Press Release: Ascentage Pharma Reports Full Year 2025 Unaudited Financial Results and Provides Business Updates

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   -- Product sales and commercial rights revenues in 2025 increased 90% 
      year-over-year to US$82.1 million (RMB574.1 million) 
 
   -- Sales of Olverembatinib increased 81% year-over-year to US$62.2 million 
      (RMB435.3 million) 
 
   -- Sales of Lisaftoclax since launch during last five months of 2025 were 
      US$10.1 million (RMB 70.6 million) 
 
   -- Nine registrational Phase III clinical trials are in progress worldwide, 
      including four cleared by FDA and EMA 
 
   -- Chinese (Mandarin) investor event with simultaneous conference call and 
      webcast at 10:00 am HKT on March 26, 2026 / 10:00 pm EDT on March 25, 
      2026; and English language investor webcast at 8:00 am EDT / 8:00 pm HKT 
      on March 26, 2026 

ROCKVILLE, Md. and SUZHOU, China, March 25, 2026 (GLOBE NEWSWIRE) -- 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 in China's NRDL."

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

Olverembatinib (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.

Commercial progress

   -- Revenue from 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. 
 
   -- All approved indications for Olverembatinib have been covered since 
      January 2025 by China's NRDL, which has bolstered the affordability and 
      accessibility of Olverembatinib. 
 
   -- The number of hospitals where Olverembatinib is on formulary in 
      Direct-to-Patient, or DTP, pharmacies reached 825 as of December 31, 
      2025, a 12.4% increase compared to 734 as of December 31, 2024. In 
      particular, the number of hospitals where Olverembatinib is on formulary 
      increased approximately 36.5% over the same period to 355 hospitals as of 
      December 31, 2025 from 260 hospitals as of December 31, 2024. 

Clinical progress

   -- Enrollment continues in a FDA and EMA-cleared, global registrational 
      Phase III clinical trial of Olverembatinib in combination with 
      chemotherapy versus investigator choice TKI in combination with 
      chemotherapy in first-line Philadelphia chromosome-positive ALL (Ph+ ALL) 
      patients (POLARIS-1). The Part 1 data from POLARIS-1 was presented at the 
      67th 2025 American Society of Hematology Annual Meeting and demonstrated 
      an MRD-negative CR rate of 64.2% by the end of the induction therapy and 
      a favorable safety profile to date. 
 
   -- Enrollment continues in a FDA and EMA-cleared, global Phase III 
      registrational clinical trial of Olverembatinib for previously treated 
      CML-CP patients, both with and without T315I mutation (POLARIS-2). 
 
   -- Enrollment continues in a multinational registrational Phase III clinical 
      trial of Olverembatinib for the treatment of patients with succinate 
      dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who 
      have not responded to prior systemic treatment (POLARIS-3). 
 
   -- Continue to evaluate Olverembatinib in combination with the Bcl-2 
      inhibitor Lisaftoclax in early phase clinical trials. 

Upcoming milestones

   -- Continue to advance enrollment in the POLARIS-1, POLARIS-2, and POLARIS-3 
      trials. 

Lisaftoclax (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 in cancer cells.

Commercial progress

   -- Commercial sales of Lisaftoclax commenced in China on July 25, 2025 as 
      the first batch of prescriptions were filled on July 25, 2025 shortly 
      after receiving approval on July 10, 2025 from China's National Medical 
      Products Administration (NMPA) for the treatment of adult patients with 
      CLL/SLL who have previously received at least one systemic therapy 
      including BTK inhibitors, which makes Lisaftoclax the first Bcl-2 
      inhibitor to receive conditional approval and marketing authorization for 
      the treatment of patients with CLL/SLL in China, and the second Bcl-2 
      inhibitor approved globally. 
 
   -- Revenue from sales of Lisaftoclax was US$10.1 million for 2025 for the 
      five-month period from August 2025 to December 2025. 

Clinical progress

   -- Enrollment continues in a FDA and EMA-cleared global Phase III 
      registrational clinical trial of Lisaftoclax in combination with AZA for 
      the treatment of front-line HR-MDS patients (GLORA-4). 
 
   -- Enrollment continues in a multinational Phase III registrational clinical 
      trial of Lisaftoclax for the treatment of front-line elderly or unfit 
      patients with acute myeloid leukemia (AML) (GLORA-3). 
 
   -- Enrollment continues in a registrational Phase III clinical trial to 
      evaluate Lisaftoclax in combination with the BTK inhibitor, acalabrutinib, 
      versus immunochemotherapy in treatment-naïve patients with CLL/SLL, 
      to validate a fixed duration of combination regimen as a first-line 
      treatment (GLORA-2). 
 
   -- Enrollment continues in a FDA and EMA-cleared global Phase III clinical 
      trial of Lisaftoclax in combination with BTK inhibitors in patients with 
      CLL/SLL previously treated with BTK inhibitors (GLORA). 
 
   -- Enrollment continues Phase Ib/II studies of Lisaftoclax as a single agent 
      or in combination with other therapies for the treatment of patients with 
      AML/MDS, including patients resistant to venetoclax, in China. 
 
   -- Enrollment continues in the Phase Ib/II clinical trials of Lisaftoclax in 
      combination therapies for the treatment of patients with multiple myeloma 
      (MM) in the United States. 

Upcoming milestones

   -- Plan to initiate clinical studies to confirm Lisaftoclax's potential to 
      overcome venetoclax resistance in patients who have failed venetoclax 
      treatment. 
 
   -- Continue to advance enrollment in GLORA, GLORA-2, GLORA-3, GLORA-4 
      trials. 
 
   -- Plan to actively advance the inclusion of Lisaftoclax in China's National 
      Reimbursement Drug List (NRDL) in 2026. 

BTK 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.

Progress

   -- Received IND clearance from the FDA and from China's Center for Drug 
      Evaluation $(CDE)$ in the first quarter of 2026. 

Upcoming milestones

   -- Plan to commence a global, multicenter, open-label Phase I study designed 
      to evaluate the safety, tolerability, pharmacokinetic $(PK)$ profile, and 
      preliminary efficacy of APG-3288 in patients with relapsed/refractory 
      hematologic malignancies. 

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.

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March 25, 2026 19:00 ET (23:00 GMT)

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