Delving into the Latest Updates on Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Hemic and Lymphatic Diseases

Neoplasms

Endocrinology and Metabolic Disease

Small molecule drug

Recombinant polypeptide

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

Hemic and Lymphatic Diseases	1
Neoplasms	1
Immune System Diseases	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	1
Recombinant polypeptide	1

Top 5 Target	Count

APB x APN x LTA4H	1
GLP-1R(Glucagon-like peptide 1 receptor)	1

[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the investigational formulation domenorrhea tablets (2 mg) and the reference formulation domenorrhea tablets (URECE®, 2 mg) in healthy adult participants in a postprandial state.

主要研究目的：研究餐后状态下单次口服受试制剂多替诺雷片（规格：2 mg，浙江普洛康裕制药有限公司生产）与参比制剂多替诺雷片（URECE ®，规格：2 mg，株式会社富士薬品生产）在健康成年试验参与者体内的药代动力学，评价餐后状态下口服两种制剂的生物等效性。次要研究目的：评估受试制剂多替诺雷片（规格：2 mg）和参比制剂多替诺雷片（URECE®，规格：2 mg）在健康成年试验参与者中的安全性。

[Translation]

Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation domenorrhea tablets (2 mg, manufactured by Zhejiang Procon Pharmaceutical Co., Ltd.) and the reference formulation domenorrhea tablets (URECE®, 2 mg, manufactured by Fuji Pharmaceutical Co., Ltd.) in healthy adult participants after a meal, and to evaluate the bioequivalence of the two formulations after an oral dose. Secondary objective: To evaluate the safety of the test formulation domenorrhea tablets (2 mg) and the reference formulation domenorrhea tablets (URECE®, 2 mg) in healthy adult participants.

Start Date06 Sep 2026

Sponsor / Collaborator

Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

CTR20262608

/ CompletedNot Applicable

评估受试制剂多替诺雷片（规格：2 mg)与参比制剂多替诺雷片 (URECE®,规格：2 mg)在健康成年试验参与者空腹状态下的单中心、随机、开放、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the test formulation domenorrhea tablets (2 mg) and the reference formulation domenorrhea tablets (URECE®, 2 mg) in healthy adult participants in fasting condition.

主要研究目的：研究空腹状态下单次口服受试制剂多替诺雷片（规格：2 mg，浙江普洛康裕制药有限公司生产）与参比制剂多替诺雷片（URECE ®，规格：2 mg，株式会社富士薬品生产）在健康成年试验参与者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性。次要研究目的：评估受试制剂多替诺雷片（规格：2 mg）和参比制剂多替诺雷片（URECE®，规格：2 mg）在健康成年试验参与者中的安全性。

[Translation]

Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation domenorrhea tablets (2 mg, manufactured by Zhejiang Procon Pharmaceutical Co., Ltd.) and the reference formulation domenorrhea tablets (URECE®, 2 mg, manufactured by Fuji Pharmaceutical Co., Ltd.) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary objective: To evaluate the safety of the test formulation domenorrhea tablets (2 mg) and the reference formulation domenorrhea tablets (URECE®, 2 mg) in healthy adult participants.

Start Date28 Jul 2026

Sponsor / Collaborator

Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

CTR20262280

/ RecruitingNot Applicable

苯磺酸美洛加巴林片人体生物等效性研究

[Translation] Human bioequivalence study of melogabalin besylate tablets

本试验旨在研究健康试验参与者单次空腹口服浙江普洛康裕制药有限公司研制、生产的苯磺酸美洛加巴林片（5 mg）的药代动力学特征；以DAIICHI SANKYO CO., LTD.持证、TAIYO Pharma Tech CO., LTD., Takatsuki Plant生产的苯磺酸美洛加巴林片（德力静®/Tarlige®，5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性，并观察两制剂在健康试验参与者中的安全性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of melogabalin besylate tablets (5 mg) developed and manufactured by Zhejiang Procon Pharmaceutical Co., Ltd., after a single fasting oral administration to healthy participants. Merogabalin besylate tablets (Tarlige®, 5 mg), licensed by DAIICHI SANKYO CO., LTD. and manufactured by TAIYO Pharma Tech CO., LTD., Takatsuki Plant, were used as a reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their human bioequivalence and to observe their safety in healthy participants.

Start Date30 Jun 2026

Sponsor / Collaborator

Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

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100 Deals associated with Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 11 Nov 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

Phase 3

1

Approved

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