On January 31, 2025, Daiichi Sankyo released its performance report for the first three quarters of the 2024 fiscal year (April 2024 - March 2025). Total revenue was ¥1,367.6 billion (approximately $9.07 billion, calculated using the 2024 average exchange rate of ¥100 = $0.66323), representing a 16.6% year-over-year increase. If calculated based on the natural year (January 2024 - December 2024), Daiichi Sankyo’s total revenue for 2024 reached ¥1,796.0 billion (approximately $11.91 billion).
Among this, Daiichi Sankyo's flagship product, Enhertu (trastuzumab deruxtecan), achieved global sales of ¥404.4 billion (approximately $2.68 billion) in the first three quarters of the 2024 fiscal year. According to further investigation, Enhertu's sales in Q1 of 2024 (the fourth quarter of fiscal year 2023) amounted to ¥119.9 billion. Therefore, based on the natural year calculation, Enhertu's global sales for 2024 reached ¥524.3 billion (approximately $3.48 billion), marking a 52.5% increase compared to 2023 (¥343.8 billion). In China, Enhertu's sales for 2024 amounted to ¥9.3 billion (approximately $62 million).
In the 2024 fiscal year, Enhertu experienced double-digit growth in both second-line treatment for HER2-positive breast cancer and HER2-low expressing breast cancer indications. In the U.S., Europe, and Japan, Enhertu maintained the leading market share in new patient share across all indications.
In China, Enhertu has also been conditionally approved for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior treatment regimens, as well as for adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations and who have received at least one prior systemic therapy, further expanding its indications.
Recently, Daiichi Sankyo also welcomed its second approved ADC product, the Trop2 ADC drug Datroway (Dato-DXd). This drug has been approved in Japan and the U.S. for the treatment of adult patients with HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have previously received chemotherapy and endocrine therapy.
Daiichi Sankyo and AstraZeneca voluntarily withdrew the previously submitted FDA application for the non-squamous NSCLC indication of Dato-DXd, resubmitting a Biologics License Application (BLA) for Dato-DXd in the treatment of adult patients with EGFR mutation-positive, locally advanced or metastatic NSCLC who have received prior systemic treatment (including EGFR-targeted therapies). This drug is expected to become a treatment option for NSCLC patients resistant to EGFR-TKIs.
Additionally, Daiichi Sankyo's HER3 ADC new drug, Patritumab Deruxtecan, for the treatment of EGFR mutation-positive NSCLC, has received a Complete Response Letter from the FDA due to third-party production issues. Once Daiichi Sankyo resolves these issues, the drug still has a chance for future approval and market entry.