Core Insights - The 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 on August 18, with a year-to-date increase of 100.88% [1][2] Company Developments - Ascentage Pharma announced that the global Phase III clinical study (GLORA-4) 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] - The GLORA-4 study is a multi-center, randomized, double-blind trial aimed at evaluating the efficacy and safety of Lisatoclax combined with AZA compared to placebo plus AZA in adult HR-MDS patients [2][3] - The study has already commenced patient enrollment globally, with the first patients enrolled in China and Europe [2] Market Context - MDS is characterized by a significant age-related incidence, with a yearly incidence rate of 22 per 100,000 in individuals over 65 years old, and a median diagnosis age of 70 years [2] - 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% [2][3] Product Efficacy - Lisatoclax is a novel oral Bcl-2 selective inhibitor that restores normal apoptosis in cancer cells, showing promising clinical benefits in previous studies [3][4] - In preliminary studies presented at major conferences, Lisatoclax combined with AZA achieved an overall response rate (ORR) of 75% in treatment-naive MDS patients, significantly higher than existing therapies [4][5] Future Prospects - The successful execution of the GLORA-4 study is expected to accelerate the clinical development and registration process for Lisatoclax in MDS indications [6] - The company aims to address unmet clinical needs globally, with hopes that Lisatoclax will become the first approved targeted therapy for first-line treatment of high-risk MDS patients [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