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from or in reliance upon the whole or any part of the contents of this announcement.
ASCENTAGE PHARMA GROUP INTERNATIONAL
(Incorporated in the Cayman
Islands with limited liability)
VOLUNTARY ANNOUNCEMENT
ASCENTAGE PHARMA ANNOUNCES INCLUSION
AND OLVEREMBATINIB IN CHINESE SOCIETY OF CLINICAL
ONCOLOGY (CSCO) 2025 GUIDELINES
Ascentage Pharma Group International
(the "Company" or "Ascentage Pharma") is pleased to announce 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.
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-na ve 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.
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,
Cautionary Statement required by Rule 18A.05
of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited: We cannot guarantee that we will be
able to obtain further approval for, or ultimately market APG-2575 successfully.
By order of the Board
Ascentage Pharma Group International Dr. Yang Dajun
Chairman and Executive Director
Suzhou, People's Republic of China, April 21, 2025
As at the date of this
announcement, the Board comprises Dr. Yang Dajun as chairman and executive Director, Dr. Wang Shaomeng and Dr. Lu Simon Dazhong as non-executive
DirectorsNote, and Mr. Ye Changqing, Mr. Ren Wei, Dr. David Sidransky, Ms. Marina S. Bozilenko, Dr.
Debra Yu and Marc E. Lippman, MD as independent non-executive Directors.
Note: Dr. Wang Shaomeng and Dr.
Lu Simon Dazhong are independent directors under NASDAQ rules.
Last updated: Apr 21, 2025