Delving into the Latest Updates on Fuan Pharmaceutical (Group) Co., Ltd. with Synapse

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Disease Domain	Count

Nervous System Diseases	5
Infectious Diseases	5
Neoplasms	3
Immune System Diseases	3
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	11
Herbal medicine	1

Top 5 Target	Count

HTR3(5-hydroxytryptamine receptors, ionotropic (HTR3))	3
PBPs(Bacterial penicillin-binding protein)	2
ER(Estrogen receptors)	1
GABAB receptor(Gamma-Aminobutyric Acid B Receptor)	1
GnRHR(Gonadotropin-releasing hormone receptor)	1

主要研究目的在健康受试者中空腹状态下分别单次口服莱博雷生片受试制剂（5mg，福安药业集团庆余堂制药有限公司生产）与参比制剂（商品名：DAYVIGO®，5mg，エーザイ株式会社持证）后的生物等效性。次要研究目的观察受试制剂与参比制剂莱博雷生片在健康受试者中的安全性。

[Translation]

Main study objectives To investigate the bioequivalence of the test formulation of Lebrexan tablets (5 mg, produced by Qingyutang Pharmaceutical Co., Ltd., Fu'an Pharmaceutical Group) and the reference formulation (trade name: DAYVIGO®, 5 mg, certified by AEISHI Co., Ltd.) after a single oral administration in healthy subjects under fasting state. Secondary study objectives To observe the safety of the test formulation and the reference formulation of Lebrexan tablets in healthy subjects.

Start Date11 Jul 2025

Sponsor / Collaborator

Chongqing Qingyutang Pharmaceutical Co. Ltd.

CTR20252309

/ Active, not recruitingNot Applicable

中国健康受试者空腹及餐后状态下单次给予丁二磺酸腺苷蛋氨酸肠溶片（规格：0.5g）的随机、开放、四周期完全重复交叉设计的生物等效性试验

[Translation] A randomized, open-label, four-period, fully repeated crossover bioequivalence study of a single dose of 0.5 g adenosine butanedisulfonate enteric-coated tablets in Chinese healthy volunteers in the fasting and fed state

主要研究目的研究空腹或餐后状态下单次口服受试制剂丁二磺酸腺苷蛋氨酸肠溶片（规格：0.5g，福安药业集团烟台只楚药业有限公司生产）与参比制剂丁二磺酸腺苷蛋氨酸肠溶片（思美泰®，规格:0.5g；ABBVIE S.R.L生产）在健康成年受试者体内的药代动力学，评价空腹及餐后状态口服两种制剂的生物等效性。次要研究目的评价受试制剂丁二磺酸腺苷蛋氨酸肠溶片和参比制剂丁二磺酸腺苷蛋氨酸肠溶片（思美泰®）在健康成年受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of a single oral administration of the test preparation succinylmethionine enteric-coated tablets (specification: 0.5g, produced by Yantai Zhichu Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group) and the reference preparation succinylmethionine enteric-coated tablets (Simetai®, specification: 0.5g; produced by ABBVIE S.R.L.) in healthy adult subjects in the fasting or fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary study objectives To evaluate the safety of the test preparation succinylmethionine enteric-coated tablets and the reference preparation succinylmethionine enteric-coated tablets (Simetai®) in healthy adult subjects.

Start Date02 Jul 2025

Sponsor / Collaborator

Fu'an Pharmaceutical Group Yantai Justaware Pharma Co., Ltd.

CTR20251898

/ Active, not recruitingNot Applicable

雷诺嗪缓释片在中国健康成年参与者中随机、开放、单剂量、交叉、空腹和餐后状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, crossover, fasting and fed bioequivalence study of ranolazine extended-release tablets in healthy Chinese adult participants

主要目的：以福安药业集团宁波天衡制药有限公司生产的雷诺嗪缓释片（500mg）为受试制剂，以 Menarini International Operations Luxembourg S.A.持有的雷诺嗪缓释片（商品名：Ranexa，规格：500mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹和餐后条件下单次给药的生物等效性。次要目的：评估单剂口服受试制剂（雷诺嗪缓释片，T）和参比制剂（Ranexa，R）在中国健康成年参与者中的安全性。

[Translation]

Primary objective: The bioequivalence study was conducted using Ranolazine sustained-release tablets (500 mg) produced by Ningbo Tianheng Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group as the test formulation and Ranolazine sustained-release tablets (trade name: Ranexa, specification: 500 mg) held by Menarini International Operations Luxembourg S.A. as the reference formulation to compare the bioequivalence of the two formulations under fasting and fed conditions after a single dose. Secondary objective: Evaluate the safety of a single oral dose of the test formulation (Ranexa sustained-release tablets, T) and the reference formulation (Ranexa, R) in healthy adult participants in China.

Start Date10 Jun 2025

Sponsor / Collaborator

Ningbo Team Pharm Co. Ltd.

100 Clinical Results associated with Fuan Pharmaceutical (Group) Co., Ltd.

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0 Patents (Medical) associated with Fuan Pharmaceutical (Group) Co., Ltd.

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15

Literatures (Medical) associated with Fuan Pharmaceutical (Group) Co., Ltd.

03 Jul 2025·Bioanalysis

A validated method for the determination of doxofylline and its pharmacokinetic application in healthy volunteers

Article

Author: Liu, Danrui ; Luo, Kaiwei ; Hu, Yu ; Zhao, Hangyu ; Zhang, Huina ; Dai, Menglong ; Yu, Yonghua

BACKGROUND:

Current HPLC-based methods for doxofylline analysis lack speed and precision. A rapid, specific, and sensitive UPLC-MS/MS method was developed for the determination of doxofylline in this study.

RESEARCH DESIGN AND METHODS:

This method was fully validated and doxophylline-d4 was used as an internal standard. A Kinetex-C18 column (EVO 100Å, 50 × 2.1 mm, 5 μm) was used for the separation procedure, with mobile phases consisting of 0.3% formic acid (A) and 90% acetonitrile solution with 0.3% formic acid (B). The total runtime of the gradient elution procedure was 2.6 minutes. The mass spectrometry analysis was carried out employing a multiple reaction monitoring model and using the transitions of m/z 267.000→181.000 for doxofylline and m/z 271.200→181.100 for the internal standard.

RESULTS:

The linear range of detection for doxophylline was between 20.0 to 16,000 ng/mL. The intra-batch accuracy deviations of each concentration level ranged from -8.0% to 2.5%, while the intra-batch precisions ranged from 1.3% to 9.0%. And the inter-batch accuracy deviations were -5.8% ~0.8%, while the inter-batch precisions were 2.2% ~7.0%.

CONCLUSIONS:

This method was applied to pharmacokinetic clinical trials of single oral administration of doxophylline tablets successfully.

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is CTR20240006 and CTR20233665.

19 May 2025·Bioanalysis

LC-MS/MS determination of trazodone in human plasma and its pharmacokinetic study in healthy Chinese

Article

Author: Lin, Jie ; Zhang, Shengshuo ; Yu, Yonghua ; Luo, Kaiwei ; Liu, Danrui ; Cheng, Qunan ; Zhang, Xin

AIMS:

This study aimed to establish a robust LC-MS/MS method for quantifying trazodone in human plasma and investigate its pharmacokinetic profile in healthy Chinese subjects under fasting and fed conditions.

MATERIALS & METHODS:

A validated LC-MS/MS method using protein precipitation was applied to analyze trazodone in 68 healthy subjects (34 fasting/34 fed), with full method validation performed.

RESULTS:

This method exhibited high selectivity, precision, and accuracy. The results showed good linearity in the range of 5-3000 ng/mL and matrix effect results showed no matrix interference. The pharmacokinetic data revealed notable differences between the fasting and postprandial states.

CONCLUSIONS:

The validated LC-MS/MS method proved reliable for trazodone quantification. The observed food effects on absorption suggest clinical dosing should consider administration conditions to ensure optimal therapeutic outcomes.

01 Dec 2024·SYNLETT

Synthesis of Fused-Ring Pyrrolizine Derivatives via a Copper-Catalyzed Radical Cascade Cyclization

Author: Wang, Yang-Yang ; Yu, Xiao ; Hao, Li-Qiang ; Ding, Dong ; Liu, Xian ; Ji, Ya-Fei ; Xu, Xiao-Bo ; Yang, Zhao-Zi-Yuan

Abstract:

Herein, an atom-economic method for the synthesis of fused-ring pyrrolizine derivatives by a cycloaddition reaction of easily accessible N-substituted pyrrole-2-carboxaldehydes with N-substituted maleimides in the presence of di-tert-butyl peroxide has been successfully developed. A total of 23 compounds were obtained by using this method, with a maximum yield of 72%, providing a practical and efficient method for the synthesis of tricyclic pyrrolizine frameworks.

100 Deals associated with Fuan Pharmaceutical (Group) Co., Ltd.

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100 Translational Medicine associated with Fuan Pharmaceutical (Group) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 29 Aug 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

Phase 1

3

1

Phase 2

Phase 3

1

7

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Granisetron ( HTR3 )	Nausea More	Approved
Ondansetron Hydrochloride ( HTR3 )	Radiation-induced nausea and vomiting More	Approved
Formoterol Fumarate ( β2-adrenergic receptor )	Asthma More	Approved
Granisetron Hydrochloride ( HTR3 )	Nausea More	Approved
Baclofen ( GABAB receptor )	Muscle Spasticity More	Approved