ASCENTAGE-B (06855) surged more than 6%, reaching HK$64.2 by the time of writing, with a trading volume of HK$19.93 million. The uptick follows the company's announcement on December 5 that its self-developed Class 1 innovative drug, olverembatinib (brand name: Nerlynx®), has received approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a global Phase III registration study (POLARIS-1, NCT06051409). The study will evaluate olverembatinib combined with chemotherapy in newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients.
As the second global Phase III registration study for Nerlynx® approved by U.S. and European regulators, POLARIS-1 will enroll patients across multiple countries and centers simultaneously, accelerating the drug's global market entry, particularly in the U.S. and Europe. Notably, the latest progress of the POLARIS-1 study will be presented at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting, marking the first public disclosure of the trial data.
Preliminary abstract data reveals that in Ph+ ALL patients treated with Nerlynx® combined with low-intensity chemotherapy, the molecular minimal residual disease (MRD) negativity rate and molecular MRD-negative complete response (CR) rate both reached approximately 65%, significantly outperforming similar overseas products under comparable conditions. The treatment also demonstrated strong efficacy in high-risk subtypes, such as patients with IKZF1plus gene mutations. Additionally, the combination therapy exhibited an excellent safety profile, with low and manageable adverse event rates.
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