Delving into the Latest Updates on Waterstone Pharmaceuticals (Wuhan) Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Waterstone Pharmaceuticals is an American company that operates out of Wuhan, China. The company specializes in research, development, and manufacturing of pharmaceutical products. Its activities include drug discovery of new chemical entities, custom development and manufacturing services, and the production of generic drugs.

Tags

Endocrinology and Metabolic Disease

Other Diseases

Immune System Diseases

Small molecule drug

Synthetic peptide

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	5
Nervous System Diseases	1
Hemic and Lymphatic Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	6
Synthetic peptide	1

Top 5 Target	Count

CYPA(Cyclophilin A)	1

主要研究目的: 评价中国健康成年受试者空腹条件下单次单剂量口服依帕司他片受试制剂（规格：50mg，申办者：中美华世通生物医药科技（武汉）股份有限公司）和参比制剂（商品名：KINEDAK®，规格：50mg，持证商：アルフレッサファーマ株式会社）后的药代动力学特点和生物等效性。次要研究目的: 研究依帕司他片受试制剂（规格：50mg）和参比制剂（商品名：KINEDAK®，规格：50mg）在中国健康成年受试者中的安全性。

[Translation]

Primary study objective: To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of epalrestat tablets (specification: 50 mg, applicant: Sino-US Huashitong Biopharmaceutical Technology (Wuhan) Co., Ltd.) and the reference formulation (trade name: KINEDAK®, specification: 50 mg, licensee: アルフレッサファーマ株式会社) after a single oral dose under fasting conditions in healthy Chinese adult subjects. Secondary study objective: To study the safety of the test formulation of epalrestat tablets (specification: 50 mg) and the reference formulation (trade name: KINEDAK®, specification: 50 mg) in healthy Chinese adult subjects.

Start Date21 Feb 2024

Sponsor / Collaborator

Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

CTR20234250

/ CompletedPhase 1

评估WS012在中国健康成人受试者中的安全性、耐受性和药效动力学的随机、双盲、安慰剂对照的单、多剂量递增的I期临床研究

[Translation] A randomized, double-blind, placebo-controlled, single- and multiple-dose ascending phase I clinical study to evaluate the safety, tolerability, and pharmacodynamics of WS012 in healthy Chinese adult subjects

主要目的：评估WS012在中国健康成人受试者中单次和多次口服给药的安全性和耐受性。次要目的：评估WS012在中国健康成人受试者中单次和多次口服给药的总胆汁酸（TBA）和粪便中TBA的药效动力学。探索性目的：探索健康受试者多次口服给药WS012对血脂（TG、TC、HDL-C、LDL-C）的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of WS012 after single and multiple oral administration in healthy Chinese adult subjects. Secondary objective: To evaluate the pharmacodynamics of total bile acid (TBA) and fecal TBA in WS012 after single and multiple oral administration in healthy Chinese adult subjects. Exploratory objective: To explore the effects of multiple oral administration of WS012 on blood lipids (TG, TC, HDL-C, LDL-C) in healthy subjects.

Start Date04 Jan 2024

Sponsor / Collaborator

Waterstone Pharmaceuticals (HuBei) Co., Ltd.

[+1]

CTR20233924

/ CompletedNot Applicable

依帕司他片生物等效性试验

[Translation] Bioequivalence study of epalrestat tablets

主要研究目的: 评价中国健康成年受试者空腹条件下单次单剂量口服依帕司他片受试制剂（规格：50mg，申办者：中美华世通生物医药科技（武汉）股份有限公司）和参比制剂（商品名：KINEDAK®，规格：50mg，持证商：アルフレッサファーマ株式会社）后的药代动力学特点和生物等效性。次要研究目的: 研究依帕司他片受试制剂（规格：50mg）和参比制剂（商品名：KINEDAK®，规格：50mg）在中国健康成年受试者中的安全性。

[Translation]

Main study objectives: To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of epalrestat tablets (specification: 50 mg, applicant: Sino-US Huashitong Biopharmaceutical Technology (Wuhan) Co., Ltd.) and the reference formulation (trade name: KINEDAK®, specification: 50 mg, licensee: アルフレッサファーマ株式会社) after a single oral dose under fasting conditions in healthy Chinese adult subjects. Secondary study objectives: To study the safety of the test formulation of epalrestat tablets (specification: 50 mg) and the reference formulation (trade name: KINEDAK®, specification: 50 mg) in healthy Chinese adult subjects.

Start Date03 Jan 2024

Sponsor / Collaborator

Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

100 Clinical Results associated with Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Login to view more data

0 Patents (Medical) associated with Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Login to view more data

1

Literatures (Medical) associated with Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Zhongguo yao xue za zhi (Zhongguo yao xue hui : 1989)

Acetyl CoA Carboxylase Inhibitor Drugs and Global Patent Information Analysis

Author: Qian, Li-na

To analyze the ACC inhibitor drugs and their layout of global patents, thus to provide experience for the domestic pharmaceutical enterprises in the R&D and patent protection.Using qual. and quant. anal., the global patents of ACC inhibitor drugs were searched, indexed, statisticed and analyzed to draw the conclusion.Patent family is key for the important market and the chem. compound patent plays a major role.The global patents of ACC inhibitor drugs are still on the early stage, and the domestic pharmaceutical enterprises could construct the crystal and composition patents in the surrounding patent layouts at the right time according the R&D strategies.

100 Deals associated with Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Login to view more data

100 Translational Medicine associated with Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Login to view more data

Corporation Tree

Boost your research with our corporation tree data.

login

or

view full example data

Boost your research with our corporation tree data.

Pipeline

Pipeline Snapshot as of 06 Mar 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

3

Phase 1

Phase 3

1

2

Other

Login to view more data

Current Projects

Drug(Targets)	Indications	Global Highest Phase

WS016	Hyperkalemia More	Phase 3
WS-015	Hyperuricemia More	Phase 1
WS-012	Cholangitis, Sclerosing More	Phase 1
WS-635 ( CYPA )	Emergence Delirium More	Phase 1
WS020	Tumor Lysis Syndrome More	Discovery