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Dong-A ST

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HOME>Business Areas>License-out

License-out

  • OUT-LICENSING PIPELINES
    NCE
    • Evogliptin (Type II diabetes [Suganon®], NASH)
    • DA-6886 (IBS-c)
    • DA-8010 (Overactive bladder)
    • DA-1241 (Type 2 diabetes)
    Botanical Drug
    • DA-9801 (Diabetic neuropathy)
    • DA-9805 (Parkinson disease)
    BIOPHARMACEUTICAL
    • Gonadopin® (Infertility)
    • Dulastin® (Neutropenia)
    • DA-3880 (Anemia of CRF)
    • DMB-3111 (Breast cancer)
    • DA-3131 (Age-related macular degeneration)
    • DMB-3115 (Psoriasis)
  • OUT-LICENSING PARTNERSHIP
    • 2018
      • DA-9801 (Botanical drug)
        Dong-A signed a license agreement with a US-based company, NeuroBo Pharmaceuticals for the territory of worldwide in January, 2018.
      • DA-9803 (Botanical drug)
        Dong-A signed an agreement with a US-based company, NeuroBo Pharmaceuticals to assign and transfer the right of DA-9803 to NeuroBo Pharmaceuticals.
    • 2016
      DA-4501 (MerTK inhibitor, Immuno-Oncology)
      Dong-A signed a development and license agreement with AbbVie for the territory of worldwide (excluding Korea) in December of 2016.
    • 2015
      Sivextro® (Tedizolid, 2nd generation Oxazolidinone-class antibiotic)
      The MAA of Sivextro was approved by the EMA in March of 2015 and Sivextro was launched in the EU by global licensee, MSD, in the first half of 2015
      Evogliptin (DPP-IV inhibitor)
      Dong-A signed a license agreement with a Brazilian company, Eurofarma Laboratórios S.A, for the territory of 17 Latin American countries including Mexico in April of 2015.
      Dong-A signed a license agreement with a Russian company, Geropharm LLC for the territory of Russia, Ukraine and Kazakhstan in July of 2015
    • 2014
      Sivextro® (Tedizolid, 2nd generation Oxazolidinone-class antibiotic)
      In June of 2014, the NDA of Sivextro was approved by the US FDA for the indication of ABSSSI (Acute bacterial skin and skin structure infection) and immediately Sivextro was launched In the USA by global licensee, Cubist (now MSD).
      DA-3880 (Darbepoetin alfa)
      In January of 2014, Dong-A ST made a license agreement with Sanwa Kagaku Kenkyusho Co., Ltd. (SKK) of Japan.
      Evogliptin (DPP-IV inhibitor)
      Dong-A signed a license agreement with a Brazilian company, Eurofarma Laboratórios S.A, for the territory of Brazil in July of 2014.
    • 2012
      Evogliptin (DPP-IV inhibitor)
      Dong-A signed a license agreement with an Indian company, Alkem Laboratories, for the territory of India and Nepal in late 2012.
    • 2011
      • Biosimilar
        Dong-A signed an agreement with Meiji Seika for a long-term collaboration partnership on biosimilars including DMB-3111 (biosimilar of trastuzumab). Under this agreement, both companies collaborate on the research, development, manufacturing and sales of biosimilars and have exclusive rights in Korea and Japan, respectively, with a joint right for global market. Also, two companies began the construction of cGMP-compliant biopharmaceutical plant in Songdo using both companies’ capital in 2012 and the construction was completed in 2013.
    • 2007
      Sivextro® (Tedizolid, 2nd generation Oxazolidinone-class antibiotic)
      Dong-A signed a license agreement with a US-based company, Trius Therapeutics (now MSD), for the territory of worldwide except Korea.
  • R&D PIPELINE
    R&D PIPELINE Brand Details table
    Code Name
    (Brand name)
    Description Indication Development Stage Licensing
    Availability
    New Chemical Entity
    DA-7218
    (Sivextro®)
    Infection (ABSSSI, Acute Bacterial Skin and Skin Structure Infections) Oxazolidinone class antibiotic Launched
    (USA, EU)
    Unavailable
    Pneumonia(Hospital-Acquired/ Ventilator-Associated Bacterial Pneumonia) Ph 3 completed (Global)
    DA-1229
    (Suganon®/
    Sugamet® XR
    Type 2 diabetes DPP(Dipeptidyl Peptidase)-4 inhibitor Launched (Korea) Available for some territories
    DA-6886 Irritable Bowel Syndrome with constipation(IBS-C) 5-HT(hydroxytryptaamine) 4 agonist Ph 1 completed (Korea) Available
    DA-8010 Overactive bladder M3 receptor antagonist Ph 1 completed (EU)
    Ph 2 (Korea)
    Available
    DA-1241 Type 2 diabetes GPR119 agonist Ph 1a completed (USA)
    Ph1b (USA)
    Available
    Phytomedicine (Botanical Drug)
    DA-9801 Diabetic neuropathy Botanical drug Ph 2 completed
    (USA)
    Available
    DA-9805 Parkinson’s disease Botanical drug Ph 2 (USA) Available
    Biopharmaceutical Products
    DA-3880 Anemia Darbepoetin α Biosimilar Ph 1 completed (EU)
    NDA submitted (Japan)
    Available for some territories
    DMB-3111 Breast cancer Trastuzumab biosimilar Ph 1 completed (Japan) Available except Japan, EU, Russia, CIS and LatAm
    DA-3131 Age-related macular degeneration New anti-VEGF mAb Non-clinical completed (Korea) Available
    DA-3115 Psoriasis Ustekinumab biosimilar Non-clinical completed (UK) Available except Japan
    *Including pipelines of Dong-A Socio Holdings
  • KEY PIPELINE ITEMS
    [DA-1229; Evogliptin; Suganon®/Sugamet® XR]

    Evogliptin is an anti-diabetic compound of the Dipeptidyl Peptidase-4 (DPP-4) inhibitor class, with high selectivity for DPP-4. A phase I clinical trial of Evogliptin showed that a single administration of Evogliptin 5mg inhibited DPP-4 activity by more than 80%, and a repeated once daily dose of Evogliptin 5mg maintained the inhibition of DPP-4 for more than 24 hours. In the phase II clinical trial, it was confirmed that Evogliptin 5mg significantly decreased HbA1C levels compared to a placebo, In phase III studies, Evogliptin 5mg showed superiority over the placebo, and non-inferiority to Sitagliptin. In addition, Evogliptin does not need dose adjustment in patients with renal impairment and showed a renal protective effect in animal studies, which would be beneficial to diabetic patients with renal disease. In March of 2016, Evogliptin monotablet was launched under the brand name of Suganon® in Korea. The combination tablet with metformin (Sugamet® XR) was also marketed in May of 2016. For global markets, Evogliptin was licensed-out to Alkem Laboratories for India and Nepal in 2012, Eurofarma Laboratorios for Brazil in 2014 and 17 countries of Latin American including Mexico in 2015 and Geropharm for Russia, Ukraine and Kazakhstan in 2015. In April of 2019, Evoliptin was successfully launched by our Indian Partner, Alkem in India.

    [DA-9801; Botanical drug]

    DA-9801 is a botanical drug, mixture of Dioscorea Rhizome and Dioscoreae Nipponicae Rhizoma in tablet form for pain associated with diabetic neuropathy. Its main mechanism is considered to be the increase of NGF (Nerve Growth Factor) level to normal level which leads to nerve regeneration. DA-9801’s efficacy on pain reduction and nerve regeneration was confirmed in various nonclinical animal disease models. A 12-week phase II study in the US was successfully completed. DA-9801 300 mg and 600 mg groups showed a statistically significant reduction of more than 2 points in mean pain scores at week 12, in comparison with their respective baseline scores. Also, improvements of 50% or more were achieved in 46.9% of patients on 300 mg, 50% on 600 mg and 43.8% in 900mg respectively. As approved drugs for diabetic neuropathy are CNS drugs or anti-depressants, their side effects like dizziness and somnolence are demanding a new, safe treatment on the market. It is believed that DA-9801 will be a new treatment option for diabetic neuropathic pain with its comparable efficacy and favorable safety profile. In January 2018, Dong-A ST had signed a global license agreement with US-based NeuroBo Pharmaceuticals, which is preparing a phase 3 study in the US.

    [DA-3880; Darbepoetin alfa Biosimilar]

    DA-3880 is a biosimilar of darbepoetin alpha (Aranesp®, Nesp®). Dong-A ST confirmed a high similarity, bioequivalence and safety profile of DA-3880 with Aranesp® as the reference drug in EU. Dong-A made a license agreement with Sanwa Kagaku Kenkyusho Co., Ltd. (SKK) for the territory of Japan. SKK has completed a phase I and phase 3 clinical trial in Japan compared with the reference drug (Nesp®) and submitted an NDA to Japan PMDA in October 2018.

    [DA-1241; GPR119 agonist]

    DA-1241 is a novel small molecule of GPR119 agonist for type 2 diabetes. Preclinical studies were successfully completed and DA-1241 showed higher potency and efficacy than its competitors via in vitro and in vivo studies. In addition to the glucose-lowering efficacy of DA-1241, it also effectively inhibited postprandial increase of plasma lipid levels in mice, at the dose showing glucose lowering effect. Therefore, it is expected that DA-1241 can offer therapeutic benefit for the treatment of type 2 diabetic patients with dyslipidemia by controlling postprandial lipid as well as glucose levels, at similar dose range. Also, based on its PK profile in animals, it is expected that DA-1241 has a feasibility of once-daily dosing in human. A phase 1a clinical trial was completed in the US and showed the feasibility for once-daily dosing of DA-1241.Currenly, a Phase 1b clinical trial in healthy volunteers and T2DM patients is on-going in the US.

PRIVACY POLICY

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    The Company may share information provided by our visitors to en.donga-st.com with service providers we have retained to perform services on our behalf. These service providers are contractually restricted from using or disclosing the information except as necessary to perform services on our behalf or to comply with legal requirements. In addition, we may disclose information about you (i) if we are required to do so by law or legal process, (ii) to law enforcement authorities or other government officials, or (iii) when we believe disclosure is necessary or appropriate to prevent physical harm or financial loss or in connection with an investigation of suspected or actual illegal activity.

  4. Changes to this Privacy Policy

    The Company will review this policy in accordance with circumstances and revise it as needed. The revised Privacy Policy will be posted on this Web site. We will treat your personal information in accordance with the Privacy Policy in place at the time of collection of such information, or as you otherwise consent.

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PRIVACY POLICY

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Dong-A ST
64 Cheonhodaero, Dongdaemun-gu,
Seoul, Korea

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