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 Olverembatinib (brand name: Nilotinib) in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive (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 registration Phase III trial for Nilotinib approved by regulatory agencies in Europe and the U.S. [1] - The trial will enroll patients across multiple countries and centers, accelerating the market entry of Nilotinib, particularly in Europe and the U.S. [1] - The latest data from the POLARIS-1 study will be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of this data [2] Group 2 - Preliminary results indicate that the molecular minimal residual disease (MRD) negative rate and complete response (CR) rate for patients treated with Nilotinib and low-intensity chemotherapy are around 65%, significantly higher than similar products under the same conditions [2] - The treatment has shown effective results even in high-risk subtypes, such as those with IKZF1plus gene mutations [2] - The safety profile of the combination therapy is favorable, with a low and manageable incidence of side 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