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Rockville, Maryland, USA and Suzhou, ChinaJune 15, 2026 /PRNewswire/ — Ascentage Pharma (Nasdaq: AAPG; HKEX: 6855), a leading biopharmaceutical company committed to developing innovative therapies for cancer and other diseases, announced that 17 clinical advances of its core products have been prominently featured at the 2026 European Hematology Association (EHA) Annual Congress, including 8 poster presentations. The data presented involve two of the company’s key products — olverembatinib (brand name: Nailike®; development code: HQP1351), China’s first approved third-generation BCR-ABL inhibitor, and lisaftoclax (brand name: Lishengtuo®; development code: APG-2575), China’s first domestically developed selective Bcl-2 inhibitor. These presentations comprehensively showcase the company’s deep strategic positioning in hematologic malignancies and its global innovation capabilities.
At this year’s EHA Congress, olverembatinib updated key evidence-based data across two therapeutic areas: chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). In the CML field, olverembatinib demonstrated durable and deep therapeutic effects in patients with chronic-phase CML (CML-CP) who are resistant to and/or intolerant of first-line TKIs without the T315I mutation, showing strong potential as a second-line therapy. For CML-CP patients who have failed at least two prior TKI therapies, olverembatinib may serve as a standard treatment. Additionally, positive clinical data were observed in CML patients with multi-TKI resistance and high-risk gene mutations. In the Ph+ ALL field, olverembatinib continued to show robust efficacy, with data from its global registrational Phase 3 study (POLARIS-1) further validating its excellent deep remission rate and manageable safety profile. Notably, in specific subgroups such as pediatric relapsed/refractory Ph+ ALL, a chemotherapy-free combination regimen with lisaftoclax yielded impressive clinical data.
Updated data from the registrational Phase 2 study of lisaftoclax in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) provided important insights through stratified analyses of baseline characteristics and prognosis, offering valuable references for refining treatment strategies and optimizing individualized dosing regimens across different patient populations. Real-world data on lisaftoclax in myeloid neoplasms also provided strong evidence of its clinical value.
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, stated: “At this year’s EHA Congress, the multiple clinical advances of olverembatinib and lisaftoclax were showcased, further confirming the therapeutic value of these two key products in the global hematologic malignancy landscape. Olverembatinib has the potential to reshape the treatment paradigm for CML and also offers new possibilities for patients with Ph+ ALL. The updated data from the registrational Phase 2 study of lisaftoclax in CLL/SLL provide important references for individualized dosing across different populations, and the real-world data in myeloid neoplasms give us strong confidence in its application for these patients. We are particularly excited about the strong potential demonstrated by the combination data of these two products. Moving forward, we will continue to accelerate the global clinical development of these two key products while actively exploring more innovative combination treatment regimens to provide truly transformative treatment options for patients worldwide.”
Key highlights of selected poster presentations at this year’s EHA Congress are as follows (for more research data on the company’s pipeline products, please visit the EHA website):
UPDATED EFFICACY AND SAFETY OF OLVEREMBATINIB (HQP1351) AS SECOND-LINE THERAPY IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML)
Updated Efficacy and Safety of Olverembatinib (HQP1351) as Second-Line Therapy in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML)
- Abstract Number: EHA-3388 (PS1733)
- First Author: Professor Weiming Li, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Key Information: This is a single-arm, multicenter, open-label Phase 2 study evaluating olverembatinib as second-line therapy in CP-CML patients without the T315I mutation. Among 42 evaluable patients, the complete cytogenetic response (CCyR) rate was 76.2%, and the major molecular response (MMR) rate was 47.6%, with response rates increasing over treatment cycles and a favorable safety profile, with no treatment-related deaths. This study demonstrates that olverembatinib provides durable and deep therapeutic effects in CP-CML patients resistant to and/or intolerant of first-line TKIs without the T315I mutation, offering an important second-line treatment option for these patients.
EFFICACY OF OLVEREMBATINIB IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) WITH PRIOR RESISTANCE TO PONATINIB OR ASCIMINIB AND ASXL1 MUTATIONS
Efficacy of Olverembatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) with Prior Resistance to Ponatinib and/or Asciminib and ASXL1 Mutations
- Abstract Number: EHA-3991 (PS1727)
- First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, USA
- Key Information: This is a Phase 1b study analyzing the genetic profiles of 22 CP-CML patients with prior resistance to ponatinib and/or asciminib to evaluate the anti-leukemic activity of olverembatinib across different mutational backgrounds. 40.9% (9/22) of patients carried ASXL1 mutations. Following olverembatinib treatment, 44.4% (4/9) of patients with ASXL1 mutations achieved clinical responses, with 22.2% (2/9) achieving MMR (including one achieving MR4.5). This study provides the first evidence that olverembatinib is effective in CP-CML patients resistant to ponatinib and/or asciminib and carrying ASXL1 mutations, offering a new treatment option for patients with multi-TKI resistance.
THE EFFICACY AND SAFETY OF SWITCHING TO OLVEREMBATINIB OR CONTINUING ORIGINAL TKI THERAPY IN CML-CP PATIENTS TREATED WITH AT LEAST TWO PRIOR TKIS: A PROSPECTIVE, MULTICENTER, CONTROLLED TRIAL
The Efficacy and Safety of Switching to Olverembatinib or Continuing Original TKI Therapy in CML-CP Patients Treated with at Least Two Prior TKIs: A Prospective, Multicenter, Controlled Trial
- Abstract Number: EHA-4595 (PS1728)
- First Author: Bingbing Wen, Shenzhen Second People’s Hospital
- Key Information: This is a prospective, multicenter, controlled trial enrolling 105 CML-CP patients who had received ≥2 prior TKIs for ≥18 months without achieving MMR. Patients were assigned in a 1:2 ratio to receive olverembatinib (40 mg every other day orally) or continue their original TKI therapy. Results showed that at 6 months, the MMR rate in the olverembatinib group was significantly higher than that in the control group (54.3% vs 10.0%, P<0.001); at 12 months, the cumulative MMR rates were 57.14% and 21.43%, respectively (P<0.0001). The most common grade 3-4 hematologic adverse events were thrombocytopenia (42.86%) and anemia (17.14%), with rare non-hematologic events. 78.57% of patients who switched to olverembatinib experienced improvement in prior TKI-related AEs. The findings support olverembatinib as a potential standard treatment for CML-CP patients who have failed ≥2 TKI therapies.
UPDATED RESULTS OF POLARIS-1 (PART 1), A GLOBAL REGISTRATIONAL PHASE 3 STUDY: OLVEREMBATINIB COMBINED WITH LOW-INTENSITY CHEMOTHERAPY IN NEWLY DIAGNOSED PH+ ALL
Updated Results of POLARIS-1 (Part 1), a Global Registrational Phase 3 Study: Olverembatinib Combined with Low-Intensity Chemotherapy in Newly Diagnosed Ph+ ALL
- Abstract Number: EHA-3437 (PS1479)
- First Author: Professor Suning Chen, The First Affiliated Hospital of Soochow University
- This is a global, multicenter, registrational Phase 3 study (POLARIS-1 Part 1) evaluating the efficacy and safety of olverembatinib combined with low-intensity chemotherapy in newly diagnosed Ph+ ALL. A total of 55 patients were enrolled. At the end of induction therapy, the CR/CRi rate was 94.4%, and the minimal residual disease (MRD)-negative CR rate was 63.0%; the MRD negativity rate continued to increase with subsequent treatment cycles, reaching 93.1% by the end of the 9th treatment cycle. The safety profile was manageable, with no significant differences in efficacy or safety between the 30mg and 40mg dose groups, and the regimen was also highly effective in patients with adverse prognostic genotypes such as IKZF1plus. This study demonstrates that olverembatinib combined with low-intensity chemotherapy can achieve rapid, deep, and durable MRD negativity in newly diagnosed Ph+ ALL patients with a favorable safety profile, providing an important basis for first-line treatment of Ph+ ALL.
SAFETY AND PRELIMINARY EFFICACY OF OLVEREMBATINIB (HQP1351) COMBINED WITH LISAFTOCLAX (APG-2575) IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY (R/R PH+ ALL): RESULTS OF A PHASE 1B STUDY
Results of a Phase 1b Study: Safety and Preliminary Efficacy of Olverembatinib (HQP1351) Combined with Lisaftoclax (APG-2575) in Pediatric Patients with Relapsed/Refractory (R/R) Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
- Abstract Number: EHA-4691 (PS1473)
- First Author: Jingliao Zhang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
- Key Information: This is an open-label, dose-escalation Phase 1b study evaluating olverembatinib combined with lisaftoclax in pediatric patients with R/R Ph+ ALL who are resistant to or intolerant of ≥1 prior TKI. A total of 17 patients were enrolled, with a median age of 13 years; 40% carried ABL1 mutations (including T315I). Among 9 evaluable patients, the ORR after combination therapy was as high as 88.9%, the MRD negativity rate was 66.7% (8/12, Day 28 of Cycle 2), and 93.3% of patients (14/15, Day 28 of Cycle 2) achieved MMR or deeper molecular responses. Both drugs were able to cross the blood-brain barrier and were effective against ABL1 mutant patients, with a manageable safety profile and no treatment-related deaths. This study demonstrates that this chemotherapy-free, oral dual-targeting regimen can achieve rapid and deep responses, offering a novel treatment option for pediatric R/R Ph+ ALL.
REAL-WORLD EFFICACY AND SAFETY OF LISAFTOCLAX IN MYELOID NEOPLASMS: A MULTICENTER STUDY
A Multicenter Study: Real-World Efficacy and Safety of Lisaftoclax in Myeloid Neoplasms
- Abstract Number: EHA-5454 (PF562)
- First Author: Chen Cao, Qilu Hospital of Shandong University
- Key Information: This is a domestic multicenter real-world study (retrospective) evaluating the efficacy and safety of the novel Bcl-2 inhibitor lisaftoclax in myeloid neoplasms. A total of 30 patients (median age 63 years) were enrolled, including 25 (83%) with acute myeloid leukemia (AML), 3 (10%) with myelodysplastic syndromes (MDS), and 2 (7%) with chronic myelomonocytic leukemia (CMML). The CR/CRi rate in AML patients was as high as 72%, with the best efficacy observed in the ELN low-risk group (87%); among patients achieving first CR/CRi, the MRD negativity rate was 61%. The CR/CRi rate was 100% in patients with NPM1 mutations and 83% in those with IDH2 mutations. Among the 3 MDS patients, 2 achieved CRi. In terms of safety, grade ≥3 treatment-emergent adverse events (TEAEs) were primarily cytopenias (thrombocytopenia 27%, anemia 23%, neutropenia 20%), which were overall manageable. This study indicates that lisaftoclax demonstrates excellent efficacy and a manageable safety profile in the real-world treatment of myeloid neoplasms, particularly AML.
CORRELATION OF BASELINE CHARACTERISTICS WITH PROGNOSIS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) TREATED WITH LISAFTOCLAX (APG-2575) IN A PIVOTAL PHASE 2 STUDY
Correlation of Baseline Characteristics with Prognosis in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Treated with Lisaftoclax (APG-2575) in a Pivotal Phase 2 Study
- Abstract Number: EHA-3984 (PS1713)
- First Author: Professor Keshu Zhou, Henan Cancer Hospital
- Key Information: This is a correlation analysis based on the pivotal Phase 2 study NCT05147467, aiming to explore the relationship between baseline characteristics and prognosis in patients with R/R CLL/SLL treated with lisaftoclax. The study enrolled 77 patients who had failed prior BTKi therapy and received lisaftoclax 600 mg once daily. Among 72 evaluable patients, the median PFS was 23.9 months, and the IRC-assessed ORR was 62.5%. Further analysis showed that TP53 mutation/del(17p), complex karyotype, larger baseline tumor burden, and mutations in SF3B1, KIT, BLM, and SETD2 were associated with poorer prognosis, with complex karyotype and tumor size being independent risk factors for shorter PFS. This study suggests that lisaftoclax has clear efficacy in R/R CLL/SLL patients after BTKi failure, and baseline risk characteristics can further identify populations with poorer prognosis, providing a basis for subsequent risk stratification and combination treatment strategies.
About Ascentage Pharma
Ascentage Pharma (Nasdaq: AAPG; HKEX: 6855) is a comprehensive global biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative therapies to address unmet clinical needs in oncology for patients worldwide. The company has built a rich pipeline of innovative drug candidates, including inhibitors targeting key proteins in the apoptosis pathway such as Bcl-2 and MDM2-p53, next-generation inhibitors targeting kinase mutants arising in cancer treatment, and protein degraders.
The company’s core product, Nailike®, is China’s first approved third-generation BCR-ABL inhibitor. It has been approved for the treatment of patients with chronic-phase CML (CML-CP) and accelerated-phase CML (CML-AP) harboring the T315I mutation, as well as adult patients with CML-CP who are resistant to and/or intolerant of first- and second-generation TKIs. All approved indications for this drug have been included in China’s National Reimbursement Drug List (NRDL). Currently, Ascentage Pharma is conducting three global registrational Phase 3 clinical studies for Nailike®: the POLARIS-1 study, authorized by the U.S. FDA and the European EMA, evaluating Nailike® in newly diagnosed Ph+ ALL; the POLARIS-2 study, authorized by the U.S. FDA and the European EMA, evaluating Nailike® in pretreated adult patients with CML-CP; and the POLARIS-3 study evaluating Nailike® in patients with SDH-deficient GIST.
The company’s other key product, Lishengtuo®, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lishengtuo® has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with CLL/SLL who have received at least one prior systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Currently, Ascentage Pharma is conducting four global registrational Phase 3 clinical studies for Lishengtuo®: the GLORA study, authorized by the U.S. FDA and the European EMA, evaluating Lishengtuo® in combination with a BTK inhibitor in CLL/SLL patients who have received prior BTK inhibitor therapy for more than 12 months and have suboptimal responses; the GLORA-2 study evaluating Lishengtuo® as a first-line treatment for treatment-naïve CLL/SLL patients; the GLORA-3 study evaluating Lishengtuo® as a first-line treatment for newly diagnosed elderly or unfit AML patients; and the GLORA-4 study, authorized by the U.S. FDA and the European EMA, evaluating Lishengtuo® as a first-line treatment for newly diagnosed intermediate- and high-risk MDS patients.
Leveraging its strong R&D capabilities, Ascentage Pharma has established a global intellectual property portfolio and has entered into global collaborations with numerous leading biopharmaceutical companies, including Takeda, AstraZeneca, Merck & Co., Inc., Pfizer, and Innovent, as well as research partnerships with academic institutions such as Dana-Farber Cancer Institute, Mayo Clinic, the National Cancer Institute, and the University of Michigan. For more information, please visit https://ascentage.com/
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact in this press release may constitute forward-looking statements, including statements of opinion, expectation, belief, plans, objectives, assumptions, or projections by Ascentage Pharma regarding future events, operating results, or financial condition.
These forward-looking statements are subject to numerous risks and uncertainties, as detailed in the documents filed by Ascentage Pharma with the U.S. Securities and Exchange Commission (SEC), including the sections titled “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed on April 29, 2026, the sections titled “Forward-Looking Statements” and “Risk Factors” in its initial public offering prospectus filed on October 16, 2019, and other documents filed from time to time with the SEC or HKEX. These factors could cause actual results, performance, levels of activity, or achievements to differ materially from those expressed or implied by the forward-looking statements. The statements in this forward-looking statement do not constitute a profit forecast by the company’s management.
Accordingly, such forward-looking statements should not be regarded as predictions of future events. The forward-looking statements in this press release are based solely on Ascentage Pharma’s current expectations and judgments regarding future developments and their potential impact and are made only as of the date of such statements. Ascentage Pharma undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.