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概览

疾病领域	数量

肿瘤	1

排名前五的药物类型	数量

重组蛋白	1

关联

1

项与江苏先声药物研究有限公司相关的药物

Pegylated recombinant human endostatin(Simcere Pharmaceutical Group Ltd.)

注射用聚乙二醇化重组人血管内皮抑制素 (先声药业)

靶点-

作用机制

血管生成抑制剂

在研机构

江苏先声药业有限公司 [+3]

原研机构

先聲藥業集團有限公司

在研适应症

实体瘤

非在研适应症-

最高研发阶段临床1期

首次获批国家/地区-

首次获批日期-

18

项与江苏先声药物研究有限公司相关的临床试验

CTR20200345 / Recruiting临床1期

聚乙二醇化重组人血管内皮抑制素在晚期/转移性非小细胞肺癌或其他实体瘤的安全性、耐受性和药代动力学研究

主要目的：评价PEG-ENDO治疗晚期/转移性NSCLC或其他实体瘤的安全性、耐受性及药代动力学特征，确定PEG-ENDO联合化疗的后续临床试验推荐剂量。次要目的：初步评价PEG-ENDO联合化疗在晚期/转移性NSCLC或其他实体瘤治疗中的临床疗效。

开始日期2020-04-15

申办/合作机构

江苏先声药业有限公司

[+3]

CTR20171512 / Completed临床1期

赛伐珠单抗联合化疗在中国铂类耐药复发性卵巢癌患者中的安全性、耐受性和药代动力学研究

主要目的：评价不同剂量赛伐珠单抗联合化疗治疗铂类耐药复发性上皮卵巢癌、输卵管癌和原发性腹膜癌患者的安全性及耐受性，推荐后续临床试验给药剂量和给药方案。

开始日期2018-04-04

申办/合作机构

江苏先声药业有限公司

[+3]

CTR20160041 / Completed临床1期

布洛芬注射液健康人体药代动力学研究

评估布洛芬注射液在健康人体的药代动力学行为特征

开始日期2017-04-19

申办/合作机构

江苏先声药物研究有限公司

[+2]

100 项与江苏先声药物研究有限公司相关的临床结果

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0 项与江苏先声药物研究有限公司相关的专利（医药）

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19

项与江苏先声药物研究有限公司相关的文献（医药）

2017-12-01·Journal of Experimental & Clinical Cancer Research1区 · 医学

Patient-derived xenograft in zebrafish embryos: a new platform for translational research in gastric cancer

1区 · 医学

ArticleOA

作者: Li, Chong-Yong ; Tan, Ai-Min ; Wu, Jia-Qi ; Zhai, Jing ; Wei, Ping ; Shen, Li-Zong ; He, Ming-Fang

BACKGROUNDGastric cancer (GC) is among the most commonly cancer occurred in Asian, especially in China. With its high heterogeneity and few of validated drug targets, GC remains to be one of the most under explored areas of precision medicine. In this study, we aimed to establish an in vivo patient-derived xenograft (PDX) model based on zebrafish (Danio rerio) embryos, allowing for a rapid analysis of the angiogenic and invasive potentials, as well as a fast drug sensitivity testing.METHODSTwo human gastric cancer cell lines (AGS and SGC-7901) were xenografted into zebrafish embryos, their sensitivity to 5-FU were tested both in vitro and in vivo. Fourteen human primary cells from gastric cancer tissue were xenografted into zebrafish embryos, their proliferating, angiogenic and metastatic activities were evaluated in vivo. Sensitivity to 5-FU, docetaxel, and apatinib were also tested on primary samples from four patients.RESULTSSGC-7901 showed higher sensitivity to 5-FU than AGS both in vitro (6.3 ± 0.9 μM vs.10.5 ± 1.8 μM) and in vivo. Nine out of fourteen patient samples were successfully transplanted in zebrafish embryos and all showed proliferating, angiogenic and metastatic potentials in the living embryos. Four cases showed varied sensitivity to the selected three chemotherapeutic drugs.CONCLUSIONSOur zebrafish PDX (zPDX) model is a preclinically reliable in vivo model for GC. The zPDX model is also a promising platform for the translational research and personalized treatment on GC.

2017-07-01·Journal of Chromatographic Science4区 · 化学

A Novel LC–MS-MS Method With an Effective Antioxidant for the Determination of Edaravone, a Free-Radical Scavenger in Dog Plasma and its Application to a Pharmacokinetic Study

4区 · 化学

Article

作者: Shan, Mang-Ting ; Shao, Feng ; Liu, Xin ; Hu, Xiao-Ling

The objective of this study was to investigate the stability of edaravone in dog plasma by using an added antioxidant stabilizer, with an ultimate goal of developing and validating a sensitive, reliable and robust LC-MS-MS method for determination of edaravone in plasma samples. Edaravone was unstable in plasma, but it presented a good stability performance in the plasma with sodium metabisulfite (SMB), an effective antioxidant. The blood sample was collected in the heparinized eppendorf tube containing SMB and plasma sample was deproteinized using acetonitrile containing 20 ng/mL of phenacetin (Internal standard). The chromatographic separation was performed on a Zorbax Extend-C18 analytical column (2.1 mm × 150 mm I.D., particle size 3.5 µm, Agilent Technologies, USA). The mobile phase consisted of 0.1% formic acid in water (v/v) and methanol, and gradient elution was used. The analyte detection was performed on a triple quadrupole tandem mass spectrometer equipped with positive-ion electrospray ionization by multiple reaction ion monitoring mode of the transitions at m/z [M + H]+ 175.1 → 77.1 for edaravone, and m/z [M + H]+ 180.2 → 110.0 for phenacetin. The linearity of this method was within the concentration range of 10-1000 ng/mL for edaravone in dog plasma. The lower limit of quantification was 10 ng/mL. The relative standard deviations of intra- and inter-precision were <10%. This method was successfully employed in the pharmacokinetics evaluation of edaravone in beagle dogs after intravenous administration.

2016-06-01·AAPS PharmSciTech3区 · 医学

Kolliphor® HS 15 Micelles for the Delivery of Coenzyme Q10: Preparation, Characterization, and Stability

3区 · 医学

Article

作者: Wang, Wenting ; Yang, Min ; Liu, Hong ; Pan, Hongchun ; Wang, Fen ; Mao, Kai ; Liu, Li

To enhance the stability of coenzyme Q10 (CoQ10), Kolliphor® HS 15 (HS15) was employed as a carrier to build up a stable CoQ10-loaded micelle delivery system. The impact of micellar compositions, the preparation condition, and the preparation method on size characteristics, the solubilization efficiency, and micellar stability were investigated. The optimal preparation conditions were 1:6, 4, 0.2%, 118°C, and 25 min for CoQ10/HS15 mass ratio, pH value, the concentration of glucose, and the sterilization conditions. Upon these conditions, the particle size, polydispersity index (PDI), zeta potential, the entrapment efficiency, drug loading, and the critical micelle concentration (CMC) of CoQ10-loaded micelles were 19.76 nm, 0.112, -3.405 mV, 99.39%, 13.77%, and 5.623 × 10(-4) g/mL, respectively. Differential scanning calorimetry (DSC) analysis collectively corroborated that CoQ10 was entrapped into the micelles in amorphous form. The release pattern of drug was analyzed and proved to follow the first order. Additionally, the samples were exposed to the temperatures of 30°C for 6 months with more significant impact on their stabilities as compared to 4 and 25°C based on particle size and PDI. Under constant humidity with light protection long-term (25 ± 2°C, relative humidity (RH) 60 ± 10%, 18 months) conditions, there was no variation except minor changes of CoQ10 content of the samples. The shelf life of the micellar samples could be predicted as 24 months based on the stability results. Consequently, the CoQ10-loaded micelles showed excellent stabilities below 25°C as a potential drug candidate for further clinical applications.

100 项与江苏先声药物研究有限公司相关的药物交易

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100 项与江苏先声药物研究有限公司相关的转化医学

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