Paltan Plant FPP Manufacturing Sites. Pyeongtaek Plant Bio Plant Cepha Plant. Hanmi Fine Chem API Business

Size: px
Start display at page:

Download "Paltan Plant FPP Manufacturing Sites. Pyeongtaek Plant Bio Plant Cepha Plant. Hanmi Fine Chem API Business"

Transcription

1

2 2

3

4 4

5 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 Pyeongtaek Plant Bio Plant Cepha Plant Production of IND(Investigational new biologics) and Cepha FPP The 2 nd 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 5

6 PAST PRESENT FUTURE Strong cash flow from traditional pharma business through inhouse 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

7

8 1,500 Sales R&D 14.2% 1, , % % 20.0% %

9 9

10 AGLYCOSYLATED FC AGLYCOSYLATED FC Therapeutic Agent : Natural/Unnatural peptide Flexible Linker :Reduce Immunogenicity Minimized loss of activity No loss of FcRn binding Aglycosylated Fc : Increase solubility 10

11 Next-generation bi-specific antibody platform technology Discovery by Beijing Hanmi with dual immunotherapy & targeted therapy Immune cell Tumor cell Key Features Redirect immune cells to tumor cells P E N O D Y Natural IgG-like bi-specific antibody format Good stability and high production efficiency T B Seeking collaboration opportunities A M (PENTAMBODY + Novel target) 11

12 Redirect immune cells to tumor cells Better anti-tumor activity compared to combination Pentambody applied PD-1/HER2 BsAb Cell-to-cell association (%) using SK-BR-3 and CHO-PD1 cells by FACS 1 Pentambody applied PD-1/PD-L1 BsAb Cell cytotoxicity assay using PD-L1 expressed NSCLC cell 2 Anti-PD-L1 mab: IC 50 >2,000 pm Anti-PD-1 mab: IC pm Combination: IC pm PD-1/PD-L1 BsAb (BH2941): IC pm 1 HER2 positive SK-BR-3 stained with CFSE, CHO-PD1 stained with PKH26, Test article 100nM, 30min; 2 E (activated hpbmc) : T (HCC827) = 20 : 1, 72hr 12

13 Pre-Clinical Phase 1 Phase 2 Phase 3 SANOFI LAPS Insulin Combo HM14220 Diabetes FLT3 Inhibitor HM43239 AML JANSSEN LAPS GLP/GCG HM12525A Diabetes/Obesity SANOFI LAPS Exd4 Analog Efpeglenatide Diabetes/Obesity SPECTRUM Rolontis Eflapegrastim Neutropenia LAPS Triple Agonist HM15211 Obesity, NASH AJOU Univ GMB Stem Cell Therapy HM21001 Glioblastoma LAPS Insulin HM12470 Diabetes SPECTRUM/LUYE Pan-HER Inhibitor Poziotinib Solid tumor ATHENEX Oraxol ** Paclitaxel+HM30181A Breast cancer LAPS Glucagon Analog HM15136 Congenital Hyperinsulinism B PD-1/HER-2 BH2950 Breast, Gastric cancer GENENTECH Pan-RAF Inhibitor HM95573 Solid tumor ELI LILLY BTK Inhibitor HM71224 Autoimmune diseases ZAI LAB Olita * Olmutinib NSCLC LAPS ASB HM15450 Mucopoysaccharidosis B PD-1/EGFR BH2922 NSCLC, Colorectal cancer ATHENEX Oratecan Irinotecan+HM30181A Solid tumor ALLEGRO Luminate Integrin inhibitor DME LAPS GLP-2 Analog HM15910 Short Bowel Syndrome PD-1/PD-L1 BH2941 Cancer B ATHENEX Src/Tubulin KX2-391 Solid tumor LAPS hgh Efpegsomatropin GH deficiency Diabetes/Obesity Rare Diseases Cancer Autoimmune Diseases Others B Beijing Hanmi 13

14 Launching 2~3 products annually in the domestic market Seeking partners for emerging market business Rosuzet Collaboration with MSD for 23 countries Plan to launch in 2017 *Incrementally Modified Drug **Fixed Dose Combination 14

15 Strong focus on R&D +500 R&D experts : Ph.D 64, MS mil USD invested in the past decade 29 Programs in Pre-clinical & Clinical Development Partnership & Alliance Broadening global & regional partnership Open innovation strategy China Market Synergy between Beijing Hanmi & Hanmi Korea Competitive R&D supported by global talents Profitable growth through business diversification

16 Est Full Value Chain : R&D to commercialization Beijing R&D center Manufacturing Sales & Marketing R&D staffs 150+ PhD.11, MS. 81 Est. Oct 2008 Animal facility for rodents, beagles, and primates High-tech enterprise certification Focus areas NCE New Biologics - Auto-immune - Diabetes - Obesity BIO Production - LAPScovery products GMP sites To provide FPP to Chinese market 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. 16

17 17

18 Strong focus on R&D +500 R&D experts : Ph.D 64, MS mil USD invested in the past decade 29 Programs in Pre-clinical & Clinical Development Partnership & Alliance Broadening global & regional partnership Open innovation strategy China Market Synergy between Beijing Hanmi & Hanmi Korea Competitive R&D supported by global talents Profitable growth through business diversification

19 19

20 Strong focus on R&D +500 R&D experts : Ph.D 64, MS mil USD invested in the past decade 29 Programs in Pre-clinical & Clinical Development Partnership & Alliance Broadening global & regional partnership Open innovation strategy China Market Synergy between Beijing Hanmi & Hanmi Korea Competitive R&D supported by global talents Profitable growth through business diversification

21 21

22 22

23 23

24 24

25 25

26 26

27 27

28 -7.3% 2.1% -2.7% -3.2% 1.0% 11.5% 5.7% 5.8% 28

29 0% %) TTB %) TTB %) TTB 29

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% 30

31 31

32 32

33 33

34 34

35