2025-06-26 12:16Company Strategy & R&D Model - BeOne aims to transform cancer care globally by delivering innovative medicines faster, more equitably, and affordably[12, 16] - The company's R&D model leverages a prolific research organization, global manufacturing, efficient clinical development, and global commercial access to achieve superior R&D returns[25] - BeOne focuses on delivering high-quality innovation by designing superior molecules with exceptional profiles and halting programs that don't meet high standards; over 60 preclinical programs have been terminated in the past 3.5 years[30, 32] - The company is building a deep pipeline, aiming to deliver 8-10 highly differentiated new molecular entities (NMEs) into the clinic in each focused disease area in the next 3-6 years[42] Hematology Portfolio & CLL - BeOne is positioned to address unmet needs in CLL with a wholly-owned portfolio including BRUKINSA, sonrotoclax, and BTK CDAC[93] - BRUKINSA is the only BTKi to demonstrate PFS superiority over ibrutinib in a head-to-head Phase 3 R/R CLL trial[100] - In treatment-naive CLL/SLL patients, 60-month PFS with zanubrutinib was 72.2% in patients with del(17p), similar to 75.8% in patients without del(17p)[105] - Sonrotoclax + zanubrutinib achieved fast and deep responses in TN CLL/SLL, with 84% uMRD at week 48 in the 160mg dose group and 92% uMRD in the 320mg dose group[133] Solid Tumor Portfolio - The global CDK4/6i market is large and growing, estimated at approximately $13 billion[244] - BG-C9074 (B7-H4 ADC) demonstrated a confirmed ORR of 24% and an unconfirmed ORR of 29% among 68 efficacy-evaluable patients, with activity at 6mg/kg Q3W showing a confirmed ORR of 43% and an unconfirmed ORR of 48%[296] - BGB-58067 (PRMT5i) showed early responses at the second dose level in a Phase 1 study, with three objective responses observed in histologically distinct tumor types[331]