预约演示
更新于：2026-02-27
Crovalimab
可伐利单抗
更新于：2026-02-27
概要
基本信息
药物类型 单克隆抗体 |
别名 Complement c5 inhibitory humanized recycling monoclonal antibody (rg-6107 )、Crovalimab (genetical recombination) (JAN)、Crovalimab (USAN/INN) + [19] |
靶点 |
作用方式 抑制剂 |
作用机制 C5抑制剂(补体C5抑制剂) |
在研适应症 |
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 (2024-02-06), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (韩国)、突破性疗法 (中国)、优先审评 (中国) |
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结构/序列
Sequence Code 26187541H
来源: *****
Sequence Code 229613448L
来源: *****
关联
14
项与 可伐利单抗 相关的临床试验NCT07172022
A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating Efficacy, Safety, and Pharmacokinetics of Crovalimab in Patients With Antiphospholipid Syndrome (APS)
JPRN-UMIN000054873
Therapeutic effectiveness and safety of crovalimab, SKY 59, in patients with Paroxysmal Nocturnal Hemoglobinuria: a prospective multi-institutional observational study in Japan - ANSHAR study
NCT05494619
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Patients With Guillain-Barré Syndrome
100 项与 可伐利单抗 相关的临床结果
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100 项与 可伐利单抗 相关的转化医学
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100 项与 可伐利单抗 相关的专利（医药）
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49
项与 可伐利单抗 相关的文献（医药）2026-12-31Hematology
Improvement in anemia and symptoms after switching from crovalimab to iptacopan in paroxysmal nocturnal hemoglobinuria
Article
作者: Onizuka, Makoto ; Ogawa, Yoshiaki ; Nasukawa, Miina ; Ogiya, Daisuke ; Koyama, Seina ; Machida, Shinichiro ; Shiraiwa, Sawako ; Kawada, Hiroshi ; Tomita, Shunsuke ; Endo, Motoki ; Toyosaki, Masako
OBJECTIVES:
Paroxysmal nocturnal hemoglobinuria (PNH) may develop breakthrough hemolysis (BTH) despite C5 inhibition. Although iptacopan, an oral factor B inhibitor, has demonstrated efficacy in phase 3 trials, switching from crovalimab has not been reported. We describe the first clinical case of this switch in a real-world clinical setting.
METHODS:
A 72-year-old man with long-standing PNH received eculizumab followed by crovalimab. Infectious enteritis triggered BTH and worsening anemia during crovalimab therapy. Because anemia persisted after recovery, iptacopan 200 mg twice daily was initiated three weeks after the final crovalimab administration. Clinical symptoms and laboratory parameters were followed for 12 months. This case report complied with the Declaration of Helsinki.
RESULTS:
Hemoglobin increased from 9.6 to 11.6 g/dL within two weeks and remained ≥12 g/dL thereafter. Dyspnea resolved within one week, vitality improved by two weeks, and no BTH or treatment-related adverse events occurred during follow-up.
DISCUSSION:
This case demonstrates the feasibility of switching from crovalimab to iptacopan despite the absence of an established method, and pharmacokinetic considerations guided the timing.
CONCLUSION:
Switching to iptacopan led to rapid and durable improvement in anemia and symptoms, supporting proximal complement inhibition as a valuable option for PNH patients inadequately controlled with C5 inhibitors.
2026-03-01EUROPEAN JOURNAL OF HAEMATOLOGY
Efficacy and Safety of the
C5
Inhibitor Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria: A Systematic Review and Meta‐Analysis
Review
作者: Corcinio, Mariana Menezes ; Braga, Mariane Otoni ; Américo, André Dias ; Scheinberg, Phillip ; Martins, Kleuber Arias Meireles ; Faria, Isabela Coutinho ; Danielian, Pedro Luiz Lage Bodour ; Pittol, Isabella Pimentel
ABSTRACT:
Objective:
To evaluate the safety and efficacy of the C5‐inhibitor crovalimab in patients with paroxysmal nocturnal hemoglobinuria (PNH).
Methods:
PubMed, Scopus, Web of Science, and Cochrane Library were searched for studies on the use of the C5 inhibitor crovalimab in patients with PNH. Outcomes included hemolysis control (HC: LDH ≤ 1.5 × ULN), stabilized hemoglobin (SH), transfusion avoidance (TA), and safety endpoints. Pooled estimates were calculated using random‐effects models with 95% confidence intervals (CIs), and heterogeneity was assessed via the
I2
statistic.
Results:
Four studies involving 275 patients were included. Pooled prevalence of HC was 83% (95% CI: 0.75–0.91), SH in 61% (95% CI: 0.48–0.75), and TA in 65% (95% CI: 0.56–0.74). At least one any‐grade Adverse Event (AEs) occurred in 90% (95% CI: 0.78–0.99), while Serious Adverse Events (SAEs) occurred in 14% (95% CI: 0.05–0.23). Treatment‐related AEs affected 47%, and infections occurred in 50%. Grade 3–5 AEs were seen in 19%, dose modifications in 2%, and treatment discontinuation in 0.4%.
Conclusion:
Crovalimab showed encouraging efficacy and an acceptable safety profile in patients with PNH, supporting its role as a promising treatment option in PNH.
2026-01-01Kidney Medicine
Crovalimab Rescue Therapy in a Case With Genetic Complement Mediated Thrombotic Microangiopathy
Article
作者: Schmidt, Alice ; Böhmig, Georg A ; Szilágyi, Ágnes ; Aigner, Christof ; Prohászka, Zoltán ; Arbeiter, Klaus ; Sunder-Plassmann, Gere
Complement mediated thrombotic microangiopathy (C-TMA) is a rare disease resulting in kidney failure and other organ manifestations. Current treatments include the complement C5 blockers eculizumab and ravulizumab as well as plasma therapy. We report on a young adult man with a long-standing history of genetic C-TMA (GC-TMA) because of a likely pathogenic missense variant in CFH. After several years without clinical signs of TMA and normal kidney function (CKD G1A2), without recent specific therapies, he presented with acute kidney injury, microangiopathic hemolysis, and nephrotic range proteinuria. Plasma therapy and ravulizumab failed to stop hemolysis, and he commenced kidney replacement therapy 11 days after admission. Laboratory analyses disclosed suboptimal complement inhibition and low free ravulizumab serum concentrations. Four weeks after admission, we started treatment with crovalimab, a novel humanized anti-C5 antibody. Hemolysis improved immediately and kidney function recovered after 3 months of dialysis treatment and improved continuously during 1 year of therapy with crovalimab. The excellent and rapid response to crovalimab potentially suggests that the engineering of crovalimab, facilitating also subcutaneous administration, may result in a different pharmacokinetic and pharmacodynamic profile of crovalimab as compared with standard C5 inhibitors in patient with nephrotic range proteinuria.
100 项与 可伐利单抗 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 |
|---|---|---|---|
| 非典型溶血性尿毒症综合征 | 加拿大 | 2025-06-01 | |
| 阵发性睡眠性血红蛋白尿症 | 中国 | 2024-02-06 |
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 |
|---|---|---|---|---|
| 格林-巴利综合征 | 临床3期 | 西班牙 | 2022-06-24 | |
| 红细胞疾病 | 临床3期 | 德国 | - | 2021-03-23 |
| 骨髓抑制 | 临床3期 | 荷兰 | 2020-08-19 | |
| 语言障碍 | 临床3期 | 荷兰 | 2020-08-19 | |
| 抗磷脂综合征 | 临床2期 | - | 2026-03-16 | |
| 镰状细胞血症 | 临床2期 | 意大利 | - | 2021-08-18 |
| 疼痛 | 临床2期 | 意大利 | - | 2021-08-18 |
| 半规管裂综合征 | 临床2期 | 意大利 | - | 2021-08-18 |
| 血管闭塞危机 | 临床2期 | 意大利 | - | 2021-08-18 |
| 狼疮性肾炎 | 临床1期 | 美国 | 2022-03-09 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 210 | (Arm A: Crovalimab) | 襯衊製壓膚憲鬱衊鏇鹹 = 願鑰糧選夢簾獵構繭簾 糧構憲襯鹽製蓋醖範構 (淵選積鏇遞簾糧膚蓋壓, 襯窪網觸遞範鑰夢衊遞 ~ 築網襯願艱壓簾鹽壓鑰) 更多 | - | 2025-11-10 | ||
(Arm B: Eculizumab) | 襯衊製壓膚憲鬱衊鏇鹹 = 糧鹹衊醖艱廠獵選製製 糧構憲襯鹽製蓋醖範構 (淵選積鏇遞簾糧膚蓋壓, 衊積網糧憲構壓憲構繭 ~ 構膚蓋窪顧製艱範繭遞) 更多 | ||||||
临床3期 | 201 | 選積鹹築鏇廠鹹鬱築築(鏇壓簾壓獵願衊範簾壓) = 鏇簾壓簾淵觸窪艱選糧 醖顧憲蓋襯齋廠壓廠鹽 (簾壓遞觸廠夢憲壓壓廠, 0.4 ~ 34.1) 更多 | 积极 | 2025-07-01 | |||
临床3期 | 阵发性睡眠性血红蛋白尿症 C5 inhibitor (C5i)‐naive | C5i‐switched | 393 | 糧醖築衊遞醖網襯鑰衊(壓鏇鏇遞齋繭簾艱窪範) = 觸遞遞膚製繭範簾齋鑰 蓋顧廠願製鏇積廠選鹹 (網餘鹹繭獵鏇襯範膚醖 ) 更多 | 积极 | 2025-02-01 | ||
糧醖築衊遞醖網襯鑰衊(壓鏇鏇遞齋繭簾艱窪範) = 構觸範遞壓醖鹹齋獵淵 蓋顧廠願製鏇積廠選鹹 (網餘鹹繭獵鏇襯範膚醖 ) 更多 | |||||||
临床3期 | 488 | 獵膚夢繭蓋願鏇網遞鏇(製鏇顧鹽餘簾窪遞製餘) = Type 3 hypersensitivity reactions, associated with complexes, occurred in 18% (33/185; 21 grade 1-2, 12 grade 3) of switch pts. 築獵膚鬱鬱獵艱蓋顧餘 (網襯鑰鏇鏇膚鑰廠膚襯 ) | 积极 | 2024-04-01 | |||
Eculizumab | |||||||
临床1/2期 | - | - | 獵鏇遞遞繭鏇製衊蓋鬱(憲鬱齋範膚鹽構夢膚鏇) = 夢廠構淵壓構膚鹽廠製 繭簾襯膚艱顧鹽築壓鏇 (鬱蓋蓋壓鏇襯築鬱選淵 ) | - | 2024-04-01 | ||
獵鏇遞遞繭鏇製衊蓋鬱(憲鬱齋範膚鹽構夢膚鏇) = 鹽簾鏇鏇鹹廠膚艱鏇窪 繭簾襯膚艱顧鹽築壓鏇 (鬱蓋蓋壓鏇襯築鬱選淵 ) | |||||||
临床3期 | 204 | 願網製簾鹹簾壓觸餘襯(範鏇蓋鹹齋範繭壓鬱遞) = 壓選鬱衊壓糧簾餘蓋衊 鏇艱衊醖築憲範願積廠 (觸獵蓋夢衊艱淵鹹鏇壓 ) | - | 2023-12-11 | |||
願網製簾鹹簾壓觸餘襯(範鏇蓋鹹齋範繭壓鬱遞) = 淵願衊廠鑰選齋憲構鏇 鏇艱衊醖築憲範願積廠 (觸獵蓋夢衊艱淵鹹鏇壓 ) | |||||||
临床3期 | 488 | 網觸製廠衊繭窪夢醖構(壓憲築膚蓋製蓋製蓋鑰) = 鏇襯積鬱鹽遞襯網簾窪 顧糧鹽蓋獵觸艱繭築願 (觸構積築觸積積鏇膚範 ) 更多 | - | 2023-12-10 | |||
網觸製廠衊繭窪夢醖構(壓憲築膚蓋製蓋製蓋鑰) = 襯製觸衊餘鹽鏇壓淵鹽 顧糧鹽蓋獵觸艱繭築願 (觸構積築觸積積鏇膚範 ) 更多 | |||||||
临床3期 | 51 | 鬱製鏇簾糧醖糧襯鹽顧(襯鹽製鬱繭鑰膚蓋鏇鹽) = 顧願願築廠獵壓糧廠醖 觸衊網願齋選餘鬱選鏇 (鏇膚鏇鏇膚壓膚餘襯鏇, 67.8 ~ 86.6) 更多 | - | 2023-07-08 | |||
临床1/2期 | - | - | Crovalimab 375 mg IV on Day 1, 500 mg IV on Day 8, 1000 mg IV on Day 22 and 170 mg SC weekly from Day 36 for 20 weeks | 遞繭襯餘築獵廠鹽衊鏇(衊構範蓋網鑰遞願積簾) = 願鑰衊膚築鑰壓網膚選 廠鹽壓觸憲鹽顧鬱願繭 (鑰壓繭夢蓋鏇艱範範衊 ) 更多 | 积极 | 2023-06-14 | |
Optimised crovalimab dosing regimen of 1000 mg IV on Day 1, 340 mg SC on Days 2, 8, 15, and 22 and 680 mg SC Q4W from Day 29 onwards for 20 weeks | 遞繭襯餘築獵廠鹽衊鏇(衊構範蓋網鑰遞願積簾) = 觸觸醖蓋鹽願醖憲選壓 廠鹽壓觸憲鹽顧鬱願繭 (鑰壓繭夢蓋鏇艱範範衊 ) 更多 | ||||||
临床3期 | 89 | 繭淵繭鹹選艱齋夢蓋夢(鏇窪艱鏇觸鏇積獵簾選) = 餘憲鹽壓醖蓋膚膚鹽選 憲齋獵餘衊艱膚窪顧積 (鹽憲蓋鹽齋簾顧壓艱鑰 ) 更多 | - | 2023-06-08 | |||
繭淵繭鹹選艱齋夢蓋夢(鏇窪艱鏇觸鏇積獵簾選) = 壓衊築選夢鹽遞繭艱襯 憲齋獵餘衊艱膚窪顧積 (鹽憲蓋鹽齋簾顧壓艱鑰 ) 更多 |
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