Delving into the Latest Updates on Shanghai Pharma Biotherapeutics Usa, Inc. with Synapse

概览

疾病领域	数量

神经系统疾病	1
肿瘤	1

排名前五的药物类型	数量

小分子化药	1

排名前五的靶点	数量

CDK4 x CDK6	1

关联

1

项与 Shanghai Pharma Biotherapeutics Usa, Inc. 相关的药物

I-022

靶点

CDK4 x CDK6

作用机制

CDK4抑制剂 [+1]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段临床2/3期

首次获批国家/地区-

首次获批日期-

2

项与 Shanghai Pharma Biotherapeutics Usa, Inc. 相关的临床试验

NCT05580588 / Recruiting临床2期

A Phase 2 Multicenter, Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas

Study SPH4336-US-01 is an open-label (no placebo), multicenter clinical trial to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug).

开始日期2023-08-31

申办/合作机构

Shanghai Pharma Biotherapeutics Usa, Inc.

NCT05019742 / Recruiting临床2期

A Double-Blind, Placebo-Controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis

SPH3127-US-01 is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics, and preliminary efficacy of SPH3127 for the treatment of mild-to-moderate ulcerative colitis.

开始日期2022-03-21

申办/合作机构

Shanghai Pharma Biotherapeutics Usa, Inc.

100 项与 Shanghai Pharma Biotherapeutics Usa, Inc. 相关的临床结果

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0 项与 Shanghai Pharma Biotherapeutics Usa, Inc. 相关的专利（医药）

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1

项与 Shanghai Pharma Biotherapeutics Usa, Inc. 相关的文献（医药）

2019-12-01·Regulatory Toxicology and Pharmacology4区 · 医学

Evaluation of preclinical safety profile of SPH3127, a direct renin inhibitor, after 28-day repeated oral administration in Sprague-Dawley rats and cynomolgus monkeys

4区 · 医学

Article

作者: Liu, Yanjun ; Mao, Yu ; Xia, Guangxin ; Li, Hua ; Zhang, Leduo ; Li, Xin

SPH3127, a newly developed oral nonpeptide direct renin inhibitor with good tolerance and favorable ADME (absorption distribution metabolism excretion) properties in preclinical species, is now being evaluated in phase Ι clinical trial. In this work, the subchronic toxicity of SPH3127 in Sprague-Dawley rats and cynomolgus monkeys has been characterized. Rats and monkeys received SPH3127 orally (30, 300, 900 and 20, 100, 450 mg/kg/day, respectively) on a consecutive daily dosing schedule for 28 days followed by a 28-days recovery period for one third of the animals. The adverse effects of SPH3127 on rats and monkeys mainly included kidney and cardiovascular toxicity, which were consistent with pharmacologic perturbations of physiologic processes associated with the intended molecular targets for this class of renin signaling inhibitors. Moderate liver weight increases accompanied by CYP3A induction were seen in 300 and 900 mg/kg/day rats but not in monkeys or in vitro human hepatocytes. One 450 mg/kg/day monkey died early at day 23 with apparent myelosuppression characterized by atrophy of thymus and spleen, and the relevance to the action of SPH3127 remained unclear. Most of the treatment-induced effects were reversible upon discontinuation of treatment. The no-observed-adverse-effect level (NOAEL) of SPH3127 was determined to be 30 mg/kg/day for Sprague-Dawley rats and 20 mg/kg/day for cynomolgus monkeys based on the kidney and cardiovascular changes found at mid- and high-dose animals.

100 项与 Shanghai Pharma Biotherapeutics Usa, Inc. 相关的药物交易

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100 项与 Shanghai Pharma Biotherapeutics Usa, Inc. 相关的转化医学

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