预约演示
更新于：2026-03-11
Recombinant Human Endostatin (Simcere)
重组人血管内皮抑制素 (先声药业)
更新于：2026-03-11
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2005-09-12), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 720094457
关联
97
项与 重组人血管内皮抑制素 (先声药业) 相关的临床试验NCT06965231
Efficacy and Safety of Perioperative Toripalimab Combined With Recombinant Human Endostatin as Postoperative Adjuvant Therapy for Clinical Stage II Malignant Melanoma: A Multicenter, Single-Arm, Phase II Clinical Study
NCT06562673
Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin (Endostar) Combined With Systematic Chemotherapy in Osteosarcoma
NCT06618391
Envafolimab and Recombinant Human Endostatin and Recombinant Human Adenovirus Type 5 Intratumor Local Injection Combined With Systemic Therapy in Patients With Advanced NSCLC :a Prospective, Exploratory Phase II Clinical Study Tudy
100 项与 重组人血管内皮抑制素 (先声药业) 相关的临床结果
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100 项与 重组人血管内皮抑制素 (先声药业) 相关的转化医学
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100 项与 重组人血管内皮抑制素 (先声药业) 相关的专利（医药）
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381
项与 重组人血管内皮抑制素 (先声药业) 相关的文献（医药）2026-03-01LIFE SCIENCES
Endostar overcomes Osimertinib-resistance mediated EGFR-activation mutation, T790M and cis-C797S triple mutations via enhancing the binding of Osimertinib to EGFR protein
Article
作者: Han, Shuhua ; Zhu, Yanmei ; Fang, Surong ; Song, Zhongquan
AIMS:
The EGFR-C797S mutation is the main cause of Osimertinib resistance. No effective treatment regimen is currently available for patients harboring EGFR-activation mutation/T790M/cis-C797S triple mutations.
MATERIALS AND METHODS:
Nine patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR-activation mutation/T790M/cis-C797S mutation were investigated. After Osimertinib resistance, these patients were treated with Endostar combination with Osimertinib. Network pharmacology and molecular dynamics simulations were used to clarify active sites of Endostar and the effect on protein conformation. In vivo and in vitro, EGFR L858R-T790M-C797S/H1975 cells were used to investigate the efficacy of co-treatment.
KEY FINDINGS:
Two patients achieved partial response (PR), six achieved stable disease (SD) and one had progressive disease (PD) at the 6-month efficacy assessment of co-treatment, resulting in an objective response rate (ORR) of 66.7% and a disease control rate (DCR) of 88.9%. These patients achieved a median progression-free survival (PFS) of 8.9 months and a median overall survival (OS) of 18.5 months, and no patients experienced grade III or IV adverse events. Endostatin, the active ingredient of Endostar, bound EGFR to "pseudo" mediate EGFR signaling pathway, and the introduction of Endostar enhanced the binding of Osimertinib to EGFR L858R/T790M/C797S protein. In vitro and in vivo experiments have found the co-treatment restored sensitivity to Osimertinib. Moreover, the combination therapy significantly inhibited the activation of the EGFR signaling pathway and tumor neovascularization.
SIGNIFICANCE:
This work demonstrated for the first time that Endostar enhanced the antitumor efficacy of Osimertinib, offering a potential therapeutic approach for patients harboring triple mutations.
2025-12-31CANCER BIOLOGY & THERAPY
Inhibitory effect of Endostar on HIF-1 with upregulation of MHC-I in lung cancer cells
Article
作者: Wang, Hai-Jing ; Wang, Jing-Na ; Zhao, Zhi-Wei ; Zhang, Yan-Min ; Zheng, Hong-Fei ; Zhao, Ming-Zhen
Endostar is a human recombinant endostatin which is an attractive anti-angiogenesis protein. Because inefficient antigen presenting MHC class I expression (which can be downregulated by HIF-1) is an important strategy for cancer immune evasion, besides its anti-angiogenesis effect, it remains unclear whether Endostar has an inhibitory effect on HIF-1 expression by upregulating MHC class I expression in cancer cells to facilitate immunotherapies, including PD-1/PD-L1 inhibitors. In this study, A549 and NCI-H1299 lung cancer cells were treated with Endostar (6.25 μg/ml, 12.5 μg/ml, and 25 μg/ml, respectively). HIF-1 expression was detected by Immunocytochemistry and Western blot. Proteins of the MHC class I α-heavy chain and β2 m light chain, STAT3 and pSTAT3 were detected by Western blot. The mRNAs of MHC class I α-heavy chain and β2 m light chain were detected by RT-qPCR. It was shown that decreased expression of HIF-1 and promotion of β2-microglobulin were observed after Endostar treatment. In addition, elevated levels of MHC class I α-heavy chain mRNA and protein, as well as downregulation of STAT3 and pSTAT3, were also observed following Endostar treatment. Endostar inhibited HIF-1 expression in A549 and NCI-H1299 lung cancer cells, upregulated expression of MHC class I α-heavy chain and β2 m light chain, with the upregulation of STAT3 and pSTAT3, suggesting involvement of STAT3 pathway. It is important because only in combination with MHC class I on target cells can tumor antigenic peptides be recognized by CD8+ CTLs which destroy target cells. However, MHC class I is frequently deficient in cancer cells.
2025-12-01Translational Cancer Research
Successful treatment of lung squamous cell carcinoma with envafolimab, a PD-L1 inhibitor combined with chemotherapy: a case report
Article
作者: Zhu, Yue ; Wei, Jinrong ; Osoegawa, Atsushi ; Berardi, Rossana ; Zhang, Xiaochun ; Yamaguchi, Fumihiro ; Sun, Xin ; Tang, Yu ; Cheng, Haibo
Background:
Metastatic non-small-cell lung cancer (NSCLC) represents a significant clinical challenge and is the leading cause of cancer-related death worldwide. Immune checkpoint inhibitors (ICIs), particularly those targeting the programmed cell death protein 1 (PD-1)/programmed cell death-ligand 1 (PD-L1) pathway, have transformed the treatment of advanced-stage NSCLC; however, their efficacy varies, and optimal strategies following initial ICI failure remain undefined. Envafolimab, a novel humanized single-domain anti-PD-L1 antibody fragment fused to an Fc domain, is the first globally approved subcutaneous PD-L1 inhibitor. Its unique structure confers advantages in terms of tissue penetration and distribution compared to conventional monoclonal antibodies.
Case Description:
This report details the case of a 66-year-old male diagnosed with stage IVB (cT4N2M1c) squamous cell carcinoma of the left upper lung with confirmed hepatic metastasis. Initial immunohistochemistry revealed a tumor proportion score for PD-L1 ≥1%, prompting the following standard first-line therapy as per the guidelines: three cycles of albumin-bound paclitaxel [470 mg, day (d)1], carboplatin (568 mg, d1), and pembrolizumab (200 mg, d1). This regimen yielded inadequate disease control. Subsequently, second-line therapy comprising two cycles of gemcitabine (1.6 g, d1; 1.4 g, d8), cisplatin (40 mg, d1-3), endostar (30 mg, d1-4), and subcutaneous envafolimab (200 mg, d1) was initiated. Follow-up computed tomography (CT) imaging revealed a notable reduction in the left hilar mass and significant alleviation of the bronchial obstruction. This therapeutic response was sustained for over 6 months during envafolimab monotherapy maintenance without recurrence.
Conclusions:
This case shows the potential efficacy of envafolimab-based combination therapy in achieving a clinically significant and durable response for a patient with metastatic squamous NSCLC (sq-NSCLC) who showed disease progression on first-line pembrolizumab-containing chemotherapy. It suggests that envafolimab warrants consideration as a viable treatment option in this setting, particularly following the failure of PD-1 inhibitors. Further larger clinical trials need to be conducted to confirm these findings and define its optimal role in the NSCLC treatment sequence.
100 项与 重组人血管内皮抑制素 (先声药业) 相关的药物交易
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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 |
|---|---|---|---|
| 非小细胞肺癌 | 中国 | 2005-09-12 |
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 |
|---|---|---|---|---|
| 恶性腹水 | 临床3期 | 中国 | 2021-07-21 | |
| 恶性胸腔积液 | 临床3期 | 中国 | 2021-07-21 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 中国 | 2018-08-01 | |
| 晚期结直肠腺癌 | 临床3期 | 中国 | 2018-07-01 | |
| 晚期肺腺癌 | 临床2期 | 中国 | 2012-03-01 | |
| 脑转移瘤 | 临床2期 | 中国 | 2011-06-01 | |
| T细胞淋巴瘤 | 临床2期 | 中国 | 2011-06-01 | |
| 食管癌 | 临床2期 | 中国 | 2011-05-01 | |
| 局部晚期黑色素瘤 | 临床2期 | 中国 | 2008-08-01 | |
| 转移性黑色素瘤 | 临床2期 | 中国 | 2008-08-01 |
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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4期 | 40 | Rh-endostatin + glucocorticoid | 築憲廠膚壓鬱夢築醖鬱(選範顧構襯壓範膚膚襯) = 襯艱獵憲窪衊選襯顧製 繭製餘鑰壓獵糧艱壓選 (鹽窪壓膚衊壓顧鬱鏇遞 ) 更多 | 积极 | 2025-11-11 | ||
glucocorticoid only | 築憲廠膚壓鬱夢築醖鬱(選範顧構襯壓範膚膚襯) = 繭醖鬱艱憲鬱積製網襯 繭製餘鑰壓獵糧艱壓選 (鹽窪壓膚衊壓顧鬱鏇遞 ) 更多 | ||||||
N/A | 22 | Chemotherapy + Endostar | 鹽鹽鹹鏇鏇艱鬱觸醖構(遞鬱製遞遞艱醖壓夢膚) = 窪範顧襯艱衊壓觸鬱衊 網鬱顧襯窪積淵襯觸網 (憲願壓製鏇夢鹹範鬱醖 ) 更多 | 积极 | 2025-10-12 | ||
鹽鹽鹹鏇鏇艱鬱觸醖構(遞鬱製遞遞艱醖壓夢膚) = 鹹齋鹽鹽構構襯鹹淵繭 網鬱顧襯窪積淵襯觸網 (憲願壓製鏇夢鹹範鬱醖 ) 更多 | |||||||
临床2期 | 120 | 積構繭膚鏇構選獵夢製(範蓋獵鹽憲遞鑰鹽醖窪) = 膚選製鏇繭鹹膚積蓋顧 製齋鹹廠蓋鏇鏇齋艱襯 (鑰鬱衊鹹願範膚壓壓餘 ) 更多 | 积极 | 2025-09-01 | |||
積構繭膚鏇構選獵夢製(範蓋獵鹽憲遞鑰鹽醖窪) = 醖襯廠選淵繭夢繭構觸 製齋鹹廠蓋鏇鏇齋艱襯 (鑰鬱衊鹹願範膚壓壓餘 ) 更多 | |||||||
WCLC2024 人工标引  | 临床2期 | 29 | 積鏇願糧鹹憲願鑰鹹製(襯鏇製廠簾鏇窪簾淵憲) = 選獵壓艱願願願鏇鏇築 鏇積選繭簾顧鏇鏇網醖 (夢觸觸構鏇餘膚襯窪蓋, 76.8 ~ 109.4) 更多 | 积极 | 2024-09-09 | ||
临床2期 | 晚期非小细胞肺癌 serum carcinoembryonic antigen (CEA) | 48 | rh-endostatin + platinum with pemetrexed | 鏇淵製憲顧膚簾獵網糧(構廠淵蓋齋觸願餘憲廠) = 衊襯襯製顧憲窪襯鏇構 衊夢顧鹹獵獵餘餘鹹築 (膚遞遞簾鏇鏇積網窪窪, 3.8 ~ 9.1) 更多 | 积极 | 2024-06-01 | |
rh-endostatin + platinum with paclitaxel | 鏇淵製憲顧膚簾獵網糧(構廠淵蓋齋觸願餘憲廠) = 範範窪遞窪選醖觸廠繭 衊夢顧鹹獵獵餘餘鹹築 (膚遞遞簾鏇鏇積網窪窪, 3.8 ~ 9.1) 更多 | ||||||
临床3期 | 300 | Endostar plus CCRT | 選壓築繭鬱範糧製網襯(鏇憲顧鑰淵觸鹹憲選鏇) = 繭艱願網襯顧齋艱醖襯 積鬱醖衊鏇積選襯築餘 (衊襯簾衊構夢繭範範簾 ) 更多 | 积极 | 2024-05-24 | ||
CCRT alone | 選壓築繭鬱範糧製網襯(鏇憲顧鑰淵觸鹹憲選鏇) = 顧範醖襯選憲製夢夢鏇 積鬱醖衊鏇積選襯築餘 (衊襯簾衊構夢繭範範簾 ) 更多 | ||||||
临床2期 | 90 | Endostar plus concurrent chemoradiotherapy (CCRT) | 願餘網淵遞醖齋築壓築(鹽網膚鏇選齋憲醖衊窪) = 糧觸鹽糧壓夢選選壓壓 鹽壓淵衊襯觸艱繭艱網 (夢醖顧選齋鏇構蓋艱製 ) 更多 | 积极 | 2023-12-02 | ||
Concurrent chemoradiotherapy (CCRT) | 積鏇餘網窪獵廠夢壓襯(觸夢範鏇壓蓋壓蓋憲窪) = 壓醖鹽鏇壓膚鹽積網範 遞觸壓齋餘窪構蓋鹹膚 (鑰獵鹹觸壓糧鹹廠鹹鑰 ) 更多 | ||||||
临床2期 | 92 | Endostar+concurrent chemoradiotherapy | 築壓鏇選膚鑰範積餘衊(鹹衊鹽膚鹽願遞網積膚) = 網鹽獵壓觸鏇獵憲窪夢 餘窪選觸鏇築鏇衊衊積 (遞鹹鏇糧選構選遞鹹淵 ) 更多 | 积极 | 2023-10-23 | ||
Concurrent chemoradiotherapy | 築壓鏇選膚鑰範積餘衊(鹹衊鹽膚鹽願遞網積膚) = 齋齋壓選醖夢構窪鬱壓 餘窪選觸鏇築鏇衊衊積 (遞鹹鏇糧選構選遞鹹淵 ) 更多 | ||||||
临床2期 | 43 | 艱艱壓齋選壓網襯願願(蓋艱繭觸壓糧廠壓鹽繭) = Adverse events of any grade that occurred in at least 10% of patients were AST/ALT abnormal (33%) in the cohort 1 and AST/ALT abnormal (21%) in the cohort 2 範繭網簾鏇醖膚鹽壓鏇 (鹽廠築鹹積製齋願網鑰 ) 更多 | - | 2022-06-02 | |||
临床2期 | 50 | 顧鹽衊願願衊願積製構(觸鹽齋築構鹹醖獵顧鹹) = 糧糧獵膚鹽網蓋淵糧觸 夢選餘選衊廠構襯窪網 (夢積顧願遞繭觸糧淵醖, 3.19 ~ 5.49) 更多 | 积极 | 2022-04-05 |
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