Company Overview - CICC maintains a "outperform" rating and a target price of HKD 89 for Ascentage Pharma-B (06855), highlighting positive recent R&D progress [1] - The global Phase III study (POLARIS-1) of Olverembatinib (耐立克) for first-line treatment of Ph+ ALL has received approval from both the FDA and EMA [2] - The company is set to present multiple data points at the 2025 American Society of Hematology (ASH) annual meeting, including domestic Phase II clinical data for APG-2575 and initial results from POLARIS-1 [2] R&D Progress - POLARIS-1 data shows that as of July 18, 2025, 94.3% of 53 first-line Ph+ ALL patients achieved CR/CRi within three months, with best MRD negative rates at 66.0% and MRD negative CR rates at 64.2% [2] - The company views Olverembatinib as its first commercial product, with steady expansion of indications and promising data readouts [2] APG-2575 Efficacy - APG-2575 demonstrated a 62.5% overall response rate (ORR) in 72 R/R CLL/SLL patients, with a median progression-free survival (mPFS) of 23.89 months and 21.8% achieving MRD negativity [3] - Notably, nearly half of the patient population had complex chromosomal abnormalities, indicating a higher risk profile and underscoring the drug's efficacy potential [3] Combination Therapy Data - The combination of APG-2575 and Azacitidine showed an ORR of 40.4% in 47 R/R AML/MPAL patients, with a complete response (CR) rate of 29.8% and mPFS of 7.6 months [4] - In 15 newly diagnosed high-risk MDS/CMML patients, the ORR was 80.0%, with CR and bone marrow CR rates at 40%, although mPFS was not reached [4]
中金:维持亚盛医药-B“跑赢行业”评级 POLARIS-1欧美获批