更新于：2023-10-19
Hutchison MediPharma Ltd.
更新于：2023-10-19
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The Efficacy and Safety of Fruquintinib Plus FOLFIRI as Second-line Treatment in RAS-mutated Metastatic Colorectal Cancer
评价HMPL-415S1治疗晚期恶性实体瘤患者的安全性、耐受性、药代动力学和初步疗效的多中心、开放性I期临床研究
一项在健康受试者中评价食物和质子泵抑制剂雷贝拉唑对HMPL-453酒石酸盐片药代动力学影响的开放、随机、四周期、六序列的I期研究
100 项与 和记黄埔医药（上海）有限公司 相关的临床结果
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2019-08-01European Journal of Pharmaceutical Sciences
Preclinical pharmacokinetics, disposition, and translational pharmacokinetic/pharmacodynamic modeling of savolitinib, a novel selective cMet inhibitor
作者: Gu, Yi ; Sai, Yang ; Wang, Jian ; Yu, Meijing ; Wang, Guanglin ; Zhang, Li ; Ren, Hongcan ; Fan, Shiming ; Ren, Yongxin ; Qing, Weiguo ; Su, Weiguo
Savolitinib is a novel small-mol. selective cMet inhibitor. This work characterized its pharmacokinetics in preclin. phase, established the preclin. relationships between PK, cMet modulation and anti-tumor efficacy. In vitro and in vivo animal studies were performed for PK characterization. Savolitinib showed good absorption, moderate tissue distribution, low to intermediate clearance, and low accumulation. Hepatic oxidative metabolism followed by urinary and biliary excretions was the major elimination pathway. Based on preclin. PK data, human PK profiles were predicted using empirical methods. Pharmacodynamic studies for evaluating cMet inhibition and anti-tumor efficacy were conducted in nude mice bearing Hs746t xenograft. PK/PD models were built to link the PD measurements to nude mouse PK. The established integrated preclin. PK/PD model contained a two-compartment non-linear PK model, a biomarker link model and a tumor growth transit model. The IC50 of cMet inhibition and the concentration achieving half of the maximal Hs746t tumor reduction by savolitinib were equal to 12.5 and 3.7 nM (free drug), resp. Based on the predicted human PK data, as well as the established PK/PD model in nude mouse, the human PD (cMet inhibition) profiles were also simulated. This research supported clin. development of savolitinib. Understanding the preclin. PK/PD relationship of savolitinib provides translational insights into the cMet-targeted drug development.
2019-05-23Journal of Medicinal Chemistry1区 · 医学
Discovery, Optimization, and Evaluation of Potent and Highly Selective PI3Kγ-PI3Kδ Dual Inhibitors
1区 · 医学
Article
作者: Jia, Hong ; Dai, Guangxiu ; Su, Weiguo ; Xiao, Kun ; Weng, Jianyang ; Zhang, Zhulin ; Wang, Qing ; Yuan, Tianhai ; Shi, Fuying ; Zhang, Zheng ; Chen, Wei ; Sai, Yang ; Wang, Jian ; Li, Xiong ; Cai, Yu ; Yu, Jun ; Ren, Ping ; Venable, Jennifer ; Rao, Tadimeti ; Edwards, James P. ; Bembenek, Scott D.
An electronic density model was developed and used to identify a novel pyrrolotriazinone replacement for a quinazolinone, a commonly used moiety to impart selectivity in inhibitors for PI3Kγ and PI3Kδ. Guided by molecular docking, this new specificity piece was then linked to the hinge-binding region of the inhibitor using a novel cyclic moiety. Further structure-activity relationship optimization around the hinge region led to the discovery of candidate 26, a highly potent and selective PI3Kγ-PI3Kδ dual inhibitor with favorable drug metabolism and pharmacokinetic properties in preclinical species.
2019-02-28European Journal of Drug Metabolism and Pharmacokinetics
Evaluation of Generic Methods to Predict Human Pharmacokinetics Using Physiologically Based Pharmacokinetic Model for Early Drug Discovery of Tyrosine Kinase Inhibitors
作者: Ren, Hong-Can ; Sai, Yang ; Chen, Tao
Background: Requirements for predicting human pharmacokinetics in drug discovery are increasing. Developing different methods of human pharmacokinetic prediction will facilitate lead optimization, candidate nomination, and dosing regimens before clin. trials at various early drug discovery stages. Objectives: To develop and validate generic methods of human pharmacokinetic prediction to meet the requirements in early drug discovery. Methods: The physiol. based pharmacokinetic (PBPK) model implemented in Gastroplus was used for human pharmacokinetic predictions. The absorption, distribution, metabolism, and excretion properties of drugs in humans predicted from mol. structure and extrapolated from tested preclin. data were used as inputs in the PBPK model. The approaches were validated by comparison of the predicted pharmacokinetic parameters with actual pharmacokinetic parameters of 15 marketed small-mol. compounds approved by the US Food and Drug Administration. Based on the validation and reported approaches, we proposed a strategy for human pharmacokinetic prediction at different drug discovery stages. Results: Obvious underestimation of exposure (< 1/3 of actual exposure) was not observed using in silico prediction as inputs, which may reduce the probability of missing the potential compounds with predicted false low exposure. The simulated human pharmacokinetic results using tested data as inputs were superior to those obtained via in silico prediction. Both methods similarly predicted the multiphasic shape of pharmacokinetic profiles. Conclusion: These generic PBPK approaches of full in silico prediction or perdition using a combination of tested in vivo and in vitro data were validated and proved useful for human pharmacokinetic predictions.
2023-10-09
核酸药物临床申请siRNA疫苗寡核苷酸
2023-09-26
100 项与 和记黄埔医药（上海）有限公司 相关的药物交易
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管线布局
2023年11月29日管线快照
管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
药物发现
1
1
临床前
临床1期
7
4
临床2期
临床3期
2
2
批准上市
其他
6
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