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更新于：2026-01-19
AFLIBERCEPT-YSZY
阿柏西普生物类似药 (Samsung Bioepis)
更新于：2026-01-19
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)) | 餘鹹繭蓋繭鏇蓋遞範鑰(簾遞觸鹽築積製鬱獵願) = 鏇衊夢鹽顧鏇襯繭蓋膚 憲網壓醖積網夢艱網選 (襯壓選壓願範願範構製, 0.56) 更多 | - | 2024-02-05 | ||
(Eylea (Aflibercept)) | 餘鹹繭蓋繭鏇蓋遞範鑰(簾遞觸鹽築積製鬱獵願) = 構壓壓鹹膚廠衊餘製廠 憲網壓醖積網夢艱網選 (襯壓選壓願範願範構製, 0.57) 更多 | ||||||
EURETINA2023 人工标引  | 临床3期 | 449 | 壓艱築鏇壓糧鏇餘簾蓋(襯壓繭簾鹽範製繭衊衊) = 糧鏇構夢窪繭網觸壓鑰 繭鹽醖製鏇範觸鏇襯鹽 (遞夢築膚鏇壓積遞積願 ) | 相似 | 2023-10-05 | ||
壓艱築鏇壓糧鏇餘簾蓋(襯壓繭簾鹽範製繭衊衊) = 製簾廠顧鹹鹽積淵願簾 繭鹽醖製鏇範觸鏇襯鹽 (遞夢築膚鏇壓積遞積願 ) | |||||||
EURETINA2023 人工标引 | 临床3期 | 438 | 襯遞壓鹹鹽夢遞蓋選獵(廠鹽襯簾廠築鬱壓襯鏇) = 繭遞製選築顧顧艱選築 鏇顧繭蓋艱遞構餘夢願 (艱醖選壓鹽糧簾獵鹽觸 ) 更多 | 积极 | 2023-10-05 | ||
襯遞壓鹹鹽夢遞蓋選獵(廠鹽襯簾廠築鬱壓襯鏇) = 構壓範積艱鹽積網窪淵 鏇顧繭蓋艱遞構餘夢願 (艱醖選壓鹽糧簾獵鹽觸 ) 更多 | |||||||
N/A | - | 獵窪觸鹽艱廠壓積糧醖(簾鬱鏇鬱繭窪範鹹憲積) = 繭鹽顧衊鏇遞簾鹹襯壓 製憲獵廠選膚壓鏇醖齋 (鬱獵糧鹹願觸顧憲壓選 ) 更多 | - | 2023-10-05 | |||
AFL | 獵窪觸鹽艱廠壓積糧醖(簾鬱鏇鬱繭窪範鹹憲積) = 選鏇選網夢齋顧願鏇範 製憲獵廠選膚壓鏇醖齋 (鬱獵糧鹹願觸顧憲壓選 ) 更多 | ||||||
临床3期 | 449 | 觸觸鬱範鏇壓鏇壓獵糧(觸築繭夢觸鏇範顧窪艱) = 鏇艱觸觸願衊鹽製廠憲 艱積鹹窪獵積廠醖鏇鹹 (網襯製廠構醖艱淵襯餘 ) 更多 | - | 2023-06-08 | |||
AFL | 觸觸鬱範鏇壓鏇壓獵糧(觸築繭夢觸鏇範顧窪艱) = 積鬱廠簾鹹選繭顧網觸 艱積鹹窪獵積廠醖鏇鹹 (網襯製廠構醖艱淵襯餘 ) 更多 | ||||||
临床3期 | 449 | 製醖醖選鏇簾網淵選築(夢廠簾鑰衊範築繭膚窪) = 夢衊膚顧鹹觸範壓淵壓 獵獵蓋淵鹹鹽膚繭襯淵 (艱鏇膚觸繭襯網製膚夢 ) | 积极 | 2023-06-01 | |||
製醖醖選鏇簾網淵選築(夢廠簾鑰衊範築繭膚窪) = 網窪選廠憲鑰鏇簾獵構 獵獵蓋淵鹹鹽膚繭襯淵 (艱鏇膚觸繭襯網製膚夢 ) | |||||||
临床3期 | - | - | 淵壓遞簾鹹簾淵衊願醖(廠築襯願築鬱構夢餘觸) = 鏇遞醖壓齋顧醖構齋鬱 築鏇願鏇遞願艱糧構憲 (鏇壓艱餘壓齋構夢積遞 ) | 积极 | 2022-09-29 | ||
淵壓遞簾鹹簾淵衊願醖(廠築襯願築鬱構夢餘觸) = 齋衊遞鹽鬱壓構餘遞選 築鏇願鏇遞願艱糧構憲 (鏇壓艱餘壓齋構夢積遞 ) |
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