Delving into the Latest Updates on Hefei Cosource Pharmaceuticals, Inc. with Synapse

Overview

Tags

Neoplasms

Other 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

Neoplasms	2
Nervous System Diseases	1
Hemic and Lymphatic Diseases	1

Top 5 Drug Type	Count

Small molecule drug	4

Top 5 Target	Count

GP IIb/IIIa(Integrin alpha-IIb/beta-3)	1
Sodium channels	1
FLT3(Tyrosine-protein kinase receptor FLT3)	1
Top II(Topoisomerase II)	1

主要目的：以药代动力学参数为终点指标，比较空腹和高脂餐后给药条件下，合肥合源药业有限公司生产的盐酸非索非那定片与OPELLA HEALTHCARE FRANCE SAS为持证商的盐酸非索非那定片（规格：180mg）在健康成年人群中吸收程度和速度的差异，对两制剂的生物等效性进行评价。次要目的：评价健康受试者在空腹和高脂餐后给药条件下口服受试制剂盐酸非索非那定片和参比制剂盐酸非索非那定片的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of fexofenadine hydrochloride tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. and fexofenadine hydrochloride tablets (specification: 180 mg) produced by OPELLA HEALTHCARE FRANCE SAS in healthy adults under fasting and high-fat meal administration conditions using pharmacokinetic parameters as endpoints, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of oral administration of the test preparation fexofenadine hydrochloride tablets and the reference preparation fexofenadine hydrochloride tablets to healthy subjects under fasting and high-fat meal administration conditions.

Start Date30 May 2025

Sponsor / Collaborator

Hefei Cosource Pharmaceuticals, Inc.

CTR20251480

/ RecruitingNot Applicable

多索茶碱片在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验。

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of doxofylline tablets in Chinese healthy subjects under fasting and fed administration conditions.

主要目的：以药代动力学参数为终点指标，比较空腹和高脂餐后给药条件下，合肥合源药业有限公司生产的多索茶碱片与ABC FARMACEUTICI S.P.A.为持证商的多索茶碱片（商品名：ANSIMAR®，规格：0.4g）在健康成年人群中吸收程度和速度的差异，对两制剂的生物等效性进行评价。次要目的：评价健康受试者在空腹和高脂餐后给药条件下口服受试制剂多索茶碱片和参比制剂多索茶碱片的安全性。

[Translation]

Primary objective: To compare the differences in absorption extent and rate between the doxofylline tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. and the doxofylline tablets (trade name: ANSIMAR®, specification: 0.4g) licensed by ABC FARMACEUTICI S.P.A. in healthy adults under fasting and high-fat meal administration conditions using pharmacokinetic parameters as endpoints, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of oral administration of the test preparation doxofylline tablets and the reference preparation doxofylline tablets in healthy subjects under fasting and high-fat meal administration conditions.

Start Date14 May 2025

Sponsor / Collaborator

Hefei Cosource Pharmaceuticals, Inc.

CTR20251066

/ RecruitingNot Applicable

坎地沙坦酯氢氯噻嗪片（Ⅱ）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验。

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of candesartan cilexetil and hydrochlorothiazide tablets (II) in healthy Chinese subjects under fasting and fed administration conditions.

以药代动力学参数为终点指标，比较空腹和高脂餐后给药条件下，合肥合源药业有限公司生产的坎地沙坦酯氢氯噻嗪片（Ⅱ）与CHEPLAPHARM Arzneimittel GmbH持证的坎地沙坦酯氢氯噻嗪片（Ⅱ）在健康成年人群中吸收程度和速度的差异，对两制剂的生物等效性进行评价。次要目的：评价健康受试者在空腹和高脂餐后给药条件下口服受试制剂坎地沙坦酯氢氯噻嗪片（Ⅱ）和参比制剂坎地沙坦酯氢氯噻嗪片（Ⅱ）的安全性。

[Translation]

The pharmacokinetic parameters were used as the endpoints to compare the differences in the extent and rate of absorption of candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) produced by Hefei Heyuan Pharmaceutical Co., Ltd. and candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) certified by CHEPHAPHARM Arzneimittel GmbH in healthy adults under the conditions of fasting and after a high-fat meal, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of oral administration of the test preparation candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) and the reference preparation candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) in healthy subjects under the conditions of fasting and after a high-fat meal.

Start Date16 Apr 2025

Sponsor / Collaborator

Hefei Cosource Pharmaceuticals, Inc.

100 Clinical Results associated with Hefei Cosource Pharmaceuticals, Inc.

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0 Patents (Medical) associated with Hefei Cosource Pharmaceuticals, Inc.

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100 Deals associated with Hefei Cosource Pharmaceuticals, Inc.

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100 Translational Medicine associated with Hefei Cosource Pharmaceuticals, Inc.

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Pipeline

Pipeline Snapshot as of 10 Aug 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

Phase 1

2

1

Phase 2

Phase 3

1

13

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

HYML-122 ( FLT3 )	FLT3 positive Acute Myeloid Leukemia More	Phase 2
Sabarubicin Hydrochloride ( Top II )	Refractory Small Cell Lung Carcinoma More	Phase 1
HYC-11395 ( GP IIb/IIIa )	Thrombosis More	Phase 1
HYA-13369	Acute Coronary Syndrome More	Discontinued
HYB-11002	Arrhythmias, Cardiac More	Discontinued