ASCENTAGE (06855.HK): Lisaftoclax wins breakthrough status in CLL/SLL
- Lisaftoclax is an oral Bcl-2 selective inhibitor approved for adults with CLL/SLL after at least one prior BTK inhibitor-containing therapy.
- The Company is running four global registrational Phase III studies, including GLORA-2 testing lisaftoclax plus acalabrutinib as first-line therapy.
NewTimeSpace News: On 21 October 2026, Ascentage Pharma Group International (stock code: 06855) announced that its Class 1 innovative drug lisaftoclax (brand name Lishengtuo, code APG-2575), an oral Bcl-2 selective inhibitor, was placed by the NMPA's Center for Drug Evaluation on the breakthrough therapy list for use with acalabrutinib in adults with previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL).
Lisaftoclax was approved in China in July 2025 for adults with CLL/SLL after at least one prior systemic therapy including a BTK inhibitor, making it the first China-developed Bcl-2 inhibitor approved and the second Bcl-2 inhibitor launched globally. The Company is running four global registrational Phase III studies, including GLORA-2, which tests lisaftoclax plus acalabrutinib as first-line therapy. Breakthrough designation gives the CDE priority in communications and allows conditional approval and priority review where eligible.
- HANSOH's ADC Licensing Deal with Roche Worth up to USD 15 Billion and a Record Share of Chinese Studies at ESMO LBA; CSOP Hang Seng Biotech ETF (03174.HK) Rises 2.09% Against the Trend on 20 October
- ASCENTAGE (06855.HK): Interim Revenue Up 29.3% to RMB 302.2 Million, Net Loss Widens to RMB 817.0 Million
- ASCENTAGE(06855.HK): 2026 Interim Report - Profit Attributable to Shareholders stood at loss of CNY 816.69 million, loss widened by 38.24% YoY
- Ascentage Pharma (06855.HK): Appoints Dr. Faïçal Miyara as CBO and Jim Ziegler as CCO to Strengthen Global Commercialization
