Top 5 Target	Count

H+/K+ ATPase(Potassium-transporting ATPase)	2
ERα(Estrogen receptor alpha)	1
NK1R(Neurokinin 1 receptor)	1
mTORC1 x mTORC2	1
SCNA(Sodium voltage-gated channel alpha subunits)	1

Drugs associated with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Tegoprazan

Target

H+/K+ ATPase

Mechanism

P-CAB

Active Org.

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. [+2]

Originator Org.

Pfizer Inc.

Active Indication

Duodenal Ulcer [+5]

Inactive Indication

Liver Injury [+2]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date05 Jul 2018

Plecanatide

Target

GC-C

Mechanism

GC-C agonists

Active Org.

Cipher Pharmaceuticals, Inc. [+3]

Originator Org.

Synergy Pharmaceuticals LLC

Active Indication

Irritable Bowel Syndrome [+3]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date19 Jan 2017

Fosaprepitant Dimeglumine

Target

NK1R

Mechanism

NK1R antagonists

Active Org.

Jiangsu Hansoh Pharmaceutical Co., Ltd. [+7]

Originator Org.

Merck & Co., Inc.

Active Indication

Nausea [+2]

Inactive Indication

Advanced Lung Non-Small Cell Carcinoma [+7]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

EU [+3]

First Approval Date11 Jan 2008

Clinical Trials associated with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

NCT06561542

/ RecruitingPhase 1

A Phase I, Escalating Single and Multiple Dose Study of LX22001 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Bioavailability in Healthy Subjects.

Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of LX22001 for injection in healthy subjects.

Start Date05 Aug 2024

Sponsor / Collaborator

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

CTR20242538

/ RecruitingPhase 1

注射用LX22001在健康成年受试者中单次/多次给药后的安全性、耐受性、药代动力学和药效学特征及生物利用度的I期临床研究

[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics and bioavailability of LX22001 for injection in healthy adult subjects after single/multiple administration

主要目的：评价注射用LX22001单次和多次给药后在中国健康受试者中的安全性和耐受性；次要目的：评价注射用LX22001单次和多次给药后的药代动力学（PK）和药效动力学（PD）特征；评价注射用LX22001与替戈拉生片单次给药后的生物利用度。

[Translation]

The primary objective is to evaluate the safety and tolerability of LX22001 for injection after single and multiple administrations in healthy Chinese subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of LX22001 for injection after single and multiple administrations; and to evaluate the bioavailability of LX22001 for injection and tegrasin tablets after single administration.

Start Date31 Jul 2024

Sponsor / Collaborator

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

[+1]

NCT05915871

/ CompletedPhase 1

An Open-label, Fixed-sequence Study to Evaluate the Drug-drug Interactions Between Tegoprazan Tablets and Bismuth Potassium Citrate Capsules, Amoxicillin Capsules, and Clarithromycin Tablets in Healthy Subjects

To evaluate the pharmacokinetic interaction between tegoprazan and combination of Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers.

Start Date23 Mar 2023

Sponsor / Collaborator

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

100 Clinical Results associated with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

0 Patents (Medical) associated with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Literatures (Medical) associated with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

01 Nov 2024·Current Medical Research and Opinion

Efficacy and safety of tegoprazan for duodenal ulcers in Chinese patients: a multicenter, randomized, double-blind, non-inferiority, phase III study

Article

Author: Wu, Yongdong ; Zhang, Shutian ; Chen, Honghui ; Liu, Side ; Liao, Aijun ; Hu, Chanyan ; Lan, Cheng ; Li, Xing ; Chen, Weixing ; Zong, Ye

OBJECTIVETegoprazan represents a newly developed potassium-competitive acid blocker utilized for the treatment of acid-related disorders. The present study aimed to explore the therapeutic effectiveness of tegoprazan in Chinese individuals with duodenal ulcers (DU).METHODSIn the current multicenter, randomized, double-blind, double-dummy, parallel-group, non-inferiority, phase III clinical trial, individuals with DU underwent randomization 1:1 to be administered tegoprazan 50 mg or lansoprazole 30 mg once daily. The primary efficacy endpoint was the 6-week cumulative endoscopic ulcer healing rate. Secondary endpoints included 4-week endoscopic ulcer healing rate and relief of DU-related gastrointestinal symptoms at weeks 2, 4, and 6. Safety analysis encompassed adverse events (AEs) and laboratory indexes.RESULTSThe 6-week cumulative endoscopic ulcer healing rates were 96.9% (188/194) and 99.0% (189/191) in the tegoprazan and lansoprazole groups, respectively, indicating a difference of -2.0% (95% confidence interval (CI) = -4.9 to 0.8) in the full analysis set (FAS). The corresponding healing rates were 98.4% (185/188) and 99.5% (183/184) in the per-protocol set, respectively, indicating a difference of -1.1% (95% CI = -3.1 to 1.0). The 4-week healing rates in the tegoprazan and lansoprazole groups were 89.2% (173/194) and 88.5% (169/191) in the FAS, respectively, with a difference of 0.7% (95% CI = -5.6 to 7.0). Treatment-related AEs, all mild-to-moderate, were reported in 38.2% (78/204) and 48.2% (94/195) of participants in the tegoprazan and lansoprazole groups, respectively.CONCLUSIONSTegoprazan 50 mg once daily is effective and non-inferior to lansoprazole 30 mg once daily in Chinese patients with DU, showing a promising safety and tolerability profile.CLINICALTRIALS.GOV REGISTRATION NUMBERNCT05010954.

01 May 2024·Clinical Drug Investigation

Pharmacokinetic Interactions Between Tegoprazan and the Combination of Clarithromycin, Amoxicillin and Bismuth in Healthy Chinese Subjects: An Open-Label, Single-Center, Multiple-Dosage, Self-Controlled, Phase I Trial

Article

Author: Li, Qinying ; Hu, Junrui ; Xu, Yusen ; Wang, Yinghui ; Deng, Bin ; Liu, Chengxin ; Zhai, Xuejia ; Chen, Yuhao ; Lu, Yongning ; Du, Yujing ; Li, Linjie ; Xie, Fang ; Yu, Lixiu ; Song, Liangwei

BACKGROUNDTegoprazan is a potassium-competitive acid blocker that inhibits gastric acid and which may be used for eradicating Helicobacter pylori. This study focuses on the pharmacokinetic interaction and safety between tegoprazan and the combination of clarithromycin, amoxicillin and bismuth in healthy Chinese subjects.METHODSAn open-label, three-period, single-center, multiple-dosage, single-sequence, phase I trial was conducted in 22 healthy subjects. In period 1, the subjects took tegoprazan 50 mg twice daily for 7 days, and in period 2 they were administered clarithromycin 500 mg, amoxicillin 1000 mg and bismuth potassium citrate 600 mg twice daily for 7 days (days 14-20). Tegoprazan, clarithromycin, amoxicillin and bismuth potassium citrate were then administered in combination for 7 days (days 21-27) in period 3. Blood samples were collected up to 12 h after the last dose of each period. Safety assessments were performed in each period.RESULTSThe geometric mean ratios (GMRs) [90% confidence interval (CI)] of maximum plasma concentration at steady state (C_max,ss) and area under the plasma concentration-time curve over the dosing interval (AUC_τ) at steady state were 195.93% (175.52-218.71%) and 287.54% (263.28-314.04%) for tegoprazan and 423.23% (382.57-468.22%) and 385.61% (354.62-419.30%) for tegoprazan metabolite M1, respectively. The GMRs (90% CI) of C_max,ss and AUC_τ were 83.69% (77.44-90.45%) and 110.30% (102.74-118.41%) for clarithromycin, 126.25% (114.73-138.93%) and 146.94% (135.33-159.55%) for 14-hydroxyclarithromycin, 75.89% (69.73-82.60%) and 94.34% (87.94-101.20%) for amoxicillin, and 158.43% (125.43-200.11%) and 183.63% (156.42-215.58%) for bismuth, respectively. All reported adverse events were mild. The frequency of adverse events during the coadministration stage was not higher than that during the single- or triple-drug administration stages.CONCLUSIONThe plasma exposure of tegoprazan, M1, 14-hydroxyclarithromycin and bismuth was increased after the coadministration of tegoprazan, clarithromycin, amoxicillin and bismuth. The coadministration exhibited favorable safety and tolerability.CLINICAL TRIALS REGISTRATIONCTR20230643.

01 May 2024·Pharmacological Research

The ADAM17 inhibitor ZLDI-8 sensitized hepatocellular carcinoma cells to sorafenib through Notch1-integrin β-talk

Article

Author: Geng, Hefeng ; Zhang, Weige ; Zhang, Yingshi ; Huang, Yaoguang ; Zhao, Qingchun ; Yang, Kaisi ; Xu, Chang ; Hou, Shanbo ; Ren, Tianshu ; Song, Aigang ; Gao, Xudong

ZLDI-8 is an A disintegrin and metalloproteinase domain 17 (ADAM17) inhibitor that suppresses the shedding of Notch1 to the Notch1 intracellular domain (NICD). In previous studies, we found that ZLDI-8 was able to sensitize HCC to sorafenib, but the mechanism of action remains unclear. The sensitizing effects of ZLDI-8 were tested both in vitro and in vivo. EMT-related factors, sorafenib sensitivity-related proteins and ECM-related gene expression were assessed using immunohistochemistry, RTPCR and Western blotting. Knockdown assays were conducted to determine the relationship between the Notch and Integrin pathways. CoIP assays, nuclear and cytoplasmic fractionation and immunofluorescence colocalization were applied to explore the interaction between the Notch and Integrin pathways. Appropriate statistical analysis methods were used to assess the significance of the experimental results and to ensure the scientific validity and reliability of the experimental design. We found that ECM- and EMT-related proteins were downregulated after ZLDI-8 treatment (P<0.05). ZLDI-8 significantly downregulated Integrinβ1 and Integrinβ3 in HCC in vitro and in vivo (P<0.05), possibly through Foxc2-dependent regulation. Mechanistically, interfering with the expression of both Integrin-linked kinase (ILK) and the NICD may downregulate the expression of proteins targeted by sorafenib, thereby sensitizing cells to sorafenib. The retroregulation of Integrinβ by ILK may occur through the interaction between the NICD and ILK and may be the result of the translocation of the complexus. Our study indicates that blocking the Notch pathway may affect Integrinβ through crosstalk between the Notch1 and Integrinβ/ILK signaling pathways, thus providing a potential therapeutic strategy for HCC.

News (Medical) associated with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

23 Oct 2023

·www.prnewswire.com

Luoxin Pharmaceutical's LX-039 (Innovative Anti-Tumor Drug): Phase I Clinical Study Data Presented at ESMO 2023

SHANGHAI, Oct. 23, 2023 /PRNewswire/ -- From October 20 to 24, the 2023 ESMO Congress was held in Madrid, Spain. LX-039, an innovative anti-tumor drug developed by Luoxin Pharmaceuticals Group Stock Co., Ltd. (Luoxin Pharmaceutical), was selected for poster presentation at the 2023 ESMO Annual Congress. ESMO is one of the most influential oncology conferences globally, attracting over 30,000 professionals every year from more than 150 countries and regions. The Congress covers basic research, translational research, and the latest advancements in clinical studies, providing an exchange platform in clinical diagnosis, treatment, and academic discussions. LX-039 is an innovative selective estrogen receptor degrader (SERD) for oral administration. The aims of the dose escalation and expansion phase I study was to explore the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) profiles of LX-039 in postmenopausal patients with ER+ and HER2- advanced breast cancer who have failed endocrine therapy. The study was led by Professor Hu Xichun from Fudan University Shanghai Cancer Center. In a 3+3 design, the trial evaluated the safety and tolerability from a daily dose of 50 mg to 1200 mg, with two dosage groups selected for expansion. [18F] Fluoroestradiol PET/CT imaging was used for PD study. All 44 enrolled subjects had previously undergone multiple lines of endocrine therapy. Specifically, 72.7% had received second-line therapy or higher. More than half had been treated with fulvestrant, a medication commonly used for hormone receptor-positive breast cancer. Also, over 50% had received advanced chemotherapy, and 40.9% had been treated with CDK4/6 inhibitors. Maximum tolerated dose (MTD) was not reached in this study. Most adverse events are graded as mild to moderate (grade 1-2). The exposure of LX-039 increased along with the dose escalation, and no obvious accumulation after multiple doses. Inhibition of the ER pathway is observed in all subjects participating in the PD exploration. Four subjects achieved partial response, with an objective response rate of 10.8% and a clinical benefit rate at 24 weeks of 40%. LX-039 demonstrates good tolerability and PK/PD properties in ER+ and HER2- advanced breast cancer and shows preliminary anti-tumor activity. These encouraging results suggest that LX-039 holds great potential for further development. Consequently, a phase II study is under planning. About 75% of breast cancer cases are classified as ER+. This subtype of breast cancer relies on the estrogen signaling pathway for its growth and progression. The primary therapeutic approach for ER+ breast cancer involves inhibiting the estrogen signaling pathway through various methods. Notably, drugs like tamoxifen and fulvestrant have been utilized in clinical settings to target the ER pathway. However, tamoxifen resistance and treatment non-compliance with fulvestrant have led to unmet clinical needs. LX-039, an orally administered selective ER degrader (SERD) developed by Louxin Pharmaceutical, specifically focuses on modulating the estrogen signaling pathway. It antagonizes ER actions and promotes its ubiquitination and degradation within breast cancer cells, downregulating ER expression. LX-039 offers unique therapeutic benefits compared to selective ER modulators and aromatase inhibitors. Additionally, its oral formulation enhances patient convenience and compliance, as it eliminates the need for injections. There are currently no domestically available oral drugs with a similar mechanism of action to LX-039 in the market. References: Wang Y, Ayres K L, Goldman D A, et al. 18F-fluoroestradiol PET/CT measurement of estrogen receptor suppression during a phase I trial of the novel estrogen receptor-targeted therapeutic GDC-0810: using an imaging biomarker to guide drug dosage in subsequent trials[J]. Clinical Cancer Research, 2017, 23(12): 3053-3060. Patel H K, Bihani T. Selective estrogen receptor modulators (SERMs) and selective estrogen receptor degraders (SERDs) in cancer treatment[J]. Pharmacology & therapeutics, 2018, 186: 1-24. About Luoxin Pharma Luoxin Pharmaceutical Group Stock Co., Ltd. ("Luoxin Pharma", stock code: 002793.SZ ) was founded in 1988. With the mission of "Source of health", Luoxin Pharma insists upon innovation of science and technology, focuses on the unmet medical needs in GI, respiratory and oncology, etc., and dedicates bringing more innovative medicine to patients around the world. Luoxin Pharma has a rich and competitive portfolio of products and the star products take the lead in GI and respiratory. Many products were listed in major science and technology projects, such as National Major New Product Plan, National Torch Plan as well as Major New Drug R&D. In addition, having been ranking among Top 100 Chinese Pharmaceutical Enterprises since 2006, and among Best Enterprises in Chinese Pharmaceutical R&D Pipelines since 2011, Luoxin Pharma was recognized as State Key High-tech Enterprise, State Technology Innovation Model Enterprise, National Industrial Quality Model Enterprise, and multiple scientific research achievements were awarded the 2nd prize for the State Sci. & Tech Progress. For more information, please visit . SOURCE Luoxin Pharmaceutical Group Stock Co., Ltd.

Phase 1Clinical ResultPhase 2ASCO

16 Mar 2015

·www.bioportfolio.com

Shandong Luoxin Pharmacy Stock Co., Ltd. (8058) - Financial and Strategic SWOT Analysis Review

Recently added to the BioPortfolio report store, Shandong Luoxin Pharmacy Stock Co., Ltd. (8058) - Financial and Strategic SWOT Analysis Review is a new report from GlobalData published on 2015-01-31. This 25-page report is available in PDF from $300. Summary Shandong Luoxin Pharmacy Stock Co., Ltd. (Shandong Luoxin) is a pharmaceutical company. The company develops, manufactures and markets drugs. Its products include digestive system drugs, respiratory drugs, antineoplastic, anti-tumor adjuvant, antiviral drugs, circulatory system drugs, nervous system drugs, nutrition drugs, quinolones, cephalosporins, ß-lactams, macrolides, tetracyclines, sulfa drugs, vitamins, antipyretic analgesics, narcotic analgesic, hormones, antifungals, anti-allergy drugs, blood and hematopoietic system medicine, general category of raw materials, and antibiotics. Shandong Luoxin offers products in the form of powder, freeze-dried powder, solid preparations, sprays, aerosols, pre-filled, high-capacity injection, and small volume injection, among others. The company markets products under brand names, Luo Xu, Kaiji, Rodin, Luo Hong and Xun Ping. It operates through subsidiaries, Shandong Yuxin Pharmaceutical Co., Ltd., and Heng Xin Pharmaceutical Co., Ltd. Shandong Luoxin is headquartered in Linyi, Shandong, China. This comprehensive SWOT profile of Shandong Luoxin Pharmacy Stock Co., Ltd. provides you an in-depth strategic analysis of the company’s businesses and operations. The profile has been compiled by GlobalData to bring to you a clear and an unbiased view of the company’s key strengths and weaknesses and the potential opportunities and threats. The profile helps you formulate strategies that augment your business by enabling you to understand your partners, customers and competitors better. This company report forms part of GlobalData’s ‘Profile on Demand’ service, covering over 50,000 of the world’s leading companies. Once purchased, GlobalData’s highly qualified team of company analysts will comprehensively research and author a full financial and strategic analysis of Shandong Luoxin Pharmacy Stock Co., Ltd. including a detailed SWOT analysis, and deliver this direct to you in pdf format within two business days. (excluding weekends). The profile contains critical company information including*, - Business description – A detailed description of the company’s operations and business divisions. - Corporate strategy – Analyst’s summarization of the company’s business strategy. - SWOT Analysis – A detailed analysis of the company’s strengths, weakness, opportunities and threats. - Company history – Progression of key events associated with the company. - Major products and services – A list of major products, services and brands of the company. - Key competitors – A list of key competitors to the company. - Key employees – A list of the key executives of the company. - Executive biographies – A brief summary of the executives’ employment history. - Key operational heads – A list of personnel heading key departments/functions. - Important locations and subsidiaries – A list and contact details of key locations and subsidiaries of the company. - Key manufacturing facilities – A list of key manufacturing facilities of the company. - Detailed financial ratios for the past five years – The latest financial ratios derived from the annual financial statements published by the company with 5 years history. - Interim ratios for the last five interim periods – The latest financial ratios derived from the quarterly/semi-annual financial… Table of Contents Section 1 - About the Company Shandong Luoxin Pharmacy Stock Co., Ltd. - Key Information Shandong Luoxin Pharmacy Stock Co., Ltd. - Overview Shandong Luoxin Pharmacy Stock Co., Ltd. - Key Employees Shandong Luoxin Pharmacy Stock Co., Ltd. - Key Employee Biographies Shandong Luoxin Pharmacy Stock Co., Ltd. - Key Operational Heads Shandong Luoxin Pharmacy Stock Co., Ltd. - Major Products and Services Shandong Luoxin Pharmacy Stock Co., Ltd. - History Shandong Luoxin Pharmacy Stock Co., Ltd. - Company Statement Shandong Luoxin Pharmacy Stock Co., Ltd. - Locations And Subsidiaries Shandong Luoxin Pharmacy Stock Co., Ltd. - Key Manufacturing facilities Head Office Other Locations & Subsidiaries Section 2 - Company Analysis Shandong Luoxin Pharmacy Stock Co., Ltd. - Business Description Shandong Luoxin Pharmacy Stock Co., Ltd. - Corporate Strategy Shandong Luoxin Pharmacy Stock Co., Ltd. - SWOT Analysis SWOT Analysis - Overview Shandong Luoxin Pharmacy Stock Co., Ltd. - Strengths Shandong Luoxin Pharmacy Stock Co., Ltd. - Weaknesses Shandong Luoxin Pharmacy Stock Co., Ltd. - Opportunities Shandong Luoxin Pharmacy Stock Co., Ltd. - Threats Shandong Luoxin Pharmacy Stock Co., Ltd. - Key Competitors Section 3 - Company Financial Performance Charts Shandong Luoxin Pharmacy Stock Co., Ltd. - Financial Ratios Financial Ratios - Capital Market Ratios Financial Ratios - Annual Ratios Financial Ratios - Interim Ratios Financial Ratios - Ratio Charts Section 4 - Appendix Appendix Methodology Ratio Definitions About GlobalData Contact Us Disclaimer Note*: Some sections may be missing if data is unavailable for the company For more information open Shandong Luoxin Pharmacy Stock Co., Ltd. (8058) - Financial and Strategic SWOT Analysis Review. SKU: GDPH138978FSA

Financial Statement

100 Deals associated with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

100 Translational Medicine associated with Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Jan 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

Preclinical

IND Approval

Phase 1 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Fosaprepitant Dimeglumine ( NK1R )	Chemotherapy-induced nausea and vomiting More	Approved
Tegoprazan ( H+/K+ ATPase )	Helicobacter pylori infection More	Approved
Ambroxol Hydrochloride ( SCNA )	Sputum excretion difficulty More	Approved
Plecanatide ( GC-C )	Constipation - functional More	Phase 3
LX-039 ( ERα )	Estrogen receptor positive breast cancer More	Phase 1

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