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PIPELINES

Our pipeline includes FDA approved antibiotic, Factive and other drug candidates in clinical and preclinical stages such as hGH, IFN-a, HBV treatment, caspase inhibitor, SR-IFNa, and oral thrombin inhibitors.

Pipeline 1. New Chemical Entities

Therapeutic
Area		 Compound/
Product		 Type Indication DS PC Clinical Trial NDA M Note
Infectious
Disease		 Factive® DNA Rep.
Inhibitor		 CAP,AECB/ABS             US FDA/KFDA
approved
Otitis media              
LB80380 DNA Pol
Inhibitor		 Hepatitis B              
LB84451 Caspase
Inhibitor		 Hepatitis C             Licensed to Gilead
Metabolic
Disease		 LC15-0444 DPP IV
Inhibitor		 Type 2
Diabetes		              
  GK Activator Type 2
Diabetes		              
  - Obesity             Collaboration
with Takeda
  Cell
Protectant		 Cell
protection		              
CV Disease   PAR-1
Inhibitor		 Atherothrombosis              
  P2Y12
Inhibitor		 Atherothrombosis              
Others   Xanthine
Oxidase		 Gout              
Uritos Muscarinic
Inhibitor		 Urinary
Incontinence		             Licensed
from Kyorin
  • CAP: Community Acquired Pneumonia
  • AECB: Acute Exacerbation of Chronic Bronchitis
  • ABS: Acute Bacterial Sinusitis
  • NASH: Non-Alcoholic Steatohepatitis
  • IPF: Idiopathic Pulmonary Fibrosis
  • DPP: Dipeptidyl Peptidase
  • GK: Glucokinase

Pipeline 2. Bio Pharmaceuticals & Medical Device

Class Product Indication DS PC Clinical Trial NDA M Note
Biogeneric hGH Valtropin® GHD, TS/CRI             US FDA/EMEA approved
Eutropin® GHD, TS/CRI             Domestic market
SGA              
EPO (Espogen®) Anemia of CRF             Cultured in roller bottle
Anemia of CRF             Cultured in bioreactor
rFSH (Follitrope®) IVF              
Anovulation              
Long Acting
Product		 SR-hGH LB03002 Adult & Pediatric GHD             Global market
Declage® Adult GHD             Domestic market
Eutropin Plus® Pediatric GHD             Domestic market
SR-IFN¥á Hepatitis C              
SR-Exendin Type 2 Diabetes              
Antibody Amevive Psoriasis             Licensed
from Astellas
TNFmab Rheumatoid
Arthritis		              
TNFcept Rheumatoid
Arthritis		              
LBRx Rheumatoid
Arthritis 		             
Vaccine DTaP-HepB D/T/P/HBV prevention             Partnered with
Kaketsuken
DTwP-HepB D/T/P/HBV prevention             Partnered with
BB-NCIPD
Hib Meningitis              
Medical
Device		 HA Mesoglow Skin Rejuvenation              
HA IDF Skin Rejuvenation              
Esthelis Skin Rejuvenation             Licensed from
Anteis S.A
  • GHD: Growth Hormone Deficiency
  • TS: Turner¡¯s Syndrom
  • CRI: Chronic Renal Insufficiency
  • SGA: Small for Gestational Age
  • SR: Sustained Released
  • CRF: Chronic Renal Failure
  • IVF: In vitro Fertilization
  • CML: Chronic Myeloid Leukemia
  • HA: Hyaluronic Acid
  • IDF: Injectable Dermal Filler

Pipeline 3. Generic / Branded Generic

Therapeutic
Area		 Compound/
Product		 Indication IND
(or CA)		 Clinical Trial
(BE test included)		 NDA
(or MA)		 M Note
CV
Disease		 Pioglitazone
(Pioglizone ®)		 Type 2
Diabetes		            
CV-1 Hyperlipidemia            
CV-2 Hypertension            
Urological
Disease		 Tolterodine
(Tolteros SR ®)		 Urinary
Incontinence		            
Tamsulosin BPH            
Tamsulosin
+finasteride		 BPH            
Musculoskeletal
Diasase		 Dualcet Chronic pain            
OS-1
(Posnyl ®)		 Osteoporosis            
OS-2
(morniflumate)		 NSAIDS            
Oncology Megestrol
Suspension
(Apetrol ®)		 Anorexia            
Casodex
(Casdel ®)		 Prostate
cancer		            
Sancuso ® Emesis
patch		            
Imatinb Breast
cancer		            
  • CA : Conditional Approval
  • MA : Market Approval
  • BE : Bioequivalence
  • BPH : Benign Prostatic Hyperplasia

Pipeline 4. Diagnostics

Area Type Product Indication DS PC CT MA M Note
Molecular
Diagnostics		 Real-time
PCR		 AdvanSure TB/NTM
real time PCR®		 Tuberculosis          
AdvanSure HPV 16/18
real time PCR®		 Cervical Cancer          
AdvanSure CT/NG
real time PCR®		 Chlamydia/
Gonorrhoeae		          
AdvanSure HCV
real time PCR®		 Hepatitis C          
AdvanSure HPV
screening PCR®		 Cervical Cancer          
AdvanSure HCV
monitoring real time PCR®		 Hepatitis C          
AdvanSure HBV
monitoring real time PCR®		 Hepatitis B          
Blood NAT
Screen		 Hepatitis/AIDS          
DNA chip AdvanSure Mycobacteria
genotyping chip®		 Tuberculosis          
AdvanSure TB MDR Tuberculosis          
Immunoblot AdvanSure
Allergy Screen®		 Immunoglobulin E          
  • TB : Tuberculosis
  • NTM : Non-tuberculous Mycobacteria
  • HPV : Human Papiloma Virus
  • CT : Chlamydia Trachomatis
  • NG : Neisseria Gonorrhoeae