Ascentage Pharma Group International reported robust commercial momentum in its interim 2025 financial results, highlighted by exceptional growth in its lead oncology product and a groundbreaking regulatory approval that positions the company as a pioneer in China's hematologic malignancy treatment landscape.
Strong Commercial Performance Drives Revenue Growth
The biopharmaceutical company's flagship product Olverembatinib (HQP1351) demonstrated remarkable commercial traction, with revenue from sales in China surging 93% to US$30.3 million for the six months ended June 30, 2025, compared to US$15.5 million in the same period of 2024. This growth was primarily attributed to the expansion of China's National Reimbursement Drug List (NRDL) coverage, which has significantly improved patient access and affordability.
Olverembatinib, a novel third-generation BCR-ABL1 tyrosine kinase inhibitor, is approved in China for treatment of patients with chronic myeloid leukemia (CML) in chronic-phase or accelerated phase with T315I mutations, and in CML-CP that is resistant and/or intolerant to first and second-generation TKIs. All approved indications for Olverembatinib have been covered by China's NRDL since January 2025.
The company's market penetration efforts showed substantial progress, with the number of direct-to-patient pharmacies and hospitals where Olverembatinib is on formulary reaching 782 as of June 30, 2025, representing a 17% increase compared to the same period in 2024. Notably, hospital formulary inclusion increased 47% over the same period to 295 hospitals from 201 hospitals.
Historic Regulatory Milestone with Lisaftoclax Approval
Ascentage Pharma achieved a significant regulatory breakthrough with the approval of Lisaftoclax (APG-2575) on July 10, 2025, by China's National Medical Products Administration (NMPA). The approval makes Lisaftoclax the first Bcl-2 inhibitor to receive conditional approval and marketing authorization for the treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China, and only the second Bcl-2 inhibitor approved globally.
Lisaftoclax is indicated for adult patients with CLL/SLL who have previously received at least one systemic therapy including Bruton's tyrosine kinase (BTK) inhibitors. The novel oral B-cell lymphoma 2 (Bcl-2) inhibitor works by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Commercial sales of Lisaftoclax commenced in China shortly after approval.
The drug received its first clinical guideline recommendation in April 2025 in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies as a monotherapy for the treatment of patients with relapsed/refractory CLL/SLL.
Robust Pipeline Advancement Across Multiple Indications
Ascentage Pharma is currently conducting nine registrational clinical trials, including three cleared by the FDA, demonstrating the breadth and depth of its development pipeline. For Olverembatinib, the company continues enrollment in three key Phase III studies: POLARIS-3 for succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor patients, the FDA-cleared POLARIS-2 for previously treated CML-CP patients, and POLARIS-1 for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients.
Lisaftoclax is being evaluated in four global registrational Phase III trials. The GLORA-4 study, investigating Lisaftoclax in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome patients, has been cleared by both the FDA and EMA, with first patients enrolled in Europe and China. Additional ongoing studies include GLORA-3 for newly diagnosed elderly and unfit acute myeloid leukemia patients, GLORA-2 for treatment-naïve CLL/SLL patients, and the FDA-cleared GLORA study for CLL/SLL patients previously treated with BTK inhibitors.
Financial Position Strengthened Through Strategic Financing
The company completed a top-up placement of ordinary shares in July 2025, resulting in US$190.1 million in net proceeds, which significantly strengthened its financial position. This follows the US$132.5 million in net proceeds from the company's U.S. initial public offering in January 2025.
Despite strong product sales growth, total revenue for the six months ended June 30, 2025 was US$32.6 million, compared to US$113.4 million for the same period in 2024, representing a decrease primarily due to intellectual property revenue of US$93.4 million recorded in the prior year period.
Research and development expenses increased 19.0% to US$73.8 million for the first half of 2025, reflecting increased external research and development expenses related to ongoing global clinical trials. The company reported a loss of US$82.5 million for the six months ended June 30, 2025, compared to a profit of US$22.4 million in the prior year period.
Dr. Dajun Yang, Chairman and Chief Executive Officer of Ascentage Pharma, commented on the results: "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."
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. Following the July 2025 top-up placement, the combined net proceeds together with existing cash and cash equivalents, loan facilities and future sales are expected to enable the company to fund operating expenses and capital expenditure requirements.
