法人說明會年度報告 陳念宜副總經理

Transcription

1 法人說明會年度報告 陳念宜副總經理

2 免責聲明 2 The statements and contents included in this presentation that are not historical in nature are forward-looking statements. These forwardlooking statements, which may include statements regarding our future results of operations, performance, financial condition, development or marketing of our products or business prospects, are subject to risks and uncertainties and are based on our current expectations. Actual results may differ materially from those expressed or implied in these forward-looking statements for a variety of reasons. Please be cautioned not to place undue reliance on these forward-looking statements which are based on information currently available. Our forward-looking statements at this time does not create any duty of disclosure beyond that which is imposed by law, and we expressly disclaim any obligation to publicly update or revise any forecasts or forward-looking statements, whether as a result of new information, future events or otherwise.

3 3 泉盛生技簡介 ( 中天生技集團成員 ) Established in Taiwan in December Publicly quoted on the Taiwan Stock Exchange. Specialized in therapeutic mab for treating Allergic diseases, Cancers and Autoimmune diseases. Global drug development strategy The benchmark highlights Bio-tech company in Taiwan in 2015

4 泉盛核心平台 4 Human Antibody Platform Preclinical Ability Clinical Experience Allergy Manufacturing Process Development Core platform Oncology Analytical Method Auto-immune diseases Animal Facility Infectious diseases

5 5 核心技術 (1/3) 全人抗體庫 Well Selection of large scale of antigens > clones Beads Cancer cell Presentation of the 3D structure of antigen Naturally presented antigen Discover novel therapeutic target > clones Artificial cell Decrease non-targeted binding Nature antigen Animal Rule out non-targeted binding in whole body Discover novel therapeutic target To date, validated antibodies against more than 12 targets.

6 核心技術 (2/3) IgE 相關技術 6 IgE Knowledge Therapeutics for Allergic Diseases Specialized Assay Platform Anti-CemX Antibody Anti-IgE Antibody Unique Animal Model Many Others

7 核心技術 (3/3) 生產製程開發 7 Cell Line Development Clone and Process Screening Formulation Development upto 6 g/l Upstream Process Development Product Analysis Quality Control Downstream Process Development Robust Process, High Product Quality, High Productivity

8 8 動物試驗中心獲 AAALAC 國際認證最高級 - 完全認證 (Full Accreditation Granted) ISO Accredited Lab SPF Facility Novel Platform Cancer (xenograft/orthotopic/metastasis) PBMC/SCID-hIgE Rheumatoid Arthritis Graft-versus-host disease Customized

9 風險平衡導向產品線 9 Name Type Target Indications Stage FB825 Humanized IgG1 CemX Segment Atopic Dermatitis Allergic Rhinitis US Phase I Completed FB317 Humanized IgG1 (Omalizumab) IgE Fc Allergic Asthma Chronic Urticaria CFDA IND reviewing FB704A Human IgG1 IL-6 Rheumatoid Arthritis Cytokine Strom Cancers Preclinical CMC/TOX in US FB121 Humanized IgG4 (Ibalizumab) CD4 HIV Infection Preclinical MCB Ready Balanced with high risk innovative pipelines and low risk biosimilars

10 主要產品 10 FB825 Long-lasting medication for IgE-related allergic diseases US phase I trial competed, approaching to phase II trial Patent secured in 12 countries covering antibody, epitope, and vaccine application. Funded 50 million NTD by MOEA FB704A Multiple indications with huge market Funded 40 million NTD by MOEA Executing Scale-up manufacturing and GLP toxicology studies in US

11 FB825 Anti-CemX 抗體新藥 長效型 IgE 相關過敏性疾病治療新藥

12 新一代過敏疾病單株抗體藥物 12 FB825 (IgE-B-cell depletion) Omalizumab (IgE neutralization) Sources: Allergens: dust mite, pollen, etc. Allergen DC MHCII TCR T H B mige PC Result A large number of inflammatory substances cause allergic reactions MC Histamine; serine proteases; leukotrienes; prostaglandins; cytokines; chemokines MC IgE FceRI

13 FB825 專一性結合獨特的 CemX 抗原決定位 13 Free IgE mige Anti-IgE Omalizumab Anti-CemX FB825 By binding to the unique CemX segment, FB825 is not sensitive to IgE level as the result no limitation in patient selection.

14 FB825 優勢與發展利基 14 Items FB825 Omalizumab Target CemX on mige B Cells IgE Fc Mechanism of Action Depleting mige B Cells Neutralizing IgE Limitation in Patient No limitation IgE < 1500IU/ml Treatment Interval 12 weeks or more 2-4 weeks Safety Less likely to induce Anaphylaxis Warring for inducing Anaphylaxis Treatment Outcome Disease Modifying Symptom Relieving

15 FB825 完整專利佈局 Territory Status Patent No. Australia Granted B2 Bazile Office Action China Granted ZL Hong Kong Granted HK Macau Granted J/ EU Office Action India Office Action Indonesia Granted W Israel Granted Japan Granted Korea Granted Malaysia Office Action Mexico Approval Process Russia Granted Singapore Granted South Africa Granted 2012/09640 Thailand Office Action USA Granted IP protection for both CemX epitope and FB825 US B2

16 FB825 美國臨床一期試驗設計 16 A Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of singleascending intravenous doses of FB825 Additional assessments with serum concentration of FB825, total IgE, and presence of anti-drug-antibody up to 140 days (Days 5, 14, 29, 85, 140). Cohort F E D C B A IV mg/kg (4: 3) Active: Placebo IV 0.03 mg/kg (4: 3) IV 0.3 mg/kg (7: 3) IV 1.5 mg/kg (7: 3) IV 5 mg/kg (7: 3) IV 10 mg/kg (7: 3)

17 FB825 安全無虞 17 There were no deaths or TEAEs that led to early discontinuation. All TEAEs resolved by the end of the study. No significant difference in the incidence of AE between FB825 and placebo

18 FB825 展現優異的藥物動力特徵 18 Cohort T 1/2 (days) Mean ±SD 1.5 mg/kg ± mg/kg ± mg/kg ±3.16

19 單劑量 FB825 即可減少 50% 總免疫球 蛋白 E(IgE) 之表現 19 Potentially 3 months per Dose

20 FB825 將可降低 66% 至 83% 藥價 20 Annual Cost of current treatment Annual Cost of FB825 treatment US dollar % Reduced Dose level Twice monthly Once monthly Once every 3 months 150 mg/dose 300 mg/dose $15,384 $7,692 $2, %, 66.7% $28,368 $14,184 $4, %, 66.0% Assumption: $541 for 150 mg dose, $100 per doctor s office visit

21 FB825 具有藥物經濟學優勢 21 Better PD profile with potential quarterly dosing Product Target Company Status Dosing Maintenance Anti-CemX mige Fountain Phase I 12 w Mono Therapy Omalizumab IgE Roche/Novartis Approved 2-4w Ligelizumab IgE Novartis Phase II 2-4w Dupilumab IL-4Ra Regeneron/Sanofi Phase III 1-4w Market Penetration Mepolizumab IL5 GSK Approved 4 w Lebrikizumab IL13 Roche Phase III 4 w 21

22 FB825 市場潛力雄厚 22 Global market of allergic diseases exceeds 26 billion USD Product Target Indication Potential Market In 2020 (mus$) Omalizumab IgE Asthma, Urticaria 3,000 Dupilumab IL-4Ra Atopic Dermatitis 746 Mepolizumab IL5 Asthma 1,161 Lebrikizumab IL13 Asthma, COPD 308 Source: Adapted from DataMonitor, BioPharma Dive,

23 FB825 Anti-CemX 人源化單株抗體 Indication Advantages Over Current Product Potential Market Competitive Edge Atopic dermatitis IgE-related allergy Larger patient pools, not interfered by serum IgE Pharmaco-economics, potential quarterly dosing or longer 20-30% population have allergic conditions. Global market of allergic diseases exceeds 26 billion USD Patent protection covers target and antibody Replace current IgE related therapeutics Status US FDA Phase I 23

24 FB704A Anti-IL6 亞洲第一個抗 IL-6 全人單株抗體新藥可廣泛應用於多種適應症

25 IL6 為已認可之藥物開發標的 25 Multiple Indications Mechanism of Action Cancers Multiple Myeloma EV71 Virus Cytokine Strom Dengue Virus Prostate Cancer Influenza Virus Castleman's Disease FB704A CAR-T Cachexia Rheumatoid Arthritis Systemic Lupus Erythematosus Juvenile Idiopathic Arthritis Ankylosing Spondylitis Autoimmune 25

26 FB704A 較市場指標藥物更具發炎抑制性 26 HUVAC cells Human PBMC Fibroblast-like synoviocytes (RA-FLS) Tocilizumab FB704A Isotype Control 26

27 FB704A 專利佈局 27 Territory Application Status Taiwan Granted in Sep China Office Action European Office Action USA Granted in Jan Israeli Office Action Indian Office Action Russian Office Action Korea Office Action Japan Office Action Canada Submitted Australia Submitted 27

28 FB704A 毒理學研究摘要 28 FB704A is well-tolerated in cynomolgus monkeys Species/ Strain Method of Administration Doses (mg/kg) Gender and No. per Group Observed Maximum Nonlethal Dose (mg/kg) Approximate Lethal Dose (mg/kg) Noteworthy Findings Testing Facility Single-Dose Toxicity Cynomolgus Monkeys IV 0, 1, 10, 100 1M, 1F 100 >100 FB704A was welltolerated in all cynomolgus monkeys at IV doses of 3 dosing groups and the NOAEL was considered to be 100 mg/kg. PharmaLegacy Laboratories, Inc. Other Toxicity Studies Cynomolgus Monkeys IM 200 µg /monkey Serum from the 3 animals from terminal blood draws were collected, pooled and subjected to purification. Charles River Laboratories

29 FB704A 相關的市場價值預估 29 Category Potential Market (billion US$) Anti-TNFa 30.0 Rheumatoid Arthritis 15.1 Castlemen s disease 0.7 CAR-T 15.0 Adapted from: Decision Resources, IMS, and EvaluatePharma

30 抗 IL6 抗體國際授權案例 30 Company Product Stage Licensor Upfront m$ Milestones Alder Biopharma ALD-518 Phase IIa BMS UCB CDP6038 Phase II R-Pharma N/A N/A Medimmune (AZ) MEDI5117 Pre-IND WuXi JV N/A Eleven Biotherapeutics EBI-031 IND Roche

31 FB704A 抗 IL-6 全人單株抗體 Indication Advantages Over Current Product Potential Market Competitive Edge Rheumatoid Arthritis Cancers Cytokine storm Fully human antibody with lower immunogenicity Target to ligand results better safety profile Superior efficacy and half-life over current treatments Global market of TNFa related diseases exceeds 30 billion USD Benefit for anti-tnfa non-responders (30%) Expended markets with multiple indications Status Preclinical study (CMC & Tox) 31

32 展望 32 Being a world leading company in developing long lasting treatment for IgE related allergic diseases. Securing market value with multiple applications of anti-il6 antibody Providing safe, efficient, convenient, and affordable solutions for patients globally.

33 誌謝 33 Academia Sinica, Taiwan Dr. Tse-Wen Chang Dr. Han-Chung Wu Taiwan University Hospital Dr. Chia-Yu Chu Fountain Team And many others

34 Thank you very much For further inquiry please contact Wayne Tan at NienYi Chen at