Daiichi Sankyo Company (4568) Status Update summary

Strategic R&D and Pipeline Progress

• Focus on expanding and extending DXd ADC indications in breast and lung cancer, with ongoing trials in earlier therapy lines and other cancer types.

• DESTINY-Breast06 met its primary endpoint in HER2-low and ultra-low breast cancer, supporting ENHERTU's efficacy, with regulatory submissions and reviews underway in major markets.

• Dato-DXd program pivots to EGFR-mutated NSCLC after TROPION-Lung01 withdrawal, with breakthrough therapy designation for TROPION-Lung05 and pooled analysis supporting robust efficacy and manageable safety.

• Multiple pivotal trials in breast and lung cancer to read out in 2025, including DESTINY-Breast09, -05, -11, and TROPION-Breast02.

• New assets and next-generation ADCs, including DS-3939, DS-2243, and DS-9606, are advancing in preclinical and early clinical development.

Clinical Data, Safety, and Biomarker Innovation

• DESTINY-Breast06, -08, and pooled analyses show robust efficacy and safety for ENHERTU, including in brain metastases and combination regimens.

• Dato-DXd demonstrates strong activity in heavily pretreated EGFR-mutated NSCLC, with a 43% response rate and manageable safety profile.

• Dato-DXd pooled analysis shows low incidence of drug-related ILD, with most cases being low grade and manageable.

• ENHERTU and Dato-DXd maintain safety profiles consistent with previous reports, with no new safety signals identified.

• Advanced digital and computational pathology (QCS-NMR, QCS for TROP2) enhances patient selection and supports biomarker-driven trials.

Manufacturing, Supply Chain, and Technology Initiatives

• Technology Unit integrates biologics, pharmaceutical tech, and supply chain for end-to-end ADC manufacturing, with over 4,000 employees across five regions.

• Five DXd ADCs identified as key growth drivers, with peak demand forecasted at over 50 million vials annually.

• Capital investments of ~JPY 600 billion planned globally to expand in-house and CMO capacity.

• Multiple manufacturing and supply routes established, balancing in-house and CMO production to mitigate risks and ensure stable global supply.

• Ongoing training, productivity improvements, and scale-up initiatives support ADC growth and process innovation.