Delving into the Latest Updates on Hainan Star Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Infectious Diseases

Respiratory Diseases

Skin and Musculoskeletal 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

Infectious Diseases	4
Immune System Diseases	2
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	4

Top 5 Target	Count

30S subunit(30S ribosomal subunit)	1
COX(Cyclooxygenases)	1
CYP51A1(Cytochrome P450 51)	1
50S subunit(50S ribosomal subunit)	1

主要研究目的：考察单次口服（空腹/餐后）受试制剂他达拉非片（规格：20 mg，海南赛立克药业有限公司生产，海南斯达制药有限公司提供）与参比制剂他达拉非片（CIALIS®，规格：20 mg，Lilly del Caribe.Inc.持证）在中国健康人体（仅男性）的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价受试制剂和参比制剂单次口服（空腹/餐后）在中国成年健康受试者（仅男性）中的安全性。

[Translation]

Main study objectives: To investigate the relative bioavailability of the test preparation tadalafil tablets (specification: 20 mg, produced by Hainan Celic Pharmaceutical Co., Ltd. and provided by Hainan Star Pharmaceutical Co., Ltd.) and the reference preparation tadalafil tablets (CIALIS®, specification: 20 mg, licensed by Lilly del Caribe. Inc.) in healthy Chinese subjects (males only) after a single oral administration (fasting/after meals), analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects (males only) after a single oral administration (fasting/after meals).

Start Date04 Jul 2024

Sponsor / Collaborator

Hainan Star Pharmaceutical Co., Ltd.

CTR20241952 / CompletedNot Applicable

美阿沙坦钾片在中国健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两周期交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-period crossover bioequivalence study of Asartan Potassium Tablets in healthy Chinese subjects

主要研究目的观察单次口服80 mg（空腹/餐后）受试制剂美阿沙坦钾片（规格：80 mg/片）与参比制剂美阿沙坦钾片（易达比，规格：80 mg/片）在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的观察单次口服受试制剂和参比制剂80 mg（空腹/餐后）在中国成年健康受试者中的安全性。

[Translation]

Main study objectives To observe the relative bioavailability of the test preparation, 80 mg/tablet (fasting/after meals) of the test preparation, 80 mg/tablet, and the reference preparation, 80 mg/tablet, in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary study objectives To observe the safety of the test preparation and the reference preparation 80 mg (fasting/after meals) in healthy Chinese adult subjects.

Start Date03 Jul 2024

Sponsor / Collaborator

Hainan Star Pharmaceutical Co., Ltd.

CTR20241582 / CompletedNot Applicable

依帕司他片在中国成年健康受试者中的一项随机、开放、空腹单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, fasting, two-formulation, two-sequence, two-period crossover bioequivalence study of epalrestat tablets in healthy adult Chinese subjects

主要研究目的：考察空腹状态下单次口服1片受试制剂依帕司他片（规格：50 mg/片，海南赛立克药业有限公司生产，海南斯达制药有限公司提供）与参比制剂依帕司他片[商品名：KINEDAK，规格：50 mg/片，アルフレッサファーマ株式会社（Alfresa Pharma Corporation）生产，海南斯达制药有限公司提供]在中国成年健康受试者体内的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要研究目的：评价空腹状态下单次口服1片受试制剂和参比制剂依帕司他片（规格：50 mg/片）在中国成年健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of a single oral tablet of the test preparation epalrestat tablets (specification: 50 mg/tablet, produced by Hainan Celic Pharmaceutical Co., Ltd. and provided by Hainan Star Pharmaceutical Co., Ltd.) and the reference preparation epalrestat tablets [trade name: KINEDAK, specification: 50 mg/tablet, produced by Alfresa Pharma Corporation and provided by Hainan Star Pharmaceutical Co., Ltd.] in healthy adult Chinese subjects in the fasting state, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. The secondary purpose of the study is to evaluate the safety of a single oral tablet of the test preparation and the reference preparation epalrestat tablets (specification: 50 mg/tablet) in healthy adult Chinese subjects in the fasting state.

Start Date28 Jun 2024

Sponsor / Collaborator

Hainan Star Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hainan Star Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Hainan Star Pharmaceutical Co., Ltd.

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100 Deals associated with Hainan Star Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Hainan Star Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 27 Dec 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

2

1

Phase 1 Clinical

Phase 3 Clinical

1

Approved

Other

1

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Azithromycin Aspartate ( 50S subunit )	Infectious Diseases More	Approved
Tobramycin ( 30S subunit )	Bronchiectasis More	Phase 3
Ibuprofen ( COX )	Migraine Disorders More	Phase 1
Ipratropium Bromide/Levalbuterol Tartrate ( mAChRs x β2-adrenergic receptor )	Bronchial Spasm More	IND Approval
Voriconazole ( CYP51A1 )	Fungal keratitis More	IND Approval