预约演示
更新于：2025-01-18
Recaticimab
瑞卡西单抗
更新于：2025-01-18
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 |
作用机制 PCSK9抑制剂(前蛋白转化酶枯草杆菌蛋白酶Kexin-9抑制剂) |
原研机构 |
非在研机构- |
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- |
登录后查看时间轴
结构/序列
Sequence Code 13495306L
来源: *****
Sequence Code 13495316H
来源: *****
关联
16
项与 瑞卡西单抗 相关的临床试验ChiCTR2200060526
A single-center, randomized, parallel, open clinical trial comparing the bioavailability, pharmacokinetics and safety of single subcutaneous injection of SHR-1209 in healthy subjects at different sites
NCT05370950
A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers
CTR20221105
比较健康受试者不同部位单次皮下注射SHR-1209的生物利用度、药效动力学和安全性的单中心、随机、平行、开放的临床研究
100 项与 瑞卡西单抗 相关的临床结果
登录后查看更多信息
100 项与 瑞卡西单抗 相关的转化医学
登录后查看更多信息
100 项与 瑞卡西单抗 相关的专利（医药）
登录后查看更多信息
4
项与 瑞卡西单抗 相关的文献（医药）2024-11-01JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia
Article
作者: Huang, Rongjie ; Huang, Zheng ; Han, Qinghua ; Sheng, Jianlong ; Yin, Delu ; Zhao, Ruiping ; Tian, Fengsheng ; Wang, Ying ; Yang, Ping ; Hu, Xitian ; Luo, Li ; Xu, Mingtong ; Jin, Chunrong ; Ma, Likun ; Zhang, Xiwen ; Feng, Wei ; Wei, Wenhua ; Luo, Suxin ; Li, Tianfa ; Deng, Chanjuan ; Wu, Yanqing ; Sun, Jiao ; Zhang, Yumin ; Lai, Chunlin ; Liu, Yong ; Liu, Zhiyuan ; Li, Liwen ; Ling, Zhiyu ; Han, Xuebin ; Ge, Xiaofeng ; Xu, Biao ; Ma, Liping ; Ge, JunBo ; Yao, Zhuhua ; Wang, Zhen ; Yan, Li ; Lv, Chao
BACKGROUND:
Monoclonal antibodies against proprotein convertase subtilisin/kexin type 9 (PCSK9) have been used to reduce the level of low-density lipoprotein cholesterol (LDL-C), but require either biweekly or monthly dosing frequency. Recaticimab is a new humanized monoclonal antibody selectively targeting PCSK9, with long-acting characteristic.
OBJECTIVES:
The purpose of this study was to assess the efficacy and safety of recaticimab monotherapy in patients with nonfamilial hypercholesterolemia and mixed hyperlipemia at low-to-moderate atherosclerotic cardiovascular disease (ASCVD) risk, and to explore different dosing strategies to provide patients with flexible administration options.
METHODS:
This was a randomized, double-blind, placebo-controlled, phase 3 study conducted at 59 sites in China. Patients with fasting LDL-C ≥2.6 to <4.9 mmol/L, fasting triglyceride ≤5.6 mmol/L, and 10-year ASCVD risk score <10% were randomly assigned (2:2:2:1:1:1) to receive subcutaneous injections of recaticimab at 150 mg every 4 weeks (Q4W), 300 mg every 8 weeks (Q8W), or 450 mg every 12 weeks (Q12W), or matching placebo, on background lipid-lowering diet. Primary endpoint was percentage change in LDL-C from baseline to week 12 for 150 mg Q4W and 450 mg Q12W and to week 16 for 300 mg Q8W.
RESULTS:
A total of 703 patients underwent randomization and received recaticimab (n = 157, 156, and 155 for 150 mg Q4W, 300 mg Q8W, and 450 mg Q12W, respectively) or placebo (n = 78, 79, and 78, respectively). Compared with placebo, recaticimab further reduced LDL-C by 49.6% (95% CI: 44.2%-54.9%) at 150 mg Q4W, 52.8% (95% CI: 48.3%-57.2%) at 300 mg Q8W, and 45.0% (95% CI: 41.0%-49.0%) at 450 mg Q12W (P < 0.0001 for all comparisons). Safety with recaticimab was comparable to placebo. After 12 or 16 weeks of treatment, patients who received recaticimab continued treatment until week 24, whereas those allocated to placebo were switched to recaticimab treatment with the same dosing strategy. Both 24-week recaticimab and 12- or 8-week recaticimab switched from placebo were effective. With 24 weeks of recaticimab treatment, the most common treatment-related adverse event was injection site reaction (n = 23 [4.9%]).
CONCLUSIONS:
Recaticimab monotherapy yielded significant LDL-C reductions and showed comparable safety vs placebo in patients with nonfamilial hypercholesterolemia and mixed hyperlipemia at low-to-moderate ASCVD risk, even with an infrequent dosing interval up to Q12W.
2024-11-01JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia
Article
作者: Sheng, Jianlong ; Ma, Xueping ; Huang, Rongjie ; Li, Juxiang ; Zheng, Zeqi ; Gu, Xiang ; Wang, Mian ; Ma, Chang-Sheng ; Han, Yajun ; Zhang, Yumin ; Sun, Yihong ; Wang, Junkui ; Su, Guohai ; Yao, Zhuhua ; Shen, Aidong ; Zheng, Mingqi ; Zhang, WeiHua ; Guo, Yuhan ; Wang, Zhifang ; Hong, Lang ; He, Liu ; Li, Yue ; Lv, Qiang ; Gao, Xiaohong ; Du, Xin ; Wu, Shaorong ; Wang, Ying ; Lai, Chunlin ; Luo, Suxin ; Zhong, Tingyan
BACKGROUND:
Currently available antiproprotein convertase subtilisin/kexin type 9 monoclonal antibodies can effectively decrease low-density lipoprotein cholesterol (LDL-C) levels, but require frequent dosing. Recaticimab is a novel humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9. In a phase 1b/2 trial, recaticimab as add-on to stable statins showed robust LDL-C reduction with a dosing interval up to every 12 weeks (Q12W) in patients with hypercholesterolemia.
OBJECTIVES:
REMAIN-2 (REcaticiMab Add-on therapy In patients with Nonfamilial hypercholesterolemia) aimed to assess the efficacy and safety of 48-week treatment with recaticimab as add-on therapy to statins in nonfamilial hypercholesterolemia.
METHODS:
REMAIN-2 was a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial. During the run-in period, patients received stable moderate or high-intensity statin, with or without cholesterol absorption inhibitors (ezetimibe) or fenofibrate, for ≥4 weeks. Patients with an LDL-C of ≥1.8 mmol/L (if with atherosclerotic cardiovascular disease [ASCVD]) or ≥2.6 mmol/L (if without ASCVD) were then randomized (2:2:2:1:1:1) to receive recaticimab 150 mg every 4 weeks (Q4W), 300 mg every 8 weeks (Q8W), or 450 mg Q12W, or matching placebo injections (Q4W, Q8W, or Q12W) for 48 weeks. The primary efficacy endpoint was percentage change from baseline to week 24 in LDL-C level.
RESULTS:
A total of 689 randomly assigned patients received treatment (mean age, 55.8 years; male, 64.4%; ASCVD history, 69.5%; concomitant ezetimibe, 11.2%; mean baseline LDL-C, 2.8 mmol/L). Percentage change in LDL-C from baseline to week 24 was significantly more pronounced with recaticimab vs placebo (P < 0.0001), with least-squares mean differences of -62.2% (95% CI: -67.0% to -57.4%), -59.7% (95% CI: -65.0% to -54.4%), and -53.4% (95% CI: -58.7% to -48.2%) for the 150 mg Q4W, 300 mg Q8W, and 450 mg Q12W regimens, respectively. The decreases in LDL-C with recaticimab were maintained through week 48. Secondary lipid variables, including non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) also favored the recaticimab groups. During the treatment period, the incidence of treatment-related adverse events (28.5% vs 26.6%) and serious treatment-related adverse events (0.4% vs 0.4%) was similarly low in both the recaticimab and placebo groups.
CONCLUSIONS:
Recaticimab as add-on to stable statin therapy significantly decreased LDL-C levels at week 24 and sustained the decreases through week 48, providing a novel therapeutic alternative with a dosing interval of up to every 12 weeks in patients with nonfamilial hypercholesterolemia.
2023-12-01Current Atherosclerosis Reports
Highlights of Cardiovascular Disease Prevention Studies Presented at the 2023 European Society of Cardiology Congress
Review
作者: Hinkamp, Colin ; Minhas, Abdul Mannan Khan ; Vaughan, Elizabeth ; Gupta, Kartik ; Kalra, Dinesh ; Slipczuk, Leandro ; Meloche, Chelsea ; Habib, Fatima Zohra ; Virani, Salim S ; Sheikh, Sana ; Andrews, Tyler
PURPOSE OF REVIEW:
To summarize selected late-breaking science on cardiovascular (CV) disease prevention presented at the 2023 European Society of Cardiology (ESC) congress.
RECENT FINDINGS:
The NATURE-PARADOX was a naturally randomized trial that used genetic data from the UK Biobank registry to create "cumulative exposure to low-density lipoprotein-cholesterol (LDL-C)" biomarker and evaluate its association with major CV events regardless of plasma LDL-C levels or age. Safety and efficacy data of inclisiran, a PCSK9-interfering mRNA (PCSK9i) administered subcutaneously twice annually, were presented. Data on two new PCSK9is were presented, recaticimab, an oral drug, and lerodalcibep, a subcutaneous drug with a slightly different architecture than currently available PSCK9is. A phase 1 trial on muvalaplin, an oral lipoprotein (a) inhibitor, was presented. An atherosclerotic CV disease (ASCVD) risk prediction algorithm for the Asian population using SCORE2 data was presented. Long-term follow-up of patients enrolled in the CLEAR outcomes trial showed sustained and more significant ASCVD risk reduction with bempedoic acid in high-risk patients. The late-breaking clinical science at the 2023 congress of the ESC extends the known safety and efficacy data of a PCSK9i with the introduction of new drugs in this class. Using cumulative exposure to LDL-C rather than a single value will help clinicians tailor the LDL-C reduction strategy to individual risk and is an important step towards personalized medicine.
100 项与 瑞卡西单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 家族性混合型高脂血症 | 临床3期 | 中国 | 2021-07-30 | |
| II型高脂蛋白血症 | 临床3期 | 中国 | 2021-07-30 | |
| 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 | |
| 纯合子家族性高胆固醇血症 | 临床2期 | - | 2020-09-01 |
登录后查看更多信息
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 | 703 | recaticimab at 150 mg every 4 weeks | 餘糧築衊鑰蓋醖憲膚衊(壓齋艱構範選鬱鬱願積) = Safety with recaticimab was comparable to placebo. the most common treatment-related adverse event was injection site reaction (n = 23 [4.9%]). 觸廠鑰壓構憲膚積構膚 (膚醖網積齋鏇衊構鹹鬱 ) | 积极 | 2024-10-23 | ||
recaticimab at 300 mg every 8 weeks | |||||||
临床3期 | 689 | recaticimab 150 mg (injection every 4 weeks) | 網鹽鹽鑰鑰繭壓遞壓齋(鬱鏇夢鹽鑰衊願鑰醖鏇) = At every dosage/interval, participants who received recaticimab had lower bad cholesterol levels at 24 weeks than those receiving a placebo.
In the 4-week injection group, bad cholesterol was reduced 62% among those taking recaticimab vs. 0% among those in the placebo group; in the 8-week injection group, bad cholesterol was reduced 59% vs. +0.4% respectively; and in the 12-week injection group bad cholesterol was reduced 51% vs. +2% respectively.
At every dosage/interval, recaticimab lowered their bad cholesterol to the target by 24 weeks compared to the placebo and these levels were maintained at 48 weeks. 齋繭構顧衊鹽淵艱願選 (觸製襯築積鑰製齋構網 ) 更多 | 积极 | 2023-11-13 | ||
Placebo (injection every 4 weeks) | |||||||
临床1/2期 | 110 | 廠繭範壓網鹽襯觸鑰壓(願夢壓齋獵憲鹹襯夢鑰) = No serious treatment-emergent adverse events (TEAEs) occurred. 艱鹹製醖觸範範範廠醖 (網網鏇鏇齋淵醖醖築糧 ) 更多 | 积极 | 2022-01-18 | |||
Placebo |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用