Ascentage Pharma Group International Stock Price, News & Analysis

Ascentage Pharma (NASDAQ: AAPG) has achieved a significant milestone with the China NMPA approval of lisaftoclax, its novel Bcl-2 inhibitor, for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received prior systemic therapy including BTK inhibitors.

The approval is based on a pivotal Phase II study where lisaftoclax demonstrated compelling efficacy and favorable safety profile, with no tumor-lysis syndrome and manageable toxicities. This makes lisaftoclax the first Bcl-2 inhibitor approved in China for CLL/SLL treatment and only the second globally.

The drug addresses a significant unmet need in China, where CLL/SLL incidence is rising rapidly with younger onset age. Lisaftoclax was recently included in the 2025 Chinese Society of Clinical Oncology Guidelines, and Ascentage is currently conducting four global Phase III trials exploring additional indications.

Ascentage Pharma (NASDAQ: AAPG), a global biopharmaceutical company focused on cancer treatments, has announced two key executive appointments. Dr. Veet Misra joins as Chief Financial Officer, bringing over 20 years of investment banking experience and a unique combination of scientific background and capital markets expertise. Eric Huang has been appointed as Senior Vice President of Global Corporate Development and Finance, contributing his extensive experience from roles at Beigene and Novartis.

Both executives will report directly to CEO Dr. Dajun Yang and are expected to play crucial roles in the company's global expansion strategy. The dual-listed company (HKEX: 6855) is positioning itself as a leader in apoptosis-targeted therapies and aims to strengthen its presence in both Asian and U.S. markets.

Ascentage Pharma presented encouraging results from 13 studies of its novel drugs at EHA 2025, with olverembatinib (HQP1351) showing significant promise in treating Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Multiple studies demonstrated olverembatinib's effectiveness in various combinations and settings, achieving high complete remission and molecular response rates. Key findings include 100% overall survival at 18 months when combined with blinatumomab, 97.3% complete remission rate with VP regimen, and 78.6% complete molecular response rate when combined with inotuzumab ozogamicin. The drug also showed promise in treating myeloid/lymphoid neoplasms with FGFR1 rearrangement, achieving 76.9% complete remission. Additionally, their investigational EED inhibitor APG-5918 demonstrated potent antitumor activity in T-cell lymphoma preclinical studies.

Ascentage Pharma (NASDAQ: AAPG) announced that 13 studies featuring its core assets will be presented at the 2025 European Hematology Association Annual Congress in Milan. The presentations include research on olverembatinib (HQP1351), lisaftoclax (APG-2575), and APG-5918. The studies encompass one oral presentation, multiple poster presentations, and online publications, covering various treatments for leukemia and other hematological conditions. Key highlights include studies on CML genomics, combination therapies for Ph+ acute lymphoblastic leukemia, and research on T-cell lymphoma. The presentations demonstrate Ascentage's progress in developing treatments for various blood cancers, with olverembatinib already approved in China for specific CML treatments and lisaftoclax undergoing priority review for CLL/SLL treatment.

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.