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].

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (POLARIS-1) for the novel drug Orebatin (brand name: Nairike) in treating newly diagnosed Philadelphia chromosome-positive (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 - POLARIS-1 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: Efficacy and Safety Data - Preliminary data from the POLARIS-1 study indicates that the molecular minimal residual disease (MRD) negative rate and complete response (CR) rate for patients treated with Nairike and low-intensity chemotherapy are approximately 65%, significantly higher than similar products under comparable conditions [2]. - The safety profile of the combination treatment is favorable, with a low and manageable incidence of adverse effects [2]. Group 3: Market Context and Product Background - Ph+ ALL accounts for about 20%-30% of adult ALL cases, characterized by high relapse rates and poor prognosis, particularly in older patients [2]. - Nairike is a third-generation TKI and the first of its kind approved in China, with commercial promotion in China being jointly managed by the company and Innovent Biologics [3]. - The drug has received multiple indications for treatment in the CML resistant field and is included in the national medical insurance drug list [3].

Core Insights - The company Ayshun Pharmaceutical-B (06855) has received approval from the FDA and EMA to conduct the global Phase III clinical trial (POLARIS-1) for its novel drug Orebatinib (brand name: Nairike®) in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients [1][2] - The POLARIS-1 study is an international, multicenter, randomized, open-label Phase III trial aimed at evaluating the efficacy and safety of Nairike® combined with chemotherapy in Ph+ ALL patients [1] - Preliminary data from the POLARIS-1 study indicates a molecular minimal residual disease (MRD) negative rate and complete response (CR) rate of approximately 65% in newly diagnosed Ph+ ALL patients treated with Nairike® and low-intensity chemotherapy, showing significant improvement compared to similar products [2] Company Developments - 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 Ayshun Pharmaceutical 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 in China [3] - Ayshun Pharmaceutical signed an exclusive option agreement with Takeda regarding Orebatinib, granting Takeda global development and commercialization rights, excluding certain regions in Greater China [3]