Download as pdf or txt
Download as pdf or txt
You are on page 1of 33

CHONG KUN DANG PHARMACEUTICAL CORP.

Better Life Through Better Medicine

PRODUCT LIST

© 2019 CKD Pharma. All rights reserved. Confidential. Latest updates in 3Q 2019
PRODUCT LIST

PRESCRIPTION DRUGS
TC Product Ingredient Strength Package Shelf life

CKD Ceftizoxime inj. Ceftizoxime 1g 10V/Box 24 M


CKD Cefotaxime inj. Cefotaxime 0.25g, 1g 10V/Box 24 M
Cerixon inj. Ceftriaxone 0.5g, 1g 10V/Box 36 M

Amoxicillin/ 375mg, 10T, 100T


Kmoxilin T 24 M
Clavulanic Acid 625mg PTP-Foil
Antibiotics
Amoxicillin/ 4:1
Kmoxilin dry syrup 50ml/Btl 24 M
Clavulanic Acid 7:1

Heliclo T Clarithromycin 250mg 30T, 100T 24 M

Piperacillin,
Tazoperan inj. 2.25g, 4.5g 10V/Box 24 M
Tazobactam
20mg,
Belotaxel inj. Docetaxel 1V/Box 36 M
80mg

50mg,
Belloxa inj. Oxaliplatin 1V/Box 36 M
100mg

200mg,
Gemtan inj. 액상 Gemcitabine 1V/Box 36 M
1g

50mg,
Calutami T Bicalutamide 28T/Box 36 M
Oncology 150mg

100mg,
Eloceta T Erlotinib 30T/Box 36 M
150mg

100mg, 60T/Box 36 M
Leukivec T Imatinib
400mg 30T/Box

100mg, 1V/Box 36 M
Pemecine inj. Pemetrexed
500mg
Tezobell inj. Bortezomib 3.5mg 1V/Box 36 M 2
PRODUCT LIST

PRESCRIPTION DRUG
TC Product Ingredient Strength Package Shelf life
0.5mg,
1.0mg,
Tacrobell C Tacrolimus 100C/Box 36 M
5.0mg

0.5mg,
Tacrobell SR C Tacrolimus 1.0mg, 50C/PTP 36 M
5.0mg

Immuno- 0.25mg,
suppressant Certirobell T Everolimus 0.5mg 60T/PTP 36M
0.75mg
1mg
25mg,
Cipol-N soft C Cyclosporine 50C/Box 36 M
100mg
Cipol-N Oral Sol. Cyclosporine 100mg/ml 50ml/1Btl 36 M
250mg, 100C/Box
Myrept C / T Mycophenolate mofetil 36 M
500mg 100T/Box

Anti- Tenofovir disoproxil


Tenofobell T 368.04mg 30T/Box 36M
infective aspartate

Acetaminophen/ 325/ 30T/Box


Rapicet T 36 M
Tramadol 37.5mg 100T/Box
Musculo-
skeletal
Acetaminophen/ 162.5/ 30T/Box
Rapicet semi T 36 M
Tramadol 18.75mg 100T/Box

Central
5mg, 30T/Box
Nervous Escital T Escitalopram oxalate 36 M
10mg 100T/Box
System
3
PRODUCT LIST

PRESCRIPTION DRUG
TC Product Ingredient Strength Package Shelf life

Duvie T Lobeglitazone (NCE) 0.5mg 30T/Box 36 M


Anti-
diabetes 0.25/500mg,
Lobeglitazone sulfate/ 0.25/750mg,
Duvimet XR T 0.25/1,000mg,
30T/Box 36 M
Metformin
0.5/1,000mg

Anydipine S T S-amlodipine besylate 2.5mg 30T/Box 24 M

20mg,
Lipilou T Atorvastatin calcium 30T/Box 36 M
40mg

150mg,
Izarbelltan T Irbesartan 100C/Box 36 M
Cardio- 300mg
vascular
System
30T/Box
Candemore plus T Candesartan/HCTZ 16/12.5mg 36 M
100T/Box

8/5mg,
Candesartan cilexetil/ 30T/Box
Cantabell T 16/10mg, 36 M
Amlodipine besylate 100T/Box
16/10mg

40mg 30T/Box
Telmitrend T Telmisartan 36M
80mg 30T/Box

4
PRODUCT LIST

OTC DRUG
TC Product Ingredient Strength Package Shelf life

ACTILIVER
Hepato- MORNING 60C x 2
tonics Soft C Milk thistle extract 350mg - small Box 24M

Biodiastase 700G 50mg


ZESPAN GOLD T Dimethicone 83mg - 10T/Box
Digestives Dl-carnitine hydrochloride 500T/Btl 36M
100mg, Pancreatin 80mg
Prozyme 20mg

MODCO S Acetaminophen 200mg,


Soft C Chlorpheniramine maleate 200mg 10C/Box 24M
1.25mg, Pseudoephedrine
hydrochloride 15mg

Acetaminophen 400mg,
MODCOUGH S Chlorpheniramin Maleate 200mg 10C/Box 24M
Cold
2.5mg, Pseudoepedrine HCl
Remedies Soft C
30mg

Acetaminophen 200mg,
Chlorpheniramine maleate
MODCOL S 1.25mg, 200mg 10C/Box 24M
DL-methylepedrine HCl
Soft C
12.5mg,Pseudoephedrine
HCl 15mg, Guaifenesi
41.6mg,Dextromethorphan
HBr hydrate 8mg
5
PRODUCT LIST

OTC DRUG
TC Product Ingredient Strength Package Shelf life

Triprolidine HCl 25mg, 100ml per 10Btl/Box 36M


MODCO Syrup Pseudoepedrine HCl Btl
600mg

MODCOL Syrup Acetaminophen 750mg


100ml per 10Btl/Box 36M
Chlorpheniramin Maleate
Btl
6.3mg,DLMethylephedrine,
Dextromethrophan HBr
hydrate, etc

Cold
Remedies
Guaifenesin 1g,
MODCOUGH Syrup 100ml per 10Btl/Box 36M
Pseudoephedrine HCl
300mg, Dextrometrophan Btl
HBr hydrate 100mg, etc

BEBYZAL Syrup 100ml per 10Btl/Box 36M


Ibuprofen 2g Btl

6
PRODUCT LIST

FOOD SUPPLEMENTS
TC Product Ingredient Strength Package Shelf life
6-year-old Red Ginseng
6 YEARS KOREAN Extract, soy bean lecithin, 1,000mg 120C/Box 36M
RED GINSENG C Taurine, Vitamin E, Vitamin
B1, B6, multiple herbs

6 YEARS KOREAN 6-year-old Red Ginseng


RED GINSENG Extract, Vitamins B1, B2, 70ml per 30P/Box 24M
Red B6, PP, Multi Herb Extract
EXTRACT LIQUID Pouch
Ginseng
6-year-old Red Ginseng,
Vitamin A, Vitamin B1, Zinc
6 YEARS KOREAN Vitamin B2, Vitamin B6,
RED GINSENG Vitamin B12, Vitamin C, 1,400mg 60T/Box 36M
MULTIVITAMIN Vitamin D3, Vitamin E,
Niacin, Pantothenic acid,
Folic Acid, Multiple-herbs

Omega 3, 6-year-old Red


Red HONG OMEGA 3 Ginseng Extract, soy bean 1,100mg 180C/Box 36M
Ginseng + oil, Lutein, Vitamin E, Garlic,
Omega linzhi, Bluberry, Ginkgo

Garcinia cambogia
PREMIUM BEAUTY extract with HCA 800mg, 8000mg 10Btl/Box 24M
DIET Sol. Fish collagen, Hyaluronic /50ml
Collagen acid, Vitamin C, Fruits
concentrate

More than 100 million


BELL PROBIOTICS beneficial bacteria, Zinc,
Probiotic PLUS Calcium, Vitamin C, 2,000mg 60 sachets 24M
Vitamin D3, Vitamin B2,
Grape extract

7
PRODUCT LIST

OTHERS
TC Product Indication Package

BELLOCITY Cover grey hair, Change hair color Colorant tube 40g,
Colorant Shampoo type only for 5 mins Gentle with skin. developer tube 40g,
(Black, Brown) pouch of conditioner 10g
Nourish and moisturize your hair scalp.
2 pair of gloves, shower
Protect hair damage from sunlight. cap, cloak, tray, leaflet

FRIENVITA
Skin Filtering
Mask (6 type) The vital vitamin and abundant
• Moisture nutrition from nature care skin 10 ea (25g) / pack
• Aqua Dead fatigued from dryness and
Skincare Skin Cell contaminated environment,
Mask pack • Whitening maintaining vital skin health.
• Wrinkle
• Re-new
• Pore

8
ABOUT THE COMPANY

R&D PIPELINES

9
ABOUT THE COMPANY

PRODUCT WITH CTD


No Category Product (Strength) API
1 Anemia Nesbell 20, 30, 40, 60, 120 µg Darbepoetin Alpha
2 Anti-diabetes Duvie Tab. 0.5mg Lobeglitazone
3 Escital Tab. 5mg Escitalopram oxalate
Central Nervous System
4 Escital Tab. 10mg Escitalopram oxalate
5 Rapicet Semi Tab. 325/37.5mg Acetaminophen/Tramadol
6 Rapicet Semi Tab. 162.5/18.75mg Acetaminophen/Tramadol
Musculoskeletal
7 Naxen S Tab 500/20mg Naproxen Esomeprazole Magnesium
Dihydrate
8 Anydipine S Tab. 5mg S-Amlodipine besylate Dihydrate
9 Lipilou Tab. 20mg Atorvastatin Calcium
10 Lipilou Tab. 40mg Atorvastatin Calcium
11 Izarbeltan Tab. 150mg Irbesartan
12 Izarbeltan Tab. 300mg Irbesartan
13 Cardiovascular System Candemore plus Tab. 16/12.5mg Candesartan/HCTZ
14 Eunexon Plus Soft Cap. Gingko biloba
15 Cantabell 8/5, 16/5, 16/10mg Candesartan/Amlodipine
16 Telmitrend Tab. 40mg Telmisartan
17 Telmitrend Tab. 80mg Telmisartan
18 Liver Protective Actiliver Soft Cap. 350mg Milk-thistle Extract
9
ABOUT THE COMPANY

PRODUCT WITH CTD


No Category Product (Strength) API
1 Belotaxel Inj. 20mg 1vial Docetaxel
2 Belotaxel Inj. 80mg 1vial Docetaxel
3 Belloxa Inj. 50mg Oxaliplatin
4 Belloxa Inj. 100mg Oxaliplatin
5 Gemtan Inj. 200mg Gemcitabine
6 Oncology Gemtan Inj. 1g Gemcitabine
7 Calutami Tab. 50mg Bicalutamide
8 Calutami Tab. 150mg Bicalutamide
9 Eloceta Tab. 100mg Erlotinib
10 Eloceta Tab. 150mg Erlotinib
11 Tezobell Inj. 3.5mg Bortezomib
12 Leukivec Tab. 100mg Imatinib
13 Leukivec Tab. 400mg Imatinib
14 Tacrobell Cap. 0.5mg (API: CKDBio) Tacrolimus
15 Tacrobell Cap. 1mg (API: CKDBio) Tacrolimus
16 Cipol-N Soft Cap. 25mg Cyclosporin
17 Cipol-N Soft Cap. 50mg Cyclosporin
18 Immuno-suppressants Cipol-N Soft Cap. 100mg Cyclosporin
19 Cipol-N Oral Solution 100mg/mL Cyclosporin
20 Myrept Cap. 250mg Mycophenolate Mofetil
21 Myrept Cap. 500mg Mycophenolate Mofetil 10
ABOUT THE COMPANY

PRODUCT WITH CTD


No Category Product (Strength) API
1 Ceftizoxime Inj. 1g Ceftizoxime
2 Cefotaxime Inj. 0.25, 1.0g Cefotaxime
3 Kmoxilin Tab. 375mg Amoxicilin/Clavulanic acid
4 Kmoxilin Tab. 625mg Amoxicilin/Clavulanic acid
5 Kmoxilin Dry syr. 4:1 Amoxicilin/Clavulanic acid
6 Antibiotic Kmoxilin Dry syr. 7:1 Amoxicilin/Clavulanic acid
7 Heliclo Tab. 250mg Clarithromycin
8 Cerixon Inj. 0.5g Ceftriaxone
9 Cerixon Inj. 1g Ceftriaxone
10 Tazoperan Inj. 2.25g Piperacillin, Tazobactam
11 Tazoperan Inj. 4.5g Piperacillin, Tazobactam

11
CHONG KUN DANG PHARMACEUTICAL CORP.
Better Life Through Better Medicine

NCE, IMD PRODUCT PROFILE

© 2019 CKD Pharma. All rights reserved. Confidential. Latest updates in 3Q 2019
BD PACKAGE

Duvie® Tab. Product Profile


Product Name Duvie® Tab.
Active Ingredient Lobeglitazone sulfate 0.5mg
MoA PPAR-g Selective Agonist, Insulin Sensitizer
Class Glitazone Anti-Diabetics
Indication Type II Diabetes
Dosage 1 tablet once a day
Development
Total 8 Clinical Studies Completed; 5 of Phase 1, 1 of Phase 2, and 2 of Phase 3 for Registration
Status
Packing Unit 30T/Bottle
Market Status Launched in Feb. 2014
 Material - PCT (KR20/00542)
 Registered in Korea, US, EU, Japan, India, China, and Canada
Patent Status  Composition - PCT/KR2015/011801
 Applying in China, Russia, Thailand, Latin America(Peru, Chile, Colombia, Argentina,
Venezuela)
 Sitagliptin Co-administration: Unlike Actos, Duvie can safely prescribed by co-administered
regimens with Sitagliptin
 Dosage & Administration: No dose adjustment is necessary in patients with mild to moderate
Advantages hepatic
impairment
 Contraindication: Hepatic impairment patients-> moderate hepatic impairment patients
→ More patients can be dosed
12
BD PACKAGE

Duvimet® Tab. Product Profile


Product Name Duvimet XR® Tab

Active Ingredient Lobeglitazone + Metformin XR

Strength 0.5/1000mg, 0.25/1000mg, 0.25/750mg, 0.25/500mg

Class Glitazone Anti-Diabetics + Biguanide

Indication Type II Diabetes

Dosage 1 tablet once a day

- Fixed dose Combination with Lobeglitazone, are insulin sensitizers and Metformin
- Customized treatment for patients with various dosage
Advantage
- Improving medication compliance, by Small drug size and one-time intake of a glitazone
and Metformin (a readily prescribed drug for diabetes in combination)

Packing Unit 30T/Bottle

Market Status Launched in Sep. 2016, Korea

13
BD PACKAGE

Camtobell Inj. Product Profile


Product Name Camtobell Injection
Active Ingredient Belotecan 2mg / vial

MoA - Topoisomerase I inhibitor

Class - Semi-synthetic substance from Camptothecin derivative

- Small cell lung cancer (2nd line)


Indication
- Ovarian cancer (2nd line)

- Starting dose : 0.5mg/m2/day


- i.v infusion for five days consecutively (1st week)
Administration
- Intermission during next 2nd and 3rd week
- 1 cycle : three weeks / 1 week : 5 days
1995 Selected leading compound of Belotecan
1997 IND approval (for injection)
Development 2000 Phase I completed
Status 2003 Phase II completed
2003 NDA approved
2004 Launched
Market Status* Launched in 2004, Korea
- Higher response rate and lower side effect than topotecan
Advantages
(lower starting dose(0.5mg) than topotecan(1.5mg))

14
BD PACKAGE

NESBELL® (Darbepoetin-α) Product Profile


PRODUCT NAME NESBELL® (Code name: CKD-11101)
ACTIVE SUBSTANCE Darbepoetin-α
ORIGINAL DRUG NESP® (Kyowa Hakko Kirin), Aranesp® (Amgen)
ROUTE OF ADMINISTRATION Intravenous (IV) or subcutaneous (SC)
DOSING REGIMEN Injection interval : 1 injection/1-2weeks
As an erythropoiesis stimulating protein, it stimulates erythropoiesis by the same mechanism as endogenous
MoA
erythropoietin.
1. Anemia associated with chronic renal failure
INDICATION
2. Anemia by cancer chemotherapy
STRENGTH 20, 30, 40, 60 and 120 in 0.5mL prefilled syringe
In phase 3 study to evaluate efficacy and safety of CKD-1101 versus NESP®:
CLINICAL RESULT * ·CKD-11101 has an equivalent therapeutic effect as NESP® in chronic kidney disease patients with renal anemia.
·CKD-11101 can be safely used for long-term treatment and in patients converted from NESP®.
KOREA: NESBELL® was approved by MFDS Korea on Nov. 28th 2018

DEVELOPMENT STATUS JAPAN: Approval for manufacturing and marketing of CKD-11101J was granted from the Japanese Ministry of
Health, Labor and Welfare (MHLW) on Sep. 20th 2019.
(Official launch is expected to be made in Dec. 2019, following drug price negotiation.)

NESP® (Kyowa-Hakko Kirin) Aranesp® (Amgen) NESBELL® (CKD Pharm.)

Marketed in Asia (including JP, KR) Marketed in US, EU and others Biosimilar
* Source: “CKD-11101 Phase 3 SC Study” (Clinical Trial Registration: NCT03431623),
“CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis” (Clinical Trial Registration: NCT03428594) 15
BD PACKAGE

Cantabell Tab. Product Profile


Product Name Cantabell® Tab.

Active Ingredient Candesartan cilexetil / Amlodipine besylate

Indication essential hypertension that cannot be controlled by Candesartan or Amlodipine alone

 Candesartan 8mg / Amlodipine 5mg


Strength  Candesartan 16mg / Amlodipine 5mg
 Candesartan 16mg / Amlodipine 10mg

Usage 1 tablet once a day

 Toxicity (4 and 13-week repeated in rat): completed at GLP level


Development
 6 clinical studies (DDI , BE, phase II/III) completed in South Korea
Status*
 Approved by MFDS in Jul. 2016

Market Status* Launched in Oct. 2016, Korea

 Providing a superior efficacy without increasing the side effects, when compared to the
monotherapies
Advantages  Currently, there is no marketed product worldwide with this combination with the same
elevated dosage
 Improving medication compliance by Small drug size
Packing Unit 30T/Bottle, 100T/Bottle
16
BD PACKAGE

Gemtan® Liquid Inj. Product Profile


Product Name Gemtan® Liquid Injection

Active Ingredient Gemcitabine hydrochloride

Class Antineoplastic

Indication Ovarian Cancer, Breast Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer

 1g/26.3mL, 200mg/5.26mL(Liquid)
Strength
 1g and 200mg (lyophilized granule)

Development
Approved by MFDS in Sep. 2015
Status

Market Status Launched in 2017, Korea

Advantages Enhancing Prescription convenience without additional reconstitution process.

17
BD PACKAGE

Pemecine® Liquid Inj. Product Profile

Product Name Pemecine® Liquid Injection

Active Ingredient
Pemetrexed disodium 2.5 hydrate, 25mg/mL

Class A folate analog metabolic inhibitor


Malignant pleural mesothelioma
Indication
Non-small cell lung cancer

Strengths 20, 32mL/vial


Development
Approved by MFDS in October, 2015
Status

Market Status Launched in 2016, Korea

Patent PCT/KR2016/014594(International filing date: 2016.12.13)

Advantages Enhancing Prescription convenience without additional reconstitution process.

18
BD PACKAGE

Tacrobell SR® Cap. Product Profile


Product Name Tacrobell SR® Cap.

Active Ingredient Tacrolimus

Class Immunosuppressant

Indication Prevention of organ rejection in transplantation

Strength Tacrolimus 5mg, 1mg, 0.5mg

Usage Prolonged release formulation with once daily dosing

Development BE Study have been completed.


Status Approved by MFDS in Feb. 2017

Packing Unit 50C/PTP

Market Status Launched in Nov. 2017, Korea

Enhancing compliance with convenient once-daily dosing option


Advantages
Providing another option as a slow-release except for the original
19
BD PACKAGE

Entecabell Tab/ODT® Product Profile


Product Entecabell Tab.® 0.5mg, 1mg
Name(Code) Entecabell ODT® 0.5mg, 1mg
Entecabell Tab.® Entecabell Tab.® Entecabell ODT® Entecabell ODT®
(Entecavir 0.5mg) (Entecavir 1mg) (Entecavir 0.5mg) (Entecavir 1mg)
Active Ingredient

Product Type Prescription Drugs / Anti-Virus


MoA A guanosine nucleoside analogue with activity against HBV reverse transcriptase (rt)
Indication Hepatitis B
1 tablet once a day on an empty stomach (at least 2 hours after a meal and 2 hours before the
Dosage
next meal).
Packing Unit Entecabell Tab.® 0.5mg, 1mg 30T/PTP, ODT® 0.5mg, 1mg 30T/PTP
Market Status Launched in Oct. 2015, Korea
Entecavir is a guanosine NA with selective activity against hepatitis B virus reverse
transcriptase. Entecavir competes with deoxyguanosine triphosphate to bind the viral reverse
transcriptase and inhibits replication of the viral genome
Advantages
Entecabell ODT is the first product in Korea that can be easily taken without water. This makes
it more convenient for patients who are suffering from medication difficulties such as elderly
patients or seriously ill patients.
20
BD PACKAGE

Tenofobell® Tab. Product Profile


※ (Ref. drug) VIREAD® Tab.
Product Name Tenofobell® Tab.
* Developed/Manufactured by GILEAD
* Distribution in Korea: YUHAN

Tenofovir disoproxil aspartate Tenofovir disoproxil fumarate


Active Ingredient 308.04mg 300mg

Product Type Prescription Drugs / Anti-Virus

MoA A nucleotide analog HIV-1 reverse transcriptase inhibitor (nRTI) and an HBV reverse transcriptase inhibitor
1. HIV-1 Infection in adults and pediatric patients 12 years of age and older
Indication 2. Chronic Hepatitis B in adults and pediatric patients 12 years of age and older
Dosage 1 tablet (308.04 mg) QD orally without regard to food

Packing Unit 30C/Bottle


 Tenofobell® is an IMD as a new formulation for Tenofovir with a new salt Aspartate.
 The first IMD that has completed phase 3 trial is proven to be non-inferior to the original VIREAD® as no
significant
differences were found in efficacy and safety between the two.

Advantages  CKD is the holder of a product patent and a process patent of Tenofobell® granted by KIPO (Korean Intellectual
Property Office), also DMF (Drug Master File) is registered by CKD BiO.
 Cost-effective as the drug price of Tenofobell® is KRW 2,400/tab.,50.77% lower than KRW 4,727 of VIREAD®.
 With improved hygroscopicity and solubility, it has the longest shelf life of 36 months.
 Reduction in tablet size by 15% can provide convenience of drug intake, and therefore improve drug compliance.
21
BD PACKAGE

OMP Tab.® Product Profile


Product Name OMP Tab® 20mg, 40mg
OMP Tab® 20mg (Omeprazole 20mg) OMP Tab® 40m (Omeprazole 40mg)

Active Ingredient

Product Type Prescription Drugs / Gastrointestinal System


MoA PPI (Proton Pump Inhibitor)
OMP® Tab. 20mg: Gastroesophageal reflux Disease
Indication
OMP® Tab. 40mg: Gastroesophageal reflux Disease, Peptic Ulcer, H.pylori eradication
Dosage 1 tablet once a day
Packing Unit OMP® 20mg 28Tab/Bottle, OMP® 40mg 14T/Bottle
Market Status Launched in 1993, Korea

 Omeprazole is the treatment of gastroesophageal reflux disease, peptic ulcer disease, and
Advantages Zollinger–Ellison syndrome. It is also used to prevent upper gastrointestinal bleeding.
Omeprazole is regarded as the “gold standard” for active gastric ulcer treatment

22
BD PACKAGE

OMP S® Tab. /OMP S® Injection. Product Profile


Product Name OMP S Tab.® 20, 40mg / OMP S Inj.® 40mg
OMP S Tab.® 20mg OMP S Tab.® 40mg OMP S Inj.® 40mg
(Esomeprazole 20mg) (Esomeprazole 40mg) (Esomeprazole sodium 42.5mg)
(Esomeprazole magnesium dihydrate 43.38mg)
(Esomeprazole magnesium dihydrate 21.69mg)

Active Ingredient

Product Type Prescription Drugs / Gastrointestinal System


MoA PPI (Proton Pump Inhibitor)
OMP S® Tab. 20mg: Gastroesophageal reflux Disease
Indication OMP S® Tab. 40mg: Gastroesophageal reflux Disease, H.pylori eradication
OMP S® Injection 40mg: Gastroesophageal reflux Disease
Dosage 1 tablet once a day, 20~40 ml once a day
Packing Unit OMP® S 20mg 28T/Alu-Alu , OMP® S 40mg 28T/Alu-Alu, OMP® S inj. 40mg/1Vial
Market Status Launched in Sep. 2015, Korea
Esomeprazole is mainly used to treat heartburn and the other symptoms of Gastro-
oesophageal reflux disease and stomach ulcers and to stop certain medicines (NSAIDs) from
Advantages causing stomach ulcers.
OMP S contain the active ingredient esomeprazole, in a strength of either 21.69mg or 43.38mg
as dihydrate per tablet.
23
BD PACKAGE

Bellmetec Plus® Tab. Product Profile

※ (Reference drug)
Olmetec® Plus Tab.
Product Name Bellmetec® Plus Tab. * Developed/Manufactured by
Daewoong
* Distribution in Korea: Daewoong

Olmesartan Medoxomil
Active Olmesartan Medoxomil
20mg
Ingredient 20mg / HCTZ 12.5mg
/ HCTZ 12.5mg

Product Type Prescription Drugs / Cardiovascular System / Antihypertensive Drugs

Essential Hypertension not Adequately Controlled by Olmesartan or Hydrochlorothiazide


Indication
MonoTherapy
A combination of an angiotensin II receptor antagonist (Olmesartan) and a diuretic (HCTZ) in a single
Advantages
tablet

MoA ARB (Angiotensin II Type 1 Receptor Blocker) + a thiazide diuretic (hydrochlorothiazide [HCTZ])

Dosage 1 tablet QD regardless of food intake

Packing Unit 30T/Bottle, 300T/Bottle

Market Status Launched in Sep. 2013, Korea

24
BD PACKAGE

Candemore Plus® Tab. Product Profile

※ (Reference drug)
Atacand® Plus Tab.
Product Name Candemore Plus® Tab. * Developed/Manufactured by
AstraZeneca
* Distribution in Korea: AstraZeneca KR

Candesartan Cilexetil
Active Candesartan Cilexetil 16mg/
16mg/
Ingredient HCTZ 12.5mg
HCTZ 12.5mg

Product Type Prescription Drugs / Cardiovascular System / Antihypertensive Drugs

Indication Essential Hypertension not Adequately Controlled by each Individual Ingredient

A combination of an angiotensin II receptor antagonist (candesartan) and a diuretic (HCTZ) in a


Advantages
single tablet

MoA ARB (Angiotensin II Type 1 Receptor Blocker) + a thiazide diuretic (hydrochlorothiazide [HCTZ])

Dosage 1 tablet QD regardless of food intake

Packing Unit 30T/Bottle, 100T/Bottle

Market Status Launched in Apr. 2011, Korea

25
BD PACKAGE

Covalsarbell® Tab. Product Profile


※ (Reference drug)
Co-Diovan® FCT.
Product Name Covalsarbell® Tab. FCT.
* Developed/Manufactured by
Novartis
* Distribution in Korea: Novartis KR

Valsartan 80mg/HCTZ Valsartan 80/HCTZ


Active 12.5mg, 12.5mg,
Ingredient Valsartan 160mg/HCTZ Valsartan 160/HCTZ
12.5mg 12.5mg

Product Type Prescription Drugs / Cardiovascular System / Antihypertensive Drugs

Indication Essential Hypertension not Adequately Controlled by Monotherapy

A combination of an angiotensin II receptor antagonist (valsartan) and a diuretic (HCTZ) in a single


Advantages
tablet

MoA ARB (Angiotensin II Type 1 Receptor Blocker) + a thiazide diuretic (hydrochlorothiazide [HCTZ])

Dosage 1 tablet QD regardless of food intake

Packing Unit 28T/Box, 98T/Box

Market Status Launched in Nov. 2011, Korea

26
BD PACKAGE

Sarlotan Plus® Tab. Products Profile


Product Sarlotan® Sarlotan® Sarlotan®
Name Plus Tab. Plus Pro Tab. Plus F Tab.

Losartan Losartan Losartan


Active
50mg/ 100mg/ 100mg/
Ingredient
HCTZ 12.5mg HCTZ 12.5mg HCTZ 25mg

Product Type Prescription Drugs / Cardiovascular System / Antihypertensive Drugs

Indication Essential Hypertension not Adequately Controlled by MonoTherapy

A combination of an angiotensin II receptor antagonist (losartan) and a diuretic (HCTZ) in a single


Advantages
tablet

MoA ARB (Angiotensin II Type 1 Receptor Blocker) + a thiazide diuretic (hydrochlorothiazide [HCTZ])

Dosage 1 tablet QD regardless of food intake

Packing Unit 30T/Bottle, 300T/Bottle

Market
Launched in Mar. 2009, Korea
Status

27
BD PACKAGE

Telmitrend Plus® Products Profile


Product Name Telmitrend® Plus Tab.

 Telmisartan 40mg/ HCTZ 12.5mg


API / Strength  Telmisartan 80mg/ HCTZ 12.5mg
 Telmisartan 80mg/ HCTZ 25mg

Product Type Prescription Drugs / Cardiovascular System / Antihypertensive Drugs


 40/12.5mg
Essential Hypertension not Adequately Controlled by Telmisartan 40mg MonoTherapy
 80/12.5mg
Indication Essential Hypertension not Adequately Controlled by Telmisartan 80mg MonoTherapy
 80/25mg
Essential Hypertension not Adequately Controlled by Telmisartan 80mg MonoTherapy,
Hydrochlorothiazide 12.5mg MonoTherapy, Combination Therapy
A combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor
Advantages
subtype, and a diuretic (HCTZ) in a single tablet
MoA ARB (Angiotensin II Type 1 Receptor Blocker) + a thiazide diuretic (hydrochlorothiazide [HCTZ])

Dosage 1 tablet QD regardless of food intake

Packing Unit 30T/Bottle


Micardis® Plus Tab. / Boehringer Ingelheim
Competitor ▪ 40/12.5mg: KRW 429/tab.
 Telmisartan 40mg/ HCTZ 12.5mg
(Original) ▪ 80/12.5mg: KRW 573/tab.
 Telmisartan 80mg/ HCTZ 12.5mg

28
BD PACKAGE

Naxen-S® Tab. Product Profile


※ (Reference drug)

Product VIMOVO® Tab.


Naxen-S® Tab.
Name * Developed/Manufactured by
AstraZeneca
* Distribution in Korea: AstraZeneca KR

Active Naproxen 500mg Naproxen 500mg


Ingredient / Esomeprazole 20mg / Esomeprazole 20mg
Product Type Prescription Drugs / Musculoskeletal / NSAIDs (Nonsteroidal Anti-Inflammatory Drugs)
Symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis in patients at
Indication risk of gastric ulcer and/or duodenal ulcer related to non-steroidal anti-inflammatory drugs(naproxen
etc.) and not sufficient by low-dose naproxen or other non-steroidal anti-inflammatory drugs

Naxen®-S is a fixed dose combination of NSAIDs(Naproxen) + PPI(Esomeprazole) in a single tablet,


with naproxen having relatively low CV risk compared with other NSAIDs, and esomeprazole providing
Advantages
greater acid control and maintaining intragastric pH >4 for a longer period of time compared with
other PPIs.

Naxen®-S consists of an immediate-release esomeprazole magnesium layer and an enteric-coated


naproxen core.
MoA
As a result, esomeprazole is released first in the stomach, prior to the dissolution of naproxen in the
small intestine. The enteric coating prevents naproxen release at pH levels below 5.5.

Dosage 1 tablet BID

Packing Unit 30T/Bottle, 300T/Bottle


29
BD PACKAGE

Esoduo® Tab. Product Profile


Product Name ESODUO® Tab.

Active Ingredient Esomeprazole 20mg + Sodium Bicarbonate 800mg

Product Type Prescription Drugs / Antiulcerants


MoA IR-PPI (Immediate Release Proton Pump Inhibitor)
Gastroesophageal reflux disease (GERD)
Indication - Long-term maintenance therapy to prevent recurrence of esophagitis
- Symptomatic treatment of gastroesophageal reflux disease without esophagitis
Dosage 1 Tablet (20/800mg) QD
Packing Unit 28T/PTP
 The World’s First and Only IR-Esomeprazole as an IMD : A new fixed dose combination of
Esomeprazole and Sodium Bicarbonate
 The Faster Onset of Action : Absorbed from the stomach, ESODUO® shows a faster onset of
action in 0.5h than 1.5h of DR-PPI.
 Dual Action : The dual action of Esomeprazole and Sodium Bicarbonate is proved to higher
Advantages
efficacy than PPI.
 Highly Economical Drug : The reimbursement price of ESODUO® is KRW 720/tab., 26% lower
than other PPIs of KRW 970.
Also, it can be taken 1 tab. QD whereas other PPIs should be taken 1 tab. of PPI QD with an
antacid TID separately.
30
Contact US

Chong Kun Dang Pharmaceutical Corporation


8, Chungjeong-ro, Seodaemun-gu,
Seoul 120-756, Korea
www.ckdpharm.com

Global Business Unit


• Phone: +82-2-2194-0337
• Fax: +82-2-2194-7813
• E-mail: global@ckdpharm.com

You might also like