Ascentage Pharma Group International · HKEX:6855
Ascentage Pharma Group International — Investor Presentation (January 2026)
43 slides from Ascentage Pharma Group International's investor presentation, January 2026
Slide 1: Ascentage Corporate Presentation January 2026
AAPG. NASDAQ | 6855. HKEX Ascentage Corporate Presentation January 2026
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements This presentation has been prepared by Ascentage Pharma Group International (the “Company”) and includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of
Slide 3: Global, Commercial Stage Hematology-Oncology Company
Global, Commercial Stage Hematology-Oncology Company Global Intellectual Property Two Novel Commercial Products1 Dual listed on Nasdaq and HKEX Portfolio 6855 AAPG Olverembatinib BCR-ABL Inhibitor 478 510+ 100+ HKEX IPO completed Nasdaq IPO completed Issued Pending Publications in October 2019 in Ja
Slide 4: Two Novel, Commercial Oncology Products with Global Opportunity
Two Novel, Commercial Oncology Products with Global Opportunity Olverembatinib Lisaftoclax • 3rd Generation BCR-ABL TKI • Novel, oral, highly selective Bcl-2 inhibitor • Approved in China for CML-CP with resistance and/or • Approved in China for CLL/SLL intolerance to two TKIs patients who previousl
Slide 5: World-class Innovative, and Highly-De-risked Late Stage Pipeline
World-class Innovative, and Highly-De-risked Late Stage Pipeline Dose Escalation/ Compound Target Indication Dose Expansion Clinical POC Registrational Trial Marketed Olverembatinib CML1 BCR-ABL (HQP1351) CML, Ph+ ALL , SDH-deficient GIST Lisaftoclax CLL/SLL2 Bcl-2 Selective (APG-2575) CLL/SLL, AML,
Slide 6: Olverembatinib (HQP1351)
Olverembatinib (HQP1351) 3rd Generation BCR-ABL TKI 6
Slide 7: Olverembatinib – 3rd Generation BCR-ABL TKI
Olverembatinib – 3rd Generation BCR-ABL TKI Dose Escalation/ Clinical Program Clinical Program Indication Phase 1 Dose Expansion Clinical Phase POC 2 Registrational Phase 3 Trial Marketed Marketed CML-CP with/without T315I Marketed in China Pivotal Ph-II Mutation1 Monotherapy Full approval and full
Slide 8: Significant Patient Populations and Unmet Needs in CML and ALL
Significant Patient Populations and Unmet Needs in CML and ALL CML ALL 64.6K 150.5K Annual global Annual global incidence incidence US$14.6B US$26.9B Market opportunity Market opportunity • 2024 global sales for BCR-ABL drugs ~US$7.6B • High prevalence in Asian populations • Asciminib peak sales gui
Slide 9: Our Solution: Olverembatinib – Novel, Commercial Stage, 3G TKI
Our Solution: Olverembatinib – Novel, Commercial Stage, 3G TKI 2024 NCCN guidelines for CML management, and Level - I 2025 CSCO guidelines for CML and Ph+ ALL Granted four ODDs and fast track designation by FDA and ODD by EMA Differentiated Efficacy Profile Long-Term Durability and Safety • Strong a
Slide 10: Phase 1b Study in Heavily Pretreated CML-CP Patients (U.S.)
Phase 1b Study in Heavily Pretreated CML-CP Patients (U.S.) • Heavily multiple TKI failed/resistant patients, including with Ponatinib and/or Ascinimib • Includes patients with T315I mutations CML-CP Study Population (N=62) Safety Profile 52% received ≥4 TKIs 29% with T315I mutations • Olverembatini
Slide 11: Phase 1b Study in Heavily Pretreated CML-CP Patients (cont’d)
Phase 1b Study in Heavily Pretreated CML-CP Patients (cont’d) Strong antileukemic activity in patients with heavily pretreated CML-CP, including T315I mutations, and Ponatinib and/or Asciminib failures (N=51) (N=59) (N=18) (N=18) (N=8) (N=9) (N=19) (N=21) (N=8) (N=12) (N=7) (N=11) 70.0% 60.8% 60.0%
Slide 12: POLARIS-1 Global Phase III Part A Results
POLARIS-1 Global Phase III Part A Results Olverembatinib + Low-intensity Chemotherapy in ND Ph+ ALL Presented at ASH 2025 Primary Endpoint: MRD Negativity Rate1 by the End of Three Induction Cycles 53 evaluable patients 94% Olverembatinib in combination with low-intensity chemotherapy was well toler
Slide 13: Olverembatinib as a Viable 2L Treatment for CML-CP: Clinical Benefit
Olverembatinib as a Viable 2L Treatment for CML-CP: Clinical Benefit Presented at ASH 2025 Multicenter, open-label study in China for adult CML-CP resistant and/or intolerant to 1L TKIs 72% CCyR and 44% MMR in efficacy-evaluable patients, increasing response over time (15/18) (32/39) (28/39) (17/39)
Slide 14: Olverembatinib as a Viable 2L Treatment for CML-CP: Treatment Improvement in 2G TKI Failures
Olverembatinib as a Viable 2L Treatment for CML-CP: Treatment Improvement in 2G TKI Failures High CCyR and MMR in 1L 2G response failures Presented at ASH 2025 Better response in patients with lower baseline BCR-ABL Subgroup Analysis (5/9) (4/9) (23/30) (13/30) (9/9) (5/9) (19/30) (12/30) 100.0% 76.
Slide 15: Olverembatinib Efficacy in MLN-FGFR1 Mutant Patients
Olverembatinib Efficacy in MLN-FGFR1 Mutant Patients Phase II, open-label, multicenter efficacy/safety MLN-FGFR1 study Presented at ASH 2025 Myeloid/lymphoid neoplasms with FGFR1 rearrangement are rare and aggressive with poor OS prognosis Current therapeutic options limited Two-month and best respo
Slide 16: Deep Remission, Improvement in Allo-HSCT Outcomes in Blast Crisis
Deep Remission, Improvement in Allo-HSCT Outcomes in Blast Crisis 64 patients enrolled with BC-CML, including with cytogenetic abnormalities and complex karyotypes1 2025 ASH 1999# Presented at ASH 2025 Received 1/2G TKIs or Olverembatinib pre-transplant 1/2G-TKI2 Olverembatinib Conclusions (N=42) (N
Slide 17: Registrational Phase II Study in CML-CP: 4-Year Follow Up
Registrational Phase II Study in CML-CP: 4-Year Follow Up Significantly longer EFS and better tolerability than BAT arm Presented at ASH 2025 Majority of patients included in study failed had all three 1G & 2G TKIs EFS: All Patients with CML-CP mEFS Olverembatinib treated: 21.2 months Safety Summary
Slide 18: Registrational Phase II Study in CML-CP: 4-Year Follow Up
Registrational Phase II Study in CML-CP: 4-Year Follow Up Favorable safety profile Presented at ASH 2025 Cycle 1-6 Cycle 7-12 Cycle 13-18 Cycle 19-24 Cycle 25-30 Cycle 31-36 Haematologic(Grade 3+) - (n=96) - (n=46) - (n=77) - (n=16) - (n=62) - (n=13) - (n=51) - (n=9) - (n=47) - (n=7) - (n=44) - (n=7
Slide 19: Olverembatinib + Bcl-2i Bridging: Potential for Chemo- or Immunotherapy Free Regimen with Lisaftoclax
Olverembatinib + Bcl-2i Bridging: Potential for Chemo- or Immunotherapy Free Regimen with Lisaftoclax Olverembatinib + Venetoclax Combination High Percentage of Relapse-Free Survival post-HSCT • 17 Ph+ ALL patients in study with MRD (15) or R/R (2). • 15 patients (83.3%) successfully bridged to Allo
Slide 20: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Bcl-2 Selective Inhibitor 20
Slide 21: Lisaftoclax – Bcl-2 Selective Inhibitor
Lisaftoclax – Bcl-2 Selective Inhibitor Dose Escalation/ Clinical Program Clinical Program Indication Indication Phase Dose 1 Expansion Clinical Phase POC 2 Registrational Phase 3 Trial Marketed Marketed Approved in Pivotal Ph-II CLL/SLL1 Monotherapy China 2025 GLORA Pretreated CLL/SLL (Add-on) + BT
Slide 22: Bcl-2 is a Critical Therapeutic Target in Multiple Heme Malignancies
Bcl-2 is a Critical Therapeutic Target in Multiple Heme Malignancies Opportunity for Superior Bcl-2 Inhibitor CLL AML MDS 119.5k 122.1k 104.1k Annual global Annual global Annual global incidence incidence incidence US$38.2bn US$10.8bn Untapped Market Market market opportunities opportunities • Ven+B
Slide 23: Our Solution: Lisaftoclax (APG-2575)
Our Solution: Lisaftoclax (APG-2575) 2025 CSCO guidelines: for diagnosis and treatment of lymphoid malignancies - Lisaftoclax first recommendation Granted five ODDs by FDA Efficacy Results Favorable Safety Profile • The first Bcl-2 inhibitor approved for CLL after • Real-world patient experience wit
Slide 24: GLORA-4 Global Trial: 1L HR MDS Cleared by FDA and EMA
GLORA-4 Global Trial: 1L HR MDS Cleared by FDA and EMA Global, Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax in Combination With AZA (NCT-06641414) ✓ Previously cleared by China CDE in 2024 and currently cleared by FDA and EMA ✓ Simultaneously enrolling patients
Slide 25: Lisaftoclax Shows Strong Clinical Activity in AML and MDS as well as in Venetoclax Refractory AML
Lisaftoclax Shows Strong Clinical Activity in AML and MDS as well as in Venetoclax Refractory AML Presented at ASH 2025 Potential to overcome Venetoclax resistance in AML 103 patients were treated with Lisaftoclax (200/400/600/800 mg) combined with AZA ORR in AML/MPAL ORR in MDS/CMML ORR in Venetocl
Slide 26: Unique Daily Dose Ramp-up Schedule Achieves Target Dose in 5 Days
Unique Daily Dose Ramp-up Schedule Achieves Target Dose in 5 Days Day 1-5 Day 6 & Onwards 20mg 50mg 100mg 200mg 400mg 600mg Combination starts on Cycle 1, Day 8 Once Daily Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 and Beyond 14-Day Cycle Lisaftoclax’s Daily Dose Ramp-up: More convenient, much lower TLS ri
Slide 27: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Oral Presentation Monotherapy in a Registrational Phase II Study of BTKi-failed R/R CLL/SLL Patients at ASH 2025 Baseline characteristics (safety population) Population, n 77 Age, yr Median age (range) 63.0 (37-84) • Patients enrolled were 100% R/R to both Sex, n (%) BTKi’s an
Slide 28: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Oral Presentation Monotherapy in a Registrational Phase II Study of BTKi-failed R/R CLL/SLL Patients at ASH 2025 Efficacy Assessment R/R CLL/SLL Evaluable patients (n) 72 Response, % (n) (Confirmed by the IRC) ORR 62.5% (45) CR/CRi 4.2% (3) PR 58.3% (42) • Single-agent demonst
Slide 29: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Oral Presentation Monotherapy in a Registrational Phase II Study of BTKi-failed R/R CLL/SLL Patients at ASH 2025 Progression-free survival (PFS) by IRC Overall survival (OS) by IRC 100 100 80 80 Probability (%) Probability (%) 60 60 40 40 20 20 0 0 0 2 4 6 8 10 12 14 16 18 20
Slide 30: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) Oral Presentation Monotherapy in a Registrational Phase II Study of BTKi-failed R/R CLL/SLL Patients at ASH 2025 Any grade treatment-related adverse events (TRAEs) Grade ≥ 3 TRAEs (˃5% incidence), n = 77 (˃10%) (N=77) Lisaftoclax 600 mg Platelet count decreased 37.7 16.9 Neutr
Slide 31: Lisaftoclax – A Potential Cornerstone for Combination Drugs Across Multiple Diseases
Lisaftoclax – A Potential Cornerstone for Combination Drugs Across Multiple Diseases Lisaftoclax Olverembatinib Alrizomadlin (APG-115) Alrizomadlin (APG-115) Synergistic anti-leukemic effect in Potential to overcome Synthetic lethality leads to CR and FLT3-ITD mutant AML Venetoclax resistance in AML
Slide 32: Other Pipeline updates
Other Pipeline updates 32
Slide 33: BTK Protein Degrader-APG-3288
BTK Protein Degrader-APG-3288 First Therapeutic Candidate from Proprietary PROTAC Technology Platform IND clearance from U.S. FDA • Novel, next-generation, orally active, potent, and highly selective BTK degrader ➢ Designed to overcome resistance to covalent and noncovalent BTKi’s • Binds to both wi
Slide 34: APG-5918: Epigenetic Therapy Targeting PRC2 via EED
APG-5918: Epigenetic Therapy Targeting PRC2 via EED Novel, Differentiated, Therapeutic Candidate for Oncology and Hematology Key Development Opportunities APG-5918 MOA Hematologic Malignancies Interferes with recognition of H3K27me by EED; Prevents EED - histone methyltransferase EZH2 interaction •
Slide 35: APG-5918
APG-5918 Overcomes IMiD resistance as monotherapy and synergizes with IMiDs/CELMoDs in MM preclinical models Presented at ASH 2025 In vitro: Human MM cell lines in vivo: s.c. KMS-11 MM CDX Vehicle control; n=6 Human MM cell lines APG-5918 100 mg/kg, PO, QD x 34D; n=6 10,000 APG-5918 Pomalidomide 10
Slide 36: APG-5918
APG-5918 Dose-dependent effect in CKD anemia rat model APG-5918 improved hematologic parameters in APG-5918 in combination with EPO is superior to adenine-induced renal anemic rat model either agent in normalizing hematologic in a dose-dependent manner parameters of rats with CKD-induced anemia 10 1
Slide 37: APG-2449 – Novel ALK/FAK/ROS1 Triple Inhibitor
APG-2449 – Novel ALK/FAK/ROS1 Triple Inhibitor APG-2449 Clinical Development APG-2449 MOA • Targets high FAK tumors and ALK/ROS1 fusion NSCLC • Dual Mechanism: ALK/ROS1 inhibition + FAK inhibition with chemo or targeted therapies to overcome resistance • Well tolerated; no obvious neurotoxicity occu
Slide 38: APG-2449 – Preliminary Clinical Benefit in NSCLC Patients
APG-2449 – Preliminary Clinical Benefit in NSCLC Patients 75% ORR in Patients with ALK+ NSCLC Previously No DLTs Occurred; MTD was not Reached; No Untreated with TKIs Treatment-related Deaths ALK + NSCLC patients ALT increased 3.5% ALK + NSCLC Patients with prior 2G TKI ECG QT prolonged 2.8% Previou
Slide 39: APG-115: Orally Bioavailable, Highly Selective, Small Molecule Inhibitor Targeting MDM2-p53
APG-115: Orally Bioavailable, Highly Selective, Small Molecule Inhibitor Targeting MDM2-p53 6 FDA Orphan Drug + 2 Rare Pediatric Disease Designations APG-115 Clinical Development APG-115 MOA • Small-molecule MDM2 inhibitor restoring p53 tumor suppressor activity • Broad clinical evaluation across so
Slide 40: Alrizomadlin (APG-115)
Alrizomadlin (APG-115) Phase 2 study of novel MDM2-p53 inhibitor alrizomadlin (APG-115) with or without PD-1 mAb (toripalimab) in patients with ACC or other solid tumors (54 pts enrolled. In monotherapy arm, 22 pts treated with alrizomadlin 150 mg) Efficacy Results - Best tumor response (%) Single-a
Slide 41: APG-1252: Dual Bcl-2 / Bcl-xL inhibition to restore apoptosis
APG-1252: Dual Bcl-2 / Bcl-xL inhibition to restore apoptosis Combination approach across solid and hematologic malignancies APG-1252 Clinical Development APG-1252 MOA • FDA Orphan Drug Designation for SCLC • NCI (NIH) CRADA supporting Phase 1 to 3 trials • Currently under investigation: • Osimeriti
Slide 42: Key Achievements in 2025 and Milestones for 2026
Key Achievements in 2025 and Milestones for 2026 Key Achievements in 2025 2026 Milestones/Catalysts ✓ ❑ Listed on Nasdaq in January 2025 ❑ Advance enrollment of GLORA trial ✓ ❑ NDA approval and commercial launch of Lisaftoclax for CLL in ❑ Majority enrollment completion of GLORA-4 trial China in 202
Slide 43: Patient-Centric Innovation; Global Breakthrough Therapies
Patient-Centric Innovation; Global Breakthrough Therapies CML DLBCL/ ALL TCL Major Hematology Malignancy +Anemia MM CLL AML/ MDS Contact us: St. Suite 30.03 133 Castlereagh 700 King Farm Blvd., Suite 510 Sydney NSW 2000 Australia ir@ascentage.com Rockville, MD 20850 USA 68 Xinqing Road, Suzhou Indus
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