Ascentage Pharma, a China-based pharmaceutical company, has secured $126.4 million through a U.S. IPO to advance the clinical development of its cancer therapies, particularly olverembatinib for chronic myeloid leukemia (CML) and lisaftoclax for chronic lymphocytic leukemia (CLL). The IPO will support ongoing Phase 3 trials and regulatory submissions in multiple countries, including the U.S.
Olverembatinib: A Next-Generation TKI for CML
Olverembatinib, a tyrosine kinase inhibitor (TKI), is already approved in China for CML patients. It targets tyrosine kinases, enzymes crucial for cancer growth. Unlike first- and second-generation TKIs, olverembatinib is designed to address CML with T315I mutations, which are associated with rapid disease progression and limited survival. Real-world data from China indicates that 73% of CML patients in the chronic phase treated with olverembatinib remained on the treatment after five years, with response rates continuing to increase and treatment-related adverse events decreasing.
Ascentage is conducting a Phase 3 clinical program for olverembatinib, enrolling patients in the U.S., Canada, Australia, and China. One pivotal study is evaluating the drug as a monotherapy for CML, with the goal of submitting a new drug application to the FDA in 2026. Additional Phase 3 trials are assessing olverembatinib in newly diagnosed Philadelphia chromosome-positive acute lymphocytic leukemia and gastrointestinal stromal tumor.
Takeda Pharmaceuticals holds an exclusive option to license olverembatinib for development and commercialization outside of Greater China and Russia. This agreement includes a $100 million option fee, with potential milestone payments reaching up to $1.2 billion.
Lisaftoclax: Targeting Bcl-2 in CLL
Lisaftoclax, a small molecule inhibitor of Bcl-2, is another key asset in Ascentage's pipeline. Overexpression of Bcl-2 can contribute to tumor growth and drug resistance. A new drug application for lisaftoclax is currently under regulatory review in China for the treatment of advanced CLL and small lymphocytic leukemia (SLL). If approved, Ascentage plans to launch lisaftoclax in China in 2025 and subsequently pursue regulatory approvals in other countries. Lisaftoclax aims to compete with Venclexta, a Bcl-2 inhibitor marketed by AbbVie and Genentech, although Venclexta is not yet approved in China for CLL or SLL.
Ascentage plans to allocate $30 million to $40 million from the IPO proceeds for the clinical development of olverembatinib in the U.S. and other countries, including expanding its label to earlier lines of CML treatment. An additional $50 million to $60 million is earmarked for the regulatory approval and potential commercial launch of lisaftoclax in China for relapsed or refractory CLL, as well as clinical trials to support approvals in the U.S. and other regions.
