Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (POLARIS-1) for the novel drug Orebatinib (brand name: Nairike®) in treating newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) patients, which is expected to accelerate its market entry in Europe and the US [1][2]. Group 1: Clinical Trial Details - The POLARIS-1 study is an international, multicenter, randomized, open-label Phase III clinical trial aimed at evaluating the efficacy and safety of Nairike® in combination with chemotherapy for newly diagnosed Ph+ ALL patients [1]. - The trial has received clinical trial approval from China's CDE in 2023 and has been rapidly initiated [1]. Group 2: Study Results and Efficacy - Preliminary data from the POLARIS-1 study indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response (CR) rate in patients treated with Nairike® and low-intensity chemotherapy are approximately 65%, significantly higher than similar products under the same conditions [2]. - The treatment shows promising efficacy even in high-risk subtypes, such as those with IKZF1plus gene mutations, and demonstrates excellent safety with low and manageable adverse effects [2]. Group 3: Market Position and Collaborations - Nairike® is a first-in-class oral third-generation TKI and the first third-generation BCR-ABL inhibitor approved in China, with commercialization in China managed by the company and Innovent Biologics [3]. - The drug has received multiple indications for treatment in CML resistance areas and is included in the national medical insurance drug list [3]. - The company has signed an exclusive option agreement with Takeda for the global development and commercialization rights of Nairike®, excluding certain regions in Greater China [3].