Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (GLORA-4) for the Bcl-2 selective inhibitor, lisatoclax (brand name: Lishengtuo), in combination with azacitidine (AZA) for treating newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients, marking a significant milestone in the drug's global clinical development [1][2]. Company Summary - As of the announcement date, lisatoclax is the only Bcl-2 inhibitor advancing to a Phase III clinical trial for high-risk MDS globally, indicating its unique position in the market [1]. - The drug has already been approved in China for use in adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one prior systemic therapy, making it the first domestically developed Bcl-2 inhibitor approved in China [3]. Industry Summary - The GLORA-4 study is an international, multicenter, randomized, double-blind Phase III trial aimed at evaluating the efficacy and safety of lisatoclax combined with AZA compared to placebo plus AZA in newly diagnosed adult HR-MDS patients [2]. - MDS is characterized by significant age-related features, with an incidence rate that increases exponentially with age, particularly affecting individuals over 65 years, where the annual incidence rate reaches 22 per 100,000 [2]. - The core risk of MDS lies in the clonal evolution leading to acute myeloid leukemia (AML) transformation, with a 5-year transformation rate of 40-60% for high-risk patients, resulting in a median survival of less than 6 months post-transformation [2]. - Current first-line treatments for high-risk MDS, such as hypomethylating agents (HMAs), show a total response rate of only 30-40% and a complete response rate of 10-17%, highlighting the urgent need for breakthrough therapies [3]. - Recent data from the 2024 American Society of Hematology (ASH) annual meeting and the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicate that lisatoclax combined with AZA achieved an overall response rate of 75% in treatment-naive MDS, significantly outperforming HMAs [4].