BeOne Medicines (ONC) Study update summary

Strategic vision, R&D strategy, and pipeline evolution

• Focus is on solid tumors, with a robust pipeline leveraging a unique discovery engine and global clinical development superhighway for sustained growth and innovation.

• Over 20 solid tumor assets target more than 20 oncogenic drivers, with strategic depth in breast, gynecologic, lung, and gastrointestinal cancers, covering about two-thirds of new diagnoses.

• Accelerated innovation pace with 18 NMEs in 2024–2025 and a target of 8–10 NMEs per year from 2026, supported by state-of-the-art technology platforms.

• Five solid tumor programs achieved clinical proof of concept in 2025, with three—CDK4 inhibitor, B7-H4 ADC, and GPC3x4-1BB bispecific—advancing rapidly toward pivotal development.

• The pipeline is designed for in-portfolio combinations, maximizing patient benefit and reducing reliance on single assets.

CDK4 inhibitor (BGB-43395) in breast cancer

• BGB-43395 is a selective CDK4 inhibitor with confirmed ORR of 68.4% at 240 mg and 63.2% at 400 mg in first-line HR+/HER2- metastatic breast cancer, showing deep and durable responses.

• Demonstrates a differentiated safety profile with low rates of hematologic toxicity, rare neutropenia, and manageable GI events, further improved with food.

• Safety profile enables broad combinability and supports expansion into early-stage breast cancer.

• Global Phase 3 trial (KANDELA-302) initiated in Q2 2026, directly comparing BGB-43395 plus letrozole to standard CDK4/6 inhibitors.

• Evidence generation in early-stage disease is in planning.

B7-H4 ADC (BG-C9074) in ovarian and other cancers

• BG-C9074 is a potential best-in-class ADC with high tumor selectivity, robust linker design, and strong efficacy in ovarian, endometrial, and triple-negative breast cancers.

• Confirmed ORR of 45.5% in ovarian cancer and 40% in triple-negative breast cancer, with efficacy observed across all B7-H4 expression levels.

• Safety profile is favorable, with low rates of high-grade toxicity, infrequent dose reductions, and low discontinuation rates.

• Phase 3 study in first-line ovarian cancer maintenance is planned for 4Q26, targeting patients ineligible for PARP inhibitors.

• AIBW-based dosing reduces pharmacokinetic variability and supports all-comer development.