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更新于：2026-02-05
Tulisokibart
更新于：2026-02-05
概要
基本信息
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
Sequence Code 719540590H
来源: *****
Sequence Code 719540597L
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关联
14
项与 Tulisokibart 相关的临床试验NCT07176390
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people.
This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart.
Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart.
Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
开始日期2025-10-08 |
申办/合作机构 |
NCT07133633
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays.
This study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.
Researchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
This study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.
Researchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
开始日期2025-09-26 |
申办/合作机构 |
NCT06956235
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderate to Severe Hidradenitis Suppurativa
This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).
开始日期2025-06-09 |
申办/合作机构 |
100 项与 Tulisokibart 相关的临床结果
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100 项与 Tulisokibart 相关的转化医学
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100 项与 Tulisokibart 相关的专利（医药）
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6
项与 Tulisokibart 相关的文献（医药）2025-08-01·Lancet Gastroenterology & Hepatology
Tulisokibart shows promise for Crohn's disease
Article
作者: Lindsay, James
2025-08-01·Lancet Gastroenterology & Hepatology
Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial
Article
作者: Llewellyn, Heather ; Al Kharrat, Houssam ; Longman, Randy S ; Jang, InSock ; Luo, Allison ; Sands, Bruce E ; Marchelletta, Ron ; Targan, Stephan R ; DuVall, Aaron ; McGovern, Dermot P B ; Siegel, Corey A ; Yen, Mark ; Wang, Yong ; Woynarowski, Marek ; Feagan, Brian G ; Bilsborough, Janine ; Anderson, Jaclyn K ; Towfic, Fadi ; Nguyen, Deanna D ; Sabino, João ; Lu, Jiandong ; Kierkus, Jaroslaw ; Laurent, Olivier ; Muñoz-Elias, Ernesto J ; Dubinsky, Marla C
BACKGROUND:
TNF-like cytokine 1A (TL1A) is a key mediator of inflammation and fibrosis. The efficacy and safety of the anti-TL1A monoclonal antibody tulisokibart as induction treatment was assessed in adults with moderately to severely active Crohn's disease with a history of insufficient response, loss of response, or intolerance to conventional or approved biological therapies.
METHODS:
In the phase 2a, multicentre, open-label APOLLO-CD study, participants aged 18 years or older with moderately to severely active Crohn's disease, as defined by a Crohn's Disease Activity Index (CDAI) of 220-450 and a Simple Endoscopy Score for Crohn's Disease (SES-CD) of at least 6 for ileocolonic or colonic disease or at least 4 for isolated ileal disease, received intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10). This Article reports the results of the primary analysis of the induction period. The primary endpoints were safety and the proportion of participants with endoscopic response at week 12, defined as a decrease in SES-CD of at least 50% from baseline. Safety was analysed in all participants treated with tulisokibart, and endoscopic response was analysed in the per-protocol analysis set, which included all participants treated with tulisokibart with baseline CDAI and SES-CD scores, except those with prespecified important protocol deviations. This trial is registered with ClinicalTrials.gov (NCT05013905) and is closed for recruitment; an open-label extension is ongoing.
FINDINGS:
Of 101 participants screened for eligibility, 55 eligible participants were enrolled and received tulisokibart. The mean age of participants was 39·1 years (SD 15·7), 34 (62%) were male, 21 (38%) were female, and 39 (71%) had received previous biological therapy. At week 12, endoscopic response was observed in 13 (26·0% [95% CI 15·9-39·6]) of 50 participants receiving tulisokibart in the per-protocol analysis set. Adverse events occurred in 43 (78%) of 55 participants, with most adverse events being mild to moderate in severity. The most frequently occurring adverse events (≥5% of participants) were COVID-19 (six [11%] participants), urinary tract infection (five [9%]), Crohn's disease (five [9%]), anaemia (four [7%]), nasopharyngitis (three [5%]), and fatigue (three [5%]). Eight (15%) participants had serious adverse events, none of which were considered related to the study drug by the investigator. There were no deaths.
INTERPRETATION:
This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well tolerated. Randomised controlled trials with longer duration are needed to confirm these results; a double-blind, placebo-controlled, phase 3 trial is currently underway.
FUNDING:
Prometheus Biosciences, a subsidiary of Merck & Co, Rahway, NJ, USA.
2025-06-01·Pharmacology Research & Perspectives
Comparative Efficacy of Different Targeted Therapies in Patients With Moderate‐to‐Severe Ulcerative Colitis: Systematic Review/Network Meta‐Analysis and Mechanistic Overview
Review
作者: Xu, Li ; Sun, Yingzhe ; Hu, Suying ; Hu, Fang ; Pan, Pingting ; Dai, Youran ; Yang, Wenhui ; Li, Qiushuang ; Liu, Shan
ABSTRACT:
Ongoing evaluations of targeted therapies for moderate‐to‐severe ulcerative colitis (UC) continue to unfold, with the emergence of novel drugs. However, head‐to‐head trials comparing these therapies are still lacking. The aim of this study is to investigate the therapeutic effects of targeted therapies in moderate‐to‐severe UC. The Cochrane Library, Web of Science, PubMed, and Embase were searched from the inception to November 12, 2024. Statistical analyses included multivariate random effects models and Bayesian modeling. Stratified and sensitivity analyses were also performed. Publication bias was assessed using funnel plots. Outcomes such as clinical response/remission, endoscopic remission, mucosal healing, quality of life, adverse events (AEs), and serious adverse events (SAEs) were used to quantify the relative therapeutic effects. Thirty‐three studies (33 reported on the induction phase; 13 reported on the maintenance phase) were identified. In the induction phase, Upadacitinib 45 mg demonstrated the highest efficacy in achieving clinical remission (OR 10.03; 95% CI, 4.83–20.80), clinical response (OR 7.96; 95% CI, 3.89–16.28), and mucosal healing rate (OR 8.91; 95% CI, 3.36–23.62). Cobitolimod 250 mg was the first‐ranked treatment (SUCRA, 92.67%) in Endoscopic remission. Vedolizumab 108 mg was the best dosage in reducing Adverse Events (AEs). The optimal dosage for reducing Serious Adverse Events (SAEs) was found to be Tulisokibart 1000/500 mg. During the maintenance phase, Etrasimod 2 mg/kg ranked first in clinical remission (OR 9.58; 95% CI, 2.82–32.59), and Upadacitinib 45 mg was superior in endoscopic remission. Additionally, the most effective medication for raising quality of life was Guselkumab 200 mg (OR 3.04; 95% CI, 1.70–5.40). Consequently, there is a need for further high‐quality research to conclusively determine the best therapeutic option.
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项与 Tulisokibart 相关的新闻（医药）2026-02-04
关注并星标CPHI制药在线
2025年，默沙东交出了一份“喜忧参半”的成绩单：K药以316亿美元再创销售神话，成为无可撼动的业绩支柱。然而，HPV疫苗在华断崖式下滑、研发投入不增反减，也暴露出其依赖单品、区域失衡的结构性隐忧。在全球医药市场竞争加剧的今天，默沙东如何破局增长瓶颈，真正实现“多元引擎”驱动？
来源：默沙东2025财报
K药“王者光环”下的隐忧：是护城河，还是天花板？
在全球生物医药产业格局中，默沙东作为跨国制药企业的核心代表，其产品管线布局与市场表现对全球医药市场具有重要影响。其中，程序性死亡受体1（PD-1）抑制剂Keytruda（帕博利珠单抗）作为默沙东旗下核心创新产品，自2014年获得美国食品药品监督管理局（FDA）批准上市以来，凭借显著的临床疗效与广泛的适应症覆盖，实现销售额持续攀升，成为全球抗肿瘤药物领域的标杆产品。2025年，Keytruda销售额达316.80亿美元，同比增长7%，持续占据全球“药王”地位，为默沙东制药业务贡献了核心收入支撑。
Keytruda的持续增长源于适应症拓展、剂型创新与联合疗法布局三大核心逻辑，三者协同构筑其市场竞争优势。其一，适应症拓展是核心驱动力，该产品以黑色素瘤为初始适应症，逐步延伸至肺癌、乳腺癌等多瘤种，截至2025年在美获批适应症超40项，其中在非小细胞肺癌（NSCLC）领域实现全治疗阶段覆盖，基于KEYNOTE系列试验证据成为临床标准方案，有效扩容市场空间。
其二，剂型创新助力竞争力提升，2025年默沙东推出Keytruda皮下注射剂型Keytruda Qlex，该剂型与静脉注射剂型生物等效，可将单次给药时间从30分钟缩短至5分钟内，解决静脉给药的医疗资源占用、就医成本等痛点；2025年第四季度其美国市场销售额达3500万美元，初步验证市场认可度，为Keytruda份额巩固奠定基础。
其三，联合疗法布局强化临床价值与市场优势，默沙东基于肿瘤免疫机制，构建涵盖化疗、靶向治疗等多维度的联合体系。例如，Keytruda联合仑伐替尼获批不可切除肝细胞癌一线治疗，联合培美曲塞+铂类成为晚期非鳞状NSCLC一线标准方案，既提升治疗效果，也进一步扩大市场渗透率。
尽管Keytruda凭借上述优势持续占据全球医药市场的核心地位，但其“王者光环”背后仍隐藏着诸多潜在风险，核心问题集中体现为默沙东对该单一产品的过度依赖，这种产品结构失衡对企业长期增长的可持续性构成显著威胁。从收入结构来看，Keytruda销售额在默沙东制药业务总收入中的占比长期维持在较高水平，形成了“单一产品支撑全局”的增长模式，这种模式使得默沙东的整体业绩对Keytruda的市场表现具有极强的依赖性，一旦Keytruda面临市场竞争加剧、专利到期、疗效争议等突发情况，将直接导致企业整体业绩出现大幅波动。
市场竞争层面，生物类似药的潜在冲击是Keytruda未来增长的核心制约。Keytruda核心专利将于2028年起陆续到期，届时全球生物类似药企业将涌入市场，引发激烈竞争。参考阿达木单抗专利到期后销售额大幅下滑、市场份额被蚕食的规律，Keytruda大概率面临类似困境，其市场份额与售价或显著下降，直接影响默沙东核心收入。
研发管线布局方面，默沙东研发投入与管线多元化进展未能匹配对Keytruda的过度依赖，加剧增长风险。2025年其研发总投入157.89亿美元，同比下降12%，或影响新药研发进度与质量。尽管该年度有18项III期临床试验获阳性结果、80余项III期试验在推进，但多数在研项目处于早期阶段，尚未形成可与Keytruda接力增长的核心产品矩阵，难以对冲其市场风险。
中国市场“失速”背后：是周期波动，还是战略掉队？
中国作为全球最大的新兴医药市场之一，凭借庞大的患者群体、持续提升的医疗支付能力与不断优化的医药创新环境，成为跨国制药企业全球布局的核心战略区域。默沙东作为较早进入中国市场的跨国药企，曾凭借其在疫苗、糖尿病、肿瘤等领域的优质产品，实现了在中国市场的快速增长，一度成为跨国药企在华收入排名前列的企业。然而，近年来默沙东在中国市场的业绩呈现急剧下滑态势，2025年，默沙东中国市场收入为18.16亿美元，同比下降66%，这一显著跌幅引发了行业对其在华战略布局的广泛探讨，其中国市场“失速”的核心原因，是短期市场周期波动的偶然结果，还是长期战略布局滞后的必然体现，值得深入剖析。
从业绩下滑的直接诱因来看，人乳头瘤病毒（HPV）疫苗产品销售的大幅萎缩是核心因素之一。HPV疫苗作为默沙东在中国市场的核心盈利产品，曾凭借其先发优势与产品口碑，占据中国HPV疫苗市场的主导地位，为公司在华收入贡献了重要支撑。但自2024年起，默沙东HPV疫苗产品佳达修（Gardasil）在中国市场的销售额呈现显著递减趋势，2024年全年销售额为35.28亿美元，而2025年默沙东宣布停止向中国市场供应HPV疫苗，全年相关产品收入仅为1.93亿美元，较2024年减少33.35亿美元，降幅达94.5%，成为其中国市场业绩下滑的主要拖累因素。
HPV疫苗销售萎缩的背后，是市场需求、市场竞争与政策环境三大因素的协同作用，且并非短期周期波动所能解释。从市场需求层面来看，中国HPV疫苗市场经过2018-2023年的快速增长期后，已逐步进入市场饱和阶段。数据显示，2018-2023年期间，默沙东九价HPV疫苗在中国市场的销量年均增长率超过50%，9-45岁女性接种率从不足5%飙升至60%，核心目标接种人群的接种需求已基本得到满足。剩余未接种人群主要受经济因素与认知误区的制约，其中九价HPV疫苗全程接种费用超过4000元，超出部分低收入群体的支付能力；同时，部分群体存在“接种HPV疫苗=鼓励性行为”的认知误区，导致其接种意愿较低，进一步加剧了市场需求的萎缩态势。
从市场竞争层面来看，国产HPV疫苗的崛起形成了对默沙东的强有力冲击，进一步挤压了其市场空间。在二价HPV疫苗领域，万泰生物、沃森生物等国内企业的产品通过国家药品集中采购，实现了价格的大幅下降，其中二价HPV疫苗价格从580元/剂降至27.5元/剂，降幅超过91%，凭借显著的性价比优势，快速占据了二价HPV疫苗市场的主导地位。2025年上半年，中国HPV疫苗双价苗批签发量中，万泰生物的产品占比超过80%，默沙东二价HPV疫苗已基本退出中国市场。在九价HPV疫苗领域，国产九价HPV疫苗于2024年获批上市，其定价仅为默沙东九价产品的40%，且在临床疗效与安全性方面与进口产品无显著差异，进一步分流了默沙东的核心客户群体，导致其市场份额大幅下滑。
政策层面，中国疫苗接种及医药行业政策调整进一步加剧默沙东HPV疫苗的困境。截至2025年5月，12个省份将国产二价HPV疫苗纳入9-14岁女孩免费接种计划，大幅提升国产疫苗接受度，挤压其市场空间；同时，集中采购、医保支付政策优化对进口疫苗价格形成制约，默沙东未及时调整价格策略，进一步削弱产品竞争力。
HPV疫苗销售萎缩仅是表面原因，深层在于默沙东在华战略滞后——产品过度集中于疫苗与成熟仿制药，新兴领域及本土化合作步伐落后。糖尿病领域，其西格列汀2023年国内公立医院销售额26.56亿元、市场份额99.65%，2024年专利到期后，因仿制药冲击及放弃集采竞标，2025年市场份额暴跌至不足10%，成熟产品优势尽失。
新兴治疗领域（细胞治疗、基因治疗等），默沙东研发推广滞后，未及时布局国内迫切需求的创新疗法，与同行存在差距；本土化合作偏保守，多集中于产品引进与推广，不及阿斯利康、罗氏等深度合作。2025年其与恒瑞医药合作，引进口服Lp（a）抑制剂HRS-5346切入心血管领域，作为战略调整信号，其市场成效仍待验证。
默沙东中国市场的“失速”并非短期市场周期波动的偶然结果，而是产品布局失衡、市场竞争应对不足、本土化战略滞后等多重长期因素协同作用的必然产物。短期来看，默沙东面临核心产品市场份额丧失、收入大幅下滑的困境；长期来看，其在华战略布局的滞后性使得其难以适应中国医药市场的创新发展趋势与政策变化。未来，默沙东若想重新激活中国市场的增长动力，亟需加快战略调整步伐，优化产品布局，加大新兴治疗领域的研发与投入，深化与国内企业的本土化合作，构建符合中国市场需求的产品矩阵与商业化体系。
管线多元化的“理想与现实”：Winrevair能否成为下一个K药？
面对Keytruda单一产品依赖的增长风险与中国市场的业绩困境，管线多元化已成为默沙东实现长期可持续增长的核心战略方向。近年来，默沙东逐步调整研发与投资布局，在心血管疾病、呼吸系统疾病、免疫炎症性疾病等多个非肿瘤治疗领域积极拓展，通过自主研发与并购整合相结合的方式，构建多元化的产品管线，试图摆脱对Keytruda的过度依赖，寻找下一个核心增长引擎。在众多在研与已上市产品中，肺动脉高压（PAH）新药Winrevair（索特西普）凭借优异的临床数据与良好的市场表现，被视为最具潜力替代Keytruda的产品，但默沙东的管线多元化布局仍面临诸多现实挑战，Winrevair能否真正成为下一个“K药”，仍需结合市场潜力、管线结构与研发能力进行综合研判。
Winrevair作为默沙东在心血管领域布局的核心创新产品，其市场表现与临床价值为默沙东的管线多元化战略注入了重要动力。该产品于2024年3月凭借III期STELLAR临床试验的阳性结果获得FDA批准上市，用于治疗成人肺动脉高压（WHO 1类），2025年实现销售额14.43亿美元，同比增长超过200%，展现出强劲的增长势头。索特西普的核心创新点在于其独特的作用机制——作为全球首个激活素信号传导抑制剂（ASI），其针对肺动脉高压的核心病理机制开展治疗，与传统治疗药物形成显著差异。肺动脉高压是一种罕见的、进行性的、危及生命的心血管疾病，全球患病人数约4000万例，患者5年死亡率高达43%，临床未满足需求极为突出。目前，临床常用的肺动脉高压治疗药物主要为血管扩张剂，通过扩张肺血管缓解患者症状，但无法从根本上逆转肺血管重塑的病理过程，治疗效果有限。
索特西普通过选择性结合TGF-β超家族配体，调节肺动脉壁与右心室重构相关信号通路平衡，抑制血管平滑肌细胞增殖、逆转肺血管重塑，从病因层面实现PAH精准干预。III期STELLAR试验显示，其治疗组患者6分钟步行距离较基线平均增加34.4米，显著优于安慰剂组的1.0米（P<0.001），且临床恶化风险降低40%；2025年10月FDA扩大其适应症，进一步拓宽临床应用场景、支撑市场增长。
除Winrevair外，默沙东通过并购完善多领域管线布局：2025年全资收购Verona Pharma，将COPD治疗药物恩司芬群（新型长效LAMA，可改善患者肺功能）纳入旗下，其第四季度贡献销售额1.78亿美元，填补默沙东呼吸领域产品空白；COPD全球患病人数超3亿例，市场空间广阔。
免疫炎症领域，默沙东收购Prometheus Biosciences，获得IBD治疗药物Tulisokibart（新型TL1A单抗）。IBD全球患病人数超600万例，现有药物存在局限，Tulisokibart可抑制免疫炎症、缓解胃肠道症状，目前处于III期临床试验阶段，有望成为该领域核心产品，完善管线布局。
尽管默沙东已形成多领域管线矩阵，但管线多元化仍面临显著挑战，短期内难以替代Keytruda。核心问题在于多数新产品处于成长期，市场规模有限：Winrevair受PAH罕见病属性制约，市场规模远低于Keytruda，千亿级销售目标面临多重不确定性；Ohtuvayre、Tulisokibart等产品仍处于市场导入期或研发后期，能否形成接力增长尚未可知。
其次，研发投入同比下滑对管线多元化构成显著制约。2025年默沙东研发总投入同比下降12%，若该趋势持续，将影响新药研发进度与质量，延缓早期在研项目推进及产品上市，拖累管线多元化节奏；相较于罗氏、辉瑞等跨国药企持续增长的研发投入，其投入不足可能导致新兴领域创新能力落后，难以推出具核心竞争力的产品。
最后，默沙东未平衡好并购整合与自主创新，影响管线多元化质量与可持续性。其通过收购Acceleron Pharma等企业快速扩充管线，但“买买买”模式存在隐患：一是并购后企业协同整合难度大，可能拖累产品研发与推广；二是过度依赖并购会削弱自主创新能力，不利于核心技术平台构建；三是存在商誉减值风险，可能影响企业财务状况。
结语
默沙东正站在新旧动能转换的关键节点。K药虽强，终有生命周期；市场虽大，也需深耕细作。从收购Verona到联手恒瑞，默沙东已展现出构建多元生态的决心。2026年，随着多个III期临床结果陆续揭晓，这家药企巨头能否真正迎来“后K药时代”的华丽转身，值得每一个行业观察者持续关注。
信息来源：
默沙东官网和2025财报
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2026-02-03
【合作窗口】2026年2月3日
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辉瑞2025财报深读：大象转身后的商业意志与技术航标
2026年2月3日，辉瑞发布了2025年全年业绩，626亿美元的营收数据背后，是一场大象转身式的战略迁徙。当新冠红利彻底退潮，这家全球药企巨头正在用真金白银定义下一个十年的生存法则。
对于正身处寒冬、寻求突破的中国Biotech而言，辉瑞的每一笔投入和每一处核销，都是极具参考价值的航标。
第一章：营收结构的“脱水”与核心业务的“肌肉”
财报事实：
2025年辉瑞总营收运营下降2%，但剔除新冠产品后，非新冠业务实现了6%的运营增长。其中，用于治疗心肌病的Vyndaqel家族表现强劲，而呼吸道合胞病毒（RSV）疫苗Abrysvo在国际市场实现了136%的爆发式增长。
商业洞察与启示：
辉瑞已经完成了“后疫情时代”的软着陆。Abrysvo在国际市场的翻倍增长，证明了市场已经回归到对慢病、免疫等长期价值赛道的考核。市场不再为“应急产品”买单，而是重新回归对“临床必需”和“长期支付能力”的考量。Biotech在打磨管线时，必须自问：我的项目能否在没有特殊政策红利的情况下，凭借临床获益实现内生增长？
第二章：2026年20项关键临床背后的“攻势”
财报事实：
辉瑞宣布将在2026年启动约20项关键性III期临床研究（Pivotal Starts）。重点指向：超长效肥胖症药物、自免双抗以及肿瘤ADC。
1. 肥胖症赛道的“代差”打击 辉瑞披露，2026年将启动10项针对源自Metsera的超长效肥胖资产的关键临床。其中PF'3944（MET-097i）通过技术手段实现了从“每周给药”向“每月给药”的跨越，且减重效果持续无平台期。
2. 自免与肿瘤的“协同”进化 辉瑞点名了从三生制药引进的PD-1 x VEGF双抗，并提到通过Seagen整合后的肿瘤业务（如Padcev）增长显著，已占据尿路上皮癌一线治疗主导地位。
商业洞察与启示：
辉瑞正在利用强大的技术储备直接杀入“月度给药”领域。“给药频率”正成为药企BD谈判的核心溢价点。如果你的项目仅仅是Me-too，在大药企看来已无价值。
同时，辉瑞对中国资产的筛选逻辑极其明确：双抗及以上的多功能分子。单抗的黄金时代正在关门。特别是针对TL1A这类热门靶点，市场反馈显示单纯的抗体已逐渐难以撑起数百亿规模的预期。而具备双靶点协同潜力且通过YTE技术大幅延长半衰期（如WM415项目，其T1/2表现显著优于常规抗体）的下一代资产，才是匹配MNC管线缺口的“标准件”。
第三章：资本配置的“断舍离”与“确定性”
财报事实：
2025年辉瑞产生了44亿美元的非现金无形资产减值损失，源于对部分研发计划的优先级调整。同时，辉瑞以18.75亿美元现金退出ViiV股权，转而将弹药投向Metsera等更具爆发力的创新研发平台。
商业洞察与启示：
44亿美元的减值反映了辉瑞“现金向研发集中、研发向后期集中、后期向高回报集中”的财务底色。这意味着License-out的门槛变高了。巨头不再为了“占位”而买早中期项目，他们现在只买“确定性”。
2026年辉瑞将面临15亿美元的专利到期损失，这15亿的缺口就是Biotech的机会。你的管线必须精准对标这些即将失去保护的品种，提供“更优解”。如果你的自研BsAb能在药效和安全性上形成闭环，它就是填补这15亿缺口的最佳候选。
第四章：安全性——慢病领域的“生死门”
财报事实：
在针对肥胖和IBD（炎症性肠病）的叙述中，辉瑞反复使用了“Competitive tolerability profile”（极具竞争力的耐受性特征）。其收购姚明生物的口服GLP-1，核心逻辑也在于便利性与可控的安全性。
商业洞察与启示：
在2026年的支付环境下，药品的“生命周期管理”变得至关重要。疗效决定了药品的上限，但耐受性决定了药品的商业下限。对于需要长期服用的药物（如IBD领域），任何细微的安全优势都会被放大。
Biotech应尽早避开具有明显毒性副作用的分子设计。如果资产（如WM415/GR2303系列）能证明在有效载荷不变的情况下，副作用（如免疫原性或非靶点毒性）低于现有标杆（如PRA023或RVT-3101），即便在临床阶段稍显落后，依然具备极高的溢价空间。
总结：辉瑞留给我们的行业启示录
从辉瑞这份业绩报告中，我们看到的不是一家药企的兴衰，而是一个“研发深水区”的到来。
1. 资产全球化是硬道理： 辉瑞从中国公司持续扫货，证明了MNC对“中国源头创新”的依赖度在增加，但前提是分子必须具备全球竞争力。
2. 长效与依从性是溢价源： 所有的代谢类药物都在向“月”或“季”为单位进化。
3. 拥抱复杂性： 简单的单抗已很难再打动辉瑞的BD。双特异性、Fc工程化（长效技术）、多靶点协同，将是2026年后中国Biotech出海的主流语言。
最后的建议： 不要盯着现在的营收看辉瑞，要盯着他们2026年启动的那20项关键临床看。那里不仅有他们的未来，也藏着中国管线走向全球的财富密码。
END
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2026-02-03
Merck & Co. CEO Rob Davis is signalling growing confidence that Keytruda's US market protection could extend beyond the widely modeled 2028 loss-of-exclusivity (LOE) date.Speaking on Merck's fourth-quarter earnings call on Tuesday, Davis laid out the structure of Keytruda's patent estate, noting that while the core compound patent expires in December 2028, two other patents – a method-of-making patent running to May 2029 and a method-of-use patent extending to November 2029 – could delay biosimilar entry of the blockbuster cancer immunotherapy.Emerging case law"As we looked at this initially, we were conservative in our assumptions and always based off the compound patent…with the intent [though] that we would defend the entire patent estate," Davis said. "What has evolved over time is that, as case law has emerged, our confidence that we will be able to defend those additional two patents has grown, and thus there is a potential that you're going to see protection actually make it through either May or November of 2029."Still, Davis said Merck continues to model a 2028 LOE "because I think that's the conservative assumption and we'll have to see where it goes."He also reminded analysts that Keytruda faces Inflation Reduction Act (IRA) pricing pressure as of the beginning in 2029. The company previously suggested that Keytruda could find itself selected for the IRA "price setting" process as early as this year with negotiated prices taking effect in early 2028. The drug was not on the list released by the Centers for Medicare & Medicaid Services for the third round of price negotiations last week (see – Vital Signs: The bark may be gone from IRA, but can it still bite?).Shift to QlexFourth-quarter sales of the intravenous PD-1 inhibitor, along with its recently approved subcutaneous formulation, Keytruda Qlex, totalled close to $8.4 billion, up 7% year over year.Qlex alone brought in $35 million, though that's likely to climb substantially as time goes on, with nearly 40% of clinicians telling FirstWord in a recent poll that they've already started weaving it into routine practice (see – Physician Views Results: Oncologists begin integrating SC Keytruda Qlex, expect meaningful uptake within a year).Davis said Merck continues to push adoption of Keytruda Qlex, which the company expects to reach 30-40% penetration by 2028. "We have priced this to drive for the adoption from Keytruda IV to Qlex," Davis said, "and frankly, whether [the Keytruda LOE is] '28 or '29 does not change the strategy we're following."Other Q4 resultsIn other financial results, Merck said total sales during the fourth quarter of 2025 reached $16.4 billion, an increase of 5% over the same time in 2024. The company saw triple-digit growth with its pulmonary arterial hypertension treatment Winrevair ($467 million, +133%) and 21-valent pneumococcal vaccine Capvaxive ($279 million, +460%), though its Gardasil HPV vaccine continues to experience significant decline ($1 billion, -35%) as driven by lower demand in China and Japan.Enflonsia, Merck's respiratory syncytial virus (RSV) mAb to protect infants, generated $21 million in the fourth quarter, reflecting a "lower-than-expected" infant passive immunisation rate and high levels of total RSV mAb inventory on the market. Still, doctors appear to like what they've seen so far in the roughly half a year it has been on the market (see – Physician Views Results: Enflonsia picks up steam but Beyfortus boasts crown as regulators probe safety of RSV antibodies).Overall group sales in 2025 were up 1% to $65 billion. The company expects sales between $65.5 billion and $67 billion this year, though the higher end of the range falls short of the $67.6 billion analysts were expecting. Merck said it expects a $2.5-billion revenue headwind this year, including from generic competition and IRA price-setting for Januvia, as well as weaker sales of its COVID-19 therapy Lagevrio.While the fourth-quarter results "build a reasonable foundation for Merck heading into 2026," BMO Capital analyst Evan Seigerman said a lower-than-expected revenue outlook may temper expectations for the year.Meanwhile, Davis reiterated the $70-billion commercial opportunity he sees for Merck over the next decade, highlighting near-term programmes such as islatravir plus lenacapavir in HIV, long-acting antiviral candidate MK-1406 (CD388) derived from its $9.2-billion Cidara Therapeutics buyout, eye disease drug MK-3000 and TL1A mAb tulisokibart for inflammatory diseases. (see – JPM26: Merck & Co. targets $70B in revenues by mid-2030s).
疫苗并购财报
100 项与 Tulisokibart 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 克罗恩病 | 临床3期 | 美国 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 中国 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 日本 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 澳大利亚 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 奥地利 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 比利时 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 巴西 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 加拿大 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 智利 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 哥伦比亚 | 2024-06-05 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
N/A | - | 選獵鏇艱選顧獵鏇鹽遞(蓋夢積簾鏇窪艱窪醖廠) = Through week 50, AEs occurred in 63% and 77% of patients receiving tulisokibart 250 mg and 100 mg, respectively; most were mild to moderate in severity. Serious AEs occurred in 1 patient (3%) and two patients (7%) in the tulisokibart 250 mg and 100 mg groups, respectively. 獵鬱糧願製衊鹽齋蓋鬱 (範鏇製淵鏇繭積網艱鹹 ) | - | 2024-10-13 | |||
临床2期 | 135 | 獵製鬱襯艱遞鏇顧鏇遞(製鏇蓋鹹鏇範築簾衊衊) = 簾獵衊壓選淵糧觸築膚 齋壓窪夢鏇膚糧範顧鹽 (艱築鬱繭觸蓋壓蓋窪蓋 ) | 积极 | 2024-09-26 | |||
Placebo | 獵製鬱襯艱遞鏇顧鏇遞(製鏇蓋鹹鏇範築簾衊衊) = 獵構鹽簾憲鹽願鹹製繭 齋壓窪夢鏇膚糧範顧鹽 (艱築鬱繭觸蓋壓蓋窪蓋 ) | ||||||
临床2期 | 178 | (Cohort 1 Tulisokibart) | 鑰觸網構鹹窪觸願憲選 = 願齋網簾鏇獵鹹鏇醖夢 齋構願膚壓窪鏇淵願膚 (鏇餘鹹壓鹽蓋觸餘獵糧, 鏇願夢顧壓製膚廠膚鹽 ~ 網襯蓋繭積遞艱網鑰構) 更多 | - | 2024-06-27 | ||
Placebo (Cohort 1 Placebo) | 鑰觸網構鹹窪觸願憲選 = 選鬱襯齋鹽選夢鏇觸膚 齋構願膚壓窪鏇淵願膚 (鏇餘鹹壓鹽蓋觸餘獵糧, 繭壓積選廠衊製壓蓋獵 ~ 淵鑰齋鑰鑰夢築醖範餘) 更多 | ||||||
临床2期 | 55 | Companion diagnostic (CDx)+PRA023 IV | 壓範壓醖遞獵願壓膚淵 = 範醖範網製壓鹽醖糧鏇 鹽製鏇憲顧糧願網夢鹽 (製壓製夢鬱鬱積選鏇鬱, 淵構選範鹽艱鹽廠選淵 ~ 遞願鹽積築夢餘糧網積) 更多 | - | 2023-11-01 | ||
N/A | - | 鹽遞鏇遞廠製鹹選憲衊(襯壓願積鏇繭廠壓夢鹹) = 窪膚觸繭製範廠鹽鬱齋 憲齋鹹夢憲壓築構製觸 (構憲鏇繭鬱範淵繭簾觸, 34.85) 更多 | - | 2023-10-15 | |||
Placebo | 鹽遞鏇遞廠製鹹選憲衊(襯壓願積鏇繭廠壓夢鹹) = 鹽獵窪範願簾壓衊構築 憲齋鹹夢憲壓築構製觸 (構憲鏇繭鬱範淵繭簾觸, 37.59) 更多 | ||||||
临床2期 | 活动性中度溃疡性结肠炎 eosinophils | neutrophils | 135 | 繭糧齋憲顧糧壓蓋襯鏇(簾顧襯鑰顧餘構築製範) = 簾鹹鑰鹽糧願淵廠製繭 襯糧膚繭製積艱夢醖範 (網淵積願網淵艱構繭鏇 ) 更多 | 积极 | 2023-10-15 | ||
Placebo | 繭糧齋憲顧糧壓蓋襯鏇(簾顧襯鑰顧餘構築製範) = 淵選憲簾艱糧製網選範 襯糧膚繭製積艱夢醖範 (網淵積願網淵艱構繭鏇 ) 更多 | ||||||
临床2期 | 活动性中度溃疡性结肠炎 TL1A | 135 | 鬱築獵壓鹽築膚襯鑰廠(齋廠襯窪積壓觸鏇鑰獵) = 繭繭積遞選鹹糧製齋餘 鬱餘積蓋鬱簾繭鑰艱襯 (遞壓鑰窪鹹顧範齋壓齋 ) 更多 | 积极 | 2023-10-15 | ||
Placebo | 鬱築獵壓鹽築膚襯鑰廠(齋廠襯窪積壓觸鏇鑰獵) = 積鏇襯鏇製範鏇鬱蓋憲 鬱餘積蓋鬱簾繭鑰艱襯 (遞壓鑰窪鹹顧範齋壓齋 ) 更多 |
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