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

Congenital Disorders

Other 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
Hemic and Lymphatic Diseases	1
Infectious Diseases	1
Immune System Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	6
Synthetic peptide	1

Top 5 Target	Count

CYPA(Cyclophilin A)	1

Drugs associated with Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

WS016

Target-

Mechanism-

Active Org.

Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Originator Org.

Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Active Indication

Hyperkalemia

Inactive Indication-

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

WS-635

Target

CYPA

Mechanism

CYPA inhibitors

Active Org.

Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Originator Org.

SCYNEXIS, Inc.

Active Indication

Hepatitis C [+1]

Inactive Indication

Chronic hepatitis C genotype 1 [+1]

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

WS-015

Target-

Mechanism-

Active Org.

Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Originator Org.

Waterstone Pharmaceuticals (Wuhan) Co., Ltd.

Active Indication

Hyperuricemia [+1]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

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

CTR20240498 / 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]

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

[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.

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

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

23 May 2024·Nephrology Dialysis Transplantation

#2341 WS016, a novel potassium binder: safety, tolerability and pharmacodynamics in first-in-human phase 1 healthy volunteer study

Author: Zhang, Faming ; Zhou, Youcheng ; Fu, Min ; Song, Aiyun ; Hu, Minglong

AbstractBackground and AimsHyperkalemia is a common and potentially serious medical condition in patients with chronic kidney disease and is associated with high rates of mortality. Partiromer and Lokelma are available recently, however, edema is the common adverse event resulted from the exceed sodium exchanged by Lokelma and constipation, hypomagnesemia are frequently found using Partiromer because of the basic structure of them. WS016 is a highly selective, non-absorbed, cation-exchange polymer binder with the potential characteristics of no edema and hypomagnesemia. The objective of the trials was to assess the safety/tolerability and pharmacodynamics (PD) profiles of WS016.MethodThis is a randomized, double-blind, placebo-controlled phase 1 clinical trial. 40 healthy volunteers were randomized (6:2 randomization within a cohort) into five different cohorts administered with 6 g, 12 g, 24 g, 36 g, 48 g WS016 orally once daily for only one dose during the single dose ascending (SAD) stage and 24 healthy volunteers were randomized (6:2 randomization within a cohort) into three different cohorts administered with 12 g, 36 g, 48 g orally once daily for consecutive seven days during the multiple dose ascending(MAD) stage. Adverse events (AE) were collected, and physical examination, laboratory tests were done at baseline and different visits according to the protocol. Urinary potassium and fecal potassium were collected, tested and calculated per 24 hour. Serum potassium was evaluated alone with the timing after administration of WS016 in different cohort.ResultsData of subjects from different placebo cohorts were pooled together for analysis in SAD and MAD stage. 40 healthy volunteers, including 6 in different WS016 cohorts and 10 in placebo cohort completed the SAD trial. 9, 5, 6, 7, 12 grade 1 AEs were reported from 12-48 g WS016 cohorts, respectively; 11 AEs were reported from placebo cohort and 1 is grade 2 AE. Totally, 5 cases with hypertriglyceridemia, 4 cases with prolonger activated partial thromboplastin time (APTT), 4 cases with decreased blood fibrinogen, 3 cases with sinus bradycardia were reported from WS016 cohort and 2 cases with hypertriglyceridemia, 1case with prolonged APTT, 1 case with decreased fibrinogen were reported from placebo cohort.24 healthy volunteers, 6 from different WS016 cohorts and 6 from placebo cohort completed the MAD trial. 12, 10, 12 AEs were reported from 12 g, 24 g, 48 g cohort, respectively and 6 AEs were from placebo cohort. Only 1 AE as hypertriglyceridemia from 24 g cohort is grade 2, while others are grade 1. 5 cases with sinus bradycardia, 4 cases with hypertriglyceridemia, 3 cases with hyperuricacidemia, 3 cases with hypotension, 3 cases with prolonged APTT were reported from all WS016 cohort totally and 1 cases with hyperuricacidemia,1 cases with hypotension, 1 cases with prolonged APTT were reported from placebo cohort.There is no AE related to gastrointestinal tract and no side effects on the other electrolytes such as magnesium, calcium, sodium and phosphorus, reported from both SAD and MAD.It was found that fecal potassium excretion increased and urinary potassium decreased on D2 in SAD (Fig. 1) and on D7 in MAD (Fig. 2) compared to baseline. The serum potassium decreased quickly at about 1-2 hour after first administration of WS016 both in SAD and MAD (Figs 1 and 2) and the mean serum potassium of placebo cohort is higher than that in other WS016 cohorts during MAD (Fig. 2).ConclusionWS016 was generally well-tolerated following single doses and multiple doses. The AEs like constipation, hypomagnesemia commonly found in Patiromer and edema commonly found in Lokelma were not reported in WS016 cohorts. In accordance to the results from pre-clinical studies, the clinical pharmacodynamics characteristics was the increased fecal potassium along with the decreased urinary potassium, meanwhile the serum potassium decreased, especially during the first 4 hours after administration of WS016 although in the normal range among the healthy volunteers.

Zhongguo Yaoxue Zazhi (Beijing, China)

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.

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

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Pipeline

Pipeline Snapshot as of 24 Dec 2024

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

Phase 1 Clinical

Phase 2 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

WS-635 ( CYPA )	Hepatitis C More	Phase 2
WS016	Hyperkalemia More	Phase 2
WS-015	Hyperuricemia More	Phase 1
WS-012	Hyperlipidemias More	Phase 1
WS019	Trimethylaminuria More	Discovery

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