Ascentage Pharma Reports 2024 Interim Results

Ascentage Pharma, the global biopharmaceutical company headquartered in ROCKVILLE, Md. and SUZHOU, China, has announced its interim results for 2024, revealing significant progress across its business operations during the reporting period. The company, listed on the Hong Kong Stock Exchange (6855.HK), has reported record-breaking revenue figures and profitability for the first time in its history, underlining the success of its global innovation strategy focused on collaboration, commercialization, and clinical development.

The first half of 2024 saw Ascentage Pharma's revenue surge by an impressive 477% year-over-year to RMB 824 million, largely driven by pharmaceutical sales and license income. For the first time, the company recorded a net profit amounting to RMB 163 million.

A key contributor to this financial success was the strong performance of olverembatinib (HQP1351), Ascentage Pharma's first approved product. Sales of olverembatinib generated RMB 113 million during the reporting period, reflecting a 120% increase from the second half of 2023 and a 5% rise year-over-year. This underscores the rapid progress in the product’s commercialization, bolstered by its inclusion in the China National Reimbursement Drug List (NRDL) and the approval of a new indication in November 2023.

In addition to its commercial achievements, Ascentage Pharma signed a significant exclusive option agreement with Takeda, a multinational pharmaceutical company. The agreement grants Takeda the right to enter into an exclusive license arrangement for olverembatinib, allowing them to develop and commercialize the drug globally, excluding certain territories such as mainland China, Hong Kong, Macau, and Taiwan. As part of this collaboration, Ascentage Pharma has received a US$100 million option payment and a US$75 million equity investment from Takeda.

The company's financial health improved notably during this period, with cash balances increasing from RMB 1.1 billion as of June 30, 2024, to RMB 1.8 billion by early July 2024. The collaboration with Takeda, valued at up to US$1.3 billion, is notably the largest business development deal for any small molecule oncology drug in China, demonstrating the global potential and clinical significance of olverembatinib.

The company's efforts to expand the accessibility of olverembatinib were noteworthy. By June 30, 2024, the drug had been adopted by 670 hospitals and direct-to-patient pharmacies across China, a 79% increase since the end of 2023. Its inclusion in various supplemental insurance plans across numerous provinces and municipalities further enhanced its accessibility and reduced the financial burden on patients.

Olverembatinib's clinical value received significant recognition both in China and internationally. The drug was included in the US National Comprehensive Cancer Network® (NCCN) Guidelines for the Management of Chronic Myeloid Leukemia (CML) in January 2024 and received multiple upgraded recommendations from the Chinese Society of Clinical Oncology (CSCO) Guidelines.

Ascentage Pharma's global innovation strategy made considerable headway with eight ongoing registrational studies. Notably, olverembatinib was cleared by the US FDA for a global Phase III study in previously treated adult patients with CML-CP in February 2024, a pivotal step in the company’s clinical development in hematologic malignancies. Additionally, the company received clearance for a global Phase III study of olverembatinib for patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) from China’s National Medical Product Administration (NMPA).

The company's pipeline remains robust with over 40 clinical trials across the US, Australia, Europe, and China, involving key drug candidates like olverembatinib, lisaftoclax (APG-2575), APG-2449, and APG-5918. The groundbreaking results were presented at major international congresses, reinforcing Ascentage Pharma's competitive edge in hematologic malignancies and other areas.

Ascentage Pharma is poised for continued growth and innovation, driven by its commitment to meeting global unmet clinical needs. With a portfolio of issued patents and strategic global partnerships with leading biotechnology and pharmaceutical companies, the company continues to strive towards bringing innovative therapies to the global market for the benefit of patients worldwide.