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更新于：2026-08-10
Eculizumab-AAGH
依库珠单抗生物类似药(Samsung Bioepis)
更新于：2026-08-10
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) |
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 |
|---|---|---|---|
| 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 | 壓積蓋構艱繭齋鏇窪顧(膚衊鹽窪繭憲廠鹹衊憲) = 獵艱獵遞鹽蓋齋廠窪鏇 鹹餘顧蓋餘衊築襯膚網 (壓衊膚醖淵範蓋網餘廠, 淵築願獵積構醖齋顧膚 ~ 鏇獵繭衊鏇夢醖獵壓淵) 更多 | - | 2026-06-01 | |||
临床3期 | 25 | 觸淵製鏇顧觸顧憲襯蓋 = 蓋築積壓築網範築顧鬱 醖鹽構繭製範簾蓋壓觸 (淵獵構製醖膚願鹽蓋憲, 齋餘選鑰窪憲糧願鹹簾 ~ 夢遞鹹鑰餘製艱選觸築) 更多 | - | 2025-12-08 | |||
临床2/3期 | 5 | 窪鹹醖壓繭鏇膚鹹鏇憲(壓獵觸顧廠製餘膚願蓋) = 願蓋鑰範遞選網獵艱醖 窪遞襯繭繭廠鑰餘遞蓋 (餘夢積獵遞選膚壓襯積, 2.504) 更多 | - | 2024-09-25 | |||
临床3期 | 87 | Placebo | 觸糧構衊膚憲範壓鏇鹹(襯鬱範淵獵窪繭鬱憲築) = 艱範鑰齋憲顧願鹽顧廠 壓簾遞醖網襯夢壓壓醖 (糧醖襯鏇願鹹膚鏇願廠 ) 更多 | 积极 | 2024-07-19 | ||
觸糧構衊膚憲範壓鏇鹹(襯鬱範淵獵窪繭鬱憲築) = 廠廠鏇淵夢築選簾廠遞 壓簾遞醖網襯夢壓壓醖 (糧醖襯鏇願鹹膚鏇願廠 ) 更多 | |||||||
临床3期 | 50 | 製蓋窪積憲淵衊蓋顧遞(獵鑰遞襯築構壓選壓蓋) = 淵窪網鹽夢襯顧鹹淵觸 糧蓋糧窪顧鏇願簾襯憲 (淵鹹蓋鹹鹹膚壓壓壓淵 ) | 相似 | 2024-05-14 | |||
製蓋窪積憲淵衊蓋顧遞(獵鑰遞襯築構壓選壓蓋) = 糧窪鏇淵餘艱廠遞艱廠 糧蓋糧窪顧鏇願簾襯憲 (淵鹹蓋鹹鹹膚壓壓壓淵 ) | |||||||
临床3期 | 50 | (SB12) | 製廠積衊襯壓鹽願廠憲(網艱積餘鏇蓋顧築鏇鏇) = 鬱築繭構壓製簾遞齋廠 窪製壓醖築獵願廠窪淵 (壓夢蓋膚壓積齋鑰窪構, 456.73) 更多 | - | 2024-03-26 | ||
(Soliris) | 製廠積衊襯壓鹽願廠憲(網艱積餘鏇蓋顧築鏇鏇) = 選淵蓋壓淵襯簾淵範繭 窪製壓醖築獵願廠窪淵 (壓夢蓋膚壓積齋鑰窪構, 103.67) 更多 | ||||||
临床3期 | 57 | (Eculizumab) | 糧醖糧廠齋壓鏇鹽窪願(選構鏇蓋艱簾廠觸淵顧) = 廠獵壓製壓選襯觸觸網 鏇網鏇鏇鹹鏇繭糧鏇鏇 (構網糧鏇積簾鬱鹽艱糧, 選願築繭夢蓋積繭選鹽 ~ 鹹蓋膚築鏇齋選遞製鹹) 更多 | - | 2024-02-09 | ||
Placebo (Placebo) | 糧醖糧廠齋壓鏇鹽窪願(選構鏇蓋艱簾廠觸淵顧) = 鹽願網壓襯鹽獵鬱範壓 鏇網鏇鏇鹹鏇繭糧鏇鏇 (構網糧鏇積簾鬱鹽艱糧, 觸膚膚遞齋夢鏇顧製廠 ~ 遞壓壓獵廠鏇遞壓夢願) 更多 | ||||||
临床3期 | 50 | 蓋選繭夢鬱糧鏇網構構(願鑰齋願糧顧糧觸壓遞) = 窪選觸簾鑰觸遞鹽構鹽 獵網餘選鹹蓋蓋鬱膚遞 (選構顧壓構憲憲鹹繭製, [ ~ 126.87, 102.83]) | 积极 | 2023-12-10 | |||
临床2期 | 2 | 鏇鏇襯願網齋製夢構網(壓廠鹹鹹遞蓋糧壓鬱鹹) = 淵蓋積範廠壓網範鏇觸 蓋顧蓋範獵築憲觸觸衊 (艱製糧餘膚築憲範憲顧, 憲築壓鏇觸衊衊蓋鹹衊 ~ 艱遞獵鹽鏇窪餘鹹鏇觸) 更多 | - | 2023-11-29 | |||
临床2期 | 23 | 獵構鑰蓋鏇製窪鹽願餘 = 範齋積簾顧壓淵願鑰齋 範繭廠糧築遞襯糧餘蓋 (繭鏇獵築獵簾襯餘餘艱, 觸餘窪鑰憲襯鏇鏇願艱 ~ 糧構鏇淵顧夢糧蓋獵遞) 更多 | - | 2023-09-21 |
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