Biotech Showcase 2016

Transcription

1 1 Biotech Showcase 2016

2 Our Value Proposition Advancing broad product pipeline of biosimilars and next generation antibody therapeutics Proven track record in superior quality, efficient R&D and manufacturing of biologics Improve access of high quality antibody therapeutics to serve patients globally 2

3 Corporate Overview Henlius Biopharmaceuticals is a specialty biologics company with operations in U.S., China & Taiwan Integrated biologics R&D and commercial manufacturing capabilities Shanghai Henlius is a joint venture with Fosun Pharma Henlix is a subsidiary of Henlius based in U.S. and Taiwan Broad product pipeline of biosimilar and novel antibodies HLX01 (Rituxan biosimilar) in Phase III development HLX02 (Herceptin biosimilar) entering Phase III in 2016 Pipeline of 6 novel antibody products in preclinical development Targeting key immuno-oncology and cancer pathways State-of-the art antibody discovery platform including ADC, bispecific and phage display IND submission with CFDA completed for 6 product candidates with 10 indications 190 employees/ftes 3

4 Experienced Team Scott Liu, Ph.D. Chief Executive Officer Weidong Jiang, Ph.D. Chief Scientific Officer Junli Zhang, Ph.D. Senior VP, Chief Operating Officer Eugene Liu, M.D., Ph.D., (Chief Medical Officer, VP Medical Affairs) Baolu Chen, Ph.D. VP, Quality & Chief Quality Officer Ziyang Zhong, Ph.D. VP, Research and Development (Henlius-TW) James Guo, MBA, VP, Regulatory Affairs Terry Chai, M.S., Director, Quality Control 4

5 Antibody R&D Capability at Henlix State-of-the-art antibody discovery platforms x naïve human phage display library - Conventional hybridoma technology - Antibody engineering and humanization technologies - Bispecific antibody platform - Antibody-Drug Conjugate (ADC) platform Enabling technologies to optimize antibody production - Proprietary monoclonal antibody gene expression system - Enhanced Fc functions through glycan engineering - Cell line development for scale-up production Accelerate access to US and Chinese markets - Concurrent IND-filings and conducting clinical trials in US, Taiwan and China x x x x x x x x x 5

6 Novel Antibody Pipeline at Henlix Highly productive integrated antibody discovery and development platform Research to preclinical candidate selection in less than 2 years Target to file 1 IND per year for the initial 2 years starting in IND per year starting in 2017 Product (MOA) HLX07 (a-egfr) Target IND Filed Target Cancers H&N, CRC, lung Research Candidate Selection Preclinical Phase I HLX06 (a-vegfr2) Oct 16 Solid tumors HLX10 (a-pd-1) Q1 17 Solid tumors HLX08 (a-pdgfra) Q1 17 Solid tumors HLX20 (a-pd-l1) Q2 17 Solid tumors HLX31 (a-her2/cd3) Q4 17 Solid tumors Current 1H

7 Biosimilar Pipeline at Henlius HLX01 Rituxan IND P 1 P 3 Launch HLX02 Herceptin PC IND P 1 P 3 Launch HLX03 Humira PC IND P 1 P 3 Launch HLX04 Avastin PC IND P 1 P 3 Launch HLX05 Erbitux PC IND P 1 P 3 Launch HLX11 Perjeta PC IND filing with CFDA completed for 5 product candidates for 8 indications HLX01 entered Phase 3 trial in 4Q, 2015 HLX02 anticipated to enter Phase 3 in 1Q,

8 Commercial Manufacturing Capability at Henlius Commercial facility located in Shanghai Conceptual, basic, and detailed designs have all been completed; began construction in Oct., 2014 Initial capacity of 2 x 2000L, expandable to N x 2000L; additional capacity available for partner s products Design based on single-use bioreactors; meeting CFDA, FDA & EMA requirements Construction completed in Q4,

9 Backup Deck

10 上海复宏汉霖生物技术有限公司 Henlius Biotech Co. Ltd. 10 The only drug that works is a drug that a patient can afford

11 Our Value Proposition Advancing broad product pipeline of biosimilars and next generation antibody therapeutics Proven track record in superior quality, efficient R&D and manufacturing of biologics Improve access of high quality antibody therapeutics to serve patients globally 11

12 Corporate Overview Henlius Biopharmaceuticals is a specialty biologics company with operations in U.S., China & Taiwan Integrated biologics R&D and commercial manufacturing capabilities Shanghai Henlius is a joint venture with Fosun Pharma Henlix is a subsidiary of Henlius based in U.S. and Taiwan Broad product pipeline of biosimilar and novel antibodies HLX01 (Rituxan biosimilar) in Phase III development HLX02 (Herceptin biosimilar) entering Phase III in 2016 Pipeline of 6 novel antibody products in preclinical development Targeting key immuno-oncology and cancer pathways State-of-the art antibody discovery platform including ADC, bispecific and phage display IND submission with CFDA completed for 6 product candidates with 10 indications 190 employees/ftes 12

13 Company Structure Henlius Biopharmaceuticals (Cayman) Fosun Pharma (China) Shanghai Henlius Biotech ( 复宏汉霖 ) (JV in Dec ) Henlius Biopharma ( 汉霖制药 ) (China) Henlix Biotech ( 汉霖生技 ) (Taiwan) Henlius Biopharm (U.S) Henlix, Inc. (U.S.) 13

14 Experienced Team Scott Liu, Ph.D. Chief Executive Officer Weidong Jiang, Ph.D. Chief Scientific Officer Junli Zhang, Ph.D. Senior VP, Chief Operating Officer Eugene Liu, M.D., Ph.D., (Chief Medical Officer, VP Medical Affairs) Baolu Chen, Ph.D. VP, Quality & Chief Quality Officer Ziyang Zhong, Ph.D. VP, Research and Development (Henlius-TW) James Guo, MBA, VP, Regulatory Affairs Terry Chai, M.S., Director, Quality Control 14

15 Biosimilar Pipeline at Henlius HLX01 Rituxan IND P 1 P 3 Launch HLX02 Herceptin PC IND P 1 P 3 Launch HLX03 Humira PC IND P 1 P 3 Launch HLX04 Avastin PC IND P 1 P 3 Launch HLX05 Erbitux PC IND P 1 P 3 Launch HLX11 Perjeta PC IND filing with CFDA completed for 5 product candidates for 8 indications HLX01 entered Phase 3 trial in 4Q, 2015 HLX02 anticipated to enter Phase 3 in 1Q,

16 Biosimilar Pipeline Status HLX01 Rituxan IND P 1 P 3 Launch HLX01: Rituxan (rituximab) Biosimilar Non-Hodgkin's Lymphoma (NHL) & Rheumatoid Arthritis (RA) NHL IND filed in Dec., 2011, IND approved in Mar., Phase 3 since Oct.,2015 RA IND filed in May, 2012,approved in April 2015 HLX02 Herceptin PC IND P 1 P 3 Launch HLX02: Herceptin (trastuzumab) Biosimilar Breast Cancer (BC), Gastric Cancer (GC) BC IND filed in Dec., 2012, IND approved in July, Entering Phase 3 in 2016 GC filed in April,

17 Biosimilar Pipeline Status cont d HLX03 Humira PC IND P 1 P 3 Launch HLX03: Humira (adalimumab) Biosimilar Rheumatoid arthritis (RA) & 7 other autoimmune disorders RA IND field in July, 2013 HLX04 Avastin PC IND P 1 P 3 Launch HLX04: Avastin (bevacizumab) Biosimilar Colorectal (mcrc), Lung (NSCLC), Renal, Brain cancers mcrc IND filed in Dec., 2013 NSCLC IND filed in July,

18 Biosimilar Pipeline Status cont d HLX05 Erbitux PC IND P 1 P 3 Launch HLX05: Erbitux (cetuximab) Biosimilar Colorectal cancer (mcrc) & Head & neck cancer (HNC) mcrc IND filed in Dec.2014 HNC filed in July 2015 HLX11 Perjeta PC HLX11: Perjeta (pertuzumab) Biosimilar Breast cancer Feasible to develop as antibody-drug conjugate (ADC) Preclinical development 18

19 International Standards: Structural Analysis All Rights Reserved

20 International Standards: Similarity Studies All Rights Reserved

21 Quality Assurance 21

22 Reduced COGS Through Innovation 22

23 Commercial Manufacturing Capability at Henlius Commercial facility located in Shanghai Conceptual, basic, and detailed designs have all been completed; began construction in Oct., 2014 Initial capacity of 2 x 2000L, expandable to N x 2000L; additional capacity available for partner s products Design based on single-use bioreactors; meeting CFDA, FDA & EMA requirements Construction completed in Q4,

24 International Standards: Commercial Manufacturing Facility 2500 m 2 per floor Total: 10,000 m 2 24

25 Henlix Inc. Accelerating Innovative Biotherapeutics to Improve Patient Lives Worldwide

26 Henlix Corporate Overview International biopharmaceutical company specialized in innovative antibody-based oncology therapeutics Experienced management with proven track record in advancing multiple biologics through approval Efficient antibody discovery and development platform Robust pipeline harnessing the power of key angiogenesis and immuno-oncology regulators IND filing of lead product to CFDA completed in 4Q

27 Our Value Proposition State-of-the-art antibody discovery platforms x naïve human phage display library - Conventional hybridoma technology - Antibody engineering and humanization technologies - Bispecific antibody platform - Antibody-Drug Conjugate (ADC) platform Enabling technologies to optimize antibody production - Proprietary monoclonal antibody gene expression system - Enhanced Fc functions through glycan engineering - Cell line development for scale-up production Accelerate access to US and Chinese markets - Concurrent IND-filings and conducting clinical trials in US, Taiwan and China x x x x x x x x x 27

28 Our Value Proposition cont d Team with extensive biologics research and development experience - Antibody discovery, high titer and high quality cell line and process development, manufacturing, quality, clinical and regulatory expertise Leverage strategic partnership with Shanghai Henlius (parent company of Henlix) - Commercial manufacturing, clinical trials and access to the China market Synergistic product pipeline including immunooncology - Worldwide rights addressing key unmet medical need - Lead product target for IND filing in 4Q

29 Henlix Antibody Discovery Process Lead Discovery Lead Optimization Candidate Selection IND Enabling Maximize lead discovery efficiency by using multiple approaches - Proprietary naïve human phage display library with (1.5 x ) - Conventional hybridoma technology Developed robust screening criteria utilizing multiple in vitro assays established for each project to determine: - Selectivity - Affinity - Potency Leverage state-of-the-art antibody technologies - Bispecific antibody platform - Antibody-Drug Conjugate (ADC) platform - Enhanced Fc functions through glycan engineering x x x x x x x x x 29

30 Henlix Antibody Discovery Process Lead Discovery Lead Optimization Candidate Selection IND Enabling Multiple strategies to improve binding affinity and efficacy - Humanization - Affinity maturation - Fc engineering Biochemical and biophysical characterization Exploratory in vivo experiments to rank order potential leads for optimization - Multiple in vivo PK/PD models - Broad range of tumor models - Benchmark with current standard of care or lead competitor 30

31 Henlix Antibody Discovery Process Lead Discovery Lead Optimization Candidate Selection IND Enabling Target product profile (TPP) for each program - TPP based on current standard of care or lead competitor product - Go/no go criteria to advance to IND enabling Multiple animal efficacy models - SC xenograft - Orthotopic - Syngeneic models In vivo pharmacology - Pharmacokinetics - Pharmacodynamics - Toxicology studies Reiterative process utilizing in vitro and in vivo models to enhance efficacy of preclinical candidate 31

32 Henlix Antibody Discovery Process Lead Discovery Lead Optimization Candidate Selection IND Enabling IND enabling studies - GLP normal tissue cross-reactivity - Monkey PK/PD study - GLP toxicology studies - Hemolytic potential - Plasma stability CMC - Cell line development - Process development - Analytics - Formulation - Quality - Scale-up IND filing preparation for FDA, TFDA and CFDA - Phase I in Taiwan, China and/or US - Phase II in China, Taiwan and/or US 32

33 Pipeline Targeting Key Cancer Pathways Highly productive integrated antibody discovery and development platform Research to preclinical candidate selection in less than 2 years Target to file 1 IND per year for the initial 2 years starting in IND per year starting in 2017 Product (MOA) HLX07 (a-egfr) Target IND Dec 15 Target Cancers H&N, CRC, lung Research Candidate Selection Preclinical Phase I HLX06 (a-vegfr2) Oct 16 Solid tumors HLX10 (a-pd-1) Q1 17 Solid tumors HLX08 (a-pdgfra) Q1 17 Solid tumors HLX20 (a-pd-l1) Q2 17 Solid tumors HLX31 (a-her2/cd3) Q4 17 Solid tumors Current 1H