Highlights

  • US FDA and EMA cleared a global Phase III study in first-line Ph+ ALL.
  • POLARIS-1 trial evaluates olverembatinib combined with chemotherapy in newly diagnosed patients.
  • China’s Center for Drug Evaluation cleared the POLARIS-1 study prior to global authorization.

Ascentage Pharma Group International (NASDAQ:AAPG) announced that regulators in both the United States and Europe have cleared its global registrational Phase III clinical trial of olverembatinib for the first-line treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study, known as POLARIS-1 (NCT06051409), received authorization from the US Food and Drug Administration and the European Medicines Agency, enabling enrollment across multiple international trial sites.

POLARIS-1 represents the second global registrational Phase III program for olverembatinib that has been approved by regulators in the US and Europe. The trial is intended to support potential international registration, with a focus on accelerating development timelines in major markets.

Trial Design and Geographic Scope

POLARIS-1 is a multicenter, randomized, open-label Phase III study assessing the efficacy and safety of olverembatinib administered in combination with chemotherapy in patients newly diagnosed with Ph+ ALL. The study was also initiated in China following clearance by the China Center for Drug Evaluation in 2023, making it a truly multinational clinical effort spanning Asia, Europe, and North America.

Early Data and ASH 2025 Presentation
The trial is scheduled to release its first dataset at the 2025 American Society of Hematology Annual Meeting. According to the published ASH abstract, treatment-naïve Ph+ ALL patients receiving olverembatinib with low-intensity chemotherapy achieved minimal residual disease negativity and molecular MRD-negative complete response rates of roughly 65% after three cycles of treatment.

The data also indicated clinical activity in patients with higher-risk genetic subtypes, including those with IKZF1plus mutations. Reported safety findings showed a low incidence of adverse events, most of which were considered manageable within the study setting.

Disease Context and Therapeutic Background
Ph+ ALL accounts for approximately 20% to 30% of adult acute lymphoblastic leukemia cases and is more frequently observed in older patients. The disease has historically been associated with high relapse rates and limited long-term survival outcomes. While tyrosine kinase inhibitors have changed treatment approaches, earlier-generation TKIs carry treatment limitations.

Olverembatinib is an oral, third-generation BCR-ABL inhibitor developed by Ascentage Pharma and is approved in China for several drug-resistant chronic myeloid leukemia indications. The drug remains investigational in the US and Europe.

Broader Development Pipeline
Beyond Ph+ ALL, Ascentage Pharma is conducting multiple global Phase III studies across hematologic malignancies, including trials of olverembatinib in chronic myeloid leukemia and lisaftoclax in several blood cancer indications.

Share Performance

The stock closed at USD 30.70 on 4 December 2025, recording a gain of 1.22% for the day. It opened at USD 30.88, touched a high of USD 31.48 and a low of USD 30.68 during the session. The company has a market capitalisation of HKD 2.33 KCr. The 52-week high stands at USD 48.45, while the 52-week low is USD 16.50.