预约演示
更新于：2026-08-26
Recaticimab
瑞卡西单抗
更新于：2026-08-26
概要
基本信息
药物类型 单克隆抗体 |
别名 SHR 1209、SHR-1209、艾心安 |
靶点 |
作用方式 抑制剂 |
作用机制 PCSK9抑制剂(前蛋白转化酶枯草杆菌蛋白酶Kexin-9抑制剂) |
非在研适应症 |
原研机构 |
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 (2025-01-08), |
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 13495306L
来源: *****
Sequence Code 13495316H
来源: *****
关联
23
项与 瑞卡西单抗 相关的临床试验NCT07466251
PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3): a Randomized, Double-blind, Placebo-controlled Trial
ChiCTR2600130597
Conversion Therapy with Irinotecan Liposome (II) plus Oxaliplatin, 5-FU/S-1, Adebrelimab, and Recaticimab in Borderline Resectable or Locally Advanced Pancreatic Cancer: A Single-Arm Exploratory Study
NCT07674368
A Prospective Single-Arm Clinical Study of Recakimab for Lorlatinib-Induced Hypercholesterolemia / Mixed Hyperlipidemia
100 项与 瑞卡西单抗 相关的临床结果
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100 项与 瑞卡西单抗 相关的转化医学
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100 项与 瑞卡西单抗 相关的专利（医药）
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7
项与 瑞卡西单抗 相关的文献（医药）2026-04-01PHARMACOTHERAPY
Safety and Efficacy of Recaticimab in Dyslipidemia: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials
Review
作者: Elsherbeeny, Ahmed ; Abdeldayem, Mohammed R.
ABSTRACT:
Dyslipidemia is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). Recaticimab is a novel humanized monoclonal antibody that specifically targets proprotein convertase subtilisin/kexin type 9 (PCSK9). It has shown promising results in reducing low‐density lipoprotein cholesterol (LDL‐C) levels. Here, we aim to further investigate the safety and efficacy of recaticimab in patients with dyslipidemia. We comprehensively searched PubMed, Scopus, Web of Science, and Cochrane Library databases to identify all randomized controlled trials (RCTs) comparing recaticimab with placebo. Eligible RCTs were selected, and their data were extracted and analyzed using the RevMan software. Four studies involving 1657 patients were included in this meta‐analysis. In terms of efficacy outcomes, compared with the placebo group, recaticimab significantly decreased levels of LDL‐C, non‐high‐density lipoprotein cholesterol (non‐HDL‐C), apolipoprotein B (ApoB), triglyceride (TG), and lipoprotein(a) [Lp(a)], with the following values, respectively: (mean difference (MD): −52.62, 95% confidence interval (CI) [−57.25, −47.99],
p
< 0.00001); (MD: −47.03, 95% CI [−48.96, −45.11],
p
< 0.00001); (MD: −44.33, 95% CI [−46.08, −42.58],
p
< 0.00001); (MD: −8.83, 95% CI [−13.03, −4.63],
p
< 0.0001); and (MD: −29.21, 95% CI [−32.10, −26.31],
p
< 0.00001). In terms of safety outcomes, there was no significant difference between recaticimab and placebo groups in the incidence of any adverse events (odds ratio (OR): 1.16, 95% CI [0.90, 1.51],
p
= 0.26), serious adverse events, upper respiratory tract infections, or elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma‐glutamyl transferase (GGT). However, recaticimab was associated with higher odds of injection site reactions compared with placebo (OR: 2.65, 95% CI [1.24, 5.67],
p
= 0.01). Recaticimab significantly reduced LDL‐C levels and was associated with a manageable safety profile, even with dosing intervals of up to 12 weeks. Further studies should be conducted globally in larger and more diverse patient populations.
2025-10-24CARDIOVASCULAR RESEARCH
Recaticimab in adult heterozygous familial hypercholesterolaemia (REMAIN-3): a multicentre, randomized, double-blind, placebo-controlled Phase 3 study
Article
作者: Han, Xuebin ; Liu, Qiyun ; Huang, Kai ; Wang, Luya ; Deng, Chanjuan ; Dong, YuGang ; Wang, Nan ; Sheng, Jianlong ; Wang, Zhen ; Zhou, Yujie ; Hu, Yuying ; Yao, Zhuhua ; Chen, Jiyan ; Wang, Ying ; Xu, Biao ; Lian, Qiufang ; Ling, Zhiyu ; Li, Liwen ; Peng, Daoquan ; Dai, Cuilian ; Zhang, Wei ; Yang, Haibo ; Zhong, Tingyan ; Liang, Yingzi ; Yu, Zaixin
Abstract:
Aims:
Heterozygous familial hypercholesterolaemia (HeFH) is a genetic disorder, characterized by high plasma concentrations of low-density lipoprotein cholesterol (LDL-C) from birth. This study aimed to assess the efficacy and safety of recaticimab, a new humanized anti-PCSK9 antibody capable of reducing LDL-C levels in patients with poorly controlled HeFH.
Methods and results:
REMAIN-3 was a multicentre, randomized, double-blind, placebo-controlled Phase 3 study done at 25 sites in China. Patients with a genetic or clinical diagnosis of HeFH, who were on stable lipid-lowering therapy for ≥28 days, had fasting LDL-C ≥ 2.6 mmol/L (or ≥1.8 mmol/L for those with a history of atherosclerotic cardiovascular disease), and had fasting triglyceride ≤5.6 mmol/L, were randomly allocated in a 2:1 ratio to receive subcutaneous recaticimab at 150 mg or matching placebo every 4 weeks for 12 weeks. The primary endpoint was the percentage change in LDL-C from baseline to Week 12. Overall, 143 patients underwent randomization and received recaticimab (n = 95) or placebo (n = 48). At Week 12, the mean percentage change in LDL-C from baseline was −54.4% (95% CI, −57.9 to −50.8%) in the recaticimab group and −4.5% (95% CI, −9.4 to 0.3%) in the placebo group, with a treatment difference of −49.8% (95% CI, −55.8 to −43.9%; P < 0.0001). Recaticimab was superior to placebo in improving other lipid variables, including non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein a. Treatment-related adverse events (TRAEs) were comparable between groups (27.4% with recaticimab vs. 25.0% with placebo). The most common TRAEs occurring more frequently with recaticimab than placebo were injection site reaction (8.4% vs. 0%) and increased blood creatine phosphokinase (5.3% vs. 2.1%).
Conclusion:
Recaticimab significantly lowered the LDL-C level compared with placebo, with an acceptable safety profile, providing a new effective treatment option for patients with inadequately controlled HeFH.
Registration:
ClinicalTrials.gov Identifier: NCT04844125
2025-10-20BIOMEDICAL AND ENVIRONMENTAL SCIENCES
Impact of PCSK9 Inhibitor Recaticimab on Hyperlipidemia and Plasma Glucose: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study.
Article
作者: Chen, Chen ; Zhang, Shu Yu ; Hu, Ye ; Wang, Xu Hong ; He, Xiao Hui
Objective:
Recaticimab (SHR-1209) significantly reduces low-density lipoprotein cholesterol levels. However, its effect on glucose metabolism remains unclear. This study aimed to evaluate its effect on glycemic parameters in a Chinese population.
Methods:
Recaticimab versus placebo was administered in a 5:1 ratio to 110 hyperlipidemia patients who were followed up for 24 weeks. Glycated hemoglobin (HbA1c) levels were measured at baseline every 12 weeks. Fasting plasma glucose (FPG) levels were measured at baseline at week 1, 3, 5, 8, 12, 16, 20, and 24. Repeated-measures mixed-effects models were used to determine the longitudinal association between reacticimab and FPG and HbA1c levels.
Results:
Among the 81 participants with normal glucose metabolism, HbA1c levels significantly decreased ( F = 4.568, P = 0.036). In the 29 participants with abnormal glucose metabolism, a significant time effect was observed for FPG levels ( F = 2.492, P = 0.016). For participants with normal and abnormal glucose metabolism, no significant group × time interaction effects on FPG or HbA1c levels were identified.
Conclusion:
Recaticimab showed no adverse glycemic effects in participants with normal or abnormal glucose metabolism, indicating its safety in patients with or without diabetes.
100 项与 瑞卡西单抗 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 |
|---|---|---|---|
| 复杂性血脂异常 | 中国 | 2025-01-10 | |
| 高胆固醇血症 | 中国 | 2025-01-10 | |
| 原发性高胆固醇血症 | 中国 | 2025-01-08 |
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 |
|---|---|---|---|---|
| III型高脂蛋白血症 | 临床3期 | 中国 | 2021-04-23 | |
| V型高脂蛋白血症 | 临床3期 | 中国 | 2021-04-23 | |
| 常染色体显性遗传性高胆固醇血症3型 | 临床3期 | 中国 | 2021-04-14 | |
| 不能切除的胆道癌 | 临床2期 | - | 2025-07-10 | |
| 不可切除的肝内胆管癌 | 临床2期 | - | 2025-07-10 | |
| 纯合子家族性高胆固醇血症 | 临床2期 | - | 2020-09-01 | |
| 颅内动脉粥样硬化 | 临床申请批准 | 中国 | 2026-08-20 | |
| 脑卒中 | 临床申请批准 | 中国 | 2026-08-20 |
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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
N/A | 1,541 | 鏇鹹糧衊觸鏇積鏇鑰鬱(襯窪願廠鹹顧遞築廠選) = 艱範壓鑰艱廠蓋蓋觸遞 齋鑰鏇獵鏇構廠壓選鬱 (獵網築鹹夢襯鏇網範鏇 ) 更多 | 积极 | 2025-11-03 | |||
Placebo | 鏇鹹糧衊觸鏇積鏇鑰鬱(襯窪願廠鹹顧遞築廠選) = 淵壓獵艱遞鑰鹽顧遞淵 齋鑰鏇獵鏇構廠壓選鬱 (獵網築鹹夢襯鏇網範鏇 ) 更多 | ||||||
临床3期 | 143 | 網觸蓋鑰鏇艱選壓壓簾(衊鏇繭醖網蓋鑰鑰遞顧) = 製憲範廠淵鹹衊簾觸鑰 鑰製獵遞醖積遞鬱繭選 (鑰築廠鹽觸積顧鬱鏇鹹, -57.9 ~ -50.8) 更多 | 积极 | 2025-09-05 | |||
Placebo | 網觸蓋鑰鏇艱選壓壓簾(衊鏇繭醖網蓋鑰鑰遞顧) = 網觸膚糧糧獵築網願糧 鑰製獵遞醖積遞鬱繭選 (鑰築廠鹽觸積顧鬱鏇鹹, -9.4 ~ 0.3) 更多 | ||||||
临床1期 | PCSK9 | 159 | Recaticimab 450 mg subcutaneous injection into the abdomen | 膚鏇淵醖構鏇範鹹網積(遞範積蓋糧鏇構淵餘廠) = Treatment-emergent adverse events were reported in 41/53 (77.4%, abdomen), 29/53 (54.7%, upper-arm), and 42/53 (79.2%, thigh) subjects, most of which were mild and resolved without treatment 淵襯夢衊積簾齋憲築襯 (襯網製構願顧鏇夢選淵 ) 更多 | 积极 | 2025-04-19 | |
| - | 143 | 願衊鹽醖願膚鹽顧餘餘(壓蓋餘構鏇憲鏇簾選繭) = 構鑰膚窪網鏇遞遞顧鑰 淵醖淵積醖觸齋範鬱築 (壓蓋壓廠鹹製窪願網廠 ) | 积极 | 2024-04-01 | |||
安慰剂 | 願衊鹽醖願膚鹽顧餘餘(壓蓋餘構鏇憲鏇簾選繭) = 餘網鏇艱顧範鏇鹽獵鏇 淵醖淵積醖觸齋範鬱築 (壓蓋壓廠鹹製窪願網廠 ) | ||||||
临床1/2期 | 110 | 膚鹽鏇衊蓋鬱糧顧窪範(壓築網鹽構鑰顧壓壓廠) = No serious treatment-emergent adverse events (TEAEs) occurred. 顧獵夢齋壓鹽鬱廠餘廠 (鬱膚製衊窪網壓製鏇鬱 ) 更多 | 积极 | 2022-01-18 | |||
Placebo |
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