Group 1 - The stock of Ascentage Pharma-B (06855) opened over 4% higher, reaching a historical high of 90 HKD, with a trading volume of 16.89 million HKD [1] - The company announced that its self-developed Bcl-2 selective inhibitor, Lisatoclax (brand name: Lifespan; R&D code: APG-2575), has received approval from the FDA and EMA to conduct a global Phase III clinical trial (GLORA-4) for the treatment of newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients [1] - GLORA-4 is the second global Phase III study for Lisatoclax approved by regulatory agencies in Europe and the US, which will accelerate the new drug's market entry process [1] Group 2 - Lisatoclax is a novel oral Bcl-2 selective inhibitor developed by Ascentage Pharma, which selectively inhibits the Bcl-2 protein to restore the normal apoptosis process of cancer cells, thereby treating tumors [2] - The product has already been approved for marketing in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least one systemic treatment including a Bruton tyrosine kinase (BTK) inhibitor [2] - Lisatoclax is the first domestically developed original Bcl-2 inhibitor approved for marketing in China and is currently the only Bcl-2 inhibitor advancing to a Phase III clinical trial for high-risk MDS internationally [2]
港股异动 | 亚盛医药-B(06855)高开逾4% 利生妥治疗中高危MDS III期临床研究获美国FDA和欧洲EMA批准