Ascentage Pharma (6855) investor relations material

Company progress and pipeline highlights

• Two novel products commercialized in China, with seven molecules in global clinical trials and over 500 patents issued worldwide.

• Lead assets include a BCL-2 selective inhibitor (lisaftoclax) and a third-generation PI3K-ABL inhibitor (olverembatinib), both in global Phase III trials.

• Lisaftoclax is the first BCL-2 inhibitor approved in China, with multiple global registration trials ongoing and strong efficacy in high-risk MDS and AML, including patients who failed prior therapies.

• Olverembatinib shows robust results in CML and Ph-positive ALL, with high response rates and favorable safety, including in heavily pretreated patients.

• Pipeline includes MDM2-p53 inhibitor, BTK degrader, EED inhibitor, and PI3K-δ inhibitor, with promising early clinical and preclinical data.

Clinical data and differentiation

• Lisaftoclax offers a convenient dosing schedule and demonstrates lower infection and drug-drug interaction risks compared to competitors.

• Olverembatinib achieves high molecular response rates, especially in patients with T315I mutation and compound mutations, and is effective in both CML and Ph-positive ALL.

• Combination regimens, such as MDM2-p53 inhibitor with lisaftoclax, show chemo-free efficacy in pediatric sarcoma and Ph-positive ALL, with high response rates.

• Recent ASCO presentations highlighted first-in-class combinations and new data in pediatric and adult oncology indications.

• Multiple assets are positioned to compete with leading global companies in terms of efficacy and safety.

Commercial and strategic outlook

• U.S. commercialization preparations underway, including hiring a chief commercial officer and building a launch team, targeting readiness by early 2028.

• First NDA filings for lead assets expected in the second half of next year, with both compounds on similar timelines.

• Olverembatinib's global commercialization will be led by Takeda under an option agreement.

• Commercial team in China to expand to 400, aiming to cover 90% of the market.

• Open to partnerships for co-development and co-promotion in the U.S. and globally.