HK Stock Market Move | ASCENTAGE-B(06855) rose by more than 6%, NEIK POLARIS-1 study receives approval from the US FDA and European EMA.

ASCENTAGE-B (06855) rose more than 6%, as of press time, up 5.67% to HK$64.2, with a turnover of HK$199.331 million. On the news front, on December 5th, ASCENTAGE-B announced that the company's original drug Osimertinib (trade name: Ntim) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) patients has received approval from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct a global Phase III clinical trial (POLARIS-1, NCT06051409). As the second global Phase III study of Ntim approved by regulatory agencies in Europe and the United States, the POLARIS-1 study will be conducted simultaneously in multiple countries and centers, accelerating the global launch process of Ntim, especially in the European and American markets. It is worth mentioning that the latest developments in the POLARIS-1 study will also be presented at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting, marking the first public announcement of the study data. The abstract data disclosed so far shows that in initial Ph+ ALL patients treated with Ntim in combination with low-intensity chemotherapy, the rates of three-cycle molecular MRD (minimal residual disease) negativity and molecular MRD-negative complete remission (CR) can reach around 65%, a significant improvement in efficacy compared to similar products abroad under the same conditions; even some high-risk subtypes such as patients carrying the IKZF1plus gene mutation have shown good efficacy. In addition, the safety profile of this combination regimen is excellent, with low and manageable rates of side effects.