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

Overview

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Respiratory Diseases

Infectious Diseases

Urogenital Diseases

Small molecule drug

Disease domain score

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Technology Platform

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Disease Domain	Count

Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

50S subunit(50S ribosomal subunit)	1

主要目的:在健康受试者体内，分别在空腹和餐后条件下，以Sanofi Clir SNC的硫酸氢氯吡格雷片（商品名：Plavix®；规格：75 mg）为参比制剂，研究乐普药业科技有限公司研制的硫酸氢氯吡格雷片（规格：75 mg；受试制剂）的吸收速度与吸收程度，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 absorption rate and extent of clopidogrel bisulfate tablets (specification: 75 mg; test preparation) developed by Lepu Pharmaceutical Technology Co., Ltd. in healthy subjects under fasting and postprandial conditions, using Sanofi Clir SNC's clopidogrel bisulfate tablets (trade name: Plavix®; specification: 75 mg) as the reference preparation, and to 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 Date-

Sponsor / Collaborator

Zhejiang Lepu Pharmaceutical Co., Ltd.

CTR20202229 / CompletedNot Applicable

甲磺酸仑伐替尼胶囊在健康受试者中分别进行空腹用药试验和餐后用药试验。均为单中心、单剂量、2制剂、2周期、2序列、开放、随机、交叉的平均生物等效性试验。

[Translation] Lenvatinib mesylate capsules were tested in healthy subjects on an empty stomach and after a meal. Both were single-center, single-dose, 2-formulation, 2-cycle, 2-sequence, open, randomized, crossover average bioequivalence trials.

主要目的：在健康受试者体内，分别在空腹和餐后状态下，以Eisai Europe Ltd.持证、Patheon Inc.生产的甲磺酸仑伐替尼胶囊（商品名：乐卫玛®；规格：4mg）为参比制剂，研究乐普药业科技有限公司研制的甲磺酸仑伐替尼胶囊（规格：4mg；受试制剂）的吸收速度和吸收程度，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 absorption rate and extent of lenvatinib mesylate capsules (specification: 4 mg; test preparation) developed by Lepu Pharmaceutical Technology Co., Ltd. (specification: 4 mg) in healthy subjects in fasting and postprandial states, using lenvatinib mesylate capsules (trade name: LENVIMA®; specification: 4 mg) produced by Eisai Europe Ltd. and Patheon Inc. as the reference preparation, and to 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 Date30 Nov 2020

Sponsor / Collaborator

Zhejiang Lepu Pharmaceutical Co., Ltd.

CTR20190390 / CompletedPhase 1

氯沙坦钾氢氯噻嗪片人体生物等效性试验

[Translation] Bioequivalence study of losartan potassium and hydrochlorothiazide tablets in healthy volunteers

主要目的是比较健康成年人群在空腹和餐后给药状态下，口服乐普药业科技有限公司生产的氯沙坦钾氢氯噻嗪片与MERCK SHARP DOHME生产在美国上市的氯沙坦钾氢氯噻嗪片（商品名：Hyzaar®，参比制剂）两种制剂人体药代动力学特点，评价两种制剂间的生物等效性。

[Translation]

The main purpose is to compare the pharmacokinetic characteristics of losartan potassium and hydrochlorothiazide tablets produced by Lepu Pharmaceutical Technology Co., Ltd. and losartan potassium and hydrochlorothiazide tablets (trade name: Hyzaar®, reference preparation) produced by MERCK SHARP DOHME and marketed in the United States in healthy adults under fasting and postprandial administration conditions, and to evaluate the bioequivalence of the two preparations.

Start Date11 Mar 2019

Sponsor / Collaborator

Zhejiang Lepu Pharmaceutical Co., Ltd.

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

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

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14

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

25 Jun 2024·Zeitschrift für Kristallographie - New Crystal Structures

The crystal structure of t-butyl 7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate, C₂₈H₃₄FNO₄

Author: Alex Vergiro, Tchuente Fofeu ; Xu, Xin-Xin ; Xie, Tai-Yang ; Jiang, Cheng-Jun ; Xu, Rou-Han ; Zou, Jing

AbstractC28H34FNO4, monoclinic, C2/c (no. 15), a = 21.7795(12) Å, b = 5.9103(4) Å, c = 39.830(2) Å, β = 100.866(3)°, V = 5035.1(5) Å3, Z = 8, Rgt(F) = 0.0487, wRref(F2) = 0.1376, T = 170 K.

25 Apr 2024·Zeitschrift für Kristallographie - New Crystal Structures

The crystal structure of t-butyl 7-[4-(4-fluorophenyl)-2-[(methanesulfonyl)(methyl)amino]-6-(propan-2-yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate, C₂₆H₃₆FN₃O₆S

Author: Sheng, Lv-Qing ; Zou, Jing ; Xu, Xin-Xin ; Xu, Rou-Han ; Jiang, Cheng-Jun

AbstractC26H36FN3O6S, monoclinic, P21 (no. 4), a = 10.6615(4) Å, b = 8.7470(3) Å, c = 29.4342(11) Å, α = 9°, β = 95.6130(10)°, γ = 90°, V = 2731.76(17) Å3, Z = 4, Rgt

${R}_{\text{gt}}$

(F) = 0.0439, wRref

$\mathrm{w}{R}_{\text{ref}}$

(F2) = 0.1083, T = 170 K.

29 Sep 2023·Organic letters

Synthesis of Fluoro 3(2H)-Furanones via a TFA-Catalyzed Dehydrofluorinative Cyclization of 2,2-Difluoro-3-hydroxy-1,4-diketones.

Article

Author: Ma, Chao ; Li, Rongyao ; Yan, Jianbo ; Sun, Manman ; Xu, Jinjing ; Wang, Zhiming ; Yang, Jianguo ; Huang, Guo-Bo ; Zhang, Jing

A TFA-catalyzed dehydrofluorinative cyclization of 2,2-difluoro-3-hydroxy-1,4-diketones has been developed in the presence of amines under mild conditions in which the difluorinated substrates are readily prepared according to our reported literature. This protocol provides a rapid construction of fluoro 3(2H)-furanones in good to excellent yields with good functional group tolerance. Easy scale-up synthesis also shows a practical advantage.

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

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

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Pipeline

Pipeline Snapshot as of 25 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

IND Approval

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Thiamphenicol Glycinate Hydrochloride ( 50S subunit )	Respiratory Tract Infections More	Approved
Ezetimibe/Pitavastatin Calcium ( CETP x HMG-CoA reductase )	Hypercholesterolemia More	IND Approval