Full Press Release Details
ASCENTAGE PHARMA REPORTS FULL YEAR 2025 UNAUDITED
FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATES
ROCKVILLE, MD and SUZHOU, China, March 25,
2026 - Ascentage Pharma Group International (Ascentage Pharma) (NASDAQ: AAPG; HKEX: 6855) (referred hereinto as "Ascentage
Pharma," the "Company," "we," "us" or "our"), a global, commercial stage, integrated
biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet
medical needs in cancer, today reported its unaudited financial results for the year ended December 31, 2025, and provided updates on
key ongoing clinical programs and commercial activities.
Dr. Dajun Yang, Chairman and Chief Executive Officer
of Ascentage Pharma, said, "2025 was a year of significant execution in advancing our mission to deliver innovative therapies to
patients worldwide. We advanced our commercialization strategy as Olverembatinib gained significant traction after receiving NRDL coverage
expansion, which has markedly enhanced affordability and accessibility for patients in China. We launched Lisaftoclax in China in late
July 2025 shortly after receiving regulatory approval and are gaining market adoption as we actively pursue the inclusion of Lisaftoclax
Dr. Yang continued, "Multiple advancements
are continuing across our de-risked late-stage pipeline. For our third-generation tyrosine kinase inhibitor Olverembatinib, three global
registrational Phase III trials, of which two are U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) cleared,
are underway. Our Bcl-2 selective inhibitor, Lisaftoclax, with its highly differentiated daily dose ramp up, is being evaluated in ongoing
global registrational Phase III trials, including two cleared by the FDA and EMA."
Key Commercial Product and Pipeline Updates
(HQP1351) is a novel, next-generation TKI and the first third-generation BCR-ABL1 TKI approved in China
for treatment of patients with chronic myeloid leukemia (CML) in chronic-phase (-CP) or CML in accelerated phase (-AP) with T315I mutations,
and in CML-CP that is resistant and/or intolerant to first and second-generation TKIs.
(APG-2575) is a novel, oral B-cell lymphoma 2 (Bcl-2) inhibitor developed
to treat a variety of hematologic malignancies and solid tumors by selectively blocking Bcl-2 to restore the normal apoptosis process
Degrader APG-3288 is the first novel, highly potent and selective BTK degrader developed utilizing Ascentage
Pharma's proprietary proteolysis-targeting chimera (PROTAC) technology platform.
Full Year 2025 Unaudited Financial Results
Revenue for the year ended December 31, 2025 was
US$82.1 million, compared to US$134.3 million for the year ended December 31, 2024, which represented a decrease of US$52.2 million, or
41.5%. The decrease was primarily due to intellectual property revenue of US$92.9 million recorded during the year ended December 31,
2024. Product sales of Olverembatinib in China increased 80.6% to US$62.2 million for the year ended December 31, 2025, compared to US$33.0
million for the year ended December 31, 2024. Product sales of Lisaftoclax in China were US$10.1 million during the last five months of
2025 as prescriptions were filled starting at the end of July following approval by China's NMPA in early July.
Selling and distribution expenses for the year
ended December 31, 2025 were US$50.6 million, compared to US$26.9 million for the year ended December 31, 2024, which represented an increase
of US$23.7 million, or 80.4%. The increase was attributable to increased commercialization activities for Lisaftoclax and Olverembatinib.
Research and development expenses for the year
ended December 31, 2025 were US$162.7 million, compared to US$129.8 million for the year ended December 31, 2024, which represented an
increase of US$32.9 million, or 20.1%. The increase was attributable to increased clinical trial expenses.
Administrative expenses for the year ended December
31, 2025 were US$35.2 million, compared to US$25.6 million for the year ended December 31, 2024, which represented an increase of US$9.6
million, or 31.6%. The increase was mainly due to additional staff hiring.
Finance costs for the year ended December 31,
2025 were US$7.7 million, compared to US$8.8 million for the year ended December 31, 2024, which represented a decrease of US$1.1 million,
or 16.1%. The decrease was due to the decrease in interest rates in relation to bank borrowings.
Other expenses for the year ended December 31,
2025 were US$10.5 million, compared to US$1.2 million for the year ended December 31, 2024. The increase of US$9.3 million was primarily
attributable to the increase in fair value loss of contingent consideration in 2025 related to the acquisition of Guangzhou Healthquest
Loss for the year ended December 31, 2025 was
US$177.7 million, compared to the US$55.6 million for the year ended December 31, 2024.
Cash and bank balances as of December 31, 2025,
were US$353.2 million, compared to US$172.8 million as of December 31, 2024, which represented an increase of US$180.4 million, or 95.9%
on a constant currency basis. The increase was primarily due to the net proceeds of US$132.5 million from the U.S. initial public offering
in January 2025 and net proceeds of US$190.1 million from the follow-on offering in July 2025.
Investor Conference Call and Webcast
Ascentage Pharma will be holding investor webcasts
to discuss its full year 2025 unaudited annual results.
Ascentage Pharma will host the Chinese (Mandarin)
investor event with simultaneous conference call and webcast at 10:00 pm EDT on March 25, 2026 / 10:00 am HKT on March 26, 2025. To
access the Chinese language investor event or conference call, please register in advance here.
The English language investor conference call
and webcast will be held at 8:00 am EDT / 8:00 pm HKT on March 26, 2026. To access the English language webcast, please register
in advance here. The webcast replay for English language conference call and presentation will also be available on the News
& Events page of the Ascentage Pharma website.
Statement Regarding Unaudited Financial Information
This press release includes unaudited condensed
consolidated financial information as of and for the fiscal year ended December 31, 2025, which has not been audited or reviewed by the
Company's auditors. The unaudited information for the year ended December 31, 2025, is preliminary, based on the information available
at this time and subject to changes in connection with the completion of the review of the Company's financial statements. As such,
the Company's actual results and financial condition as reflected in the financial statements that will be included in the Company's
Annual Report on Form 20-F for the year ended December 31, 2025, may be adjusted or presented differently from the financial information
herein and the variations could be material. The unaudited condensed consolidated financial statements for the fiscal year ended December
31, 2025 include the accounts of the Company and its subsidiaries. All periods presented have been accounted for in conformity with IFRS
accounting standard as issued by the International Accounting Standards Board and pursuant to the rules and regulations of the U.S. Securities
and Exchange Commission (the "SEC").
Currency and Exchange Rate Information
Unless otherwise indicated, translations from
RMB to U.S. dollars for 2025 and 2024 are made at RMB6.9931 to US$1.00 and RMB 7.2993 to US$1.00, representing the noon buying rate in
the City of New York, as certified by the Federal Reserve Bank of New York, on December 31, 2025 and December 31, 2024, respectively.
Ascentage Pharma makes no representation that the RMB or U.S. dollar amounts referred to in this press release could have been or could
be converted into U.S. dollars or RMB, as the case may be, at any particular rate or at all.
About Ascentage Pharma
Ascentage Pharma Group International (NASDAQ:
AAPG; HKEX: 6855) ("Ascentage Pharma" or the "Company") is a global, commercial stage, integrated
biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet
medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting
key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders.
The Company's first approved product, Olverembatinib,
is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP)
with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and
second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an
FDA-cleared registrational Phase III trial, called POLARIS-2, of Olverembatinib for CML, as well as registrational Phase III trials for
patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3.
The Company's second approved product, 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 previously received at least one systemic therapy including Bruton's tyrosine kinase (BTK) inhibitors. The Company
is currently conducting four global registrational Phase III trials: the FDA-cleared GLORA study of Lisaftoclax in combination with BTK
inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2
study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA-cleared