Ascentage Pharma Group International ((HK:6855)) announced an update on their ongoing clinical study.
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Study Overview: The clinical study titled ‘A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4)’ aims to evaluate the overall survival of patients using Lisaftoclax combined with azacitidine versus a placebo with azacitidine. This study is significant as it targets higher-risk myelodysplastic syndrome, a condition with limited treatment options.
Intervention/Treatment: The study tests the combination of Lisaftoclax (APG-2575), an oral drug, with Azacitidine, administered via injection, against a placebo combined with Azacitidine. The purpose is to improve patient survival rates.
Study Design: This is an interventional, randomized, double-blind study with a parallel assignment. Both participants and investigators are masked to the treatment groups, focusing on treatment as the primary purpose.
Study Timeline: The study began on October 12, 2024, with its primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on October 13, 2025, indicating the study is actively recruiting.
Market Implications: The outcome of this study could significantly impact Ascentage Pharma’s stock performance, as successful results may enhance investor confidence and position the company as a leader in HR-MDS treatment. Competitors in the oncology space will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.