Ascentage Pharma Group International Stock Price, News & Analysis

Ascentage Pharma presented promising clinical data for its Bcl-2 inhibitor lisaftoclax at ASCO 2025. The Phase Ib/II study enrolled 103 patients and evaluated lisaftoclax in combination with azacitidine for treating acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Notably, the drug showed effectiveness in venetoclax-refractory patients, with a 31.8% overall response rate. In treatment-naive AML/MPAL patients, the combination achieved an 83.3% response rate, while R/R AML/MPAL patients showed 43.2% response. For MDS/CMML, newly diagnosed patients had 80% response rate, and R/R patients showed 50% response. The drug demonstrated manageable safety profile with primarily hematologic adverse events. Lisaftoclax is currently under Priority Review in China for R/R CLL/SLL treatment and is being evaluated in four global Phase III trials.

Ascentage Pharma (NASDAQ: AAPG) presented promising Phase II clinical data for alrizomadlin at ASCO 2025, showing effectiveness both as monotherapy and in combination with PD-1 inhibitor toripalimab. The MDM2-p53 inhibitor demonstrated significant results in treating advanced adenoid cystic carcinoma (ACC) and other solid tumors. As monotherapy, alrizomadlin achieved a 16.7% objective response rate (ORR) and 100% disease control rate (DCR) in ACC patients. In combination therapy, two MPNST patients achieved long-term responses lasting over 60 and 96 weeks. The drug showed manageable safety profiles with 33.3% grade 3+ treatment-related adverse events in monotherapy and 44.4% in combination therapy. This marks a potential breakthrough for rare cancers like ACC and MPNST that currently lack effective treatment options.

Ascentage Pharma announced that clinical data for two of its key drug candidates, lisaftoclax and alrizomadlin, will be presented at ASCO 2025. The Phase 1b/2 study of lisaftoclax combined with azacitidine showed promising results in treating blood cancers. In treatment-naïve MDS/CMML patients, the overall response rate was 64%, while R/R AML patients showed ORRs of 39-50%. Notably, the drug demonstrated efficacy in venetoclax-refractory patients, with ORRs of 17% in AML/MPAL and 50% in HR-MDS. The drug was well-tolerated with no dose-limiting toxicities. Additionally, alrizomadlin showed antitumor activity in various solid tumors, achieving a 22.2% ORR and 100% DCR in ACC patients. If approved, lisaftoclax would become the second Bcl-2 inhibitor approved globally.

Ascentage Pharma (NASDAQ: AAPG) presented results from five preclinical studies at the 2025 AACR Annual Meeting in Chicago. The studies focused on drug candidates including olverembatinib, lisaftoclax, APG-2449, APG-5918, and AS03157.

Key findings showed strong synergistic effects when combining olverembatinib with lisaftoclax in treating acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL). The combination successfully overcame venetoclax resistance in preclinical AML models. Additionally, APG-5918 demonstrated potent antitumor activity in prostate cancer models, APG-2449 showed promise in small-cell lung cancer treatment when combined with chemotherapy, and AS03157 exhibited strong potential as an IAP antagonist with high affinity for cIAP1 and XIAP.

Ascentage Pharma (NASDAQ: AAPG) will present data from two clinical studies at the 2025 ASCO Annual Meeting. The presentations include an oral report on a Phase Ib/II study of lisaftoclax combination regimen for myeloid malignancies and a poster presentation on alrizomadlin for advanced adenoid cystic carcinoma.

The oral presentation will focus on lisaftoclax (APG-2575) combined with azacitidine in patients with treatment-naïve or prior venetoclax-exposed myeloid malignancies. The poster presentation will showcase results from a Phase 2 study of alrizomadlin (APG-115) with or without toripalimab in patients with advanced ACC or other solid tumors.

This marks Ascentage's eighth consecutive year presenting at ASCO, which will be held both online and in-person at McCormick Place, Chicago, from May 30-June 3, 2025.

Ascentage Pharma (NASDAQ: AAPG) announced the inclusion of two proprietary drugs in the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines. Lisaftoclax, their novel oral Bcl-2 selective inhibitor, received its first CSCO recommendation for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). It is the world's second Bcl-2 inhibitor to submit a New Drug Application and the first China-developed one to receive Priority Review.

Olverembatinib, their next-generation tyrosine kinase inhibitor, received an upgraded recommendation to Level I for treating children with Ph+ ALL harboring the T315I BCR-ABL1 mutation. The drug retained its recommendations in other CSCO Guidelines for various CML treatments. Notably, olverembatinib is included in China's National Reimbursement Drug List and is being jointly commercialized with Innovent Biologics.

Ascentage Pharma (NASDAQ: AAPG) reported strong financial results for 2024, with revenue surging 342% year-over-year to US$134.3 million, driven by a US$100 million Takeda option payment and robust olverembatinib sales growth of 52% to US$33.0 million in China.

Key developments include the successful completion of a US$132.5 million IPO on Nasdaq in January 2025 and lisaftoclax's NDA acceptance with Priority Review in China. The company is currently conducting ten registrational trials, including two FDA-cleared studies.

Financial highlights show reduced losses of US$55.6 million (down 56.2% YoY) and increased cash position of US$172.8 million (up 15.3%). Research and development expenses rose 34% to US$129.8 million, while selling and administrative expenses remained relatively stable.

Ascentage Pharma (NASDAQ: AAPG) has announced the presentation of five preclinical studies at the upcoming 2025 American Association of Cancer Research (AACR) Annual Meeting in Chicago. The presentations will showcase results from their innovative pipeline including:

• Olverembatinib combined with lisaftoclax for overcoming venetoclax resistance in acute myeloid leukemia (AML)
• Combination therapy effects in T-cell acute lymphoblastic leukemia (T-ALL)
• APG-5918's antitumor activity in prostate cancer models
• APG-2449's enhancement of chemotherapy in small-cell lung cancer
• AS03157 as an IAP antagonist

The presentations are scheduled between April 27-29, 2025, covering various experimental and molecular therapeutics sessions.

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company focused on developing therapies for hematological malignancies, has scheduled its full year 2024 financial results announcement and corporate update for March 27, 2025.

The company will host two investor events: an English conference call and webcast at 8:00 am EDT/8:00 pm HKT on March 27, and a Chinese (Mandarin) investor event at 9:30 am HKT on March 28. Both events will include Q&A sessions with management and will be available for replay on the company's website for 30 days.