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更新于：2026-01-27
Bevacizumab biosimilar(Samsung Bioepis Co., Ltd.)
贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.)
更新于：2026-01-27
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 欧盟 (2020-08-19), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 41632H
当前序列信息引自: *****
Sequence Code 41637L
当前序列信息引自: *****
关联
2
项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的临床试验NCT02754882
A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
NCT02453672
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects
100 项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的临床结果
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100 项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的转化医学
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100 项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的专利（医药）
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30
项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的文献（医药）2025-03-01CONTRACEPTION
The impact of the SB 8 Texas abortion ban on pregnancy duration at time of abortion in a large volume Colorado clinic
Article
作者: Sheeder, Jeanelle ; Coleman-Minahan, Kate ; Dindinger, Eva ; Fang, Nancy Z
OBJECTIVES:
To assess changes in type of abortion, gestational duration, and changes in the proportion of out-of-state residents at a university-affiliated clinic in Denver, Colorado after Texas passed Senate Bill 8 (SB 8) that banned abortion after embryonic cardiac activity can be detected.
STUDY DESIGN:
We reviewed records of all visits of patients obtaining an abortion ≤22 weeks and 6 days gestation between January 2019 and June 2022. We created two time periods: before SB 8 (January 2019-August 2021) and after SB 8 (September 2021-June 2022). We assessed changes in type of abortion, gestational duration, and the proportion of out-of-state residents. We determined the odds of a second-trimester abortion (≥13 weeks and 0 day) after SB 8 using logistic regression models adjusted for gravida, parity, age, and the proportion of out-of-state residents.
RESULTS:
There were 3844 abortions: 2875 before and 969 after SB 8. Second trimester abortions increased from 16.8% to 24.4% for Colorado residents and from 19.5% to 33.5% for out-of-state residents (p < 0.001). The proportion of patients that were Texas residents increased from 1.2% to 17.7% after SB 8 (p < 0.001). The adjusted odds of a second trimester abortion nearly doubled overall (adjusted odds ratio [aOR] 1.86 95% CI 1.55-2.23) and for Colorado residents (aOR,1.76, 95% CI, 1.44-2.16, respectively), and more than doubled for out-of-state residents (aOR, 2.34, 95% CI,1.53-3.59).
CONCLUSIONS:
Laws that ban abortion early in pregnancy delay care and increase abortions occurring later in pregnancy, not only for people forced to seek care out of state, but for residents of states with abortion access.
IMPLICATIONS:
Our data suggests that abortion bans may increase wait times, gestational duration, and force people to travel great distances for care. As more states ban abortion or restrict abortion, surrounding states where abortion is protected may need to meet the needs of those traveling in addition to their in-state residents.
2025-01-01JOURNAL OF ETHNOPHARMACOLOGY
Caffeoylquinic acids from Silphium perfoliatum L. show hepatoprotective effects on cholestatic mice by regulating enterohepatic circulation of bile acids
Article
作者: Luo, Huiqin ; Hai, Ping ; Liu, Liying ; Yue, Huilan ; Yue, Min ; Xu, Jiyu ; Zhang, Dejun ; Wang, Luya ; Xu, Mingting ; Zhao, Xiaohui ; Jia, Wenjing ; Tao, Jihong ; Zhang, Guoying
ETHNOPHARMACOLOGICAL RELEVANCE:
The incidence of cholestatic liver disease (CLD), which is primarily marked by abnormal bile acids (BAs) metabolism and can result in significant hepatic injury, is rising. Nevertheless, there remains a lack of effective treatments and drugs in clinical practice. Silphium perfoliatum L. (SP) is rich in various structural types of caffeoylquinic acid (CQA) compounds, and it is a traditional herb of North American Indians with hepatobiliary therapy effects. However, its therapeutic effect and mechanism of action on CLD have never been studied.
AIM OF THE STUDY:
To determine if SP-8, an extract rich in CQAs from SP, protects against cholestatic liver injury induced by alpha-naphthylisothiocyanate (ANIT) and to clarify its mechanism based on the farnesoid x receptor (FXR) signaling pathway and enterohepatic circulation of BAs.
MATERIALS AND METHODS:
The therapeutic efficacy of SP-8 was evaluated by assessing the serum biochemical indices, inflammatory factors, and liver histopathology. Targeted metabolomics of the BAs was studied in the feces, liver, serum, and bile using UPLC-MS/MS. Additionally, a Western blot analysis was used to examine the expression levels of the peroxisome proliferator-activated receptor γ (PPARγ), the FXR, and proteins related to the synthesis and transport of BAs. 16S rRNA gene sequencing was performed to evaluate the gut microbiota (GM). Finally, molecular docking simulations were conducted to assess the interaction between seven types of CQAs from SP-8 with FXR and PPARγ.
RESULTS:
SP-8 significantly enhanced the health status of cholestatic mice induced by ANIT as evidenced by a notable reduction in the liver function indices and pro-inflammatory factors, restoration of liver pathological damage, and acceleration of BAs excretion through the feces. In addition, the levels of harmful secondary BAs in the liver and blood were significantly reduced by SP-8. Furthermore, the results of the study on the mechanism of action confirmed that SP-8 not only regulated FXR and PPARγ but also significantly ameliorated the GM structure, thereby promoting the enterohepatic circulation of BAs and achieving the homeostasis of the BAs in the blood and liver. In addition, SP-8 successfully reduced the inflammatory response by strongly suppressing the nuclear translocation of NF-κBp65. According to the molecular docking results, the extract's primary active ingredients could be the seven CQAs in SP-8, as they exhibited a strong affinity for both FXR and PPARγ. Finally, the Mantel test analysis revealed a significant correlation among cholestatic-associated parameters, the GM, and BAs.
CONCLUSION:
It was confirmed for the first time that the SP-8 extract of Silphium perfoliatum L. that is rich in seven CQAs had a strong therapeutic effect on ANIT-induced CLD. Its mechanism may involve the regulation of the FXR signaling pathway and the amelioration of the GM structure to promote the homeostasis of BAs enterohepatic circulation. This study provides a potential candidate medicinal herb and its components for the development of CLD therapeutic drugs.
2024-11-01EUROPEAN JOURNAL OF PHARMACOLOGY
Protopanaxadiol derivative: A plant origin of novel selective glucocorticoid receptor modulator with anti-inflammatory effect
Article
作者: Xie, Wenbin ; Fan, Huaying ; Wang, Zhixia ; Yang, Mingyan ; Li, Zhenyuan ; Gong, Baifang ; Liu, Ke ; Liu, Teng ; Bai, Xinxin ; He, Yaping ; Xie, Zeping
Constant efforts have been made to move towards maintaining the positive anti-inflammatory functions of glucocorticoids (GCs) while minimizing side effects. The anti-inflammatory effect of GCs is mainly attributed to the inhibition of major inflammatory pathways such as NF-κB through GR transrepression, while its side effects are mainly mediated by transactivation. Here, we investigated the selective glucocorticoid receptor modulator (SGRM)-like properties of a plant-derived compound. In this study, glucocorticoid receptor (GR)-mediated alleviation of inflammation by SP-8 was investigated by a combination of in vitro, in silico, and in vivo approaches. Molecular docking and cellular thermal shift assay suggested that SP-8 bound stably to the active site of GR via hydrogen bonding and hydrophobic interactions. SP-8 activated GR, induced GR nuclear translocation, and inhibited NF-κB pathway activation. Furthermore, SP-8 did not up-regulate the gene and protein expression of PEPCK and TAT in HepG2 cells, and it did not induce fat deposition like GC and has little effect on bone metabolism. Interestingly, SP-8 upregulated GR protein expression and did not cause GR phosphorylation at Ser211 in RAW264.7 cells. This work proved that SP-8 dissociated characteristics of transrepression and transactivation can be separated. In addition, the in vitro and in vivo anti-inflammatory effects of SP-8 were confirmed in LPS-induced RAW 264.7 cells and in a mouse model of DSS-induced ulcerative colitis, respectively. In conclusion, SP-8 might serve as a potential SGRM and might hold great potential for therapeutic use in inflammatory diseases.
19
项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的新闻（医药）2026-01-18
临床3期生物类似药抗体药物偶联物临床1期临床2期
2026-01-15
100 项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的药物交易
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外链
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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 |
|---|---|---|---|
| 晚期肾细胞癌 | 澳大利亚 | 2024-01-24 | |
| 高级别胶质瘤 | 澳大利亚 | 2024-01-24 | |
| 局部晚期乳腺癌 | 澳大利亚 | 2024-01-24 | |
| 转移性结直肠癌 | 澳大利亚 | 2024-01-24 | |
| 转移性肾细胞癌 | 澳大利亚 | 2024-01-24 | |
| 非鳞状非小细胞肺癌 | 澳大利亚 | 2024-01-24 | |
| 乳腺癌 | 韩国 | 2021-03-10 | |
| 结直肠癌 | 韩国 | 2021-03-10 | |
| 胶质母细胞瘤 | 韩国 | 2021-03-10 | |
| 复发性原发性腹膜癌 | 欧盟 | 2021-01-11 | |
| 复发性原发性腹膜癌 | 冰岛 | 2021-01-11 | |
| 复发性原发性腹膜癌 | 列支敦士登 | 2021-01-11 | |
| 复发性原发性腹膜癌 | 挪威 | 2021-01-11 | |
| 结肠癌 | 欧盟 | 2020-08-19 | |
| 结肠癌 | 冰岛 | 2020-08-19 | |
| 结肠癌 | 列支敦士登 | 2020-08-19 | |
| 结肠癌 | 挪威 | 2020-08-19 | |
| EGFR阳性非鳞状非小细胞肺癌 | 欧盟 | 2020-08-19 | |
| EGFR阳性非鳞状非小细胞肺癌 | 冰岛 | 2020-08-19 | |
| EGFR阳性非鳞状非小细胞肺癌 | 列支敦士登 | 2020-08-19 |
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临床结果
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临床3期 | 763 | (Bevacizumab (Avastin)) | 網膚憲鏇製憲鬱廠膚淵 = 顧膚窪網醖積餘憲窪憲 襯繭積廠鏇淵齋網構願 (範簾鑰齋餘構鹹鏇鑰蓋, 艱廠鹹鬱夢製醖築構範 ~ 願夢鏇築鹹蓋繭醖選醖) 更多 | - | 2024-12-16 | ||
(SB8 (A Proposed Bevacizumab Biosimilar)) | 網膚憲鏇製憲鬱廠膚淵 = 顧鬱餘廠蓋顧襯艱廠糧 襯繭積廠鏇淵齋網構願 (範簾鑰齋餘構鹹鏇鑰蓋, 繭壓範願憲衊繭鏇鹹積 ~ 襯鑰壓鏇製蓋齋廠繭餘) 更多 | ||||||
临床3期 | 665 | 積窪齋積願襯蓋簾餘遞(夢襯鬱鬱醖網願壓積構) = 糧觸構窪餘鹹糧網範網 範簾膚襯衊壓繭選築獵 (構糧觸顧築網壓壓築顧 ) | 积极 | 2020-09-17 | |||
積窪齋積願襯蓋簾餘遞(夢襯鬱鬱醖網願壓積構) = 鬱糧積鹽製淵網鹽願觸 範簾膚襯衊壓繭選築獵 (構糧觸顧築網壓壓築顧 ) | |||||||
临床3期 | 763 | 鏇築簾選齋蓋築鹹鏇顧(膚餘鏇願壓膚鹹糧壓醖): RR = 1.11 (90% CI, 0.975 ~ 1.269) 更多 | 相似 | 2020-08-01 | |||
临床3期 | 763 | 積鹽夢鬱醖襯鹹齋糧廠(繭鏇築廠醖齋膚鬱夢簾) = 網積齋衊積鹽鹹選夢鹽 鑰蓋顧艱夢壓夢廠觸齋 (鹽築鏇簾鏇艱觸鹽鏇鹽, [0.975 ~ 1.269]) 更多 | 积极 | 2019-09-28 | |||
積鹽夢鬱醖襯鹹齋糧廠(繭鏇築廠醖齋膚鬱夢簾) = 襯簾鑰艱艱齋構窪遞製 鑰蓋顧艱夢壓夢廠觸齋 (鹽築鏇簾鏇艱觸鹽鏇鹽 ) 更多 | |||||||
临床1期 | - | 119 | (EU Sourced Avastin®) | 鹹淵糧顧築繭積遞蓋繭(淵製鹽膚憲衊淵鑰艱遞) = 繭壓鹹築糧衊網淵鬱窪 鏇憲淵願範願範積簾淵 (窪簾繭醖餘醖夢遞鏇襯, 6221.62) 更多 | - | 2019-06-03 | |
(US Sourced Avastin®) | 鹹淵糧顧築繭積遞蓋繭(淵製鹽膚憲衊淵鑰艱遞) = 遞積廠齋網憲顧壓顧鏇 鏇憲淵願範願範積簾淵 (窪簾繭醖餘醖夢遞鏇襯, 5425.14) 更多 |
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