Core Viewpoint - Ascentage Pharma-B (06855) saw a stock increase of over 6%, currently trading at 64.2 HKD with a transaction volume of 19.93 million HKD, following the announcement of the global registration Phase III clinical trial POLARIS-1 for its novel drug Olverembatin (brand name: Nairik) in treating newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which received approval from both the FDA and EMA [1][2]. Group 1 - The POLARIS-1 study is the second global registration Phase III trial for Nairik approved by regulatory agencies in Europe and the US, which will expedite its market entry, particularly in Europe and the US [1]. - The POLARIS-1 study's latest progress will be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of the study data [2]. - Preliminary data from the study indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response (CR) rate for patients treated with Nairik combined with low-intensity chemotherapy reached approximately 65%, significantly outperforming similar products under comparable conditions [2]. Group 2 - The treatment regimen demonstrated excellent safety profiles, with a low and manageable incidence of side effects, even for high-risk subtypes such as those carrying the IKZF1plus gene mutation [2].
亚盛医药-B涨超6% 耐立克 POLARIS-1研究获美国FDA和欧洲EMA批准