Ascentage Pharma Group International · HKEX:6855
Ascentage Pharma Group International — FY2023 Earnings Presentation
38 slides from Ascentage Pharma Group International's earnings presentation, Mar 28, 2024
Slide 1: 2023 Annual Results & Business Updates
(Ticker: 6855.HK) 2023 Annual Results & Business Updates March 28, 2024
Slide 2: Disclaimer
Disclaimer DISCLAIMER FOR INVESTOR MATERIALS By attending the meeting where this presentation is made, or by reading the presentation materials, you agree to be bound by the following limitations: The information in this presentation has been prepared by representatives of Ascentage Pharma Group Int
Slide 3: Vision and Value
VISION To become a global leading integrated biopharmaceutical company VALUE Ascentage Pharma 3
Slide 4: Blood cancer market at a glance
Blood cancer market at a glance 1.24 million US$90bn Global blood cancer Global hematological annual incidence malignancy treatment market (2028E) 6% 30% of all cancer cases of total cancer therapy market CML ALL CLL AML MM MDS $7.2bn $2.3 bn $13.2 bn $3.1 bn $25.7 bn $3.3 bn With proper treatments
Slide 5: Clearance from FDA and CDE for global registrational trials
CLEARANCE FROM FDA AND CDE FOR GLOBAL REGISTRATIONAL TRIALS Olverembatinib Lisaftoclax CDE • CML • CLL/SLL • CLL/SLL • Monotherapy • Combination with BTKi • Combination with acalabrutinib • r/r patients • Patients previously treated with BTKi • 1L To submit NDA in CDE CDE CDE China in 2024 • Ph+ ALL
Slide 6: 40+ publications; 498 issued patents globally
40+ PUBLICATIONS AT INTERNATIONAL CONGRESSES AND LITERATURES; 498 ISSUED PATENTS GLOBALLY 20+ publications Oral report on olverembatinib for 6 years in row, Data release on Lisaftoclax MM, AML, etc 4 publications Olverembatinib, lisaftoclax, APG-115, APG-2449 2 publications Oral report on APG-1252 2
Slide 7: Olverembatinib approved for new indication, benefiting more patients
OLVEREMBATINIB APPROVED FOR NEW INDICATION, BENEFITING MORE PATIENTS Full approval in November 2023 NRDL coverage since March 2023 Approved for CML-CP adult patients who are resistant Favorable price under NRDL while significantly and/or intolerant to 1G and 2G TKIs improving access and affordabilit
Slide 8: Olverembatinib achieved commercial breakeven in 2023
As sales and marketing efficiency improved, olverembatinib Since NRDL inclusion, affordability significantly increased achieved commercial breakeven in 2023 Product Total sales 222m revenue Sales volume revenue increased 259% in 2023 RMB in 2023 Product Number of hospitals listed increased 567% sale
Slide 9: Olverembatinib and Lisaftoclax
Olverembatinib Lisaftoclax Global best-in-class 3rd gen BCR-ABL TKI 2nd Bcl-2 inhibitor globally Commercialized China launch in 2025 • Effective in 1G/2G/3G TKI (including ponatinib and • Best-in-class potential with better safety profile and asciminib) resistant/intolerant CML patients dose ramp-up
Slide 10: Olverembatinib: global best-in-class 3rd generation BCR-ABL TKI
Olverembatinib Olverembatinib: global best-in-class 3rd generation BCR-ABL TKI ¹ n Effective in CML patients who are n Effective and durable anti-leukemic effects in CML and Ph+ ALL patients n 80% of patients continue treatment after resistant to ponatinib and asciminib - including those harboring T
Slide 11: Olverembatinib development by indication
Olverembatinib Phase 1 and 2 Registrational Approved For patients with TKI-resistant CML-CP or CML-AP harboring T315I mutation Approved in China CML For adult patients with CML-CP resistant and/or intolerant to 1st and 2nd generation TKIs Approved in China Cleared by FDA to commence global r/r CML r
Slide 12: Registrational phase 2 study: Efficacy versus Best Available Treatment
Olverembatinib Registrational phase 2 study: Efficacy versus Best Available Treatment (BAT)¹ in TKI-resistant CML-CP patients Olverembatinib significantly improved event-free survival (EFS) at 21.22 months, compared with BAT arm EFS at 2.86 months Olverembatinib reduced the event risk 65%, compared
Slide 13: 5-year data on R/R CML from phase 1 study
Olverembatinib 5-year data on R/R CML from phase 1 study: Durable efficacy and differentiated safety profile ü 80% and 71% of CML-CP patients achieved MCyR and CCyR, respectively ü Therapy responses increased over time and correlated with favorable long-term outcomes ü 80% of patients remain on ther
Slide 14: Global phase 2 study in heavily pretreated patients
Olverembatinib Global phase 2 study: Favorable clinical benefit and tolerability in heavily pretreated, particularly ponatinib- or asciminib-failed patients Olverembatinib monotherapy in heavily pre-treated CML-CP patients (N=44) (N=49) (N=15) (N=16) (N=7) (N=8) 60.0% 56.8% 53.3% 50.0% 42.9% 42.9% 4
Slide 15: Cornerstone treatment for 1L therapy for Ph+ ALL
Olverembatinib Potentially constitute the cornerstone treatment for 1L therapy for Ph+ ALL Olverembatinib combination therapies as 1L treatment for Ph+ ALL demonstrated deep response in real world data, and may potentially offer a “chemo-free” treatment option Olverembatinib + venetoclax and reduced
Slide 16: Lisaftoclax: China launch in 2025 for r/r CLL
Lisaftoclax China launch in 2025 for r/r CLL To submit NDA in 2024 and to be approved in 2025 Global registrational Ph3 for CLL FDA cleared Lisaftoclax + BTKi, adds-on clinical trials for patients who do not achieve CR from BTKi treatment US$4bn+ Global market Global registrational Ph3 for 1L CLL op
Slide 17: Lisaftoclax: improved benefit-risk and superior convenience
Lisaftoclax Improved benefit-risk and superior overall convenience Clinical validation Efficacy Safety Unique clinical profile • 800+ subjects enrolled • Clinical benefit shown in • Lower incidence of • Highly convenient to patients into lisaftoclax studies, subjects who progressed neutropenia and a
Slide 18: Lisaftoclax daily dose ramp-up schedule
Lisaftoclax 20 50 100 200 400 X target dose Lisaftoclax D1 D2 D3 D4 D5 + C1D1-C1D8 at Target Lisaftoclax continued at target dose from C1D1 <2 weeks Combination starts Cycle 1 Day 8 Ritux or Acala No BTKi or mAb Lead-in Source: Davids M et al.(2022) Lisaftoclax (APG-2575) Safety and Activity As Mono
Slide 19: Updated data from 14-month follow-up in R/R CLL patients
Lisaftoclax Updated data from 14-month follow-up in R/R CLL patients Favorable tolerability and efficacy in R/R CLL patients, including heavily pretreated and BTKi-treated patients No significant new or unmanageable safety findings were observed Best overall responses mPFS was 18.53 months mOS not r
Slide 20: Lisaftoclax clinical activity in CLL/SLL
Lisaftoclax ORR Lisaftoclax + Acalabrutinib (N=74) %ΔSPD lymph node Monotherapy 67% (n=43) Lisaftoclax + Rituximab 79% (n=34) Lisaftoclax + Acalabrutinib (TN) 100% (n=16) Lisaftoclax + Acalabrutinib (R/R) 98% (n=57) Lisaftoclax + Acalabrutinib (R/R) - BTKi naïve 100% (n=46) Lisaftoclax + Acalabrutin
Slide 21: Lisaftoclax + acalabrutinib safety
Lisaftoclax Lisaftoclax + acalabrutinib Reported Treatment Emergent AEs in ≥ 10% of pts (n = 79) Neutropenia 9 23 n No DLTs observed Diarrhea 28.2 1.3 n MTD has not been reached Covid-19 infection 17 11.5 Anemia 13 10 n No DDI in combination with BTKi Grade 1 and 2 Thrombocytopenia 15.6 6.4 n Low TL
Slide 22: Activity in R/R MM or AL amyloidosis
Lisaftoclax Demonstrated preliminary anti-tumor activity and favorable safety profile in R/R MM or AL amyloidosis patients 30 patients (with a median of 4 lines of prior therapy) Favorable safety profile; grade 3 or 4 AEs were minimal were enrolled in this multi-center trial and tolerated Best n ove
Slide 23: Efficacy and tolerability in AML and MDS patients
Lisaftoclax Encouraging clinical efficacy and tolerability in AML and MDS patients Lisaftoclax + azacitidine (AZA) resulted in 75% and 71% ORR Favorable tolerability as monotherapy and when combined in R/R AML and TN older/unfit AML patients, respectively with AZA or HHT As of July 19, 2023, 115 pts
Slide 24: Other pipeline candidates
APG-115 • Conducting clinical studies in melanoma, salivary gland cancer, MPNST, AML, CMML, MDS, liposarcoma and pediatric neuroblastoma and solid tumors ¹ MDM2-P53 inhibitor • Potential synergies with APG-2575 to achieve “synthetic lethality” APG-1252 • 205 patients treated: SCLC, NSCLC, neuroendoc
Slide 25: Alrizomadlin (APG-115)
Alrizomadlin Product highlights (APG-115) n Orally bioavailable, highly selective, small molecule inhibitor targeting MDM2-p53. Designed to restore the activation of p53 tumor suppressor activity by blocking the MDM2-p53 interaction PPI (protein-protein interaction) MDM2-p53 inhibitor n 6 orphan dru
Slide 26: Targeting MDM2-P53 and BCL-2 pathways for synthetic lethality
Targeting the MDM2-P53 and BCL-2 apoptosis pathways simultaneously can achieve "synthetic lethality" n Pediatric tumors are the leading cause n Compared with adult tumors, pediatric n Phase 1 clinical study of the safety, of death in children solid tumors are characterized by low tolerability, PK an
Slide 27: APG-115 in salivary gland cancer
APG-115 monotherapy demonstrates promising antitumor activity in patients with progressive salivary gland cancer including adenoid cystic carcinoma (ACC) with good tolerability The phase I/II multicenter, open-label study enrolled 31 patients with metastatic salivary gland cancer refractory to stand
Slide 28: APG-2449: potentially first ALK/FAK/ROS1 triple inhibitor
Potentially the 1st ALK/FAK/ROS1 triple inhibitor globally APG-2449 n Innovative drug aiming at high FAK-expressing tumors and ALK/ROS1 fusion mutant NSCLC n Through (1) effective ALK/ROS1 inhibitor and (2) FAK inhibitor in combination with ALK/FAK/ROS1 chemotherapy or targeted therapies, effectivel
Slide 29: APG-2449 efficacy and safety
Efficacy Best tumor response (%) in patients with 2nd Best tumor response (%) in patients with TKI-naïve pFAK fold change from baseline in PBMCs Best tumor response vs. pFAK expression at the gen TKI resistant ALK+ NSCLC ALK/ROS1+ NSCLC collected from pts with NSCLC post treatment tumor tissues coll
Slide 30: Pelcitoclax (APG-1252)
Product highlights n Restore apoptosis through dual inhibition of the Bcl-2 and Bcl-xL proteins n Novel combination in solid tumors and hematologic malignancies Pelcitoclax n ODD received from FDA for the treatment of SCLC (APG-1252) n A total of 205 patients have been treated with pelcitoclax as mo
Slide 31: Pelcitoclax plus osimertinib in NSCLC
Pelcitoclax plus osimertinib may improve clinical outcomes of patients with NSCLC harboring TP53- and EGFR- positive mutations Best tumor 1G TKI 3G TKI TKI-naïve response resistant n=7 resistant n=28 n=26 Overall n=61 ORR 71.4% 10.7% 80.8% 47.5% PR 71.4% 10.7% 80.8% 47.5% SD 28.6% 64.3% 15.4% 39.3%
Slide 32: APG-1387
Chronic HBV infection n Completed phase I study of monotherapy in treatment-naïve CHB patients APG-1387 n Conducting phase II clinical trial of APG-1387 combined with entecavir in CHB patients, compared to entecavir monotherapy An Antagonist of IAP/XIAP (SMAC Mimetic) Dimmer Solid tumors n Completed
Slide 33: APG-5918
China's first EED inhibitor to enter clinical trials n APG-5918 binds to the H3K27me3-interacting EED domain, resulting in a conformational change in the EED H3K27me3 binding pocket, and prevents EED APG-5918 from interacting with histone methyltransferase EZH2 n APG-5918 has potent in vitro and in
Slide 34: Ascentage Pharma pipeline
Resistant CML Olverembatinib Resistant CML(Global-FDA) (cleared by US FDA) BCR-ABL/KIT (HQP1351) TN Ph+ ALL GIST BTKi treated CLL/SLL (Global-FDA) (cleared by US FDA) r/r CLL/SLL (China) TN CLL/SLL (Global) AML Lisaftoclax WM Bcl-2 Selective (APG-2575) MDS MM T-PLL MCL ER+/HER2-BC and Solid Tumors M
Slide 35: Ascentage Pharma 2026 - beyond
Global sales China sales Leading international Twin product engines biopharma with multiple driving sales blockbuster products Olverembatinib new Executing global indication approved and registrational trials Lisaftoclax and olverembatinib to enter First proprietary Lisaftoclax to be approved in Chi
Slide 36: Products strategically target the global blood cancer market
Products strategically target the US$10bn+ global blood cancer market • Products cover all major hematological malignancies, with each product entering billion+ USD market Focus on global BIC and FIC products with unique and valuable advantages • Unique clinical advantages establish commercial value
Slide 37: Patient-Centric Innovation; Global Breakthrough Therapies
Patient-Centric Innovation; Global Breakthrough Therapies CML Olverembatinib MM ALL Lisaftoclax Major Bcl-2 Selective Inhibitor Hematology Malignancy +Anemia MDS CLL AML Alrizomadlin MDM2-p53 Inhibitor Contact us: 68 Xinqing Road, Suzhou Industrial Park 700 King Farm Blvd., Suite 510 Suzhou, Jiangsu
Slide 38: 2023 Annual Results & Business Updates
2023 Annual Results & Business Updates March 28, 2024 Ascentage Pharma 38
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