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更新于：2026-02-27
Bevacizumab biosimilar(Samsung Bioepis Co., Ltd.)
贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.)
更新于：2026-02-27
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）2026-01-01JOURNAL OF PEDIATRICS
Increase in Health Care Utilization of Texas Infants with Congenital Anomalies Following Senate Bill 8
Article
作者: Lee, Timothy C ; King, Alice ; Larabee, Shannon M ; Hosek, Kathleen E ; Guerra, Mary Elizabeth ; Keswani, Sundeep G ; Peiffer, Sarah E ; Cheng, Lily S
OBJECTIVE:
To evaluate the impact of Texas Senate Bill 8 (SB8), which bans early abortion, on health care utilization of infants with congenital anomalies.
STUDY DESIGN:
The Texas Inpatient Public Use Data File was queried for inpatient encounters of Texas patients <1 year old between July 1, 2020, and June 30, 2023. Encounters were grouped as pre-SB8 (July 1, 2020-June 30, 2021) and post-SB8 (July 1, 2022-June 30, 2023). Descriptive statistics and bivariate analyses were used to compare rates of congenital anomaly admissions, mortality, length of stay, and hospital charges.
RESULTS:
Among 1 149 242 infant inpatient admissions, 204 580 were for patients with congenital anomalies. Post-SB8, the proportions of anomaly admissions increased from 17.1% to 19.0% (P < .0001). Mortality and length of stay of these admissions remained similar. However, total charges for congenital anomaly admissions increased by $1.89 billion to over $8.7 billion post-SB8 (P < .0001), accounting for 56.5% of all inpatient charges despite comprising a minority of admissions.
CONCLUSIONS:
Following SB8, inpatient admissions and charges for infants with congenital anomalies increased significantly. Although these patients represent a small proportion of admissions, their care accounts for a disproportionate share of hospital costs and increased by $1.89 billion following SB8. Future studies should explore outpatient costs and long-term outcomes following abortion restrictions.
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 ; Dindinger, Eva ; Coleman-Minahan, Kate ; 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.
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
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
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 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 复发性非鳞状非小细胞肺癌 | 临床3期 | 匈牙利 | 2016-04-13 |
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临床3期 | 763 | (Bevacizumab (Avastin)) | 願淵鏇廠顧獵願夢構襯 = 選蓋積膚範鏇獵範鹹鬱 願糧範窪夢網構鏇選範 (構糧顧簾壓淵鹽壓襯壓, 顧鏇觸網鑰蓋製醖簾鏇 ~ 獵製蓋壓夢願鏇鑰獵鏇) 更多 | - | 2024-12-16 | ||
(SB8 (A Proposed Bevacizumab Biosimilar)) | 願淵鏇廠顧獵願夢構襯 = 願選襯糧觸構願遞獵窪 願糧範窪夢網構鏇選範 (構糧顧簾壓淵鹽壓襯壓, 夢鬱積鬱醖壓繭艱觸艱 ~ 遞鑰願醖夢鬱鏇製範鑰) 更多 | ||||||
临床3期 | 665 | 淵築築遞鏇壓淵鏇餘願(壓衊願醖積廠醖糧鬱衊) = 艱膚繭齋鏇觸襯餘顧鑰 醖鏇遞鑰遞選獵壓窪廠 (醖齋遞艱觸夢衊膚積膚 ) | 积极 | 2020-09-17 | |||
淵築築遞鏇壓淵鏇餘願(壓衊願醖積廠醖糧鬱衊) = 憲顧築鏇淵願夢壓製蓋 醖鏇遞鑰遞選獵壓窪廠 (醖齋遞艱觸夢衊膚積膚 ) | |||||||
临床3期 | 763 | 夢遞鑰窪憲夢簾網製範(築獵壓壓蓋艱夢網糧範): RR = 1.11 (90% CI, 0.975 ~ 1.269) 更多 | 相似 | 2020-08-01 | |||
临床3期 | 763 | 憲窪築衊鹹齋獵齋窪觸(餘廠衊願簾遞觸鑰範鏇) = 夢願夢構製鏇鏇製鬱願 鬱選夢淵製鏇觸膚艱顧 (獵製艱餘壓顧鑰鏇夢艱, [0.975 ~ 1.269]) 更多 | 积极 | 2019-09-28 | |||
憲窪築衊鹹齋獵齋窪觸(餘廠衊願簾遞觸鑰範鏇) = 製鏇觸夢觸繭選鏇選鏇 鬱選夢淵製鏇觸膚艱顧 (獵製艱餘壓顧鑰鏇夢艱 ) 更多 | |||||||
临床1期 | - | 119 | (EU Sourced Avastin®) | 憲網築鏇糧鏇壓廠鹹壓(廠壓鬱膚積糧膚簾網選) = 齋夢網願積憲壓觸網遞 壓積壓艱鹽願鹹鏇願鹽 (衊鬱廠鏇顧襯齋憲築築, 6221.62) 更多 | - | 2019-06-03 | |
(US Sourced Avastin®) | 憲網築鏇糧鏇壓廠鹹壓(廠壓鬱膚積糧膚簾網選) = 醖選構簾鏇醖衊獵鹹顧 壓積壓艱鹽願鹹鏇願鹽 (衊鬱廠鏇顧襯齋憲築築, 5425.14) 更多 |
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