Ascentage Pharma Announces Inclusion of Lisaftoclax and Olverembatinib in Chinese Society of Clinical Oncology (CSCO) 2025 Guidelines
ROCKVILLE, Md. and SUZHOU, China, April 21, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ:AAPG, HKEX: 6855)), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for hematological malignancies, today announced that two of its proprietary novel drugs have been included in the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines. Lisaftoclax (APG-2575), the company's investigational novel oral Bcl-2 selective inhibitor, received its first recommendation in the CSCO Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies. Olverembatinib, the company's novel next-generation tyrosine kinase inhibitor (TKI), received an upgraded recommendation in the CSCO Guidelines for the Diagnosis and Treatment of Leukemias in Children and Adolescent, and retained its recommendations in the CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies.
Bcl-2 inhibitor lisaftoclax (APG-2575) receives its first CSCO Guidelines recommendation
As the world's second Bcl-2 inhibitor to submit a New Drug Application (NDA) and the first China-developed Bcl-2 inhibitor to submit an NDA and receive Priority Review designation in China, lisaftoclax (APG-2575), supported by its robust clinical data, has been recommended in the CSCO 2025 Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies, as a monotherapy for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first CSCO Guidelines recommendation for lisaftoclax (APG-2575), making it the only China-developed Bcl-2 inhibitor recommended in the CSCO Guidelines. This marks a milestone achieved by Ascentage Pharma in advancing the development of this innovative drug to bring meaningful benefit to patients as well as a major breakthrough in the field of hematological malignancies.
Prof. Jun Ma, from Harbin Institute of Hematology and Oncology, stated: "These CSCO Guidelines recommendations for lisaftoclax (APG-2575) indicate recognition of the drug's robust data by a top medical association in China. In the data, lisaftoclax (APG-2575) monotherapy showed a high overall response rate and a fast onset of action that can enable rapid disease control. Moreover, the incidence of tumor-lysis syndrome in patients treated with lisaftoclax (APG-2575) was far lower than was shown in the early data of other Bcl-2 inhibitors, highlighting a favorable tolerability profile that could potentially change the clinical risk management in CLL/SLL. We look forward to lisaftoclax (APG-2575)'s approval in China through the Priority Review pathway, which will bring this innovative therapeutic to patients in need."
In November 2024, the NDA for lisaftoclax (APG-2575) monotherapy for the treatment of R/R CLL/SLL was accepted and granted the Priority Review designation by the Center for Drug Evaluation (CDE) of China National Medical Product Administration (NMPA). Globally, lisaftoclax (APG-2575) is being evaluated in two registrational Phase III studies for the treatment of CLL/SLL, including an international registrational Phase III study of lisaftoclax (APG-2575) combined with a BTK inhibitor in patients with CLL/SLL who had previously received BTK inhibitors (the GLORA Trial); and an international registrational Phase III study evaluating lisaftoclax (APG-2575) combined with acalabrutinib, versus immunochemotherapy in treatment-naïve patients with CLL/SLL (the GLORA-2 Trial). These studies were designed to further broaden the treatment window of lisaftoclax (APG-2575).
The first China-approved BCR-ABL inhibitor olverembatinib receives an upgraded recommendation in the CSCO Guidelines
In the CSCO 2025 Guidelines for the Diagnosis and Treatment of Leukemias in Children and Adolescent, the recommendation for olverembatinib for the treatment of children with Ph+ ALL who harbor the T315I BCR-ABL1 kinase domain mutation was upgraded to Level I, thus opening a whole new chapter for olverembatinib in pediatric hematology.
Prof. Xiaofan Zhu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, noted, "As a China-developed third-generation TKI, olverembatinib has achieved a major breakthrough in the treatment of children with Ph+ ALL. In the CSCO 2025 Guidelines, the recommendation for olverembatinib in the treatment of patients with Ph+ ALL who harbor the T315I BCR-ABL1 kinase domain mutation or are intolerant to dasatinib has been upgraded to Level I, an update that reflects the drug's promising clinical utility. Looking ahead, we hope to see more studies further evaluating olverembatinib's long-term efficacy and searching for more optimized combinations of the drug that can bring greater hope for curative care to children with Ph+ ALL."
In the CSCO 2025 Guidelines for the Diagnosis and Treatment of Hematological Malignancies, olverembatinib retained a number of major recommendations which solidified the drug's vital role in the treatment of CML. In chronic-phase CML (CML-CP), olverembatinib retained a Level I recommendation for the treatment of all lines of T315I mutant CML-CP; a Level I recommendation for the second-line treatment of patients who had failed first-line treatment with nilotinib or dasatinib and the third-line treatment of patients who are intolerant to and/or failed on two or more TKIs. In progressive-phase CML, olverembatinib retained a Level I recommendation as a treatment option for patients with T315I mutant CML-AP, and those who progressed from CML-CP to CML-AP, or from CML-CP/AP to CML-BP. Moreover, the CSCO 2025 Guidelines emphasized olverembatinib's advantages in addressing a range of BCR::ABL1 mutations (including T315I, V299L, F317L/V/I/C, T315A, Y253H, E255K/V, and F359C/V/I) and any other mutation (including complex/compound mutations).
In Ph+ ALL, olverembatinib has retained its Level I recommendation for response induction and the treatment of relapsed/refractory patients.
Olverembatinib is a novel drug developed by Ascentage Pharma with support from China's National Major New Drug Development Program. As the first approved third-generation BCR-ABL inhibitor in China, olverembatinib is indicated for the treatment of adult patients with TKI-resistant CML-CP or -AP harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs. Furthermore, all approved indications of olverembatinib have been included in the China National Reimbursement Drug List (NRDL) which has greatly improved the drug's accessibility to patients. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "CSCO Guidelines are among the most recognized clinical guidelines in China, providing crucial guidance to Chinese physicians on the diagnosis and treatment of malignancies. The recommendations for both olverembatinib and lisaftoclax (APG-2575) in the updated guidelines are a testament to our strong and innovative pipeline. In particular, the CSCO Guidelines' very first recommendations for lisaftoclax (APG-2575), the second Bcl-2 inhibitor to reach NDA submission anywhere in the world, reflect the clinical experts' forward-looking recognition of this innovative drug, providing much needed new guidance to clinical practices and the answer to a major treatment gap. Meanwhile, we are greatly encouraged by the Guidelines' upgraded recommendation for olverembatinib in pediatric patients with ALL. In the future, we hope to see additional positive clinical data that can pave the way for upgraded recommendations for these two innovative drugs. We will continue to accelerate the clinical development and commercialization of our drug candidates for the benefit of more patients."
*Lisaftoclax (APG-2575) and olverembatinib are investigational drugs and not yet approved in the US.
About Ascentage Pharma
Ascentage Pharma is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in hematological malignancies. Ascentage Pharma has been listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK since October 2019 and has also been listed on the Nasdaq Global Market under the ticker symbol "AAPG" since January 2025.
The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53; and next-generation TKIs that target kinase mutants emergent during cancer treatment. Ascentage Pharma is also the only company in the world with active clinical programs targeting all known key apoptosis regulators.
Olverembatinib, one of the company's lead assets, is already approved in China with all of its approved indications included into the China National Reimbursement Drug List (NRDL). Meanwhile, a New Drug Application (NDA) for another one of Ascentage Pharma's key drug candidates, the novel Bcl-2 selective inhibitor lisaftoclax (APG-2575), has already been accepted and granted the Priority Review designation by the China CDE.
To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer and Innovent; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan.
The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfill its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.
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