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Rockville, Maryland, USA and Suzhou, ChinaJune 1, 2026 /PRNewswire/ — Ascentage Pharma (Nasdaq: AAPG; HKEX: 6855), a leading biopharmaceutical company dedicated to developing innovative drugs in oncology and other fields, announced that the company presented the latest data from a Phase Ib study of its core product, Noltec® (generic name: Olverembatinib; development code: HQP1351), in combination with Blinatumomab for the treatment of lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL) in a rapid oral presentation at the 62nd American Society of Clinical Oncology (ASCO) Annual Meeting.
The annual ASCO meeting is one of the most important and authoritative academic exchange events in the global oncology field, showcasing the latest cutting-edge clinical oncology research achievements and cancer treatment technologies. This year marks Ascentage Pharma’s ninth consecutive appearance at the ASCO Annual Meeting, with a total of six studies from three key pipeline candidates selected, three of which were presented as rapid oral presentations.
This rapid oral presentation study marks the first disclosure of Noltec® in combination with Blinatumomab in an international patient population. The data showed that this combination regimen demonstrated encouraging clinical activity in patients with relapsed/refractory Ph+ BCP-ALL or CML-LBP, with positive response rates and minimal residual disease (MRD) negativity rates. In terms of safety, the combination regimen was generally well-tolerated, with a safety profile consistent with the known toxicities of each single agent.
Noltec® is a first-in-class innovative drug developed by Ascentage Pharma and is the first approved third-generation BCR-ABL inhibitor in China. Its commercialization in China is jointly managed by Ascentage Pharma and Innovent Biologics. Currently, Noltec® has been approved in China for the following indications: treatment of adult patients with chronic myeloid leukemia in chronic phase (CML-CP) and accelerated phase (CML-AP) with T315I mutation who are resistant to any tyrosine kinase inhibitor (TKI); and treatment of adult patients with CML-CP who are resistant and/or intolerant to first- and second-generation TKIs. All approved indications have been included in the National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting three global registrational Phase III clinical studies of Noltec®, covering indications including CML-CP, newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST). Two of these studies have been authorized by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, Ascentage Pharma has signed an exclusive option agreement with multinational pharmaceutical company Takeda for Noltec®. Upon exercise of the option, Takeda will obtain the global rights to develop and commercialize Noltec®, excluding Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan region of China.
Professor Elias Jabbour, Principal Investigator of this clinical study, Department of Leukemia, The University of Texas MD Anderson Cancer Center, stated: “There is a significant unmet clinical need for patients with relapsed/refractory Ph-positive ALL or CML in lymphoid blast phase. The encouraging activity and tolerability observed with Olverembatinib combined with Blinatumomab highlight the potential of this chemotherapy-free strategy in such difficult-to-treat diseases.”
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said: “This rapid oral presentation study validates for the first time in an international patient population the therapeutic potential of Noltec® in combination with Blinatumomab for CML-LBP and R/R Ph+ BCP-ALL. These two areas have long been considered the ‘toughest nuts to crack’ among BCR-ABL-driven hematologic malignancies, representing end-stage conditions with the poorest prognosis and fewest treatment options. The data presented today are very encouraging and have the potential to fill a long-standing treatment gap in blast phase. We look forward to translating these results into sustained benefits for patients through subsequent studies. Moving forward, we will continue to uphold our original mission of ‘addressing unmet clinical needs for patients in China and around the world,’ accelerate clinical development, and bring more safe and effective drugs to market as soon as possible to benefit patients.”
Key highlights of this study presented at the 2026 ASCO Annual Meeting are as follows:
Olverembatinib (HQP1351) combined with blinatumomab in patients with lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL)
Abstract Number: 6513
Presentation Format: Rapid Oral Abstract
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center
Key Highlights:
- Background: Previously, Olverembatinib has demonstrated clinical activity in TKI-resistant Ph+ hematologic malignancies. This study explored the use of Olverembatinib combined with Blinatumomab in patients with relapsed/refractory (R/R) Ph+ BCP-ALL or CML-LBP outside of China.
- Efficacy Data: 91% (10/11) of patients achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi), 67% (8/12) of patients achieved BCR::ABL1 negativity (≤0.01%), and 80% (8/10) of patients achieved MRD negativity by flow cytometry (≤0.01%).
- Safety Data: The combination regimen showed a manageable safety profile, with most adverse events (AEs) being Grade 1-2, consistent with the known toxicities of each single agent.
- Conclusions: This study validates for the first time in an international patient population the feasibility of Olverembatinib combined with immunotherapy in CML-LBP and R/R Ph+ BCP-ALL.
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 drugs to address unmet clinical needs for patients worldwide in the field of oncology. The company has established a rich pipeline of innovative drug candidates, including inhibitors targeting key proteins in apoptosis pathways such as Bcl-2 and MDM2-p53, next-generation inhibitors targeting kinase mutations arising in cancer treatment, and protein degraders.
The company’s core product, Noltec®, is the first approved third-generation BCR-ABL inhibitor in China, approved for the treatment of patients with chronic myeloid leukemia in chronic phase (CML-CP) and accelerated phase (CML-AP) with T315I mutation, as well as adult patients with CML-CP who are resistant and/or intolerant to first- and second-generation TKIs. All approved indications for this drug have been included in the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting three global registrational Phase III clinical studies of Noltec®: the POLARIS-1 study evaluating Noltec® in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients, authorized by the U.S. FDA and European EMA; the POLARIS-2 study evaluating Noltec® in pretreated adult CML-CP patients, authorized by the U.S. FDA and European EMA; and the POLARIS-3 study evaluating Noltec® in SDH-deficient GIST patients.
Another key product, Lisaftoclax®, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax® has been approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least one prior systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Ascentage Pharma is currently conducting four global registrational Phase III clinical studies of Lisaftoclax®: the GLORA study evaluating Lisaftoclax® in combination with a BTK inhibitor in CLL/SLL patients who have received BTK inhibitor therapy for more than 12 months with suboptimal response, authorized by the U.S. FDA and European EMA; the GLORA-2 study evaluating Lisaftoclax® as first-line treatment in treatment-naïve CLL/SLL patients; the GLORA-3 study evaluating Lisaftoclax® as first-line treatment in newly diagnosed elderly or unfit AML patients; and the GLORA-4 study evaluating Lisaftoclax® as first-line treatment in newly diagnosed intermediate- to high-risk MDS patients, authorized by the U.S. FDA and European EMA.
Leveraging its strong R&D capabilities, Ascentage Pharma has established a global intellectual property layout and entered into global collaborations with numerous leading biopharmaceutical companies, including Takeda, AstraZeneca, Merck & Co., Inc., Pfizer, and Innovent Biologics, as well as 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
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