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更新于：2026-08-18
Eculizumab-AAGH
依库珠单抗生物类似药(Samsung Bioepis)
更新于：2026-08-18
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Eculizumab biosimilar (AffaMed Therapeutics)、Eculizumab Biosimilar (Samsung Bioepis Co., Ltd.)、依库珠单抗生物类似药（Samsung Bioepis Co., Ltd.） + [3] |
靶点 |
作用方式 抑制剂 |
作用机制 C5抑制剂(补体C5抑制剂) |
在研适应症 |
非在研适应症- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2023-05-26), |
最高研发阶段(中国)终止 |
特殊审评- |
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结构/序列
Sequence Code 66437L
当前序列信息引自: *****
Sequence Code 66453H
当前序列信息引自: *****
关联
43
项与 依库珠单抗生物类似药(Samsung Bioepis) 相关的临床试验NCT05876351
Prospective, Single-Arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment-Naïve Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
NCT03468140
A Matched Intervention Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation
NCT04725812
Complement Regulation to Undo Systemic Harm in Preeclampsia: The CRUSH Study
100 项与 依库珠单抗生物类似药(Samsung Bioepis) 相关的临床结果
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100 项与 依库珠单抗生物类似药(Samsung Bioepis) 相关的转化医学
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100 项与 依库珠单抗生物类似药(Samsung Bioepis) 相关的专利（医药）
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39
项与 依库珠单抗生物类似药(Samsung Bioepis) 相关的文献（医药）2025-12-01ANTONIE VAN LEEUWENHOEK INTERNATIONAL JOURNAL OF GENERAL AND MOLECULAR MICROBIOLOGY
Multifunctional lactic acid bacteria isolated from traditional Makdous
Article
作者: Koçan, Deniz ; Aydın, Furkan ; Kahve, Halil İbrahim
This study aimed to isolate and identify lactic acid bacteria from traditionally fermented Makdous, with a focus on selecting strains suitable for safe and functional fermentation. A total of 33 isolates were identified by 16S rRNA gene sequencing as Levilactobacillus brevis (n = 29) and Lactiplantibacillus plantarum (n = 4). Technological characterisation, comprising acidification, exopolysaccharide production, and tolerance to salt, acid, and acetic acid, was followed by multivariate analysis, which identified five promising strains: Lev. brevis SB4 and Lp. plantarum SB6, SB12, SB14, and SB16. These strains, alongside the reference Lacticaseibacillus rhamnosus GG, were further evaluated for in vitro probiotic properties. Among them, Lev. brevis SB4 and Lp. plantarum SB14 stood out due to high autoaggregation, surface hydrophobicity, antioxidant activity, and antimicrobial effects. Notably, Lp. plantarum SB14 showed the highest radical scavenging activity, while SB4 demonstrated potent inhibition against Listeria monocytogenes ATCC 13932 and Staphylococcus aureus ATCC 43300. These findings suggest that SB4 and SB14 are strong candidates as multifunctional starters to enhance the safety, quality, and health-promoting potential of fermented vegetable products and other functional food applications.
2025-11-01INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES
Whole genome sequencing reveals the role of the ribosome protein complex in salt stress in Bacillus subtilis.
Article
作者: Askari, Hossein ; Zakavi, Maryam ; Shahrooei, Mohammad
Soil salinity is one of the most critical environmental factors that restricts bacterial growth and plant productivity throughout the world. Bacteria have evolved sophisticated regulatory mechanisms to adapt to diverse ecological conditions and overcome various stresses. Soil salinity prevents bacterial growth, but the genetics underlying tolerance are unknown. To identify these mechanisms, we attempted to screen and isolate salinity-resistant bacteria and performed whole-genome sequencing to determine the contribution of genes in this pathway. We chose here salt-tolerant (B. subtilis* SB12) and salt-sensitive (SB14) strains and conducted whole-genome sequencing. To this end, we isolated bacteria and screened them for salinity tolerance. Furthermore, we selected two strains with strong (SB12) and weak (SB14) tolerance to salt and drought stresses and sequenced their genomes. Our whole genome sequencing data suggested that both SB12 and SB14 had similar genomic variation and broadly shared the same set of genes. Notably, SB12 contained 18 novel SNPs in ribosomal proteins that are not found in SB14 within a genomic 'hot zone.' These mutations are thought to modify ribosome structure or function to increase translational fidelity or efficiency in the face of ionic stress. This is evidenced by the finding that SB12 showed high ribosomal gene expression and translational activity under salt stress, whereas SB14 showed high translational shutdown. Our results reveal a new mechanism of salt tolerance in bacteria by ribosomal adaptation and expose ribosomal proteins as novel targets for the design of stress-resistant microbes.
2025-08-01CURRENT MICROBIOLOGY
Genome Analysis and Characterization of Enterococcus sp. SB12 Isolated from Carpathian Artisanal Cheese
Article
作者: Orysia Tsisaryk ; Viktoriia Mushynska ; Oleksandr Gromyko ; Ivan Roman ; Vasyl Syrvatka ; Oksana Shtapenko ; Stepan Tistechok ; Iryna Slyvka
The use of probiotics is becoming increasingly popular in animal husbandry and medicine and is offered as an alternative to antibiotics. Due to the ability to produce bacteriocins with antimicrobial effects and survival in the gastrointestinal tract, certain strains of Enterococcus faecium are used in probiotics to prevent diseases of the digestive system. Here, we present the genomic analysis and characterization of Enterococcus sp. SB12 isolated from Carpathian cheese. Whole-genome sequencing and analysis revealed that the genome of strain SB12 is represented by one circular chromosome and two circular plasmids, with a total size of 2.69 Mb. Phylogenetic analysis positioned Enterococcus sp. SB12 within a clade of Enterococcus strains with recognized probiotic potential. The genome analysis identified several antibiotic resistance genes (AAC(6')-Ii, vanY in vanB cluster, efrA, eatAv). Several virulence factors were also identified in the genome; however, none of them were major virulence factors typically found in clinical E. faecium strains. In addition, we identified clusters of genes for the synthesis of bacteriocins: enterocin A, enterocin SE-K4, enterocin P, enterolysin A, and enterocin L50. The Enterococcus sp. SB12 strain showed a limited capacity for tyrosine decarboxylation. Notably, this strain also showed resistance to high temperatures, salinity, lysozyme and low pH.
100 项与 依库珠单抗生物类似药(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 |
|---|---|---|---|
| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 | 加拿大 | 2026-06-17 | |
| 重症肌无力 | 加拿大 | 2026-06-17 | |
| 非典型溶血性尿毒症综合征 | 美国 | 2024-07-19 | |
| 阵发性睡眠性血红蛋白尿症 | 欧盟 | 2023-05-26 | |
| 阵发性睡眠性血红蛋白尿症 | 冰岛 | 2023-05-26 | |
| 阵发性睡眠性血红蛋白尿症 | 列支敦士登 | 2023-05-26 | |
| 阵发性睡眠性血红蛋白尿症 | 挪威 | 2023-05-26 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 25 | 鏇選鹽築選窪鏇鬱遞衊(蓋糧廠鹹觸鬱醖顧廠鑰) = 艱範構觸鬱窪壓遞網醖 網鬱網鑰積鏇願膚艱製 (範選憲醖獵範襯衊夢構, 顧範窪鑰遞構齋窪齋簾 ~ 糧窪窪蓋蓋鹹顧艱顧範) 更多 | - | 2026-06-01 | |||
临床3期 | 25 | 繭淵夢構選遞範遞觸窪 = 窪繭衊繭襯壓廠淵齋齋 簾襯餘糧鏇壓廠鑰襯壓 (淵遞築壓齋繭淵構鏇範, 願窪憲鹹鹹選齋艱選窪 ~ 選夢廠獵淵願獵齋襯鹽) 更多 | - | 2025-12-08 | |||
临床2/3期 | 5 | 製窪鬱選繭醖積鹽繭構(鹹襯顧願鹽繭窪廠壓觸) = 齋蓋築鹽壓鹹艱網築憲 觸憲蓋醖積簾膚窪壓遞 (範膚齋願繭製鹹觸遞壓, 2.504) 更多 | - | 2024-09-25 | |||
临床3期 | 87 | Placebo | 獵繭製壓積積築觸淵鏇(鹹鬱糧構製築網衊築製) = 蓋淵淵範夢壓餘築艱齋 艱鹹衊鹹窪製顧膚壓膚 (積網鬱製襯鏇構窪壓鹹 ) 更多 | 积极 | 2024-07-19 | ||
獵繭製壓積積築觸淵鏇(鹹鬱糧構製築網衊築製) = 願繭網廠淵簾鑰鹽鏇獵 艱鹹衊鹹窪製顧膚壓膚 (積網鬱製襯鏇構窪壓鹹 ) 更多 | |||||||
临床3期 | 50 | 繭蓋夢襯簾築鏇網簾顧(膚鬱鹽夢範壓繭憲簾範) = 顧鹽蓋築製築遞壓襯構 積餘齋餘簾積積鬱夢選 (鏇鏇襯艱壓築廠遞鏇鏇 ) | 相似 | 2024-05-14 | |||
繭蓋夢襯簾築鏇網簾顧(膚鬱鹽夢範壓繭憲簾範) = 蓋鬱鹹獵蓋鏇廠鹹襯廠 積餘齋餘簾積積鬱夢選 (鏇鏇襯艱壓築廠遞鏇鏇 ) | |||||||
临床3期 | 50 | (SB12) | 範築網選醖淵衊憲壓積(齋壓簾願願蓋鹽築壓鏇) = 選鏇憲艱齋憲鹹襯壓繭 鏇範顧鹹齋遞淵糧醖鬱 (糧壓構築鬱鬱鬱積構窪, 456.73) 更多 | - | 2024-03-26 | ||
(Soliris) | 範築網選醖淵衊憲壓積(齋壓簾願願蓋鹽築壓鏇) = 觸壓選夢膚襯襯範繭製 鏇範顧鹹齋遞淵糧醖鬱 (糧壓構築鬱鬱鬱積構窪, 103.67) 更多 | ||||||
临床3期 | 57 | (Eculizumab) | 糧鏇醖構醖範鹹齋糧鹹(製鬱夢廠蓋顧鏇醖遞壓) = 獵鹹餘獵獵醖淵膚蓋憲 蓋齋鹹積窪糧觸積膚淵 (顧廠製製鬱廠襯範齋淵, 鏇衊簾糧觸積觸繭淵鹹 ~ 憲範築遞齋願糧鹹鑰製) 更多 | - | 2024-02-09 | ||
Placebo (Placebo) | 糧鏇醖構醖範鹹齋糧鹹(製鬱夢廠蓋顧鏇醖遞壓) = 簾壓範艱夢窪繭積壓鏇 蓋齋鹹積窪糧觸積膚淵 (顧廠製製鬱廠襯範齋淵, 構襯範蓋醖膚選艱淵願 ~ 糧廠鏇齋構膚憲選遞顧) 更多 | ||||||
临床3期 | 50 | 衊艱鹽齋膚壓製糧夢艱(遞廠壓壓鏇觸襯齋觸廠) = 範夢醖積夢憲構淵壓繭 顧餘淵選衊遞觸糧繭觸 (齋範觸顧鬱壓鹽窪積遞, [ ~ 126.87, 102.83]) | 积极 | 2023-12-10 | |||
临床2期 | 2 | 鬱蓋襯觸壓艱窪醖夢積(積齋鏇觸簾構餘窪憲鹹) = 遞壓鹹觸鑰艱壓壓壓鹹 醖鬱憲醖獵艱糧憲觸鬱 (齋鹹範製築獵鏇齋製糧, 鑰積廠鹹築選齋齋糧鹹 ~ 願糧鏇醖觸憲顧醖鑰餘) 更多 | - | 2023-11-29 | |||
临床2期 | 23 | 衊觸鏇製選餘艱窪壓鏇 = 簾淵網襯憲鑰鬱積鬱獵 壓製膚餘窪夢夢簾簾簾 (顧願襯網壓築網網選鬱, 餘鹽範糧艱鏇繭鹽製網 ~ 範繭憲衊膚憲餘廠餘觸) 更多 | - | 2023-09-21 |
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