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合作机会来了！ 药时代BD团队现有优质项目：具有三重作用的口服小分子 11β-HSD1抑制剂，适应症覆盖MASH,IPF，间质性肺病（PF-ILD），放射性肺纤维化（RIPF）等领域。MASH适应症IIa期已完成，观察到强有力的疗效信号及良好的安全性；IPF适应症处于IND ready阶段。 请感兴趣的公司立即联系：药时代BD团队 BD@drugtimes.cn 备注项目代号：DT-20260325-122 正文共：2646字    预计阅读时间：8分钟 随着人口老龄化进程加快，亚健康人群也呈现出明显的年轻化趋势，大健康市场已成为消费领域中增长最为迅猛的板块之一。替尔泊肽的成功恰恰印证了一个趋势：一款药物若能同时承载严肃医学价值与消费级需求，其市场空间将迎来百倍级的放大。 然而，尽管2025年全球“药王”榜单的前两位仍被GLP-1类药物包揽，但随着市场竞争日趋激烈、支付方压力不断上升，这类药物的“黄金时代”正渐入尾声。 在此背景下，礼来在凭借GLP-1类药物夯实减重赛道优势之后，战略路径愈发清晰：向“消费属性医疗”纵深布局。睡眠障碍，正是其瞄准的下一个爆点。 一场78亿的押注 2026年3月31日，礼来与Centessa Pharmaceuticals共同宣布一项收购协议：礼来将斥资最高78亿美元收购Centessa，以获得其潜在 Best-in-Class的食欲素受体2（OX2R）激动剂管线。这是礼来自2019年以80亿美元收购Loxo Oncology以来的最大规模并购。目前，两家公司的董事会均已批准该交易，预计将于2026年第三季度正式完成。 根据双方签署的交易协议，交易结构主要分为两部分： 高额现金首付：礼来将以每股38.00美元的现金价格收购Centessa的所有发行股份，首付款总计约合63亿美元。这一报价较Centessa过去30天的成交量加权平均交易价格溢价约40.5%（较上周一收盘价溢价更高），显示出礼来对其管线价值的高度认可。 或有价值权（CVR）：除了前期现金，Centessa股东还将获得一项不可转让的或有价值权。若Centessa的候选药物（包括cleminorexton和ORX142）在未来几年内达成多项FDA获批的里程碑事件，股东还将额外获得每股最高9.00美元的收益，这部分潜在价值约15亿美元。 为何Centessa值78亿美元？ 礼来首席执行官戴文睿（Dave Ricks）曾直言，睡眠与保持清醒是人类身体功能的核心，其市场潜力可能与GLP-1相当。随着替尔泊肽在减重与睡眠呼吸暂停领域取得的成功，礼来已初步尝到“消费级医疗”的甜头。而睡眠障碍药物，正是另一个具备广泛患者基础、高度未满足需求的消费级赛道。 嗜睡症并非简单的“爱睡觉”或“睡眠不足”，它是由产生食欲素的神经元被选择性破坏而引起的。患者会在毫无预兆的情况下突然入睡，无论是在开会、开车还是吃饭时；有时会因肌肉张力瞬间丧失而导致猝倒。若长期不加控制，病情可显著影响记忆、注意力和认知功能，严重降低生活质量。 Centessa正在推进以食欲素受体2（OX2R）激动剂为核心的研发管线，主要用于治疗日间过度嗜睡及其他觉醒受损相关疾病。 食欲素（Orexin）系统在调节人体的睡眠-觉醒周期中扮演着至关重要的角色。如果把食欲素比作大脑的“觉醒信号”，那么当这一信号缺失时，患者便会陷入无法控制的嗜睡与猝倒之中。 传统的兴奋剂（如莫达非尼）仅能非特异性地刺激多巴胺或去甲肾上腺素系统，相当于强行“提神”，不仅副作用较大，且无法改善猝倒症状。而OX2R激动剂则通过直接模拟内源性食欲素，精准结合并激活OX2R受体，从源头上重建睡眠-觉醒的稳态。相较于传统药物，其耐受性更佳，且无成瘾性及“次日宿醉”等副作用。因此，OX2R激动剂被视为治疗发作性睡病及其他严重嗜睡症的新一代疗法，极具潜力。 Centessa的核心管线cleminorexton（曾用名ORX750）是一款口服OX2R激动剂，目前正在针对1型发作性睡病（NT1）、2型发作性睡病（NT2）及特发性嗜睡症（IH）开展II期临床试验。 Centessa公布cleminorexton在健康受试者中进行的1期临床试验结果显示：口服5毫克cleminorexton的受试者平均入睡潜伏期达37.9分钟，而安慰剂组受试者的入睡时间平均延迟15.3分钟，这一治疗差异具有统计学意义；此外，服用cleminorexton的受试者在白天表现出更高警觉性，效果持续至少3小时，表明其治疗发作性睡病及其他睡眠障碍的潜力。 华尔街分析师指出，Ccleminorexton具备每日一次给药的便利性与更优的耐受性，展现出极强的“同类最佳”潜力。若能顺利推进并于2028年获批，该药物到2034年的销售峰值有望达到23亿美元。对礼来而言，这不仅意味着有望收回78亿美元的投资，更是其在未来“生活方式医疗”时代的又一张王牌。 除了核心药物，Centessa还拥有一系列临床前资产，有望将OX2R激动剂的应用扩展至更广泛的神经退行性疾病和神经精神疾病领域。据奥本海默分析师测算，仅发作性睡病和特发性嗜睡症这两个适应症，若仅有四分之一患者寻求治疗，其市场规模就可达150亿至200亿美元。如果药物能拓展至阿尔茨海默病、抑郁症等伴随嗜睡症状的更广泛神经系统疾病，其天花板将不可估量。 当代谢疾病遇上睡眠障碍？ 从礼来的发展战略来看，自研与并购并重、借助外部创新注入新鲜血液，对于大型制药企业维持并提升长期竞争力具有不可或缺的意义。礼来此次进军睡眠市场，不仅是补强神经科学管线，更是践行“消费属性医疗”的战略：即寻找那些兼具医学刚需与消费场景、且具备高支付意愿的疾病干预领域。 睡眠，正是这样一个精准的切入点：它并非传统意义上的致命疾病，却是现代人愿意为之投入重金的生活痛点。而OX2R激动剂，凭借其安全性与便捷性，有望继GLP-1之后，成为下一个从“严肃治疗”走向“消费健康”的重磅品类。 更何况，睡眠与代谢肥胖之间本身就存在着深刻的生物学关联。肥胖可导致夜间睡眠呼吸暂停、缺氧与睡眠碎片化，进而引发日间嗜睡；而嗜睡又进一步减少活动、诱发食欲亢进与代谢紊乱，推动体重增加，形成恶性循环。 这正是礼来此次布局的精妙之处。作为代谢领域的领军企业，礼来已手握GLP-1类减重药物这一核心资产，如今再布局睡眠赛道，实则打通了两个相互强化、互为因果的消费场景。未来，替尔泊肽控制食欲，OX2R激动剂优化睡眠节律，二者有望构建起一个完整的“代谢-睡眠”干预闭环。这一组合不仅具备协同增效的临床潜力，更有望实现“1+1>2”的商业价值，从而在消费者端形成更强的用户黏性。 蓝海卡位战 当然，礼来并非唯一嗅到这一蓝海机遇的玩家。其中最具分量的当属日本制药巨头武田，以及刚刚完成重金招揽、阵容齐整的Alkermes。 武田凭借其全球首创的选择性OX2R激动剂 Oveporexton（TAK-861），已在赛道上暂时领先。武田计划尽快提交上市申请，并预测Oveporexton未来的年销售峰值可达20亿至30亿美元，成为该领域的重磅炸弹级产品。 Alkermes则与礼来一样，重金收购睡眠疗法公司。2025年10月22日，Alkermes宣布以21亿美元收购Avadel。此次收购的核心目标，正是Avadel旗下已上市的嗜睡症治疗药物：LUMRYZ™（羟丁酸钠口服混悬液）。LUMRYZ™是首个也是目前唯一获批用于发作性嗜睡症的每日一次口服药物，被批准用于治疗7岁或以上发作性睡症患者的猝倒或白天过度嗜睡。与此同时，Alkermes自主研发的OX2R激动剂alixorexton（ALKS 2680）已在一项Vibrance-1的II期临床试验中取得积极结果。两款药物还存在潜在的协同空间，有望成为组合疗法，共同治疗嗜睡症。这种“已上市产品+在研管线”的双轮驱动，使其在短期内具备较强的市场抗风险能力。 礼来能否在2030年前后实现“后来居上”，成为睡眠健康赛道的主导者，再现药王神话？答案尚需等待，等待临床数据的顺利读出，等待上市进程的如期推进。 插播一个广告 目前，睡眠赛道正不断涌动着创新活力。一家专注于中枢神经系统一类新药研发，管线中推进最快的是一款OX2R拮抗剂，已完成针对失眠症的临床I期，结果优异，即将进入临床II期。也已完成了治疗抑郁症的概念验证（POC），即将启动探索性临床研究（IIT）和IND申报。 药时代协助寻找优质的合作伙伴，合作模式包括：license（许可）、co-development（联合开发）、M&A（兼并购）。 参考资料： 1.https://investors.centessa.com/news-releases/news-release-details/lilly-acquire-centessa-pharmaceuticals-advance-treatments-sleep 2.Centessa’s Narcolepsy Drug Shows ‘Compelling’ Effect in Early Study 3.其他公开资料 封面图来源：即梦AI 破局三十载垄断：国产内镜从“跟随者”到“定义者” 2026-03-27 沙利文发布《2026全球抗体药物行业发展蓝皮书》（内附全文获取方式） 2026-03-26 不止66.666亿：复宏汉霖公布2025财报，剑指C-MNC 2026-03-23 版权声明/免责声明 本文为原创文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！

Millions of people start work before sunrise—but their brains aren’t ready for it. A new clinical trial has found that the wake-promoting drug solriamfetol can significantly boost alertness in early-morning shift workers struggling with shift work disorder. Participants who took the drug were able to stay awake and function better throughout full shifts, with improvements in productivity, safety, and daily performance.Far more people work very early morning shifts than overnight schedules, yet many struggle with severe fatigue linked to shift work disorder. This condition can interfere with concentration, job performance, and safety. A new clinical trial led by researchers at Mass General Brigham found that the wake-promoting drug solriamfetol (Sunosi) helped early morning shift workers stay more alert. The findings were published in NEJM Evidence. "Until now, no clinical trial had tested a treatment for shift work disorder in early-morning shift workers, even though this is the most common type of shift schedule," said senior author Charles A. Czeisler, PhD, MD, chief and senior physician of the Division of Sleep and Circadian Medicine in the Mass General Brigham Department of Medicine. "This study addresses a major gap by focusing on the workers who start their day when most people are still asleep." Why Early Shifts Disrupt the Body's Clock Roughly one in four workers operates outside the standard 9 to 5 schedule, including those who begin work very early in the morning. Many people with these schedules do not consider themselves shift workers and instead see their routine as simply starting the day earlier than usual. However, they may still face a high risk of shift work disorder, which involves disrupted sleep patterns and persistent daytime sleepiness. "People who start work between 3 a.m. and 7 a.m. are waking up at a time when the brain is biologically programmed to sleep. That makes staying alert extraordinarily difficult, even when they are highly motivated," said first author Kirsi-Marja Zitting, PhD, an investigator with the Division of Sleep and Circadian Medicine in the Mass General Brigham Department of Medicine. "They are often dealing with a double burden -- excessive sleepiness during work hours and difficulty sleeping enough when they have the chance to rest." Health and Safety Risks of Shift Work Disorder Shift work disorder is linked to a range of serious concerns, including reduced mental sharpness, lower productivity, increased risk of car accidents, and more workplace injuries. Medications such as modafinil are sometimes used to promote wakefulness, but these drugs have mainly been studied in overnight workers and can interfere with sleep later in the day. Solriamfetol, the drug evaluated in this study, is already approved for treating excessive sleepiness in people with obstructive sleep apnea and narcolepsy. Researchers considered it a promising option because it can promote alertness for extended periods without significantly disrupting later sleep. Clinical Trial Shows Improved Alertness and Performance The study included 78 early morning shift workers diagnosed with shift work disorder. Participants were randomly assigned to take either solriamfetol or a placebo on workdays over a four-week period. Researchers assessed their ability to stay awake in a controlled, low-stimulation setting during hours that matched their typical work schedule. Participants also reported on their daily functioning and met regularly with clinicians. After four weeks, those who received solriamfetol showed clear improvements. They were less sleepy and could remain awake longer during simulated work hours. Both participants and their doctors noted better overall functioning, improved work performance, and greater ability to manage daily tasks. "The improvement we saw is clinically meaningful. These workers were able to stay awake and alert throughout a full eight-hour shift, which has real implications for performance, safety, and quality of life," Czeisler said. "Shift workers are essential to how our society functions, yet they often pay a hidden biological cost. This study shows we can do better for them." More Research Needed on Long-Term Effects The researchers emphasized that early morning shift workers have not been widely studied, and the current trial lasted only four weeks and included otherwise healthy adults. More research will be needed to understand the long-term effects of the treatment. The team is now enrolling participants for a follow-up clinical trial to study solriamfetol in overnight shift workers, which could help support broader approval for treating shift work disorder. In addition to Zitting and Czeisler, Mass General Brigham authors include Katherine R. Gilmore, Brandon J. Lockyer, Wei Wang, Nicolas C. Issa, Stuart F. Quan, Jonathan S. Williams, and Jeanne F. Duffy. Additional authors include Eileen B. Leary. Funded by Jazz Pharmaceuticals, Axsome Therapeutics, and Brigham and Women's Hospital Center for Clinical Investigation; NCT04788953(2021-03-09)