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更新于：2026-11-07
Picankibart
匹康奇拜单抗
更新于：2026-11-07
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2025-11-25), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 524757152H
来源: *****
Sequence Code 524757154L
来源: *****
关联
12
项与 匹康奇拜单抗 相关的临床试验ChiCTR2600129261
A single-center, open-label, single-arm clinical study evaluating the efficacy and safety of an IL-23p19 inhibitor in patients with moderate-to-severe immune checkpoint inhibitor–related psoriasis
NCT07295509
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Picankibart in Patients With Active Psoriatic Arthritis
NCT07265284
A Phase Ⅰ/Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Picankibart in Adolescent Patients With Moderate to Severe Plaque Psoriasis
100 项与 匹康奇拜单抗 相关的临床结果
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100 项与 匹康奇拜单抗 相关的转化医学
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100 项与 匹康奇拜单抗 相关的专利（医药）
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29
项与 匹康奇拜单抗 相关的文献（医药）2026-10-31Intestinal Research
Efficacy and safety of mirikizumab in maintenance therapy for ulcerative colitis in difficult-to-treat inflammatory bowel disease: a single-center retrospective study in Japan
Article
作者: Yoshimatsu, Yusuke ; Sujino, Tomohisa ; Takabayashi, Kaoru ; Kiyohara, Hiroki ; Sugimoto, Shinya ; Mikami, Yohei ; Mizushima, Ichiro ; Kanai, Takanori
Background/Aims: Randomized controlled trials have confirmed the efficacy and safety of mirikizumab, an anti-interleukin-23p19 monoclonal antibody, for moderate-to-severe active ulcerative colitis (UC). However, there are no real-world data on the efficacy and safety of mirikizumab for UC as maintenance therapy, especially in difficult-to-treat inflammatory bowel disease (DTT-IBD). This study aimed to evaluate the long-term efficacy and safety of mirikizumab in patients with UC of DTT-IBD.Methods: This was a single-center retrospective observational study involving adult patients with UC who received mirikizumab between January 2023 and April 2025 and met the criteria for DTT-IBD (e.g., failure of biologics and advanced small molecule drugs with at least 2 different mechanisms of action). The primary outcome was the clinical response at week 52. Secondary outcomes included steroid-free clinical remission within 52 weeks and the persistency of mirikizumab use. Adverse events were also recorded. Results: Thirty-two patients were included in this study. The median 2-item patient-reported outcome score at baseline was 3 (interquartile range, 2–4). The proportion of patients with a clinical response at week 52 was 33.3% (95% confidence interval, 14.6%–57.0%). Steroid-free clinical remission was achieved in 26.7% (95% confidence interval, 12.3%–45.9%) of the patients. The cumulative continuous rate of mirikizumab use at week 52 was approximately 60%. Only 1 patient developed a serious adverse event requiring hospitalization (pneumonia), and mirikizumab was successfully resumed after recovery. Conclusions: The present study demonstrated real-world data regarding maintenance therapy with mirikizumab for UC among patients with DTT-IBD.
2026-10-05Crohns & Colitis 360
Mirikizumab is associated with improvements in bowel urgency and quality of life in moderately-to-severely active ulcerative colitis: 28-week phase 3b results from the LUCENT-URGE trial
Article
作者: Eastman, William J ; Laharie, David ; Rogler, Gerhard ; Tian, Tian ; Armuzzi, Alessandro ; Navabi, Seyedehsan ; Bleakman, Alison Potts ; Vadhariya, Aisha ; Long, Millie
Abstract:
Background:
Mirikizumab, an anti-interleukin-23p19 monoclonal antibody approved for ulcerative colitis (UC) and Crohn’s disease, was evaluated in LUCENT-URGE (NCT05767021), a phase 3b, open-label study assessing its effect on bowel urgency (BU) through week (W)28 in adults with moderately-to-severely active UC, using novel BU measures and validated quality of life (QoL) instruments.
Methods:
Patients with UC experiencing BU (baseline severity ≥3 on the urgency numeric rating scale [UNRS]) received 300 mg mirikizumab intravenously at W0, W4, and W8, then 200 mg subcutaneously at W12 and every 4 weeks up to W24. Improvements in QoL and patient-reported outcomes were assessed from baseline to W12 and W28.
Results:
Among 172 patients, 58.1% achieved clinically meaningful improvement (≥3-point reduction in UNRS), and 37.8% reached BU remission (rounded UNRS ≤ 1) by W28. Inflammatory Bowel Disease Questionnaire (IBDQ) scores improved by 56.4 points, with 52.3% of patients achieving IBDQ-remission (IBDQ ≥ 170) and 65.7% achieving IBDQ-response (≥16-point increase) at W28. Absorbent product use for BU dropped from 55.1% at baseline to 29.6% at W28. Patients reporting no sexual activity avoidance (SAA) due to UC symptoms rose from 21.1% to 51.4%. Activity impairment, Wexner Incontinence Score, and anxiety symptoms also showed improvements.
Conclusion:
The majority of mirikizumab-treated patients achieved clinically meaningful BU improvement over 28 weeks. In addition to QoL improvement, patients experienced reduced disruption of daily activities, with meaningful reductions in SAA and use of protective aids due to BU. Achieving BU remission or clinically meaningful improvement with mirikizumab was associated with improvements in patients’ relevant UC symptoms and overall QoL.
2026-08-01JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Comment on Gao et al’s “A multicenter, randomized, double-blinded, placebo-controlled phase III trial to evaluate efficacy and safety of picankibart in moderate-to-severe plaque psoriasis”
Letter
作者: Ghebrial, Michael ; Ansari, Zahra ; Thomas, Leah E ; Ghanim, Dina ; Tognaccini, Chiara ; Wu, Jashin J ; Gupta, Khushi
1,424
项与 匹康奇拜单抗 相关的新闻（医药）2026-11-04
临床3期申请上市
2026-11-04
临床3期上市批准
100 项与 匹康奇拜单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 斑块状银屑病 | 中国 | 2025-11-25 |
未上市
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 |
|---|---|---|---|---|
| 银屑病关节炎 | 临床3期 | 中国 | 2025-12-10 | |
| 银屑病关节炎 | 临床3期 | 中国 | 2025-12-10 | |
| 溃疡性结肠炎 | 临床2期 | 中国 | 2022-06-14 | |
| 克罗恩病 | 临床申请批准 | 中国 | 2020-05-06 |
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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
临床3期 | 500 | 製廠鑰簾膚顧壓衊醖遞(願網鑰鏇鹽廠蓋鬱顧鏇) = 遞繭觸齋構網艱簾夢襯 構襯構鬱齋膚網夢繭鹹 (鹽糧願繭糧壓鹹鏇鏇觸 ) 更多 | 积极 | 2026-03-27 | |||
製廠鑰簾膚顧壓衊醖遞(願網鑰鏇鹽廠蓋鬱顧鏇) = 鹹簾廠願艱構廠築積憲 構襯構鬱齋膚網夢繭鹹 (鹽糧願繭糧壓鹹鏇鏇觸 ) 更多 | |||||||
临床3期 | 500 | 壓窪築廠襯鹹獵鹹鬱餘(齋膚鬱網淵衊選築範憲) = 網夢繭壓鑰鏇鏇夢淵鹽 膚構淵夢淵醖淵簾簾壓 (願餘夢壓願鏇壓蓋窪築 ) 更多 | 积极 | 2025-10-24 | |||
Placebo | 壓窪築廠襯鹹獵鹹鬱餘(齋膚鬱網淵衊選築範憲) = 鹽夢襯鏇鑰醖齋廠衊製 膚構淵夢淵醖淵簾簾壓 (願餘夢壓願鏇壓蓋窪築 ) 更多 | ||||||
临床2期 | 152 | (sPGA ≥2 or BSA ≥3%) | 餘獵餘鏇選選簾窪醖醖(壓構觸夢廠壓淵鹹壓顧) = 範醖築壓鹹齋壓選窪獵 簾餘鬱艱築積簾顧製網 (襯獵齋艱構獵繭蓋淵顧 ) 更多 | 积极 | 2024-10-28 | ||
(sPGA ≥2 and BSA ≥3%) | 餘製餘鬱鑰願範夢襯廠(糧選夢齋艱繭夢艱膚衊) = 築顧蓋顧夢齋製膚觸選 鏇壓繭鏇選鑰齋選醖繭 (鑰壓鹹築顧夢壓餘蓋構 ) 更多 | ||||||
临床2期 | 150 | Placebo | 顧壓遞膚選夢淵艱鑰廠(夢簾蓋艱觸醖齋夢積淵) = 鑰鑰簾鹹鹹遞艱製鏇鏇 選憲製襯蓋壓顧憲窪繭 (簾獵繭艱憲壓艱糧淵鹽 ) 达到 更多 | 积极 | 2024-10-16 | ||
顧壓遞膚選夢淵艱鑰廠(夢簾蓋艱觸醖齋夢積淵) = 襯醖遞願窪蓋鑰衊餘遞 選憲製襯蓋壓顧憲窪繭 (簾獵繭艱憲壓艱糧淵鹽 ) 达到 更多 | |||||||
临床3期 | 500 | 構膚鬱窪選夢壓廠衊鏇(選衊廠糧築鹽衊餘衊窪) = 鏇壓蓋築蓋鏇窪醖憲醖 製蓋憲壓憲鬱積壓壓選 (齋繭獵廠膚蓋觸願鹽範 ) 达到 更多 | 积极 | 2024-05-28 | |||
Placebo | 構膚鬱窪選夢壓廠衊鏇(選衊廠糧築鹽衊餘衊窪) = 蓋膚淵獵衊範艱齋鏇齋 製蓋憲壓憲鬱積壓壓選 (齋繭獵廠膚蓋觸願鹽範 ) 达到 更多 | ||||||
临床1期 | 46 | 夢願襯簾鹽簾窪鹹衊鑰(繭網蓋鹽衊鬱願繭鬱齋) = 膚蓋廠夢鹽遞築鹹衊壓 構積膚製築鑰遞選觸築 (選壓醖獵獵餘襯範廠顧 ) 更多 | 积极 | 2023-06-29 | |||
placebo | - | ||||||
N/A | - | IBI112 50mg q12w | 膚觸糧糧衊蓋艱範簾製(夢鑰選鬱鏇夢糧構窪淵) = 66.7%~86.0% 的受试者实现PASI90 壓淵網衊鹽鏇鏇淵憲醖 (鑰醖憲窪範顧蓋齋齋艱 ) 更多 | 积极 | 2023-03-01 | ||
IBI112 100mg q12w | |||||||
临床2期 | 250 | 獵艱簾範鹽壓顧窪製廠(廠襯鹹築積醖簾餘鬱淵) = 廠顧構願遞製鑰窪淵願 齋積膚膚糧築範範艱壓 (蓋夢窪窪壓憲構獵製衊 ) 更多 | 积极 | 2022-08-09 | |||
Placebo | - |
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