Ascentage Pharma's Lisaftoclax Wins China Breakthrough Therapy Designation in First-Line CLL/SLL

Ascentage Pharma said on October 20, 2026 that China's Center for Drug Evaluation granted a Breakthrough Therapy Designation to lisaftoclax combined with acalabrutinib for treatment-naïve adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. The designation covers the CDE arm of the National Medical Products Administration, TradingView reported.

What the China Designation Covers

Ascentage Pharma is a dual-listed biopharmaceutical company developing small-molecule therapies that modulate programmed cell death for hematologic malignancies and solid tumors, with two products approved in China.

The designation applies to lisaftoclax (APG-2575), the company's oral selective Bcl-2 inhibitor, in combination with acalabrutinib. The CDE grants such designations to innovative drugs or modified new drugs intended to prevent or treat serious, life-threatening diseases for which no effective treatment exists, or where evidence shows significant clinical advantages over available options. Designated candidates receive priority from the CDE for communications and development guidance. If the applicant meets the relevant conditions after evaluation, it may apply for Priority Review status and conditional approval when submitting a New Drug Application in China.

CLL/SLL is a clonal proliferative malignancy of B lymphocytes that predominantly affects older adults, with more than 100,000 new cases worldwide each year. The company said immunochemotherapy and BTK inhibitors have been used as first-line options with favorable response rates and survival outcomes, though limitations remain, including insufficient depth of response and long-term safety concerns with BTK inhibitor monotherapy.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "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."

Lisaftoclax's Approval and Trial History

Lisaftoclax was approved in China in July 2025 for adult CLL/SLL patients who had previously received at least one systemic therapy including a BTK inhibitor. It is the first China-developed Bcl-2 inhibitor approved in China and the second Bcl-2 inhibitor approved globally. Ascentage Pharma is conducting four global registrational Phase III trials of lisaftoclax, including GLORA-2, which evaluates the combination with acalabrutinib as a first-line treatment for CLL/SLL. In the United States, lisaftoclax is investigational and has not been approved by the FDA, and the combination with acalabrutinib is investigational and has not been approved in any market.

Ascentage Pharma's Recent Filings and Results

According to akta.pro company records, Ascentage Pharma listed on the NASDAQ stock exchange on January 24, 2025 under the stock code AAPG, and closed a US$190.1 million follow-on equity offering on NASDAQ in July 2025, lifting cash reserves by about 95.9% to US$353.2 million. The same records show full-year 2025 product sales of $82.1 million, representing 90% year-over-year growth, with olverembatinib sales of $62.2 million and lisaftoclax sales of $10.1 million in its first five months.

Earlier Ascentage Pharma Developments

Ascentage Pharma reported first-half revenue of RMB 302.2 million, Seeking Alpha reported in September 2026. Pulse 2.0 reported in August 2026 that the company's first-half product sales rose 33% to $41.6 million, driven by expanded hospital formulary coverage for olverembatinib in China. AInvest reported in August 2026 that the company posted a first-half net loss of $120.4 million alongside that product sales growth.

What Comes Next for the Lisaftoclax Filing

Ascentage Pharma said it is continuing to accelerate the global clinical development of lisaftoclax across relevant indications. The company is conducting the GLORA-2 global registrational Phase III trial of lisaftoclax with acalabrutinib as a first-line CLL/SLL treatment.