Ascentage Pharma Group International · HKEX:6855
Ascentage Pharma Group International — Ascentage Pharma Group — J.P. Morgan Healthcare Conference 2023
42 slides from Ascentage Pharma Group International's conference presentation, Jan 11, 2023
Slide 1: Ascentage Pharma Group
Ascentage Pharma Group Patient-Centric Innovation Cutting-Edge Therapies Dr. Dajun Yang January 11, 2023 PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 0
Slide 2: Disclaimer
Disclaimer PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 1
Slide 3: Year 2022: Accelerating Commercialization of Olverembatinib
Year 2022：Accelerating Commercialization of Olverembatinib Revenue Cash Amount RMB1.7 Almost RMB 95.76 636.9% similar million billion Revenue (RMB Million) • Included in 2022 edition of CSCO and CACA Guidelines for Commercial team of 100+ CML and Ph+ ALL staff to cover 800+ hospitals, with Innovent
Slide 4: Global Commercialization Potential of Olverembatinib
Global Commercialization Potential of Olverembatinib Market potential - Maximizing market value ~ 40% received 2nd+ line CML patients in therapy China Along with the increase usage of • Olverembatinib was granted Priority Review Designation 2nd generation TKIs, the number of and acceptance of NDA fo
Slide 5: Rapid Progress with Global Clinical Development Programs
Rapid Progress with Global Clinical Development Programs Resistant CML Resistant CML，Ph+ ALL HQP1351 BCR-ABL/KIT GIST Ph+ ALL r/r CLL/SLL (China) r/r CLL/SLL (Global) WM AML APG-2575 Bcl-2 Selective MDS MM T-PLL MCL ER+/HER2-BC and Solid Tumors Melanoma and Solid Tumors(IO Combo) APG-115 MDM2-p53 AC
Slide 6: Transition Towards a Fully-Integrated Global Biopharma Company
Transition Towards a Fully-Integrated Global Biopharma Company Confidential & Proprietary Copyright 2023@Ascentage 6
Slide 7: Ascentage Pharma Hematology Portfolio
Lisaftoclax a Bcl-2 Olverembatinib Selective Inhibitor Multi-Kinase BCR-ABL TKI Ascentage Pharma Hematology Portfolio Alrizomadlin an APG-5918 a MDM2-p53 inhibitor potent EED inhibitor Confidential & Proprietary Copyright 2023@Ascentage
Slide 8: Hematology Markets
CML Anemia ALL Hematology Markets Major Hematology Markets Our Portfolio aligns with Significant Growth Opportunities MDS CLL AML Confidential & Proprietary Copyright 2023@Ascentage 8
Slide 9: Recognitions by the Global Research Community
Recognitions by the Global Research Community abstracts selected for presentations Drug candidate： Olverembatinib ， Lisaftoclax， Alrizomadlin，APG-2449，APG-1252 abstracts selected for presentations Drug candidate ： Lisaftoclax，Alrizomadlin，APG-2449， APG-5918 etc. abstract selected for presentation Dr
Slide 10: olverembatinib
olverembatinib Confidential & Proprietary Copyright 2023@Ascentage
Slide 11: 5 years roadmap: From IND to NDA Approval
5 years roadmap: From IND to NDA Approval n 2022.03: granted Orphan Drug Designation nClinical results of olverembatinib (ALL) in CML were selected for oral n 2022.04: Included in 2022 CSCO and CACA presentation at ASH 2018-2022 guidelines for CML and Ph+ ALL and nominated as “Best of n 2022.07: Rec
Slide 12: Ph I: Demonstrated Durable Efficacy and Differentiated Safety Profile
Ph I: Demonstrated Durable Efficacy and Differentiated Safety Profile Ph I: 5-year data for Olverembatinib 100 80 Probability (%) 60 40 PFS % (95% CI) at 48 mo 20 CML-CP 88.6 (79.2, 93.9) CML-AP 50.0 (22.9, 72.2) 0 0 6 12 18 24 30 36 42 48 54 60 Months 80% of patients remain on therapy for more than
Slide 13: Pivotal Trial: Deep & Durable Efficacy in T315i CML
Pivotal Trial: Deep & Durable Efficacy in T315i CML Cumulative Incidence of Responses, DOT, PFS & Response by Mutational Status PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Jiang Q et al. ASH abstract #81, 2022 Copyright 2023@Ascentage 13
Slide 14: Pivotal Trial: Differentiated Safety Profile, enables long remissions
Pivotal Trial: Differentiated Safety Profile, enables long remissions PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Jiang Q et al. ASH abstract #81, 2022 Copyright 2023@Ascentage 14
Slide 15: US Ph Ib/II: Olverembatinib Potentially Effective in Ponatinib Resistant CML
US Ph Ib/II: Olverembatinib is Potentially Effective in Ponatinib Resistant CML PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Jabbour E et al. ASH abstract #82, 2022 Copyright 2023@Ascentage 15
Slide 16: US Ph Ib/II: Safety & Activity in Ponatinib Resistant PH+ALL
US Ph Ib/II: Safety & Activity in Ponatinib Resistant PH+ALL PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Jabbour E et al. ASH abstract #82, 2022 Copyright 2023@Ascentage 16
Slide 17: Preclinical Data: Olverembatinib Potential in Treating COVID-19
Preclinical Data Demonstrating Olverembatinib s Therapeutic Potential in Treating COVID-19 • Olverembatinib blocks the activity of several kinases essential for cytokine signalling, thereby dampening the Omicron-NTD-mediated cytokine release and reducing inflammations. • Targeting multiple essential
Slide 18: Confidential & Proprietary Copyright 2023@Ascentage
Confidential & Proprietary Copyright 2023@Ascentage
Slide 19: Lisaftoclax: Potential best-in class Bcl-2 inhibitor
Lisaftoclax：Potential best-in class Bcl-2 inhibitor PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 19
Slide 20: Global Phase II Study in the US: Safety + Efficacy
Global Phase II Study in the US: Safety+ Efficacy Daily Dose Ramp-up: More HCP & Patient Friendly & Eliminated TLS Risk PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 21
Slide 21: Global Phase II Study: Lisaftoclax Best-In-Class Safety Profile
Global Phase II Study: Lisaftoclax shows Best-In-Class Safety Profile Lisaftoclax monotherapy Lisaftoclax + Rituximab Lisaftoclax + Acalabrutinib Reported Treatment Emergent AEs in ≥ 10% of pts (n = 39) Reported Treatment Emergent AEs in ≥ 10% of pts (n = 46) Reported Treatment Emergent AEs in ≥ 10%
Slide 22: Global Phase II Study: Lisaftoclax Efficacy Summary
Global Phase II Study: Lisaftoclax Efficacy Summary In r/rCLL, with ORR of: § Monotherapy (n=43): 67.4% § Lisaftoclax + Rituximab (n=34): 79.4% § Lisaftoclax + Acalabrutinib: TN(n=16):100% § Lisaftoclax + Acalabrutinib R/R (n=57): 98% o Lisaftoclax + Acalabrutinib R/R BTKi naïve (n=46): 100% o Lisaf
Slide 23: Strong Differentiation From Venetoclax
Strong Differentiation From Venetoclax PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 24
Slide 24: Lisaftoclax Potential
Lisaftoclax Potential Significant Opportunity for 2nd Gen, Better Safety Profile, More Patient & HCP Friendly BCL-2 Inhibitor US CLL Patient Forecast US AML Patient Forecast Significant Patient Growth in each Disease Source: Cerner Enviza CancerMPact 2022, Clarivate; Reported Sales and Consensus For
Slide 25: Alrizomadlin (APG-115)
Alrizomadlin (APG-115) MDM2-p53 Inhibitor Activates p53 tumor suppression via MDM2-p53 PPI Potential First-in-Class Drug Confidential & Proprietary Copyright 2023@Ascentage
Slide 26: Alrizomadlin: Mechanism
Alrizomadlin : Mechanism PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 27
Slide 27: Alrizomadlin: Clinical Development and Progress
Alrizomadlin ：Clinical Development and Progress n n n n n n PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 28
Slide 28: Alrizomadlin Plus Pembrolizumab: Efficacy
Alrizomadlin Plus Pembrolizumab: Efficacy PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 29
Slide 29: Alrizomadlin plus pembrolizumab: phase 2 study in solid tumors
Alrizomadlin plus pembrolizumab: phase 2 study in adults and children with various solid tumors Safety n (%) n (%) n (%) n (%) n (%) n (%) • This phase 2 study continues to demonstrate that alrizomadlin in combination with pembrolizumab is well tolerated in 150 subjects. • These preliminary and inte
Slide 30: Confidential & Proprietary Copyright 2023@Ascentage
Confidential & Proprietary Copyright 2023@Ascentage
Slide 31: APG-1252 plus Osimertinib: Efficacy
APG-1252 plus Osimertinib：Efficacy APG-1252 240mg APG-1252 160mg Expansion Arm-1 100 80 Maximum % Decrease 60 40 20 0 (20) (40) (60) n n n PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 32
Slide 32: Milestones & Clinical Developments
Milestones & Clinical Developments We have already completed a phase I study for the treatment of patients with CHB. The stage 1 safety evaluation of APG-1387 in combination with Entecavir (ETV) for a phase II study has completed. With well- tolerated safety data, the study moved forward to stage 2,
Slide 33: Milestones & Clinical Developments
Milestones & Clinical Developments APG-2449 is a novel, orally active, small molecule FAK/ALK/ROS1 triple ligase kinase inhibitor designed and developed by Ascentage. It is the first third-generation ALK inhibitor being developed in China. Pre-clinical data indicated that It is a very potential nove
Slide 34: First-in-human phase 1 results of APG-2449 in ALK/ROS1+ NSCLC or mesothelioma
First-in-human phase 1 results of APG-2449 with second-generation TKI-resistant ALK/ROS1+ NSCLC or mesothelioma Efficacy Summaries for APG-2449 in Patient with ALK+NSCLC • APG-2449 has demonstrated a favorable safety and PK profile and was well tolerated in 84 patients with NSCLC or mesothelioma. •
Slide 35: PROPRIETARY AND CONFIDENTIAL Confidential& Proprietary Copyright 2023@Ascentage
PROPRIETARY AND CONFIDENTIAL Confidential& Proprietary 36 Copyright 2023@Ascentage
Slide 36: Study Rationale – Advanced Solid tumor & NHL
Study Rationale – Advanced Solid tumor & NHL Mechanisms Preclinical IND clearance • APG-5918 binds to the domain of • APG-5918 has shown potent in vitro • Gained IND approval for first-in- EED that interacts with H3K27me3, and in vivo on-target human study in patients with which leads to a conformat
Slide 37: Pre-Clinical Assets
Pre-Clinical Assets Focused on validated targets with clear biomarker, clinical High unmet medical needs indications and fast regulatory approval MDM2-p53 Degrader APG-265 Transformative new First-in-class or technology best-in-class potential PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary
Slide 38: IP Portfolio for Key Clinical Assets
IP Portfolio for Key Clinical Assets Key Clinical Assets Estimated Patent Expired Year HQP1351 2035-2041* APG-2575 2037-2042* APG-115 2035-2042* APG-1387 2033-2042* APG-1252 2034-2041* APG-5918 2040-2042* PROPRIETARY *including composition, process, formulation, combination, use, new indication etc；
Slide 39: Our Experienced Executives Team
Our Experienced Executives Team PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 40
Slide 40: Innovative and Proprietary Platform Delivering Potentially First and/or Best-in-Class Drugs
Innovative and Proprietary Platform Delivering Potentially First and/or Best- in-Class Drugs 205 600 1 10+ 12 50+ 30+ Integrated global organization PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Source：Company database，as of June 30, 2022 Copyright 2023@Ascentage 41
Slide 41: Ascentage Pharma Group
Ascentage Pharma Group Patient-Centric Innovation Cutting-Edge therapies Contact us: ir@ascentage.com PROPRIETARY AND Confidential CONFIDENTIAL & Proprietary Copyright 2023@Ascentage 42
Slide 42: Thank You
Thank You CHINA UNITED STATES Suzhou Guangzhou Rockville 68 Xinqing Road , Suzhou Industrial Park, Room 2706, GIE Tower, 403 Huanshi Road East, 700 King Farm Blvd., Suite 510, Suzhou, Jiangsu, 215000 Yuexiu District, Guangzhou, Rockville, MD 20850 T : 86-512-85557777 Guangdong, 510095 T : +1 3012915
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