Delving into the Latest Updates on Jiangsu Xuantai Pharmaceutical Co., Ltd with Synapse

Overview

Tags

Immune System Diseases

Hemic and Lymphatic Diseases

Respiratory 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

Hemic and Lymphatic Diseases	1
Infectious Diseases	1
Immune System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

PA protein x RdRp	1
PI3Kδ(Phosphatidylinositol 3 kinase delta)	1

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, sitagliptin metformin extended-release tablets (II) (strength: 50 mg/1000 mg) and the reference preparation (JANUMET® XR) (strength: 50 mg/1000 mg) in healthy adult participants under fasting conditions.

主要试验目的：研究空腹状态下单次口服受试制剂西格列汀二甲双胍缓释片（Ⅱ）（规格：50 mg/1000 mg，江苏宣泰药业有限公司生产）与参比制剂西格列汀二甲双胍缓释片（JANUMET® XR，规格：50 mg/1000 mg；Merck Sharp & Dohme Corp为持证商）在健康参与者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂西格列汀二甲双胍缓释片（Ⅱ）（规格：50 mg/1000 mg）和参比制剂西格列汀二甲双胍缓释片（JANUMET® XR）（规格：50 mg/1000 mg）在健康参与者中的安全性。

[Translation]

Main purpose of the study: To study the pharmacokinetic characteristics of a single oral dose of the test preparation Sitagliptin Metformin Sustained-Release Tablets (II) (Specification: 50 mg/1000 mg, produced by Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference preparation Sitagliptin Metformin Sustained-Release Tablets (JANUMET® XR, Specification: 50 mg/1000 mg; Merck Sharp & Dohme Corp is the licensee) in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. Secondary purpose of the study: To study the safety of the test preparation Sitagliptin Metformin Sustained-Release Tablets (II) (Specification: 50 mg/1000 mg) and the reference preparation Sitagliptin Metformin Sustained-Release Tablets (JANUMET® XR) (Specification: 50 mg/1000 mg) in healthy participants.

Start Date03 Dec 2024

Sponsor / Collaborator

Jiangsu Xuantai Pharmaceutical Co., Ltd

CTR20243683

/ CompletedNot Applicable

多索茶碱片在健康受试者中餐后状态下的单剂量、随机、开放、四周期、完全重复交叉设计的生物等效性试验

[Translation] A single-dose, randomized, open-label, four-period, completely repeated crossover bioequivalence study of doxofylline tablets in healthy volunteers in the fed state

主要研究目的：研究餐后状态下单次口服受试制剂多索茶碱片（规格：400mg，江苏宣泰药业有限公司）与参比制剂多索茶碱片（商品名：ANSIMAR®，规格：400mg，ABC FARMACEUTICI S.P.A.）在健康成年受试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: 评价健康受试者餐后单次口服受试制剂（T）多索茶碱片和参比制剂（R）多索茶碱片（商品名：ANSIMAR®）后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation Doxofylline Tablets (Specification: 400mg, Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference preparation Doxofylline Tablets (Trade name: ANSIMAR®, Specification: 400mg, ABC FARMACEUTICI S.P.A.) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objectives: To evaluate the safety of the test preparation (T) Doxofylline Tablets and the reference preparation (R) Doxofylline Tablets (Trade name: ANSIMAR®) after a single oral administration in healthy subjects.

Start Date08 Oct 2024

Sponsor / Collaborator

Jiangsu Xuantai Pharmaceutical Co., Ltd

CTR20242047

/ CompletedNot Applicable

多索茶碱片在健康受试者中餐后状态下的单剂量、随机、开放、四周期、完全重复交叉设计的生物等效性试验

[Translation] A single-dose, randomized, open-label, four-period, completely repeated crossover bioequivalence study of doxofylline tablets in healthy volunteers in the fed state

主要研究目的：研究餐后状态下单次口服受试制剂多索茶碱片（规格：400mg，江苏宣泰药业有限公司）与参比制剂多索茶碱片（商品名：ANSIMAR®，规格：400mg，ABC FARMACEUTICI S.P.A.）在健康成年受试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: 评价健康受试者餐后单次口服受试制剂（T）多索茶碱片和参比制剂（R）多索茶碱片（商品名：ANSIMAR®）后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation Doxofylline Tablets (Specification: 400mg, Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference preparation Doxofylline Tablets (Trade name: ANSIMAR®, Specification: 400mg, ABC FARMACEUTICI S.P.A.) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objectives: To evaluate the safety of the test preparation (T) Doxofylline Tablets and the reference preparation (R) Doxofylline Tablets (Trade name: ANSIMAR®) after a single oral administration in healthy subjects.

Start Date29 Jun 2024

Sponsor / Collaborator

Jiangsu Xuantai Pharmaceutical Co., Ltd

100 Clinical Results associated with Jiangsu Xuantai Pharmaceutical Co., Ltd

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0 Patents (Medical) associated with Jiangsu Xuantai Pharmaceutical Co., Ltd

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100 Deals associated with Jiangsu Xuantai Pharmaceutical Co., Ltd

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100 Translational Medicine associated with Jiangsu Xuantai Pharmaceutical Co., Ltd

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Pipeline

Pipeline Snapshot as of 07 Feb 2025

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

NDA/BLA

2

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

ZX-7101A ( PA protein x RdRp )	Influenza, Human More	NDA/BLA
Linperlisib ( PI3Kδ )	Peripheral T-Cell Lymphoma More	NDA/BLA
ZL-2302 ( ALK )	Lung Cancer More	Pending