Ascentage Pharma (6855) Study update summary

Key study presentations and clinical trial updates

• Presented pivotal phase II data for lisaftoclax in BTK inhibitor-failed RR/CLL SLL, showing over 62% ORR, high MRD negativity, and strong efficacy in high-risk subgroups with excellent safety and no tumor lysis syndrome or drug-related deaths.

• Released updated results for lisaftoclax in AML and high-risk MDS, achieving 80% ORR in high-risk MDS and 31% ORR in venetoclax-resistant AML/MDS when combined with azacitidine.

• Highlighted global phase III GLORIA-4 trial for first-line high-risk MDS, cleared by FDA, EMA, and China CDE, with strong investigator interest following the negative VERONA trial.

• Showcased POLARIS-1 phase III trial for first-line Ph-positive ALL, with part A showing 64% MRD-negative CR rate and over 94% overall CR rate, outperforming historical controls.

• Provided four-year follow-up data for olverembatinib in CML patients failing three TKIs, demonstrating sustained efficacy and improved safety profile over time.

Differentiation and strategic insights

• Lisaftoclax offers a unique daily dose ramp-up, rapid target dosing, and no need for BTK inhibitor lead-in, providing convenience and safety advantages over venetoclax.

• Demonstrated less marrow toxicity and no drug-drug interactions, supporting broader combination potential and favorable safety profile.

• GLORIA-4 and GLORIA CLL trials use add-on strategies with BTK inhibitors as control arms, aligning with regulatory guidance and clinical practice trends.

• Olverembatinib shows best-in-class activity against T315I and compound BCR-ABL mutations, with deep molecular responses in CML and ALL, and strong efficacy in rare FGFR1-rearranged neoplasms.

• EED inhibitor APG-5918 and MDM2-p53 degrader programs highlighted for synergy in resistant models and potential in anemia and oncology indications.

Commercial and pipeline outlook

• Lisaftoclax launched in China with strong early uptake across multiple indications, supported by a dedicated sales force and positive market penetration.

• Pipeline includes multiple late-stage hematologic malignancy-focused compounds, with ongoing global collaborations and investigator engagement.

• Protein degrader pipeline, including MDM2-p53 degrader, positioned for competitive advantage over inhibitors, with promising preclinical results.