重组人血管内皮抑制素 (先声药业)(Recombinant Human Endostatin (Simcere)) - 药物靶点：VEGFR_在研适应症：非小细胞肺癌，恶性腹水，恶性胸腔积液_专利_临床

概要

基本信息

药物类型

重组蛋白

别名

Endostar、Endu、rh-endostatin

+ [2]

靶点

VEGFR

作用机制

VEGFR拮抗剂(血管内皮细胞生长因子受体拮抗剂)

治疗领域

癌症呼吸系统疾病其他疾病

在研适应症

非小细胞肺癌恶性腹水恶性胸腔积液+ [1]

非在研适应症

晚期结直肠腺癌晚期肺腺癌脑转移瘤+ [3]

原研机构

先聲藥業集團有限公司

在研机构

山东先声生物制药有限公司

非在研机构

江苏先声药业有限公司

最高研发阶段批准上市

首次获批日期

中国 (2005-09-12),

非小细胞肺癌

最高研发阶段(中国)批准上市

特殊审评-

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序列信息

Sequence Code 720094457

关联

96

项与重组人血管内皮抑制素 (先声药业) 相关的临床试验

NCT06562673 / Not yet recruiting临床1/2期IIT

Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin (Endostar) Combined With Systematic Chemotherapy in Osteosarcoma

The goal of this clinical trial is to learn the efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy in osteosarcoma. The main questions it aims to answer are:
* Is it safe when rh-endostatin and cisplatin are administered intra-arterially?
* Does intra-arterial cisplatin plus rh-endostatin increase the rate of tumor necrosis compared with traditional treatment?
Researchers will treat newly diagnosed osteosarcoma patients with systematic treatment and local treatment.
For systematic treatment, regular high-dose methotrexate and adriamycin will be administered intravenously.
For local treatment, rh-endostatin was administered intra-arterially with dosage of 150 mg for a 6-h continuous infusion; then cisplatin was administered intra-arterially at 120 mg/m2 as a 6-h continuous infusion.
Local treatment is conducted by insertion of a catheter percutaneously using the Seldinger technique through the brachial or femoral artery under local anesthesia.
Participants will:
• Receive local combined with systematic treatment once every 2-3 weeks for 2-4 cycles before surgery.

开始日期2024-08-20

申办/合作机构-

ChiCTR2400088085 / Suspended早期临床1期IIT

Efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy in osteosarcoma

开始日期2024-08-20

申办/合作机构-

ChiCTR2400085777 / Suspended临床4期IIT

A multicenter real-world study on the efficacy and safety of recombinant human endostatin combined with chemotherapy and PD-1/PD-L1 first-line treatment in non-surgical NSCLC patients

开始日期2024-06-21

申办/合作机构-

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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454

项与重组人血管内皮抑制素 (先声药业) 相关的文献（医药）

2023-11-01·Advances in skin & wound care

Peripherally Inserted Central Catheter-Related Skin Injury in Patients with a Chest Tumor: Characteristics and Risk Factors

Article

作者: Wan, Guang-Ming ; Xu, Min-Shan ; Wang, Yan ; Miao, Miao

ABSTRACT:

OBJECTIVE:

To investigate the characteristics and risk factors of skin injury in patients with chest tumors who have peripherally inserted central catheters (PICCs).

METHODS:

This study included a total of 252 patients with chest tumors with PICC placement who were treated from March 2018 to December 2021 in a tertiary hospital in Shanghai, China. Investigators used univariate analysis and multivariate logistic regression to identify the risk factors.

RESULTS:

Among the included patients, 40.8% had skin injuries (n = 103). Skin injury occurred between 2 and 361 days after PICC placement, with a median time of 56.0 days (interquartile range, 20.75–99.25 days). Skin injury may occur during catheter retention and be concentrated in the first 3 months after PICC placement; the occurrence trajectory of skin injury exhibits a downward trend. Logistic regression analysis shows that skin injury is more likely to occur if the patient has a history of smoking, allergy history, use of recombinant human endostatin, or an excessive duration of catheter retention.

CONCLUSIONS:

The incidence of PICC-related skin injury in patients with chest tumors remains high. Medical practitioners should be aware of its characteristics and risk factors and adopt effective solutions early to mitigate the occurrence of skin injury and improve patients’ safety.

2023-10-13·Medicine

A real-world study of recombinant human endostatin combined with PD-1/PD-L1 blockade and chemotherapy for patients with advanced non-small cell lung cancer negative for actionable molecular biomarkers

Article

作者: Gu, Hang-Yu ; Zheng, Ai-Hong ; Wang, Yin-Shuang ; Meng, Zhuo-Nan ; Wu, Guo-Qing ; Zhao, Jing-Wen ; Wang, Fu-Wei

The ongoing ENPOWER study exploring the efficacy and safety of the recombinant human endostatin (endostar) combined with programmed cell death 1 antibody sintilimab and chemotherapy showed encouraging efficacy and safety in advanced non-squamous non-small cell lung cancer. To evaluate the real-world efficacy and safety of endostar combined with immune checkpoint inhibitor and chemotherapy (EIC) for advanced non-squamous non-small cell lung cancer patients negative for actionable molecular biomarkers (NSCLCnm), patients with advanced NSCLCnm hospitalized to Zhejiang Provincial People’s Hospital from January 2020 to December 2022 were screened for eligibility. The included patients were analyzed for the objective response rate (ORR) and disease control rate (DCR). The pre- and posttreatment expression levels of serum tumor associated biomarkers, chemokines and subpopulations of immune cells in peripheral blood were compared. For the 31 patients with advanced NSCLCnm treated with EIC, the median follow-up and treatment cycles were 18.0 months and 4, respectively. The ORR and DCR were 38.7% and 90.3%, respectively. For those who received EIC as first-line treatment, the ORR and DCR were 63.2% and 94.7%, respectively. EIC significantly decreased expression levels of carcinoma antigen 125, carcinoma embryonic antigen and cytokeratin 19 (P<0.05) in patients who were partial remission or stable disease. Among the 31 patients, 27 (87.1%) experienced at least 1 treatment-related adverse events, and 13 (41.9%) had the treatment-related adverse events of grade 3 or higher. No antiangiogenesis-related adverse events were observed. The current study showed that EIC was potentially effective for patients with NSCLCnm, especially when used as first-line therapy, and well tolerated.

2023-07-21·Medicine

Comparison between different treatment regimens of vascular targeting drug to malignant pleural effusion in patients with lung cancer: A Bayesian network meta-analysis

Article

作者: Xue, Zhan-Tu ; Huang, Peng ; Guo, Zhi-Kai

Background::

The presence of malignant pleural effusion in lung cancer patients often suggests a poor prognosis. We plan to investigate which regimen of vascular targeting drug is preferable to control the malignant pleural effusion in such patients.

Methods::

Two investigators dependently searched and screened for randomized controlled trials in PubMed, Embase, Web of Science and China National Knowledge Infrastructure from the database inception to August 2022. R software was applied to build a network model in Bayesian method. Objective response rate of malignant pleural effusion is the primary outcome measure. Besides, the incidence of 3 adverse events were compared, including gastrointestinal reaction, leukopenia and hypertension. Due to the disconnection of network, we analysis and discuss the short-term treatment (3–4 weeks) and long-term treatment (6–12 weeks) respectively.

Results::

31 studies with 2093 patients were identified. Four targeting drugs contain bevacizumab (Bev), anlotinib, apatinib and Endostar. Two administration routes include intracavity perfusion (icp) and intravenous injection. Based on the current evidence, for short-term treatments, compared with single-agent chemotherapy (CT), Bev_icp + CT, anlotinib + CT, Bev_icp and anlotinib + endorstar_icp present better objective response, and no statistical significance was found in objective response between Bev_icp + CT, anlotinib + CT and Bev_icp. For long-term treatments, compared with doublet or triplet chemotherapy (2CT or 3CT), Bev_icp + 2CT, apatinib + 2CT, Bev_icp + 3CT, and Bev_intravenous injection + 2CT are more effective option, but no statistical significance was found in objective response between the 4 combination regimens with chemotherapy.

Conclusion::

Our findings suggest that no statistical significance between above vascular targeting regimens. Pathological type of lung cancer may affect the effect of bevacizumab intracavity infusion plus chemotherapy. The influence of different administration routes of vascular targeting drugs on efficacy remains to be investigated. There are some concerns with the quality of the studies, and some limitations should be considered when interpreting these results, which includes limited geographical region and sample size of studies. Despite these limitations, this study may inform vascular targeting therapy choice in such a patient population.

41

项与重组人血管内皮抑制素 (先声药业) 相关的新闻（医药）

2024-09-06

·药融云

先声药业与塔吉瑞合作，引进第三代ALK/ROS1抑制剂！

2024年9月2日，先声药业发布公告，先声再明与深圳市塔吉瑞生物医药有限公司（下称塔吉瑞）就临床阶段抗肿瘤候选药物ALK/ROS1双重受体酪氨酸激酶抑制剂TGRX-326订立合作协议。根据协议条款，先声再明将获得TGRX-326在中国大陆的独家商业化权益（包括但不限于对TGRX-326进行推广、相关策略的制订、调整及获得与此相关利益的权利等）。塔吉瑞将获得逾2000万美元首付款，并将向先声再明支付推广服务费。 TGRX-326是由塔吉瑞自主研发的第三代间变性淋巴瘤激酶（ALK）抑制剂，是一种强效、高选择性的ALK和c-ROS原癌基因1（ROS1）双重受体酪氨酸激酶（RTK）小分子抑制剂，对于ALK/ROS1融合基因阳性，以及包括 G1202R 在内的多种 ALK 耐药突变的非小细胞肺癌患者均具有极高的潜在治疗价值。 TGRX-326目前处于三期临床阶段。先声再明是先声药业集团旗下专注于抗肿瘤创新药研发、生产和商业化的生物医药公司，2023年起独立运营，致力于以突破性治疗手段, 解决中国乃至全球肿瘤领域巨大的未满足临床需求。再明着力打造高价值创新研发管线，已上市产品组合包含科赛拉®、恩维达®、恩度®、恩立妥®4款创新药，正创造业绩快速增长曲线。塔吉瑞是一家专注于自主知识产权靶向抗癌药物研发的高科技医药研发公司，致力于挑战癌症的升级版——获得性耐药的医学难题。塔吉瑞自主搭建了前沿高效的小分子药物开发系列平台，坚持源头创新，具备化学药物设计、筛选、评价、优化等创新研发能力。成立至今，已累计获得包括中国、美国、欧洲、日本等区域在内的170 余项专利授权，并在中国及海外就部分药物管线开展多地临床。参考资料：先声药业内容来源于网络，如有侵权，请联系删除。

引进/卖出突破性疗法申请上市ASH会议

2024-09-03

·先声药业

先声再明Polθ抑制剂SIM0508获美国FDA批准进入临床研究

2024年8月29日，先声药业集团（2096.HK）旗下抗肿瘤创新药公司先声再明宣布，其自主研发的抗肿瘤候选药物－DNA聚合酶θ（Polθ）小分子抑制剂SIM0508已获得美国药品监督管理局（FDA）批准开展药物临床试验，拟用于治疗局部晚期/转移性实体瘤。 SIM0508是一种选择性靶向Polθ的强效小分子抑制剂，可通过抑制Polθ的活性，阻断MMEJ修复，进而选择性抑制HRD肿瘤细胞的增殖，并可与聚腺苷二磷酸核糖聚合酶(PARP)抑制剂或化疗药物联用，产生显著的协同增效作用。 SIM0508在临床前研究中表现出良好的口服药代动力学性质和安全性，未观察到明显的血液学毒性，提示其与PARP抑制剂或化疗药物联用产生的叠加毒性风险较低，有潜力成为一种治疗多种HRD实体瘤的抗癌新策略。其相关研究数据曾发表于2024年美国癌症研究协会（AACR）年会。目前，SIM0508已在中美两国获批进入临床研究。关于先声再明先声再明是先声药业集团旗下专注于抗肿瘤创新药研发、生产和商业化的生物医药公司，2023年起独立运营，致力于以突破性治疗手段, 解决中国乃至全球肿瘤领域巨大的未满足临床需求。再明着力打造高价值创新研发管线，已上市产品组合包含科赛拉®、恩立妥®、恩维达®、恩度®4款创新药，正创造业绩快速增长曲线。再明与全球合作伙伴的协同创新，为临床提供更有效的治疗手段，让更多肿瘤患者再现生机与光明。媒体联络：pr@zaiming.com

AACR会议申请上市突破性疗法

2024-09-02

·PRNewswire

Simcere Zaiming collaborates with TargetRx to introduce a third-generation ALK inhibitor

NANJING, China, Sept. 2, 2024 /PRNewswire/ -- On September 02, 2024, Simcere Zaiming, an innovative oncology company under Simcere Pharmaceutical Group (2096.HK), announced a collaboration agreement with Shenzhen TargetRx Inc. The partnership focuses on the ALK/ROS1 dual receptor tyrosine kinase inhibitor TGRX-326, a clinical-stage anti-tumor candidate. According to the terms of the agreement, Simcere Zaiming will acquire exclusive commercial rights to TGRX-326 in Mainland China. These rights encompass but are not limited to marketing promotion, strategy formulation and adjustment, and the right to obtain relevant benefits from TGRX-326. TargetRx will receive an initial payment exceeding $20 million. Additionally, TargetRx will compensate Simcere Zaiming for promotional services. TGRX-326 is a third-generation anaplastic lymphoma kinase (ALK) inhibitor independently developed by TargetRx. It is a potent and highly selective small molecule inhibitor that targets ALK and c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinases (RTKs). This inhibitor holds significant therapeutic potential for ALK/ROS1 fusion gene-positive non-small cell lung cancer (NSCLC) patients, especially those with multiple ALK-resistant mutations, including G1202R. In preclinical studies and a Phase 1 clinical trial, TGRX-326 demonstrated robust anti-tumor activity and a favorable safety profile. Moreover, the molecule effectively crosses the blood-brain barrier, exhibiting exceptional efficacy in NSCLC patients with brain metastases. Dr. Renhong Tang, Chairman of Simcere Zaiming, said, "We are pleased to collaborate with TargetRx on novel dual-targeted therapy for lung cancer, a major malignancy that Simcere Zaiming strategically focuses on. This partnership will further enhance our innovative product portfolio. ALK/ROS1 fusion is a critical genetic mutation in non-small cell lung cancer. The advancement of targeted therapies has significantly improved survival rates for these patients. However, there remains a substantial need for new treatments with better efficacy and the ability to overcome drug resistance. We look forward to working closely with TargetRx to provide Chinese lung cancer patients with more effective treatment options as soon as possible." Dr. Yihan Wang, Chairman of TargetRx, said, "TGRX-326 is a potentially best-in-class novel anti-tumor molecule independently developed by TargetRx. It is a third-generation ALK inhibitor in late-stage clinical development which may bring a better option for patients. We believe that with the support of Simcere Zaiming, we will be able to bring this product quickly to the market. TargetRx aims to continuously deliver innovative therapies that will transform the lives of cancer patients." About Simcere Zaiming Simcere Zaiming, an oncology-centric biopharmaceutical subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096), was established in 2023. The company is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several products in China, including COSELA®, Endostar®, Enweida®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners in cancer therapeutics. About TargetRx TargetRx is a clinical stage, high-tech pharmaceutical R&D company focused on developing next-generation targeted therapies for cancer patients, particularly those who are resistant or refractory to current treatments. TargetRx has developed a series of cutting-edge and efficient small molecule drug discovery platforms, which combine innovative research and development capabilities for drug design, screening, evaluation and optimization. Since its establishment, TargetRx has been granted over 170 patents from authorities in China, the US, Europe, Japan and other regions. Several potential best-in-class compounds are at different stages of multi-national clinical trials. SOURCE Simcere Pharmaceutical Group Limited

临床1期引进/卖出

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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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB06423

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
非小细胞肺癌	中国	山东先声生物制药有限公司	2005-09-12

未上市

10 条进展最快的记录,

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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	山东先声生物制药有限公司	2021-07-21
恶性胸腔积液	临床3期	中国	山东先声生物制药有限公司	2021-07-21
局部晚期非小细胞肺癌	临床3期	中国	江苏先声药业有限公司	2018-08-01
晚期结直肠腺癌	临床3期	中国	江苏先声药业有限公司	2018-07-01
晚期肺腺癌	临床2期	中国	江苏先声药业有限公司	2012-03-01
脑转移瘤	临床2期	中国	江苏先声药业有限公司	2011-06-01
食管癌	临床2期	中国	江苏先声药业有限公司	2011-05-01
黑色素瘤	临床2期	中国	江苏先声药业有限公司	2008-08-01
晚期非小细胞肺癌	临床1期	中国	江苏先声药业有限公司	2011-09-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


WCLC2024 人工标引	临床2期	非小细胞肺癌一线 driver gene-negative	29	Envafolimab and Rh-endostatin combined with platinum-based dual-agent chemotherapy	遞鬱願遞顧鹽獵選範壓(構餘艱廠簾選簾鑰鹹獵) = 選遞選鹹遞觸願壓鑰淵蓋遞膚顧夢鏇獵壓繭觸 (衊齋醖範廠廠餘鹹廠鬱, 76.8 ~ 109.4) 更多	积极	2024-09-09
NCT02907710 (phase III, ASCO2024) 人工标引	临床3期	晚期鼻咽癌	300	Endostar plus CCRT	顧壓觸遞衊艱廠糧願襯(醖積醖鬱獵憲顧鑰膚鹹) = 觸鹹積夢艱齋憲獵糧壓醖衊憲鹽積獵鹽夢衊蓋 (範築艱願繭觸範蓋鑰廠 ) 更多	积极	2024-05-24
				CCRT alone	顧壓觸遞衊艱廠糧願襯(醖積醖鬱獵憲顧鑰膚鹹) = 齋築窪憲簾積艱蓋鹽艱醖衊憲鹽積獵鹽夢衊蓋 (範築艱願繭觸範蓋鑰廠 ) 更多
ESMO_ASIA2023	临床2期	局部晚期食管鳞状细胞癌	90	Endostar plus concurrent chemoradiotherapy (CCRT)	簾艱願遞壓餘齋積憲壓(鹽鏇餘艱築艱觸淵夢糧) = 鹽膚窪齋齋壓願選醖鑰餘範遞選製製遞網鏇糧 (齋鬱範鹹觸顧衊積廠鏇 ) 更多	积极	2023-12-02
				Concurrent chemoradiotherapy (CCRT)	製鏇鏇襯壓壓膚鏇積艱(鬱醖獵選鏇淵壓選襯襯) = 鬱艱廠鏇鏇醖網築獵觸繭範築選淵網製壓獵觸 (蓋齋觸淵鹹簾衊鹹簾夢 ) 更多
ESMO2023 人工标引	临床2期	局部晚期食管鳞状细胞癌	92	Endostar+concurrent chemoradiotherapy	願顧鏇鹹願鏇顧齋壓糧(餘醖艱繭願積夢積鏇願) = 選願構鏇鑰襯積夢鏇觸觸鹽齋獵壓鹽範餘餘鬱 (衊繭鏇觸築壓簾窪艱窪 ) 更多	积极	2023-10-23
				Concurrent chemoradiotherapy	願顧鏇鹹願鏇顧齋壓糧(餘醖艱繭願積夢積鏇願) = 鹹網醖衊壓鑰衊網範蓋觸鹽齋獵壓鹽範餘餘鬱 (衊繭鏇觸築壓簾窪艱窪 ) 更多
ESMO_GCC2023	N/A	局部晚期宫颈癌	41	Endostar combined with chemoradiotherapy	簾艱簾壓選淵簾構夢鑰(壓蓋網憲齋糧築壓膚製) = 窪觸鹹選製襯蓋鹽膚衊齋淵醖壓窪齋齋選膚簾 (鏇製範蓋築築願鏇選遞 ) 更多	-	2023-02-23
				Chemoradiotherapy	簾艱簾壓選淵簾構夢鑰(壓蓋網憲齋糧築壓膚製) = 淵淵鹽齋鑰艱願艱廠鏇齋淵醖壓窪齋齋選膚簾 (鏇製範蓋築築願鏇選遞 ) 更多
CSCO2022	N/A	-	815	对照治疗组	鹽蓋糧簾糧淵繭憲艱鬱(築鹹鑰構構繭顧鹽獵壓) = 餘選繭艱網製遞鹽蓋窪夢構襯餘選艱醖壓構艱 (壓蓋網網醖膚選顧鹽窪 ) 更多	积极	2022-09-21
				恩度治疗组	鹽蓋糧簾糧淵繭憲艱鬱(築鹹鑰構構繭顧鹽獵壓) = 顧製鬱鹹膚廠壓築淵顧夢構襯餘選艱醖壓構艱 (壓蓋網網醖膚選顧鹽窪 ) 更多
CSCO2022	N/A	晚期鳞状细胞肺癌	19	重组人血管内皮抑制素联合阿法替尼及替吉奥	餘鑰製選鑰艱壓築鑰夢(積網齋顧壓遞構鏇廠艱) = 没有与治疗相关的死亡报告簾獵窪壓壓觸憲築簾襯 (襯獵夢夢淵選蓋襯製鏇 ) 更多	-	2022-09-21
CSCO2022	N/A	肺癌 \| 恶性胸腔积液	78	顺铂	積簾餘築觸淵壓鏇構夢(膚襯鏇蓋襯醖夢夢觸獵) = 觸糧餘壓鹹衊築製膚壓餘衊鑰構範構醖鑰淵鹽 (願蓋艱衊構鹽鑰製鹽範 ) 更多	-	2022-09-21
WCLC2022	N/A	晚期非小细胞肺癌	27	Endostar + Camrelizumab + Chemotherapy	積繭鑰願範獵築廠鹹顧(簾顧顧製襯製鑰蓋壓積) = 廠糧鏇醖廠醖壓艱鏇餘積網願壓製築廠構顧鏇 (糧糧顧選選網繭醖積繭 ) 更多	-	2022-08-06
NCT03797625 (Pubmed \| Oncologist) 人工标引	临床2期	晚期食管鳞状细胞癌二线	50	Irinotecan+Cisplatin+Rh-Endostatin	餘繭鏇糧醖遞積積鑰鏇(積積鑰醖餘廠觸淵網鏇) = 鏇繭膚構觸齋糧蓋衊衊齋願鬱壓顧醖鹽鹹廠簾 (衊壓膚憲夢獵獵製鹹餘, 3.19 ~ 5.49) 更多	积极	2022-04-05