Top 5 Target	Count

LpxC(UDP-3-O-acyl-N-acetylglucosamine deacetylase)	2
CLDN18.2(Claudin 18.2)	2
DPP-4(Dipeptidyl peptidase IV)	2
SHP1(protein tyrosine phosphatase non-receptor type 6)	2
TCR(T-cell receptor)	1

Drugs associated with Dong-A ST Co., Ltd.

Evogliptin Tartrate/Metformin Hydrochloride

Target

DPP-4 x PRKAB1

Mechanism

DPP-4 inhibitors [+1]

Active Org.

Dong-A Pharmaceutical Co., Ltd. [+1]

Originator Org.

Dong-A Pharmaceutical Co., Ltd.

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date31 Dec 2015

Evogliptin

Target

DPP-4

Mechanism

DPP-4 inhibitors

Active Org.

Alkem Laboratories Ltd. [+3]

Originator Org.

Dong-A Pharmaceutical Co., Ltd.

Active Indication

Diabetes Mellitus, Type 2 [+2]

Inactive Indication

Bicuspid Aortic Valve Disease [+3]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date02 Oct 2015

Evogliptin Tartrate

Target

DPP-4

Mechanism

DPP-4 inhibitors

Active Org.

Shandong Luye Pharmaceutical Co., Ltd. [+1]

Originator Org.

Dong-A Pharmaceutical Co., Ltd.

Active Indication

Diabetes Mellitus

Inactive Indication

Diabetes Mellitus, Type 2

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date02 Oct 2015

149

Clinical Trials associated with Dong-A ST Co., Ltd.

NCT06627322 / Not yet recruitingNot ApplicableIIT

Registry Based Randomized Controlled Trial of Multiple Combination Strategies of Intensive Glycemic Control to Reduce a Composite of Macrovascular and Microvascular Events in Type 2 Diabetes with Cardiovascular Risk Factors (REMATCH Study)

Glycemic control is a mainstay of diabetes management to reduce the risk of microvascular complications and cardiovascular outcomes in people with type 2 diabetes (T2D). However, intensive control to near-normal glycated hemoglobin (HbA1c) yielded complex results in previous landmark trials. Potential risks of intensive glycemic control, such as hypoglycemia and weight gain, may partly contributed to the possible harms associated with this approach. Recent advances in diabetes management with development of newer antidiabetic drugs which minimize possible harms of intensive glycemic control as well as reduce cardiorenal risks enabled safer glycemic reduction. Thus, this randomized trial aims to evaluate the effects of near normalization of HbA1c with novel approaches on microvascular complications and cardiovascular outcomes in people with T2D.

Start Date21 Oct 2024

Sponsor / Collaborator

Yeungnam University

[+6]

NCT06616883 / Not yet recruitingPhase 1

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Study to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Single Administration of DA-5221_01 and Concomitant Administration of DA-5221_01-R1 and DA-5221_01-R2 Under Fasting Conditions in Healthy Adult Volunteers

Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

Start Date30 Sep 2024

Sponsor / Collaborator

Dong-A ST Co., Ltd.

NCT06590714 / RecruitingNot ApplicableIIT

Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.

1. **One day (±1 day) before surgery:** The investigator or designated study staff will thoroughly explain the clinical trial process to the participant and their guardian (representative) based on the informed consent form and provide the form so that all participants and their guardians have sufficient time to read, discuss, and decide. Participants who agree to participate in the clinical trial will voluntarily sign the written consent form and receive a copy of the signed consent form before any study-related procedures are conducted. The clinical trial site will assign a screening number to patients who voluntarily provide consent and undergo screening. The screening number can be assigned in the order in which the participants sign the consent within the study site. After confirming eligibility based on inclusion/exclusion criteria, randomization will be performed to assign participants to either the treatment group or the control group (with a 1:1 ratio). If assigned to the treatment group, participants will receive 'Polacoxib (preventive Acelex cap 2mg) once daily, NSAIDs-excluded non-opioid/opioid analgesics - PRN use.' If assigned to the control group, participants will receive NSAIDs-excluded non-opioid or opioid analgesics. Data will be collected by comparing the two groups in a double-arm setup. Pain scores, UCLA/ASES scores, and joint range of motion will be collected, and this data will be valid up to 3 months before the surgery. (For patients taking NSAIDs or Ultracet, the dose will be maintained until v5.)
2. **Two hours before surgery:** Administration of medication begins.
3. **Three days after surgery:** Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (post-surgery). Non-opioid or opioid analgesics (e.g., Fentanyl injection or Ultracet) will be used to manage post-surgical pain, and the number of doses will be collected to assess the participant's pain.
4. **Two weeks after surgery:** An outpatient visit will be conducted one week after discharge. Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses at the two-week mark.
5. **Six weeks after surgery:** Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses.
6. **Three months after surgery:** MRI will be performed to check for re-tears (optional for participants). This visit will be the study's completion visit, during which pain scores, UCLA/ASES scores, joint range of motion, and cumulative doses of NSAIDs-excluded non-opioid or opioid analgesics will be collected. If adverse events occurring during the treatment period have resolved before this completion visit, no additional safety follow-up will be performed, and this visit will be considered the end of the clinical trial. If adverse events have not resolved by the completion visit, follow-up will continue until the adverse events have either returned to pre-study or baseline levels, or the principal investigator or designee determines that the adverse events have stabilized, or no further follow-up is deemed necessary. This follow-up will mark the completion of the clinical trial.

Start Date23 Aug 2024

Sponsor / Collaborator

Eulji University

[+2]

100 Clinical Results associated with Dong-A ST Co., Ltd.

0 Patents (Medical) associated with Dong-A ST Co., Ltd.

Literatures (Medical) associated with Dong-A ST Co., Ltd.

01 Dec 2023·Molecular Cancer Therapeutics

Abstract C075: A first-in-class and highly selective SHP1 allosteric inhibitor exhibits robust anti-tumor immunity and synergizes with PD-1 blockade

Author: Lee, Song Yi ; Hwang, Joon Yonug ; Kim, Kyu Hwan ; Seong, Dae Hyeon ; Ryu, Ki Moon ; Jang, Mi Yeon ; Lee, Dae Young ; Yang, SeungMin ; Kim, Dajeong ; Han, Hong Sik ; Kim, Jun Gyu ; Cho, Jongho ; Doh, Hyounmie ; Shin, Jeong Yoon ; Han, Tae-Dong ; Ryu, Chae Lim ; Jang, Ik-Soo

AbstractBackground: SHP1 is a member of the src homology 2 (SH2) domain-containing protein phosphatases. It contains two SH2 domains at the N-terminus, a catalytic domain and a C-terminal tail. SHP1 is primarily expressed in hematopoietic cells and commonly recognized as a negative regulator of multiple signaling pathways. It has been known that SHP1 interacts with proteins of the inhibitory-receptor superfamily containing immunoreceptor tyrosine-based inhibitory motifs.Methods: To screen for SHP1 allosteric inhibitors, we employed a DiFMUP high-throughput biochemical assay system. Compounds that only perturbed the activity of SHP1 was further optimized for cellular activity on target, in vitro ADME, and in vivo pharmacokinetic properties. X-ray crystallography has been introduced to determine the interaction between the inhibitor and the allosteric site of SHP1. We also evaluated the lead series in in-vitro studies with human primary immune cells and in-vivo efficacy studies in syngeneic mouse models.Results: We discovered a series of SHP1 allosteric inhibitors with IC50 values at the nanomolar level and high selectivity over the other PTP enzymes, including SHP2. Structurally, SHP1 adopts an autoinhibited conformation in its basal state, where the N-SH2 domain interacts with the PTP domain and blocks access to the catalytic site. X-ray crystallography reveals that our SHP1 inhibitors are bound to non-catalytic sites of the SHP1 inactive conformation. Among the compounds, SB6299 demonstrated potent cytokine responses in various human primary immune cell types. SB6299 significantly enhanced IL-2, IFN-γ, and TNF-α productions in human primary pan-T, NK, and monocyte cells, respectively. The cytokine release was confirmed as a result of selective SHP1 inhibition through the evaluation of SHP1 knockout in primary immune cells. Moreover, SB6299 showed dose responses in costimulatory molecules and cytokines (TNF-α and IL6) in human monocyte derived dendritic cells (DCs) and enhanced DC maturation markers such as CD80, CD86, and CD40. The anti-tumor efficacy of SB6299 was evaluated in the CT26 and MC38 syngeneic mouse models. Orally administered SB6299 showed tumor growth inhibition as a single agent, and the efficacy was further enhanced when administered in combination with an anti-PD1 antibody.Conclusions: 1. Our studies successfully demonstrate that SHP1 can be allosterically inhibited, allowing selectivity with other phosphatases, including SHP2. 2. SB6299 is the first-in-class orally available, potent, and selective SHP1 allosteric inhibitor. 3. Attenuation of SHP1 activity by SB6299 could promote cytokine secretion and cytotoxic effects in human primary immune cells. 4. Orally administered SB6299 induced tumor growth inhibition as a single agent and in combination with an anti-PD1 antibody. 5. Currently, more selective and potent inhibitors are being tested.Citation Format: Jun Gyu Kim, Ki Moon Ryu, Mi Yeon Jang, Jongho Cho, Dajeong Kim, Dae Hyeon Seong, Kyu Hwan Kim, Ik-Soo Jang, Jeong Yoon Shin, Hong Sik Han, Joon Yonug Hwang, Dae Young Lee, Chae Lim Ryu, Song Yi Lee, Tae-Dong Han, SeungMin Yang, Hyounmie Doh. A first-in-class and highly selective SHP1 allosteric inhibitor exhibits robust anti-tumor immunity and synergizes with PD-1 blockade [abstract]. In: Proceedings of the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics; 2023 Oct 11-15; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2023;22(12 Suppl):Abstract nr C075.

01 Oct 2023·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

GPR119 activation by DA-1241 alleviates hepatic and systemic inflammation in MASH mice through inhibition of NFκB signaling.

Article

Author: Kim, Mi-Kyung ; Kim, Tae-Hyoung ; Yang, Eun-Kyoung ; Lee, Bo Ram ; Park, Hansu ; Goo, Moon Jung ; Chae, Yuna ; Lee, Seung-Ho ; Jung, Il-Hoon

BACKGROUND AND PURPOSEGPR119 activation has been suggested to improve hyperglycemia, dyslipidemia and hepatic steatosis. But its therapeutic potential for metabolic dysfunction-associated steatohepatitis (MASH) are underexplored. Here, we investigated the effects of DA-1241, a novel GPR119 agonist, on MASH and explored its underlying mechanism of anti-inflammatory effects.EXPERIMENTAL APPROACHThe in vivo anti-MASH effect was assessed by examining the preventive effect in MS-MASH and Ob-MASH mice and the therapeutic effect in MASH with severe hyperglycemia and diet-induced obese (DIO)-MASH mice. Histological and biochemical changes in liver tissue were assessed. Both plasma and hepatic biomarkers related to inflammation and fibrosis were comprehensively analyzed. To understand its mode of action, changes in NFκB signaling were determined in HepG2 and THP-1 cells.KEY RESULTSDA-1241 attenuated MASH progression and alleviated the MASH phenotypes in MASH mouse models with different etiologies, regardless of glucose-lowering activity. In DIO-MASH mice, DA-1241 significantly reduced biochemical parameters related to steatosis, inflammation and fibrosis in the liver with reduced plasma liver enzymes. When used in combination with a dipeptidyl peptidase 4 (DPP4) inhibitor, DA-1241 further improved the MASH phenotype by increasing endogenous glucagon-like peptide-1 effect. Notably, DA-1241 alone and in combination reduced liver inflammation and restored inflammation-related hepatic gene expression, leading to remission of systemic inflammation as assessed by plasma inflammatory cytokines and chemokines. We demonstrated that DA-1241 reduces macrophage differentiation through downregulation of NFκB signaling by activating GPR119.CONCLUSIONOur data suggest the therapeutic potential of DA-1241, alone and in combination with a DPP4 inhibitor, for MASH.

04 May 2023·Xenobiotica

Pharmacokinetics of the novel 5-HT ₄ receptor agonist, DA-6886, in dogs

Article

Author: Kang, Hee Eun ; Lee, Dae Young

The pharmacokinetics of a new 5-hydroxytryptamine receptor 4 agonist, DA-6886, intended for the treatment of constipation-predominant irritable bowel syndrome, were evaluated in beagle dogs following both intravenous and oral administration of DA-6886 (1-10 mg/kg). The study also examined the effects of gender and food on the pharmacokinetics of DA-6886 in dogs.DA-6886 demonstrated dose-proportional area under the plasma concentration-time curve (AUC) values and dose-independent clearance (21.0-24.6 mL/min/kg) after administration via both routes. The steady-state volume of distribution (V_ss) for DA-6886 was dose-independent and relatively large (6.76-8.57 L/kg), aligning with its observed high distribution in rat tissues.No significant differences were observed in the pharmacokinetics of DA-6886 between male and female dogs. Post oral administration, extent of absolute oral bioavailability (BA) was relatively high (48.2-96.1%) in contrast to the rates observed in rats (18.9-55.0%).Dogs that were fed exhibited a significantly lower C_max and a delayed T_max in comparison to those that were fasted. However, the AUC values were similar between the two groups. The extended stomach transit time in the fed state may account for this delayed absorption of DA-6886 without substantial changes in AUC.

News (Medical) associated with Dong-A ST Co., Ltd.

12 Oct 2024

·pipelinereview.com

US FDA Approves Dong-A ST’s IMULDOSA™ (ustekinumab-srlf), a Biosimilar to STELARA®

Dong-A ST’s biologics license application (BLA) for Imuldosa, submitted in October 2023, is approved by the U.S. Food and Drug Administration SEOUL, South Korea I October 11, 2024 I Dong-A ST (President/CEO Jae-Hun Jung, KRX: 170900) announced on October 11 that Imuldosa™ (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara®, has won U.S. Food and Drug Administration (FDA) approval. As its second FDA-approved biosimilar after Sivextro® (tedizolid phosphate) in 2014, the company has once again demonstrated its R&D competence. The news comes following the FDA acceptance of the biologics license application (BLA) submitted by Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, in October 2023. Imuldosa is a biosimilar to Stelara, a blockbuster drug developed by Janssen Biotech Inc. for the treatment of patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. It is one of the highest-grossing biopharmaceuticals generating US$10.86 billion globally (IQVIA Accumulative Sales in 2023). Dong-A Socio Holdings and Meiji Seika Pharma began joint development for Imuldosa in 2013, and the rights for R&D and commercialization were transferred from Dong-A Socio Holdings to Dong-A ST in July 2020 for efficient project management. In July 2021, Dong-A ST and Meiji Seika Pharma signed a global license agreement with Intas Pharmaceuticals, who is set to commercialize the biosimilar with its global subsidiaries including Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada. Accord Healthcare has also submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) in June 2023, which was accepted in the following month of July 2023. Dr. Jae-Hong Park, the Head of R&D at Dong-A ST commented, “This FDA approval indicates global recognition of Dong-A ST’s R&D excellence and global competitiveness. We look forward to a successful launch of Imuldosa in the U.S., the world’s largest pharmaceutical market, as we continue to develop innovative medicines to further strengthen our global presence.” SOURCE: Dong-A ST

Drug ApprovalLicense out/in

11 Oct 2024

·www.pharmaceutical-technology.com

South Korean company Dong-A ST wins FDA approval for Stelara biosimilar

Stelara is indicated for use in patients with active psoriatic arthritis as well as moderate to severe Crohn’s disease, plaque psoriasis, and active ulcerative colitis. Credits: Tada Images/Shutterstock.com South Korea-based Dong-A ST has received a US Food and Drug Administration (FDA) approval for Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar that references Johnson & Johnson ’s (J&J) blockbuster therapy Stelara (ustekinumab). As per an 11 October press announcement, the company will launch Imuldosa in the US. However, it did not specify the product’s launch date. While Stelara’s composition of matter patent expired in September 2023, none of the approved biosimilars have been launched yet, and Imuldosa will face an increasingly crowded biosimilar market when it can be made available. The list of already approved biosimilars includes Amgen ’s interchangeable biosimilar Wezlana (ustekinumab-auub), which became the first approved Stelara biosimilar when it gained FDA approval in November 2023. However, Amgen’s copycat therapy will not enter the market until 1 January 2025 after settling a patent lawsuit with J&J. Similarly, Samsung Bioepis’s Pyzchiva (ustekinumab-ttwe), another interchangeable biosimilar, which gained approval in July 2024, will not gain its “interchangeable” designation until the exclusivity period for Wezlana ends, and will be launched in February 2025. Additional approved biosimilars include Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) and Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz). The latter became the fourth approved biosimilar earlier this month and is expected to launch on the market a month after Wezlana. See Also: Activist investor Starboard cries foul play in exec U-turn at Pfizer Activist investor Starboard forges $1bn stake in Pfizer to swing profits In accordance with the 2023 patent expiry, which tends to weaken sales of a brand name product, GlobalData’s consensus forecasts project a steady drop in the total sales of Stelara starting in 2024. While Stelara generated $10.9bn in sales in 2023 in a market without any biosimilars, the forecast predicts Stelara’s revenue to slip to $10bn in 2024, $7.1bn in 2025, and $5.2bn in 2026. GlobalData is the parent company of Pharmaceutical Technology. Stelara is a human IgG1 kappa monoclonal antibody designed to bind with high affinity and specificity to the IL-12 subunit beta used by the interleukin (IL)-12 and IL-23 cytokines, which are implicated to play a role in inflammation. Stelara is indicated for use in patients with active psoriatic arthritis as well as moderate to severe Crohn’s disease, plaque psoriasis, and active ulcerative colitis. Other Stelara biosimilars in development include Accord BioPharma’s DMB-3115, Celltrion ’s CT-P43, and Biocon ’s BMAB-1200. Earlier in February 2024, Rani Therapeutics announced positive topline data from its Phase I study (NCT05890118) of RT-111, a non-injectable Stelara biosimilar version that contains CT-P43.

Phase 1Drug ApprovalBreakthrough TherapyClinical Result

11 Oct 2024

·www.pharmaceutical-technology.com

CPHI Europe: Overcoming the unique challenges with high-concentration mAbs

Image credit: Shutterstock/aceshot1 There is an increasing number of high-concentration mAbs among approved therapeutics, with 76% of US Food and Drug Administration (FDA)-approved mAbs having high concentration formulations, says Antonio Pierno, senior manager, Scientific Laboratory Services of Cytiva. The manufacturing of monoclonal antibodies and the latest trends in this sector were discussed at length by Pierno at a talk during the CPHI Europe conference, which took place 8–10 October in Milan, Italy. In recent times, there has been an increasing number of subcutaneous therapeutics compared to intravenous therapeutics due to various benefits with the former, including the ability to self-administer, and reduced cost and time spent at care facilities. Subcutaneous delivery requires high-concentration therapeutics due to the lower volume of product being administered through an injection. High-concentration biologics have final concentrations of over 100g/L and some companies are targeting final product concentrations of 250g/L, Pierno highlighted. Pierno said there is a need for biosimilar reformulation, which is partially driving high-concentration therapeutic demand, he said. Some key high-concentration biologics include Novartis ’s interleukin (IL)-17A Cosentyx (secukinumab), Genentech and Novartis’s Xolair (omalizumab), and Sanofi / Regeneron Pharmaceuticals ’ IL-4/IL-13 antibody Dupixent (dupilumab). See Also: South Korean company Dong-A ST wins FDA approval for Stelara biosimilar FDA AdCom votes in favour of Stealth’s Barth syndrome drug Most challenges in high concentration therapeutic manufacturing stem from sterile filtration and tangential flow filtration (TFF) according to Pierno, which may lead to increased viscosity, longer processing times, and aggregate formation. This in turn leads to high costs per unit volume and lower processing times. In order to combat this, Pierno says it is important to focus on the optimisation of TFF parameters, and the development of new cassettes to improve recovery procedures. The importance of selecting the right membrane for high-concentration mAbs was highlighted throughout Pierno’s talk. The first essential step for suitable membrane development is to understand the characteristics of high-concentration mAbs, such as their viscosity and flux and perform preliminary studies to determine them, he said. To directly address the challenges of high-concentration mAb filtration, the goal is “to develop a new sterile filter with high throughput for high-concentration mAbs”. There is a need to maximise membrane area and improve the filtration process while maintaining quality and simultaneously reducing costs, he said.

Drug Approval

100 Deals associated with Dong-A ST Co., Ltd.

100 Translational Medicine associated with Dong-A ST Co., Ltd.

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Pipeline

Pipeline Snapshot as of 20 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

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Efinaconazole ( fungal CYP51A1 )	Onychomycosis More	Approved
Evogliptin Tartrate ( DPP-4 )	Diabetes Mellitus More	Approved
Somatropin biosimilar (Dong-A ST Co., Ltd.) ( GHR )	Idiopathic short stature More	Approved
Udenafil ( PDE5A )	Erectile Dysfunction More	Approved
Sivelestat Sodium Hydrate ( ELA2 )	Acute Lung Injury More	Approved

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