Paltan Plant FPP Manufacturing Sites. Pyeongtaek Plant Bio Plant Cepha Plant. Hanmi Fine Chem API Business
|
|
- Bonnie Anthony
- 5 years ago
- Views:
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/ LAPS Insulin Analog HM12460A/HM12470 Diabetes SPECTRUM/LUYE Pan-HER Inhibitor Poziotinib Solid tumor ATHENEX Oraxol ** Paclitaxel+HM30181A Breast cancer LAPS Glucagon Analog HM15136 Congenital Hyperinsulinism INNOVENT B PD-1/TAA1 Solid tumor Targeted Immuno-oncology 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/TAA2 Solid tumor Targeted Immuno-oncology ATHENEX Oratecan Irinotecan+HM30181A Solid tumor ALLEGRO Luminate Integrin inhibitor DME LAPS GLP-2 Analog HM15910 Short Bowel Syndrome B PD-1/TAA3 Solid tumor Targeted Immuno-oncology 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 Amosartan Plus approved in June, Amosartan Q in July 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 17.0% 35.6% 32.6% 34.1% 25.4% 42.7% 40.9% 41.2% 28
29 29
30 -14.9% 7.2% -8.7% -13.6% -25.6% -1.8% -5.6% -10.7% 9.7% 24.5% -25.0% -32.1% 53.8% 53.8% -22.2% -17.6% 30
31 31
32 32
33 33
34 34
35