A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

开始日期2025-08-26

申办/合作机构

Bristol Myers Squibb Co.

NCT06875960

/ Not yet recruiting临床4期

A Continuation Protocol for Deucravacitinib in Patients With Patients With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132

开始日期2025-03-17

申办/合作机构

Bristol Myers Squibb Co.

CTIS2024-517262-41-00

/ Recruiting临床3期

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents from 5 to less than 18 Years of Age with Active Juvenile Psoriatic Arthritis - IM011-1071

开始日期2025-03-13

申办/合作机构

Bristol Myers Squibb Co.

100 项与氘可来昔替尼相关的临床结果

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100 项与氘可来昔替尼相关的转化医学

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100 项与氘可来昔替尼相关的专利（医药）

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281

项与氘可来昔替尼相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Cardiovascular safety of Janus kinase inhibitors in inflammatory bowel disease: a systematic review and network meta-analysis

Review

作者: Wang, Bangmao ; Yang, Huibin ; Zhang, Qingyu ; Zhao, Yuxuan ; An, Ting ; Shi, Xiaojing

BACKGROUND AND OBJECTIVE:

Janus kinase (JAK) inhibitors (JAKinibs) are effective for inflammatory bowel disease (IBD), but their cardiovascular safety is inconclusive. We aim to assess the cardiovascular risks associated with JAKinibs in IBD patients.

PATIENTS AND METHODS:

Systematic searches of seven databases and ClinicalTrials.gov from inception to February 2024 were conducted. Outcomes included major adverse cardiovascular events (MACE), venous thromboembolism events (VTE) and cardiovascular events (CVE), which were separately evaluated based on whether or not the dose was considered. P-score was applied to rank interventions.

RESULTS:

A total of 26 trials involving 10,537 IBD patients were included, and results showed no significantly increased risk of MACE, VTE and CVE was associated with JAKinibs. However, when the dose was considered, Tofacitinib 5 mg BID (versus placebo) showed a trend towards an increased risk of MACE [odds ratio (OR)=1.05, 95% confidence interval (CI): 0.23-4.82], as well as Upadacitinib 30 mg QD (versus placebo) showed a trend towards increased risks of VTE (OR=1.36, 95% CI: 0.23-8.03) and CVE (OR=1.08, 95% CI: 0.24-4.85), and ranked higher than placebo for the risk of VTE [P-score=0.766 (versus 0.722)]. Notably, Deucravacitinib ranked lowest for all cardiovascular risks, and significantly decreased the risks of VTE (OR=0.03, 95% CI: 0.00-0.87) and CVE (OR=0.03, 95% CI: 0.00-0.87) compared with placebo.

CONCLUSIONS:

Although a trend of increased cardiovascular risks was found considering dose, no significantly increased cardiovascular risk was associated with JAKinibs in IBD patients, and Deucravacitinib significantly decreased the risks of VTE and CVE.

2025-06-01·PHARMACOLOGICAL RESEARCH

Properties of FDA-approved small molecule protein kinase inhibitors: A 2025 update

Review

作者: Roskoski, Robert

Because of the deregulation of protein kinase action in many inflammatory diseases and cancer, the protein kinase family has become one of the most significant drug targets in the 21st century. There are 85 FDA-approved protein kinase antagonists that target about two dozen different enzymes and four of these drugs were approved in 2024 and a fifth was approved in 2025. Of these drugs, five target dual specificity protein kinases (MEK1/2), fourteen inhibit protein-serine/threonine protein kinases, twenty-one block nonreceptor protein-tyrosine kinases, and 45 target receptor protein-tyrosine kinases. The data indicate that 75 of these drugs are prescribed for the treatment of neoplasms. Seven drugs (abrocitinib, baricitinib, deucravacitinib, deuruxolitinib, ritlecitinib, tofacitinib, upadacitinib) are prescribed for the management of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis). Of the 85 FDA-approved agents, about two dozen are used in the treatment of multiple diseases. The following four drugs received FDA approval in 2024 - deuruxolitinib (alopecia areata), ensartinib and lazertinib (non-small cell lung cancer), and tovorafenib (pediatric glioma) while mirdametinib was approved in 2025 for the treatment of type I neurofibromatosis (von Recklinghausen disease). Apart from netarsudil, temsirolimus, and trilaciclib, the approved protein kinase blockers are orally bioavailable. This article summarizes the physicochemical properties of all 85 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 39 of the 85 FDA-approved drugs have a least one Lipinski rule of 5 violation.

2025-05-23·CLINICAL AND EXPERIMENTAL DERMATOLOGY

Efficacy of deucravacitinib and guselkumab in a patient with psoriasis who had experienced multiple failures of biologics: a case report

Article

作者: Lovell, Katie K ; Daniel, Sophia ; Feldman, Steven R ; McGrath, Lauren

We report the successful use of combination therapy in a 69-year-old man with recalcitrant psoriasis, achieving clinically significant improvement with deucravacitinib and guselkumab after multiple failures with biologics. The selective inhibition of tyrosine kinase 2 by deucravacitinib, combined with the blockade of interleukin-23 by guselkumab, may have led to enhanced suppression of the T helper cell 17 inflammatory pathway. Further research is needed to define the efficacy and tolerance of such combination regimens in patients with severe, difficult-to-treat psoriasis.

430

项与氘可来昔替尼相关的新闻（医药）

2025-05-22

·药事纵横

BMS 氘可来昔替尼新适应症上市申请获受理

5月20日，CDE官网显示百时美施贵宝（BMS）的氘可来昔替尼片（商品名：颂狄多®）新适应症上市申请获受理。结合临床试验进展推测，业内普遍推测此次申报的适应症为银屑病关节炎。作为全球首个获批的口服选择性酪氨酸激酶2（TYK2）变构抑制剂，氘可来昔替尼早前于2023年10月在中国获批用于中重度斑块状银屑病。图源：CDE官网氘可来昔替尼不同于传统JAK抑制剂通过竞争ATP结合位点发挥作用，它选择性与TYK2的调节结构域（JH2）结合，通过变构效应抑制其活化，从而精准阻断IL-23、IL-12和I型干扰素等核心炎症信号通路。这种机制不仅提高了靶点选择性，还避免了因抑制JAK1/2/3导致的广泛免疫抑制，为患者提供了更安全的长期用药选择。银屑病关节炎(PsA)是一种兼具关节炎症和皮肤表现的异质性疾病，传统治疗药物如TNF抑制剂虽有效，但部分患者应答不足或出现耐药，且存在感染风险升高的问题。氘可来昔替尼通过靶向TYK2这一IL-23/Th17轴的关键节点，既能控制关节炎症，又能同步改善皮肤症状，实现了“双管齐下”的治疗效果。此外，其对头皮、掌跖等难治部位皮损的显著改善进一步巩固了其在复杂病例中的治疗地位。在针对银屑病关节炎的III期试验POETYKPsA-2中，治疗16周时，氘可来昔替尼组患者的ACR20 （疾病体征和症状至少改善20%）应答率达54.2%，显著优于安慰剂组的39.4%（p=0.0002），同时PASI75（银屑病面积和严重程度指数改善至少75%）应答率也明显提升。该药不仅在关节症状控制上表现优异，还显著改善了患者生活质量指标如HAQ-DI，较安慰剂组有更显著的基线改善（−0.32vs.−0.21，p=0.0013）。安全性上，III期试验中氘可来昔替尼组因不良事件停药率仅为2.2%，远低于参照组阿普米司特的10.5%，其选择性抑制TYK2而非JAK家族的特性显著降低了传统JAK抑制剂常见的感染、血液学异常等风险。在当前银屑病关节炎治疗市场中，生物制剂如TNF-α抑制剂、IL-17/23抑制剂占据主导地位，而口服药如JAK抑制剂、PDE4抑制剂则以便捷性吸引部分患者。氘可来昔替尼则兼具口服便捷性和安全性优势。相比需注射的生物制剂，氘可来昔替尼每日一次口服给药极大提升了患者依从性。对于许多对注射恐惧或需长期管理的患者而言，口服药的便利性无疑是巨大的吸引力。此外，该药无需冷藏保存，便于携带，进一步提高了患者的用药体验。与同为口服药的JAK抑制剂相比，氘可来昔替尼的选择性TYK2抑制机制避免了JAK家族广泛抑制带来的潜在风险。传统JAK抑制剂如托法替尼、乌帕替尼等虽能有效控制病情，但可能增加感染、心血管事件、血栓等风险。而氘可来昔替尼在治疗剂量下不抑制JAK1、JAK2或JAK3，从而显著降低了这些风险。尽管优势明显，但氘可来昔替尼仍面临市场竞争压力。生物制剂如司库奇尤单抗（IL-17A抑制剂）凭借高应答率（ACR50可达51%）占据一线治疗地位，而JAK抑制剂乌帕替尼虽安全性争议较大，但其在PsA适应症上的先发优势不可忽视。此外，仿制药的冲击也可能影响原研药的市场份额，老挝、孟加拉等国已上市氘可来昔替尼仿制药，价格仅为原研药的十分之一，尽管国内患者获取存在法律和渠道障碍，但跨境购药需求可能分流部分市场。氘可来昔替尼的研发管线显示，其正在拓展系统性红斑狼疮、干燥综合征等适应症的III期临床试验。若这些适应症获批，将极大拓宽其市场空间。此外，作为口服靶向药，其与生物制剂的联合应用潜力也值得关注，与IL-23抑制剂联用可能通过双重阻断炎症通路增强疗效，或与低剂量生物制剂联用以减少后者用量并降低副作用风险。未来，仿制药的冲击可能影响原研药的市场份额。目前老挝、孟加拉等国已上市氘可来昔替尼仿制药，价格仅为原研药的十分之一，尽管国内患者获取仿制药存在法律和渠道障碍，但跨境购药需求可能分流部分市场，原研厂商需通过持续创新和医保谈判巩固优势。氘可来昔替尼在银屑病关节炎领域的申报进展，不仅是BMS在免疫赛道的重要布局，也为患者提供了更安全、便捷的治疗选择。后续，如何在生物制剂主导的市场中突围，如何平衡原研药与仿制药的竞争，仍需企业通过真实世界疗效验证、差异化推广策略及灵活定价机制应对。参考来源：[1]CDE官网[2]https://news.pharmnet.com.cn/news/2025/03/11/600775.html药事纵横投稿须知：稿费已上调，欢迎投稿

2025-05-21

·FierceBiotech

Accropeutics\' TYK2/JAK1 inhibitor hits psoriasis endpoints in Chinese biotech\'s first phase 2 win

Accropeutics’ AC-201 hit its secondary endpoint across all three cohorts as measured by PASI 90.\n Accropeutics’ drug has hit the goals of a phase 2 psoriasis trial in China, prompting the biotech to pledge to “accelerate” the TYK2/JAK1 inhibitor’s clinical development.The study saw 145 Chinese patients with moderate to severe plaque psoriasis receive one of three doses of the drug, dubbed AC-201, or placebo. All three of the dose cohorts hit the trial’s primary endpoint as measured by the proportion of patients achieving a 75% improvement on the Psoriasis Area and Severity Score (PASI 75) at Week 12 compared to placebo.Specifically, the PASI-75 response rate was 31.4% for the 25-mg twice-daily dose cohort, 74.3% for those receiving a 50-mg dose twice a day and and 59.5% for the 100-mg daily dose group, compared to 8.1% for the placebo cohort.For comparison, Bristol Myers Squibb’s TYK2 inhibitor Sotyktu, which was approved for psoriasis in 2022, triggered 75% or greater improvements in psoriasis area and severity in 53% and 58% of patients in a pair of 16-week phase 3 clinical trials.Meanwhile, Accropeutics’ AC-201 also hit its secondary endpoint across all three cohorts as measured by PASI 90, with the greatest effect being 48.6% for the 50-mg cohort, the biotech said in a post-market release May 20.AC-201 was well tolerated, according to Accropeutics, with no serious adverse events or other adverse events that led patients to permanently discontinue the study. The majority of treatment-emergent adverse events were mild or moderate in severity, with the most common being upper respiratory tract infection or high amounts of triglycerides in the blood. “We are excited to see the positive results from the phase 2 study of AC-201, and we will accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases,” Accropeutics’ CEO and co-founder Xiaohu Zhang, Ph.D., said in the release.AC-201 is Accropeutics’ most advanced asset. In March, the company secured $12 million in series B funds that was earmarked to continue the clinical development of its RIPK2 inhibitor AC-101, which is currently undergoing a phase 1b trial for ulcerative colitis. The biotech’s other clinical-stage candidate is a RIPK1 inhibitor dubbed AC-003, which is now being evaluated in a phase 1b trial for the treatment of acute graft-versus-host disease.Roivant has its own TYK2/JAK1 inhibitor in development in the form of brepocitinib, which the biopharma licensed from Pfizer back in 2022. While Roivant dropped development of brepocitinib in lupus after a phase 2 fail, the company is still evaluating the drug in non-infectious uveitis and dermatomyositis.

$Accropeutics\' TYK2/JAK1 inhibitor hits psoriasis endpoints in Chinese biotech\'s first phase 2 win$

临床2期临床结果上市批准临床1期临床3期

2025-05-19

·E药经理人

AZ猛攻，默沙东难独霸，罗氏、强生守擂！肿瘤“五霸”ASCO激战打响

谁将是下一个“肿瘤霸主”？成，意味着荣耀、地位、话语权，以及囊中数百亿美金的真金白银。撰文| 润屿肿瘤领域的纷争，永不落幕。作为肿瘤学领域最重要的盛事，2025年美国临床肿瘤学会（ASCO）年会将于美国东部时间5月30日至6月3日召开，来自全球的肿瘤药创新力量将同台竞技。今年最大的两个亮点，除了中国药企刷屏外，全球“肿瘤五霸”PK再度升级，战况前所未有地激烈。按2024年肿瘤业务收入计，肿瘤五霸依次为默沙东（全球唯一一家肿瘤收入超300亿的药企），BMS，罗氏，阿斯利康（AZ）和强生。K药在Q1已失去“药王”宝座，默沙东免疫肿瘤“金字塔”策略需重新建顶。BMS——今年专利悬崖风险敞口最大的巨头，有报告预计其64%的收入将受专利损失和仿制药冲击影响，现有新品商业化不及预期，需尽快找到潜力大单品。罗氏，昔日让出“肿瘤霸主”之位后，重获荣光略显有心无力，如何运用“a pipeline in a company”策略将肿瘤产品组合精准击破，迫在眉睫。AZ，Q1彻底退出神经领域，以集中精力更好聚焦肿瘤、免疫等。但奥希替尼与DS-8201，两个明星单品皆群敌环伺，需快速加固壁垒。强生，能否在“All in”血液瘤之道上杀出重围，现在正是关键分水岭。当然，从五霸争锋里，产业界最能窥见全球未来肿瘤药物创新与差异化趋势。同时，当他们将中国创新变成竞逐的关键法宝，也能从这一维度看到中国在肿瘤药领域的崛起，好比默沙东与科伦博泰的牵手，BMS押宝百利天恒的双抗ADC。“拼”家底式ASCO大秀五大肿瘤线年收入超200亿美元的MNC，即将同台拼家底式“秀肌肉”。最激烈竞争，一源自两大癌种，肺癌与乳腺癌，二是两大机制，ADC与双抗。而最具亮点的MNC，分别是默沙东和AZ。肿瘤药“销冠”默沙东，狂甩PD-1之外的大招，将呈现超25种肿瘤治疗方案研究，主要面向肺癌，重点是几款进度最靠前的ADC和KRAS G12C 抑制剂：将展示KRAS G12C 抑制剂 MK-1084在结直肠癌和非小细胞肺癌中的数据，这与BMS直接展开竞争——BMS将口头报告一线Adagrasib联合K药治疗晚期/转移性KRASG12C突变NSCLC患者结果，以期缔造新型抗癌王炸组合。展示ROR1 ADC产品zilovertamab vedotin治疗复发或难治性弥漫性大 B 细胞淋巴瘤患者的进展。展示TROP2 ADC芦康沙妥珠单抗(sac-TMT）在中国进行的II OptiTROP-Lung03 研究关键数据，该研究由科伦博泰独立领导，用于治疗既往接受过治疗的晚期 EGFR 突变 NSCLC 患者。展示全球进展最快的HER3 ADC药物Patritumab Deruxtecan（默沙东/第一三共）数据，也是面向NSCLC患者。业绩同受PD-1影响颇深的BMS，与默沙东“单抗联用”的开发思路相同，如与免疫抑制剂联用，研发固定复方制剂。此次ASCO会上，BMS重点仍放在了给O药找新拍档上，口头报告大部分为与免疫抑制剂的联用方案，如与CTLA4和LAG3联用。 AZ，本届ASCO会上最值得关注另一大巨头。会上，最可能影响临床实践的5项最新突破性摘要（LBA）将公布，其中AZ的就占了两项：乳腺癌内分泌疗法新突破：Camizestrant联合CDK4/6 抑制剂治疗 ESR1 突变激素受体阳性晚期乳腺癌；胃癌围术期治疗新突破：度伐利尤单抗联合FLOT方案（5-FU、亚叶酸、奥沙利铂、多西他赛）治疗局部晚期可切除胃癌和胃食管交界处癌（GC/GEJC）患者。此外，AZ还将作约10项口头报告，覆盖HER2 ADC产品Dato-DXd，PD-L1度伐利尤单抗，PARP抑制剂奥拉帕利等，三代EGFR-TKI奥希替尼等，整体来看，其在早期治疗布局加速。罗氏与强生，此次带来的全新创新产品较少，两者均致力于夯实自身最核心的优势领域。罗氏，守擂血液瘤与乳腺癌领域，此次将亮点聚焦在PI3Kα抑制剂和双抗上，将口头报告PI3Kα抑制剂Inavolisib(伊那利塞)针对HR+/HER2-的PI3Kα突变型晚期乳腺癌患者研究；同时，双抗高罗华(格菲妥单抗/Glofitamab)联合化疗治疗弥漫大B细胞淋巴瘤数据也将展现。该产品是全球首个作用于复发难治淋巴瘤的靶向CD20/CD3的双抗创新药。而强生，一边将同时拿出手里Carvykti（BCMA CAR-T），达雷妥尤单抗和BCMA/GPRC5D/CD3三抗三张“王牌”，强化其在多发性骨髓瘤上的绝对性霸主地位。另一边，则用一个尼拉帕利和KLK2-CD3双抗新药78278343 (pasritamig)，展示其在前列腺癌（mCRPC）上的差异化竞争力。值得一提的是，辉瑞在此次ASCO大会上将大秀夺回肿瘤领导者地位的野心，其两个LBA和多个口头报告将呈现。2024年，辉瑞在万众瞩目中重回制药业务营收第一的位置，其肿瘤业务收入更表现出进击肿瘤五霸的潜质，全年收入超150亿美元。推荐阅读 * AZ超罗氏，礼来追赛诺菲，诺华掉出前五，全球制药营收TOP10洗牌* 辉瑞杀进第一！恒瑞自研全球第二，百济、石药、中生、华东爆发！6823家药企研发盘点“拼老命式”攻与守从“五霸”以及所有MNC在2025年ASCO会上的展示亮点，能够看出几大行业趋势：其一，ADC“排位赛”格局，将在近两年大洗牌。其二，肺癌作为全球第一大癌种，仍旧为“必争”领域，但已从最初的默沙东与BMS的肺癌两厢对决，过渡到了多方势力竞争白热化阶段。不过，默沙东优势仍很明显，通过精细的人群划分与扬长避短的临床设计，早已占领在辅助/新辅助治疗、转移性肺癌治疗高地。其三，历史上再无任何一个靶点比PD-(L)1更具代表性，现阶段，PD-(L)1“四霸主”——默沙东、BMS、AZ、罗氏继续在为PD-(L)1做更好的生命周期管理，如联用ADC、mRNA肿瘤疫苗等进行疗法升级；通过IO组合、双抗等，实现PD-(L)1抗体升级；拓展前线疗法潜在带动皮下剂型的处方转换，使得可及性升级。其四，肿瘤PD-(L)1“四霸主”分庭抗礼的时代已经过去，在K药已经捅破天花板、单抗赛道已是红海一片后，接下来注定将在双抗、多抗、ADC等创新疗法掀起新的血雨腥风。唯一不变的，是MNC新的光荣与梦想，捷径与殊途，围剿与突围，继续生动上演。而现在的关键要务，是要在各种新技术、新靶点中挖掘到下一个超级肿瘤大药。为此，攻势最猛的两家MNC，目前看来是默沙东和AZ。默沙东作为现任肿瘤药冠军，面对K药即将到来的专利悬崖，全球竞争对手的虎视眈眈，以及非肿瘤药的强势威胁，正在打系统保卫战：广铺路，研发新型BTK抑制剂、KRAS G12C抑制剂和癌症疫苗等创新产品。覆盖更广阔的癌种和向前线拓展。以K药为中心，搭建联合治疗网络，尤其以研发系列ADC、肿瘤疫苗等为利用，形成联合药物治疗方案。通过自研快速占领单药适应证高地，通过广泛合作拓宽联用疗法。在此不得不提BMS。某种程度上，手握O药的BMS比默沙东的压力更大，其新药表现尚不够理想，尤其是心脏药物Camzyos（Mavacamten)、银屑病药物Sotyktu（氘代来昔替尼）和CAR-T疗法Abecma的销售额均低于早前预期。面临专利悬崖带来的“青黄不接”困境，BMS正在“开源节流”，一面大增研发投入，另一方面推出新的成本削减计划。 AZ，2024年肿瘤、心血管/肾脏/代谢疾病(CVRM)、呼吸与免疫(R&I)三大核心业务皆实现超过20%的高速增长。另外，其研发投入增长达到24%，助力其坐稳全球肿瘤五霸之一的地位，尤其是在ADC领域。开年至今，AZ已经宣布了五项积极的III期研究结果。为了化解明星肿瘤产品“围剿”困局，AZ研发力度，管线深度及研发效率明显加强。而昔日的肿瘤霸主、现任肿瘤药“老三”罗氏，从打肿瘤专注赛，发展到了打肿瘤、神经科学、眼科等五大核心治疗领域的组合拳。目前，肿瘤仍是其最核心的业务，2024年收入占比超50%，但增速不及其它领域亮眼。不过好消息是，罗氏的血液肿瘤仍然取得了79.09亿瑞士法郎（约95亿美元），同比增长保持在两位数（17.1%）。罗氏与强生颇为相似，都是靠血液瘤重磅炸弹登陆肿瘤药王者高地。另外，罗氏深度布局了乳腺癌治疗这一领域，采取“a pipeline in a company”策略，依托于HER2+乳腺癌向外扩展，通过系列产品组合精准击破。事实上，无论是过去还是“新三驾马车”的搭建，罗氏都主要基于乳腺癌市场。但德曲妥珠单抗（DS-8201）的上市，对罗氏HER2乳腺癌王牌产品市场份额造成了冲击。对此，罗氏的应对策略相对清晰，在HER2靶点基础上进一步拓展HR+乳腺癌市场。关键反击武器有两款，Giredestrant和前述提到要在ASCO上展现的Inavolisib。但整体来看，罗氏在肿瘤领域的布局，现在更多是为了纵深，求稳，循序渐进，这样的风格与强生仍较类似。最初，强生是“入侵”肿瘤领域的后来者，通过一步步“All in”血液瘤，从末线到一线地位跨越，在血液瘤领域接连创造重磅炸弹。尤其在多发性骨髓瘤领域，从硼替佐米到达雷妥尤单抗，再到双抗和CAR-T疗法，强生致力于将多发性骨髓瘤慢病化管理，让更多患者有机会实现功能性治愈。值得一提的是，2024年，强生的抗肿瘤业务可圈可点，与传奇合作的BCMA CAR-T疗法西达基奥仑赛和全球首款CD38单抗达雷妥尤单抗销售额均实现了不错增长。不仅如此，强生在ADC上布局也不容小觑，2024年豪掷数十亿美元收购了Ambrx，收获多款FIC潜力ADC。结语纵观2025年ASCO释放的行业信号，肿瘤治疗战场已迈入百花齐放的创新纪元。双抗、ADC与癌症疫苗等疗法重塑竞争格局，而“五霸”们正通过靶点升级、适应证前移和联用生态构建巩固护城河，而博弈胜出的核心，无疑取决于两点：谁能率先在“后K药时代”孵化出兼具临床突破与商业爆发的超级疗法，以及谁能在类似的管线布局中，率先实现治疗场景从单点突破到全程管理，从技术迭代到生态垄断。而这场关乎万亿市场的竞速，唯创新者永立潮头，唯变革者执掌未来。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

ASCO会议抗体药物偶联物临床结果

100 项与氘可来昔替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11817	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
红皮病性银屑病	日本	Bristol-Myers Squibb KK	2022-09-26
寻常性银屑病	日本	Bristol-Myers Squibb KK	2022-09-26
脓疱型银屑病	日本	Bristol-Myers Squibb KK	2022-09-26
斑块状银屑病	美国	Bristol Myers Squibb Co.	2022-09-09

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
银屑病关节炎	申请上市	中国	百时美施贵宝（中国）投资有限公司	2025-05-20
幼年特发性关节炎	临床3期	美国	Bristol Myers Squibb Co.	2025-03-13
幼年特发性关节炎	临床3期	中国	Bristol Myers Squibb Co.	2025-03-13
幼年特发性关节炎	临床3期	巴西	Bristol Myers Squibb Co.	2025-03-13
幼年特发性关节炎	临床3期	保加利亚	Bristol Myers Squibb Co.	2025-03-13
幼年特发性关节炎	临床3期	捷克	Bristol Myers Squibb Co.	2025-03-13
幼年特发性关节炎	临床3期	德国	Bristol Myers Squibb Co.	2025-03-13
幼年特发性关节炎	临床3期	意大利	Bristol Myers Squibb Co.	2025-03-13
幼年特发性关节炎	临床3期	罗马尼亚	Bristol Myers Squibb Co.	2025-03-13
幼年特发性关节炎	临床3期	西班牙	Bristol Myers Squibb Co.	2025-03-13

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05478499 (CTgov)	临床4期	头皮银屑病	154	Deucravacitinib	齋鬱糧艱膚願鑰網鬱膚 = 夢糧襯製製構鏇蓋積憲窪憲觸醖餘艱壓膚鏇夢 (構簾襯願醖憲觸築觸願, 顧蓋遞艱艱夢網齋醖簾 ~ 糧鏇選遞顧積構餘夢夢) 更多	-	2025-03-13
NCT04908189 (POETYK PsA-2 \| IM011-055, NEWS) 人工标引	临床3期	银屑病关节炎	730	氘可来昔替尼	餘築簾醖窪廠簾醖遞選(夢鬱壓糧顧夢鹽顧觸鹽) = 製顧鹽積醖獵襯鹹齋齋積顧鹽醖壓鹹範選鏇積 (窪獵願鑰糧憲壓獵範範 ) 达到更多	积极	2025-03-10
				安慰剂	餘築簾醖窪廠簾醖遞選(夢鬱壓糧顧夢鹽顧觸鹽) = 糧淵鏇簾顧選積願製築積顧鹽醖壓鹹範選鏇積 (窪獵願鑰糧憲壓獵範範 ) 达到更多
NCT03624127 \| NCT03611751 \| NCT04036435 (POETYK PSO-LTE, PipelineReview) 人工标引	临床3期	斑块状银屑病	-	deucravacitinib (1-year)	鏇簾顧構壓壓淵獵顧鏇(願觸鹽鏇憲選廠鹹鑰網) = 積鹽獵積膚觸構憲鏇築蓋鏇築艱壓廠獵選糧餘 (窪鏇積構夢糧獵夢鹽鏇 ) 更多	积极	2025-02-17
				deucravacitinib (5-year)	鏇簾顧構壓壓淵獵顧鏇(願觸鹽鏇憲選廠鹹鑰網) = 範觸鬱鑰衊觸遞選醖夢蓋鏇築艱壓廠獵選糧餘 (窪鏇積構夢糧獵夢鹽鏇 ) 更多
NCT04908189 (POETYK PsA-2, Company_Website) 人工标引	临床3期	银屑病关节炎	730	deucravacitinib	艱夢襯鹹選遞願繭衊衊(鹹築觸淵鑰觸淵範膚糧) = significantly greater proportion of Sotyktu -treated patients achieving ACR20 response. 餘顧醖窪窪遞觸構夢獵 (窪衊製網鹹窪繭憲艱膚 ) 达到更多	积极	2024-12-23
				Placebo
NCT04908202 (POETYK PsA-1, Company_Website) 人工标引	临床3期	银屑病关节炎	670	deucravacitinib	壓製壓簾餘鑰壓觸遞鏇(遞衊鑰窪鑰網壓鏇範築) = significantly greater proportion of Sotyktu -treated patients achieving ACR20 response. 構膚繭淵鏇範艱艱簾願 (製淵築蓋獵觸選鹽築廠 ) 达到更多	积极	2024-12-23
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NCT03624127 \| NCT03611751 \| NCT04036435 (POETYK PSO-1, PSO-2, and LTE trials, Pubmed \| JAMA Dermatol)	临床3期	斑块状银屑病	1,519	Deucravacitinib 6 mg once daily	繭構鹽製選選壓膚艱顧(製蓋鹽廠獵餘簾憲簾繭) = 選夢觸選遞鬱蓋網製鹹鏇製艱夢網餘遞憲襯齋 (簾鹹衊鹽膚餘鏇糧簾壓, 215.4 ~ 243.9) 更多	积极	2024-11-27
				Apremilast 30 mg twice daily	繭構鹽製選選壓膚艱顧(製蓋鹽廠獵餘簾憲簾繭) = 襯獵壓窪淵構鬱觸蓋選鏇製艱夢網餘遞憲襯齋 (簾鹹衊鹽膚餘鏇糧簾壓, 137.1 ~ 153.0) 更多
NCT04877990 (CTgov)	临床2期	克罗恩病 \| 溃疡性结肠炎	67	Deucravacitinib (BMS-986165) (Crohn's Disease)	網齋製鑰積構鏇廠壓夢 = 顧齋壓鏇選繭艱鬱廠廠鬱願廠繭膚夢窪顧製積 (憲願網簾繭餘鏇餘壓顧, 鹽膚淵窪築範艱鹽壓觸 ~ 遞蓋範鏇膚鹽膚製遞遞) 更多	-	2024-09-24
				Deucravacitinib (BMS-986165) (Ulcerative Colitis)	網齋製鑰積構鏇廠壓夢 = 鬱製簾廠築觸選鹹簾艱鬱願廠繭膚夢窪顧製積 (憲願網簾繭餘鏇餘壓顧, 蓋襯選願廠壓鏇夢範積 ~ 艱鹹鹹蓋淵鬱衊窪壓襯) 更多
NCT04613518 (CTgov)	临床2期	溃疡性结肠炎	38	BMS-986165 (BMS-986165 12 mg BID)	積廠夢鏇構築獵顧憲壓 = 齋壓鹹選簾淵醖鏇範範膚蓋構窪範膚鏇壓膚願 (壓繭範顧構選鹹醖鹽簾, 獵蓋簾範簾衊繭製窪壓 ~ 鬱醖觸蓋築夢積醖製鹽) 更多	-	2024-07-12
				Placebo (Placebo BID PO)	積廠夢鏇構築獵顧憲壓 = 餘餘膚獵餘簾構艱襯鹽膚蓋構窪範膚鏇壓膚願 (壓繭範顧構選鹹醖鹽簾, 範廠築襯膚鑰選蓋鏇窪 ~ 憲膚獵淵鏇蓋鹹繭壓壓) 更多
NCT03599622 (CTgov)	临床2期	克罗恩病	239	Placebo	憲壓積選願醖構廠繭襯 = 顧憲鑰廠艱夢醖鏇淵鬱襯構繭構艱觸壓願衊鏇 (襯蓋構築遞獵構鏇蓋簾, 鏇遞齋鏇窪蓋壓構餘構 ~ 顧艱餘壓襯艱願艱網糧) 更多	-	2024-07-03
NCT03252587 (PAISLEY, EULAR2024) 人工标引	临床2期	系统性红斑狼疮 antinuclear antibody \| anti-double-stranded DNA \| anti-Smith antibody	363	Deucravacitinib 3mg BID	餘積憲構構觸蓋夢餘憲(壓襯簾遞獵夢廠鑰膚鬱) = 糧選淵廠餘製願壓獵鏇範選願鹹獵觸鏇鑰繭糧 (窪鹹壓襯積簾觸鹽艱襯, 2.7) 更多	积极	2024-06-05
				Deucravacitinib 6mg BID	餘積憲構構觸蓋夢餘憲(壓襯簾遞獵夢廠鑰膚鬱) = 膚選簾顧製鹹獵鬱窪範範選願鹹獵觸鏇鑰繭糧 (窪鹹壓襯積簾觸鹽艱襯, 2.6) 更多