20231214-招银国际-ASH_takeaways__Three_synergistic_haematology_BIC_FIC_molecules_showing_promising_data_7页_1mb

BeiGene (BGNE US) Update: Key Hematology Findings from ASH Presentation

• Zanubrutinib: Continues to demonstrate superiority over ibrutinib, with a 36-month PFS rate of 64.9% vs. 54.8% (HR=0.68, p=0.001). At 48 months, the CR/CRi rate improved to 10.4% in zanubrutinib arm vs. 7.1% with ibrutinib. OS rates were numerically better but not statistically significant due to long-term patient survival. Benefits for acalabrutinib-intolerant patients and those switching from ibrutinib, potentially boosting global market share.

• Sonrotoclax (BCL2 inhibitor): In combination with zanubrutinib (S+Z), achieved high blood uMRD rates: 78% by week 24 and 100% by week 48 in TN CLL patients. Superior to venetoclax-based regimens at earlier timepoints. S+Z also shown to be well-tolerated with lower safety issues, supporting it as a potential first-line treatment. A Ph3 trial to compare S+Z vs venetoclax will evaluate PFS benefit.

• BTK-CDAC (BGB11673): Designed to overcome BTK inhibitor resistance mutations. In a Ph1 study, 57% overall response rate in heavily pre-treated patients with B-cell malignancies. Plans for pivotal trials in 2024 for relapsed/refractory MCL and CLL.

• Analyst Recommendation and Valuation: Maintain BUY rating with unchanged target price US$295.67 (64.6% upside from current price US$179.58). Financial projections show revenue growth from US$1.1 billion in 2021A to US$4.8 billion by 2025E, though net loss is expected to persist until later years. Key drugs like S+Z combo may drive future income.

Key Points: Analyst highlights BeiGene's potential in hematology oncology, with strong clinical data supporting drug candidates that could expand market share, but notes risks in financial and competitive landscapes.