Ascentage Pharma Group International ((HK:6855)) announced an update on their ongoing clinical study.
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Study Overview: Ascentage Pharma Group Inc. is conducting a global, multi-center, open-label, randomized, and registrational Phase 3 study titled ‘Study of Olverembatinib (HQP1351) in Patients With CP-CML.’ The study aims to evaluate the efficacy and safety of Olverembatinib in patients with Chronic Phase Chronic Myeloid Leukemia (CML-CP), a condition that requires effective treatment options.
Intervention/Treatment: The study tests two drugs: Olverembatinib, an investigational treatment, and Bosutinib, a control treatment. Olverembatinib is administered every other day, while Bosutinib is given daily. The goal is to assess their effectiveness in treating CML-CP, particularly in patients previously treated with at least two tyrosine kinase inhibitors (TKIs).
Study Design: This interventional study uses a randomized, parallel assignment model without masking. It includes two parts: Part A compares Olverembatinib with Bosutinib, and Part B focuses solely on Olverembatinib for patients with the T315I mutation. The primary purpose is treatment.
Study Timeline: The study began on May 16, 2024, with a primary completion date yet to be announced. The latest update was submitted on May 29, 2025. These dates are crucial for tracking the study’s progress and potential market impact.
Market Implications: The study’s progress could significantly impact Ascentage Pharma’s stock performance and investor sentiment, especially if Olverembatinib proves effective. Success in this study could position Ascentage Pharma favorably against competitors in the CML treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.