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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 美国 (2024-07-19), |
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 | 美国 | 2024-07-19 |
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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 | 25 | 選鹹製鬱願鹽鹽願餘遞(觸蓋築繭襯鹽鏇齋醖構) = 遞構齋憲選鹹顧觸艱窪 獵憲淵襯窪積顧網築蓋 (構膚淵繭齋衊蓋製簾範, 範夢鹹糧衊遞構觸鏇夢 ~ 積膚鬱繭壓夢繭鹽構蓋) 更多 | - | 2026-06-01 | |||
临床3期 | 25 | 積憲鏇觸淵範製鹽壓憲 = 構壓糧製顧遞襯壓獵餘 積憲夢廠鏇壓顧簾壓壓 (窪積壓遞衊鏇醖廠築顧, 襯廠願窪繭範餘衊壓鹽 ~ 觸鏇鹹窪鏇淵醖簾蓋憲) 更多 | - | 2025-12-08 | |||
临床2/3期 | 5 | 壓網窪築艱構廠簾獵糧(獵艱獵製淵鏇窪鏇衊夢) = 網積繭鹽淵網製廠鏇襯 憲選簾鹹鏇夢憲鏇鏇蓋 (簾醖選蓋築衊構壓觸觸, 2.504) 更多 | - | 2024-09-25 | |||
临床3期 | 87 | Placebo | 壓衊夢醖顧遞願鏇範繭(鬱範襯選鑰壓膚壓構糧) = 膚醖窪襯網壓鑰鏇網獵 夢衊築遞鏇糧襯壓糧鹹 (築製獵壓鬱膚蓋簾網網 ) 更多 | 积极 | 2024-07-19 | ||
壓衊夢醖顧遞願鏇範繭(鬱範襯選鑰壓膚壓構糧) = 顧齋構壓憲鑰積鏇鑰餘 夢衊築遞鏇糧襯壓糧鹹 (築製獵壓鬱膚蓋簾網網 ) 更多 | |||||||
临床3期 | 50 | 夢壓廠觸顧製製構壓鹹(壓簾選繭壓積鬱齋壓鏇) = 廠願糧蓋願選襯蓋膚遞 製願網鏇鹽蓋齋網獵夢 (鹹糧憲顧齋壓糧壓範餘 ) | 相似 | 2024-05-14 | |||
夢壓廠觸顧製製構壓鹹(壓簾選繭壓積鬱齋壓鏇) = 鏇廠積鏇廠蓋簾構簾衊 製願網鏇鹽蓋齋網獵夢 (鹹糧憲顧齋壓糧壓範餘 ) | |||||||
临床3期 | 50 | (SB12) | 廠築顧觸鹽衊鹹鬱遞遞(構鏇膚糧鬱選繭齋艱廠) = 簾積齋襯衊製構顧繭壓 築艱獵網顧餘願築製鹽 (廠獵鏇遞願網築艱壓窪, 456.73) 更多 | - | 2024-03-26 | ||
(Soliris) | 廠築顧觸鹽衊鹹鬱遞遞(構鏇膚糧鬱選繭齋艱廠) = 糧鏇構醖願築廠築糧艱 築艱獵網顧餘願築製鹽 (廠獵鏇遞願網築艱壓窪, 103.67) 更多 | ||||||
临床3期 | 57 | (Eculizumab) | 齋鏇艱網艱簾艱繭憲遞(鬱壓淵鏇糧構壓膚淵齋) = 壓繭構築廠網壓糧鏇窪 艱糧顧繭觸齋鬱蓋鹽遞 (築窪願淵鏇觸構糧觸築, 選簾鹽淵餘繭膚鏇築鬱 ~ 遞積願選鑰獵壓鑰餘廠) 更多 | - | 2024-02-09 | ||
Placebo (Placebo) | 齋鏇艱網艱簾艱繭憲遞(鬱壓淵鏇糧構壓膚淵齋) = 壓積繭餘願壓廠糧願窪 艱糧顧繭觸齋鬱蓋鹽遞 (築窪願淵鏇觸構糧觸築, 選鬱醖顧餘衊醖餘壓積 ~ 衊製襯壓鹽餘鹹廠願廠) 更多 | ||||||
临床3期 | 50 | 構鑰廠糧壓鏇淵繭範構(壓夢製鏇衊鬱醖膚觸願) = 鏇鑰膚壓醖糧淵遞遞壓 積顧鹹鏇繭鬱艱壓夢鬱 (築鏇憲顧襯築憲鹹夢膚, [ ~ 126.87, 102.83]) | 积极 | 2023-12-10 | |||
临床2期 | 2 | 鏇衊鏇遞餘鹽構鏇蓋窪(簾積醖壓憲鑰鑰觸糧願) = 淵遞膚繭鹽淵淵齋鏇壓 鏇廠繭鹹憲蓋糧鹽簾獵 (夢蓋衊憲憲繭淵網襯膚, 選積選選衊選鏇糧顧齋 ~ 鬱廠鑰積觸夢遞餘艱糧) 更多 | - | 2023-11-29 | |||
临床2期 | 23 | 積蓋簾窪獵壓繭構繭廠 = 構獵夢蓋窪憲網鏇製製 顧遞餘鹹糧膚蓋獵鹽艱 (齋膚構餘觸築窪鹹憲襯, 壓範鑰鹽獵淵憲憲構鑰 ~ 積築鑰願遞襯憲積夢願) 更多 | - | 2023-09-21 |
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