Ascentage Gets Regulatory Clearance In The US And Europe To Conduct POLARIS-1 Trial

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(RTTNews) - Suzhou, China-based Ascentage Pharma Group International (AAPG, 6855.HK) announced that the FDA and the European Medicines Agency have given clearance to conduct a global registrational Phase III study of its lead asset Olverembatinib, dubbed POLARIS-1.

POLARIS-1 is phase III trial of Olverembatinib, in combination with chemotherapy for the treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This marks the second global registrational Phase III study of Olverembatinib that has been cleared by regulators in the US and Europe.

In China, the POLARIS-1 study was initiated in 2023, and the first dataset is expected to be presented at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting on December 6, 2025. The POLARIS-1 study is also being conducted in Australia.

Other Ongoing Olverembatinib Trials

-- In the U.S., an FDA-regulated registrational phase III trial of Olverembatinib as a monotherapy for chronic myeloid leukemia, dubbed POLARIS-2, is underway, and subject to the successful completion, a New Drug Application is planned for submission in 2026.

-- A phase III trial of Olverembatinib as a monotherapy for SDH-deficient gastrointestinal stromal tumor, dubbed POLARIS-3, is ongoing in multiple countries, with enrollment expected to be completed this year.

Olverembatinib, a next-generation tyrosine kinase inhibitor (TKI), is approved in China for treatment of patients with chronic myeloid leukemia (CML) in chronic-phase (-CP) or CML in accelerated phase (-AP) with T315I mutations, and in CML-CP that is resistant and/or intolerant to first and second-generation TKIs.

For the six months of 2025, revenue from sales of Olverembatinib in China increased 93% to US$30.3 million from US$15.5 million a year ago.

AAPG shares closed Thursday's trade at $30.70, up 1.22 %.