Delving into the Latest Updates on Lepu Pharmaceutical Technology Co., Ltd. with Synapse

Overview

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Other Diseases

Congenital Disorders

Endocrinology and Metabolic Disease

Small molecule drug

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A glimpse into the focused therapeutic areas

Technology Platform

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Targets

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Disease Domain	Count

Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

CETP x HMG-CoA reductase	1

主要目的：在健康受试者体内，在空腹和餐后条件下，以 Organon Healthcare GmbH 持证、Merck Sharp & Dohme B.V.生产的依折麦布阿托伐他汀钙片（商品名：Atozet®，规格：10mg/20mg）为参比制剂，研究乐普制药科技有限公司研制的依折麦布阿托伐他汀钙片（规格：10mg/20mg）的药代动力学，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察健康受试者口服受试制剂、参比制剂的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of ezetimibe atorvastatin calcium tablets (specifications: 10mg/20mg) developed by Lepu Pharmaceutical Technology Co., Ltd. under fasting and postprandial conditions in healthy subjects, using ezetimibe atorvastatin calcium tablets (trade name: Atozet®, specifications: 10mg/20mg) licensed by Organon Healthcare GmbH and produced by Merck Sharp & Dohme B.V. as the reference preparation, and evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of oral administration of the test preparation and the reference preparation in healthy subjects.

Start Date20 Dec 2023

Sponsor / Collaborator

Lepu Pharmaceutical Technology Co., Ltd.

CTR20231124 / CompletedNot Applicable

依帕司他片的空腹生物等效性试验

[Translation] Fasting bioequivalence study of epalrestat tablets

主要目的：健康受试者在空腹条件下，以Ono Pharmaceutical Co., Ltd/アルフレッサファーマ株式会社（Alfresa Pharma Corporation）持有的依帕司他片（商品名：Kinedak；规格：50 mg）为参比制剂，研究乐普制药科技有限公司研制的依帕司他片（规格：50 mg）的药代动力学，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察健康受试者空腹口服受试制剂、参比制剂的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of epalrestat tablets (specification: 50 mg) developed by Lepu Pharmaceutical Technology Co., Ltd., using epalrestat tablets (trade name: Kinedak; specification: 50 mg) owned by Ono Pharmaceutical Co., Ltd/Alfresa Pharma Corporation as the reference preparation under fasting conditions in healthy subjects, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation and the reference preparation when taken orally on an empty stomach in healthy subjects.

Start Date15 May 2023

Sponsor / Collaborator

Lepu Pharmaceutical Technology Co., Ltd.

CTR20222390 / CompletedPhase 1

依折麦布匹伐他汀钙片的生物等效性试验

[Translation] Bioequivalence study of ezetimibe and pitavastatin calcium tablets

主要目的：在健康受试者体内，在空腹条件下以乐普制药科技有限公司生产的依折麦布匹伐他汀钙片（规格：10mg/2mg）为试验药物，以MSD Pharma（Singapore）Pte. Ltd.持证原研进口的依折麦布片（商品名：益适纯®；规格：10mg）及 Kowa Company, Ltd. 持证原研进口匹伐他汀钙片（商品名：力清之®；规格 2mg）为参照药物，研究健康受试者口服试验药物、参照药物后的药代动力学特征，评价试验药物与参照药物是否具有生物等效性。次要目的：观察健康受试者口服试验药物、参照药物的安全性及耐受性。

[Translation]

Primary objective: In healthy subjects, under fasting conditions, ezetimibe and pitavastatin calcium tablets (specifications: 10mg/2mg) produced by Lepu Pharmaceutical Technology Co., Ltd. were used as test drugs, and ezetimibe tablets (trade name: Yishichun®; specification: 10mg) imported with a license by MSD Pharma (Singapore) Pte. Ltd. and pitavastatin calcium tablets (trade name: Liqingzhi®; specification 2mg) imported with a license by Kowa Company, Ltd. were used as reference drugs to study the pharmacokinetic characteristics of the test and reference drugs after oral administration in healthy subjects, and to evaluate whether the test and reference drugs are bioequivalent. Secondary objective: To observe the safety and tolerability of the test and reference drugs after oral administration in healthy subjects.

Start Date20 Sep 2022

Sponsor / Collaborator

Lepu Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Lepu Pharmaceutical Technology Co., Ltd.

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0 Patents (Medical) associated with Lepu Pharmaceutical Technology Co., Ltd.

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2

Literatures (Medical) associated with Lepu Pharmaceutical Technology Co., Ltd.

Zhongnan Yaoxue

Preparation of memantine hydrochloride sustained release tablets and influence factors of drug release

Author: Cui Meng-suo ; Zhang Jin-liang ; Pan Wei-san ; Pan Yu-sheng

Objective To prepare memantine hydrochloride sustained release tablets and determine the factors affecting the drug release behaviors in vitro,and to explore the pharmacokinetics of the tablets in Beagle dogs.Methods We used single factor experiments to determine the factors that influenced the drug release.The similar factors of in vitro release data of self-made tablets and com. available tablets were used as evaluation indexes to optimize the formulation of memantine hydrochloride sustained release tablets by orthogonal design.Results The amount of HPMC K100M,HPMC E50,PEG 4000 and the weight gain of the coating had a significant effect on the drug.The self-made sustained release tablets of memantine hydrochloride were released slowly and stably within 12 h,which was consistent with the zero-order release model.The self-made sustained release preparation of memantine hydrochloride and the reference preparation were bioequivalent with similar blood concentration-time curve in Beagle dogs,and the relative bioavailability was 94.92%.Conclusion The self-made memantine hydrochloride sustained release tablets are stably released in vitro and show good pharmacokinetic characteristics in vivo.

Zhongnan Yaoxue

Preparation of gliclazide sustained release tablets and influence factors for drug release

Author: Cui Meng-suo ; Zhang Jin-liang ; Pan Wei-san ; Pan Yu-sheng

Objective To prepare gliclazide sustained release tablets,and determine the influence factors for drug release and in vivo pharmacokinetic characteristics.Methods The single factor inspection test was used to determine the key factors affecting the drug release.Results of similar factors of the in vitro release of self-made and reference tablets were used as evaluation indicators.Orthogonal experiment was designed to optimize the best formulation of gliclazide sustained-release tablets.Results The amount of HPMC K15M,HPMC K100LV and calcium hydrogen phosphate had significant effect on the drug release.The release of self-made gliclazide sustained release tablets within 12 h conformed to the zero-order release model.The blood concentration-time curve of the self-made preparation and the reference preparation in Beagle dogs was similar,and the relative bioavailability was 102.64%,suggesting bioequivalence.Conclusion The self-made gliclazide sustained release tablets have stable in vitro release behaviors and good in vivo pharmacokinetic characteristics.

100 Deals associated with Lepu Pharmaceutical Technology Co., Ltd.

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100 Translational Medicine associated with Lepu Pharmaceutical Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 Nov 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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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ezetimibe/Pitavastatin Calcium ( CETP x HMG-CoA reductase )	Primary hypercholesterolemia More	Phase 1
Vortioxetine Hemihydrobromide	Depressive Disorder More	Clinical