Investment Rating - The report assigns an "Outperform" rating for BeiGene, indicating an expected total return over the next 12-18 months that exceeds the relevant market benchmark by more than 10% [16]. Core Insights - In Q3 2025, BeiGene achieved revenue of USD 1.4 billion, a year-on-year increase of 41%, and a quarter-on-quarter increase of 7.7% from USD 1.3 billion in Q2 2025. The U.S. market contributed USD 743 million, reflecting an 8.5% increase from the previous quarter. GAAP operating profit was USD 163 million, up 73.4% quarter-on-quarter [5][6]. - Management has updated its full-year guidance for 2025, projecting total revenue between USD 5.1 billion and USD 5.3 billion, with GAAP operating expenses expected to be between USD 4.1 billion and USD 4.3 billion [5][6]. Revenue Breakdown - Global revenue for Zanubrutinib reached USD 1.0 billion, representing a 51% year-on-year increase and a 5.3% quarter-on-quarter increase. In the U.S., revenue was USD 740 million, up 47% year-on-year and 8% quarter-on-quarter. European revenue was USD 160 million, a 68% year-on-year increase and an 8.7% quarter-on-quarter increase [2][6]. - Tislelizumab revenue in Q3 2025 was USD 190 million, reflecting a 17% year-on-year increase but a slight decline of 1.5% quarter-on-quarter [6]. Clinical Development Progress - Sonrotoclax (BCL2 inhibitor) received Breakthrough Therapy Designation for RR MCL, and patient enrollment for a potential registrational Phase 2 study in RR WM has been completed [7]. - BGB-16673 (BTK CDAC) has initiated a global Phase 3 trial against pirtobrutinib in R/R CLL, with patient enrollment currently underway [7]. - BGB-45035 (IRAK4 CDAC) has started a Phase 2 trial for moderate-to-severe rheumatoid arthritis, with patient enrollment initiated [7]. Expected R&D Milestones - BGB-43395 (CDK4 inhibitor) plans to initiate a Phase 3 trial in 1L HR+/HER2- breast cancer in H1 2026 [8]. - BGB-16673 (BTK CDAC) expects data readout in R/R CLL in H1 2026 to support an accelerated approval application [8]. - Sonrotoclax plans to initiate patient enrollment for a Phase 3 trial combining with BTK inhibitor versus acalabrutinib + venetoclax in H1 2026, and a Phase 3 trial in multiple myeloma in H2 2026 [8].
百济神州（06160）：三季度业绩：泽布替尼销售稳健增长，管理层上调全年指引