Core Viewpoint - Ascentage Pharma-B (06855) has seen a stock price increase of over 6%, currently trading at 64.2 HKD, following the announcement of the global Phase III clinical trial POLARIS-1 for its novel drug Olverembatinib (brand name: Nilotinib) in treating newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) patients, which has received approval from both the FDA and EMA [1][2] Group 1 - The POLARIS-1 study is the second global Phase III trial for Nilotinib approved by major regulatory agencies in Europe and the U.S., which will expedite its market entry, particularly in Europe and the U.S. [1] - The study will present its latest findings at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of the data [2] - Preliminary data indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response rate for patients treated with Nilotinib combined with low-intensity chemotherapy are around 65%, significantly outperforming similar products under comparable conditions [2] Group 2 - The treatment has shown promising efficacy even in high-risk subtypes, such as those with IKZF1plus gene mutations, demonstrating good therapeutic outcomes [2] - The safety profile of the combination therapy is favorable, with a low and manageable incidence of adverse effects [2]
港股异动 | 亚盛医药-B(06855)涨超6% 耐立克®POLARIS-1研究获美国FDA和欧洲EMA批准