更新于：2024-11-15
Stapokibart
司普奇拜单抗
更新于：2024-11-15
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-09-10), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、突破性疗法 (中国) |
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序列信息
Sequence Code 936773293H
来源: *****
Sequence Code 936773294L
来源: *****
关联
50
项与 司普奇拜单抗 相关的临床试验A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Patients With Allergic Rhinitis
一项评价司普奇拜单抗注射液治疗过敏性鼻炎患者的有效性和安全性的随机、双盲、安慰剂平行对照Ⅱ期临床研究
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease（COPD）
100 项与 司普奇拜单抗 相关的临床结果
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100 项与 司普奇拜单抗 相关的转化医学
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100 项与 司普奇拜单抗 相关的专利（医药）
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29
项与 司普奇拜单抗 相关的文献（医药）2024-11-01ANALYTICAL BIOCHEMISTRY
Development and validation of an enzyme-linked immunosorbent assay for the quantification of a recombinant humanized anti-IL-4Rα monoclonal antibody CM310 in serum and its application to pharmacokinetic study in Sprague-Dawley Rats
Article
作者: Hao, Yimeng ; Zhang, Libo ; Zhang, Xuemei ; Jia, Qian ; Ma, Jing ; Meng, Qinghe
CM310 is a recombinant humanized monoclonal antibody targeting Interleukin (IL)-4 receptor alpha (IL-4Rα). IL-4Rα blockade prevents IL-4 and IL-13 from binding to their receptor, thereby inhibiting downstream signaling pathways that drive Type 2 helper T-cell (Th2) inflammation. CM310 holds potential for treating Th2-related inflammatory diseases, such as asthma, atopic dermatitis and chronic sinusitis with nasal polyposis. In this study, a direct enzyme-linked immunosorbent assay (ELISA) was developed to measure the concentrations of CM310 in rat serum. Seven calibration standards (ranging from 25 to 1600 ng/mL) and three quality controls (70, 500 and 1250 ng/mL) were defined. The limit of detection (LOD), lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 13, 25 and 1600 ng/mL, respectively. The method exhibited excellent precision and accuracy and successfully applied to in vitro serum stability and pharmacokinetic (PK) studies. In conclusion, we have developed and validated a highly sensitive and selective method for measuring CM310 in Sprague-Dawley rats. The development and validation ELISA method met the acceptable criteria, which suggested that these can be applied to quantify CM310, as well as in PK studies.
2024-11-01The journal of allergy and clinical immunology. Global
Biomarkers and patient-related factors associated with clinical outcomes in dupilumab-treated atopic dermatitis
Article
作者: Nakajima, Kimiko ; Kinoshita, Yuki ; Kamiya, Koji ; Aoki, Natsuko ; Matsumoto, Mai ; Ishiuji, Yozo ; Fujimoto, Rai ; Katsuta, Michie ; Abe, Riichiro ; Kaneko, Sakae ; Izuhara, Kenji ; Tanese, Keiji ; Kabata, Yudai ; Masuda, Koji ; Mitsui, Hiroshi ; Takeichi, Takuya ; Furue, Masutaka ; Tonomura, Kyoko ; Katoh, Norito ; Tanaka, Akio ; Okano, Tatsuro ; Saeki, Hidehisa ; Kawasaki, Hiroshi ; Yamamoto, Aya ; Morita, Eishin ; Ichiyama, Susumu ; Ohtsuki, Mamitaro ; Nakagawa, Yukinobu ; Hatano, Yutaka ; Nakahara, Takeshi ; Morita, Akimichi ; Kido-Nakahara, Makiko ; Nunomura, Satoshi ; Onozuka, Daisuke ; Akiyama, Masashi ; Tateishi, Chiharu ; Tamagawa-Mineoka, Risa ; Kawamura, Tatsuyoshi ; Miyagaki, Tomomitsu ; Matsuda-Hirose, Haruna ; Kataoka, Yoko ; Takenaka, Motoi ; Hide, Michihiro ; Tsuji, Gaku
Background:
Atopic dermatitis (AD) is a common chronic eczematous skin disease with severe pruritus. Several new therapeutic agents for AD such as dupilumab, an anti-IL-4Rα antibody, have been developed in recent years. We need to predict which agent is the best choice for each patient, but this remains difficult.
Objective:
Our aim was to examine clinical background factors and baseline biomarkers that could predict the achievement of improved clinical outcomes in patients with AD treated with dupilumab.
Methods:
A multicenter, prospective observational study was conducted on 110 patients with AD. The Eczema Area and Severity Index was used as an objective assessment, and the Patient-Oriented Eczema Measure and Numerical Rating Scale for Pruritus were used as patient-reported outcomes. In addition, some clinical background factors were evaluated.
Results:
The achievement of an absolute Eczema Area and Severity Index of 7 or less was negatively associated with current comorbidity of food allergy and baseline serum lactate dehydrogenase (LDH) levels. There were negative associations between achievement of a Patient-Oriented Eczema Measure score of 7 or less and duration of severe AD and between achievement of an itching Numerical Rating Scale for Pruritus score of 1 or less and current comorbidity of allergic conjunctivitis or baseline serum periostin level. Furthermore, signal detection analysis showed that a baseline serum LDH level less than 328 U/L could potentially be used as a cutoff value for predicting the efficacy of dupilumab.
Conclusion:
Baseline biomarkers such as LDH and periostin and clinical background factors such as current comorbidity of food allergy and a long period of severe disease may be useful indicators when choosing dupilumab for systemic treatment for AD, as they can predict the efficacy of dupilumab.
2024-10-01JOURNAL OF PHARMACEUTICAL SCIENCES
Utility of Cellular Measurements of Non-Specific Endocytosis to Assess the Target-Independent Clearance of Monoclonal Antibodies
Article
作者: Primack, Ronya ; Poon-Andersen, Carrie ; Chung, John ; Tuhin, Md Tariqul Haque ; Wong, Diana ; Shomin, Carolyn D ; Nasrollahi, Fatemeh ; Conner, Kip P ; Ojeda, Esperanza ; Bryniarski, Mark A ; Soto, Marcus ; Cook, Kevin D ; Chung, Kyu ; Ko, Eunkyung Clare
Past studies have demonstrated higher clearance for monoclonal antibodies possessing increased rates of non-specific endocytosis. However, this metric is oftentimes evaluated indirectly using biophysical techniques or cell surface binding studies that may not provide insight into the specific rates of cellular turnover. Furthermore, few examples evaluating non-specific endocytosis have been reported for a therapeutic antibody that reached clinical assessment. In the current report, we evaluated a therapeutic human immunoglobulin G2 monoclonal antibody targeted against the interleukin-4 receptor alpha chain (IL-4Rα) that exhibited elevated target independent clearance in previous Phase 1 and 2 studies. We confirmed high non-specific clearance of the anti-IL-4Rα antibody as compared to a reference antibody during pharmacokinetic assessments in wild type mice where target-mediated disposition was absent. We then developed a cell-based method capable of measuring cellular protein endocytosis and demonstrated the anti-IL-4Rα antibody exhibited marked non-specific uptake relative to the reference compound. Antibody homology modeling identified the anti-IL-4Rα antibody possessed positive charge patches whose removal via targeted mutations substantially reduced its non-specific endocytosis. We then expanded the scope of the study by evaluating panels of both preclinical and clinically relevant monoclonal antibodies and demonstrate those with the highest rates of non-specific uptake in vitro exhibited elevated target independent clearance, low subcutaneous bioavailability, or both. Our results support the observation that high non-specific endocytosis is a negative attribute in monoclonal antibody development and demonstrate the utility of a generic cell-based screen as a quantitative tool to measure non-specific endocytosis of protein therapeutics at the single-cell level.
196
项与 司普奇拜单抗 相关的新闻（医药）2024-11-13
2024-11-11
抗体药物偶联物引进/卖出申请上市临床结果
2024-11-11
100 项与 司普奇拜单抗 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 |
|---|---|---|---|
| 特应性皮炎 | 中国 | 2024-09-10 |
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 |
|---|---|---|---|---|
| 慢性鼻窦炎伴鼻息肉 | 申请上市 | 中国 | 2024-06-06 | |
| 季节性过敏性鼻炎 | 申请上市 | 中国 | 2024-04-29 | |
| 结节性痒疹 | 临床3期 | 中国 | 2024-06-25 | |
| 哮喘 | 临床3期 | 中国 | 2023-03-15 | |
| 慢性阻塞性肺疾病 | 临床3期 | 中国 | 2023-03-15 | |
| 中度特应性皮炎 | 临床3期 | 中国 | 2022-04-22 | |
| 重度特应性皮炎 | 临床3期 | 中国 | 2022-04-22 | |
| 过敏性鼻炎 | 临床2期 | 中国 | 2024-09-30 | |
| 过敏性鼻炎 | 临床2期 | 中国 | 2024-09-30 | |
| 瘙痒 | 临床2期 | - | 2022-08-30 |
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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 | 430 | 顧製憲願餘遞顧襯襯築(衊鏇製網鹹糧繭築築鹹) = 範範廠鬱鹽製願艱艱窪 願鏇淵衊顧選範鏇餘鹹 (築觸繭淵願網鹹選遞夢 ) 更多 | 积极 | 2024-10-25 | |||
Placebo; 16-week double-blstapokibart + | 顧製憲願餘遞顧襯襯築(衊鏇製網鹹糧繭築築鹹) = 艱膚範築淵繭網壓簾構 願鏇淵衊顧選範鏇餘鹹 (築觸繭淵願網鹹選遞夢 ) 更多 | ||||||
临床2/3期 | 72 | (Healthy Volunteers) | 鏇範餘艱憲鬱鏇鏇齋衊(構襯衊繭遞願網鏇艱糧) = 範膚廠衊觸鬱願遞鬱淵 築範積觸蓋艱遞觸蓋鬱 (範衊鏇繭醖鹽鬱願餘範 ) 更多 | 积极 | 2024-07-01 | ||
(Atopic Dermatitis) | 鏇範餘艱憲鬱鏇鏇齋衊(構襯衊繭遞願網鏇艱糧) = 範簾窪觸鏇製醖積餘窪 築範積觸蓋艱遞觸蓋鬱 (範衊鏇繭醖鹽鬱願餘範 ) 更多 | ||||||
临床3期 | 500 | 餘夢積網築艱艱糧簾積(膚鑰構醖夢鹹遞願衊獵) = 鹽襯憲構蓋憲鑰淵壓鹹 夢壓艱壓簾繭憲窪遞餘 (願蓋衊選鹽獵廠選遞壓 ) 更多 | 积极 | 2024-06-03 | |||
安慰剂转司普奇拜单抗组 | 餘夢積網築艱艱糧簾積(膚鑰構醖夢鹹遞願衊獵) = 積積獵艱範鹽膚構醖鏇 夢壓艱壓簾繭憲窪遞餘 (願蓋衊選鹽獵廠選遞壓 ) 更多 | ||||||
临床3期 | 108 | 司普奇拜单抗 | 憲鏇選蓋觸窪蓋淵製網(繭願獵鬱願網鹹窪繭築) = 完全达标 觸製鏇鑰糧簾襯窪構鏇 (鹹範鏇廠艱獵醖膚遞憲 ) 达到 | 积极 | 2024-04-28 | ||
Placebo | |||||||
临床2期 | 120 | 憲鬱獵遞遞廠鹹憲壓築(膚遞鑰淵糧築網繭鹹遞) = 膚鹽製鬱獵夢製網簾齋 襯窪衊窪淵廠壓築獵餘 (鬱蓋蓋餘廠鑰襯遞獵鏇 ) | 积极 | 2023-07-21 | |||
憲鬱獵遞遞廠鹹憲壓築(膚遞鑰淵糧築網繭鹹遞) = 簾糧壓廠範夢鏇觸鏇製 襯窪衊窪淵廠壓築獵餘 (鬱蓋蓋餘廠鑰襯遞獵鏇 ) | |||||||
临床2期 | 56 | 鹽構淵膚鹹簾構鹹蓋構(醖憲壓淵襯築膚窪衊膚): LS mean difference = -7.6 (95% CI, -9.4 ~ -5.8) | 积极 | 2023-07-01 | |||
Placebo | |||||||
临床3期 | - | 壓鏇窪夢鏇憲範鹽願齋(鬱遞窪糧積製鬱積膚鏇) = 主要疗效终点均成功达到 艱遞淵膚窪築觸構網醖 (鑰壓鹹蓋鏇艱壓艱糧鏇 ) 达到 更多 | 积极 | 2023-03-28 | |||
安慰剂 | |||||||
临床2期 | 56 | 蓋範膚齋網餘獵艱鹹憲(餘齋積淵觸壓顧鑰鏇網) = 簾齋願鬱鑰鏇鬱鹽觸鹹 簾壓鑰醖醖觸鬱選獵蓋 (構襯鏇觸夢選窪襯範壓 ) 更多 | 积极 | 2022-03-30 | |||
Placebo | 蓋範膚齋網餘獵艱鹹憲(餘齋積淵觸壓顧鑰鏇網) = 構窪鹽齋繭淵餘鑰鑰繭 簾壓鑰醖醖觸鬱選獵蓋 (構襯鏇觸夢選窪襯範壓 ) 更多 |
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