Full Press Release Details
ASCENTAGE PHARMA REPORTS 2025 INTERIM UNAUDITED
SIX MONTHS FINANCIAL RESULTS AND BUSINESS UPDATES
ROCKVILLE, MD and SUZHOU, China, August 20,
2025 - 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 six months ended June 30, 2025, and provided updates on
key ongoing clinical programs and commercial activities.
Dr. Dajun Yang, Chairman and Chief Executive Officer
of Ascentage Pharma, said, "We reported strong momentum across our business in the first half of 2025, highlighted by the remarkable
93% year-over-year growth in Olverembatinib sales of $30.3 million, driven by expanded National Reimbursement Drug List (NRDL) coverage
that has significantly improved patient access in China. In addition, the historic approval of Lisaftoclax in July marks a pivotal milestone
as the first Bcl-2 inhibitor to receive conditional approval for chronic lymphocytic leukemia (CLL) / small lymphocytic leukemia (SLL)
treatment in China. Our robust pipeline continues to advance with nine registrational clinical trials, all of which are actively ongoing,
including three cleared by the FDA, demonstrating our commitment to bringing innovative cancer therapies to patients globally. The successful
completion of our financing in July, raising US$190.1 million in net proceeds, strengthens our balance sheet and provides additional resources
needed to execute our commercialization strategy and development programs. These achievements highlight our capability to execute globally
and our commitment to delivering novel therapies to patients worldwide."
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. Since 2021, commercialization of Olverembatinib
in China continues to perform well. Additional potential indications for Olverembatinib are being evaluated in ongoing clinical trials.
Anticipated progress
(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. Lisaftoclax is approved in China for the treatment of adult patients with CLL/SLL who have previously received at least
one systemic therapy including Bruton's tyrosine kinase (BTK) inhibitors and is being evaluated for additional potential indications
in ongoing clinical trials.
Half Year 2025 Unaudited Financial Results
Revenue for the six months ended June 30, 2025
was US$32.6 million, compared to US$113.4 million for the six months ended June 30, 2024, which represented a decrease of US$80.7 million,
or 71.6% on a constant currency basis. The decrease in revenue was primarily due to intellectual property revenue of US$93.4 million recorded
during the six months ended June 30, 2024. Product sales of Olverembatinib in China increased by US$14.8 million, or 92.5% on a constant
currency basis, to US$30.3 million for the first half of 2025 from US$15.5 million for the six months ended June 30, 2024.
Selling and distribution expenses for the six
months ended June 30, 2025 were US$19.2 million, compared to US$12.3 million for the six months ended June 30, 2024, which represented
an increase of US$6.9 million, or 53.7% on a constant currency basis. The increase was attributable to expansions in commercialization
efforts of Olverembatinib and preparation for anticipated launch of Lisaftoclax.
Research and development expenses for the six
months ended June 30, 2025 were US$73.8 million, compared to US$61.1 million for the six months ended June 30, 2024, which represented
an increase of US$12.7 million, or 19.0% on a constant currency basis. The increase was attributable to increased external research and
development expenses related to our ongoing global clinical trials.
Administrative expenses for the six months ended
June 30, 2025 were US$13.9 million, compared to US$12.0 million for the six months ended June 30, 2024, which represented an increase
of US$1.9 million, or 14.6% on a constant currency basis. The increase was due to the increase in the consulting fees and agency fees.
Financing costs for the six months ended June
30, 2025 were US$3.9 million, compared to US$4.7 million for the six months ended June 30, 2024, which represented a decrease of US$0.8
million, or 18.4% on a constant currency basis. The decrease was due to lower effective interest rates in relation to bank borrowings.
Other expenses for the six months ended June 30,
2025 were US$5.6 million, compared to US$1.0 million for the six months ended June 30, 2024, which represented an increase of US$4.6 million,
or 465.6% on a constant currency basis. The increase was primarily attributable to the increase in fair value loss of contingent consideration
related to acquisition of Guangzhou Healthquest Pharma Co., Ltd.
Loss for the six months ended June 30, 2025 was
US$82.5 million, compared to the profit of US$22.4 million for the six months ended June 30, 2024. The loss per share attributable to
ordinary equity holders was $0.24 per ordinary share for the six months ended June 30, 2025, compared to the earnings per share of $0.08
per ordinary share for the six months ended June 30, 2024.
Cash and bank balances as of June 30, 2025, were
US$231.9 million, compared to US$172.8 million as of December 31, 2024, which represented an increase of US$59.1 million, or 31.7% 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
Following the top-up placement in July 2025, which
resulted in US$190.1 million in net proceeds, these net proceeds together with existing cash and cash equivalents, loan facilities and
future sales will enable the Company to fund operating expenses and capital expenditure requirements.
Investor Conference Call and Webcast
Ascentage Pharma will be holding investor webcasts
to discuss its six months 2025 unaudited interim results.
Ascentage Pharma will host a Chinese (Mandarin)
language investor webcast at 9:00 pm EDT on August 20, 2025 / 9:00 am HKT on August 21, 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 August 21, 2025. 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 six months ended June 30, 2025, which has not been audited by the Company's
auditors. The unaudited information for the six months ended June 30, 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 6-K, may be adjusted or presented differently from the financial information herein and the variations could be
material. The unaudited condensed consolidated financial statements 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 the six months ended June 30, 2025 and 2024 and as at December 31, 2024 are made at RMB7.1636 to US$1.00, RMB
7.2672 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 June 30, 2025, June 28, 2024 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 and next-generation kinase inhibitors.
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