Ascentage Pharma said on October 20, 2026, that its lisaftoclax combination with acalabrutinib received Breakthrough Therapy Designation in China for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The decision provides priority development support, not permission to market the combination, which remains investigational in every market.
Key Takeaways
- China's designation covers lisaftoclax plus acalabrutinib for previously untreated adults with CLL/SLL.
- Priority regulatory communication could support development; additional review pathways remain conditional.
- The ongoing GLORA-2 Phase III trial is evaluating the combination as a first-line treatment.
Table of Contents
- Lisaftoclax combination gains development support
- Existing approval covers previously treated patients
- GLORA-2 is the relevant Phase III study
- Conclusion
Lisaftoclax combination gains development support
The Center for Drug Evaluation of China's National Medical Products Administration granted the breakthrough therapy designation. The pathway gives qualifying drug candidates priority communication and development guidance from the regulator, with the aim of accelerating development.
Applicants may also seek Priority Review and conditional approval when submitting a New Drug Application if they meet the relevant requirements after evaluation. Those possibilities are separate from the designation itself and were not announced as granted.
For Ascentage, which trades on Nasdaq as AAPG and in Hong Kong under stock code 6855, the milestone concerns potential expansion into first-line treatment rather than a newly approved commercial use.
| Item | Details |
|---|---|
| GLORA | CLL/SLL patients treated with BTK inhibitors for more than 12 months with a suboptimal response. |
| GLORA-3 | Newly diagnosed, elderly and unfit patients with acute myeloid leukemia. |
| GLORA-4 | Patients with newly diagnosed higher-risk myelodysplastic syndromes. |
Existing approval covers previously treated patients
Lisaftoclax, also known as APG-2575, is an oral, selective Bcl-2 inhibitor developed by Ascentage. China approved it in July 2025 for adults with CLL/SLL who had received at least one prior systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
The newly designated combination targets a different population: adults who have not yet received treatment. Lisaftoclax itself remains investigational in the United States and has not been approved by the Food and Drug Administration.
Ascentage described a need for fixed-duration combinations that could improve the depth of response while reducing adverse events. It noted that BTK inhibitor monotherapy requires continuous treatment. These are development objectives, not benefits established by the designation.
GLORA-2 is the relevant Phase III study
Ascentage is conducting GLORA-2, a global registrational Phase III trial evaluating lisaftoclax with acalabrutinib as first-line treatment for CLL/SLL. The announcement did not provide efficacy results, a trial completion date or a timetable for an approval application.
Chief Medical Officer Dr. Yifan Zhai said the designation recognized the combination's clinical potential and that the company was continuing its global development work. Lisaftoclax has four ongoing global registrational Phase III trials, including GLORA-2; the other three cover the populations below.
Conclusion
The designation gives Ascentage additional regulatory support for developing the first-line combination, while leaving its approval status unchanged. The ongoing GLORA-2 study is the next development to watch; no results or filing timetable was announced.
Read More News
Disclaimer
This FinanceVelix article provides general information, not personalized financial, investment, legal, or tax advice. Market prices, interest rates and economic conditions can change; investments carry a risk of loss. Facts reflect the material available when published and may change. Check important information independently and consult a qualified professional when needed. Mentioning an asset, company, or service is not an endorsement.
