Enhanced EGFR inhibition and distinct epitope recognition by EGFR ...
Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted...
Transcript of Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted...
35th Annual J.P. Morgan Healthcare Conference
Gwan Sun Lee President & CEO
This presentation contains forward-looking statements with respect to the financial
condition, results of operations and businesses of Hanmi Pharmaceutical Company.
By their nature, forward- looking statements and forecasts involve r isk and
uncertainty because they relate to events and depend on circumstances that will
occur in the future. There are a number of factors that could cause actual results
and developments to differ materially from that expressed or implied by these
forward-looking statements. These factors include, among other things, the loss or
expirat ion of patents, market ing exclusivi ty or trade marks; exchange rate
fluctuations; the risk that R&D will not yield new products that achieve commercial
success; the impact of competition, price controls and price reductions; taxation
risks; the risk of substantial product liability claims; the impact of any failure by
third parties to supply materials or services; the risk of delay to new product
launches; the difficulties of obtaining and maintaining governmental approvals for
products; the risk of failure to observe ongoing regulatory oversight; the risk that
new products do not perform as we expect; and the risk of environmental liabilities.
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Acquisition
in June 2016
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PAST PRESENT FUTURE
Strong cash flow from
traditional pharma business
through our own value-
added products & generics
Heavy investment in
innovation R&D from the
early 2000s
Robust pipeline from
in-house R&D as well as
open innovation
Leading in our core
businesses in Korea &
China
Investment in the highest-
potential business
To be a global R&D
powerhouse through
continuous new drug
discovery & development
in core therapeutic areas
To significantly grow
through innovative new
drugs
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Obesity Oncology Auto-immune Diabetes
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Obesity
Oncology
Auto-immune
Diabetes
Others
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B
B
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Key Features
Redirect immune cells to tumor cells
Natural IgG-like bispecific antibody format
Good stability and high production efficiency
Seeking collaboration opportunities
(PENTAMBODY + Novel target)
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Next generation bispecific antibody platform technology,
developed by Beijing Hanmi for both immunotherapy & targeted therapy
Tumor cell
Immune cell
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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
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LAPSCOVERY : Long-Acting Protein/Peptide Discovery
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3 Focus Areas
Obesity Diabetes Rare Diseases
(enzyme)
Seeking new opportunities by expanding indications
8 Programs
5 Clinical programs 3 Non-clinical programs
• LAPS GCSF
• LAPS hGH
• LAPS Insulin115
• LAPS Exd4
• LAPS GLP/GCG
• LAPS Insulin combo
• Diabetes/Obesity Program
• Rare Disease Program
LAPS is the best long-acting solution for ERT
PK extension with best-in-class
potential
(Subcutaneous self administration)
Higher exposure & tissue delivery
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HM95573, pan-RAF inhibitor
An orally active, selective and potent next generation
RAF inhibitor with anti-tumor effect on BRAF mutant
as well as RAS mutant cancer
A variety of science-driven combinations will be assessed, as well as monotherapy
Exclusive License Agreement with Genentech (Sep 2016)
Upfront : USD 80M / Milestones : up to USD 830M / Tiered double-digit royalty
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3rd generation EGFR targeted therapy
NDA approved and commercialized in Korea in
May 2016
Boehringer Ingelheim returned
development and global commercial rights
of olmutinib to Hanmi in Sep 2016
In China, IND submitted to CFDA by our
partner, Zai Lab
Seeking opportunities for global
collaboration
olmutinib Quantum Project
A portfolio of long-acting diabetes treatments :
1) efpeglenatide, 2) weekly insulin, and 3)
efpeglenatide/weekly insulin combo
Sanofi is responsible for the development
and commercialization of efpeglenatide
Sanofi returned its rights to Hanmi weekly
insulin in Dec 2016
Hanmi will continue its efforts, in solid
cooperation with Sanofi, for the
development and commercialization of
efpeglenatide/weekly insulin combo
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Korea China
Emerging market US / Europe
Sustain double-digit growth through
new value-added programs with data
exclusivity
Maintain a profitable performance with
Beijing Hanmi’s key brands
Seek synergies with JVM
Expand market access and enhance
sales for value-added programs
through partnership & collaboration
Continue our effort to develop and
commercialize Hanmi’s innovative
R&D pipeline with partners
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Double-digit
Rx Growth in 2016
CAPEX Completion of
New Plant
at Paltan site
15.3%* 8.8% 1+3
New Products
Launch 1 NCE & 3 value-
added products
2B
max.
10B
*Ubist, YOY growth rate of accumulated Rx until Nov 2016
Driving growth and delivering profits with new products
Capacity expansion for future global business
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Launching 2~3 products annually in the domestic market
8 new products under development
Seeking partners for emerging market business
‘Rosuzet® ’ Collaboration with MSD for 23 countries
*Incrementally Modified Drug **Fixed Dose Combination 15
Performance R&D Expand Local
Partnerships
Sustain No.1 position in
pediatric market
Maintain profits from key
brands
Business diversification
through JVM’s products
Focus on innovative R&D
for global development
strategy
160 R&D staffs
New platform technology
“Pentambody”
Fast & successful
development in collaboration
with local partners with in-
depth understanding of
Chinese market
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Hanmi Science acquired JVM in Jun 2016
Global No.1 company making automated system for hospitals & pharmacies
JVM’s competitive technology to create new value to Hanmi group
Sales and distribution by Online Pharm
R&D & manufacture by JVM
Beijing Hanmi will act as the operation
hub for JVM Chinese business
Build new business structure to
maximize synergistic effect
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To be more efficient and effective
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Thank you