Delving into the Latest Updates on JIANGSU ALICORN PHARMACEUTICAL CO.,LTD with Synapse

Overview

Basic Info

Introduction

Founded in 2015, Alebion Pharmaceuticals Co., Ltd. has its headquarters in Haining, Zhejiang, and operates as a high-tech pharmaceutical company with a focus on developing and industrializing small molecule drugs. It oversees three subsidiaries: Jiangsu Alebion Medical Technology Co., Ltd., Zhejiang Alebion New Drug R&D Co., Ltd., and Anhui Ailide Pharmaceuticals Co., Ltd. With a dedication to becoming a globally leading innovation-driven technology enterprise, Alebion is engaged in the creation of first-class innovative drugs and modified new drugs with full independent intellectual property rights. Its research pipeline is filled with products targeting oncology, autoimmunity, cardiovascular and cerebrovascular, and neurological diseases.

Tags

Nervous System Diseases

Other 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

Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

SV2A(Synaptic vesicle glycoprotein 2A)	1

主要目的：本试验旨在研究单次空腹口服江苏艾立康医药科技有限公司研制、安徽艾立德制药有限公司生产的布立西坦缓释片（100 mg）的药代动力学特征；以UCB, Inc.生产的布立西坦片（Briviact®，50 mg）作为对照，比较两制剂中药动学参数的差异。次要目的：观察受试制剂和对照制剂在中国健康受试者中单次给药的耐受性和安全性。

[Translation]

Primary objective: This study aims to study the pharmacokinetic characteristics of a single fasting oral dose of brivaracetam sustained-release tablets (100 mg) developed by Jiangsu Ailikang Pharmaceutical Technology Co., Ltd. and produced by Anhui Aili Pharmaceutical Co., Ltd.; using brivaracetam tablets (Briviact®, 50 mg) produced by UCB, Inc. as a control, to compare the differences in pharmacokinetic parameters between the two preparations. Secondary objective: To observe the tolerability and safety of a single dose of the test preparation and the control preparation in healthy Chinese subjects.

Start Date16 Dec 2023

Sponsor / Collaborator

JIANGSU ALICORN PHARMACEUTICAL CO.,LTD

CTR20233613 / CompletedNot Applicable

马来酸氟伏沙明片在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of fluvoxamine maleate tablets in humans under fasting and fed conditions

研究健康受试者在空腹及餐后条件下，单次口服由江苏艾立康医药科技有限公司持有（安徽艾立德制药有限公司生产）的马来酸氟伏沙明片（受试制剂T，规格：50mg）与相同条件下单次口服由Abbott Laboratories（Singapore）Private Limited.持证的马来酸氟伏沙明片（参比制剂R，商品名：LUVOX®，规格：50mg）的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

[Translation]

To study the pharmacokinetic characteristics of a single oral administration of fluvoxamine maleate tablets (test preparation T, specification: 50 mg) owned by Jiangsu Ailikang Pharmaceutical Technology Co., Ltd. (produced by Anhui Aili Pharmaceutical Co., Ltd.) to healthy subjects under fasting and postprandial conditions and a single oral administration of fluvoxamine maleate tablets (reference preparation R, trade name: LUVOX®, specification: 50 mg) certified by Abbott Laboratories (Singapore) Private Limited under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Start Date07 Dec 2023

Sponsor / Collaborator

JIANGSU ALICORN PHARMACEUTICAL CO.,LTD

CTR20233190 / CompletedNot Applicable

阿戈美拉汀片在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of agomelatine tablets in humans under fasting and fed conditions

考察健康受试者在空腹及餐后条件下，单次口服由江苏艾立康医药科技有限公司提供的阿戈美拉汀片（受试制剂，规格：25mg）与相同条件下单次口服由Les Laboratoires Servier公司持证的阿戈美拉汀片（参比制剂，商品名：Valdoxan®，规格：25mg）的药代动力学特征，评价两制剂间的生物等效性和安全性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of agomelatine tablets (test preparation, strength: 25 mg) provided by Jiangsu Ailikang Pharmaceutical Technology Co., Ltd. and agomelatine tablets (reference preparation, trade name: Valdoxan®, strength: 25 mg) certified by Les Laboratoires Servier in healthy subjects under fasting and postprandial conditions, and to evaluate the bioequivalence and safety of the two preparations, so as to provide a basis for the registration application of the test preparation.

Start Date23 Oct 2023

Sponsor / Collaborator

JIANGSU ALICORN PHARMACEUTICAL CO.,LTD

100 Clinical Results associated with JIANGSU ALICORN PHARMACEUTICAL CO.,LTD

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0 Patents (Medical) associated with JIANGSU ALICORN PHARMACEUTICAL CO.,LTD

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Literatures (Medical) associated with JIANGSU ALICORN PHARMACEUTICAL CO.,LTD

Analytical Methods

A selective and sensitive pre-column derivatization HPLC method for the trace analysis of genotoxic impurity hydroxylamine in active pharmaceutical ingredients

Author: Hang, Tai-jun ; Lu, Ping-bo ; Song, Min ; Wu, Sha ; Qiao, Ya-nan

A simple and robust high-performance liquid chromatographic (HPLC) method for the trace analysis of genotoxic impurity hydroxylamine in Vorinostat and Zileuton, two active pharmaceutical ingredients, is described.

100 Deals associated with JIANGSU ALICORN PHARMACEUTICAL CO.,LTD

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100 Translational Medicine associated with JIANGSU ALICORN PHARMACEUTICAL 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

Phase 1 Clinical

1

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