Delving into the Latest Updates on Jewim Pharmaceutical (Shandong) Co., Ltd with Synapse

Overview

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Respiratory Diseases

Nervous System Diseases

Cardiovascular Diseases

Chemical drugs

Small molecule drug

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A glimpse into the focused therapeutic areas

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Disease Domain	Count

Nervous System Diseases	2
Immune System Diseases	1
Infectious Diseases	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Chemical drugs	6
Small molecule drug	1

Top 5 Target	Count

GABA receptor(Gamma-aminobutyric acid (GABA) receptors)	1

主要目的以山东京卫制药有限公司生产的茚达特罗格隆溴铵吸入粉雾剂为受试制剂，以Siegfried Barbera, S.L.生产的茚达特罗格隆溴铵吸入粉雾剂（商品名：杰润®）为参比制剂，比较受试制剂（T）和参比制剂（R）在慢性阻塞性肺疾病（COPD）受试者体内的药效动力学特征，评价两制剂在COPD受试者中的PD-BE等效性，为受试制剂的生产注册申请提供支持。次要目的观察受试制剂和参比制剂在COPD受试者中的安全性。

[Translation]

Primary Objective: To compare the pharmacokinetic characteristics of indacatetroglycopyrronium bromide inhalation powder (T) manufactured by Shandong Jingwei Pharmaceutical Co., Ltd., and indacatetroglycopyrronium bromide inhalation powder (trade name: JERUN®) manufactured by Siegfried Barbera, S.L., in subjects with chronic obstructive pulmonary disease (COPD), evaluate the PD-BE equivalence of the two formulations in COPD subjects, and provide support for the production registration application of the investigational formulation. Secondary Objective: To observe the safety of the investigational and reference formulations in COPD subjects.

Start Date18 Nov 2025

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

CTR20253949

/ CompletedPhase 1

JW202313吸入粉雾剂和布地格福吸入气雾剂（倍择瑞®令畅®）、布地奈德福莫特罗吸入粉雾剂（Ⅱ）（信必可都保）及茚达特罗格隆溴铵吸入粉雾剂（杰润®）在中国健康受试者中的药代动力学对比研究。

[Translation] A comparative pharmacokinetics study of JW202313 inhalation powder, budegol inhalation aerosol (Bexora® Remchang®), budesonide and formoterol inhalation powder (II) (Symbicort Turbo), and indacaterol and glycopyrronium bromide inhalation powder (Jierun®) in healthy Chinese subjects.

主要目的以AstraZeneca AB持证的布地格福吸入气雾剂（倍择瑞®令畅®）、布地奈德福莫特罗吸入粉雾剂（Ⅱ）（信必可都保）及Novartis Pharma Schweiz AG持证的茚达特罗格隆溴铵吸入粉雾剂（杰润®）为对照药品，比较中国健康受试者单次给予JW202313吸入粉雾剂和对照药品后的药物代谢动力学特征。次要目的评价JW202313吸入粉雾剂和布地格福吸入气雾剂（倍择瑞®令畅®）、茚达特罗格隆溴铵吸入粉雾剂（杰润®）及布地奈德福莫特罗吸入粉雾剂（Ⅱ）（信必可都保）的安全性。

[Translation]

Primary Objective To compare the pharmacokinetic profiles of JW202313 inhalation powder in healthy Chinese volunteers after a single dose, using AstraZeneca AB's licensed budegol inhalation aerosol (Bexer® Remchang®), budesonide and formoterol inhalation powder (II) (Symbicort Turbo), and Novartis Pharma Schweiz AG's licensed indacaterol and glycopyrronium inhalation powder (Jierun®) as comparators. Secondary Objective To evaluate the safety of JW202313 inhalation powder in comparison with budegol inhalation aerosol (Bexer® Remchang®), indacaterol and glycopyrronium inhalation powder (Jierun®), and budesonide and formoterol inhalation powder (II) (Symbicort Turbo).

Start Date10 Oct 2025

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

CTR20253816

/ CompletedNot Applicable

丙酸氟替卡松雾化吸入用混悬液在中国健康志愿者中空腹状态下的人体生物等效性试验

[Translation] Bioequivalence study of fluticasone propionate nebulized inhalation suspension in Chinese healthy volunteers under fasting condition

要目的：依据生物等效性试验的相关规定，选择生产商GlaxoSmithKline Australia Pty Ltd.生产的丙酸氟替卡松雾化吸入用混悬液（规格：2ml:0.5mg）为参比制剂，对山东京卫制药有限公司生产并提供的受试制剂丙酸氟替卡松雾化吸入用混悬液（规格：2ml:0.5mg）进行空腹给药条件下的人体生物等效性试验，比较受试制剂与参比制剂的药代动力学特征，评价两种制剂在空腹给药条件下的生物等效性。次要目的：观察健康受试者经口吸入受试制剂丙酸氟替卡松雾化吸入用混悬液（规格：2ml:0.5mg）和参比制剂丙酸氟替卡松雾化吸入用混悬液（规格：2ml:0.5mg）的安全性。

[Translation]

Primary objective: Based on the relevant regulations for bioequivalence studies, a fluticasone propionate suspension for nebulized inhalation (2 ml, 0.5 mg) manufactured by GlaxoSmithKline Australia Pty Ltd. was selected as the reference preparation. A fasting bioequivalence study was conducted on the test preparation, fluticasone propionate suspension for nebulized inhalation (2 ml, 0.5 mg), manufactured and provided by Shandong Jingwei Pharmaceutical Co., Ltd. The pharmacokinetic characteristics of the test preparation and the reference preparation were compared, and the bioequivalence of the two preparations under fasting conditions was evaluated. Secondary objective: To observe the safety of oral inhalation of the test preparation, fluticasone propionate suspension for nebulized inhalation (2 ml, 0.5 mg), and the reference preparation, fluticasone propionate suspension for nebulized inhalation (2 ml, 0.5 mg), in healthy volunteers.

Start Date09 Oct 2025

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

100 Clinical Results associated with Jewim Pharmaceutical (Shandong) Co., Ltd

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0 Patents (Medical) associated with Jewim Pharmaceutical (Shandong) Co., Ltd

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4

Literatures (Medical) associated with Jewim Pharmaceutical (Shandong) Co., Ltd

28 Oct 2024·ZEITSCHRIFT FUR KRISTALLOGRAPHIE-NEW CRYSTAL STRUCTURES

The crystal structure of (Z)-3′-(2-(1-(3,4-dimethyl-phenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene)hydrazinyl)-2′-hydroxy-[1,1′-biphenyl]-3-carboxylicacid ─ methanol (1/1), C₂₆H₂₆N₄O₅

Author: Guo, Xiao ; Cao, Xueli ; Li, Tiejun ; Zhang, Wenhao

Abstract:

C26H26N4O5, triclinic, P1‾$\overline{1}$ (no. 2), a = 7.245(2) Å, b = 12.522(3) Å, c = 13.789(3) Å, α = 75.420(1)°, β = 79.628(1)°, γ = 83.226(1)°, V = 1,187.5(5) Å3, Z = 2, Rgt(F) = 0.0467, wRref(F2) = 0.1399, T = 298 K.

27 Aug 2024·ZEITSCHRIFT FUR KRISTALLOGRAPHIE-NEW CRYSTAL STRUCTURES

The crystal structure of (3aS, 4R, 7S, 7aR)-hexahydro-4, 7-methano-1H-isoindole-1, 3-(2H)-dione, C₉H₁₁NO₂

Author: Guo, Xiao ; Cao, Xueli

Abstract:

C9H11NO2, monoclinic, P21/c (no. 14), a = 11.293(4) Å, b = 6.998(3) Å, c = 10.932(4) Å, β = 104.175(7)°, V = 837.6(5) Å3, Z = 4, Rgt(F) = 0.0578, wRref(F2) = 0.1330, T = 296 K.

CRYSTENGCOMM

Chiral resolution of dl-leucine via salifying tartaric acid derivatives

Author: Hou, Lingli ; Hao, Hongxun ; De, Ruiyu ; Luo, Xiaofang ; Wang, Ting ; Shi, Linlin ; Zhou, Lina ; Wang, Na ; Wu, Hongchang ; Huang, Xin ; Guo, Zhiqiang

dl-LEU and d-DTTA form diastereomeric salt pairs consisting of d-LEU:d-DTTA:0.5H2O and l-LEU:d-DTTA:0.357CH3OH:0.75H2O.

100 Deals associated with Jewim Pharmaceutical (Shandong) Co., Ltd

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100 Translational Medicine associated with Jewim Pharmaceutical (Shandong) Co., Ltd

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Pipeline

Pipeline Snapshot as of 15 Jan 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

3

1

IND Approval

Phase 1

2

1

Phase 2

Phase 3

1

7

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

JW2202	Pulmonary Emphysema More	Phase 3
XJN010	Parkinson Disease More	Phase 2
W-1302 ( GABA receptor )	Dementia, Vascular More	Phase 1
JW202313	Asthma More	IND Approval
JW202232	Pulmonary Disease, Chronic Obstructive More	IND Approval