Delving into the Latest Updates on Fujian Haixi New Drug Creation Co., Ltd with Synapse

Overview

Basic Info

Introduction

Fujian Haixi Pharmaceutical Co., Ltd. is a leading asset-light pharmaceutical company, operating as a Market Authorization Holder (MAH) without manufacturing facilities. Since its inception in Fuzhou in 2012, Haixi Pharma has charted a unique course among start-up pharma ventures. The company prioritizes the development of small-molecule innovative drugs with clear clinical needs and global market potential and concentrates on first-to-market generics, complex generics, and high-quality generic drugs.

Tags

Neoplasms

Congenital Disorders

Nervous System 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	3
Endocrinology and Metabolic Disease	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	3

Top 5 Target	Count

CSF-1R x DDR1 x VEGFR2	1

主要目的：本研究以福建海西新药创制股份有限公司研制的己酮可可碱缓释片（规格：0.4 g）为受试制剂，按生物等效性研究的有关规定，以Sanofi持证，Sanofi S.r.l.生产的己酮可可碱缓释片（规格：400 mg，商品名称：Trental®）为参比制剂，评估受试制剂和参比制剂在空腹条件下给药后的生物等效性。次要目的：观察受试制剂己酮可可碱缓释片和参比制剂己酮可可碱缓释片（商品名称：Trental®）在健康受试者中的安全性。

[Translation]

Main purpose: This study used pentoxifylline sustained-release tablets (specification: 0.4 g) developed by Fujian Haixi New Drug Creation Co., Ltd. as the test preparation, and pentoxifylline sustained-release tablets (specification: 400 mg, trade name: Trental®) produced by Sanofi S.r.l., certified by Sanofi, as the reference preparation according to the relevant provisions of bioequivalence studies, to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting conditions. Secondary purpose: To observe the safety of the test preparation pentoxifylline sustained-release tablets and the reference preparation pentoxifylline sustained-release tablets (trade name: Trental®) in healthy subjects.

Start Date16 Aug 2024

Sponsor / Collaborator

Fujian Haixi New Drug Creation Co., Ltd

CTR20242249 / Active, not recruitingNot Applicable

己酮可可碱缓释片（0.4 g）健康人体生物等效性研究

[Translation] Bioequivalence study of pentoxifylline sustained-release tablets (0.4 g) in healthy volunteers

主要目的：本研究以福建海西新药创制股份有限公司研制的己酮可可碱缓释片（规格：0.4 g）为受试制剂，按生物等效性研究的有关规定，以Sanofi持证，Sanofi S.r.l.生产的己酮可可碱缓释片（规格：400 mg，商品名称：Trental®）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察受试制剂己酮可可碱缓释片和参比制剂己酮可可碱缓释片（商品名称：Trental®）在健康受试者中的安全性。

[Translation]

Main purpose: This study used pentoxifylline sustained-release tablets (specification: 0.4 g) developed by Fujian Haixi New Drug Creation Co., Ltd. as the test preparation. According to the relevant provisions of bioequivalence studies, pentoxifylline sustained-release tablets (specification: 400 mg, trade name: Trental®) produced by Sanofi S.r.l., certified by Sanofi, were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: To observe the safety of the test preparation pentoxifylline sustained-release tablets and the reference preparation pentoxifylline sustained-release tablets (trade name: Trental®) in healthy subjects.

Start Date19 Jun 2024

Sponsor / Collaborator

Fujian Haixi New Drug Creation Co., Ltd

CTR20240484 / CompletedNot Applicable

采用单中心、随机、开放、四周期、两序列、完全重复、单次空腹/餐后给药生物等效性研究。

[Translation] A single-center, randomized, open-label, four-period, two-sequence, fully repeated, single fasting/fed administration bioequivalence study was conducted.

本研究以福建海西新药创制股份有限公司研发的盐酸贝尼地平片（规格：8 mg）为受试制剂，按生物等效性研究的有关规定，以持有人Kyowa Kirin Co., Ltd.，生产企业Kyowa Kirin Co., Ltd. Ube Plant生产的盐酸贝尼地平片（规格：8 mg，商品名称：可力洛®Coniel®）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。

[Translation]

In this study, benidipine hydrochloride tablets (specification: 8 mg) developed by Fujian Haixi New Drug Creation Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence studies, benidipine hydrochloride tablets (specification: 8 mg, trade name: Coniel®) produced by the holder Kyowa Kirin Co., Ltd. and the manufacturer Kyowa Kirin Co., Ltd. Ube Plant were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.

Start Date26 Feb 2024

Sponsor / Collaborator

Fujian Haixi New Drug Creation Co., Ltd

100 Clinical Results associated with Fujian Haixi New Drug Creation Co., Ltd

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0 Patents (Medical) associated with Fujian Haixi New Drug Creation Co., Ltd

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1

Literatures (Medical) associated with Fujian Haixi New Drug Creation Co., Ltd

Scientific ReportsQ3 · CROSS-FIELD

Effect of BZG-4000, a novel multi-targeted kinase inhibitor with potent anticancer activity, on a hepatocellular carcinoma xenograft model

Q3 · CROSS-FIELD

ArticleOA

Author: Deng, Dan-Feng ; Ding, Lie-Ming ; Zhou, Jue ; Qiu, Yun-Qing ; Kang, Xin-Shan ; Tan, Fen-Lai ; Yu, Wei

The present study was to synthesize a novel multi-targeted kinase inhibitor and evaluated its anticancer effects on a hepatocellular carcinoma xenograft model. In our study, in vivo efficacy was determined in nude mice bearing HuH7 human HCC xenografts. The mice were randomly divided into the following five groups with the use of a randomization chart (n = 8 in each group): high-dose BZG-4000 group, medium-dose BZG-4000 group, low-dose BZG-4000 group, sorafenib group, and model group. Tumor size measurements included the length (L) and width (W) measured with calipers, and tumor volume was calculated as (LW∧2)/2. Tumor tissues slides were hematoxylin and eosin (HE) stained for histopathological examination. Immunohistochemistry detected CD31 expression, and Western blotting measured VEGF protein expression. We found that when BZG-4000 was administered orally to xenograft HuH7 nude mice, tumor growth was inhibited and significant tumor shrinkage was evident. After oral administration of BZG-4000 at 40 mg/kg/day, the tumor weight and volume were significantly lower than tumors of the sorafenib group. BZG-4000 considerably decreased the expression of CD31 and VEGF in tumors compared to tumors treated with positive control drug. It was concluded that BZG-4000 has the potential to inhibit the tumorigenesis of hepatocellular carcinoma in vivo by decreasing the expression of CD31 and VEGF.

100 Deals associated with Fujian Haixi New Drug Creation Co., Ltd

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100 Translational Medicine associated with Fujian Haixi New Drug Creation Co., Ltd

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Pipeline

Pipeline Snapshot as of 14 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

Discovery

2

1

Phase 2 Clinical

Other

5

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

C-019199 ( CSF-1R x DDR1 x VEGFR2 )	Advanced Malignant Solid Neoplasm More	Phase 2 Clinical
HXP056	Dystrophy, Macular More	Discovery
HXP045	Renal Cell Carcinoma More	Discovery
HXP-0057 ( GPR40 )	Diabetes Mellitus More	Pending
Rituximab biobetter(Fujian Haixi Pharmaceuticals) ( CD20 )	Neoplasms More	Pending