Delving into the Latest Updates on Shenzhen Kexing Biotech Co. Ltd. with Synapse

Overview

Basic Info

Introduction

Kexing Biotech is a privately-owned corporation based in Shenzhen, China, specializing in the production of recombinant alpha-1 interferon for the treatment of hepatitis-B within the Chinese market. Established in 1989, the company has been dedicated to advancing medical research and development in this field.

Tags

Endocrinology and Metabolic Disease

Respiratory Diseases

Infectious Diseases

Small molecule drug

Hormone

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

Endocrinology and Metabolic Disease	1
Infectious Diseases	1

Top 5 Drug Type	Count

Hormone	1
Small molecule drug	1

Top 5 Target	Count

INSR(Insulin receptor)	1
RdRp(RNA-directed RNA polymerase)	1

主要目的：通过健康受试者单次口服由深圳科兴药业有限公司提供的受试制剂阿齐沙坦片与日本武田药品工业株式会社生产的参比制剂阿齐沙坦片，进行人体相对生物利用度研究，评价受试制剂与参比制剂的生物等效性。次要目的：通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况评估阿齐沙坦片的安全性。

[Translation]

Primary objective: To conduct a human relative bioavailability study on healthy subjects by taking a single oral dose of the test preparation Azilsartan tablets provided by Shenzhen Kexing Pharmaceutical Co., Ltd. and the reference preparation Azilsartan tablets produced by Takeda Pharmaceutical Co., Ltd. of Japan, and to evaluate the bioequivalence of the test preparation and the reference preparation. Secondary objective: To evaluate the safety of Azilsartan tablets by changes in the incidence of adverse events, laboratory test results, vital signs and physical examinations.

Start Date21 May 2019

Sponsor / Collaborator

Hebei Zhiheng Pharmaceutical Co., Ltd.

[+1]

CTR20190044 / Completed

阿齐沙坦片随机、开放、两周期、两交叉健康人体空腹/餐后状态下生物等效性试验（预试验）

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of azilsartan tablets in healthy volunteers in the fasting/fed state (preliminary study)

主要目的：通过健康受试者单次口服由深圳科兴药业有限公司提供的受试制剂阿齐沙坦片与日本武田药品工业株式会社生产的参比制剂阿齐沙坦片，进行人体相对生物利用度研究，评价受试制剂与参比制剂的生物等效性。次要目的：通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况评估阿齐沙坦片的安全性。

[Translation]

Primary objective: To conduct a relative bioavailability study on healthy subjects by taking a single oral dose of the test preparation Azilsartan tablets provided by Shenzhen Kexing Pharmaceutical Co., Ltd. and the reference preparation Azilsartan tablets produced by Takeda Pharmaceutical Co., Ltd. of Japan, and to evaluate the bioequivalence of the test preparation and the reference preparation. Secondary objective: To evaluate the safety of Azilsartan tablets by changes in the incidence of adverse events, laboratory test results, vital signs and physical examinations.

Start Date16 Nov 2018

Sponsor / Collaborator

Hebei Zhiheng Pharmaceutical Co., Ltd.

[+1]

CTR20181921 / Completed

阿齐沙坦片随机、开放、两周期、两交叉健康人体空腹/餐后状态下生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of azilsartan tablets in healthy volunteers under fasting and fed conditions

通过健康受试者在空腹和餐后状态下分别单次口服由深圳科兴药业有限公司提供的受试制剂阿齐沙坦片（规格：40mg）与日本武田药品工业株式会社生产的参比制剂阿齐沙坦片（Azilva®，规格：40mg），进行人体相对生物利用度研究，评价受试制剂与参比制剂的生物等效性。

[Translation]

A relative bioavailability study was conducted in healthy subjects by taking a single oral dose of the test preparation Azilsartan tablets (specification: 40 mg) provided by Shenzhen Sinovac Pharmaceutical Co., Ltd. and the reference preparation Azilsartan tablets (Azilva®, specification: 40 mg) produced by Takeda Pharmaceutical Company Limited in the fasting and fed states, respectively, to evaluate the bioequivalence of the test preparation and the reference preparation.

Start Date22 Oct 2018

Sponsor / Collaborator

Hebei Zhiheng Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Shenzhen Kexing Biotech Co. Ltd.

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0 Patents (Medical) associated with Shenzhen Kexing Biotech Co. Ltd.

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2

Literatures (Medical) associated with Shenzhen Kexing Biotech Co. Ltd.

Zhongguo Yiyuan Yaoxue Zazhi

A primary research on spermicidal action of povidone-iodine ointment

Author: Wu, Jing ; Wang, Qianlan ; Liu, Zilong

The spermicidal effect of providone-iodine (PVP-I) ointment was tested to explore its safety to woman's reproductionThe method in vitro came from the improved spermicidal test method in vitro recommended by International Planned Parenthood Foundation (IPPF), and the method in vivo came from principle of pharmacodynamic research on spermicidal drugs from SFDA.In vitro, PVP-I ointment could kill all the tested sperms from rat or mankind in 20 s.In vivo, all rabbits treated with PVP-I ointment could not become pregnant.It determined primarily that the PVP-I ointment had spermicidal effect in vitro.

Zhongguo Shenghua Yaowu Zazhi

Comparison of analyzing methods for activity of hepatocyte growth factor

Author: Wang, Qianlan

Merits and demerits of three kinds of methods for measurements of hepatocyte growth-promoting factor (HGF) activity were compared.With human hepatoma HepG2 cells as materials, the bioactivity of HGF was detected by ³H-TdR incorporation, tetrazolium bromide (MTT) colorimetry and trypan-blue exclusion test XTT/PMS, resp.Linear correlation coefficient (r), the maximum stimulation index (SI) and operation simplicity of the three methods were compared.Both the sensitivity (SI=3.65) and the accuracy (r=0.91) of the MTT method were poor.The sensitivity of the XTT/PMS method (SI=23.19) was not as good as that of the ³H-TdR method (SI=23.19), but its accuracy (r=0.98) was the best, with the most simple operation.After adjustment by the standard, the XTT/PMS method can be the first choice for the routine measurement of the HGF activity.

100 Deals associated with Shenzhen Kexing Biotech Co. Ltd.

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100 Translational Medicine associated with Shenzhen Kexing Biotech Co. Ltd.

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Pipeline

Pipeline Snapshot as of 17 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

IND Application

1

Approved

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