Core Viewpoint - The recent approval of the second global Phase III clinical trial for the drug Lisatoclax (brand name: Lishengtuo®) has led to a significant increase in the stock price of Ascentage Pharma-B (06855), reaching a new high of 95.35 HKD, with a year-to-date increase of 100.88% [1][2]. Group 1: Clinical Development - The GLORA-4 study, which is a global Phase III clinical trial for Lisatoclax in combination with Azacitidine (AZA) for newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients, has received approval from the FDA and EMA [1][2]. - This study is notable as it is the only ongoing Phase III clinical trial for a Bcl-2 inhibitor in the high-risk MDS category, aiming to address a significant clinical gap in this area [2]. - The trial is designed as an international, multi-center, randomized, double-blind study to evaluate the efficacy and safety of Lisatoclax combined with AZA compared to placebo plus AZA in adult HR-MDS patients [2]. Group 2: Disease Context - Myelodysplastic syndromes (MDS) are characterized by a significant age-related incidence, with a rate of 22 per 100,000 in individuals over 65 years old, and a median diagnosis age of 70 years [3]. - The transformation rate to acute myeloid leukemia (AML) in high-risk MDS patients is alarmingly high, with a 5-year transformation rate of 40-60%, leading to poor prognosis [3]. - Current first-line treatments for high-risk MDS, such as demethylating agents, show limited efficacy, with overall response rates of only 30-40% and complete response rates of 10-17% [3]. Group 3: Drug Profile - Lisatoclax is a novel oral Bcl-2 selective inhibitor developed by Ascentage Pharma, designed to restore normal apoptosis in cancer cells [4]. - The drug has already been approved in China for use in adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone prior systemic therapy [4]. - Preliminary data from the 2024 American Society of Hematology (ASH) and 2025 American Society of Clinical Oncology (ASCO) meetings indicate that Lisatoclax combined with AZA achieves an overall response rate of 75% in treatment-naive MDS, significantly outperforming existing therapies [4]. Group 4: Market Potential - The approval of the GLORA-4 study is expected to accelerate the clinical development and registration process for Lisatoclax in MDS indications, addressing a substantial unmet clinical need in the market [5][6]. - The company aims to position Lisatoclax as the first targeted therapy approved for first-line treatment of high-risk MDS patients, potentially reshaping the treatment landscape in this area [5][6].
亚盛医药-B(06855)股价翻倍再创上市新高，利生妥®全球临床开发持续发力