Delving into the Latest Updates on Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Cardiovascular Diseases

Endocrinology and Metabolic Disease

Nervous System 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

Endocrinology and Metabolic Disease	2
Nervous System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	4

Top 5 Target	Count

ACE(Angiotensin-converting enzyme)	1
Proton pump	1
APP x MUT	1
Cav2.2(Voltage-gated N-type calcium channel alpha-1B subunit)	1

观察单次口服30mg（空腹/餐后）受试制剂盐酸地尔硫卓片（规格：30mg/片，上海信谊万象药业股份有限公司生产）与参比制剂盐酸地尔硫卓片（HERBESSER，规格：30mg/片，MITSUBISHI TANABE PHARMA CORPORATION生产）在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态下分别口服两种制剂的生物等效性。

[Translation]

To observe the pharmacokinetic characteristics of the test preparation Diltiazem Hydrochloride Tablets (Specification: 30 mg/tablet, produced by Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.) and the reference preparation Diltiazem Hydrochloride Tablets (HERBESSER, Specification: 30 mg/tablet, produced by MITSUBISHI TANABE PHARMA CORPORATION) in healthy adult Chinese subjects after a single oral administration of 30 mg (fasting/fed), and to evaluate the bioequivalence of the two preparations when taken orally in fasting and fed states, respectively.

Start Date04 Aug 2018

Sponsor / Collaborator

Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.

CTR20181264 / CompletedPhase 1

健康志愿者空腹及餐后辛伐他汀片随机、开放、三周期、三序列、部分重复交叉设计生物等效性研究

[Translation] A randomized, open-label, three-period, three-sequence, partially repeated crossover bioequivalence study of simvastatin tablets in healthy volunteers with fasting and postprandial administration

（1）通过辛伐他汀片空腹和餐后给药的生物等效性研究，评价上海信谊万象药业股份有限公司生产的辛伐他汀片(规格：20mg)与Merck Sharp & Dohme B.V.（持证商）的辛伐他汀片（规格：20mg）的生物等效性，为上海信谊万象药业股份有限公司生产的辛伐他汀片与Merck Sharp & Dohme B.V.（持证商）的辛伐他汀片临床疗效的一致性提供证据。（2）对辛伐他汀片的安全性进行评价。

[Translation]

(1) The bioequivalence study of simvastatin tablets administered on an empty stomach and after a meal was conducted to evaluate the bioequivalence of simvastatin tablets (specification: 20 mg) produced by Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd. and simvastatin tablets (specification: 20 mg) produced by Merck Sharp & Dohme B.V. (licensed manufacturer), and to provide evidence for the consistency of clinical efficacy between simvastatin tablets produced by Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd. and simvastatin tablets produced by Merck Sharp & Dohme B.V. (licensed manufacturer). (2) The safety of simvastatin tablets was evaluated.

Start Date12 Jul 2018

Sponsor / Collaborator

Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.

CTR20171460 / Not yet recruiting

盐酸地尔硫卓片健康志愿者空腹及餐后单剂量、随机、开放、双周期、双交叉的人体生物等效性研究

[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of diltiazem hydrochloride tablets in healthy volunteers after fasting and postprandial administration

观察单次口服30mg（空腹/餐后）受试制剂盐酸地尔硫卓片（规格：30mg/片，上海信谊万象药业股份有限公司生产）与参比制剂盐酸地尔硫卓片（HERBESSER，规格：30mg/片，MITSUBISHI TANABE PHARMA CORPORATION生产）在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态下分别口服两种制剂的生物等效性。

[Translation]

To observe the pharmacokinetic characteristics of the test preparation Diltiazem Hydrochloride Tablets (Specification: 30 mg/tablet, produced by Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.) and the reference preparation Diltiazem Hydrochloride Tablets (HERBESSER, Specification: 30 mg/tablet, produced by MITSUBISHI TANABE PHARMA CORPORATION) in healthy adult Chinese subjects after a single oral administration of 30 mg (fasting/fed), and to evaluate the bioequivalence of the two preparations when taken orally in fasting and fed states, respectively.

Start Date30 Dec 2017

Sponsor / Collaborator

Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.

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100 Deals associated with Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Shanghai Xinyi Wanxiang Pharmaceutical 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

Approved

4

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Lisinopril ( ACE )	Hypertension More	Approved
Lansoprazole/Sodium Bicarbonate ( Proton pump )	Stomach Ulcer More	Approved
Ditiazem Hydrochloride ( Cav2.2 )	Hypertension More	Approved
L-Lysine hydrochloride/Cyanocobalamin/Inositol ( APP x MUT )	Malnutrition More	Approved