Delving into the Latest Updates on LUNAN BETTER PHARMACEUTICAL CO.,LTD. with Synapse

Overview

Tags

Urogenital Diseases

Other Diseases

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

Immune System Diseases	1
Infectious Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	6

Top 5 Target	Count

mAChRs x β2-adrenergic receptor	1
PBPs(Bacterial penicillin-binding protein)	1
SCNA x VDCCs	1
5-HT4 receptor(Serotonin 4 (5-HT4) receptor)	1
cGMP-PDE(3',5'-cyclic phosphodiesterase)	1

主要研究目的：以Chiesi GmbH持证的布地奈德吸入气雾剂（规格：200μg/揿）为参比制剂，以鲁南贝特制药有限公司研制的布地奈德吸入气雾剂（规格：200μg/揿）为受试制剂，考察两制剂在空腹状态下单次给药吸收速度和程度的差异，评价两制剂是否具有生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The main purpose of the study is to use the budesonide inhalation aerosol (specification: 200μg/press) certified by Chiesi GmbH as the reference preparation and the budesonide inhalation aerosol (specification: 200μg/press) developed by Runan Beite Pharmaceutical Co., Ltd. as the test preparation to investigate the difference in the absorption rate and extent of the two preparations after a single administration under fasting conditions and to evaluate whether the two preparations are bioequivalent. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date30 Dec 2024

Sponsor / Collaborator

LUNAN BETTER PHARMACEUTICAL CO.,LTD.

NCT06924190

/ CompletedNot Applicable

Clinical Equivalency Study of Two Formulations of Budesonide Inhalation Aerosol

The test formulation of Budesonide Inhalation Aerosol is bioequivalent to the reference formulation in healthy Chinese subjects under fasting conditions.

Start Date30 Dec 2024

Sponsor / Collaborator

LUNAN BETTER PHARMACEUTICAL CO.,LTD.

[+1]

100 Clinical Results associated with LUNAN BETTER PHARMACEUTICAL CO.,LTD.

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0 Patents (Medical) associated with LUNAN BETTER PHARMACEUTICAL CO.,LTD.

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8

Literatures (Medical) associated with LUNAN BETTER PHARMACEUTICAL CO.,LTD.

Qilu Yaoshi

Determination of aniracetam by GC

Author: Lin, Xiao-lei ; Pei, Fu-jun

A GC method for the determination of aniracetam was established.The GC internal standard method was adopted.DB-1 capillary column and FID detector were used.The injector temperature was 260°C, the detector temperature was 300°C and the column temperature was 200°C.N₂ was used as carrier gas at flow rate of 5.0 mL·min^-1.The makeup flow was 50 mL·min^-1 and the split ratio was 10:1.Caffeine was used as internal standardA good linearity of aniracetam was obtained within 10-110 μg·mL^-1 (r=0.9998) and the average recovery was 100.1%.The method was simple, rapid and accurate, and it can be used for the determination of aniracetam.

Shandong Huagong

Analysis method development for determination of impurity A in tirofiban hydrochloride injection

Author: Zhang, Guimin ; Cui, Qinqin ; Li, Facheng

Objective: To develop an HPLC method for the determination of the impurity A in tirofiban hydrochloride injection.Methods: The anal. was conducted on an octadecyl bonded silica column [YMC-Triart C₁₈ (4.6 mm × 250 mm, 5μm)] with the isocratic elution of 0.01 mol/L potassium dihydrogen phosphate buffer and acetonitrile (70:30) at the flow rate of 1.0 mL/min for 40 min.The temperature was 35°C, the detection wavelength was 227 nm and the injection volume was 50μL.Results: The principal components of tirofiban hydrochloride injection were well separated from the know impurities and the degraded produced by forced degradationThe test solutions with impurity A were stable within 12 h.The calibration curves of impurity A were linear in the self-concentration range of 0.013-0.082μg/mL, with the correction factors of 0.93.The average recovery (n = 7) was 98.7%, and the RSD (n = 7) was 1.7%.The RSDs (n = 9) of repeatability (n = 9) and the intermediate precision (n = 12) for impurity A were 3.7%, 0.5% and 1.2%, 3.4%, resp.The results showed that every impurity of A was less than identification limit of 0.2%, and the total impurity level was no more than 0.3% in the three batches of tirofiban hydrochloride injection.Conclusion: The established method is suitable for the determination of the related substances in tirofiban hydrochloride injection.

Shandong Huagong

Determination of nitrate in isosorbide mononitrate dispersible tablets by HPLC

Author: Fang, Zhaoying ; Zhang, Guimin ; Liu, Ali

Objective: To determine the contents of nitrates in isosorbide mononitrate dispersible tablets by using HPLC.Methods: An ODS column was used.The mobile phase consisted of 0.02 mol/L potassium dihydrogen orthophosphate buffer (pH 3.3) was used as the mobile phase A and methanol as the mobile phase B.Gradient elution was used.The detection wavelength was 220 nm.Results: Under the detection conditions, the nitrate content in isosorbide mononitrate tablets showed good linearity.The detection limit was 0.156 ng and the quant. limit was 0.32 ng.The recovery rate was 98.41%.This method is simple, accurate and reliable.

100 Deals associated with LUNAN BETTER PHARMACEUTICAL CO.,LTD.

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100 Translational Medicine associated with LUNAN BETTER PHARMACEUTICAL CO.,LTD.

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Pipeline

Pipeline Snapshot as of 11 May 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

IND Approval

2

1

Phase 1 Clinical

Approved

5

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ipratropium Bromide/Salbutamol sulfate ( mAChRs x β2-adrenergic receptor )	Asthma More	Approved
Mosapride Citrate Hydrate ( 5-HT4 receptor )	Urinary Calculi More	Approved
Milrinone Lactate ( cGMP-PDE )	Heart Failure More	Approved
Faropenem Sodium Hydrate ( PBPs )	Bacterial Infections More	Approved
Diatrizoate Sodium	Contrast agents More	Approved