Daiichi Sankyo Company (4568) Status Update summary

Oncology pipeline and clinical achievements

• Significant expansion of the oncology pipeline and product portfolio, driven by strategic alliances and internal R&D, with multiple phase III successes and new approvals for key ADCs, especially Enhertu and Datroway.

• Enhertu approved for six indications, including recent first-line HER2-positive metastatic and early-stage breast cancer, with three positive phase III datasets announced this year.

• Datroway achieved a second indication post-launch, with positive data in triple-negative breast cancer and over 10 phase III trials ongoing; showed a 5-month improvement in both median overall and progression-free survival in 1L metastatic TNBC.

• I-DXd and R-DXd showed favorable efficacy and safety in phase II, with ongoing regulatory discussions and expansion into new cancer types.

• HER3-DXd and DS-3939 advancing in solid tumors, with DS-3790 entering clinical trials for hematological malignancies.

Growth catalysts and commercial performance

• Enhertu has become the standard of care in multiple indications, achieving rapid market share leadership and benefiting 194,000 patients globally, with FY2024 revenue of ¥552.8B and strong growth in the US and EU.

• Global net sales for Enhertu reached JPY 163.2 billion in Q2 FY2025, up 24% from the previous year, with the U.S. leading growth.

• Datroway global net sales exceeded ¥10B in Q2 FY2025, with rapid adoption in the US and Japan and EMA approval in April 2025.

• Multiple new growth catalysts expected through 2030, including new indications for Enhertu and Dato-DXd, and pivotal trial readouts across four ADCs.

• The company anticipates a continuous stream of launches and aims to become a top-10 global oncology leader by 2030.

Manufacturing and supply chain strategy

• Rapidly expanding global manufacturing and supply systems for five DXd ADCs, with capital investments to enhance production capacity and ensure stable supply.

• Multiple manufacturing sites established or planned in Japan, Germany, China, and the U.S., with a balanced approach between in-house and CMO production.

• Integrated manufacturing systems and local production strategies aim to reduce lead times and increase flexibility.

• Integrated organizational structure and talent development programs established to support rapid growth and operational efficiency.