酸）和用于脂质储存病脑腱黄瘤病的 Ctexli（chenodiol）。</p>
<p>后两种产品是 Mirum 通过收购 Travere 的胆汁酸产品组合获得的，交易金额高达 4.45 亿美元（2023 年）。</p>
<p>Mirum 的首席执行官 Chris Peetz 表示：“这项收购与我们最擅长的领域完全契合——通过严格的开发、监管创新和商业卓越，推动针对罕见疾病患者的高影响力药物。”</p>
<p>Mirum 的管线包括肠道胆盐转运蛋白抑制剂 volixibat，该药物正在进行两项 IIb 期研究（NCT05050136，NCT04663308），用于两种类型的胆管炎。该公司还有 MRM-3379，一种在 II 期试验（NCT07209462）中用于治疗脆性 X 综合症的 PDE4D 抑制剂。</p>
<p>Peetz 补充道：“在丁型肝炎中使用 brelovitug 利用了我们在罕见肝病方面的深厚专业知识，并建立了我们通过 volixibat 和 Livmarli 项目与关键提供者建立的关系。”</p>
<h2>制药技术卓越奖 - 提名已关闭</h2>
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<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开展肿瘤试验的方式。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>

MIRM

<p>Mirum Pharmaceuticals 将以高达 8.2 亿美元收购 Bluejay Therapeutics，获得 Bluejay 针对慢性乙型肝炎的 III 期单克隆抗体 brelovitug 的使用权。该交易包括 2.5 亿美元现金、3.7 亿美元股票和 2 亿美元的销售里程碑。Mirum 计划在 2027 年提交 FDA 申请，利用其在罕见肝病方面的专业知识。这项收购与 Mirum 推进罕见疾病药物的战略相一致</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2514407931-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2514407931-430x241.jpg"/></p>
<p>Brelovitug neutralises hepatitis D and hepatitis B viruses by binding to surface antigens. Credit: Vink Fan via Shutterstock.com.</p>
<div class="lb-trans"><p>Brelovitug 通过与表面抗原结合来中和乙型肝炎和丁型肝炎病毒。图片来源：Vink Fan via Shutterstock.com。</p>
</div><p>Mirum Pharmaceuticals has agreed to acquire Bluejay Therapeutics in a deal worth up to $820m, adding a Phase III liver disease candidate to its portfolio.</p>
<div class="lb-trans"><p>Mirum Pharmaceuticals 已同意以高达 8.2 亿美元的交易收购 Bluejay Therapeutics，为其投资组合增加一项 III 期肝病候选药物。</p>
</div><p>According to the agreement, US-based Mirum will pay $250m in cash and $370m in its own stock upfront to buy the private biotech. Bluejay is also in line to receive a further $200m in potential sales-based milestones.</p>
<div class="lb-trans"><p>根据协议，总部位于美国的 Mirum 将支付 2.5 亿美元现金和 3.7 亿美元的自有股票作为收购这家私人生物技术公司的预付款。Bluejay 还将有机会获得额外的 2 亿美元基于销售的里程碑付款。</p>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Bexmarilimab 在急性髓性白血病（AML...</h4>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Bexmarilimab 在骨髓增生异常综合症中</h4>
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</div><p>The deal gives Mirum access to brelovitug, Bluejay’s monoclonal antibody (mAb) currently being evaluated in a Phase III trial for chronic hepatitis D, a rare and severe liver infection for which there are no US Food and Drug Administration (FDA)-approved therapies. Gilead’s Hepcludex (bulevirtide) is approved as a hepatitis D treatment in the EU.</p>
<div class="lb-trans"><p>该交易使 Mirum 获得了 brelovitug，Bluejay 的单克隆抗体（mAb），目前正在进行 III 期试验，针对慢性丁型肝炎，这是一种罕见且严重的肝脏感染，目前没有美国食品和药物管理局（FDA）批准的治疗方案。吉利德的 Hepcludex（bulevirtide）已在欧盟获得批准作为丁型肝炎的治疗。</p>
</div><p>Only occuring in people already infected with hepatitis B due to the surface proteins needed for viral replication, chronic hepatitis D is considered the most severe type of chronic viral hepatitis and leads to cirrhosis, liver failure, and liver cancer.</p>
<div class="lb-trans"><p>慢性丁型肝炎仅发生在已经感染乙型肝炎的人群中，因为病毒复制所需的表面蛋白，慢性丁型肝炎被认为是最严重的慢性病毒性肝炎类型，导致肝硬化、肝衰竭和肝癌。</p>
</div><p>Brelovitug neutralises hepatitis D and hepatitis B virusus by binding to surface antigens, clearing hepatitis B Surface Antigen (HBsAg)-containing particles and activating antigen-specific T cells.</p>
<div class="lb-trans"><p>Brelovitug 通过与表面抗原结合来中和丁型肝炎和乙型肝炎病毒，清除含有乙型肝炎表面抗原（HBsAg）的颗粒，并激活特异性抗原的 T 细胞。</p>
</div><p>In November 2025, Bluejay reported positive data from a Phase II study evaluating brelovitug in patients with chronic hepatitis D. The drug achieved a 100% virologic response, along with beneficial effects on liver inflammation and viral load reduction.</p>
<div class="lb-trans"><p>2025 年 11 月，Bluejay 报告了在慢性丁型肝炎患者中评估 brelovitug 的 II 期研究的积极数据。该药物实现了 100% 的病毒学反应，并对肝脏炎症和病毒载量减少产生了有益效果。</p>
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<p>GlobalData Strategic Intelligence</p>
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</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 ongoing global AZURE Phase III programme is currently enrolling patients, with top-line data expected in H2 2026. Mirum anticipates submitting an application to the FDA in 2027, with a launch occurring in the same year.</p>
<div class="lb-trans"><p>正在进行的全球 AZURE III 期项目目前正在招募患者，预计在 2026 年下半年公布初步数据。Mirum 预计将在 2027 年向 FDA 提交申请，并在同年推出。</p>
</div><p>Mirum said it has also secured $200m through a private placement with new and existing healthcare investors to help fund the drug’s development and commercialisation.</p>
<div class="lb-trans"><p>Mirum 表示，它还通过与新老医疗投资者的私募融资获得了 2 亿美元，以帮助资助该药物的开发和商业化。</p>
</div><p>Mirum’s commercial portfolio includes Livmarli (maralixibat) for chronic itching due to Alagille syndrome, Cholbam (cholic acid) for bile acid synthesis disorders, and Ctexli (chenodiol) for lipid storage disease cerebrotendinous xanthomatosis.</p>
<div class="lb-trans"><p>Mirum 的商业产品组合包括用于阿拉吉尔综合症引起的慢性瘙痒的 Livmarli（maralixibat）、用于胆汁酸合成障碍的 Cholbam（胆酸）和用于脂质储存病脑腱黄瘤病的 Ctexli（chenodiol）。</p>
</div><p>The latter two products were acquired by Mirum in a buyout of Travere’s bile acid product portfolio for up to $445m in 2023.</p>
<div class="lb-trans"><p>后两种产品是 Mirum 通过收购 Travere 的胆汁酸产品组合获得的，交易金额高达 4.45 亿美元（2023 年）。</p>
</div><p>Mirum’s CEO Chris Peetz said: “This acquisition fits squarely with what we do best – advancing high-impact medicines for patients with rare diseases through disciplined development, regulatory innovation, and commercial excellence.”</p>
<div class="lb-trans"><p>Mirum 的首席执行官 Chris Peetz 表示：“这项收购与我们最擅长的领域完全契合——通过严格的开发、监管创新和商业卓越，推动针对罕见疾病患者的高影响力药物。”</p>
</div><p>Mirum’s pipeline includes ileal bile acid transporter inhibitor volixibat, which is in two Phase IIb studies (NCT05050136, NCT04663308) for two types of cholangitis. The company also has MRM-3379, a PDE4D inhibitor in a Phase II trial (NCT07209462) for the treatment of fragile X syndrome.</p>
<div class="lb-trans"><p>Mirum 的管线包括肠道胆盐转运蛋白抑制剂 volixibat，该药物正在进行两项 IIb 期研究（NCT05050136，NCT04663308），用于两种类型的胆管炎。该公司还有 MRM-3379，一种在 II 期试验（NCT07209462）中用于治疗脆性 X 综合症的 PDE4D 抑制剂。</p>
</div><p>Peetz added: “Brelovitug in hepatitis D leverages our deep expertise in rare liver disease and builds on the relationships we’ve established with key providers through the volixibat and Livmarli programmes.”</p>
<div class="lb-trans"><p>Peetz 补充道：“在丁型肝炎中使用 brelovitug 利用了我们在罕见肝病方面的深厚专业知识，并建立了我们通过 volixibat 和 Livmarli 项目与关键提供者建立的关系。”</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>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开展肿瘤试验的方式。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>

Mirum 计划以最高 8.2 亿美元收购 Bluejay，以推动其在罕见肝病领域的进展