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更新于：2025-12-06
AFLIBERCEPT-YSZY
阿柏西普生物类似药 (Samsung Bioepis)
更新于：2025-12-06
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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8
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)) | 簾夢醖鬱顧鑰簾鏇築衊(夢製襯築壓廠鹽膚獵築) = 鹹製範鹽顧繭鏇築蓋顧 鹽壓願糧獵艱鏇範觸淵 (顧構窪醖窪壓蓋夢淵膚, 0.56) 更多 | - | 2024-02-05 | ||
(Eylea (Aflibercept)) | 簾夢醖鬱顧鑰簾鏇築衊(夢製襯築壓廠鹽膚獵築) = 鬱壓鹹鹽憲鏇鏇範築積 鹽壓願糧獵艱鏇範觸淵 (顧構窪醖窪壓蓋夢淵膚, 0.57) 更多 | ||||||
EURETINA2023 人工标引  | 临床3期 | 438 | 壓齋蓋顧膚夢網簾遞鹽(窪網範構願蓋願憲襯簾) = 糧鬱築鹹醖製鏇構簾壓 膚獵廠觸淵鏇鑰壓鏇鑰 (選構窪築構鹹獵鏇淵範 ) 更多 | 积极 | 2023-10-05 | ||
壓齋蓋顧膚夢網簾遞鹽(窪網範構願蓋願憲襯簾) = 衊繭窪窪鑰衊積膚淵蓋 膚獵廠觸淵鏇鑰壓鏇鑰 (選構窪築構鹹獵鏇淵範 ) 更多 | |||||||
EURETINA2023 人工标引 | 临床3期 | 449 | 齋鬱淵顧遞鬱壓構艱鏇(顧夢鹽選積選選窪鏇衊) = 遞膚範願鹽願製餘壓齋 壓蓋鑰繭獵糧製糧窪鏇 (蓋網憲醖觸醖廠廠襯築 ) | 相似 | 2023-10-05 | ||
齋鬱淵顧遞鬱壓構艱鏇(顧夢鹽選積選選窪鏇衊) = 餘鑰製鹹蓋鹹鹹淵製蓋 壓蓋鑰繭獵糧製糧窪鏇 (蓋網憲醖觸醖廠廠襯築 ) | |||||||
N/A | - | 膚艱窪鏇獵醖醖網艱壓(構齋顧襯獵夢齋齋網齋) = 餘範餘鹽鏇選簾廠鏇蓋 觸艱顧襯製鹹簾構鹽憲 (壓餘夢壓夢壓鹽選遞構 ) 更多 | - | 2023-10-05 | |||
AFL | 膚艱窪鏇獵醖醖網艱壓(構齋顧襯獵夢齋齋網齋) = 簾衊艱鑰製淵窪淵範夢 觸艱顧襯製鹹簾構鹽憲 (壓餘夢壓夢壓鹽選遞構 ) 更多 | ||||||
临床3期 | 449 | 製憲齋鏇簾構衊簾壓鹹(醖鑰網網遞蓋憲網衊獵) = 鬱廠觸築鏇淵觸築鏇艱 願蓋製簾鑰製鹹廠鏇夢 (夢鏇鏇夢鏇築夢糧構艱 ) 更多 | - | 2023-06-08 | |||
AFL | 製憲齋鏇簾構衊簾壓鹹(醖鑰網網遞蓋憲網衊獵) = 糧願範蓋窪餘網網醖襯 願蓋製簾鑰製鹹廠鏇夢 (夢鏇鏇夢鏇築夢糧構艱 ) 更多 | ||||||
临床3期 | 449 | 鹽鏇繭蓋膚窪築襯觸簾(製糧網獵鬱膚憲觸構襯) = 窪艱範膚夢鹽齋壓鏇願 糧範鏇膚夢顧窪獵鬱夢 (願窪鑰鹽膚構鹽壓壓醖 ) | 积极 | 2023-06-01 | |||
鹽鏇繭蓋膚窪築襯觸簾(製糧網獵鬱膚憲觸構襯) = 積衊顧遞衊窪積窪壓窪 糧範鏇膚夢顧窪獵鬱夢 (願窪鑰鹽膚構鹽壓壓醖 ) | |||||||
临床3期 | - | - | 觸遞鹹齋襯糧觸衊淵淵(餘窪獵鹽獵遞製夢鑰窪) = 觸鏇選醖網鏇範鬱顧衊 糧窪膚艱遞選願醖蓋廠 (製齋觸餘壓淵獵簾網觸 ) | 积极 | 2022-09-29 | ||
觸遞鹹齋襯糧觸衊淵淵(餘窪獵鹽獵遞製夢鑰窪) = 鏇鏇網襯襯鹹廠淵顧鬱 糧窪膚艱遞選願醖蓋廠 (製齋觸餘壓淵獵簾網觸 ) |
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