Company Overview - CICC maintains a "outperform" rating and a target price of HKD 89 for Ascentage Pharma-B (06855), citing positive recent R&D progress [1] - The global Phase III study (POLARIS-1) for Nilotinib (Orelabrutinib) as a first-line treatment for Ph+ ALL has received approval from both the FDA and EMA [1][2] - The company plans to present multiple data points for three products at the 2025 American Society of Hematology (ASH) annual meeting, including oral reports on APG-2575's domestic Phase II registration clinical data and the first readout of POLARIS-1 data [1] POLARIS-1 Study Results - The POLARIS-1 study shows promising initial data, with 94.3% of 53 first-line Ph+ ALL patients achieving complete response (CR) or complete response with incomplete blood count recovery (CRi) within three months [2] - The best minimal residual disease (MRD) negative rate and MRD negative CR rate were reported at 66.0% and 64.2%, respectively [2] APG-2575 Efficacy in High-Risk Populations - APG-2575 demonstrated a 62.5% overall response rate (ORR) in 72 patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), with a median progression-free survival (mPFS) of 23.89 months [3] - Notably, nearly half of the patient population had complex chromosomal abnormalities, indicating a higher risk profile, which underscores the drug's potential efficacy [3] Combination Therapy Data - The combination of APG-2575 and Azacitidine showed an ORR of 40.4% in 47 patients with R/R acute myeloid leukemia/mixed phenotype acute leukemia (AML/MPAL), with a complete response (CR) rate of 29.8% and mPFS of 7.6 months [4] - In 15 patients with newly diagnosed high-risk myelodysplastic syndromes/chronic myelomonocytic leukemia (MDS/CMML), the ORR was 80.0%, with CR and bone marrow CR rates of 40% [4]
中金:维持亚盛医药-B(06855)“跑赢行业”评级 POLARIS-1欧美获批