Core Insights - The company Ascentage Pharma-B (06855.HK) announced that its self-developed Bcl-2 selective inhibitor, Lisatoclax (brand name: Lifespan®; research code: APG-2575), has received approval from the FDA and EMA to initiate a global Phase III clinical trial (GLORA-4) for the treatment of newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients [1] Group 1 - The GLORA-4 study is the second global Phase III trial for Lifespan® approved by regulatory agencies in Europe and the United States [1] - The trial will enroll patients simultaneously across multiple countries and centers, which is expected to accelerate the drug's market launch process [1] - As of the announcement date, Lifespan® is the only Bcl-2 inhibitor in the world advancing to a Phase III clinical trial for high-risk MDS [1] Group 2 - The GLORA-4 study is anticipated to address a long-standing clinical gap in the high-risk MDS field, marking another significant milestone in the global clinical development of Lifespan® [1] - Following the announcement, Ascentage Pharma's stock rose by 9.18%, reaching HKD 94 [1]
亚盛医药-B:涨逾9% 利生妥治疗中高危MDS的III期临床研究获美国FDA和欧洲EMA批准