Ascentage Pharma Wins FDA and EMA Clearance for Global Phase III Study of Olverembatinib in Ph+ ALL
Ascentage Pharma has received FDA and EMA clearance for a global Phase III study of olverembatinib in Ph+ ALL. This approval allows patient enrollment across multiple countries, potentially accelerating olverembatinib's registration in the US and Europe.
Ascentage Pharma Group International has received clearance from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct a global registrational Phase III study (POLARIS-1; NCT06051409) of olverembatinib in combination with chemotherapy for the first-line treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This approval enables the company to enroll patients across multiple countries, accelerating the potential registration of olverembatinib in the US and European markets. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ascentage Pharma Group International published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20251205-11945433), on December 04, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
