Nanchang Hongyi Technology Co., Ltd., established in 1998, is a limited liability company involved in pharmaceutical research and development. Nanchang Hongyi Pharmaceutical Co., Ltd., a subsidiary controlled by Nanchang Hongyi Technology Co., Ltd., was established in 2002. In 2005, the company's workshops in Nanchang High-Tech Zone for active pharmaceutical ingredient, traditional Chinese medicine pretreatment and extraction, tablet, pill, granule, dry mixed suspension, and inhalation formulation (powder mist) production passed inspections and certification, obtaining a "Pharmaceutical Production License" and a "Pharmaceutical GMP Certificate".

Tags

Neoplasms

Immune System Diseases

Hemic and Lymphatic 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	2
Immune System Diseases	1
Hemic and Lymphatic Diseases	1

Top 5 Drug Type	Count

Small molecule drug	3

Top 5 Target	Count

S1PR1(Sphingosine 1-phosphate receptor Edg-1)	1
KDM1A(Lysine-specific histone demethylase 1)	1
VEGFR2 x c-Met	1

Drugs associated with Nanchang Hongyi Technology Co., Ltd.

HE006

Target

KDM1A

Mechanism

KDM1A inhibitors

Active Org.

Nanchang Hongyi Pharmaceutical Co. Ltd.

Originator Org.

Nanchang Hongyi Pharmaceutical Co. Ltd.

Active Indication

Acute Promyelocytic Leukemia [+1]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

HE009

Target

S1PR1

Mechanism

S1PR1 antagonists

Active Org.

Nanchang Hongyi Pharmaceutical Co. Ltd.

Originator Org.

Nanchang Hongyi Pharmaceutical Co. Ltd.

Active Indication

Systemic Lupus Erythematosus

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

LMV-12

Target

VEGFR2 x c-Met

Mechanism

VEGFR2 antagonists [+1]

Active Org.

Nanchang Hongyi Technology Co., Ltd.

Originator Org.

Nanchang Hongyi Pharmaceutical Co. Ltd.

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Nanchang Hongyi Technology Co., Ltd.

CTR20243785

/ RecruitingPhase 1

[14C]HE009 在中国健康受试者体内的物质平衡临床研究

[Translation] [14C] HE009 Clinical study on material balance in healthy Chinese subjects

主要目的： 1. 定量分析男性健康受试者口服[14C]HE009 后排泄物中的总放射性，获得人体放射性总回收率、放射性排泄率数据和主要排泄途径； 2. 定量分析男性健康受试者单次口服[14C]HE009 后人血浆、尿液和粪便的放射性代谢物谱，鉴定主要代谢产物，确定 HE009 在人体内的代谢和消除途径； 3. 定量分析男性健康受试者单次口服[14C]HE009 后全血和血浆中的总放射性，获得全血（如适用）和血浆总放射性的药代动力学参数，考察全血和血浆中总放射性的分配情况。次要目的： 1. 采用经验证的液相色谱串联质谱联用法（LC-MS/MS）定量分析血浆中 HE009 及其代谢产物（如适用）的浓度，获得血浆中 HE009 及其代谢产物（如适用）的药动学参数； 2. 观察男性健康受试者单剂量口服[14C]HE009 后的安全性。

[Translation]

Main objectives: 1. To quantitatively analyze the total radioactivity in the excreta of male healthy subjects after oral administration of [14C]HE009, and obtain the total recovery rate of human radioactivity, radioactive excretion rate data and the main excretion pathway; 2. To quantitatively analyze the radioactive metabolite profiles in human plasma, urine and feces of male healthy subjects after a single oral administration of [14C]HE009, identify the main metabolites, and determine the metabolism and elimination pathways of HE009 in the human body; 3. To quantitatively analyze the total radioactivity in whole blood and plasma of male healthy subjects after a single oral administration of [14C]HE009, obtain the pharmacokinetic parameters of the total radioactivity in whole blood (if applicable) and plasma, and investigate the distribution of the total radioactivity in whole blood and plasma. Secondary objectives: 1. To quantitatively analyze the concentrations of HE009 and its metabolites (if applicable) in plasma using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method and obtain the pharmacokinetic parameters of HE009 and its metabolites (if applicable) in plasma; 2. To observe the safety of [14C]HE009 after a single oral dose in healthy male subjects.

Start Date23 Oct 2024

Sponsor / Collaborator

Nanchang Hongyi Pharmaceutical Co. Ltd.

CTR20232499

/ RecruitingPhase 1

评价LMV-12(HE003)片治疗局部晚期或转移性恶性实体瘤的有效性和安全性的Ⅰb/Ⅱ期临床试验

[Translation] Phase Ib/II clinical trial to evaluate the efficacy and safety of LMV-12 (HE003) tablets in the treatment of locally advanced or metastatic malignant solid tumors

在局部晚期或转移性非小细胞肺癌和肾细胞癌受试者中初步评价LMV-12（HE003）片的安全性，确定后续研究的给药剂量。

[Translation]

To preliminarily evaluate the safety of LMV-12 (HE003) tablets in subjects with locally advanced or metastatic non-small cell lung cancer and renal cell carcinoma and to determine the dosage for subsequent studies.

Start Date06 Sep 2023

Sponsor / Collaborator

Nanchang Hongyi Technology Co., Ltd.

[+1]

CTR20223233

/ CompletedPhase 1

单中心、随机、双盲、安慰剂对照、单次递增给药、多次给药评估口服HE009片在中国健康受试者中的安全性、耐受性和药代/药效动力学特征和及食物影响的I期临床研究

[Translation] A single-center, randomized, double-blind, placebo-controlled, single ascending dose, multiple dose phase I clinical study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effects of oral HE009 tablets in healthy Chinese subjects

主要目的：评估健康成人单次/多次口服HE009片后的安全性和耐受性。次要目的：评估健康成人单次/多次口服HE009片的药代/药效动力学特征；评估进食对健康成人单次口服HE009片药代动力学特征的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of HE009 tablets after single/multiple oral administration in healthy adults. Secondary objective: To evaluate the pharmacokinetic/pharmacodynamic characteristics of HE009 tablets after single/multiple oral administration in healthy adults; To evaluate the effect of food intake on the pharmacokinetic characteristics of HE009 tablets after single oral administration in healthy adults.

Start Date26 Dec 2022

Sponsor / Collaborator

Nanchang Hongyi Pharmaceutical Co. Ltd.

100 Clinical Results associated with Nanchang Hongyi Technology Co., Ltd.

0 Patents (Medical) associated with Nanchang Hongyi Technology Co., Ltd.

Literatures (Medical) associated with Nanchang Hongyi Technology Co., Ltd.

01 Jan 2025·Journal of Ethnopharmacology

Chemometric-based analysis and bioassay guided identification of potent compounds with intestinal motility promoting effects from Dalitong Granules

Article

Author: Kang, An ; Aa, Jiye ; Ma, Jiayi ; Wang, Xiaoxia ; Su, Yan ; Xie, Jingru ; Kuang, Zhenying ; Zhao, Yan ; Sheng, Xianjie ; Wang, Guangji ; Tao, Lin

ETHNOPHARMACOLOGICAL RELEVANCEDalitong Granules (DLT), a potent Traditional Chinese Medicine known for its ability to promote gastrointestinal motility, is widely used in clinical practice for the treatment of Functional Dyspepsia (FD). Despite the remarkable clinical efficacy of DLT, the specific components responsible for its effectiveness remains unclear.AIM OF THE STUDYThe study aimed to identify potential active ingredients of DLT for treating FD through spectrum-effect relationship analysis, multivariate statistical analysis and network pharmacology analysis. The efficacy of these identified compounds was subsequently validated using the zebrafish intestinal peristalsis model.MATERIALS AND METHODSThe fingerprints of various solvent-extracted DLT were analyzed using high performance liquid chromatography coupled with tandem high-resolution mass spectrometry. The intestinal motility-promoting activities of DLT extracted by different solvents were evaluated through an intestinal propulsion test in mice. Potential therapeutic substances in DLT for treating FD were screened via chemometric analysis based on spectrum-effect relationship analysis. The correlation between the intensity of common peaks in the total ion chromatogram and the pharmacodynamic indices was assessed using multivariate statistical analysis. Additionally, given the complexity of Traditional Chinese Medicine, which comprises multiple components and targets, a network pharmacology analysis was performed to investigate the potential active ingredients in DLT. Finally, the pharmacological effects of these compounds in DLT were validated using a zebrafish intestinal motility model.RESULTSThrough spectral-effect relationships analysis and network pharmacology analysis, it was determined that ten ingredients in DLT contribute to the promotion of intestinal motility. In a zebrafish intestinal motility model, it was observed that eight chemicals (excluding tetrahydropalmatine) demonstrate favorable activity of promoting gastrointestinal motility. These findings suggest that these ingredients may serve as potential therapeutic agents for improving gastric motility disorders.CONCLUSIONSThis study employed spectral-effect relationship and network pharmacology analysis to identify the active ingredients in DLT. The findings were then validated using a zebrafish intestinal peristalsis model. These results provide a scientific foundation for the clinical application of DLT as a key traditional herbal formula for managing FD.

01 Jan 2023·Journal of Pharmaceutical and Biomedical Analysis

Non-targeted characteristic filter analysis combined with in silico prediction strategies to identify the chemical components and in vivo metabolites of Dalitong Granules by UPLC-Q-TOF/MS/MS

Article

Author: Sheng, Xianjie ; Zhang, Xiaoli ; Aa, Jiye ; Yin, Tao ; Wang, Guangji ; Li, Qin ; Tao, Lin ; Kang, An ; Fei, Wenying ; Su, Yan

Dalitong Granules, a potent gastrointestinal motility promoting traditional Chinese medicine, is used to treat functional dyspepsia clinically. It shows good effect on alleviating gastrointestinal motility disorders and has a broad prospect of clinical application. However, there is no comprehensive study on its in vivo and in vitro chemical analysis. UPLC-Q-TOF-MS combined with the non-targeted characteristic filter analysis and in silico prediction strategies (NCFS) were used to deduce and identify the chemical components and in vivo metabolites in the bio-samples of rats following oral administration of Dalitong Granules. In this study, 108 chemical components were identified in Dalitong granules, including 50 flavonoids, 22 alkaloids, 13 terpenes, 11 organic acids, 10 coumarins and 2 volatile oils. In the plasma, tissue, urine and fecal samples of rats after administration of Dalitong granules, a total of 147 compounds were speculated (60 prototype compounds and 87 metabolites). The main metabolic pathways in vivo include methylation, demethylation, deglycosylation, hydrogenation, hydroxylation, sulfonation and glucuronidation as there are many flavonoids existing in Dalitong Granules. In conclusion, the chemical components and metabolites of Dalitong Granules were comprehensively identified by using a rapid and accurate analysis method, which laid a foundation for dissecting its bioactive substances. In addition, it provides a scientific basis for the in-depth study of the material basis of Dalitong Granules efficacy and its further comprehensive development and utilization.

Zhongguo Yaopin Biaozhun

Study on the dissolution in nimesulide suspension

Author: Gong, Chunyan ; Zhan, Mingqing ; Fu, Haihui ; Zhong, Shuying

A method for testing the dissolution of nimesulide suspension was established.Using Apparatus II of dissolution test method of ChP 2005 edition vol II, dissolution medium was phosphate buffer solution (pH 8.8).After 40 min the dissolution solution was taken and analyzed by UV method at the wavelength of 393 nm.The linear relationship was in the range of 2-20 mg/L (r = 0.9999).The mean recovery of nimesulide was 99.6% with relative standard deviation (RSD) 0.51% (n=9).The dissolution solution was stable in 8 h.The result showed that the mean dissolution of nimesulide suspension was 88.2%, and the dissolution uniformity was good with RSD 3.86%, (n = 6).The method was simple, practical, and accurate to determine the dissolution of nimesulide suspension.

100 Deals associated with Nanchang Hongyi Technology Co., Ltd.

100 Translational Medicine associated with Nanchang Hongyi Technology Co., Ltd.

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Phase 1 Clinical

Current Projects

Drug(Targets)	Indications	Global Highest Phase

LMV-12 ( VEGFR2 x c-Met )	Advanced Malignant Solid Neoplasm More	Phase 1
HE009 ( S1PR1 )	Systemic Lupus Erythematosus More	Phase 1
HE006 ( KDM1A )	Acute Promyelocytic Leukemia More	Phase 1

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