This study, titled "IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study," is conducted by researchers from the First Affiliated Hospital of Wenzhou Medical University. The primary aim of this research is to evaluate the efficacy and safety of ustekinumab, an IL-23 inhibitor, for patients with fibrostenotic Crohn's disease (CD) who have failed standard treatments.
The study is a prospective, open-label, randomized controlled trial involving 260 participants across three major hospitals: the First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province, and the Second Affiliated Hospital of Wenzhou Medical University. The participants are divided into two groups: one receiving ustekinumab and the other receiving a placebo. The study is designed to assess whether ustekinumab can improve clinical outcomes and reduce fibrosis progression in patients with fibrotic CD.
The study involves a comprehensive assessment of participants, including clinical history, physical examination, laboratory tests, and imaging studies. Key inclusion criteria include age between 18-80 years, confirmed diagnosis of fibrostenic CD, and failure of conventional or biological therapies. Participants are excluded if they are under 18, pregnant, breastfeeding, or have certain medical conditions that could interfere with the study.
The primary endpoint of the study is a clinical-imaging composite endpoint, which includes imaging assessment of bowel wall thickness and clinical symptoms. Secondary endpoints include safety, tolerability, and various functional and quality of life indicators. The study also explores the potential of ustekinumab to modulate immune responses and fibrosis-related biomarkers.
The study is expected to run from October 2025 to October 2028, with follow-up visits scheduled at regular intervals. The results will provide valuable insights into the potential of ustekinumab as a novel treatment for fibrotic CD, offering a new therapeutic option for patients who do not respond to existing treatments.
This research is crucial because fibrotic CD is a severe and progressive disease with limited treatment options. Ustekinumab, by targeting the IL-23 pathway, may offer a more effective and targeted approach to manage this condition. The study's findings could significantly impact clinical practice and improve patient outcomes.
For more detailed information, please refer to the study protocol document titled "IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study" dated September 2, 2025. For further inquiries, contact the principal investigators Dr. Wu Fang or Dr. Wu Xiaoli at the First Affiliated Hospital of Wenzhou Medical University.

开始日期2025-10-20

申办/合作机构

温州医科大学附属第一医院

[+2]

NCT07138898

/ Not yet recruiting临床2期IIT

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

开始日期2025-09-01

申办/合作机构

NYU Langone Health

CTIS2025-521424-30-00

/ Not yet recruiting临床4期IIT

A Phase 4 Mechanistic Longitudinal Study to Evaluate the Impact of EARLY Risankizumab Treatment on TRM Cell Levels in Moderate-to-Severe Psoriasis

开始日期2025-08-25

申办/合作机构-

100 项与利生奇珠单抗相关的临床结果

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100 项与利生奇珠单抗相关的转化医学

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100 项与利生奇珠单抗相关的专利（医药）

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706

项与利生奇珠单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Switching biologic agent in patients with psoriasis: a systematic review and meta-analysis

Review

作者: Sun, YuanQiang ; Zhao, XiTong ; Li, WenChao ; Liu, Hong ; Zhang, LiHong

BACKGROUND:

Multiple biologics are available for psoriasis treatment, but switching treatments is often necessary at some point. The choice between intraclass or interclass biologic switching has not been extensively investigated.

METHODS:

Two independent authors searched the databases PubMed and EMBASE for studies reporting on biologic switching in psoriasis patients. Our study was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines.

RESULTS:

A total of 19 publications, comprising 679 patients, were included. The intraclass switching group consisted of 519 patients, while the interclass switching group included 139 patients. For intraclass switching, there are respectively 160, 326 and 33 patients switched of TNF-α, IL-17, IL-23. For interclass switching, 11 patients switched from TNF-α to IL-17, 6 from IL-17 to IL-23, 41 from IL-17 to IL-12/23, 29 from IL-17 to TNF-α, 15 from IL-12/23 to IL-17, 8 from IL-12/23 to IL-23. After 12 weeks, the proportion of patients achieving Psoriasis Area and Severity Index (PASI)75 was significantly higher in the intraclass switching group compared to the interclass switching group. However, after 16-52 weeks, the PASI75 proportions were comparable between the groups.

CONCLUSION:

Intraclass switching shows better short-term efficacy than interclass switching. However, in the long term, both switching strategies are effective and safe. This study also shows that adalimumab, ixekizumab, and risankizumab are the preferred agents for intraclass switching, whereas guselkumab serves as the primary agent for interclass transitions.

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Interleukin-23p19 inhibitors for the treatment of moderate-to-severe psoriasis: an expert opinion of real-world evidence studies in Europe

Review

作者: Thaçi, D. ; Ständer, S.

Background: Psoriasis is a chronic inflammatory disease affecting about 2% of the global population, with moderate-to-severe forms requiring systemic treatment for successful disease management. By targeting the interleukin (IL)-23p19 subunit of IL-23, the master cytokine of psoriasis pathogenesis, guselkumab, tildrakizumab, and risankizumab offer improved risk-benefit profiles.Objective: While randomized clinical trials (RCTs) provide controlled data, real-world evidence (RWE) offers insights into the performance of these therapies in diverse patient populations, including those with comorbidities or difficult-to-treat areas affected. With RWE on these inhibitors constantly emerging, a comprehensive overview and expert interpretation are essential for providing key insights into psoriasis management in clinical practice.Methods: This review, therefore, examined RWE on the effectiveness and safety of IL-23p19 inhibitors compared to their pivotal RCTs.Results: Despite some gaps between RCT and RWE outcomes, particularly in underrepresented subpopulations, IL-23p19 inhibitors show strong effectiveness and favorable safety across both settings in the short- and especially in the long term, accompanied by an improvement in health-related quality of life and reduction of the main symptoms.Conclusion: Altogether, these factors make these medicines ideal treatment options. Future research should focus on improving patient-reported outcomes, specifically addressing psychological and quality-of-life aspects, to further optimize psoriasis management.

2025-12-01·Rheumatology and Therapy

Real-World Effectiveness and Satisfaction with Risankizumab for the Treatment of Psoriatic Arthritis in Biologic-Naïve Patients: A Population Survey in the United States and Europe

Article

作者: Vora, Jamie ; Biljan, Ana ; Ostor, Andrew ; Patel, Manish ; Milligan, Gary ; Walsh, Jessica A ; Ye, Xiaolan ; Truman, Isabel ; Saffore, Christopher D ; Edwards, Molly

INTRODUCTION:

This study assessed the real-world effectiveness of risankizumab (RZB) and treatment satisfaction in biologic-naïve patients with psoriatic arthritis (PsA) across the USA and Europe.

METHODS:

Data were drawn from the Adelphi Real World Spondyloarthritis Disease Specific Programme™, a cross-sectional survey of physicians and their adult patients with PsA receiving RZB 150 mg subcutaneous injections in Europe (France, Germany, Italy, Spain, UK) and the US, conducted from June 2023-June 2024. Physicians reported changes in body surface area (BSA), dactylitis, enthesitis, TJC68, and SJC66 and assessments of pain and fatigue on a 0-10 scale (higher scores indicating worse outcomes) from initiation to data collection, evaluated using McNemar or t-tests (p < 0.05 considered significant). Clinically meaningful improvements were complete resolution of dactylitis, enthesitis, TJC68, and SJC66 and pain (≥ 1.0-unit) and fatigue (≥ 3.0-unit) reductions. Physician and patient satisfaction with disease control was also reported. Outcomes were analyzed for the full cohort and stratified by prescription of a conventional synthetic disease-modifying antirheumatic drug (csDMARD) prior to the survey or at data collection vs csDMARD-naïve.

RESULTS:

Overall, 127 physicians reported on 192 patients with PsA (Europe 64%, US 36%). Mean ± SD patient age was 44.2 ± 10.7 years, and 45% were female. From RZB treatment initiation to time of data collection, resolution of dactylitis (82%) and enthesitis (90%), and improvements to TJC68 (- 3.7 ± 6.3), SJC66 (- 2.5 ± 5.1), pain (- 3.9 ± 2.4), fatigue (- 2.7 ± 2.6), and BSA (- 10 ± 10%) were observed (p < 0.001 for each) for the full cohort, with significant changes observed in both csDMARD subgroups. Patient and physician satisfaction with disease control was 95% and 98%, respectively.

CONCLUSION:

Biologic-naïve patients with PsA starting RZB demonstrated significant and meaningful improvements in joint symptoms, pain, and fatigue in real-world settings. High levels of satisfaction with RZB for disease control were reported by both patients and physicians.

928

项与利生奇珠单抗相关的新闻（医药）

2025-12-01

·搜狐新闻

中重度克罗恩病有了治疗新选择

克罗恩病患者正在注射新的药物。受访单位供图深圳晚报讯（记者周倩） 12月1日，南方医科大学深圳医院开出利生奇珠单抗注射液（喜开悦®）在深圳的首张克罗恩病适应证处方。新型靶向IL-23的中重度克罗恩病治疗药物未来可惠及更多患者，为患者提供更多临床用药选择。据了解，克罗恩病（CD）是一种慢性、反复发作的炎症性疾病。流行病学研究显示，东亚地区已进入IBD“发病率加速期”，中国患者数量正以每年5%-10%的速率攀升。“克罗恩病对于肠道的损坏是不可逆的。”南方医科大学深圳医院消化内科李夏西教授表示，克罗恩病可累及胃肠道全段，炎症穿透肠壁全层，不仅导致腹痛、腹泻、瘘管形成等反复症状，还会引发营养不良、心理焦虑及社交障碍，严重影响患者生活质量。临床数据显示，传统治疗及部分生物制剂常面临应答不足、失应答或不耐受问题，中重度患者长期陷入症状反复以及现有药物疗效有限的困境，同时需承担高额用药成本，亟需更优的治疗选择。作为全球首个获批用于治疗中重度活动性克罗恩病白介素-23抑制剂（IL-23i），利生奇珠单抗已在全球拥有超过3年的临床应用，安全性有效性得到充分验证。目前在全球上市的国家和地区超过40个，惠及超过4万名患者。南方医科大学深圳医院消化内科主任医师曹晓沧教授表示，长期以来，中重度克罗恩病患者面临治疗应答不佳、长期管理困难等问题，喜开悦®作为全球首个获批克罗恩病患者适应症的IL-23抑制剂，为患者提供了更精准的治疗选择，更推动中国克罗恩病诊疗从“症状控制”向“黏膜愈合、长期缓解”的目标迈进。返回搜狐，查看更多

2025-12-01

·GlobeNewswire-Health Care

SKYRIZI® (risankizumab) Receives Positive Reimbursement Recommendation by Canada’s Drug Agency for Ulcerative Colitis and AbbVie Concludes Letter of Intent with the pan-Canadian Pharmaceutical Alliance

SKYRIZI® (risankizumab), an IL-23 inhibitor, received two consecutive positive reimbursement recommendations by Canada’s Drug Agency (CDA-AMC) for inflammatory bowel diseases, initially for Crohn’s disease (CD) and now for ulcerative colitis (UC), supported by evidence from pivotal phase 3 clinical trials including MOTIVATE, ADVANCE, FORTIFY (for CD), and INSPIRE, COMMAND (for UC).1,2 AbbVie concludes letter of intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI® for UC.3 Nov. 28, 2025 -- Today, AbbVie (NYSE: ABBV) has announced two positive updates for Canadians living with ulcerative colitis (UC). Canada’s Drug Agency (CDA-AMC) has recommended SKYRIZI® (risankizumab) to be reimbursed with conditions by public drug plans for the treatment of adults with moderately to severely active UC who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor if certain conditions are met.2 The CDA-AMC’s positive recommendation was informed by feedback from 25 Canadian clinicians and two patient organizations, including the GI Society and Crohn’s and Colitis Canada, ensuring that the voices of those living with UC were considered. AbbVie has also successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI® for UC and a Letter of Intent (LOI) has been signed by both parties.3 “UC can be an incredibly debilitating disease and patients need effective, safe treatment options that can help restore quality of life,” said Dr. Christopher Ma, MD, MPH, FRCPC, Cumming School of Medicine, University of Calgary. “This is a positive step towards ensuring that Canadians living with UC have access to treatments options that can help them achieve remission and improve their long-term outlook.” “We are delighted that the Common Drug Review recommends that the public formularies cover the costs of an additional therapeutic option for ulcerative colitis. This new treatment is so desperately needed,” said Gail Attara, CEO of the Gastrointestinal Society, a patient group known by its badgut.org website. “Individuals living with UC are all different, requiring personalized treatment. Having a new therapy offers more hope and a chance to improve the quality of life by alleviating some symptoms.” “This is a testament to the mutual commitment of AbbVie and the Health Authorities to improve patient access to innovative medicines for inflammatory bowel disease,” said Rami Fayed, Vice President and General Manager, AbbVie Canada. “AbbVie in Canada is encouraged by the opportunity to work in collaboration with the CDA-AMC and the pCPA throughout this process to provide access to innovative solutions that has the potential to impact eligible patients’ lives.” Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease affecting the large intestine, causing persistent inflammation and ulceration of the colon’s lining. Common symptoms include frequent diarrhea, abdominal pain, and rectal bleeding, which can lead to significant impacts on patients’ daily lives, emotional wellbeing, and productivity. Approximately 120,000 Canadians are estimated to live with UC, and its prevalence continues to rise across the country.4 SKYRIZI® (risankizumab) is a humanized monoclonal antibody that selectively inhibits interleukin-23 (IL-23), a key cytokine involved in inflammatory processes. SKYRIZI® is indicated for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response, intolerance, demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies. SKYRIZI® is also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or were intolerant to conventional therapy, biologic treatment, or a Janus kinase (JAK) inhibitor. SKYRIZI® is approved in Canada for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, the treatment of adult patients with active psoriatic arthritis and it can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate). AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. The content above comes from the network. if any infringement, please contact us to modify.

上市批准临床结果生物类似药

2025-12-01

·医药专利

银屑病3个月一针匹康奇拜单抗——2025年中国上市的第94款新药

中国NMPA2025年批准新药94个（新药定义为含中国首次上市的活性成分）。 1类新药中药生物药化药合计 5 36 53 94 国产 5 23 31 59 进口 0 13 22 35 94 匹康奇拜单抗注射液（2025.11.25）银屑病近日，国家药品监督管理局批准信达生物医药科技（杭州）有限公司申报的匹康奇拜单抗注射液（商品名：信美悦）上市，适用于适合系统性治疗的中重度斑块状银屑病成人患者。该品种的上市为相关患者提供了新的治疗选择。匹康奇拜单抗（信美悦，Picankibart，IBI112）是由信达生物（01801.HK）自主研发、具有自主知识产权的一款重组抗白介素23p19亚基（IL-23p19）抗体注射液，通过特异性结合IL-23p19亚基，阻止IL-23与细胞表面受体结合，阻断IL-23受体介导信号通路发挥抗炎作用。 2024年5月，信达生物宣布，匹康奇拜单抗治疗中重度斑块状银屑病的III期CLEAR-1研究达到主要终点和所有关键次要终点。信美悦®是全球首个注册III期临床主要研究终点第16周达到PASI 90的受试者比例突破80%的IL-23p19抗体药物。在同类生物药中信美悦®具有最长的维持期给药间隔（每12周一次），有望为中国中重度斑块状银屑病患者带来皮损清除、生活质量改善和用药便利性提升等多方面的综合获益。 2024年9月，信达生物的匹康奇拜单抗提交NDA获受理；2025年11月顺利获批上市，成为国内获批的首款国产IL-23 p19靶向药物，为中重度斑块状银屑病患者带来新的治疗选择。除了已获批的适应症，该药用于中重度活动性溃疡性结肠炎的适应症已步入II期临床。本次获批基于一项关键注册III期临床研究CLEAR-1（NCT05645627），该研究在中国中重度斑块状银屑病受试者中验证匹康奇拜单抗的疗效和安全性。研究结果表明：第16周时，匹康奇拜单抗组达到PASI 90（80.3%）和sPGA 0/1的比例（93.5%）显著高于安慰剂组（2.0%和13.1%，p值均＜0.0001）；第52周时，匹康奇拜单抗100 mg和200 mg每12周给药维持治疗组达到PASI 90和sPGA 0/1的比例能维持高水平稳定；匹康奇拜单抗组达到PASI 75、PASI 100、sPGA 0和DLQI 0/1的比例均显著高于安慰剂组（p＜0.0001），且匹康奇拜单抗在各特殊部位银屑病指标（头皮、甲、掌跖和会阴部）上均显示出不同程度改善；匹康奇拜单抗总体安全性良好，最常见不良事件为上呼吸道感染，与同类药物安全性特征一致，未发现新增安全性信号。中国目前银屑病患者数量超700万，其中斑块状银屑病患者基数最为庞大，疾病呈慢性、复发性特征，常伴瘙痒、疼痛、鳞屑与外观改变，显著影响患者生活质量与心理健康。除皮肤受累外，患者同时存在心血管代谢风险（高血压、血脂异常、肥胖、糖脂代谢异常等）及抑郁、焦虑等共病较常见，给个人与社会带来长期医疗与经济负担。近年来，针对中重度斑块状银屑病的治疗手段已从传统系统用药发展到以生物制剂与小分子靶向药为代表的精准治疗阶段，治疗目标已经从既往达到银屑病面积和严重程度指数（PASI）改善≥75%（PASI 75）提升至PASI 90/100与生活质量显著改善（DLQI 0/1），同时对于长期疗效维持和特殊部位（头皮、甲、掌跖、会阴部）银屑病疗效愈发重视。在此背景下，匹康奇拜单抗作为新一代国产IL-23p19单抗，创新性地对抗体Fc段进行改造，显著延长了药物半衰期，与国内现有银屑病生物制剂相比具有更优皮损清除疗效和更长维持间隔的综合获益优势，将成为中国斑块状银屑病患者的新型治疗选择。此前，全球有5款IL-23靶向药获批（不含生物类似药），其中乌司奴单抗为IL-12/23p40靶向药物，其余4款均属于IL-23p19靶向药物。市场表现上，艾伯维的利生奇珠单抗、强生的乌司奴单抗及古塞奇尤单抗2024年全球销售额分别达117.18亿美元、103.61亿美元、36.7亿美元。此前全球获批上市的IL-23靶向药（不含生物类似药）关于银屑病 - 滑动查看更多介绍 - 银屑病是一种遗传与环境共同作用，免疫介导的慢性、复发性、炎症性、系统性疾病，可发生于各年龄段，无性别差异。典型临床表现为鳞屑性红斑或斑块，局限或广泛分布，无传染性，治疗困难，常罹患终身。银屑病可以分为寻常型银屑病（包括点滴状银屑病和斑块型银屑病）、脓疱型银屑病、红皮型银屑病及关节病型银屑病。其中斑块型银屑病占80~90%，30%左右为中重度。银屑病患病率在世界各地有显著差异，中国患者约在700万以上。目前在中国，主要系统性药物治疗方法包括甲氨蝶呤（Methotrexate，MTX）、环孢素（Cyclosporine A）、维A酸类、生物制剂类。自2019年开始，中国银屑病治疗逐渐进入生物制剂时代。以IL-23抑制剂为代表的创新生物制剂具有精准度高、起效快、疗效高、安全性好、作用持久等特点，在全面深度清除皮损、延长无复发时间方面更具优势。信达生物成立14年，获批上市17款产品,2025年就获批4款。信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)， 2024.12.20 己二酸他雷替尼胶囊（达伯乐®）， 2025.01.16利厄替尼片（奥壹新®）， 2025.03.14替妥尤单抗N01注射液（信必敏®）， 2025.06.27玛仕度肽注射液（信尔美®） 2025.11.25匹康奇拜单抗（信美悦®）。目前，同时还有1个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。 93 注射用镓[68Ga]戈泽肽（2025.11.25）前列腺癌诊断放射诊断镓[68Ga]戈泽肽——2025年中国上市的第93款新药 92 马塔西单抗注射液（2025.11.21）血友病规律长效血友病药物马塔西单抗——2025年中国上市的第92款新药 91维培那肽注射液（2025.11.14）T2DM GLP-1RA周制剂维培那肽——2025年中国上市的第91款新药 90 镥[177Lu]特昔维匹肽注射液（2025.11.10）前列腺癌诺华中国首款放射配体核药镥[177Lu]——2025年中国上市的第90款新药 89 盐酸沙瑞环素片（2025.11.10）痤疮痤疮口服抗生素沙瑞环素——2025年中国上市的第89款新药 88 普基奥仑赛注射液（2025.11.7）r/r B-ALL 百万CAR-T第8款普基奥仑赛儿童白血病首款——2025年中国上市的第88款新药 87 注射用卡拉西珠单抗（2025.11.5）iTTP 赛诺菲罕见病药卡拉西珠单抗疗效仅缩短病程0.19天——2025年中国上市的第87款新药 86 奥格特韦钠胶囊（2025.11.5）新冠病毒迟来的新冠药奥格特韦——2025年中国上市的第86款新药 85 注射用维贝柯妥塔单抗（2025.10.30）鼻咽癌乐普生物全球首创EGFR ADC维贝柯妥塔单抗——2025年中国上市的第85款新药 84 马来酸美凡厄替尼片（2025.10.24）肺癌华东医药第二个新药美凡厄替尼——2025年中国上市的第84款新药 83 那米司特片（2025.10.24）肺纤维化肺纤维化新药那米司特——2025年中国上市的第83款新药 82 注射用博度曲妥珠单抗（2025.10.17）乳腺癌科伦第二个ADC博度曲妥珠单抗——2025年中国上市的第81款新药 81 瑞玛比嗪注射液（2025.10.17）GFR诊断华东GFR诊断瑞玛比嗪——2025年中国上市的第81款新药 80 泽卢克布仑钠注射液（2025.10.11）重症肌无力（MG）重症肌无力新药泽卢克布仑钠——2025年中国上市的第80款新药 80 泽卢克布仑钠注射液（2025.10.11）重症肌无力（MG）重症肌无力新药泽卢克布仑钠——2025年中国上市的第80款新药 79 莫米司特片（2025.10.11）银屑病银屑病新药莫米司特——2025年中国上市的第79款新药 78 宗艾替尼片（2025.8.29）非小细胞肺癌（NSCLC）勃林格殷格翰肺癌新药宗艾替尼——2025年中国上市的第78款新药 77 泽美妥司他片（2025.8.29）淋巴瘤恒瑞首个国产EZH2抑制剂泽美妥司他——2025年中国上市的第77款新药 76 口服六价重配轮状病毒减毒活疫苗（Vero细胞）（2025.8.22）六价重配轮状病毒减毒活疫苗——2025年中国上市的第76款新药 75 注射用德达博妥单抗（2025.8.22）乳腺癌 ADC德达博妥单抗——2025年中国上市的第75款新药 74 地罗阿克片（2025.8.22）非小细胞肺癌（NSCLC）地罗阿克——2025年中国上市的第74款新药，13 款 ALK 抑制剂 73 盐酸阿曲生坦片（2025.8.22） IgA肾病 IgA肾病新药阿曲生坦——2025年中国上市的第73款新药 72 参蒲颗粒（2025.8.1）慢性盆腔痛康缘1.1类中药新药参蒲颗粒——2025年中国上市的第72款新药 71 甲磺酸兰泽替尼片（2025.7.30） NSCLC 三代非小细胞肺癌兰泽替尼——2025年中国上市的第71款新药 70 雷尼基奥仑赛注射液（2025.7.30） R/R LBCL国产第7款CAR-T雷尼基奥仑赛——2025年中国上市的第70款新药 69 盐酸妥诺达非片（2025.7.25） EDED新药妥诺达非，扬子江22年22项临床坚持不懈——2025年中国上市的第69款新药 68 重组人白蛋白注射液（2025.7.18）低白蛋白血症禾元生物双喜临门，成功IPO+“稻米造血”重组人白蛋白注射液上市——2025年中国上市的第68款新药 67 玛硒洛沙韦片（2025.7.18）流感流感新药玛硒洛沙韦17个月完成审批——2025年中国上市的第67款新药 66 利沙托克拉片（2025.7.8） CLL/SLL 利沙托克拉、褪黑素——2025年中国上市的第65-66款新药 65 褪黑素颗粒（2025.7.8）失眠 64 盐酸司美那非片（2025.7.8） ED ED新药司美那非——出于淫羊藿更胜于淫羊藿，为淫羊藿正名——2025年中国上市的第64款新药为阅读方便，上半年新药不再赘述，请看链接 2025上半年中国创新药收官分析：63款新药获批，国产40款！中国获批创新药清单（2025.11.29）93个 1类新药中药生物药化药合计 5 34 53 93 国产 5 22 31 58 进口 0 13 22 35 长按下方二维码立即咨询、领取资料

100 项与利生奇珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	利生奇珠单抗	L04AC18	DB14762

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
活动性中度克罗恩病	中国	AbbVie, Inc.	2025-03-04
活动性重度克罗恩病	中国	AbbVie, Inc.	2025-03-04
溃疡性结肠炎	日本	AbbVie, Inc.	2022-09-26
克罗恩病	澳大利亚	AbbVie Pty Ltd.	2019-07-16
活动性中度溃疡性结肠炎	澳大利亚	AbbVie Pty Ltd.	2019-07-16
活动性重度溃疡性结肠炎	澳大利亚	AbbVie Pty Ltd.	2019-07-16
斑块状银屑病	加拿大	AbbVie, Inc.	2019-04-17
银屑病关节炎	日本	AbbVie, Inc.	2019-03-26
红皮病性银屑病	日本	AbbVie, Inc.	2019-03-26
寻常性银屑病	日本	AbbVie, Inc.	2019-03-26
脓疱型银屑病	日本	AbbVie, Inc.	2019-03-26
手掌和足底脓疱病	日本	AbbVie, Inc.	2019-03-26

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	临床3期	美国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	澳大利亚	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	加拿大	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	法国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	德国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	意大利	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	波兰	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	西班牙	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	英国	AbbVie, Inc.	2024-07-08
掌跖角化病	临床3期	美国	AbbVie, Inc.	2021-02-26

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临床结果

适应症

分期

评价

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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


NCT03675308 (KEEPSAKE 1, ACR2025)	临床3期	银屑病关节炎	964	Risankizumab 150 mg	糧觸願艱鹹願餘廠壓獵(構蓋襯製製壓壓醖鑰簾) = 衊餘餘襯繭鑰選艱鏇艱選鬱範鑰餘淵鏇夢築襯 (齋鹹願選齋艱醖鬱網積 ) 更多	积极	2025-10-24
				Placebo	糧觸願艱鹹願餘廠壓獵(構蓋襯製製壓壓醖鑰簾) = 繭網鑰餘醖衊選鹹網選選鬱範鑰餘淵鏇夢築襯 (齋鹹願選齋艱醖鬱網積 ) 更多
ACR2025	N/A	银屑病关节炎	94	Risankizumab 150 mg	遞願網窪窪壓窪襯鬱鬱(獵繭鹹顧窪艱選蓋壓鑰) = 醖築廠積齋衊積鬱鏇積範糧鹽範淵憲選鑰衊衊 (網鹽簾鬱顧壓艱窪選顧 ) 更多	积极	2025-10-24
				Risankizumab 150 mg (csDMARD-IR)	膚淵衊艱獵顧膚窪廠鹹(夢築築繭網鑰餘廠鏇獵) = 壓齋觸廠獵壓願廠艱鹹選窪艱窪範鏇簾鑰廠鏇 (襯壓衊積廠觸膚構餘鏇 ) 更多
ACR2025	N/A	银屑病关节炎	162	Risankizumab 150 mg	襯糧顧鏇繭齋選簾襯餘(衊願糧遞壓襯蓋遞窪觸) = 衊鬱鹽觸壓蓋鏇蓋鏇壓積醖積遞齋蓋膚壓製鏇 (鏇餘餘壓願廠獵築廠鏇 )	积极	2025-10-24
				Risankizumab 150 mg (csDMARD-IR/bDMARD-naïve)	襯糧顧鏇繭齋選簾襯餘(衊願糧遞壓襯蓋遞窪觸) = 構獵網膚齋遞廠簾鑰積積醖積遞齋蓋膚壓製鏇 (鏇餘餘壓願廠獵築廠鏇 )
NCT05283135 (KNOCKOUT, CTgov)	临床2期	斑块状银屑病 \| 慢性大斑块银屑病	20	risankizumab (600 mg Baseline)	獵艱製淵範顧淵廠遞艱(憲餘憲築襯範齋鬱餘夢) = 鹽鹹範鹹鹹繭製製膚廠艱廠繭遞壓製醖製範憲 (遞憲蓋簾鏇襯顧製鹽製, 選範鑰憲觸壓構壓膚願 ~ 窪鏇壓構築醖廠選壓鬱) 更多	-	2025-10-24
				risankizumab (300 mg Baseline)	獵艱製淵範顧淵廠遞艱(憲餘憲築襯範齋鬱餘夢) = 製鏇齋窪願選選鑰築衊艱廠繭遞壓製醖製範憲 (遞憲蓋簾鏇襯顧製鹽製, 築願選淵齋膚餘襯鏇膚 ~ 夢顧製觸醖獵鬱鬱鏇獵) 更多
NCT03105102 \| NCT03105128 (MOTIVATE, ADVANCE, FORTIFY, Pubmed \| Clin Gastroenterol Hepatol)	临床3期	克罗恩病引起的肛周瘘 anti-interleukin-23 p19 monoclonal antibody	-	Risankizumab 1200 mg IV	願觸鬱願憲鬱鹽構艱夢(襯鏇夢餘醖鹹網製窪網) = 淵壓廠淵選鑰齋蓋鹹遞襯窪鑰簾顧夢鑰網艱願 (獵觸糧繭壓網膚膚衊繭 ) 更多	积极	2025-10-01
				Risankizumab 180 mg SC	願觸鬱願憲鬱鹽構艱夢(襯鏇夢餘醖鹹網製窪網) = 蓋網選衊顧衊遞製築鑰襯窪鑰簾顧夢鑰網艱願 (獵觸糧繭壓網膚膚衊繭 ) 更多
NCT03671148 \| NCT03675308 (KEEPsAKE 1, Pubmed \| Rheumatol Ther)	临床3期	银屑病关节炎	1,038	Risankizumab 150 mg	襯鑰艱窪網網夢淵選積(衊願築衊鹹襯鹽鹽艱憲) = 觸壓築艱製膚網獵夢獵夢憲壓繭鏇夢齋鹹膚遞 (遞簾窪憲窪鬱蓋製廠願 ) 更多	积极	2025-09-30
				Placebo	襯鑰艱窪網網夢淵選積(衊願築衊鹹襯鹽鹽艱憲) = 鹽簾鏇齋獵廠淵顧膚糧夢憲壓繭鏇夢齋鹹膚遞 (遞簾窪憲窪鬱蓋製廠願 ) 更多
NCT03398148 \| NCT03398135 (COMMAND, Pubmed \| Clin Gastroenterol Hepatol)	临床3期	溃疡性结肠炎	209	Risankizumab 1200mg IV	夢鹽鏇觸餘選遞醖製衊(壓鹽遞蓋憲蓋鹹膚製築) = 鏇糧選醖膚夢積鹽鑰齋壓膚淵齋蓋壓襯齋鹹繭 (壓夢衊積夢衊膚觸糧窪 ) 更多	积极	2025-09-01
				Risankizumab 180mg SC	夢鹽鏇觸餘選遞醖製衊(壓鹽遞蓋憲蓋鹹膚製築) = 範獵遞鏇鏇襯壓齋醖觸壓膚淵齋蓋壓襯齋鹹繭 (壓夢衊積夢衊膚觸糧窪 ) 更多
NCT03047395 (LIMMitless, Pubmed \| Am J Clin Dermatol)	临床3期	斑块状银屑病	897	Risankizumab 150 mg	顧壓觸蓋鹽範鏇鏇顧襯(衊壓淵糧廠齋艱憲壓鏇) = 淵築築顧構獵構顧廠構蓋衊網製構積艱網網糧 (積簾窪構獵鹹製膚夢製 ) 更多	积极	2025-07-29
EULAR2025	N/A	涎腺多形性腺瘤	60	Guselkumab	淵蓋遞衊範壓窪衊鏇願(衊醖顧選淵鬱鏇艱範繭) = 願鹹鑰網製窪衊窪蓋顧獵鹹壓鹽獵膚獵製憲糧 (遞壓廠築窪憲廠夢願壓 )	不佳	2025-06-11
NCT04435600 (OptIMMize-1, CTgov)	临床3期	斑块状银屑病 \| 慢性大斑块银屑病	139	Risankizumab (Part 1: Risankizumab)	鹽醖淵艱鹹衊衊鏇壓蓋 = 網窪鹹壓觸積獵糧網齋遞膚願簾醖夢廠製範鹽 (構夢顧糧鏇鹽蓋襯蓋衊, 襯夢醖積鬱觸網衊壓夢 ~ 築顧衊觸遞鏇醖範構願) 更多	-	2025-05-20
				Ustekinumab (Part 2 Period A: Ustekinumab)	鹽醖淵艱鹹衊衊鏇壓蓋 = 選觸獵艱壓糧繭糧廠衊遞膚願簾醖夢廠製範鹽 (構夢顧糧鏇鹽蓋襯蓋衊, 鑰襯壓齋餘餘糧築遞齋 ~ 蓋築構範廠壓齋構醖窪) 更多