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• OUT-LICENSING PIPELINES

  NCE

  • Evogliptin (Type 2 diabetes [Suganon®])
  • DA-8010 (Overactive bladder)
  • DA-1241 (Type 2 diabetes, NASH)
  • DA-5207 (Alzheimer’s disease)
  • DA-7310 (Gram-negative infection)
  • DA-4210 (Sarcopenia)
  • DA-1726 (Obesity)

  Botanical Drug

  • DA-9805 (Parkinson disease)

  BIOPHARMACEUTICAL

  • DA-3880 (Anemia due to Chronic Kidney Disease (CKD) / the effects of concomitant myelosuppressive chemotherapy)
  • DMB-3111 (Breast cancer)
  • DMB-3115 (Psoriasis, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis)
  • DMB-3116 (Cancers)

• OUT-LICENSING PARTNERSHIP

  • 2021

    • DMB-3115 (Ustekinumab [Stelara®] Biosimilar)

      In July of 2021, Dong-A ST and its strategic collaboration partner Meiji Seika Pharma signed an exclusive license agreement with Intas Pharmaceuticals Ltd. for commercialization of DMB-3115 worldwide, excluding Korea, Japan, and certain countries in Asia.

    • DA-7310 (Multidrug-resistant Gram(-) Antibiotic)

      In August of 2021, Dong-A ST signed an exclusive license agreement with Yangtze River Pharmaceutical Group for Mainland China, Hong Kong and Macau.

  • 2020

    • Evogliptin (DPP-IV inhibitor)

      In March of 2020, Evogliptin was launched in Russia by Geropharm under the name of Evodin.

  • 2019

    • Evogliptin (DPP-IV inhibitor)

      In April of 2019, Evogliptin was launched in India by Alkem Laboratories under the name of Valera.

    • DA-3880 (Darbepoetin alfa)

      In November of 2019, a biosimilar of Darbepoetin alfa was launched in Japan by Sanwa Kagaku Kenkyusho Co., Ltd.

  • 2018

    • DA-9801 (Botanical drug)

      Dong-A ST 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 ST 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 ST 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 ST 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 signed a license agreement with Sanwa Kagaku Kenkyusho Co., Ltd. (SKK) of Japan.

    Evogliptin (DPP-IV inhibitor)

    Dong-A ST 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 ST signed a license agreement with an Indian company, Alkem Laboratories, for the territory of India and Nepal in late 2012.

  • 2011

    • Biosimilar

      Dong-A ST 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 ST 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)	Indication	Description	Development Stage	Licensing Availability
  New Chemical Entity
  DA-1229 (Suganon®/ Sugamet® XR)	Type 2 diabetes	DPP(Dipeptidyl Peptidase)-4 inhibitor	Launched (Korea, India, Russia) Registered (Brazil and some Latin American countries)	Available for some territories
  	Calcific Aortic Valve Disease	DPP(Dipeptidyl Peptidase)-4 inhibitor	Ph II (Korea) Ph II/III (USA)	Not available
  DA-8010	Overactive bladder	M3 receptor antagonist	Ph I completed (EU) Ph Ⅱ completed (Korea) Ph III (Korea)	Available
  DA-1241	Type 2 diabetes, NASH	GPR119 agonist	Ph Ia completed (USA) Ph Ib completed (USA)	Available
  DA-5207	Alzheimer’s disease	Donepezil transdermal patch	Ph Ia completed (Korea) Ph Ib (Korea) Ph Ia (India)	Available
  DA-7310	Gram-negative Infections	LpxC inhibitor	Preclinical (Korea)	Available except China
  DA-4210	Sarcopenia	Selective Androgen Receptor Modulator	Preclinical (Korea)	Available
  DA-1726	Obesity	Oxyntomodulin Analogue	Preclinical (Global)	Available
  Phytomedicine
  DA-9801	Diabetic neuropathy	Botanical (Herbal extract)	Ph II completed (USA)	Not available
  DA-9805	Parkinson's disease	Botanical (Herbal extract)	Ph IIa completed (USA)	Available
  Biopharmaceutical Products
  DA-3880	Anemia due to Chronic Kidney Disease (CKD) / the effects of concomitant myelosuppressive chemotherapy	Darbepoetin α Biosimilar	Ph I completed (EU) Launched (Japan)	Available for some territories
  DMB-3111	Breast Cancer	Trastuzumab Biosimilar	Ph I completed (Japan)	Available except Japan
  DMB-3115	Psoriasis, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis	Ustekinumab biosimilar	Ph I completed (EU) Ph III (Global)	Available for some territories

• 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. Evogliptin was successfully launched in India and Russia by our partners, Alkem and Geropharm in April of 2019 and March of 2020, respectively.
  
  In addition to diabetes, Dong-A ST signed a licensing-out agreement with REDNVIA in 2019 to develop Evogliptin for a treatment for Calcific aortic valve disease (CAVD). REDNVIA initiated phase 2 clinical trial in Korea in June 2019 and is currently in progress. For the US, an IND for phase 2/3 clinical trial was approved in September 2020.

  [DA-8010; M3 receptor antagonist]

  DA-8010 is a highly potent and selective Muscarinic M3 receptor antagonist with the best-in-class potential for the treatment of overactive bladder (OAB). There remains significantly unmet need in the current OAB market due to the frequent and intolerable side effects (e.g., dry mouth, constipation, etc) of the currently available therapeutic options. DA-8010 was highly selective for the urinary bladder compared to the salivary gland, gut, heart, and brain, indicating a decreased potential for dry mouth, constipation, cardiovascular and central nervous system adverse effects. DA-8010 has undergone safety, tolerability and PK studies in healthy subjects in UK, and successfully completed the Ph 2 study in OAB patients in Korea by significantly reducing the number of micturitions compared to placebo. Now the Ph 3 study is ongoing in Korea.

  [DA-1241; GPR119 agonist]

  DA-1241 is a novel small molecule of GPR119 agonist for type 2 diabetes and/or NASH. 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. In the animal models, DA-1241 showed potential for NASH treatment. A phase 1a clinical trial was completed in healthy subjects in the US and showed the feasibility for once-daily dosing of DA-1241. Phase 1b clinical trial in healthy subjects and type 2 diabetes patients was completed in the US, proving glucose lowering efficacy outperformed to placebo and similar to that of sitagliptin.

  [DA-5207; Donepezil transdermal patch]

  DA-5207 is a donepezil weekly patch being developed by Dong-A ST for the treatment of Alzheimer’s disease (AD). DA-5207 has excellent stability with minimum impurities. DA-5207 enhancer showed superior skin permeability and donepezil was permeated through human skin over a period of 7-day in vitro Franz cell. After applications of DA-5207 in hairless rats and rabbit, PK profiles were observed in a dose-dependent manner. Donepezil was continuously long-time released from DA-5207 for 7 days compared to oral treatment in hairless rats and rabbits. There was no dermal irritation (erythema/edema) in vivo mini-pig during the patch application. Inhibition of AChE activity was plasma concentration dependent and data showed excellent PK/PD correlation. DA-5207 is generally safe and well tolerated. Phase 1a study to assess safety, tolerability and PK of DA-5207 in healthy subjects was completed in Korea (NCT04013477). Currently, it is in pilot BE study with healthy subjects in Korea. Phase 1a study in India is also planned.

  [DA-7310; LpxC inhibitor]

  DA-7310 is a novel LpxC inhibitor with an activity against Gram-negative pathogens including multidrug resistant strains. LpxC is a zinc-dependent deacetylase responsible for the biosynthesis of Lipid A, an essential component for Gram-negative bacteria, which is an attractive target with potential to provide a solution to the problem of dramatically growing antibiotic resistance. DA-7310 is developed as injection, and is currently in preclinical stage, and the safety evaluation was completed. In August of 2021, Dong-A ST signed an exclusive license agreement with Yangtze River Pharmaceutical Group for Mainland China, Hong Kong and Macau.

  [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.

  [DA-9805; Botanical drug]

  DA-9805 is a proprietary botanical drug consisting of three bioactive ingredients designed as an oral pill for the treatment of Parkinson’s Disease (PD). DA-9805 development approach is based on the combination of extensive expertise in botanical drug design and proprietary insights into the common driver of PD. DA-9805 is being developed as a potential disease-modifying treatment for PD. DA-9805 prevents dopaminergic neurodegeneration via multiple neuroprotective and anti-inflammatory effects. In preclinical studies, DA-9805 demonstrated anti-Parkinsonian efficacy with reduced neuronal loss and accumulated α-synuclein as well as improved behavior outcomes in PD animal models. No toxicity was observed in acute and sub-chronic GLP toxicity studies. Dong-A ST initiated a phase IIa study with PD patients from 2017 after gaining an IND approval from the US FDA, and completed it in 2019.

  [DA-3880; Darbepoetin alfa Biosimilar]

  DA-3880 is a biosimilar of darbepoetin alfa (Aranesp®, Nesp®). Dong-A ST performed phase 1 clinical trial in EU and confirmed PK bioequivalence and similarity of PD, safety and immunogenicity profile of DA-3880 to Aranesp®, the reference drug. Dong-A made a license agreement with Sanwa Kagaku Kenkyusho Co., Ltd. (SKK) for the territory of Japan. SKK has completed a phase 1 and phase 3 clinical trials in Japan compared with the reference drug (Nesp®). In November of 2019, a biosimilar of darbepoetin alfa (Nesp®) was successfully launched in Japan.

  [DA-1726; Oxyntomodulin (OXM) Analogue]

  DA-1726 is an Oxyntomodulin (OXM) analog currently under preclinical development to treat overweight obesity and type 2 diabetes. OXM is a GLP1R/GCGR dual agonist that reduces food intake and increases energy expenditure, and is expected to have superior weight loss benefits over selective GLP1R agonists. It is also expected to be developed as a potent and balanced dual agonist that can safely lose weight in obese patients better than small molecule drugs. Currently, preclinical studies are underway, including evaluation of pharmacology in animal models as a treatment for obesity.

  [DA-4210; novel oral selective androgen receptor modulator (SARM)]

  Sarcopenia is a progressive and generalized skeletal muscle disorder that is associated with increased likelihood of adverse outcomes including falls, fractures, physical disability and mortality. According to the change of perception of sarcopenia from a natural phenomenon to a novel target for drug intervention, a new ICD code was given to sarcopenia in 2016, but patients still depend on supplement or hormone replacement therapy as there is no approved drug yet. DA-4210 is a novel oral selective androgen receptor modulator (SARM) in preclinical stage which shows excellent efficacy on muscle mass/strength improvement and less androgen-related adverse events with high selectivity for muscle tissue compared to its competitors.

  [DMB-3115; Ustekinumab (Stelara®) Biosimilar]

  DMB-3115 is a proposed biosimilar to Stelara® (ustekinumab), a recombinant monoclonal antibody for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Dong-A ST has been developing DMB-3115 in collaboration with Meiji Seika Pharma, a strategic collaboration partner for biosimilar products, since 2013. Phase 1 clinical trial which was completed in 2021 demonstrated that DMB-3115 was bioequivalent to US- and EU-sourced Stelara® in terms of PK parameters and showed no significant difference in safety and immunogenicity from Stelara®. In July of 2021, Dong-A ST and Meiji Seika Pharma signed a license agreement with Intas Pharmaceuticals Ltd. for commercialization of DMB-3115 worldwide, excluding Korea, Japan, and certain Asian countries. Currently, global phase 3 clinical trial is ongoing.