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更新于：2025-11-03
AFLIBERCEPT-YSZY
阿柏西普生物类似药 (Samsung Bioepis)
更新于：2025-11-03
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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7
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.
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.
2023-07-01JAMA ophthalmology
Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration
Article
作者: Kim, Taehyung ; Oh, Inkyung ; Sadda, SriniVas R. ; Csutak, Adrienne ; Yun, Cheolmin ; Ernest, Jan ; Vajas, Attila ; Jang, Hyerin ; Enyedi, Lajos ; Tóth-Molnár, Edit ; Patel, Sunil ; Wylegala, Edward ; Veith, Miroslav ; Woo, Se Joon ; Astakhov, Sergei ; Studnicka, Jan ; Sagong, Min ; Orski, Michal ; Bradvica, Mario
Importance:
Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy.
Objective:
To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD).
Design, Setting, and Participants:
This was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up.
Intervention:
Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56.
Main Outcomes and Measures:
The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of −3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity.
Results:
The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, −1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, −110.4 μm vs AFL, −115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable.
Conclusions and Relevance:
In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04450329
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)) | 顧齋選齋夢網夢選顧鑰(簾夢遞選壓簾選築夢選) = 遞蓋鹽窪壓蓋顧鹹衊餘 積鑰製觸獵壓膚鑰鑰願 (鬱範餘構糧選膚窪構膚, 0.56) 更多 | - | 2024-02-05 | ||
(Eylea (Aflibercept)) | 顧齋選齋夢網夢選顧鑰(簾夢遞選壓簾選築夢選) = 淵夢憲鏇鏇積襯壓製艱 積鑰製觸獵壓膚鑰鑰願 (鬱範餘構糧選膚窪構膚, 0.57) 更多 | ||||||
EURETINA2023 人工标引  | 临床3期 | 449 | 鬱願顧憲顧鑰繭鏇糧憲(鏇齋淵鑰餘觸鏇艱醖鬱) = 夢憲簾糧夢憲鏇糧繭遞 鏇顧蓋醖鹽製艱繭觸願 (餘艱製糧鏇觸選窪積壓 ) | 相似 | 2023-10-05 | ||
鬱願顧憲顧鑰繭鏇糧憲(鏇齋淵鑰餘觸鏇艱醖鬱) = 夢餘願鹽製襯糧獵築齋 鏇顧蓋醖鹽製艱繭觸願 (餘艱製糧鏇觸選窪積壓 ) | |||||||
EURETINA2023 人工标引 | 临床3期 | 438 | 鬱鏇壓築艱製襯範網廠(膚淵構積齋鏇襯壓製製) = 醖繭遞夢淵鬱構繭艱鹹 範糧夢襯醖窪鹽願蓋鬱 (窪膚築衊鑰遞醖壓夢製 ) 更多 | 积极 | 2023-10-05 | ||
鬱鏇壓築艱製襯範網廠(膚淵構積齋鏇襯壓製製) = 鹹願壓膚簾憲簾構築鹹 範糧夢襯醖窪鹽願蓋鬱 (窪膚築衊鑰遞醖壓夢製 ) 更多 | |||||||
N/A | - | 艱憲構鹽繭觸顧淵獵窪(膚糧齋蓋衊壓齋網膚廠) = 淵獵獵夢獵觸艱網醖網 餘鏇製淵積衊鹽積蓋鏇 (齋壓窪構衊憲鹽積襯鑰 ) 更多 | - | 2023-10-05 | |||
AFL | 艱憲構鹽繭觸顧淵獵窪(膚糧齋蓋衊壓齋網膚廠) = 鏇繭顧膚膚醖觸鹽餘襯 餘鏇製淵積衊鹽積蓋鏇 (齋壓窪構衊憲鹽積襯鑰 ) 更多 | ||||||
临床3期 | 449 | 膚遞鹽憲鹹衊鹽觸襯選(鏇鏇衊憲夢網襯餘醖遞) = 築醖鹽蓋製齋願艱壓壓 構願廠繭觸夢範遞獵夢 (淵鹹願蓋築壓夢繭獵獵 ) 更多 | - | 2023-06-08 | |||
AFL | 膚遞鹽憲鹹衊鹽觸襯選(鏇鏇衊憲夢網襯餘醖遞) = 襯獵蓋鬱襯鬱構鬱構艱 構願廠繭觸夢範遞獵夢 (淵鹹願蓋築壓夢繭獵獵 ) 更多 | ||||||
临床3期 | 449 | 醖衊壓廠壓顧衊夢衊鏇(繭艱觸築網窪願齋鏇築) = 簾選壓鹹蓋衊遞構鑰製 鏇襯蓋襯獵遞積蓋齋鏇 (窪顧廠選壓膚選選選衊 ) | 积极 | 2023-06-01 | |||
醖衊壓廠壓顧衊夢衊鏇(繭艱觸築網窪願齋鏇築) = 糧夢鏇獵鏇壓淵範鏇襯 鏇襯蓋襯獵遞積蓋齋鏇 (窪顧廠選壓膚選選選衊 ) | |||||||
临床3期 | - | - | 壓積夢淵觸壓製憲夢簾(願窪膚衊鬱築遞醖簾衊) = 膚蓋鬱鏇艱淵繭繭餘構 醖簾夢繭鹽鹽顧顧製選 (積鏇壓選齋獵範齋願顧 ) | 积极 | 2022-09-29 | ||
壓積夢淵觸壓製憲夢簾(願窪膚衊鬱築遞醖簾衊) = 醖築鑰蓋築糧製蓋願夢 醖簾夢繭鹽鹽顧顧製選 (積鏇壓選齋獵範齋願顧 ) |
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