China-based Ascentage Pharma (HKG: 6855) has announced its 2022 financial results, marking the first year of commercial sales for olverembatinib (HQP1351). The third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI) was approved in November 2021 to treat TKI-resistant chronic-phase CML (CML-CP) or accelerated-phase CML (CML-AP) with the T315I mutation. The company recorded revenues of RMB 210 million (USD 30.77 million), a 652% increase year-on-year (YOY), with RMB 182 million generated from olverembatinib sales. The drug was launched in partnership with Innovent Biologics as the commercial partner.
R&D Expenditure and Pipeline Development
Ascentage’s research and development (R&D) expenditure reached RMB 740 million (USD 108.44 million) in 2022. The company is advancing 9 Category 1 small molecule drugs through 40 Phase I/II clinical trials in China, the United States, Australia, Europe, and Canada. As of December 31, 2022, Ascentage owns 235 patents globally and has filed more than 600 patent applications.
Olverembatinib’s Market Expansion and NRDL Inclusion
Olverembatinib was added to the National Reimbursement Drug List (NRDL) in January 2023, paving the way for further rapid expansion. Ascentage has signed up 117 distributors, covering 177 DTP pharmacies and over 800 hospitals for the drug. The company is also pursuing full approval to enhance its market reach.
Global Clinical Development of Other Pipeline Candidates
In addition to olverembatinib, Ascentage’s Bcl-2 inhibitor APG-2575 is undergoing 19 clinical studies globally, including a pivotal Phase II study in recurrent/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL). The embryonic ectodermal development (EED) inhibitor APG-5918 also entered clinical trials in 2022.-Fineline Info & Tech
