Daewon Pharmaceutical was founded in 1958 with the vision of promoting human health. As a specialized pharmaceutical company, they have consistently strived to adapt to contemporary environmental changes and maintain human health.

Tags

Endocrinology and Metabolic Disease

Cardiovascular Diseases

Urogenital Diseases

Small molecule drug

Synthetic peptide

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	9
Neoplasms	2
Nervous System Diseases	2
Infectious Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	16
Synthetic peptide	2
Recombinant polypeptide	1

Top 5 Target	Count

DDX53(DEAD-box helicase 53)	1
COX(Cyclooxygenases)	1
GnRHR(Gonadotropin-releasing hormone receptor)	1
AT1R x HMG-CoA reductase x VDCCs	1
AT1R x VDCCs	1

Drugs associated with Daewon Pharmaceutical Co., Ltd.

Dimenhydrinate/Pyridoxine Hydrochloride

Target

H1 receptor

Mechanism

H1 receptor antagonists

Active Org.

Daewon Pharmaceutical Co., Ltd.

Originator Org.

Daewon Pharmaceutical Co., Ltd.

Active Indication

Motion Sickness

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date25 Jul 2024

Olmesartan Medoxomil/Amlodipine Maleate

Target

AT1R x VDCCs

Mechanism

AT1R antagonists [+1]

Active Org.

Daewon Pharmaceutical Co., Ltd.

Originator Org.

Daewon Pharmaceutical Co., Ltd.

Active Indication

Hypertension

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date01 Dec 2014

Eperisone Hydrochloride

Target

VDCCs

Mechanism

VDCCs blockers

Active Org.

Tsuruhara Pharmaceutical Co. Ltd.

Originator Org.-

Active Indication

Muscle Hypertonia [+2]

Inactive Indication

Acute low back pain [+3]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date16 May 2014

Clinical Trials associated with Daewon Pharmaceutical Co., Ltd.

NCT05365425 / RecruitingPhase 4IIT

Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia

This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.

Start Date01 Jun 2023

Sponsor / Collaborator

Seoul National University Bundang Hospital

[+1]

CTR20230036 / Active, not recruitingPhase 1

培比洛芬缓释片在中国健康受试者中药代动力学临床试验研究

[Translation] Clinical trial study on the pharmacokinetics of pebiprofen sustained-release tablets in Chinese healthy subjects

（1）评价单次给药和多次给药的安全性；（2）考察单次给药和多次给药的药代动力学特征。

[Translation]

(1) Evaluate the safety of single and multiple administrations; (2) Investigate the pharmacokinetic characteristics of single and multiple administrations.

Start Date30 Jan 2023

Sponsor / Collaborator

Daewon Pharmaceutical Co., Ltd.

[+1]

NCT05970679 / CompletedPhase 3

A Randomized, Double Blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient With Primary Hypercholesterolemia or Mixed Dyslipidemia

A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia

Start Date17 Aug 2022

Sponsor / Collaborator

Daewon Pharmaceutical Co., Ltd.

100 Clinical Results associated with Daewon Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Daewon Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Daewon Pharmaceutical Co., Ltd.

01 Jan 2024·Translational and Clinical Pharmacology

Comparison of the pharmacokinetic characteristics and bioequivalence between two nanosuspension formulations of megestrol acetate in healthy Korean male subjects

Article

Author: Park, Se Rin ; Choi, Bong-Hoi ; Park, Min Kyu ; Choi, Young-Sim ; Min, Hyo Jin ; Kim, Hye Yun ; Hwang, Jun Gi ; Jeong, Sae Im

Megestrol is commonly used to address appetite loss, cachexia, and significant weight loss in cancer or acquired immune deficiency syndrome patients. This study aimed to assess the pharmacokinetics and determine the bioequivalence of two orally administered megestrol acetate suspensions (625 mg/5 mL) in healthy Korean male subjects. A randomized, open-label, single-dose crossover study was conducted involving fifty-four healthy male subjects who were randomized into two sequence groups. Each subject received either a test or reference drug formulation of 625 mg/5 mL megestrol acetate with a two-week washout period between treatments. Plasma samples were collected before and up to 120 hours after administration, and their plasma drug concentrations were analyzed using validated liquid chromatography-mass spectrometry/mass spectrometry. The pharmacokinetic parameters were calculated, and bioequivalence was confirmed if the 90% confidence intervals of the geometric mean ratios were within the specified bounds of 80.00% to 125.00%. In total, fifty-two subjects completed the study, contributing to the pharmacokinetic analysis. The 90% confidence intervals for the geometric mean ratios of the test formulation compared to the reference formulation were 93.85% to 108.90% for maximum plasma concentration and 91.60% to 101.78% for area under the concentration-time curve from the point of administration to last time point of blood sampling. Throughout the study, no serious or unexpected adverse events were observed. The pharmacokinetic profiles of both formulations of megestrol acetate (625 mg) were comparable and well tolerated in healthy Korean male adult subjects. The test formulation met regulatory criteria for bioequivalence.Trial RegistrationClinicalTrials.gov Identifier: NCT06147908.

19 Apr 2023·Pharmaceutics

Pharmacokinetic and Pharmacodynamic Characteristics of Pelubiprofen Tromethamine vs. Pelubiprofen in Healthy Subjects

Article

Author: Park, Hyeon-Jeong ; Hwang, Jun-Gi ; Kim, Ha-Yeon ; Jang, Ye-Lim ; Kim, Yu-Kyong ; Seo, Ji-Hyung ; Son, Yu-Jeong ; Choi, Young-Sim ; Park, Min-Kyu

Compared to pelubiprofen, a cyclooxygenase-2-selective inhibitor, pelubiprofen tromethamine has been reported to exhibit improved solubility and absorption.Pelubiprofen tromethamine combines the anti-inflammatory effect of pelubiprofen with the gastric protective function of tromethamine salt, making it a relatively safe class of non-steroidal anti-inflammatory drugs with low levels of gastrointestinal side effects in addition to its original analgesic, anti-inflammatory, and antipyretic effects.This study assessed the pharmacokinetic and pharmacodynamic characteristics of pelubiprofen and pelubiprofen tromethamine in healthy subjects.Two independent clin. trials were performed in healthy subjects using a randomized, open-label, oral, single-dose, two-sequence, four-period, crossover design.In Study I and Study II, subjects received 25 mg of pelubiprofen tromethamine and 30 mg of pelubiprofen tromethamine, resp., with 30 mg of pelubiprofen being the referenceStudy I fell within the bioequivalence study criteria.A trend of increased absorption and exposure for 30 mg of pelubiprofen tromethamine vs. the reference in Study II was observedThe maximum cyclooxygenase-2 inhibitory effect of 25 mg of pelubiprofen tromethamine was approx. 98% compared to the reference, showing no significant pharmacodynamic variation.It is thus predicted that 25 mg of pelubiprofen tromethamine would show no clin. significant discrepancies in clin. analgesic and antipyretic effects from 30 mg of pelubiprofen.

04 Apr 2023·Cancer Research

Abstract 1582: Inhibition of autophagy by CAGE targeting peptide retard tumor growth in non-small cell lung cancer of EGFR TKI resistance

Author: Koh, Jaemoon ; Lee, Mi-Ran ; Kang, Jin Hyoung ; Il, Kim Joo ; Jeon, Doyong ; Jeoung, Dooil ; Shin, Jung-Young ; Lee, Hankyu ; Baek, Seung Ryel ; Kim, Min-Young

AbstractEpidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) is the standard of care as 1st-line treatment for NSCLC patients with activating EGFR mutations (exon 19 deletion or L858R mutation). However, EGFR-TKI therapy eventually leads to acquired drug resistance approximately 1-2 years from the beginning of treatment. Multiple acquired resistance mechanisms including on-target EGFR mutations, phenotype transformation, and activation of bypass signaling molecules have been identified, but over 35% still remains unknown. CAGE, a cancer/testis antigen, was originally isolated from the sera of patients with gastric cancer and is known to regulate the autophagic flux in acquired resistance to EGFR TKI in NSCLC. Herein, the expression of CAGE was found in more than 50% of NSCLC patients using immunohistochemistry (IHC). Interestingly, the expression level was increased especially for the patients acquiring resistance to EGFR-TKIs. In addition, both PC-9/ER (Erlotinib-resistance cells) and H1975/OR (Osimertinib-resistant cells) cells demonstrated increased CAGE expression and autophagic flux, when compared with their parental cells. Thus, we developed the peptide drugs targeting the DEAD box domain of CAGE. This novel peptide effectively inhibited tumor cell proliferation in EGFR-TKI resistant cell line. Moreover, in Erlotinib-resistant patient-derived xenograft (PDX) mice, the peptide drug retarded tumor growth and enhanced anti-tumor efficacy. Collectively, our data suggest that CAGE plays a crucial role in the tumor progression and acquired resistance of EGFR TKI by the modulation of autophagic flux. Furthermore, we provided evidence that the inhibition of autophagy through CAGE- derived peptide could overcome the acquired resistance to EGFR TKIs in advanced/metastatic NSCLC patients.Citation Format: Jung-Young Shin, Min-Young Kim, Mi-Ran Lee, Hankyu Lee, Doyong Jeon, Seung Ryel Baek, Kim Joo Il, Jaemoon Koh, Dooil Jeoung, Jin Hyoung Kang. Inhibition of autophagy by CAGE targeting peptide retard tumor growth in non-small cell lung cancer of EGFR TKI resistance [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1582.

News (Medical) associated with Daewon Pharmaceutical Co., Ltd.

08 Apr 2024

·www.koreabiomed.com

Daewon Pharm applies for trial of patch-type obesity treatment

Daewon Pharmaceutical has taken the first step toward conducting clinical trials to develop a semaglutide-based obesity treatment as a patch. Daewon Pharm and Raphas said Tuesday they had completed the investigational new drug application for a phase 1 clinical trial of DW-1022, a microneedle patch obesity treatment candidate jointly developed by the two companies. Daewon and Raphas have been researching to develop Novo Nordisk's Wegoby (semaglutide) injection into a microneedle patch. The joint development was selected as a key technology development project for the bio-industry by the Ministry of Trade, Industry, and Energy in 2020. The two companies also completed the registration of a joint patent for a microneedle patch with synthetic semaglutide last month. Daewon has been developing raw materials equivalent to new drugs by converting genetically recombinant semaglutide into synthetic peptides and conducting nonclinical studies of finished drugs. Raphas has been developing formulations of finished drugs for microneedle patches. Based on the research, Daewon will lead the phase 1 trial. Semaglutide was developed to increase insulin secretion in diabetic patients and approved by the U.S. Food and Drug Administration as a treatment for diabetes in 2017 and as a treatment for obesity in 2021. However, existing self-injectable drugs have the disadvantage of causing pain and secondary infections, resulting in high patient burden and medical waste. Daewon expects DW-1022 to be a patch that can be easily applied, eliminating the hassle of direct injection for patients. Utilizing fine needles of 1mm or less is also expected to have an excellent delivery rate in the body and fewer skin side effects.“ For chronic diseases that must be managed for a long time, such as diabetes and obesity, the convenience of taking medication is an important factor,” a Daewon official said. “We expect this to be an innovative treatment that will greatly increase absorption and convenience compared to existing injections."

100 Deals associated with Daewon Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Daewon Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 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

Discovery

Preclinical

IND Application

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Pelubiprofen ( COX )	Back Pain More	Approved
Spherical adsorptive carbon(Daewon Pharmaceutical Co., Ltd.)	Chronic Kidney Diseases More	Approved
Dimenhydrinate/Pyridoxine Hydrochloride ( H1 receptor )	Motion Sickness More	Approved
Olmesartan Medoxomil/Amlodipine Maleate ( AT1R x VDCCs )	Hypertension More	Approved
DW-1804	Metabolic Diseases More	NDA/BLA

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