医药生物行业周报：BTK抑制剂市场竞争格局持续变化

Investment Rating - The industry investment rating is maintained as "Add" for the pharmaceutical and biotechnology sector [5]. Core Viewpoints - The competitive landscape of the BTK inhibitor market is continuously changing, with BeiGene's Zanubrutinib rapidly approaching a leading market share position in the U.S. market. In 2024, BeiGene reported product revenue of 26.994 billion yuan, a significant increase from 15.504 billion yuan in the previous year, primarily driven by sales growth of Zanubrutinib and other licensed products [2][12]. - Zanubrutinib's global sales in 2024 reached 18.859 billion yuan, reflecting a growth of 106.4%. U.S. sales accounted for 13.890 billion yuan, also up by 107.5%, largely due to expanded use in CLL indications. In Europe, sales were 2.564 billion yuan, a 195.4% increase, while in China, sales reached 1.856 billion yuan, growing by 35.2% [2][12]. - The company expects revenue for 2025 to be between 35.2 billion and 38.1 billion yuan, driven by Zanubrutinib's leading position in the U.S. and ongoing expansion in Europe and other key global markets [2][12]. Market Review - During the week of February 24 to February 28, 2025, the A-share pharmaceutical and biotechnology sector fell by 2.72%, underperforming the CSI 300 index by 0.49 percentage points, while outperforming the ChiNext index by 1.74 percentage points. The sector ranked 23rd among 31 first-level sub-industries [1][17]. - The Hang Seng Healthcare Index decreased by 3.22%, underperforming the Hang Seng Index by 0.93 percentage points, ranking 8th among 12 first-level sub-industries [1][17]. Company Dynamics - BeiGene's Zanubrutinib ranked first in prescription volume among new CLL patients in the U.S., achieving a 97% year-on-year revenue growth in Q4 2024, surpassing competitors Ibrutinib and Acalabrutinib [3][13]. - Another domestic BTK inhibitor, Orelabrutinib from Innovent Biologics, received CDE approval for a Phase III clinical trial in combination with a BCL-2 inhibitor for first-line CLL/SLL treatment. The company also reached an agreement with the FDA regarding the clinical development of Orelabrutinib for MS [3][15]. Investment Recommendations - BTK inhibitors demonstrate significant advantages in treating B-cell malignancies and certain B-cell immune disorders, making them a hot target for blood malignancies and autoimmune diseases. Companies to watch include BeiGene and Innovent Biologics [4][16].