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更新于：2026-04-03
Bevacizumab biosimilar(Samsung Bioepis Co., Ltd.)
贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.)
更新于：2026-04-03
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
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Sequence Code 41637L
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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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31
项与 贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的文献（医药）2025-11-01AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
Association of reproductive access restrictions and out-of-state abortion care in Colorado: an interrupted time series analysis for 2018 to 2024
Article
作者: Neophytou, Andreas M ; Gutilla, Margaret J ; DeBie, Kelly A ; Keller, Kayleigh P ; Peel, Jennifer L
OBJECTIVE:
Access to abortion has changed dramatically in the United States in recent years, both at the federal and state level. For nearly 50 years, the right to abortion was considered a federally protected right under the Roev. Wade (1973) recognition of privacy rights under the 14th Amendment. In September 2021, Texas passed State Bill 8 which implemented a 6-week restriction on access to abortion. The following year, in 2022, the Supreme Court issued the Dobbs v. Jackson Women's Health Organization decision. Dobbs reversed Roe v. Wade and shifted determinations about legal access to the states, several of which already had trigger bans awaiting the potential removal of this constitutional right. To explore how these legal alterations to access are associated with changes in travel into abortion rights-protective states for abortions by residents of abortion-restrictive states, we sought to measure monthly abortion trends. Specifically, our goal is to compare monthly abortion utilization in Colorado by resident status before and after the introduction of abortion access restrictions, while adjusting for overall temporal trends.
STUDY DESIGN:
Utilizing monthly count data for induced abortions from the Colorado Department of Health and Environment from 2018 to 2024, an interrupted time series analysis was used to assess the association between changes in federal and state law and the number of out-of-state patients traveling to Colorado for abortions. Secondary analysis focused specifically on Texas residents. Quasi-Poisson time series regression models adjusted for time in two ways: first, we used a linear time adjustment to account for any long-term trends and second, we used harmonic terms to account for any seasonal variation present in the data.
RESULTS:
Out-of-state residents were over twice as likely to travel to Colorado after Dobbs compared to before: rate ratio (RR), 2.14 (95% confidence interval, 1.54, 2.99; P<.001). Texas residents were over 7 times more likely to travel to Colorado for abortions after the enactment of State Bill 8. Rate ratio, 7.86 (95% confidence interval, 3.30, 20.09, P<.001). Although initial spikes in travel to Colorado, particularly by Texas residents, have shown a gradual reduction over time, these patterns have not returned to baseline. This may indicate a long-term shift in how abortion care is provided and obtained in the United States in the wake of changes in the law.
CONCLUSION:
There has been a substantial increase in the number of patients traveling to Colorado for abortions associated with changes to both federal and state laws, carrying implications for clinicians and patients alike. While some of the initial demand for abortions from out-of-state residents appears to have reduced in Colorado, it has not returned to baseline and may reflect a permanent shift in how and where abortion care is provided.
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
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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)) | 顧積鑰衊鬱鹽膚範廠艱 = 窪齋廠窪壓鑰網製蓋鬱 淵繭醖鹹觸夢鑰鹽壓繭 (衊顧構廠膚膚鹽鏇鬱衊, 鑰觸齋膚廠鹹鏇壓遞廠 ~ 鑰築夢壓製鹹廠願製艱) 更多 | - | 2024-12-16 | ||
(SB8 (A Proposed Bevacizumab Biosimilar)) | 顧積鑰衊鬱鹽膚範廠艱 = 遞衊衊鹹築鏇夢製製餘 淵繭醖鹹觸夢鑰鹽壓繭 (衊顧構廠膚膚鹽鏇鬱衊, 夢夢選廠鑰壓衊糧糧觸 ~ 膚遞艱積製顧醖壓構憲) 更多 | ||||||
临床3期 | 665 | 糧範遞襯膚積願構艱襯(壓構糧鏇艱遞簾齋壓選) = 選廠糧鏇蓋積願獵範淵 鏇鹽壓鬱選餘鏇膚膚齋 (齋觸膚膚簾襯鬱鹹積艱 ) | 积极 | 2020-09-17 | |||
糧範遞襯膚積願構艱襯(壓構糧鏇艱遞簾齋壓選) = 範鑰鹽淵廠構膚繭齋願 鏇鹽壓鬱選餘鏇膚膚齋 (齋觸膚膚簾襯鬱鹹積艱 ) | |||||||
临床3期 | 763 | 鹽蓋餘鏇願夢繭餘願艱(蓋憲壓衊觸艱獵廠衊衊): RR = 1.11 (90% CI, 0.975 ~ 1.269) 更多 | 相似 | 2020-08-01 | |||
临床3期 | 763 | 廠窪積夢鹽齋膚遞鏇蓋(構齋製網窪衊壓遞製艱) = 範範積齋糧獵蓋艱淵夢 窪願壓製鬱鹽鹽繭觸憲 (獵構鬱餘製襯遞範艱構, [0.975 ~ 1.269]) 更多 | 积极 | 2019-09-28 | |||
廠窪積夢鹽齋膚遞鏇蓋(構齋製網窪衊壓遞製艱) = 繭構蓋膚鑰鏇淵遞膚鏇 窪願壓製鬱鹽鹽繭觸憲 (獵構鬱餘製襯遞範艱構 ) 更多 | |||||||
临床1期 | - | 119 | (EU Sourced Avastin®) | 壓齋遞餘憲艱醖鏇簾鹹(淵淵餘艱顧積膚鏇餘壓) = 鏇窪鬱糧範淵廠網網壓 艱蓋觸顧鑰壓艱鬱鬱窪 (築鏇願鹽艱製獵鹹觸蓋, 6221.62) 更多 | - | 2019-06-03 | |
(US Sourced Avastin®) | 壓齋遞餘憲艱醖鏇簾鹹(淵淵餘艱顧積膚鏇餘壓) = 鹹鏇憲鏇鹹壓鹽繭蓋衊 艱蓋觸顧鑰壓艱鬱鬱窪 (築鏇願鹽艱製獵鹹觸蓋, 5425.14) 更多 |
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