Beone Medicines Ltd. Class A · SSE:688235
Beone Medicines Ltd. Class A — BeiGene — J.P. Morgan Healthcare Conference 2020
82 slides from Beone Medicines Ltd. Class A's conference presentation, Jan 13, 2020
Slide 1: J.P. Morgan Healthcare Conference 2020
J.P. Morgan Healthcare Conference 2020 January 12, 2020
Slide 2: Forward-looking statements
• Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Examples of such forward-looking statements include statements regarding clini
Slide 3: Fully-Integrated Global Biotech Company With Unique Strategic Competitive Advantages
Fully-Integrated Global Biotech Company With Unique Strategic Competitive Advantages in Clinical Science and China Commercial Broad portfolio over 30 assets Global 3,400+ organization Key 2020 catalysts • 6 commercial assets • 10 offices on 4 continents • Up to 9 potentially registration- • 5 NDAs i
Slide 4: Significant Recent Accomplishments
Significant Recent Accomplishments + tislelizumab Global $2.8 billion U.S. approval Read out of China Opening of strategic investment for R/R MCL1 head-to-head approval for state-of-the-art collaboration zanubrutinib R/R cHL2 biologics vs ibrutinib manufacturing3 in WM 1. November 14, 2019; this ind
Slide 5: Transformational Collaboration with Amgen
Transformational Collaboration with Amgen Validates BeiGene’s China-inclusive global development and commercial capabilities • Collaboration rationale − Joining forces to fight one common enemy: cancer − Expected to accelerate access to important oncology medicines for patients in China and globally
Slide 6: Rapid Developments in China Create an Historic Opportunity
Rapid Developments in China Create an Historic Opportunity for New Global Industry Leaders to Emerge China is the second largest MNC Oncology Product Sales in China($M) pharmaceutical market in the world with large unmet medical 2019 (Q1-3) YoY Growth: 68% needs and patient resources: 4.3 million ne
Slide 7: Our Strategies for Building a Leading Global Innovative Biotech Company from China
Our Strategies for Building a Leading Global Innovative Biotech Company from China • Realize two large internally-developed near-term commercial opportunities ⎻ BRUKINSA (zanubrutinib) for the global market as a potentially best-in-class BTK inhibitor ⎻ Tislelizumab as a uniquely designed PD-1 antib
Slide 8: China Is Becoming an Important Clinical Science Center
China Is Becoming an Important Clinical Science Center BeiGene is well-positioned within this ecosystem; leveraging our platform to expand the portfolio NMPA reforms expand Effectively operating in But BeiGene Uniquely Well- China’s role in global China can significantly bottlenecks development enha
Slide 9: Brukinsa (Zanubrutinib): Significant Commercial Opportunities
Brukinsa (Zanubrutinib): Significant Commercial Opportunities Potentially best-in-class BTK inhibitor ▪ Second generation, maximize BTK occupancy, minimize off-target binding ▪ Advantageous label in R/R MCL (59% CR, dosing flexibility- QD/BID, 100% BTK occupancy, PPI/H2RA) ADVANTAGES ▪ Randomized Ph
Slide 10: ASPEN Efficacy and Safety Favors Zanubrutinib
ASPEN Efficacy and Safety Favors Zanubrutinib • Head-to-head trial of zanubrutinib vs. ibrutinib in WM patients • First report of a randomized Phase 3 study comparing two BTK inhibitors OVERALL OVERALL Zanubrutinib Ibrutinib Zanubrutinib Ibrutinib (N = 102) (N = 99) (N =101) (N = 98) Any Adverse Eve
Slide 11: Tislelizumab: Significant Commercial Opportunities
Tislelizumab: Significant Commercial Opportunities PD-1 inhibitor targeting Asia-prevalent tumors ▪ Differentiated mechanism: minimized binding to FcγR ▪ Differentiated Hodgkin’s data with high CR rate ADVANTAGES ▪ To enable broad reimbursement, aggressively pursuing label in most common cancers in
Slide 12: Our Leadership Team
Our Leadership Team Attracting global talent to build a world-class team John V. Oyler Xiaodong Wang, Ph.D. Xiaobin Wu, Howard Founder, CEO, and Chairman Founder and Chairman SAB Ph.D. Liang, Ph.D. BioDuro, Galenea, Telephia, NIBS: National Institute of Biological GM of China, CFO and Chief Genta, M
Slide 13: Established Commercial Footprint in the Two Largest Pharmaceutical Markets
Established Commercial Footprint in the Two Largest Pharmaceutical Markets in the World Marketed product growth and commercial team expansion Marketed brand revenue A growing 900+1 top innovative oncology commercial since transition to BeiGene team covering 800 – 1,000 hospitals in China 1000 80 800
Slide 14: Growing Commercial-Stage Portfolio
Growing Commercial-Stage Portfolio Global China COMMERCIAL 2018 GLOBAL PRODUCT LEAD INDICATIONS MECHANISM OF ACTION REGULATORY STATUS RIGHTS SALES Approved in the U.S. R/R mantle cell lymphoma BTK inhibitor NA NDA filed in China tislelizumab R/R classical Hodgkin’s Anti-PD-1 antibody Approved in Chi
Slide 15: BeiGene Selected Product Portfolio and Pipeline
BeiGene Selected Product Portfolio and Pipeline Global Four marketed products, three late-stage, and eight early-stage clinical assets China DOSE ESC. DOSE EXPANSION PIVOTAL COMMERCIAL ASSETS PROGRAMS FILED MARKET PH1a PH1b PH2* PH2** PH3 RIGHTS R/R MCL (Accelerated approval in the U.S. Nov. 14, 201
Slide 16: Amgen Collaboration Assets Further Broaden BeiGene's Portfolio
Amgen Collaboration Assets Further Broaden BeiGene’s Portfolio Total of 20 pipeline assets HEMATOLOGIC TUMORS SOLID TUMORS ASSET TARGET INDICATION MODALITY STAGE ASSET TARGET INDICATION MODALITY STAGE AMG 701 BCMA MM HLE BiTE Phase 1 AMG 510 KRAS G12C Solid tumors SM Phase 1 AMG 420 BCMA MM BiTE Pha
Slide 17: BeiGene – Striving to Be the Partner of Choice
BeiGene – Striving to Be the Partner of Choice Leveraging China for global clinical development • Unique value proposition for partners to accelerate global trials through heavily China- inclusive clinical development ⎻ Hard-to-recreate ability, and scale ⎻ Leader for innovative science-based commer
Slide 18: Financial Summary
Financial Summary Selected Financials Nine Months Ended Amounts in millions of U.S. dollars Sept. 30, 2019 Sept. 30, 2018 (unaudited) (unaudited) Total Revenue $ 371 $ 140 Product revenue, net 166 93 Collaboration revenue 206 46 Total Expenses (943) (565) Cost of sales – products (53) (20) Research
Slide 19: Upcoming Milestones and Catalysts
Upcoming Milestones and Catalysts Zanubrutinib (BTK Inhibitor) Timing Approval ▪ Approval in China for R/R MCL and R/R CLL/SLL ▪ 1H20 Submission ▪ File sNDA for WM in China ▪ 2020 Regulatory ▪ Discuss ASPEN data with US FDA and EMA ▪ 1H20 Data ▪ Present full Phase 3 data of zanubrutinib vs. ibrutini
Slide 20: Key Takeaways
Key Takeaways • Major achievements in 2019 further transformed BeiGene ⎻ Strategic collaboration with Amgen, Brukinsa US approval, topline data readout from ASPEN trial, tislelizumab China approval, opened Guangzhou plant • 2020 could be another exciting year for BeiGene ⎻ Catalysts include pivotal
Slide 21: Thank You
Thank You 21
Slide 22: Backup
Backup
Slide 23: Other Clinical-Stage Drug Candidates and Internal Combinations
Other Clinical-Stage Drug Candidates and Internal Combinations ROBUST PIPELINE BEYOND BTK AND PD-1 Global China DOSE ESC. DOSE EXPANSION pamiparib • Late stage studies in ovarian cancer in China INDICATIONS * (PARP1&2 Inhibitor) • Combination studies with temozolomide PH1a PH1b PH2 sitravatinib1 • C
Slide 24: China Label: Summary of Adverse Reactions in BGB-A317-203 Study
China Label: Summary of Adverse Reactions Occurring in ≥5% of Patients in BGB-A317-203 Study1 Tislelizumab 200mg every 3 weeks n=70 Tislelizumab 200mg every 3 weeks n=70 Preferred term† All grades*, n(%) ≥Grade3**, n(%) Preferred term All grades*, n(%) ≥Grade3**, n(%) General disorders and administr
Slide 25: Strong Manufacturing Capabilities
Strong Manufacturing Capabilities MULTI-FUNCTIONAL • Manufacturing collaborations with BIOLOGICS leading high-quality manufacturers MANUFACTURING in biologics and small molecules MANUFACTURING FACILITY IN SUZHOU • BI collaboration established in FACILITY IN 2013; cell line and CMC process GUANGZHOU
Slide 26: Review of Product Candidates
Review of Product Candidates
Slide 27: Overview of Zanubrutinib (BGB-3111)
• Optimized pharmacologic properties relative to ibrutinib: superior bioavailability and higher selectivity OVERVIEW • Development hypothesis: more complete target inhibition, deeper responses, and Overview of favorable safety profile Zanubrutinib • More than 1,7001 patients enrolled across trials,
Slide 28: Brukinsa Broad Clinical Development Program
Brukinsa Broad Clinical Development Program Nine ongoing potentially registration-enabling studies Pivotal Phase 2 (n=86) in R/R MCL Approved zanu monotherapy, PE: ORR Phase 3 (n=500) in 1L MCL Phase 1/2 cohort (n=45) in MCL MCL Initiated: Mar 2017, Enrollment complete: Sep 2017 R+zanu vs. R+chemo,
Slide 29: Zanubrutinib Clinical Program
Zanubrutinib Clinical Program Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) FILED MARKET*** PH1a PH1b PH2* PH2** PH3 R/R MCL (Accelerated approval by US FDA Nov 14, 2019) R/R MCL (NDA accepted by NMPA) R/R CLL/SLL (NDA Accepted by NMPA) WM: zanubrutinib vs. ibrutinib, ASPEN (T
Slide 30: Zanubrutinib – Pharmacokinetics Profile
Zanubrutinib – Pharmacokinetics Profile zanubrutinib ibrutinib acalabrutinib Data from separate Ph1/2 trials^ 700 700 700 Ph3 Dose: Approved Doses: Ph3 Dose: • 160mg BID • 420mg QD for CLL/WM • 100mg BID 600 600 600 • 560mg QD for MCL/MZL 500 500 500 400 400 400 300 300 300 200 200 Adapted from 200
Slide 31: ASPEN Topline Efficacy Summary: Response Rate
ASPEN Topline Efficacy Summary Primary Endpoint Response Rate* Relapsed or Refractory Overall Zanubrutinib Ibrutinib Zanubrutinib Ibrutinib (N = 83) (N = 81) (N = 102) (N = 99) CR 0 0 0 0 VGPR 24 (28.9) 16 (19.8) 29 (28.4) 19 (19.2) PR 41 (49.4) 49 (60.5) 50 (49.0) 58 (58.6) MR 13 (15.7) 11 (13.6) 1
Slide 32: ASPEN Topline Efficacy Summary: Landmark PFS and OS
ASPEN Topline Efficacy Summary Landmark Data PFS and OS* Relapsed or Refractory Overall Zanubrutinib Ibrutinib Zanubrutinib Ibrutinib (N = 83) (N = 81) (N = 102) (N = 99) 6-month PFS, % 96.3 91.1 95.0 91.6 (CI) (88.9 - 98.8) (82.3 - 95.7) (88.4 - 97.9) (83.9 - 95.7) 12-month PFS, % 92.4 85.9 89.7 87
Slide 33: ASPEN Topline Safety: Overall Summary
ASPEN Topline Safety: Overall Summary Overall Zanubrutinib Ibrutinib (N =101) (N = 98) Any Adverse Event (AE) 98 (97%) 97 (99.0%) Grade 3 or Higher AE 59 (58.4%) 62 (63.3%) Serious Adverse Event (SAE) 40 (39.6%) 40 (40.8%) Fatal AE 1 (1%) 4 (4.1%) AE Leading to Treatment Discontinuation 4 (4%) 9 (9.
Slide 34: ASPEN Adverse Events of Special Interest
ASPEN Adverse Events of Special Interest Overall Zanubrutinib Ibrutinib (N = 102) (N = 99) AEs of Interest, n, % Atrial fibrillation/flutter (all grades) 2 (2.0%) 15 (15.3%) Minor bleeding 49 (48.5%) 58 (59.2%) (bruising, contusion, petechiae) Major hemorrhage* 6 (5.9%) 9 (9.2%) Diarrhea (all grades
Slide 35: Zanubrutinib MYD88WT Data Suggest Activity in Difficult-to-Treat WM Patients
Zanubrutinib MYD88WT Data from Phase 3 Cohort 2 and Phase 1 Suggest Activity in Difficult-to-Treat WM Patients Best response, Phase 3 cohort 21 Phase 12 n (%) (n=26) (n=8) EHA 2019 ORR 21 (80.8) 7(87.5) MRR 14 (53.8) 5(62.5) CR / VGPR 6 (23.1)a,b 2(25.0) PR 8 (30.8) 3(37.5) MR 7 (26.9) 2(25.0) SD 4
Slide 36: Zanubrutinib Efficacy in R/R MCL
Zanubrutinib Efficacy in R/R MCL From U.S. approved label Best Response Zanubrutinib RR RR Study BGB-3111-206 BGB-3111-AU-003 Source Ph2 study Ph1/2 study Evaluable for efficacy, n 86 32 Median DoR in months 19.5 (16.6, NE) 18.5 (12.6, NE) Response Criteria Lugano 2014 Median Prior Lines of Therapy
Slide 37: Zanubrutinib Efficacy in CLL/SLL – Phase 1/2
Zanubrutinib Efficacy in CLL/SLL Frequent and durable responses – Phase 1/2 Overall Response Rate (ORR) Progression Free Survival (PFS) zanubrutinib TN CLL R/R CLL Total CLL n 16 50 66 free Median follow- - 7.6 14.0 10.5 up (mo) Best Response ORR 16 (100%) 46 (92%) 62 (94%) CR 1 (6%) 1 (2%) 2 (3%) S
Slide 38: Zanubrutinib Efficacy in CLL/SLL – Phase 2
Zanubrutinib Efficacy in CLL/SLL Frequent and durable responses – Phase 2 Best Overall Response by IRC (ORR) Progression Free Survival by IRC (PFS) zanubrutinib Total CLL n 91 Median follow-up (mo) 15.1 Best Response ORR 77 (84.6%) CR 3 (3.3%) PR 54 (59.3%) PR-L 20 (22.0%) SD 4 (4.4%) Non-evaluablea
Slide 39: Ibrutinib Efficacy in CLL/SLL
Ibrutinib Efficacy in CLL/SLL Overall Response Rate (Relapsed / Refractory) Progression Free Survival (Relapsed / Refractory) n=85 free - Median FU (mo) 20.9 Best Response ORR 75 (88%) CR 2 (2%) PR 58 (68%) Survival PR-L 15 (18%) SD NR PD NR Probability Progression of Probability Overall Response Ra
Slide 40: Ibrutinib Discontinuation in CLL/SLL
Ibrutinib Discontinuation for toxicity or progression in CLL/SLL Treatment-Naïve (n=80) Relapsed/Refractory (n=536) Total (n=616) Median Follow-Up 14.5 months Total Treatment Discontinuation 19 (24%) 231 (43%) 250 (41%) Toxicity/Tolerability 12 (15%) 117 (22%) 129 (21%) CLL/SLL Progression 3 (4%) 49
Slide 41: Zanubrutinib Discontinuation in CLL/SLL is Uncommon
Zanubrutinib Discontinuation for toxicity or progression in CLL/SLL is uncommon Treatment-Naïve (n=18) Relapsed/Refractory (n=51) Total (n=69) Median Follow-Up 10.3 months Total Treatment D/C 0 (0%) 2 (4%) 2 (3%) Toxicity/Tolerability 0 (0%) 1 (2%) 1 (1%) CLL/SLL Progression 0 (0%) 0 (0%) 0 (0%) Tra
Slide 42: Zanubrutinib Safety and Tolerability Summary
Zanubrutinib Safety and tolerability summary; over 600-patient experience Adverse Events of Interest for BTK Inhibitors in Patients Treated with Zanubrutinib Zanubrutinib Zanubrutinib AE of Interest (All Causes)1 (Including Patients AE of Interest (All Causes)2 (Single Agent Only) Enrolled in Combo
Slide 43: Zanubrutinib Responses Across Additional B-Cell Malignancies
Zanubrutinib Responses Across Additional B-Cell Malignancies MZL MCL MCL FL FL DLBCL China CSCO Source ASH 20171 ICML 20193 pivotal data ASH 20171 ASH 20171 20184 ASH20182 n 9 48 85 17 26 26 Follow-up 7.0 mo 16.7 mo 35.9 wk 7.8 mo 9.5 mo 4.2 mo (med) Prior Lines 2 (1-8) 1 (1-4) 2 (1-4) 2 (1-8) 3 (1-
Slide 44: Zanubrutinib Plus Obinutuzumab Combination in Follicular Lymphoma
Zanubrutinib Plus Obinutuzumab Combination in Follicular Lymphoma Data from separate trials Zanubrutinib + FL Zanubrutinib Ibrutinib Obinutuzumab Idelalisib Obinutuzumab Source ICML 20191 ASH 20172 ASH 20163 JCO 20134 NEJM 20145 n 36 17 110 34 72 prior alkylator and CD20, prior alkylator and CD20, m
Slide 45: Ongoing Global Phase 3 Studies: ASPEN
Ongoing Global Phase 3 Studies ASPEN topline results announced in December 2019 Zanubrutinib vs. Ibrutinib in WM Cohort 1: R/R or TN* WM with MYD88L265P mutation Arm A *TN must be unsuitable for standard chemoimmunotherapy Zanubrutinib 160 mg BID until PD MYD88MUT WM patients R (N=201, 164 R/R) 1:1
Slide 46: Ongoing Global Phase 3 Studies in CLL/SLL
Ongoing Global Phase 3 Studies in CLL/SLL SEQUOIA and ALPINE Zanubrutinib vs. BR in 1L CLL/SLL Zanubrutinib vs. Ibrutinib in R/R CLL/SLL Cohort 1: Non–17p del TN CLL Arm A Must be not suitable for FCR Zanubrutinib Relapsed/Refractory CLL/SLL 160 mg BID until PD Arm A Previously (received ≥ 1 prior t
Slide 47: Ongoing Pivotal Study: Zanubrutinib + Obinutuzumab in R/R FL
Ongoing Pivotal Study Phase 2 Zanubrutinib + Obinutuzumab vs Obinutuzumab in R/R FL Relapsed/Refractory FL (received ≥2 prior treatments*) Arm A Zanubrutinib 160 QD + Obinutuzumab X 6 cycles then q 8 wks until PD Grade 1, 2, or 3a FL (n = 140) patients R 2:1 (N=210) Arm B Obinutuzumab X 6 cycles the
Slide 48: Zanubrutinib Potentially Addresses Areas of Need for Patients
Zanubrutinib Potentially Addresses Areas of Need for Patients Treated with BTK Inhibitors Efficacy • Complete and sustained target inhibition may result in better response quality • We are testing this hypothesis in Phase 3 head-to-head trials against ibrutinib in WM and CLL Tolerability • In “real-
Slide 49: U.S. BRUKINSA Launch Progress
U.S. BRUKINSA Launch Progress BRUKINSA made commercially available within four days of November approval Josh Neiman Head, U.S. Commercial Flatiron Onyx Pharmaceuticals Genentech • patient support program launched within BRUKINSA™ (zanubrutinib) is minutes of approval approved in the U.S. for R/R MC
Slide 50: Overview of Tislelizumab (BGB-A317)
• Tislelizumab is a PD-1 checkpoint inhibitor designed to minimize binding to FcγR, which is believed to play an essential role in activating phagocytosis in macrophages to minimize its negative impact on T effector cells.1 Overview of • China label data: 77% ORR (62% CR) in R/R cHL Tislelizumab • B
Slide 51: Tislelizumab Broad Late-stage Development Program
Tislelizumab Broad Late-stage Development Program .Fifteen ongoing potentially registration-enabling studies Phase 3 (n=360) in 1L Stage IIIB or IV squamous NSCLC Approved Phase 3 (n=800) in 2L NSCLC tislelizumab+ paclitaxel and carboplatin combo or nab-paclitaxel and carboplatin tislelizumab vs. do
Slide 52: Tislelizumab Clinical Program
Tislelizumab Clinical Program Broad development for Asia-prevalent cancers Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) TUMOR FILED MARKET PH1a PH1b PH2* PH2** PH3 R/R cHL (Approved by NMPA Dec. 27, 2019) Heme R/R NK/T-cell lymphoma 2L+ UC (NDA accepted) Bladder 1L UC 2L NSCL
Slide 53: Tislelizumab's Lack of FcγR Binding Prevents Macrophage-Mediated T-Cell Clearance
Tislelizumab’s Lack of FcγR Binding Is Designed to Prevent Macrophage-Mediated T-Cell Clearance We believe the different FcγR design may have meaningful differences in the clinic Antibody-Dependent Cellular Phagocytosis Tislelizumab Differential Preclinical Efficacy in in vivo Mouse Tumor Model Base
Slide 54: Tislelizumab China cHL Pivotal Trial Data
Tislelizumab China cHL Pivotal Trial Data Deep and frequent responses observed in both transplant-ineligible patients and patients who failed transplant Baseline Characteristics Total (N=70) Age (years), median (range) 32.5 (18, 69) Age group <65 / 65-74 years, n (%) 66 (94.3) / 4 (5.7) 40 (57.1) /
Slide 55: Summary of Tislelizumab Adverse Events
Summary of Tislelizumab Adverse Events cHL pivotal trial Summary of Treatment-Emergent TEAEs in ≥10% of Patients and Grade ≥3 TEAEs in ≥2 Adverse Events Patients Regardless of Causality Event, n (%) N=70 Pyrexia Grade ≥3 TEAE 21 (30) Hypothyroidism Serious TEAE 12* (17.1) Weight increased TEAE leadi
Slide 56: Tislelizumab China UC Pivotal Trial Data
Tislelizumab China UC Pivotal Trial Data Activity in previously treated patients UC Enrolled Patients/evaluable N=113/104 Median Follow-up 8 months ORR 23.1% CR 7.7% PR 15.4% PFS median (95% CI) 2.1 (2.00, 2.46) OS median (95% CI) 9.8 months (7.46, 13.50) • IRC assessed • Per the investigator, treat
Slide 57: Tislelizumab Response Data in Disease-Specific Cohorts
Tislelizumab Response Data in Disease-Specific Cohorts Gastric Esophageal Esophageal Head & Ovarian Urothelial MSI-H / Tumor Type HCC NSCLC NPC Cancer Cancer Cancer Neck SCC Cancer Cancer dMMR ESMO-IO ESMO-IO ESMO-IO Source CSCO 20198 ESMO 20172 ESMO 20173 ESMO 20194 WCLC 20197 CSCO 20185 ASCO 20196
Slide 58: Tislelizumab Common AEs in ≥10% of Patients
Tislelizumab Phase 1 Common AEs in ≥ 10% of Patients Phase 1a Phase 1b Total System Organ Class Preferred Term N=116 N=335 N=451 n (%) n (%) n (%) Patients with at least one TEAE 114 (25.3) 322 (71.4) 436 (96.7) Fatigue 47 (10.4) 78 (17.3) 125 (27.7) Nausea 41 (9.1) 68 (15.1) 109 (24.2) Decreased ap
Slide 59: Tislelizumab Chemotherapy Combination Data in Lung Cancers
Tislelizumab Chemotherapy Combination Data in Lung Cancers Non-Sq Sq Sq SCLC Tislelizumab + Tislelizumab + Tislelizumab + Tislelizumab + Total Responses pemetrexed + paclitaxel + gemcitabine + etoposide + (N=54) platinum (n=16) platinum (n=15) platinum (n=6) platinum (n=17) Best Overall Response, n
Slide 60: Overview of Pamiparib (BGB-290)
• Highly selective PARP1 and PARP2 inhibitor with potential brain OVERVIEW Overview of penetration and strong PARP trapping activity in preclinical studies Pamiparib • Ph1/2 data demonstrated pamiparib was generally well-tolerated with CLINICAL promising anti-tumor activity in ovarian cancer (BGB-29
Slide 61: Pamiparib Clinical Program
Pamiparib Clinical Program Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) PH1a PH1b PH2* PH2** PH3 3L gBRCA+ OC 2L platinum-sensitive OC maintenance pamiparib (BGB-290, PARP) 1L platinum-sensitive GC maintenance Solid tumors + TMZ (Chemo) Solid tumors + RT/TMZ (RT/Chemo) Solid
Slide 62: Pamiparib Monotherapy Phase 1/2 Data
Pamiparib Monotherapy Phase 1/2 Data Promising activity and generally well-tolerated Best Change from Baseline in Target Lesions in Ovarian and Summary of Adverse Events from Across the Ph1/2 Trial Associated Cancer Patients Ph1A Ph1B Total (n=64) (n=37) (N=101) Patient Reporting ≥1 TEAE 64 (100.0)
Slide 63: Tislelizumab/Pamiparib Combination Escalation Data
Tislelizumab/Pamiparib Combination Escalation Data Generally well-tolerated with preliminary anti-tumor activity in multiple tumor types • Ovarian or fallopian tube cancer patients (n=29) had best responses of CR (1), PR (2 confirmed, 5 unconfirmed), and SD (7). Breast cancer patients (n=2) had 1 co
Slide 64: Thank you
Thank you 64
Slide 65: Supporting Information
Supporting Information
Slide 66: BRUKINSA Approved by U.S. FDA for R/R MCL
BRUKINSATM (zanubrutinib) Approved by U.S. FDA for R/R MCL BeiGene’s first internally developed drug is approved Best Response Zanubrutinib in R/R MCL RR RR Study BGB-3111- BGB-3111-AU-003 Source 206 Ph1/2 study Ph2 study Evaluable for efficacy, n 86 32 Median DoR in months 19.5 (16.6, NE) 18.5 (12.
Slide 67: Key Collaboration Terms
Key Collaboration Terms Commercial Product Terms Pipeline Product Terms Financial Terms • BeiGene received China • BeiGene jointly developing a • Amgen made a ~$2.8B equity commercial rights to three of pipeline of 20 oncology assets, and investment in BeiGene Amgen’s oncology medicines for will rec
Slide 68: Transformational Collaboration Accelerates BeiGene's Strategic Growth
Transformational Collaboration Accelerates BeiGene’s Strategic Growth • Further strengthens BeiGene’s position as a leader in China biotech industry − Potentially eight internally discovered or in-licensed cancer products commercialized in China by the end of 2020 − Combined synergistic offering of
Slide 69: BTK Occupancy Is Not Sustained With Ibrutinib
BTK Occupancy Is Not Sustained With Ibrutinib Preclinical models* show significant recovery of target Clinical data show borderline target inhibition by occupancy in disease relevant tissues for ibrutinib ibrutinib in the blood at approved dose PBMC Spleen Ibrutinib Clinical Data in Blood 150 100 10
Slide 70: Zanubrutinib Achieves Complete and Sustained BTK Occupancy
Zanubrutinib Achieves Complete and Sustained BTK Occupancy in Blood and Lymph Nodes PBMC* Lymph Node ▪ Complete BTK inhibition in PBMCs at the starting dose ▪ Paired lymph node biopsies were collected during (40 mg) screening or pre-dose on day 3 ▪ Median trough occupancy: 100% (160 mg BID) vs. 94%
Slide 71: ASPEN MYD88WT Cohort Best Response
ASPEN MYD88WT Cohort Best Response Total Best response, n (%) (n=26) Overall response rate (ORR) 21 (80.8) Major response rate (MRR, PR or better) 14 (53.8) VGPR 6 (23.1)a,b PR 8 (30.8)b MR 7 (26.9) SD 4 (15.4) PD 1 (3.8) Time to MR, med (range), mo Months 2.9 (1.9 -7.4) Study follow-up time, med (r
Slide 72: MYD88WT Cohort Adverse Events Overview
MYD88WT Cohort Adverse Events Overview Treatment Emergent Adverse Event n (%) 2 patients discontinued due to AEs Patients with ≥1 AE grade ≥3 12 (46.2) • Grade 4 subdural hemorrhage Patients with ≥1 serious AE 8 (30.8) • Grade 3 diarrhea AE leading to treatment discontinuation 2a (7.7) Major hemorrh
Slide 73: Zanubrutinib Monotherapy Studies Pooled Safety Data
Zanubrutinib Monotherapy Studies Pooled Safety Data (n=682) Most Common AEs (All Grade in ≥10% or Grade 3 or Higher in ≥ 3%) AEs of Interest by Category % of patients with ≥ 1 AE of interest Infections Bleeding (petechiae/contusion/hemorrhage)* Neutropenia Thrombocytopenia Anemia Grade 1-2 Hypertens
Slide 74: Pooled Safety Data
Pooled Safety Data* Zanubrutinib Zanubrutinib Acalabrutinib6 Ibrutinib Background EHA 20181 EHA 20192 Rate n 476 682 612 7565; 1,124b; 2,0904-2,1523 1,605c Major hemorrhage % 2% 2.5% 2.8% 4%5 (Gr≥3) (2%) (2.1%) (2.0%) (3%)5 [events/100 pt. yrs.] [2.07] - [3.0]3 [1.9]3 Atrial fibrillation % ~2% 1.9%
Slide 75: Zanubrutinib Efficacy in WM
Zanubrutinib Efficacy in WM Favorable response depth and durability Overall Response Rate (ORR) Progression Free Survival (PFS) Best Response in zanubrutinib WM Overall TN RR Evaluable for 73 24 49 efficacy, n 95% CI Median Follow-up 23.9 mo 12.3 mo 24.8 mo Mod. 6th IWWM Response Criteria (IgM decre
Slide 76: Ibrutinib Efficacy in WM
Ibrutinib Efficacy in WM Overall Response Rate (ORR) Progression Free Survival (PFS) Best Response ibrutinib Enrolled, n 63 100 free Median Time-on-Treatment 19.1 months - 90 80 Modified 3rd IWWM 70 Response Criteria (IgM only) 60 50 Median Prior Lines of Tx 2 (1-9) 40 Survival (%) 30 20 ORR, n (%)
Slide 77: BTK Inhibitors and PD-1 Antibodies Represent Large Market Opportunities
BTK Inhibitors and PD-1 Antibodies Represent Large Market Opportunities BTK global and PD-1 in China opportunities Historical and Forecasted Market Size of Global BTK Historical and Forecasted Market Size of China BTK BTK Inhibitors Market 2014-2030E (Billion USD) Inhibitors Market 2017-2030E (Billi
Slide 78: BTK VGPR Rate By Median Follow-Up
BTK VGPR Rate By Median Follow-Up VGPR Rate Over Time 50 45 40 35 30 25 20 VGPR Rate % 15 10 5 0 0 5 10 15 20 25 30 35 40 45 50 Median Months Follow-Up Ibrutinib pivotal Ibrutinib iNNovate 78
Slide 79: Mechanistically PD-1 Antibodies Bind PD-1 in Significantly Different Ways
Mechanistically PD-1 Antibodies Bind PD-1 in Significantly Different Ways — Tislelizumab’s Binding Surface Has the Highest Overlap with that of PD-L1 Structures of PD-L1 and three PD-1 antibodies in complex with PD-1 shown in the same orientation Strong blocking activity of tislelizumab in compariso
Slide 80: Zanubrutinib: Highly Potent and Selective BTK Inhibitor
Zanubrutinib: Highly Potent and Selective BTK Inhibitor In Preclinical Studies, Equipotent against BTK compared to ibrutinib Higher selectivity vs EGFR, ITK, JAK3, HER2 and TEC Ibrutinib Zanubrutinib Ratio Targets Assays IC50 (nM) IC50 (nM) (Zanubrutinib:Ibrutinib) BTK-pY223 Cellular Assay 3.5 1.8 0
Slide 81: Zanubrutinib Efficacy in WM
Zanubrutinib Efficacy in WM Favorable response depth and durability Overall Response Rate (ORR) Progression Free Survival (PFS) Best Response in zanubrutinib WM Overall TN RR Evaluable for 73 24 49 efficacy, n 95% CI Median Follow-up 22.5 mo 10.6 mo 23.1 mo Mod. 6th IWWM Response Criteria (IgM and l
Slide 82: Commercial Rights and Royalties - Details
Commercial Rights and Royalties - Details Products / Rights Following Profit Share For Products Retained After China Royalties After Worldwide Ex-China Royalties Pipeline Assets Approval or Commercialization Commercialization Commercialization From Launch Transition Period in China Period Period Com