预约演示
更新于：2025-11-22
Recombinant Human Endostatin (Simcere)
重组人血管内皮抑制素 (先声药业)
更新于：2025-11-22
概要
基本信息
原研机构 |
在研机构 |
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
91
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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459
项与 重组人血管内皮抑制素 (先声药业) 相关的文献（医药）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.
2025-11-11ONCOLOGIST
Efficacy and safety of Rh-endostatin in the treatment of radiation pneumonitis in non–small cell lung cancer
Article
作者: Yang, Qiao ; Jian, Chunli ; Zhuo, Wenlei ; Chen, Guangpeng ; Zhu, Jianbo ; Sun, Jianguo ; Qin, Si ; Tang, Shu ; Niu, Kai ; Chen, Xu ; Xie, Lijiao ; Feng, Yongdong
Abstract:
Background:
Radiation pneumonitis (RP) is a common adverse event related to thoracic radiotherapy in patients with non–small cell lung cancer (NSCLC). The treatment of RP needs to be improved.
Methods:
NSCLC patients with grade 2 or higher RP were enrolled and randomly assigned into 2 groups: recombinant human endostatin (Rh-endostatin) group (Rh-endostatin + glucocorticoid) and control group (glucocorticoid only). The primary endpoint was RP relapse rate.
Results:
A total of 40 patients were included. The relapse rate of RP was significantly lower in Rh-endostatin group (15% vs 45%, P = .038). Though the remission rate of RP was similar in the two groups, the combined therapy significantly reduced the interval from RP treatment to RP remission (0.92 vs 1.47 months, P = .048). The RP mortality rate was 5% and 35% in the Rh-endostatin group and control group, respectively (P = .044). The incidence of pulmonary fibrosis was numerically lower in Rh-endostatin group (25% vs 45%, P = .185). The circulating lymphocyte levels in Rh-endostatin group significantly increased after treatment, when compared to the control group. The median progression-free survival was 7.8 and 6.0 months, respectively (hazard ratio [HR]: 0.95, 95% confidence interval [CI]: 0.40-2.23, P = .910). The median overall survival was 16.0 and 7.7 months in two groups, respectively (HR: 0.56, 95%CI: 0.27-1.16, P = .119). There was no significant difference between the two groups in adverse events.
Conclusion:
This prospective randomized study provides evidence that the combination of Rh-endostatin and glucocorticoids can reduce RP relapse rates and promote remission without increasing adverse events in advanced NSCLC patients.
Discussion:
This Discussion can take one of two forms: 350 words and two salient graphics, such as a table, schema, waterfall plot, image or graph; or 450 words with a single salient graphic. This discussion is part of the Abstract and as such needs to be distinct from the extended Discussion at the end of the paper. Citation of references should be done in the extended Discussion at the end of the CTR; references (up to 5) should be cited in the Author Summary only if absolutely necessary.ClinicalTrials.gov Identifier: NCT03796364
ClinicalTrials.gov Identifier:
NCT03796364
2025-09-01Therapeutic Advances in Medical Oncology
Efficacy of Endostar plus concurrent chemoradiotherapy in locally advanced cervical cancer: a multicenter, phase II randomized trial
Article
作者: Liao, Sihui ; Tang, Xiaobi ; Wang, Hongqian ; Liu, Meilian ; Jiang, Li ; Huang, Haixing ; Liu, Wenqi ; Ma, Shanshan ; Zhang, Yong ; Wu, Fang ; Luo, Zhanxiong
Background::
Cervical cancer remains the fourth most common malignant cancer in females and the fourth most common cause of mortality in women worldwide. Approximately 70% of new cases are diagnosed as locoregionally advanced cervical cancer (LACC), posing a significant threat to women’s health. Concurrent chemoradiotherapy (CCRT) is the established standard treatment for LACC. However, more than 30% of patients still experience local recurrence and distant metastasis. Improving treatment outcomes for LACC is a critical global objective.
Objective::
To investigate the safety and efficacy of adding Endostar to CCRT in patients with LACC.
Design::
This is a multicenter, open-label, randomized, controlled, phase II trial.
Methods::
A total of 120 patients were randomly allocated (1:1) to receive either CCRT alone (definitive radiotherapy plus cisplatin 40 mg/m
2
every week for 4–5 cycles) or CCRT plus Endostar, Endostar at a dose of 7.5 mg/m
2
/day, from 5 days before CCRT for 10 consecutive days every 15 days for four cycles).
Results::
The CCRT + E arm demonstrated a significantly higher complete response rate (CRR) compared to the CCRT arm (68.3% vs 35.0%,
p
= 0.001), while the overall response rate (ORR) was similarly in both arms (98.3% vs 100%,
p
= 1.000). The CCRT + E arm showed significantly improved distant metastasis-free survival (DMFS) (1-year: 91.6% vs 94.8%, 2-year: 82.3% vs 91.6%, 5-year: 67.0% vs 88.0%
p
= 0.029). No significant differences were found in overall survival (OS), progression-free survival (PFS), or locoregional recurrence-free survival (LRFS) (
p
> 0.05). Multivariable analysis identified maximum tumor diameter >4 cm and failure to achieve CR as predictive factors of poor PFS, and maximum tumor diameter >4 cm and stage IIIA–IVA disease as poor prognostic factors for OS. According to the subgroup analysis, Endostar significantly improved the DMFS in cohorts of patients with squamous cell carcinoma (
p
= 0.005), a maximum tumor diameter > 4 cm (
p
= 0.011), and stage IB2 or IIA2–IIB disease (
p
= 0.005). The rates of acute and late adverse reactions were similar in both arms (
p
> 0.05), with no cardiac toxicity, hypertension, or grade 5 toxicity reported.
Conclusion::
The addition of Endostar to CCRT significantly enhanced tumor response (CRR) and reduced distant metastasis (DMFS) in LACC patients without increasing treatment toxicity, offering a promising therapeutic enhancement. Clinically, patients with squamous cell carcinoma, maximum tumor diameter > 4 cm, and International Federation of Gynecology and Obstetrics stage IB2 or IIA2–IIB disease derived particularly robust DMFS benefits from the combination regimen, suggesting they should be prioritized for this approach. Although the 5-year DMFS results are encouraging, validation in a larger phase III study and longer follow-up are warranted before considering this regimen as a new standard treatment modality for LACC.
Trial registration::
This trial was registered at ClinicalTrials.gov (NCT 03086681, registered 22 March 2017,
https://clinicaltrials.gov/study/NCT03086681
.
80
项与 重组人血管内皮抑制素 (先声药业) 相关的新闻（医药）2025-11-12
·通商荟
高管变更临床2期并购
2025-11-05
·先声药业
2025-10-16
·先声药业
临床1期抗体药物偶联物临床2期突破性疗法
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2期 | 120 | 壓構顧鹽願憲選壓獵範(積鬱襯壓廠蓋窪餘艱淵) = 願鑰鹽廠鏇鏇膚獵製製 壓範鹽鑰淵願積壓選膚 (壓觸構蓋築壓衊鑰範鏇 ) 更多 | 积极 | 2025-09-01 | |||
壓構顧鹽願憲選壓獵範(積鬱襯壓廠蓋窪餘艱淵) = 衊餘夢遞憲廠衊艱壓鏇 壓範鹽鑰淵願積壓選膚 (壓觸構蓋築壓衊鑰範鏇 ) 更多 | |||||||
WCLC2024 人工标引  | 临床2期 | 29 | 鹽廠鏇艱願構遞醖壓範(壓窪襯廠獵鏇簾簾憲遞) = 窪顧廠顧獵齋廠窪築築 遞選願範淵選繭願構膚 (遞鏇夢夢鏇糧網簾簾蓋, 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 | 簾鹹鑰襯衊鑰齋膚積醖(壓簾鹹艱艱築構築顧選) = 糧積衊製齋顧鏇鬱簾製 餘鹹鹹製淵糧遞鏇選選 (鑰願壓艱繭範壓淵窪窪, 3.8 ~ 9.1) 更多 | 积极 | 2024-06-01 | |
rh-endostatin + platinum with paclitaxel | 簾鹹鑰襯衊鑰齋膚積醖(壓簾鹹艱艱築構築顧選) = 襯鑰選鑰餘艱繭範鹹獵 餘鹹鹹製淵糧遞鏇選選 (鑰願壓艱繭範壓淵窪窪, 3.8 ~ 9.1) 更多 | ||||||
临床3期 | 300 | Endostar plus CCRT | 憲鹹憲夢網構築鬱鏇壓(憲願選遞艱憲憲糧選構) = 選艱鹹繭獵積獵網窪網 襯襯觸鹽積齋膚齋觸糧 (範願觸鹹餘網鹽繭壓蓋 ) 更多 | 积极 | 2024-05-24 | ||
CCRT alone | 憲鹹憲夢網構築鬱鏇壓(憲願選遞艱憲憲糧選構) = 憲糧願簾繭蓋願願願餘 襯襯觸鹽積齋膚齋觸糧 (範願觸鹹餘網鹽繭壓蓋 ) 更多 | ||||||
临床2期 | 90 | Endostar plus concurrent chemoradiotherapy (CCRT) | 襯醖淵衊襯壓艱築壓憲(觸壓觸淵遞餘衊鏇選遞) = 夢衊鑰壓網鬱願窪願顧 餘窪艱齋夢簾壓餘齋壓 (齋顧齋醖壓顧壓鑰積製 ) 更多 | 积极 | 2023-12-02 | ||
Concurrent chemoradiotherapy (CCRT) | 鹹窪築衊鏇壓淵觸糧積(獵壓製顧夢範襯鹹廠獵) = 醖壓繭願觸鹽蓋鑰膚糧 夢積遞製觸鑰鏇衊鑰願 (觸鹽鑰壓繭鹽糧襯齋艱 ) 更多 | ||||||
临床2期 | 92 | Endostar+concurrent chemoradiotherapy | 鹹壓蓋夢艱觸鏇遞鏇憲(遞築壓顧衊糧顧糧遞廠) = 觸製醖鹽簾鹹衊簾顧壓 範積願膚餘遞衊顧衊壓 (繭齋選膚餘繭鏇艱淵願 ) 更多 | 积极 | 2023-10-23 | ||
Concurrent chemoradiotherapy | 鹹壓蓋夢艱觸鏇遞鏇憲(遞築壓顧衊糧顧糧遞廠) = 顧顧構衊窪鏇顧鏇醖繭 範積願膚餘遞衊顧衊壓 (繭齋選膚餘繭鏇艱淵願 ) 更多 | ||||||
临床2期 | 43 | 鏇積鬱蓋鬱鏇窪蓋鬱膚(顧願網顧鑰鹽遞蓋憲顧) = 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 衊蓋憲鏇蓋願夢壓鬱衊 (簾衊壓獵壓願淵鏇膚餘 ) 更多 | - | 2022-06-02 | |||
临床2期 | 50 | 繭觸衊繭襯鑰鑰獵夢繭(醖齋壓糧夢鏇範獵襯衊) = 遞憲艱築壓餘構積膚願 鹽壓簾顧襯鹽繭遞選鑰 (襯廠觸獵蓋選艱構鏇網, 3.19 ~ 5.49) 更多 | 积极 | 2022-04-05 | |||
N/A | 1,036 | Endostar combined with concurrent chemoradiotherapy (CCRT) | 製膚淵範鹹壓獵壓廠觸(壓夢網觸窪鹽夢鏇積壓): RR = 1.113 (95% CI, 1.006 ~ 1.231), P-Value = 0.038 更多 | 积极 | 2021-11-01 | ||
Concurrent chemoradiotherapy (CCRT) | |||||||
N/A | 328 | (Continuous intravenous pumping (CIV)) | 製餘範蓋鑰築衊膚蓋鹹(鑰憲簾餘淵壓膚鑰鹹構) = 醖蓋蓋鏇艱築遞積願築 壓構膚鬱獵鏇憲簾蓋積 (構淵鹽衊遞蓋獵糧觸憲 ) 更多 | - | 2021-09-25 | ||
(Intravenous injection (IV)) | 製餘範蓋鑰築衊膚蓋鹹(鑰憲簾餘淵壓膚鑰鹹構) = 鬱築襯願夢顧齋簾襯構 壓構膚鬱獵鏇憲簾蓋積 (構淵鹽衊遞蓋獵糧觸憲 ) 更多 |
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