 |
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 areas, announced that it presented the latest efficacy and safety data of its core product, Noltec® (generic name: Olverembatinib; development code: HQP1351), as a second-line treatment for patients with chronic-phase chronic myeloid leukemia (CML-CP) in a rapid oral presentation at the 62nd American Society of Clinical Oncology (ASCO) Annual Meeting.
The annual ASCO Annual 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 results and cancer treatment technologies. This year marks the ninth consecutive year that Ascentage Pharma has presented at the ASCO Annual Meeting, with a total of six studies from three key drug candidates selected, three of which were accepted as rapid oral presentations.
Data from this rapid oral presentation showed that in CML-CP patients treated with Noltec®, the complete cytogenetic response (CCyR) rate reached 91.3% and the major molecular response (MMR) rate reached 60.9% after 24 cycles of treatment. Furthermore, the depth of response increased with longer treatment duration. In terms of safety, Noltec® maintained a stable and manageable safety profile during long-term administration, with no new safety signals observed and good overall tolerability. With extended follow-up, this study yielded more mature and encouraging progress, once again demonstrating the favorable efficacy and safety of Noltec® in CML patients without the T315I mutation, providing an important potential second-line treatment option for CML-CP patients who have failed first-line TKI therapy.
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® is approved in China for the treatment of adult patients with CML-CP and accelerated phase (CML-AP) who are resistant to any tyrosine kinase inhibitor (TKI) and have the T315I mutation, as well as for 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 for 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 cleared by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, Ascentage Pharma has entered into an exclusive option agreement with multinational pharmaceutical company Takeda for Noltec®. Upon exercise of the option, Takeda will receive a license to develop and commercialize Noltec® globally, excluding Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (China).
Professor Li Weiming, the principal investigator of this study from the Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, stated: “Overall, with extended treatment duration, Noltec® not only helps patients achieve deeper remissions but also provides sustained and stable clinical benefits, while maintaining a favorable safety and tolerability profile with high patient compliance. This further indicates that the drug has the potential to be an important second-line treatment option for CP-CML patients without the T315I mutation, providing a stronger evidence base for clinical practice. In the future, we look forward to the release of more long-term follow-up data to further validate its efficacy and safety, and to provide more robust evidence-based medical support for the standardized application and guideline recommendations of Noltec® in second-line therapy, offering optimized treatment options for patients and clinicians.”
Dr. Zhai Yifan, Chief Medical Officer of Ascentage Pharma, stated: “The updated data from this ASCO presentation once again demonstrates the solid performance of Noltec® in second-line CML therapy, giving us confidence in advancing this drug to earlier lines in the CML treatment pathway. We look forward to continuously accumulating evidence from second-line and earlier-line settings to further optimize the full-course management of CML, enabling patients to achieve greater clinical benefits, longer survival, and better quality of life. Moving forward, we will continue to uphold our original mission of ‘addressing unmet clinical needs of 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:
Updated efficacy and safety of Olverembatinib (HQP1351) as second-line therapy in patients with chronic-phase chronic myeloid leukemia (CP-CML)
Olverembatinib (HQP1351) as second-line therapy in patients with chronic-phase chronic myeloid leukemia (CP-CML): Updated efficacy and safety data
Abstract Number: 6510
Presentation Format: Rapid Oral Abstract
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
First Author: Professor Li Weiming, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Key Highlights:
- Background: This is a single-arm, multicenter, open-label study conducted in China evaluating the efficacy and safety of Olverembatinib as a second-line treatment.
- Efficacy Data: In 42 evaluable patients, Olverembatinib demonstrated significant and sustained antitumor activity. As of the data cutoff date, the best CCyR rate was 76.2%, and the best MMR rate was 47.6%, with efficacy progressively improving over treatment cycles, reaching 91.3% and 60.9% by cycle 24, respectively. High efficacy was maintained even in patients previously treated with second-generation TKIs.
- Safety Data: In terms of safety, the overall incidence of treatment-related adverse events was 89.4%, but most were manageable low-grade events, primarily including hyperpigmentation, hyperuricemia, and elevated creatine kinase. Although some ≥Grade 3 hematologic toxicities occurred, they all resolved with supportive care.
- Conclusion: Overall, the drug achieved durable and progressively enhanced efficacy while maintaining a manageable safety profile, demonstrating promising clinical prospects.
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 of patients worldwide in oncology. 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 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. It is approved for the treatment of patients with chronic-phase chronic myeloid leukemia (CML-CP) and accelerated-phase CML (CML-AP) harboring the 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 have been included in China’s National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting three global registrational Phase III clinical studies for Noltec®: the POLARIS-1 study evaluating Noltec® in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), cleared by the U.S. FDA and European EMA; the POLARIS-2 study evaluating Noltec® in previously treated adult patients with CML-CP, cleared by the U.S. FDA and European EMA; and the POLARIS-3 study evaluating Noltec® in patients with SDH-deficient GIST.
Another key drug candidate, Lisaftoclax®, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax® has been approved by China’s 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 for Lisaftoclax®: the GLORA study evaluating Lisaftoclax® 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 response, cleared by the U.S. FDA and European EMA; the GLORA-2 study evaluating Lisaftoclax® as a first-line treatment for treatment-naïve CLL/SLL patients; the GLORA-3 study evaluating Lisaftoclax® as a first-line treatment for newly diagnosed elderly or unfit AML patients; and the GLORA-4 study evaluating Lisaftoclax® as a first-line treatment for newly diagnosed intermediate- to high-risk MDS patients, cleared by the U.S. FDA and European EMA.
Leveraging its strong R&D capabilities, Ascentage Pharma has established a global intellectual property portfolio and entered into global collaborations with numerous leading biopharmaceutical companies, including Takeda, AstraZeneca, Merck & Co., Pfizer, and Innovent Biologics, 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 opinions, expectations, beliefs, plans, objectives, assumptions, or predictions of 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 “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” sections in the Annual Report on Form 20-F for the year ended December 31, 2025, filed on April 29, 2026, the “Forward-Looking Statements” and “Risk Factors” sections in the prospectus for the initial public offering filed on October 16, 2019, and other documents we file from time to time with the SEC or HKEX. These factors could cause actual results, performance levels, operating results, or achievements to differ materially from those expressed or implied in 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 speak 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.