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

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

CTR20242046 / CompletedNot Applicable

多索茶碱片在健康受试者中空腹状态下的单剂量、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 subjects under fasting conditions

主要研究目的：研究空腹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，评价空腹状态下口服两种制剂的生物等效性。次要研究目的: 评价健康受试者空腹单次口服受试制剂（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 under fasting conditions, and to evaluate the bioequivalence of the two preparations after oral administration under fasting conditions. 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 under fasting conditions in healthy subjects.

Start Date14 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 05 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

NDA/BLA

2

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

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