Delving into the Latest Updates on SPH-6516 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

I-022-K, SPH 6516, SPH-6516

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Target

CDK4 x CDK6

Mechanism

CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication-

Inactive Indication

Advanced Malignant Solid NeoplasmSolid tumor

Originator Organization

Shanghai Pharmaceuticals Holding Co., Ltd.

Active Organization-

Inactive Organization

Shanghai Pharmaceuticals Holding Co., Ltd.

Shanghai Pharmaceutical Group (Benxi) North Pharmaceutical Co., Ltd.

Drug Highest PhaseDiscontinuedPhase 1

First Approval Date-

Regulation-

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主要研究目的：确定SPH6516片在晚期实体瘤患者中的安全性、耐受性、最大耐受剂量和II期试验推荐剂量。次要研究目的：评价SPH6516片在晚期实体瘤患者中的初步疗效；观察SPH6516片在晚期实体瘤患者中的群体药代动力学特征、暴露-反应关系

[Translation]

The main purpose of the study is to determine the safety, tolerability, maximum tolerated dose and recommended dose for Phase II trials of SPH6516 tablets in patients with advanced solid tumors. The secondary purpose of the study is to evaluate the preliminary efficacy of SPH6516 tablets in patients with advanced solid tumors; to observe the population pharmacokinetic characteristics and exposure-response relationship of SPH6516 tablets in patients with advanced solid tumors.

Start Date07 Jan 2022

Sponsor / Collaborator

Shanghai Pharmaceuticals Holding Co., Ltd.

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100 Clinical Results associated with SPH-6516

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100 Translational Medicine associated with SPH-6516

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100 Patents (Medical) associated with SPH-6516

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100 Deals associated with SPH-6516

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shanghai Pharmaceutical Group (Benxi) North Pharmaceutical Co., Ltd.	07 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shanghai Pharmaceuticals Holding Co., Ltd.	07 Jan 2022
Solid tumor	IND Approval	CN	Shanghai Pharmaceuticals Holding Co., Ltd.	30 Aug 2021