Ascentage Pharma, a commercial-stage biopharmaceutical company developing cancer therapies, with U.S. operations in Rockville, Maryland, announced on October 20, 2026 that its Bcl-2 inhibitor lisaftoclax (APG-2575) has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA). The designation covers lisaftoclax in combination with acalabrutinib for adults with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
“This BTD recognizes the clinical potential of Lisaftoclax in combination with acalabrutinib for patients with treatment-naïve CLL/SLL and the urgent unmet need in this setting,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “Moving forward, we are continuing to accelerate the global clinical development of lisaftoclax across relevant indications and are striving to bring this treatment to more patients as quickly as possible.”
What the Designation Means
China’s BTD pathway is designed to accelerate the development and review of drugs for serious or life-threatening conditions that lack effective treatment, or that show significant clinical advantages over existing options. Designated candidates receive priority communication and development guidance from the Center for Drug Evaluation. If they meet the relevant conditions, they may also apply for Priority Review and conditional approval when submitting a New Drug Application in China.
An Unmet Need in First-Line CLL/SLL
CLL/SLL is a cancer of B lymphocytes that mainly affects older adults, with more than 100,000 new cases worldwide each year. Its incidence in China has been rising, with some patients presenting younger and with more aggressive disease.
First-line options, including immunochemotherapy and BTK inhibitors, have achieved favorable response rates and survival outcomes but have limitations. Immunochemotherapy is less effective in patients with high-risk features, while BTK inhibitor monotherapy can lack depth of response, raises long-term safety concerns, and requires continuous treatment. Once treatment fails, patients have limited options, which the company says creates an urgent need for fixed-duration combination strategies that improve efficacy and depth of response while reducing side effects.
About Lisaftoclax
Lisaftoclax is an oral, selective Bcl-2 inhibitor. In July 2025, it was approved in China for adults with CLL/SLL who had previously received at least one systemic therapy, including a BTK inhibitor. According to the company, it is the first China-developed Bcl-2 inhibitor approved in China and the second Bcl-2 inhibitor approved globally.
Ascentage is running four global registrational Phase III trials of lisaftoclax, including GLORA-2, which evaluates lisaftoclax with acalabrutinib as a first-line treatment for CLL/SLL.
In the United States, lisaftoclax is an investigational compound and has not been approved by the FDA. The combination of lisaftoclax and acalabrutinib is investigational and has not been approved in any market.
About Ascentage Pharma
Ascentage Pharma is a global, commercial-stage biopharmaceutical company developing therapies for cancer, including inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders. Its first approved product, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for certain patients with chronic myeloid leukemia, and the company is conducting registrational Phase III trials of it cleared by the FDA and the European Medicines Agency.
