Delving into the Latest Updates on Shanghai Gusen Medical Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Anovent, operating as Shanghai Gusen Medical Co. Ltd., is a Shanghai-based corporation that focuses on the development and production of biological products, excluding diagnostic substances. The company was established in 2017 by its founder, Cai Gu Huang.

Tags

Respiratory Diseases

Infectious Diseases

Small molecule drug

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

Infectious Diseases	3
Nervous System Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	3

Top 5 Target	Count

RdRp(RNA-directed RNA polymerase)	1
SARS-CoV-2 3CLpro(SARS-CoV-2-3C-like-proteinase)	1
mAChRs(Muscarinic acetylcholine receptor)	1

[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the test formulation of tiotropium bromide inhalation spray (strength: 2.5 micrograms/press) and the reference formulation (Spiriva Respimat) (strength: 2.5 micrograms/press) in healthy adult subjects under fasting state

主要目的：研究空腹状态下单次口服受试制剂噻托溴铵吸入喷雾剂（规格：2.5 微克/揿，南昌谷森生物制药有限公司生产）与参比制剂噻托溴铵吸入喷雾剂（商品名Spiriva Respimat，规格：2.5 微克/揿；Boehringer Ingelheim Pharma GmbH and Co.KG生产）在健康受试者体内的药代动力学特征，评价空腹状态经口腔吸入两种制剂的生物等效性。次要目的：研究受试制剂噻托溴铵吸入喷雾剂（规格：2.5 微克/揿）和参比制剂噻托溴铵吸入喷雾剂（商品名Spiriva Respimat）（规格：2.5 微克/揿）在健康受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetic characteristics of a single oral dose of the test preparation tiotropium bromide inhalation spray (specification: 2.5 micrograms/press, produced by Nanchang Gusen Biopharmaceutical Co., Ltd.) and the reference preparation tiotropium bromide inhalation spray (trade name Spiriva Respimat, specification: 2.5 micrograms/press; produced by Boehringer Ingelheim Pharma GmbH and Co.KG) in healthy subjects, and to evaluate the bioequivalence of the two preparations by oral inhalation in the fasting state. Secondary objective: To study the safety of the test preparation tiotropium bromide inhalation spray (specification: 2.5 micrograms/press) and the reference preparation tiotropium bromide inhalation spray (trade name Spiriva Respimat) (specification: 2.5 micrograms/press) in healthy subjects.

Start Date18 Nov 2022

Sponsor / Collaborator

Shanghai Gusen Medical Co., Ltd.

CTR20233563

/ Not yet recruitingNot Applicable

中国健康受试者空腹经口腔吸入噻托溴铵吸入喷雾剂的随机、开放、两序列、四周期、完全重复交叉设计的生物等效性试验

[Translation] A randomized, open-label, two-sequence, four-period, completely repeated crossover bioequivalence study of tiotropium bromide inhalation spray in Chinese healthy subjects after oral inhalation on an empty stomach

研究空腹状态下单次经口腔吸入受试制剂噻托溴铵奥达特罗吸入喷雾剂与参比制剂在健康参与者体内的药代动力学特征，评价空腹状态下经口强吸入两种制剂的生物等效性

[Translation]

To investigate the pharmacokinetic characteristics of the test preparation tiotropium bromide olodaterol inhalation spray and the reference preparation in healthy participants after single oral inhalation in the fasting state, and to evaluate the bioequivalence of the two preparations after oral intensive inhalation in the fasting state

Start Date-

Sponsor / Collaborator

Shanghai Gusen Medical Co., Ltd.

CTR20232850

/ Not yet recruitingPhase 1

评价在空腹状态下格隆溴铵吸入喷雾剂与格隆溴铵吸入粉雾剂在中国健康受试者中随机、开放、空腹、单次给药、二周期交叉设计的药物动力学性能及安全性

[Translation] To evaluate the pharmacokinetic properties and safety of glycopyrrolate inhalation spray and glycopyrrolate inhalation powder in a randomized, open-label, fasting, single-dose, two-period crossover design in healthy Chinese subjects under fasting conditions

1) 比较格隆溴铵吸入喷雾剂 (GB SMI)与粉雾剂(DPI)在健康受试者体内的药代动力学性能、评价在本次试验条件下两种剂型的等效性； 2) 研究格隆溴铵吸入喷雾剂 (GB SMI)在健康受试者中的安全性。

[Translation]

1) To compare the pharmacokinetic properties of glycopyrrolate inhalation spray (GB SMI) and powder inhaler (DPI) in healthy subjects and evaluate the equivalence of the two dosage forms under the conditions of this study; 2) To study the safety of glycopyrrolate inhalation spray (GB SMI) in healthy subjects.

Start Date-

Sponsor / Collaborator

Shanghai Gusen Medical Co., Ltd.

[+1]

100 Clinical Results associated with Shanghai Gusen Medical Co., Ltd.

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0 Patents (Medical) associated with Shanghai Gusen Medical Co., Ltd.

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100 Deals associated with Shanghai Gusen Medical Co., Ltd.

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100 Translational Medicine associated with Shanghai Gusen Medical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 01 Apr 2026

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

IND Application

1

IND Approval

Phase 1

2

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Glycopyrrolate ( mAChRs )	Pulmonary Emphysema More	Phase 1
GS-00202 ( SARS-CoV-2 3CLpro )	COVID-19 More	Phase 1
Glycopyrrolate/OLODATEROL HYDROCHLORIDE ( mAChRs x β2-adrenergic receptor )	Pulmonary Emphysema More	IND Approval
GS-2801 ( RdRp )	COVID-19 More	IND Application