Delving into the Latest Updates on Hanhui Pharmaceutical Co. Ltd. (China) with Synapse

Overview

Tags

Neoplasms

Skin and Musculoskeletal Diseases

Digestive System Disorders

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	4
Endocrinology and Metabolic Disease	1
Hemic and Lymphatic Diseases	1
Immune System Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	4

Top 5 Target	Count

DNA x Top II	1
PI3Kγ(Phosphatidylinositol-4,5-Bisphosphate 3 kinase gamma)	1
NTRK x ROS1	1

本试验旨在研究餐后单次口服瀚晖制药有限公司研制、浙江海正药业股份有限公司生产的海博麦布阿托伐他汀钙片（20 mg/10 mg）的药代动力学特征；以浙江海正药业股份有限公司生产的海博麦布片（赛斯美®，20 mg）及辉瑞制药有限公司生产的阿托伐他汀钙片（立普妥®，10 mg）联用作为对照，比较海博麦布阿托伐他汀钙片与海博麦布片和阿托伐他汀钙片联用的药动学参数〔总海博麦布（海博麦布+海博麦布-葡萄糖醛酸结合物）、海博麦布、阿托伐他汀：Cmax、AUC0-t、AUC0-∞〕，评价海博麦布阿托伐他汀钙片与海博麦布片和阿托伐他汀钙片联用的人体生物等效性。次要目的：评价海博麦布阿托伐他汀钙片在健康成年受试者中的安全性。

[Translation]

This study aims to study the pharmacokinetic characteristics of Hebomib Atorvastatin Calcium Tablets (20 mg/10 mg) developed by Hanhui Pharmaceutical Co., Ltd. and produced by Zhejiang Hisun Pharmaceutical Co., Ltd. after a single oral administration after a meal; using Hebomib Tablets (Cesme®, 20 mg) produced by Zhejiang Hisun Pharmaceutical Co., Ltd. and Atorvastatin Calcium Tablets (Lipitor®, 10 mg) produced by Pfizer Pharmaceuticals Co., Ltd. as controls, to compare the pharmacokinetic parameters of Hebomib Atorvastatin Calcium Tablets and Hebomib Tablets and Atorvastatin Calcium Tablets in combination [total Hebomib (Hebomib + Hebomib-glucuronic acid conjugate), Hebomib, Atorvastatin: Cmax, AUC0-t, AUC0-∞], and to evaluate the bioequivalence of Hebomib Atorvastatin Calcium Tablets and Hebomib Tablets and Atorvastatin Calcium Tablets in humans. Secondary objective: To evaluate the safety of Hebomib Atorvastatin Calcium Tablets in healthy adult subjects.

Start Date23 Jul 2024

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+1]

CTR20241415 / CompletedNot Applicable

阿帕他胺片（60mg）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 apalutamide tablets (60 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Janssen-Cilag International NV的阿帕他胺片（商品名：Erleada(安森珂)；规格：60mg）为参比制剂，对瀚晖制药有限公司提供的受试制剂阿帕他胺片（规格：60mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂阿帕他胺片（规格：60mg）和参比制剂阿帕他胺片（商品名：Erleada(安森珂)；规格：60mg）的安全性。

[Translation]

Main study purpose: According to the relevant provisions of bioequivalence test, Janssen-Cilag International NV's apalutamide tablets (trade name: Erleada; specification: 60mg) were selected as the reference preparation, and the test preparation apalutamide tablets (specification: 60mg) provided by Hanhui Pharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation apalutamide tablets (specification: 60mg) and the reference preparation apalutamide tablets (trade name: Erleada; specification: 60mg) to healthy subjects.

Start Date08 May 2024

Sponsor / Collaborator

Hanhui Pharmaceutical Co. Ltd. (China)

CTR20232954 / CompletedNot Applicable

海博麦布阿托伐他汀钙片在健康受试者中的随机、开放、单剂量、四周期、两序列完全重复交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, four-period, two-sequence complete repeated crossover bioequivalence study of Hebomib atorvastatin calcium tablets in healthy subjects

主要目的：研究空腹和餐后单次口服瀚晖制药有限公司研制的海博麦布阿托伐他汀钙片（20 mg/10 mg）的药代动力学特征；以浙江海正药业股份有限公司生产的海博麦布片（赛斯美®，20 mg）及辉瑞制药有限公司生产的阿托伐他汀钙片（立普妥®，10 mg）联用作为对照，评价海博麦布阿托伐他汀钙片与海博麦布片和阿托伐他汀钙片联用的人体生物等效性。次要目的：评价海博麦布阿托伐他汀钙片在健康成年受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetic characteristics of Hebomib Atorvastatin Calcium Tablets (20 mg/10 mg) developed by Hanhui Pharmaceutical Co., Ltd. after single oral administration on an empty stomach and after meals; to evaluate the bioequivalence of Hebomib Atorvastatin Calcium Tablets with Hebomib Tablets and Atorvastatin Calcium Tablets in combination, using Hebomib Tablets (Cesme®, 20 mg) produced by Zhejiang Hisun Pharmaceutical Co., Ltd. and Atorvastatin Calcium Tablets (Lipitor®, 10 mg) produced by Pfizer Pharmaceuticals Co., Ltd. as controls. Secondary objective: To evaluate the safety of Hebomib Atorvastatin Calcium Tablets in healthy adult subjects.

Start Date09 Oct 2023

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Hanhui Pharmaceutical Co. Ltd. (China)

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0 Patents (Medical) associated with Hanhui Pharmaceutical Co. Ltd. (China)

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100 Deals associated with Hanhui Pharmaceutical Co. Ltd. (China)

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100 Translational Medicine associated with Hanhui Pharmaceutical Co. Ltd. (China)

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Pipeline

Pipeline Snapshot as of 18 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

1

Phase 1 Clinical

Phase 2 Clinical

1

2

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Floxuridine	Lung Cancer More	Approved
Epirubicin Hydrochloride ( DNA x Top II )	Acute Lymphoblastic Leukemia More	Approved
HS-301 ( NTRK x ROS1 )	Solid tumor More	Phase 2 Clinical
HS248 ( PI3Kγ )	Advanced Malignant Solid Neoplasm More	Phase 1
Atorvastatin Calcium Hydrate/Hyzetimibe ( HMG-CoA reductase x NPC1L1 )	Hypercholesterolemia More	IND Approval