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更新于：2026-01-21
AFLIBERCEPT-YSZY
阿柏西普生物类似药 (Samsung Bioepis)
更新于：2026-01-21
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 韩国 (2024-02-23), |
最高研发阶段(中国)申请上市 |
特殊审评- |
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结构/序列
Sequence Code 4715606
当前序列信息引自: *****
关联
1
项与 阿柏西普生物类似药 (Samsung Bioepis) 相关的临床试验NCT04450329
A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration
100 项与 阿柏西普生物类似药 (Samsung Bioepis) 相关的临床结果
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100 项与 阿柏西普生物类似药 (Samsung Bioepis) 相关的转化医学
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100 项与 阿柏西普生物类似药 (Samsung Bioepis) 相关的专利（医药）
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9
项与 阿柏西普生物类似药 (Samsung Bioepis) 相关的文献（医药）2025-01-09Journal of Physical Chemistry Letters
Evaluating the Synergistic Effects of Multi-Epitope Nanobodies on BA.2.86 Variant Immune Escape
Article
作者: Liu, Jinxin ; Zhang, Enhao ; Duan, Lili ; Xu, Xiaole ; Zhang, John Z. H. ; Luo, Song ; Liang, Houde
Addressing the frequent emergence of SARS-CoV-2 mutant strains requires therapeutic approaches with innovative neutralization mechanisms. The targeting of multivalent nanobodies can enhance potency and reduce the risk of viral escape, positioning them as promising drug candidates. Here, the synergistic mechanisms of the two types of nanobodies are investigated deeply. Our research revealed that the Fu2-1-Fu2-2 system exhibited significant synergy, whereas the Sb#15-Sb#68 system demonstrated antagonism, in which entropy was the dominant contributor to antagonism. Conformational analysis further demonstrated that the presence of a monomeric nanobody influenced the flexibility of residues near other epitopes, thereby affecting the overall synergy of the systems. Moreover, we identified that changes in the hydrogen bond network and the charge of residues played a critical role in the binding between nanobodies and spike. We hope this study will provide novel insights into the development of multivalent nanobody combinations.
2024-08-01Ophthalmology and Therapy
Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea®)
Article
作者: Lee, Jaeil ; Kim, Beom Chan ; Lee, Hangyeore ; Song, Jinsu ; Lee, Soye ; Huh, Jongcheol ; Kim, Dayoung ; Lee, Jungmin
INTRODUCTION:
SB15 is a proposed biosimilar product of reference aflibercept (Eylea®), an approved biological drug product for retinal diseases including neovascular age-related macular degeneration (nAMD). This study aimed to assess the analytical similarity between SB15 and its commercially available reference product (RP) sourced from the United States (US-aflibercept) and European Union (EU-aflibercept) in terms of structural, physicochemical, and biological properties.
METHODS:
A panel of state-of-the-art analytical methods was used for the comprehensive characterization of SB15 and US/EU-aflibercept. In terms of the structural and physicochemical properties, primary structure; post-translational modifications (PTM); higher-order structure; purity and impurities; charge variants; and glycosylation were compared. In addition, biological characterization including mechanism of action (MoA)-related and Fc-related biological activities was conducted.
RESULTS:
Analytical similarity between SB15 and US/EU-aflibercept was demonstrated. The primary and higher-order structure of SB15 was confirmed to be comparable to that of US/EU-aflibercept. In addition, there were no meaningful differences in the physicochemical properties in terms of size and charge heterogeneity between SB15 and its RP. SB15 and RP were similar in biological activities including MoA-related binding activities, potencies, and Fc-related biological functions. Consequently, SB15 was confirmed to be highly similar to US/EU-aflibercept.
CONCLUSIONS:
Based on a comprehensive analytical similarity assessment of structural, physicochemical, and biological properties, SB15 was demonstrated to be highly similar to US/EU-aflibercept RP, supporting safe and effective use of SB15.
2023-12-01BMJ open ophthalmology
Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial
Article
作者: Studnička, Jan ; Oh, Inkyung ; Csutak, Adrienne ; Yun, Cheolmin ; Ernest, Jan ; Vajas, Attila ; Sadda, SriniVas R ; Jang, Hyerin ; Choi, Wooree ; Enyedi, Lajos ; Tóth-Molnár, Edit ; Patel, Sunil ; Wylegala, Edward ; Veith, Miroslav ; Astakhov, Sergei ; Woo, Se Joon ; Sagong, Min ; Orski, Michal ; Bradvica, Mario
Background/aims:
To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).
Design:
Prospective, double-masked, randomised, phase 3 trial.
Methods:
Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch’s membrane). Additional endpoints included safety, PK and immunogenicity.
Results:
Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (−2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were −119.2 µm and −132.4 µm for SB15/SB15 and −126.6 µm and −136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (−6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (−18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (−2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups.
Conclusions:
Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.
49
项与 阿柏西普生物类似药 (Samsung Bioepis) 相关的新闻（医药）2026-01-18
临床3期生物类似药抗体药物偶联物临床1期临床2期
2026-01-15
100 项与 阿柏西普生物类似药 (Samsung Bioepis) 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| 糖尿病性视网膜病变 | 美国 | 2024-05-20 | |
| 糖尿病性黄斑水肿 | 韩国 | 2024-02-23 | |
| 近视脉络膜新生血管 | 韩国 | 2024-02-23 | |
| 视网膜静脉阻塞相关黄斑水肿 | 韩国 | 2024-02-23 | |
| 湿性年龄相关性黄斑变性 | 韩国 | 2024-02-23 |
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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 | 449 | (SB15 (Proposed Aflibercept Biosimilar)) | 顧窪觸鹽襯鹹襯獵築選(鬱願製鹹窪構網衊襯蓋) = 襯願製製觸鬱齋繭淵選 顧衊憲餘憲鹹獵鏇廠觸 (鹽襯簾範築醖製淵構鬱, 0.56) 更多 | - | 2024-02-05 | ||
(Eylea (Aflibercept)) | 顧窪觸鹽襯鹹襯獵築選(鬱願製鹹窪構網衊襯蓋) = 鑰蓋壓鹹襯夢獵製構鹹 顧衊憲餘憲鹹獵鏇廠觸 (鹽襯簾範築醖製淵構鬱, 0.57) 更多 | ||||||
EURETINA2023 人工标引  | 临床3期 | 449 | 顧獵觸齋觸選遞遞廠夢(網醖範壓膚廠選膚衊醖) = 遞願願鏇鹽積願衊範鑰 製積積鏇壓願選繭憲顧 (遞鬱醖齋艱顧夢鏇構構 ) | 相似 | 2023-10-05 | ||
顧獵觸齋觸選遞遞廠夢(網醖範壓膚廠選膚衊醖) = 壓淵構構願觸襯積蓋憲 製積積鏇壓願選繭憲顧 (遞鬱醖齋艱顧夢鏇構構 ) | |||||||
EURETINA2023 人工标引 | 临床3期 | 438 | 築繭網淵蓋獵醖壓觸鏇(膚獵選夢窪繭齋鏇壓築) = 鏇壓衊積餘醖鏇糧蓋鑰 獵廠蓋構製襯觸構憲製 (糧艱鬱窪網遞淵鬱衊範 ) 更多 | 积极 | 2023-10-05 | ||
築繭網淵蓋獵醖壓觸鏇(膚獵選夢窪繭齋鏇壓築) = 衊製積廠鏇願觸築憲願 獵廠蓋構製襯觸構憲製 (糧艱鬱窪網遞淵鬱衊範 ) 更多 | |||||||
N/A | - | 夢醖積積積願糧襯餘鏇(簾鬱淵網艱鬱壓窪襯觸) = 糧衊觸簾齋夢膚築鬱廠 獵鏇構淵憲艱鬱網壓鏇 (繭製獵選蓋鏇積範製齋 ) 更多 | - | 2023-10-05 | |||
AFL | 夢醖積積積願糧襯餘鏇(簾鬱淵網艱鬱壓窪襯觸) = 艱廠積窪鑰鬱窪鹽築窪 獵鏇構淵憲艱鬱網壓鏇 (繭製獵選蓋鏇積範製齋 ) 更多 | ||||||
临床3期 | 449 | 壓醖顧鏇齋糧膚願糧膚(襯鏇築構膚廠構網積廠) = 繭窪鑰鬱鏇繭築糧廠襯 繭淵窪繭鏇選網觸範構 (築蓋壓構觸鹹築鏇壓鑰 ) 更多 | - | 2023-06-08 | |||
AFL | 壓醖顧鏇齋糧膚願糧膚(襯鏇築構膚廠構網積廠) = 觸襯夢糧鑰襯網範鏇壓 繭淵窪繭鏇選網觸範構 (築蓋壓構觸鹹築鏇壓鑰 ) 更多 | ||||||
临床3期 | 449 | 醖範鑰鑰範繭製積衊積(醖膚醖繭壓衊鹽餘範鹽) = 製鑰壓夢窪醖顧淵選醖 鬱齋鑰鹹糧餘齋齋選鏇 (醖鹹顧衊憲衊膚憲鹽蓋 ) | 积极 | 2023-06-01 | |||
醖範鑰鑰範繭製積衊積(醖膚醖繭壓衊鹽餘範鹽) = 選醖積淵繭顧襯夢繭鑰 鬱齋鑰鹹糧餘齋齋選鏇 (醖鹹顧衊憲衊膚憲鹽蓋 ) | |||||||
临床3期 | - | - | 醖衊淵齋廠鏇顧觸淵遞(蓋艱鹹膚壓顧顧糧糧艱) = 壓廠構範製襯積醖餘衊 鹹憲艱憲糧艱憲醖鬱衊 (憲憲鏇繭網築窪構簾窪 ) | 积极 | 2022-09-29 | ||
醖衊淵齋廠鏇顧觸淵遞(蓋艱鹹膚壓顧顧糧糧艱) = 襯壓觸鹽製廠築襯築憲 鹹憲艱憲糧艱憲醖鬱衊 (憲憲鏇繭網築窪構簾窪 ) |
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