Delving into the Latest Updates on Jilin Huisheng Biological Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Endocrinology and Metabolic Disease

Immune System Diseases

Biosimilar

Hormone

Recombinant polypeptide

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	7
Immune System Diseases	1

Top 5 Drug Type	Count

Hormone	4
Biosimilar	4
Recombinant polypeptide	2
Small molecule drug	1

Top 5 Target	Count

INSR(Insulin receptor)	5
PRKAB1 x SGLT2	1
GLP-1R(Glucagon-like peptide 1 receptor)	1

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂瑞格列奈片（规格：2.0mg；生产企业：南京海纳制药有限公司）和参比制剂瑞格列奈片（商品名：NovoNorm；规格：2.0mg；持证商：Novo Nordisk A/S）后的药代动力学特征，进行药代动力学关键参数的比较，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂瑞格列奈片和参比制剂瑞格列奈片（NovoNorm）在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation repaglinide tablets (specification: 2.0 mg; manufacturer: Nanjing Haina Pharmaceutical Co., Ltd.) and the reference preparation repaglinide tablets (trade name: NovoNorm; specification: 2.0 mg; licensee: Novo Nordisk A/S) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, to compare the key pharmacokinetic parameters, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation repaglinide tablets and the reference preparation repaglinide tablets (NovoNorm) in healthy Chinese subjects.

Start Date08 Aug 2023

Sponsor / Collaborator

Jilin Huisheng Biological Pharmaceutical Co., Ltd.

CTR20231819 / CompletedNot Applicable

达格列净片在中国健康人群中餐后状态下单中心、随机、开放、两序列、两周期、交叉生物等效性试验

[Translation] A single-center, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of dapagliflozin tablets in the postprandial state in healthy Chinese population

主要研究目的：考察单次单剂量口服（餐后）受试制剂达格列净片（规格：10mg，惠升生物制股份药有限公司申办）与参比制剂达格列净片（安达唐®，规格：10mg，AstraZenecaPharmaceuticalsLP生产），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：评价餐后单次口服受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of the single-dose oral (postprandial) test preparation dapagliflozin tablets (specification: 10 mg, applied for by Huisheng Biopharmaceutical Co., Ltd.) and the reference preparation dapagliflozin tablets (Andatang®, specification: 10 mg, produced by AstraZeneca Pharmaceuticals LP) 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. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation after a single oral administration in healthy Chinese subjects.

Start Date16 Jun 2023

Sponsor / Collaborator

Jilin Huisheng Biological Pharmaceutical Co., Ltd.

CTR20230895 / CompletedNot Applicable

达格列净片在中国健康人群中空腹和餐后状态下单中心、随机、开放、两序列、两周期、交叉生物等效性试验

[Translation] A single-center, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of dapagliflozin tablets in the fasting and fed state in healthy Chinese people

主要研究目的：考察单次单剂量口服（空腹/餐后）受试制剂达格列净片（规格：10mg，吉林惠升生物制药有限公司申办）与参比制剂达格列净片（安达唐®，规格：10mg，AstraZenecaPharmaceuticalsLP生产），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：评价空腹、餐后单次口服受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of the test preparation dapagliflozin tablets (specification: 10 mg, applied for by Jilin Huisheng Biopharmaceutical Co., Ltd.) and the reference preparation dapagliflozin tablets (Andatang®, specification: 10 mg, produced by AstraZeneca Pharmaceuticals LP) in healthy Chinese subjects after a single oral dose (fasting/postprandial) and to analyze the pharmacokinetic parameters of the two preparations and evaluate the bioequivalence of the two preparations to provide a reference for the application and clinical use of the drug. Secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects after a single oral dose on an empty stomach and after a meal.

Start Date05 Apr 2023

Sponsor / Collaborator

Jilin Huisheng Biological Pharmaceutical Co., Ltd.

100 Clinical Results associated with Jilin Huisheng Biological Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Jilin Huisheng Biological Pharmaceutical Co., Ltd.

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100 Deals associated with Jilin Huisheng Biological Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Jilin Huisheng Biological Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 27 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

Preclinical

1

IND Approval

Phase 3 Clinical

2

1

NDA/BLA

Approved

3

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Insulin degludec/Insulin aspart (Huisheng Pharm) ( INSR )	Diabetes Mellitus, Type 2 More	Approved
Insulin aspart (Huisheng Biological) ( INSR )	Diabetes Mellitus More	Approved
Insulin Degludec biosimilar (Huisheng Biological) ( INSR )	Diabetes Mellitus, Type 2 More	Approved
Janagliflozin/Metformin ( PRKAB1 x SGLT2 )	Diabetes Mellitus, Type 2 More	NDA/BLA
Isophane Protamine Recombinant Human Insulin(Jilin Huisheng Biological Pharmaceutical Co., Ltd.) ( INSR )	Diabetes Mellitus, Type 2 More	Phase 3