Company Updates - The company announced that the global registration Phase III study POLARIS-1 for Narlik (Orelabrutinib) in 1L treatment of Ph+ ALL has received approval from the US FDA and European EMA [1] - The company will present multiple data sets for three products at the 2025 American Society of Hematology (ASH) annual meeting in December, including oral reports on domestic Phase II registration clinical data for Lisengrat (APG-2575) and the first readout of POLARIS-1 data [1] Clinical Data Highlights - POLARIS-1 has become the second global registration Phase III study for Narlik approved in Europe and the US, with preliminary data showing that as of July 18, 2025, 94.3% of 53 1L Ph+ ALL patients achieved CR/CRi within three months, with best MRD negative rates and MRD negative CR rates at 66.0% and 64.2% respectively [1] - Lisengrat demonstrated good efficacy in a high-risk population for R/R CLL/SLL, with an ORR of 62.5% and mPFS of 23.89 months as of July 25, 2025, with 21.8% achieving MRD negativity [2] - The combination of Lisengrat and Azacitidine in R/R AML/MPAL patients showed an ORR of 40.4% and CR of 29.8%, while in newly diagnosed high-risk MDS/CMML patients, the ORR was 80.0% [2] Financial Forecast and Valuation - The company maintains its net profit forecast for 2025 and 2026 at -1.09 billion and -0.30 billion respectively, and continues to outperform the industry model [2] - Based on DCF valuation, the target price is maintained at 89 HKD, indicating a potential upside of 56.3% from the current stock price [2]
亚盛医药-B(06855.HK)：POLARIS-1欧美获批 利生妥注册临床数据读出