powerpoint 프레젠테이션 - hanmi.co.kr · strong cash flow from traditional pharma business...
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Pyeongtaek Plant – Bio Plant ∙ Cepha Plant • Production of IND(Investigational new biologics) and Cepha FPP
• The 2nd Bio Plant under construction for global clinical trials and
commercialization of LAPSCOVERY based new biologics
• Certified by PIC/S
Hanmi Fine Chem – API Business • 30% M/S of European cephalosporin antibiotics API market
• FDA(US), BSG(GER), TGA(AUS), PMDA(JPN), EDQM(EU),
MHRA(GB) GMP received
Paltan Plant – FPP Manufacturing Sites • ODM Partnership with global partners : MSD, Sanofi, etc
• The New Global Smart Plant completed and received operation
approval in Dec 2016
• Annual capsule production capacity : 2B → max. 10B
5
Strong cash flow from
traditional pharma
business through in-
house FCD/IMD
products & generics
Heavy investment in
innovative R&D from
early 2000s
Robust pipeline from
in-house, as well as
external R&D
Maintain leadership in
core businesses in
Korea & China
Investment in areas of
high-growth potential
Become a global R&D
powerhouse through
continuous new drug
discovery &
development in core
therapeutic areas
To achieve significant
growth through
innovative new drugs
6
PAST PRESENT FUTURE
674.0 730.1 761.3
1,317.5
882.7
91.0 115.6
152.5 187.1
162.6
-
200
400
600
-
500
1,000
1,500
2012 2013 2014 2015 2016
Sales R&D
20.0%
14.2%
8
13.5% 15.8%
18.4%
10
Therapeutic Agent : Natural/Unnatural peptide
Flexible Linker :Reduce Immunogenicity Minimized
loss of activity
No loss of FcRn binding
Aglycosylated Fc : Increase solubility
AG
LY
CO
SY
LA
TE
D F
C
AG
LY
CO
SY
LA
TE
D F
C
11
Key Features
Redirect immune cells to tumor cells
Natural IgG-like bi-specific antibody format
Good stability and high production efficiency
Seeking collaboration opportunities
(PENTAMBODY + Novel target)
Next-generation bi-specific antibody platform technology
Discovery by Beijing Hanmi with dual immunotherapy & targeted therapy
Tumor cell
Immune cell
P
E
N
T
A M
B
O D
Y
12
Pentambody applied PD-1/HER2 BsAb
Cell-to-cell association (%) using SK-BR-3 and CHO-PD1 cells by FACS1
1HER2 positive SK-BR-3 stained with CFSE, CHO-PD1 stained with PKH26, Test article 100nM, 30min; 2E (activated hPBMC) : T (HCC827) = 20 : 1, 72hr
Redirect immune cells to tumor cells
Better anti-tumor activity compared to combination
Pentambody applied PD-1/PD-L1 BsAb
Cell cytotoxicity assay using PD-L1 expressed NSCLC cell2
Anti-PD-L1 mAb: IC50 >2,000 pM
Anti-PD-1 mAb: IC50 440 pM
Combination: IC50 50 pM
PD-1/PD-L1 BsAb (BH2941): IC50 10 pM
13
LAPSInsulin Combo HM14220
Diabetes
SANOFI
GMB Stem Cell Therapy HM21001
Glioblastoma
AJOU Univ
LAPSTriple Agonist HM15211
Obesity, NASH
LAPSGlucagon Analog HM15136
Congenital Hyperinsulinism
LAPSASB HM15450
Mucopoysaccharidosis
FLT3 Inhibitor HM43239
AML
PD-1/HER-2 BH2950
Breast, Gastric cancer
B
PD-1/PD-L1 BH2941
Cancer
B LAPSGLP-2 Analog
HM15910
Short Bowel Syndrome
Pre-Clinical Phase 2 Phase 3 Phase 1
LAPSGLP/GCG HM12525A
Diabetes/Obesity
JANSSEN
LAPSInsulin HM12470
Diabetes
Pan-RAF Inhibitor HM95573
Solid tumor
GENENTECH
Oratecan™ Irinotecan+HM30181A
Solid tumor
ATHENEX
Src/Tubulin KX2-391
Solid tumor
ATHENEX
PD-1/EGFR BH2922
NSCLC, Colorectal cancer
B
LAPSExd4 Analog Efpeglenatide
Diabetes/Obesity
SANOFI
LAPShGH Efpegsomatropin
GH deficiency
Olita® * Olmutinib
NSCLC
ZAI LAB
Luminate®
Integrin inhibitor
DME
ALLEGRO
BTK Inhibitor HM71224
Autoimmune diseases
ELI LILLY
Pan-HER Inhibitor Poziotinib
Solid tumor
SPECTRUM/LUYE
Rolontis™ Eflapegrastim Neutropenia
SPECTRUM
Oraxol™** Paclitaxel+HM30181A
Breast cancer
ATHENEX
Diabetes/Obesity
Rare Diseases
Cancer
Autoimmune Diseases
Others
B Beijing Hanmi
14
Launching 2~3 products annually in the domestic market
Seeking partners for emerging market business
‘Rosuzet® ’ Collaboration with MSD for 23 countries
*Incrementally Modified Drug **Fixed Dose Combination
Plan to launch in 2017
Strong focus
on R&D
Partnership
& Alliance
China
Market
+500 R&D experts : Ph.D 64, MS. 305
+800 mil USD invested in the past decade
29 Programs in Pre-clinical & Clinical Development
Broadening global & regional partnership
Open innovation strategy
Synergy between Beijing Hanmi & Hanmi Korea
Competitive R&D supported by global talents
Profitable growth through business diversification
16
Sales force 1,000+
About 70% : Doctors and Pharmacists
Directly covering 9,000 hospitals and over
150,000 doctors, keeping the No.1 position
in pediatric drug market.
Sales & Marketing Manufacturing Beijing R&D center
New Biologics BIO Production NCE
- Auto-immune - Diabetes
- Obesity
- LAPScovery
products
PhD.11, MS. 81
Est. Oct 2008
Animal facility for rodents, beagles,
and primates
High-tech enterprise certification
Focus areas
R&D staffs 150+ GMP sites
To provide FPP to
Chinese market
Est. 1996 Full Value Chain : R&D to commercialization
Strong focus
on R&D
Partnership
& Alliance
China
Market
+500 R&D experts : Ph.D 64, MS. 305
+800 mil USD invested in the past decade
29 Programs in Pre-clinical & Clinical Development
Broadening global & regional partnership
Open innovation strategy
Synergy between Beijing Hanmi & Hanmi Korea
Competitive R&D supported by global talents
Profitable growth through business diversification
Strong focus
on R&D
Partnership
& Alliance
China
Market
+500 R&D experts : Ph.D 64, MS. 305
+800 mil USD invested in the past decade
29 Programs in Pre-clinical & Clinical Development
Broadening global & regional partnership
Open innovation strategy
Synergy between Beijing Hanmi & Hanmi Korea
Competitive R&D supported by global talents
Profitable growth through business diversification
30
-21.1% 31.4%
0.9% 25.3%
-19.1% 107.8%
-1.9% 25.0%
-25.6% -28.0%
35.9% 39.5%
-18.8% 8.3%
-15.0% 0%