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亚盛医药-B(06855)将在2026年美国癌症研究协会年会上公布四项最新临床前进展
智通财经网· 2026-03-18 00:21
Core Viewpoint - Ascentage Pharma-B (06855) announced that four preclinical research advancements will be presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting, scheduled from April 17 to April 22, 2026, in San Diego, California [1] Group 1: Company Developments - The data to be showcased involves three products: the original first-in-class BCR-ABL inhibitor Olverembatinib (brand name: Nilotinib; research code: HQP1351), the FAK/ALK/ROS1 triple tyrosine kinase inhibitor APG-2449, and the EED inhibitor APG-5918 [1] - The AACR Annual Meeting serves as a significant platform for advancing anti-tumor initiatives, bringing together scientists, clinicians, healthcare professionals, cancer survivors, patients, and advocates to share and discuss the latest breakthroughs in cancer research [1] Group 2: Industry Context - The AACR Annual Meeting comprehensively showcases cutting-edge cancer science and medical achievements, covering areas from population science and prevention to cancer biology, translational medicine, clinical research, and survivor care and advocacy [1]
亚盛医药-B(06855)耐立克一线治疗Ph+ ALL的全球注册III期临床研究获美国FDA和欧洲EMA批准
智通财经网· 2025-12-05 00:24
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].