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PHARMACEUTICAL

02 PHARMACEUTICAL PRODUCT LIST DONG-A ST DONG-A ST 03

Dong-A
Developed Growtropin®, a first-
generation biomedicine and
Established the
central research
Ranked 1st in sales
among domestic pharma-
Founded as a pharma-
ceutical and hygiene PRODUCT
PRODUCT A Novel DPP-4 Inhibitor
A Novel DPP-4 Inhibitor
Suganon® Tab.Suganon
/ Sugamet
Tab.
® ®
XR/ Sugamet® XR Tab.

LIST LIST
human growth hormone center ceutical companies material wholesaler

R&D 1997
1993 1977 1967 1932 Compositions Compositions
• Suganon® : Evogliptin 5mg• Suganon® : Evogliptin 5mg

History
Became the first in • Sugamet® XR (Evogliptin/Metformin)
• Sugamet®2.5mg/500mg,
XR (Evogliptin/Metformin) 2.5mg/500mg,
Korea to develop 2.5mg/850mg, 5mg/1000mg 2.5mg/850mg, 5mg/1000mg
a tuberculosis
Indications Indications
treatment, Closerin®
New New • Type 2 diabetes mellitus • Type 2 diabetes mellitus
Dosage & Administration Dosage & Administration
2002 2005
Released Stillen , Dong-A’s first
®
Released Zydena , Dong-A’s
® Chemical Chemical • QD • QD
in-house developed original drug
and a phytomedicine for gastritis
in-house developed original drug and
an erectile dysfunction treatment Entities Entities
A Novel PDE-5 Inhibitor
A Novel PDE-5 Inhibitor
2012 2011 2006 Zydena® Tab. Zydena® Tab.
Licensed out Monotaxel , ® Signed strategic alliance Released Gonadopin®,
an incrementally modified drug(IMD) with Meiji Seika Pharma a first-generation Compositions Compositions
for cancer, to Gloria Pharmaceutical, Co., Ltd. of Japan for the biomedicine and
• Udenafil 50mg, 75mg, 100mg,
• Udenafil
200mg 50mg, 75mg, 100mg, 200mg
of China for the Chinese market development of biosimilar infertility treatment
Indications Indications
• Erectile dysfunction • Erectile dysfunction
Dosage & Administration Dosage & Administration
2013 2014 • 100mg & 200mg : On demand
• 100mg & 200mg : On demand
• Established a Korea’s first • Licensed out DA-3880 (Darbepoetin-α), a long-acting bio- • 50mg & 75mg : QD • 50mg & 75mg : Once a day
dementia research center pharmaceutical drug stimulating erythropoiesis, to Sanwa
• Completed the construction of Kagaku Kenkyusho (SKK) of Japan for the Japanese market
a biopharmaceutical plant in • Obtained US FDA approval and launched Sivextro®
Songdo, Korea in conjunction (Tedizolid), an oxazolidinone class antibiotic, in the
with Meiji Seika Pharma US by Cubist (acquired by MSD)

A Novel Drug for Functional


A Novel Drug
Dyspepsia
for Functional Dyspepsia

2018
2016 2015 Motilitone® Tab.
Motilitone® Tab.
Novel Novel
®
Licensed out DA-4501, a MerTK Received Korean MFDS approval for Suganon
Completed the construction inhibitor, to Abbvie for the (Evogliptin) and Sugamet® XR (Evogliptin Compositions Compositions
of a biopharmaceutical
Phyto- Phyto-
worldwide territory except Korea in combination with metformin), in-house
production plant in Indonesia • Corydalis tuber & pharbitis•seed
Corydalis
ext. 30mg
tuber & pharbitis seed (5:1) 50% ethanol ext. 30mg
developed diabetes treatments
as part of a strategic alliance Indications Indications
with Combiphar.
medicines medicines • Functional dyspepsia • Functional dyspepsia

2019 2021 Dosage & Administration Dosage & Administration


• TID before meal • TID before meal
Obtained PMDA approval and launched Signed a global licensing-out agreement
DA-3880, a biosimilar of Darbepoetin-α for DMB-3115, a biosimilar of Ustekinumab
(Aranesp®, Nesp®) in Japan in partnership (Stelara®) with Intas Pharmaceuticals
with Sanwa Kagaku Kenkyusho(SKK)
A Novel Cytoprotectant
A Novel
for Cytoprotectant for
Prevention of NSAIDs-induced
Prevention of
Gastritis
NSAIDs-induced Gastritis
Stillen® Tab. Tab. / Stillen
Stillen®
Tab.® 2X
Tab.
Tab.
/ Stillen® 2X Tab.
Dong-A 90+ 6
Dong-A has more than
90 years of history as a We have 6 state of the art Stillen® Stillen®
leading pharmaceutical manufacturing sites in Korea

Socio
Compositions Compositions
company in Korea
• Artemisiae argy folium 95%
• Artemisiae
ethanol viscous
Argyi ext.
Folium
60mg
95% Ethanol Soft Extract (20→1) 60mg
[0.48~1.44mg
[Eupatilin 0.48~1.44mg, Jaceosidin as Eupatilin, 0.15~0.45mg as jaceosidin]
0.15~0.45mg]

Group
Indications Indications

26 &
4
• Acute & chronic gastritis, Prevention
• Acute & chronic
of NSAIDs-induced
gastritis, Prevention
ga of NSAIDs-induced gastritis
Dong-A family has 26

at a
affiliates with more than We establish 4 subsidiaries in USA, Dosage & Administration Dosage & Administration

5,000+
5,000 employees Brazil, China, and India, respectively • TID • TID

Glance
Stillen® 2X Stillen® 2X
Compositions Compositions

300+ 50+
We export a variety of • Artemisiae argy folium 95%
• Artemisiae
ethanol viscous
Argyi ext.
Folium
90mg
95% Ethanol Soft Extract (20→1) 90mg
We have over 300 products to more than 50 [0.72~2.16mg as Eupatilin, 0.225~0.675mg as jaceosidin]
[Eupatilin 0.72~2.16mg, Jaceosidin 0.225~0.675mg]
world-class R&D experts countries (Biologics, APIs,
Indications Indications
Finished Products, OTC/Drinks)
• Acute & chronic gastritis • Acute & chronic gastritis
Dosage & Administration Dosage & Administration
• BID • BID
04 PHARMACEUTICAL PRODUCT LIST DONG-A ST 05

PRODUCT PRODUCT
A Wide Range of rhGH Dosages Anti-metabolite Agent
Growtropin II Inj. / AQ / Cartridge
®
Gemcit® Inj.

LIST LIST
Compositions
Recombinant Somatropin Compositions
• Lyophilized Powder Injection - 4IU, 12IU • Gemcitabine 200mg, 1g
• AQ Injection - 4IU, 12IU, 16IU Indications
• Cartridge for Pen - 20IU, 30IU • Non-small cell lung cancer, Pancreatic cancer, Breast cancer,
Indications Bladder cancer, Ovarian cancer
• Growth failure due to an inadequate secretion of growth hormone (GHD)
• Idiopathic Short Stature (ISS) Anti-
Biologics • Small for gestational age(SGA)
• Turner Syndrome (TS) neoplastic Pre-mixed Docetaxel Solution
Monotaxel® Inj.
Dosage & Administration
• The weekly dose of 0.6IU/kg should be divided into 2 to 4 IM or 5 to57to
SC7(GHD)
SC (GHD) 5 to 7 SC (GHD) Agents
• A dose of 1.11IU/kg body weight/week is recommended (ISS) Compositions
• 0.14IU(0.047mg)/kg(weight) is administered, subcutaneous injection daily(TS) • Docetaxel anhydrous 20mg, 80mg
• 1.44IU(0.48mg)/kg(weight) is administered, divided into 6 to 7 subcutaneous
Indications
injections per week(SGA)
• Breast cancer, Non-small cell lung cancer, Prostate cancer,
Gastric adenocarcinoma, Head and neck cancer
Best Choice for Treatment of Anemia
Eporon® Inj. / PFS
Compositions Solution and Lyophilized Pemetrexed
Recombinant Erythropoietin
• AQ Injection - 2000IU, 4000IU Mainta® Inj.
• PFS - 1000IU, 2000IU, 3000IU, 4000IU, 5000IU, 6000IU, 10000IU
Indications Compositions
• Anemia associated with chronic renal failure • Pemetrexed disodium 100mg, 500mg, 800mg
Dosage & Administration Indications
• IV of 50IU/kg three times weekly • Non-small cell lung cancer, Malignant pleural mesothelioma

The First G-CSF Developed in Korea


Leucostim® Inj. / PFS
Compositions
Recombinant Filgrastim Best Choice for MDR-TB
• AQ Injection - 75㎍, 150㎍, 300㎍
• PFS - 75㎍, 150㎍, 300㎍, 480㎍ Anti- Closerin® Cap.
Indications
• Neutropenia in patients receiving myelosuppressive chemotherapy
tuberculosis Compositions
• Cycloserine 250mg
Dosage & Administration
umor)
• SC of 100㎍/m2 for adults or 50㎍/m 2 for children once a day (Solid Tumor)
umor) Agents Indications
• Active pulmonary & extra-pulmonary tuberculosis
• IV of 200㎍/m once a day (Blood Cancer)
2
Dosage & Administration
• BID
A long-lasting EPO as an ARENESP / NESP Biosimilar
DA-3880®/ PFS
Compositions
Essential Medicine for MDR-TB
• Darbepoetin-alfa Clofazimine Cap.
• PFS - 5㎍, 10㎍, 15㎍, 20㎍, 30㎍, 40㎍, 60㎍, 120㎍, 180㎍
Indications Compositions
• Renal anemia • Clofazimine 100mg
Dosage & Administration Indications
• IV of 30 ~ 120 µg once every two weeks for adult patients on hemodialysis • Lepromatous Leprosy
• SC or IV of 60 ~ 180 µg once every 4 weeks for adult patients on peritoneal • WHO included Clofazimine in its Essential List of
dialysis and patients with chronic kidney disease not on dialysis
Medicine for Treatment of MDR-TB

Antitubercular Agent
Gonadopin® Inj. / PFS Terizidone Cap.*
Compositions
Recombinant Follitropin Preparing Compositions
• AQ Injection - 75IU, 150IU • Terizidone 250mg
• PFS - 75IU, 150IU, 225IU, 300IU
Indications
Indications
• Ovarian hyperstimulation in Assisted Reproductive Technology • Active Pulmonary & extra-pulmonary tuberculosis
• Anovulation in WHO group II patients Dosage & Administration
Dosage & Administration • BID
cle (Ovanian
• IM or SC of 150~225IU on 2nd day or 3rd day of cycle (Ovarian hyperstimulation)
hyperstimulation) cle (Ovanian hyperstimulation)
• IM or SC of 75IU daily (Anovulation) * Brand name is to be decided.
06 PHARMACEUTICAL PRODUCT LIST DONG-A ST 07

NCE and BIO PIPELINE Global Network


Exporting Countries Overseas Subsidiaries

Code Name Licensing


Indication Description Development Stage
(Brand name) Availability

Launched (Korea, India, China USA


DPP(Dipeptidyl Peptidase) Russia) Available for some Suzhou Dong-A Dong-A America Corp.
Type 2 diabetes
DA-1229 -4 inhibitor Registered (Brazil and some territories E-mail : zhangjg@donga.co.kr E-mail : rsy@donga.co.kr
(Suganon®/ Latin American countries) Tel : +86-21-5308-7880 Tel : +1-562-860-3153
Sugamet® XR)

Calcific Aortic Valve Disease DPP(Dipeptidyl Peptidase) Ph II (Korea) Not available


-4 inhibitor Ph II/III (USA)

Ph I completed (EU)
DA-8010 Overactive bladder M3 receptor antagonist Ph Ⅱ completed (Korea) Available
Ph III (Korea)

New Chemical Ph Ia completed (USA)


Entity DA-1241 Type 2 diabetes, NASH GPR119 agonist Available
Ph Ib completed (USA)
India Brazil
Dong-A ST India PVT., LTD. Dong-A Brasil Farmacêutica Ltda.
Ph Ia completed (Korea) E-mail : focusonsk@donga.co.kr E-mail : smile@donga.co.kr
DA-5207 Alzheimer’s disease Donepezil transdermal Available
Ph Ib (Korea) Tel : +91-22-67253071 Tel : +55-11-94198-6013
patch
Ph Ia (India)

DA-7310 Gram-negative Infections LpxC inhibitor Preclinical (Korea) Available except China

Selective Androgen
Manufacturing Sites
DA-4210 Sarcopenia Preclinical (Korea) Available
Receptor Modulator

DA-1726 Obesity Oxyntomodulin Analogue Preclinical (Global) Available


Songdo Research Center

DA-9801 Diabetic neuropathy Botanical (Herbal extract) Ph II completed (USA) Not available Biologics Innovative new drugs
Phytomedicine
DA-9805 Parkinson's disease Botanical (Herbal extract) Ph II completed (USA) Available

Anemia due to Chronic Kidney


Disease (CKD) / the effects of Ph I completed (EU) Available for some cGMP-compliant plant
DA-3880 Darbepoetin α Biosimilar Recombinant-protein
concomitant myelosuppressive Launched (Japan) territories
chemotherapy Monoclonal Antibody
Stillen®(Artemisia extract, Gastritis treatment)
Biopharmaceutical Zydena®(Udenafil, Erectile dysfunction treatment)
Products DMB-3111 Breast Cancer Trastuzumab Biosimilar Ph I completed (Japan) Available except Japan Sihwa Plant, Motilitone®(Corydaline, Functional dyspepsia treatment)
Banwol Plant Sivextro®(Tedizolid, Oxazolidinone class antibiotic)
Suganon®(Evogliptin, Diabetes treatment)
Psoriasis, Psoriatic Arthritis,
Ph I completed (EU) Available for some
API
DMB-3115 Crohn’s Disease, Ulcerative Ustekinumab biosimilar Songdo Plant
Ph III (Global) territories
Colitis
Tablets

New solvate & prodrug

Cheonan Plant The state of the art facility for tablet products

Tablets, Injections
Dalseong Plant
Biologics

Growtropin II® (Somatropin, Growth hormone deficiency)


Manufacture over 130 products
Eporon® (Erythropoietin, Anemia with CRF)
A sterile oncology manufacturing facility Gonadopin® (Follitropin, Infertility)
Leucostim® (Filgrastim, Anti-cancer adjuvant)
Dulastin® (PEG-filgrastim, Neutropenia)
64, Cheonho-daero, Dongdaemun-gu, Seoul, South Korea Tel: +82-2-920-8075 Fax: +82-2-924-2662 http://en.donga-st.com PL-2210-ver 2.1

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